What is Act No. 373 / 2011 Coll.?

Act No. 373 / 2011 Coll., on Specific Health Services — Law on Specific Health Services.

When it became Act No. 373 / 2011 Coll. effectiveness?

Act No. 373 / 2011 Coll. became effective 01.04.2012.

Is Act No. 373 / 2011 Coll. still valid?

Yes, Act No. 373 / 2011 Coll. is still valid and effective.

How many times was it Act No. 373 / 2011 Coll. amended?

Act No. 373 / 2011 Coll. has 23 time versions of the text.

Act No. 373 / 2011 Coll. - Law on Specific Health Services

373

THE LAW

of 6 November 2011

on specific health services

Parliament has decided on this law of the Czech Republic:

HLAVA I

GENERAL PROVISIONS

Basic provisions

§ 1

This law

(a) regulate the provision of specific health services and the associated exercise of public administration, the rights and obligations of patients and providers of health services (the provider) and the rights and obligations of other legal and natural persons in connection with the provision of specific health services;

(b) it shall incorporate the relevant provisions of the European Union1), lay down general principles for the radiation protection of persons in the context of medical radiation, a regime for the implementation of radiological procedures and activities involving medical exposure and the degree of responsibility of providers and health professionals in relation to such procedures and activities, and lay down measures to ensure safety and health at work.

§ 2

(1) Specific health services are health services provided under this Act.

(2) The provisions of the Health Services Act shall apply in relation to the provision of specific health services, unless otherwise provided for in that Act.

HLAVA II

HEALTH SERVICES PROVIDED UNDER SPECIFIC CONDITIONS

Díl 1

Acquired reproduction

§ 3

(1) Aimed reproduction means the methods and procedures by which germ cells are collected, handled, produced by human embryo by fertilisation of an egg of sperm outside the body of a woman, handled, including storage, of human embryos, for the purpose of artificial fertilisation of a woman

(a) for health reasons in the treatment of its infertility or infertility, if:

1. it is unlikely or completely excluded for a woman to become pregnant in a natural way or to have a viable foetus; and

2. other treatments for her infertility or infertility have not led to or with a high degree of probability lead to her pregnancy; or

(b) as regards the need for an early genetic examination of the human embryo where the health of the future child is at risk because of the demonstrable risk of transmission of genetically conditioned diseases or defects borne by that woman or man.

(2) Germ cells are ova and sperm for assisted reproduction purposes.

(3) Artificial insemination of a woman means:

(a) the introduction of sperm into the female sex organs; or

(b) the transfer of a human embryo resulting from fertilisation of a sperm egg outside the body of a woman to the female's sex organs.

(4) For artificial insemination of a woman can be used

(a) ova obtained from this woman (2);

(b) sperm obtained from a man (2) which undergoes fertility treatment with a woman together,

(c) germ cells donated by a person (2) other than those referred to in (a) and (b) ("anonymous donor"); an anonymous donor may only be a woman who has completed the age of 18 and has not exceeded the age of 35, or a man who has completed the age of 18 and has not exceeded the age of 40.

(5) Germ cells and human embryos can only be used for artificial insemination. This does not apply if human embryos are not used for artificial insemination that can be used for human stem embryonic cell research under the conditions and for the purposes laid down by the Act governing human stem embryonic cell research (3).

§ 4

The treatment of assisted reproduction methods may only be carried out by a provider authorised to provide health services in the field of reproductive medicine or in the case of artificial insemination in accordance with § 3 (3) (a) in the field of gyno and obstetrics.

§ 5

(1) The methods and procedures of assisted reproduction may be implemented if the requirements laid down in the Human Tissue and Cell Act (2) have been met.

(2) The use of assisted reproduction methods and procedures shall not be permitted for the purposes of the choice of the sex of the future child, except in cases where the use of assisted reproduction methods and procedures can be avoided by serious genetically modified diseases linked to sex.

§ 6

(1) Artificial insemination may be carried out on a woman of her childbearing age if her age does not exceed 49 years, at the written request of the woman and the man who intends to undergo this service together (hereinafter referred to as "infertile couple"). The application of a infertile couple applying for artificial insemination shall not be more than 6 months old; is part of the medical documentation of a woman.

(2) Artificial insemination may not be carried out on a woman who has had a relationship with a man with whom he has submitted an application pursuant to paragraph 1, excluding a relationship of kin under another legal provision concerning the conclusion of marriage.

§ 7

(1) Germ cells may be collected and used for assisted reproduction methods and procedures if medical fitness has been assessed

(a) persons to whom germ cells are to be collected; and

(b) women to be artificially inseminated (hereinafter referred to as "the recipient").

(2) The beneficiary shall not be a person whose incapacity is restricted in such a way that he is not able to assess the provision of health services or, where appropriate, the consequences of such provision, or to parental responsibility, even in part. The beneficiary may also not be a person placed in a police cell, in the exercise of custody, in prison or in detention.

(3) The anonymous donor must not be a person,

(a) whose competence is limited in such a way that it is not capable of assessing the provision of health services or, where appropriate, the consequences of providing them;

(b) which is located in a police cell, in the exercise of custody, in a prison sentence or in a detention facility or in a asylum facility;

(c) which have been ordered to be isolated, to be quarantined or in the performance of bed protection treatment; or

(d) which is hospitalized without consent.

§ 8

(1) Before commencing the methods and procedures of assisted reproduction, the provider shall submit to the infertile couple information on the nature of the proposed methods and procedures, their permanent consequences and potential risks and the manner in which superfluous human embryos may be handled, including the estimated financial costs of their storage and the duration of their storage. Part of the lesson of the infertile couple is also information on the determination of parenthood to a child under the Civil Code, if the child was conceived by artificial insemination. An infertile couple may require that a witness of his choice be present when submitting the information. The record of the submission of the information shall be signed by the infertile couple, the attending physician or, where appropriate, the witness; the record is part of the health file of the recipient.

(2) On the basis of the information referred to in paragraph 1, the infertile couple shall give written consent to performing assisted reproduction; written consent shall be given repeatedly before any artificial insemination is carried out. Consent is part of the medical documentation of the recipient.

(3) Individual performances of assisted reproduction may be performed by the beneficiary if they have given their consent prior to their commencement. The consent shall be entered in the health file of the beneficiary by the doctor who signs the alert; the record shall also be signed by the beneficiary.

§ 9

(1) If not all human embryos produced for the benefit of the infertile pair have been used in the artificial insemination of the recipient, they may be stored and used for further artificial insemination of the recipient. This is not the case if the infertile couple declares in writing that they do not intend to use the embryos for their further artificial insemination and at the same time give their consent to be used for another anonymous infertile couple, or consent to the use of excess embryos for research under the Human Embryonic Stem Cell Research Act or their disposal. The declaration may be withdrawn at any time by the infertile couple; This does not apply if human embryos have been used in another infertile pair or disposed of in accordance with the declaration. A human embryo resulting from the recipient's ova or sperm of a man from an infertile pair may be used for the artificial insemination of another recipient, provided that the fitness of the infertile pair has been assessed to the extent specified for anonymous donors.

(2) If the human embryos have not been used or the infertile couple has not made a written declaration of destruction as referred to in paragraph 1, the provider may, after 10 years of storage, repeatedly demonstrate in writing that the infertile couple has made observations on the continued storage of those embryos, including the granting of consent to their destruction. If the infertile couple does not respond to a repeated proven written request from the provider, the human embryos may be disposed of without expressing the infertile couple.

(3) A repeated written invitation referred to in paragraph 2 shall mean its demonstrable transmission through the postal service operator to the address of the infertile couple known to the provider at least twice with a time interval of at least 60 days. The time limit for expressing the infertile couple on the basis of the second call shall be 30 days from the date of its delivery.

(4) The invitation shall be received on the date on which the addressee takes it over, otherwise it shall be deemed to have been received by the expiry of a period of 10 days from the date of notification of its deposit with the postal operator. Where an invitation with regard to a change in the address of the infertile couple is untouchable or refused to take over, the invitation shall be deemed to have been received on the date of its return to the provider. Similarly, if the call is not delivered to only one person from a barren pair, the procedure shall be followed.

(5) On the basis of the written declaration referred to in paragraph 1 or the written consent made following the invitation referred to in paragraph 2, the provider shall ensure the disposal of frozen human embryos in the presence of at least two health professionals. The health file kept on the recipient shall include a written declaration or written consent, or, where appropriate, a delivery or other document certifying that a written invitation to the infertile couple has been sent and a record of the destruction of human embryos; the entry shall be signed by the health professionals present at the disposal of the human embryos.

§ 10

(1) The provider who is authorised to carry out the methods and procedures of assisted reproduction shall ensure that the anonymity of the anonymous donor and the infertile couple and the anonymity of the anonymous donor and of the child born from assisted reproduction is maintained.

(2) The provider who has carried out an assessment of the medical fitness of the anonymous donor and of the woman or man from the infertile couple shall be obliged to transmit the information on their health necessary for artificial insemination to the provider carrying out artificial insemination; the provider is obliged to retain the data on the state of health of the anonymous donor for 30 years after the artificial insemination has been carried out and, upon written request, to pass on to the infertile couple or adult born from assisted reproduction information on the state of health of the anonymous donor.

§ 11

The collection of germ cells shall not entitle the person who has been withdrawn to a financial or other remuneration. The supplier who has carried out the procurement shall, upon request, pay the anonymous donor effectively, economically and demonstrably the costs incurred in the donation of germ cells. Their replacement may require the recipient to be artificially inseminated or the provider to whom the germ cells or human embryos have been transmitted to perform assisted reproduction. The provider who has taken over the germ cells or human embryos to perform assisted reproduction and who has paid the expenditure referred to in the second sentence may claim compensation for such expenditure for the recipient to be artificially inseminated.

Díl 2

Sterilisation

§ 12

Sterilisation means a health performance preventing fertility without removing or damaging the sex glands. Sterilisation may be carried out for health or other than health reasons. Health reasons are those diseases or defects where there is a high level of likelihood of a serious threat to health or life due to pregnancy or childbirth or healthy development of the fetus or to the health or life of a future child.

§ 13

(1) Sterilisation for health reasons shall be performed on a patient who has completed 18 years of age, provided that written consent is given to carry out sterilisation.

(2) A patient whose incapacity is restricted in such a way that he is unable to assess the provision of health services or, where appropriate, the consequences of such provision (hereinafter referred to as "a patient with limited incapacity"), or a minor may only be sterilised for medical reasons, on the basis of:

(a) the written consent of the guardian of a patient with limited professional capacity (hereinafter referred to as "the guardian of the patient") or the legal representative of a minor patient (hereinafter referred to as "the legal representative of the patient"); This is without prejudice to the provisions of Section 35 of the Health Services Act,

(b) the favourable opinion of the Panel of Experts; and

(c) the consent of the judical22a).

(3) The expert committee is set up by the provider. The members of the expert committee shall be:

(a) 3 doctors with specialised competence in urology, if it is about sterilisation in men,

(b) 3 doctors with specialised competence in the field of gyno and obstetrics, when it comes to sterilisation in a woman,

(c) a clinical psychologist; and

(d) a person designated by a provider who received a higher education in a Master's Law Study Programme (hereinafter referred to as "lawyer").

(4) At least 4 members of the Panel shall not be in employment or similar relations with the provider, a member of the monitoring body of the provider or a statutory body, a member of the statutory body or a member of the provider.

(5) The treating physician of the patient who recommended the conduct of the medical performance is always invited to attend the panel meetings, but the attending physician must not be present during the interview with the patient.

(6) The patient and the legal representative of the patient or guardian of the patient are always invited to the meetings of the expert committee; the deliberations of the expert committee must be initiated in such a way as to avoid endangering the patient's life or health. The expert committee shall provide the patient and his legal representative or the patient's guardian with information on the nature of the medical performance, its lasting consequences and potential risks and shall verify that the patient and the patient's legal representative or the patient's guardian have fully understood this information. The patient will take into account his rational maturity. The record of the submission of information shall be signed by members of the expert committee, patient and legal representative of the patient or guardian of the patient. The patient's opinion is part of the record. If the patient is unable to understand the information or to sign the alert due to his reasonable maturity, this shall be recorded. The record is part of the patient's medical file.

(7) The expert panel shall draw up a written expert opinion assessing whether all the conditions for sterilisation are fulfilled; indicate, at the same time, the period of validity of the opinion, taking into account the urgency of the performance of health. The approval of all members of the Panel of Experts is required for a positive opinion on the implementation of sterilisation. In the event that the consent of all members is not achieved, the Panel shall describe in its opinion the reasons for this. The provider shall forward a copy of the Panel's opinion to the legal representative of the patient or the guardian of the patient.

(8) The application for authorisation to carry out sterilisation is submitted to the court by the provider. The provider shall attach to the application the written consent of the legal representative of the patient or the guardian of the patient, a copy of the record of the submission of the information referred to in paragraph 6 and the opinion of the Panel. If the patient is unable to express his or her opinion pursuant to paragraph 6 in view of his or her reasonable maturity, the provider shall state the reasons for this in the proposal.

§ 14

Sterilisation for reasons other than health can be performed on a patient who has completed 21 years of age, unless there are serious health reasons preventing it from being carried out, following his written request. The application is part of a patient-led medical file.

§ 15

(1) Before performing sterilisation for medical or non-medical reasons, the treating physician is required to provide the patient with information on the nature of the medical performance, its lasting consequences and potential risks. The information shall be submitted before a witness to whom he is a medical professional. If the patient requests the presence of another witness of his choice, the provider will allow it. The record of the submission of the information shall be signed by the treating physician, patient, witness or, where appropriate, by witnesses; the record is part of the patient's medical file. There shall be a reasonable period between the submission of information and the granting of consent; if there is sterilisation for health reasons, the period shall be at least 7 days; If there is sterilisation for reasons other than health, the period shall be at least 14 days.

(2) The conduct of sterilisation may be initiated if the patient or the legal representative of the patient or the patient's guardian has given written consent immediately before the patient is started.

§ 16

Sterilisation cannot be carried out in medical facilities Prison services of the Czech Republic ("Prison Service").

Díl 3

Therapeutic castration, testicular pulpectomy

§ 17

(1) Therapeutic castration or testicular pulpectomy (hereinafter "castration") means the medical performance of removing the hormone-active part of the sex gland in a man in order to suppress its sexuality.

(2) Castration may be given to a patient who has completed 21 years of age in whom:

(a) a specialist medical examination has demonstrated a specific paraphile disorder;

(b) a proven specific paraphile disorder has manifested itself by committing a sexually motivated crime; a sexually motivated criminal offence means, for the purposes of this law, a violent sexually motivated crime and a sexual abuse offence;

(c) a professional medical examination has demonstrated a high degree of probability of committing a sexually motivated crime in the future; and

(d) other treatment methods have not been successful or other treatment methods cannot be used for health reasons; the fact that other treatment methods cannot be effectively applied to the patient for medical reasons, the results of expert examinations must be demonstrated.

(3) Castration may also be carried out in specially justified cases where the conditions laid down in paragraph 2 (a), (c) and (d) are met, the age of 21 years of the patient and the proven paraphile disorder has a serious negative impact on the quality of life of the patient.

(4) The patient's castration is based on:

(a) his written request; and

(b) positive opinions of the Panel of Experts.

(5) The castration referred to in paragraph 2 shall only be carried out to a patient who is in protective treatment or in the performance of a protective response, where the proven paraphile disorder has a serious negative impact on the quality of his life, on the basis of:

(a) his written request;

(b) the favourable opinion of the Panel of Experts; and

(c) the consent of the court.

§ 18

(1) The Technical Commission is set up by the Ministry of Health (hereinafter referred to as the Ministry). The members of the expert committee shall be:

(a) a medical professional who is an employee of the State assigned to the Ministry;

(b) a doctor with specialised competence in the field of sexuality or with special competence in the field of sexuality;

(c) a physician with specialised competence in the field of psychiatry,

(d) a clinical psychologist,

(e) a doctor with specialised competence in urology,

(f) a lawyer with knowledge of medical law.

(2) A member of the Panel of Experts may not be in employment or similar relations with the provider, may not be a member of the monitoring body of the provider or the statutory body, a member of the statutory body or member of the provider.

(3) The patient's request shall be transmitted without delay by the provider to the Ministry; the application shall be accompanied by:

(a) a favourable opinion with castration processed by the treating physician with specialised competence in the field of sexuality or with special competence in the field of sexuality; Part of the agreed opinion is the diagnosis and description of the treatment to date, including a medical report, which clearly shows that other treatment methods cannot be effectively used to treat the patient for medical reasons, and that, if castration is carried out in accordance with § 17 (3) or (5), an assessment of the severity of the impact of paraphile disorder on the quality of life of the patient,

(b) a medical report demonstrating a high degree of probability that the patient will commit a sexually motivated crime in the future, processed by a doctor with specialised competence in the field of sexuality or with specific competence in the field of sexuality, which is not the treating physician referred to in (a) and by an employee of the provider who transmits the patient's application.

The Ministry may, in order to verify compliance with the conditions for the commission of a criminal offence referred to in Article 17 (2) (b), request a copy of the Register of Penalties; a request for the issuance of a copy of the Register of Penalties and a copy of the Register of Penalties shall be transmitted in electronic form in a way enabling remote access.

(4) The patient is always invited to a meeting of the expert committee, which takes place no later than 3 months after the date of the patient's request. The expert committee shall provide the patient with information on the nature of the health performance, its lasting consequences and potential risks and shall verify whether the patient has fully understood this information and whether the patient has come forward on a voluntary basis. The patient who is in protective treatment or in the performance of security detention will be advised that castration does not give entitlement to his release.

(5) The record of the submission of information will be signed by members of the expert committee and the patient.

(6) The expert panel shall, after consulting the request, draw up a written expert opinion assessing whether all the conditions for castration are fulfilled; indicate, at the same time, the period of validity of the opinion, taking into account the urgency of the performance of health. The approval of all members of the Panel of Experts is required for a positive opinion on castration. In the event that the consent of all members is not achieved, the Panel shall describe in its opinion the reasons for this. The expert committee shall forward to the Ministry a technical opinion in 3 copies and a copy of the record of the hearing.

(7) The treating physician of the patient who recommended the conduct of the medical performance is always invited to attend the panel meetings, but the attending physician must not be present during the interview with the patient.

(8) Part of the patient's medical documentation

(a) the patient's written request;

(b) a copy of the consensual opinion of the treating physician with specialised competence in the field of sexuality or with special competence in the field of sexuality;

(c) the medical report referred to in paragraph 3;

(d) an entry from the meetings of the expert committee; and

(e) the opinion of the expert committee.

(9) The Ministry shall transmit:

(a) a copy of the opinion of the Panel of Experts and a copy of the record from the panel's deliberations to the patient;

(b) (2) a copy of the opinion of the Panel of Experts to the health care provider referred to in paragraph 8 and a copy of the report of the Panel's deliberations.

(10) The application for approval of the castration shall be submitted to the court by the provider. The provider shall attach a written request from the patient and the opinion of the expert committee to the proposal.

§ 19

Castration may be initiated if the patient has given written consent immediately prior to its initiation.

§ 20

Castration may not be carried out in the health facilities of the Prison Service and persons in custody and in prison. Castration may also not be performed on a patient with limited capacity.

Díl 4

Gender change in transsexual patients

§ 21

(1) A transsexual patient is a person in whom there is a permanent mismatch between the psychological and physical sex (hereinafter referred to as "sexual identification disorder").

(2) Surgical procedures towards gender change may be performed on the patient,

(a) which has been clearly identified as having a sexual identification disorder and demonstrated the ability to live permanently as a person of the opposite sex; and

(b) who has not entered into a marriage or who has not entered into a registered partnership or similar union of persons of the same sex abroad, proving, where appropriate, that his marriage or registered partnership or similar union has ceased to exist.

(3) Surgical procedures towards gender change should be performed on the basis of a patient who has completed the age of 18 years.

(a) his written request; and

(b) positive opinions of the Panel of Experts.

(4) Surgical procedures towards gender change should be performed on the basis of a patient with limited fitness,

(a) the written request of the patient's guardian; This is without prejudice to the provisions of Section 35 of the Health Services Act,

(b) the favourable opinion of the Panel of Experts; and

(c) the consent of the court.

§ 22

(1) The Ministry shall establish the expert committee. The members of the expert committee shall be:

(a) a medical professional who is an employee of the State assigned to the Ministry;

(b) a doctor with specialised competence in the field of sexuality or with special competence in the field of sexuality;

(c) a physician with specialised competence in the field of psychiatry,

(d) a clinical psychologist,

(e) a physician with specialised competence in endocrine and diabetes,

(f) a doctor with specialised competence in urology or gynaecology and obstetrics;

(g) a lawyer with knowledge of medical law.

(2) A member of the Panel of Experts may not be in employment or similar relations with the provider, may not be a member of the monitoring body of the provider or the statutory body, a member of the statutory body or member of the provider.

(3) The patient's or the patient's guardian's request shall be transmitted by the provider to the Ministry without delay; The application shall be accompanied by the consent of the treating physician with specialised competence in the field of sexuality or with specific competence in the field of sexuality with the implementation of gender change.

(4) The patient and the guardian of the patient are always invited to a meeting of the expert committee, which shall take place no later than 3 months after the date of the application of the patient or the guardian of the patient. The expert panel shall provide the patient and the patient's guardian with information on the nature of the health performance, its lasting consequences and potential risks and shall verify whether the patient and the patient's guardian fully understand this information and whether the patient and the patient's guardian have received the application on a voluntary basis. If the patient referred to in Paragraph 21 (4) is involved, he shall take into account his reasonable maturity.

(5) The record of the submission of information shall be signed by members of the expert committee, the patient and the patient's guardian. The record also includes the opinion of a patient with limited incapacity. If the patient is unable to express his or her opinion or to sign the alert due to his or her reasonable maturity, this shall be recorded.

(6) The expert committee shall, after consulting the request, draw up a written expert opinion assessing whether all the conditions for a sex change are fulfilled; indicate, at the same time, the period of validity of the opinion, taking into account the urgency of the performance of health. The consent of all members of the Panel of Experts is required for a positive opinion on the implementation of the sex change. In the event that the consent of all members is not achieved, the Panel shall describe in its opinion the reasons for this. The expert committee shall forward to the Ministry a technical opinion in 3 copies and a copy of the record of the hearing.

(7) The treating physician of the patient who recommended the performance of health care is always invited to the meeting of the Panel of Experts, but the attending physician must not be present during the interview with the patient.

(8) Part of the patient's medical documentation

(a) the patient's written request or the patient's guardian;

(b) a copy of the consensual opinion of the treating physician with specialised competence in the field of sexuality or with special competence in the field of sexuality;

(c) an entry from the meetings of the expert committee; and

(d) the opinion of the expert committee.

(9) The Ministry shall transmit:

(a) a copy of the opinion of the Panel and a copy of the minutes of the Panel's deliberations to the patient or the patient's guardian;

(b) (2) a copy of the opinion of the Panel of Experts to the health care provider referred to in paragraph 8 and a copy of the report of the Panel's deliberations.

(10) The application for consent to a sex change shall be submitted to the court by the provider. The provider shall add to the application a written request from the patient or a written request from the guardian of the patient, a statement from the patient with limited competence and the opinion of the expert committee. If the patient is unable to make a statement in the light of his reasonable maturity, the provider shall state the reasons for this in the proposal.

§ 23

(1) A change in sex may be initiated if the patient or the patient's guardian has given written consent to this immediately prior to its initiation.

(2) The provider shall issue a confirmation to the patient and the patient's guardian about the sex change.

Díl 5

Psychosurgery

§ 24

(1) Psychosurgery is a neurosurgery performed to remove or relieve symptoms of mental illness when other therapeutic methods are already exhausted and when there is a high degree of probability that performance will be effective.

(2) Psychosurgery should be performed on a patient who has completed 18 years of age, based on:

(a) the patient's written consent; and

(b) positive opinions of the Panel of Experts.

(3) A patient who has completed the age of 18 years and who is in custody, a custodial sentence, a security detention or a protective treatment shall only have psychosurgery performed on a case-by-case basis, on the basis of:

(a) his written consent;

(b) the favourable opinion of the Panel of Experts; and

(c) the consent of the court.

(4) To an underage patient or patient with limited capacity, psychosurgery shall only be performed on a case-by-case basis.

(a) the written consent of the patient's legal representative or guardian; This is without prejudice to the provisions of Section 35 of the Health Services Act,

(b) the favourable opinion of the Panel of Experts; and

(c) the consent of the court.

§ 25

(1) The Ministry shall establish the expert committee. The members of the expert committee shall be:

(a) a medical professional who is an employee of the State assigned to the Ministry;

(b) a physician with specialised competence in the field of psychiatry,

(c) a physician with specialised competence in neurology,

(d) a physician with specialised competence in neurosurgery;

(e) a clinical psychologist,

(f) a lawyer with knowledge of medical law.

(2) A member of the Panel of Experts may not be in employment or similar relations with the provider, may not be a member of the monitoring body of the provider or the statutory body, a member of the statutory body or member of the provider.

(3) The consent of the patient or the legal representative of the patient or the guardian of the patient shall be transmitted without delay by the provider to the Ministry; the consent shall be accompanied by the consent of the attending physician with specialised competence in the field of psychiatry with the performance of psychosurgery.

(4) The patient and the legal representative of the patient or the guardian of the patient are always invited to a meeting of the expert committee, which shall take place no later than 3 months after the date of the application of the patient or the legal representative of the patient or the guardian of the patient. The expert committee shall provide the patient and the legal representative of the patient or the patient's guardian with information on the nature of the health performance, its lasting consequences and potential risks and verify that the patient and the patient's legal representative or the patient's guardian have fully understood this information. If the patient referred to in § 24 (4) is involved, he shall take into account his reasonable maturity.

(5) The record of the submission of information shall be signed by members of the expert committee, patient and legal representative of the patient or guardian of the patient. The alert shall also include the opinion of a minor or a patient with limited professional capacity. If the patient is unable to express his or her opinion or to sign the alert due to his or her reasonable maturity, this shall be recorded.

(6) The expert committee shall, after consulting the request, draw up a written expert opinion assessing whether all the conditions for carrying out the psychosurgical exercise are fulfilled; indicate, at the same time, the period of validity of the opinion, taking into account the urgency of the performance of health. The approval of all members of the Panel of Experts is required for a positive opinion on the conduct of psychosurgery. In the event that the consent of all members is not achieved, the Panel shall describe in its opinion the reasons for this. The expert committee shall forward to the Ministry a technical opinion in 3 copies and a copy of the record of the hearing.

(7) The treating physician of the patient who recommended the performance of health care is always invited to the meeting of the Panel of Experts, but the attending physician must not be present during the interview with the patient.

(8) Part of the patient's medical documentation

(a) the written consent of the patient or the legal representative of the patient or the guardian of the patient;

(b) a copy of the agreed opinion of the treating physician with specialised competence in the field of psychiatry;

(c) an entry from the meetings of the expert committee; and

(d) the opinion of the expert committee.

(9) The Ministry shall transmit:

(a) a copy of the opinion of the Panel and a copy of the minutes of the Panel's deliberations to the patient or the legal representative of the patient or the patient's guardian;

(b) (2) a copy of the opinion of the Panel of Experts to the health care provider referred to in paragraph 8 and a copy of the report of the Panel's deliberations.

(10) The application for consent to perform psychosurgery shall be submitted to the court by the provider. The provider shall add to the application the written consent of the patient or the written consent of the legal representative of the patient or the guardian of the patient and the statement of the minor or the patient with limited competence and the opinion of the expert commission. If the patient is unable to make a statement in the light of his reasonable maturity, the provider shall state the reasons for this in the proposal.

§ 26

The conduct of psychosurgery may be initiated if the patient or the legal representative of the patient or the patient's guardian has given written consent immediately before the patient is started.

§ 27

Psychosurgery may not be carried out in the health facilities of the Prison Service.

Díl 6

Genetic examinations

§ 28

(1) The genetic examination shall include clinical and genetic laboratory tests; to determine the proportion of variations in the human genome to the development of the disease in the person under investigation or its offspring. The human genome means a summary of hereditary information which has been inherited from the ancestors or newly created by the person under investigation and can be transmitted to future generations. Genetic laboratory testing means laboratory analysis of the structure and function of the human genome or parts thereof, which must be indicated on the basis of its clinical validity and usefulness for the person under investigation or future generations. The performance of a genetic laboratory examination shall be justified in detail in the health file.

(2) Genetic laboratory tests under this law shall not be considered to be carried out

(a) to assess a suitable donor for the recipient of blood, blood components, cells, tissues or organs;

(b) to detect pathogenic organisms occurring in humans,

(c) to analyse parts of the human genome carried out to reduce the false positivity of neonatal laboratory screening;

(d) in order to assess the effect of genotoxic factors of the environment and the working environment;

(e) for the purpose of neonatal laboratory screening of congenital and hereditary diseases; or

(f) solely for the purpose of identifying the individual.

(3) Genetic laboratory tests may only be carried out by a provider who has the field of medical genetics or clinical genetics or a laboratory of clinical genetics (hereinafter referred to as "the provider of medical genetics") in a laboratory which is its workplace and which, according to the relevant harmonised standard (5), is accredited by an accreditation body under the law governing the assessment of conformity (6).

(4) A provider in the field of medical genetics who does not comply with the condition of an accredited laboratory referred to in paragraph 3 and who intends to carry out genetic laboratory tests in a laboratory which is his workplace shall:

(a) submit an application to, or conclude with, the accreditation agreement with the accreditation body within 60 days of the date of commencement of these examinations; and

(b) notify, not later than 14 days before the commencement of the genetic laboratory tests, the administrative authority which granted the health service provider authorisation under the Health Services Act (hereinafter referred to as "the competent administrative authority") of the date from which it intends to start carrying out the tests.

(5) A provider in the field of medical genetics who does not fulfil the condition of an accredited laboratory referred to in paragraph 3 and who has begun carrying out the genetic laboratory tests referred to in paragraph 4,

(a) may carry out such genetic laboratory tests until accreditation has been granted, or until the date on which the decision to refuse an application for accreditation or an order to terminate the procedure, or until the date on which accreditation or refusal to grant accreditation under a public contract is granted, but not more than 12 calendar months after the date on which such examinations are started;

(b) publish information on the carrying out of genetic laboratory tests in a laboratory which is under the accreditation requirements assessment regime for the purpose of granting accreditation for carrying out such tests in accordance with the relevant harmonised standard (5), on site accessible to patients as well as on its website if it is set up.

(6) A provider in the field of medical genetics which does not fulfil the conditions of an accredited laboratory referred to in paragraph 3 and which has commenced carrying out the genetic laboratory tests referred to in paragraph 4 shall cease to carry out them out if, within the time limit referred to in paragraph 4 (a), he does not submit an application to, or conclude with, the public contract for the granting of accreditation, on the day following the date of expiry of that period.

(7) A provider in the field of medical genetics which does not fulfil the condition of an accredited laboratory referred to in paragraph 3 may also ensure that laboratory tests are carried out in a laboratory which, according to the relevant harmonised standards (5), is accredited by an accreditation body under the law governing the assessment of conformity (6) and which is the workplace of another provider in the field of medical genetics, under contract with that provider.

(8) Where a provider in the field of medical genetics who does not fulfil the condition of an accredited laboratory referred to in paragraph 3 and who has begun carrying out the genetic laboratory tests referred to in paragraph 4,

(a) has not submitted an application or concluded a public contract for the granting of accreditation within the time limit referred to in paragraph 4 (a), it may, in accordance with paragraph 4, reapply at the earliest after 12 calendar months from the day following the expiry date referred to in paragraph 4 (a); or

(b) has not been accredited to carry out these examinations, it may, in accordance with paragraph 4, re-operate not earlier than 12 calendar months from the date of:

1. the acquisition of legal power by decisions rejecting an application for accreditation;

2. the acquisition of legal power by a resolution terminating the application procedure; or

3. Refusal of accreditation under a public contract.

(9) Genetic examinations in the field of health may be offered or carried out only for the purposes of:

(a) health services,

1. pre-implantation diagnostics in assisted reproduction;

2. to diagnose genetically conditioned diseases, congenital defects and genetic changes obtained;

3. to determine the degree of predisposition for disease and congenital defects,

4. to determine the non-symptom transmission of human genome variants causing disease or birth defects,

5. to optimise treatment and monitor its effectiveness; and

(b) biomedical research related to health and disorders.

(10) Genetic laboratory tests may be offered or carried out on the subject only

(a) following the submission of information on its purpose, nature and impact on its health, on the risks of unexpected findings for it and genetically related persons, including the impact of this examination on the health of future generations and the severity of its results for the partner of the subject; and

(b) on the basis of its written consent or the written consent of the legal representative or guardian of the person under investigation.

(11) For the purposes of genetic examinations under this Act, relatives with a medical serious genetic risk shall be considered to be genetically related persons under investigation, namely relatives in a line

(a) direct by grandparents, parents and their children; and

(b) secondary where the level of that risk is determined by the degree of affinity and the type of GM disease.

(12) Where a diagnostic conclusion can be expected from a genetic laboratory according to which a serious medical impact can be expected on the health of the embryo, foetus or person under investigation, including future generations, or on the health of their genetically related persons, the provider shall always recommend genetic advice by a physician with specialised competence in the field of medical genetics before and after the examination. The genetic advice referred to in the first sentence shall be recommended by the provider to the parents of the embryo or foetus, the legal representative or guardian of the person under investigation, the person under investigation and the genetically related persons concerned. If the purpose of the genetic laboratory examination is to analyse somatic changes in the human genome, it is not necessary to conduct genetic advice by a physician with specialised competence in the field of medical genetics.

§ 29

(1) Biological material taken from the person under investigation in the provision of health services or in connection with an autopsy of the deceased's body may only be used for genetic laboratory testing on the basis of the demonstrable consent expressed by the person under investigation, by his legal representative or guardian or by the deceased in his life or by a person close to the deceased. Without consent, genetic laboratory examination of biological material according to the first sentence

(a) to carry out, if it is necessary to identify or verify without delay, the relevant information on changes in the human genome needed to ensure the protection of the health of genetically related persons and it has not been possible to obtain the consent of the person under investigation, or its legal representative or guardian after appropriate efforts have been made; This examination may only be carried out to the extent necessary to ensure the protection of the health of genetically related persons and provided that the benefit of the examination for such persons cannot be otherwise achieved,

(b) to carry out, for the purposes of teaching, science or research, unless, for biological material or in connection with its use for that purpose, such data can be identified as the subject or deceased.

(2) A person under investigation may not be offered or offered a financial reward or other benefit for undergoing a genetic examination under Paragraph 28 (9) (a). No harm shall be associated with the refusal of a genetic examination, nor shall the person under investigation be subjected to psychological coercion. The results of genetic examinations shall not be made available to third parties without the written consent of the person under investigation. The sale or donation of genetic testing results to third parties without the written consent of the person under investigation, including the written consent of the genetically related person concerned, shall be prohibited. The results of the genetic examination shall not be used for any discrimination against the person under investigation and the genetically related persons.

(3) Genetic laboratory testing of the human embryo or foetus, including the determination of its sex prior to the completion of the twelfth week of pregnancy, must not be carried out for reasons other than those referred to in § 28 (9) (a) (1) to (3) and (5).

§ 30

(1) The action to change the human genome may be carried out on the subject for preventive or therapeutic purposes only in the case of serious genetically modified diseases, provided that its natural biological integrity is maintained in germ cells. These interventions shall not be carried out if they could lead to permanent changes in germ cell genetic equipment.

(2) Any procedure designed to create a human being having the same human genome with another human being, whether alive or dead, is prohibited.

(3) It is prohibited to transmit:

(a) the whole human genome into cells of another species and vice versa;

(b) the human embryo to the sex organs of another animal species.

Díl 7

Human blood and its components, blood treatment or its components

§ 31

Collection of human blood and its components

(1) Only the provider authorised for such manufacture under the Drug Act can carry out samples of human blood and its components (blood) for the manufacture of blood products and blood derivatives and for human use.

(2) Blood for the needs referred to in paragraph 1 may not be taken from persons:

(a) minors; This does not apply in cases where blood collection from a minor cannot be replaced by blood collection from an adult; in such a case, the legal representative of the minor to whom blood is collected must give his written consent and be approved by the authorised medical officer of the provider referred to in paragraph 1;

(b) located in a police cell, in the exercise of custody, in prison or in detention;

(c) located in a school establishment for the pursuit of constitutional or protective education or in a social services establishment, where constitutional education or protective education has been ordered,

(d) in the case of ordered isolation, quarantine measures or in the context of the exercise of bed protection treatment; or

(e) hospitalised without their consent,

(f) which do not meet the criteria for receiving blood donors laid down in other legislation29),

(g) permanently or temporarily excluded from the donation of blood or persons for whom the minimum prescribed interval between sampling under another legislation29 would be exceeded.

The prohibition on blood collection referred to in points (b) to (e) shall not apply to direct donation between direct relatives which cannot be replaced by blood collection from another person and to blood collection for the need for health services to the person to whom blood is collected, such as autotransfusion.

(3) The provider is required to verify the admissibility of the blood collection

(a) by verifying the data kept in the National Blood Donor Register and those permanently excluded from blood donation (30), if this register is operational;

(b) carrying out checks to determine whether the donor meets the criteria for receiving blood donors or is not a person permanently or temporarily excluded from the blood donation (29).

(4) For the purposes referred to in paragraph 1, blood may be taken only from the person who has given his written consent. Where a minor is involved or has limited professional capacity, the written consent shall be given by his legal representative or guardian; This is without prejudice to the provisions of Section 35 of the Health Services Act.

§ 32

Treatment of blood or its components

(1) Blood treatment means the administration of blood transfusions and blood derivatives and other medicinal products derived from human blood to the patient as part of preventive or therapeutic care. Prior to administration of the transfusion product, the compatibility of the transfusion product with the blood of the recipient of the transfusion product is assessed. The supplier performing the transfusion shall be responsible for assessing the compatibility of the transfusion preparation with the blood of the recipient. A record of the compatibility of the transfusion product with the patient 's blood is included in the patient' s medical documentation; the entry shall be signed by a health care professional who has verified the compatibility of the blood of the blood of the blood of the recipient.

(2) For blood collected for the production of blood derivatives and for human use under other legislation and for the collection thereof, a person who has been collected shall not be entitled to a financial or other remuneration, with the exception of effectively, economically and demonstrably incurred expenses associated with the collection of his blood for which he has requested, up to a maximum of 5% of the minimum wage.

(3) The provider may increase the reimbursement of the expenditure provided for in paragraph 2 accordingly in respect of blood collection

(a) in order to produce a single transfusion product for the provision of health care to a particular patient and if blood from another donor cannot be used,

(b) requiring special donor preparation or selection of donor according to the tissue characteristics and blood groups of the recipient.

HLAVA III

VERIFICATION OF NEW PROCEDURES BY METHODS NOT INCLUDED IN THE CLINICAL PRACTICES OF THE LIFE PERSON

§ 33

(1) In a living person, verification of new procedures in the field of preventive, diagnostic and medical care or biomedical research related to health and its disorders may be carried out by applying a method which has not yet been established in clinical practice (the "non-established method ') only under the conditions laid down by this law.

(2) Non-implemented methods shall not be considered

(a) methods introduced into clinical practice in a Member State of the European Union, the European Economic Area or the Swiss Confederation;

(b) modification of methods already in place, the use of which does not adversely affect the patient's health.

(3) In case of doubt as to whether the method referred to in paragraph 2 (b) is a method, the Ministry shall decide, on its own initiative or at the request of the provider wishing to use the modification of the methods in the provision of health services. The submission of decomposition against the Ministry's decision has no suspensory effect. The parties to the proceedings are only providers that intend to use the modification of the methods already established in the provision of health services.

(4) Verification of the non-implemented method may be carried out only if:

(a) the patient on whom the non-established method is to be verified has given written consent to the verification of the non-established method on the basis of the information provided for in Article 34 (1);

(b) the non-established method may be expected to produce favourable results to the patient on which it is to be verified, and it may reasonably be expected to become a new method of prevention, diagnosis or treatment after successful verification;

(c) verification of the non-implemented method cannot be achieved by any other means with comparable efficiency; and

(d) there is no justified risk of long-term or serious damage to the health of the patient on which the non-established method is to be verified as a result of the verification of the non-established method.

(5) Verification of the non-established method may be carried out on a minor patient or a patient with limited professional capacity only on the written consent of the legal representative of the patient or the guardian of the patient after the submission of the information referred to in Article 34, provided that:

(a) the conditions laid down in points (b) to (d) of paragraph 4 are fulfilled;

(b) verification of a non-established method of comparable effectiveness cannot be carried out on patients able to give consent; and

(c) such patients, in view of their reasonable maturity or their ability to understand information, have given their consent to the verification; non-compliance with the verification need not be respected if such verification is the only possible alternative to treatment in an otherwise incurable disease;

This is without prejudice to the provisions of Section 35 of the Health Services Act.

(6) Verification of non-established methods may not be carried out on persons in custody, imprisonment or detention, unless such verification is the only alternative to treatment in an otherwise incurable disease.

§ 34

(1) Information on the non-established method submitted to the patient or to the legal representative of the patient or the guardian of the patient on which this method is to be verified must be verifiable and understandable and include:

(a) details of the validated method, including the purpose for which it is verified;

(b) the specific procedure concerning the patient;

(c) the potential benefit of the validated method to the patient;

(d) foreseeable risks and potential difficulties or limitations associated with the verification of the method and anticipated risks associated with early withdrawal of consent;

(e) data on other treatment options,

(f) data on how the data obtained from the patient are protected and on how the information and data found in connection with the verification of the method applicable to the evaluation and implementation of the validated method are disclosed; and

(g) the requirements for cooperation and patient treatment;

This is without prejudice to the provisions of Section 35 of the Health Services Act.

(2) The consent of the patient or the legal representative of the patient or the guardian of the patient to verify the non-established method must continue throughout the verification period. In the event of withdrawal of consent by a patient or by a legal representative of a patient or by a patient's guardian, verification of the method may not be continued.

§ 35

Verification of the non-established method may be carried out by a provider to which the Ministry has granted authorisation to verify the non-established method. The application for authorisation shall include, in addition to the formalities laid down in the administrative rules:

(a) a description of the method not implemented;

(b) justification for the effectiveness of the verification of the non-established method;

(c) a report on the results obtained by laboratory research, animal experiments or other preclinical research;

(d) an overview of the current findings relating to the validated procedures, including those obtained from abroad;

(e) a detailed verification plan for the non-implemented method;

(f) the place where the non-established method is to be verified, specifying the name and / or names, surnames of the healthcare professionals who will verify it, including the names of those who will manage the verification and their qualifications;

(g) the assessment of health risks, taking into account all available information on the method that might arise from the verification of the non-implemented method;

(h) information on the patient population on which the non-established method is to be verified;

(i) a binding opinion of the State Office on Nuclear Safety on the verification of non-established medical exposure methods.

§ 36

(1) The Ministry shall grant permission to the provider to verify the non-established method if it concludes that:

(a) new procedures under Article 33 (1) are subject to verification of the non-implemented method;

(b) verification of the non-implemented method is useful; and

(c) the provider is competent to verify the non-established method.

(2) The State Nuclear Safety Authority shall issue a binding opinion on the verification of the non-established medical exposure method on the basis of a written request from the provider within 60 days of its receipt. The application shall contain the data referred to in Article 35 to the extent necessary to assess the non-established method in relation to medical exposure and radiation protection.

(3) The Ministry shall decide on the application in accordance with Paragraph 35 within 90 days of its receipt. If there is a verification of the non-established medical exposure method, the Ministry may decide to grant authorisation only on the basis of a binding opinion of the State Office for Nuclear Safety.

(4) The decision to grant an authorisation for the verification of non-compliant methods, in addition to the formalities laid down in the administrative rules, contains:

(a) the definition of the non-implemented method;

(b) the definition of the conditions under which the non-established method can be verified;

(c) deadlines for reporting on each stage of verification.

(5) The Ministry may withdraw the authorisation to verify the non-compliant method if:

(a) the provider has infringed the conditions laid down for the verification of the non-established method by this law or in the authorisation to verify the non-established method, on the basis of the results of his own findings or of the initiative of the Ethics Committee set up by the non-established method verification provider (hereinafter referred to as the Ethics Commission); or

(b) in order to withdraw authorisation, the competent administrative authority has initiated an infringement of the conditions for the provision of health services under this law or other legislation.

(6) The provider who has been withdrawn from the authorisation to verify the non-established method is obliged to terminate the verification without delay and to carry out such operations so that the health or life of patients is not jeopardised in the context of the completion of the verification.

(7) A party to the procedure for granting an authorisation to verify the non-established method shall be the provider who submitted the application pursuant to Paragraph 35.

§ 37

Provider before start of verification of non-established method

(a) establish an Ethics Commission;

(b) take out health liability insurance for patients in connection with the verification of the non-established method, with an insurance undertaking authorised to conduct insurance activities under the law governing insurance (7); the extent of insurance must correspond to the risks associated with the specific non-verified non-established method.

§ 38

(1) The Ethics Commission is an independent committee whose task is to:

(a) to assess from an ethical point of view the verification of the non-implemented method;

(b) supervise the verification process of the non-established method in terms of safety and the maintenance of the rights of patients on whom the non-established method is verified.

(2) The members of the Ethics Commission are health professionals and other persons, of which at least two thirds may not be a member of the statutory body or a member of the statutory body or a member of that provider in a professional or similar relationship with the provider which has established it. The Ethics Committee shall have at least five members. The Chairman and members of the Ethics Commission shall be appointed and withdrawn by the provider. Only persons without personal interest in the verification of the non-implemented method may be members of the Ethics Committee; A member of the Ethics Committee shall submit an affidavit of this fact.

(3) Where the Ethics Committee finds, in its activities, facts suggesting that the conditions under which the non-established method can be verified are not respected, it shall immediately communicate those facts to the provider and the Ministry.

§ 39

(1) The verifier shall:

(a) report to the Ministry within the time limits laid down in the authorisation to verify the non-implemented methods on the different stages of the verification;

(b) immediately suspend or suspend the verification of the non-established method where there is reasonable doubt that the non-established method will not produce the expected result or that its verification could lead to long-term or serious damage to the health of the patient on which it is verified; it is obliged to notify the Ministry without delay,

(c) without delay notify the Ministry and the State Office of the Nuclear Safety, if it has issued a favourable binding opinion, of an adverse incident; adverse event means an adverse change in the patient 's health status resulting from the verification of the non-established method,

(d) to allow checks during the verification of the non-implemented method to be carried out by persons authorised by the Ministry, the State Office for Nuclear Security, where a binding opinion has been issued, or by members of the Ethics Commission.

(2) Within 30 days of the completion of the verification of the non-established method, the provider shall submit to the Ministry a final report on the outcome of the verification, which shall at the same time assess the non-established method in terms of its use in the provision of health services. If a satisfactory binding opinion has been issued by the State Nuclear Safety Authority for the granting of the authorisation to verify the non-implemented method, the provider shall, within 30 days of the completion of the verification, submit to the State Nuclear Safety Authority a report on the progress of medical exposure and the facts relevant to radiation protection.

§ 40

(1) The Ministry will assess, on the basis of the final report on the outcome of the verification of the non-established method, which shows that it can be used in the provision of health services, whether the non-established method fulfils the conditions for introduction into clinical practice. In assessing the results of the verification of the non-established method, it takes into account the benefits of this method for improving patients' health.

(2) The Ministry will issue a decision by which the non-established method

(a) recognise as a standard method if, on the basis of the assessment referred to in paragraph 1, it concludes that the conditions for its introduction into clinical practice have been met and the new standard method contributes to improving patients' health; or

(b) it shall not recognise as a standard method if, on the basis of an assessment of the non-established method, it concludes that the conditions for its introduction into clinical practice have not been met.

(3) A party to the proceedings referred to in paragraph 2 shall only be the provider who verified the non-established method.

(4) The Ministry will publish in the Ministry of Health Bulletin and in a way that allows remote access

(a) a recognised standard method;

(b) the unrecognised non-established method, including the grounds for non-recognition.

HLAVA IV

SUPPORT SUPPORT AND DOCTOR SUPPLIES, WORKING SERVICES, HEALTH AID PROGRAMMES, ASSESSMENT OF NON-AUTHORISATIONS

Díl 1

Assessment and medical opinions

§ 41

Assessment is part of the assessment

(a) medical fitness for education and during education (hereinafter referred to as "education") for the needs of schools and educational establishments or physical education and sports or other activities under this law or other legislation;

(b) medical fitness for use and at the request of administrative or other authorities in cases provided for by other legislation;

(c) medical fitness on request by a patient or legal representative of a patient or by a patient's guardian or with their consent by a legal person;

(d) fitness to work on the basis of a medical examination; Part of the assessment of medical fitness for work is in particular the assessment of the medical fitness of workers or persons applying for employment;

(e) health status related to occupational disease or to the risk of occupational diseases (hereinafter referred to as "occupational disease"),

(f) health status for sickness insurance purposes and for the needs of the employment office;

(g) the patient's health for other purposes.

§ 42

(1) A medical opinion on medical fitness or medical condition (hereinafter referred to as the "medical opinion") shall be issued by the provider, at the request of the patient who is the subject of the assessment, or by another authorised person following an assessment of medical fitness or, where appropriate, of the health status of the person under assessment, by the assessor, based on an assessment of:

(a) the results of the medical examination and other technical examinations required (hereinafter referred to as the "medical examination");

(b) an extract from the medical file maintained by the person concerned by his or her registered provider in the field of general medical practice or in the field of practical medicine for children and adolescents (hereinafter referred to as "the registrant"), if the person concerned is registered with such provider, or if the person under examination is in the state of health of which the medical file is kept in the territory of another State, also on the basis of an extract from that dossier, accompanied by an officially certified translation into the Czech language; an officially certified translation shall not be submitted to an extract from the medical file in the Slovak language,

(c) the health requirements for the pursuit of work, occupation, education, sport, physical education or other activities (hereinafter referred to as "activity") for which the person is assessed and the conditions under which the activity is carried out or the health claims of the person under consideration.

(2) A medical opinion shall be given unless otherwise provided for in this law or other legislation,

(a) the registering provider of the person under assessment; or

(b) a provider in the field of general practical medicine or practical medicine for children and adolescents, unless the person under consideration has a registered provider; This fact shall be recorded in the medical file kept by the medical assessor on the subject; the entry shall be signed by the assessor and the assessor.

The medical assessor is a doctor with specialised competence in general medical practice or in practical medicine for children and adolescents, unless otherwise provided for in this law or other legislation.

(3) If the person under assessment does not have a registrant, paragraph 1 (a) and (c) shall apply when assessing the medical fitness and, where appropriate, the medical condition of the person under assessment.

(4) Where a medical opinion is issued for the purposes of employment relations, the authorised person shall without undue delay ensure that a medical opinion is issued to determine whether the disease is caused by an accident at work or an occupational disease. This assessment may be given after the end of the employment relationship.

§ 42a

(1) The extract from the medical file referred to in Article 42 (1) (b) may be replaced for the assessment of the health status or medical fitness of the person under assessment for the same purpose by a statement that no change in health status has been detected since the last issue of the medical file extract (hereinafter referred to as the "Unaltered Health Certificate"), provided that:

(a) the extract is requested by the same provider which has previously issued a medical opinion; and

(b) there shall be no change in the state of health or medical fitness of the person under consideration since the medical records previously issued.

(2) The registered provider shall issue an extract or, where appropriate, an unaltered health certificate within a maximum of 10 working days of the date of receipt of the application. The extract or certificate may be used to assess the health or medical fitness of the person under assessment within a maximum period of 90 days from the date of its issue by the registrant.

(3) The extract from the health file referred to in Article 42 (1) (b) or, where appropriate, the certificate of unaltered health, should not be required if, in view of the reasons for the assessment of the health status or medical fitness of the person under consideration or other supporting documents submitted, this is not necessary. The reasons for not requiring an extract from the medical file or, where appropriate, a certificate of unaltered health shall be laid down in the implementing legislation provided for in Article 60.

(4) An extract from the medical file or, where appropriate, an unaltered medical certificate may be requested by the assessor through the person under consideration.

§ 43

(1) A medical opinion must be issued, unless otherwise provided for by this law or other legislation, for the longest time.

(a) within 10 working days of the date of receipt or oral submission of an application pursuant to Article 42 (1);

(b) within 45 working days of the date of receipt or oral submission of an application pursuant to Paragraph 42 (1), if there is a medical opinion on an occupational disease; or

(c) within 45 working days of the date of receipt or oral submission of the application referred to in Article 42 (1), if there is a medical opinion for the purposes of labour law and if it is necessary for the assessor to assess whether the long-term loss of medical fitness to work has been caused by an accident at work or an occupational disease, the purpose of which is not an assessment of medical fitness to work.

The time limits referred to in points (a) to (c) shall not run until the last medical or health assessment material required under Paragraph 42 (1) has been received. The written request referred to in points (a) to (c) or the record of its oral submission shall form part of the medical file kept on the person concerned. The record shall be signed by the assessor and by the person who made the oral request.

(2) For the purpose of assessing the continued duration of medical fitness, a medical examination of the person under assessment may be carried out not earlier than 90 days before the expiry of an existing medical opinion, the duration of which shall not be changed unless the medical assessor has identified a change in the state of health leading to a medical assessment with the conclusion of § 44 (4) (a). If there are periodic recurrent medical examinations, the time limits for their implementation laid down by implementing legislation pursuant to § 52 or 60 or other legislation, and the validity of a medical opinion with the conduct of a medical examination according to the first sentence do not change if the medical assessor does not detect a change in the health status leading to a medical assessment with the conclusion of § 44 (4) (a). This shall be without prejudice to the possibility of carrying out or suspecting any change in medical fitness or medical condition.

(3) The medical opinion must have the formalities laid down in the legislation governing medical documents23) and, according to the purpose of its issue, the formalities laid down in the implementing legislation pursuant to § 52, 60 or 65 or, where appropriate, other legislation. The conclusion of the medical opinion shall make it clear whether the person under assessment is disabled, incapacitated or disabled for the purpose for which he is assessed, with the condition, if any, that he or she has lost long-term medical fitness or that his or her health status meets the conditions or requirements for which he or she has been assessed. A medical opinion shall include a lesson on the possibility to submit a proposal for a review pursuant to Article 46 (1) to the provider who issued the opinion and a lesson on the possibility of waiving the right to review the medical opinion pursuant to Article 46 (1). The instruction shall also indicate the period within which the review proposal may be submitted, the date on which that period is calculated and whether or not the review proposal has suspensory effect under this law or other legislation.

(4) If there is a medical opinion on medical fitness for work, the assessment conclusion that the person under assessment is disabled may be given only in the case of an initial medical examination; in other cases, it shall be concluded that the person under assessment has ceased to have long-term medical capacity to carry out the previous work. The long-term disability of existing work means a stabilised state of health which limits the physical, sensory or mental capacity of a staff member relevant to his or her ability to perform existing work, if that condition lasts for more than 180 days or it can be assumed that this condition will last for more than 180 days, and the performance of such work would seriously jeopardise his or her health. This is without prejudice to the definition of long-term loss of competence to perform the existing service under the Civil Service Act.

(5) Where a medical opinion is issued for the purposes of employment relationships, but not for the purpose of assessing medical fitness for work, but for determining whether the disease is an accident at work or an occupational disease, the assessment conclusion on the long-term loss of medical fitness shall indicate whether the person under assessment may or may not continue to work for an accident at work or an occupational disease. This assessment may already be made in the medical opinion referred to in paragraph 4 if, at the time of its issue, it is clear that the reason for the long-term loss of medical capacity is an accident at work or an occupational disease.

(6) The same copy of the medical opinion is part of the medical file of the person under assessment. The medical assessment or medical condition for the purpose of issuing a medical assessment shall be borne by the person requesting it, unless otherwise provided for in this law or other legislation. A written medical opinion may make corrections to obvious inconsistencies which do not affect its conclusion in accordance with paragraph 3, 4 or 5. Corrections shall be carried out by the provider on the initiative of the person referred to in Paragraph 44 (1) or on its own initiative. It shall inform the person referred to in Article 44 (1) of the correction of the assessment.

(7) A medical assessment shall not be issued if the person concerned refuses to undergo a medical examination or examination which is part of it; the assessor shall record this in the medical file of that person.

(8) Where the medical assessment has not been issued for the reason referred to in paragraph 7, or where the person under assessment has not undergone a medical examination for the purpose of further assessment of medical fitness or medical condition within a specified time limit, without giving a serious reason, it shall be regarded as unfit for the activity for which he was intended to be assessed, or as a person who has ceased to be fit to work in the long term or as a person whose medical condition does not meet the conditions or requirements for which he was assessed. In the case where it is a recurrent medical examination and the person under consideration has not submitted to it, it shall be regarded as a person unfit for health under the first sentence from the date on which the previous medical assessment expires.

(9) Where a medical assessment for the purpose of assessing medical fitness or medical condition has been requested by the authorised person and the person under consideration is regarded as unfit under paragraph 7, or as having ceased to be fit for long-term work, or as a person whose medical condition does not meet the conditions or requirements for which he has been assessed, the provider shall inform the authorised person in writing.

§ 44

(1) The provider who has issued the medical opinion shall ensure that it is immediately demonstrated that:

(a) to the person under consideration; and

(b) a person who has legally requested the assessment of the medical fitness of the person under assessment for the purpose of issuing the assessment, if not the person under consideration.

(2) Proven transfer of the medical opinion referred to in paragraph 1 means taking over:

(a) by the person referred to in paragraph 1, endorsed by the signature of that person, indicating the date of taking over, and, if the person referred to in paragraph 1 is the person referred to in point (a), (b) or the person by delegation of that person, the identity card or other identity document number and the reason for the opinion shall also be indicated; the certificate of receipt of the medical opinion is part of the medical file kept on the subject;

(b) upon delivery by the postal service operator; the service must be supported by a receipt; or

(c) on the basis of an electronic notification signed in a manner to which other legislation links the effects of a handwritten signature in the course of the exercise of its powers (22) to the clipboard indicated by the person under consideration and by the person who requested the medical assessment.

The medical opinion shall also be considered to be demonstrably submitted if the person authorised to take the opinion refuses to take the opinion or to sign it; This fact shall be recorded by the medical assessor in the medical file of the assessor; the entry shall be signed by the assessor and another health professional present to take over the assessment. In the event of a refusal to take over a medical opinion delivered through a postal service operator, the provisions of Paragraph 9 (4) shall apply mutatis mutandis.

(3) A person who is not a person referred to in paragraph 1 (b) and who, by applying a medical opinion, arises from rights or obligations shall submit a medical opinion to the person under consideration, unless otherwise provided for in this law or other legislation.

(4) Legal effects of the medical opinion

(a) the conclusion on the medical incapacity, the long-term loss of medical fitness of the person under consideration or medical fitness, subject to the condition laid down for the first time, shall take place for the person who has been surrendered on the date of his demonstrable transmission;

(b) the conclusion on the medical fitness of the person under assessment or medical fitness, subject to a condition which is repeated in a medical opinion issued for the same purpose and consists of the use of a particular compensated establishment or medical device, shall take place for the person who has been submitted, on the date on which the previous opinion expires, but first on the date of expiry of the deadline for the submission of the application for its examination or on the date on which the decision to confirm the opinion has been delivered by the administrative authority which has granted the provider's authorisation to provide health services;

(c) the health status of the person who has been submitted shall be the date of expiry of the deadline for the submission of the application for its examination or the date on which the decision to confirm the opinion is demonstrated by the administrative authority which has granted the provider an authorisation to provide health services.

Where the person entitled renounces the right to review a medical opinion under Paragraph 46 (1) with a conclusion under (b) or (c), the legal effects of that opinion shall arise on the first working day following the day on which the last of them has done so.

(5) The medical opinion may be used for the purposes for which it was issued within 90 days of the date of its issue, unless a shorter period is provided for in it or other legislation. If the administrative authority which has granted the provider an authorisation to provide health services confirms the contested medical opinion referred to in Article 47 (2) (a), that opinion may be used by the authorised person for the purposes for which it was issued within 10 working days of the date of demonstrable receipt of the validated opinion. The first and second sentences shall not apply if the opinion on the medical fitness of the person assessed is for participation in a school in nature or in a recovery operation under the Public Health Protection Act. The first and second sentences shall not apply if the assessment of the medical fitness of the person concerned is carried out for the purpose of admission to secondary school; This assessment may be used for the purpose for which it was issued within 1 year of its issue.

(6) The medical opinion expires

(a) the expiry of the period for which it was issued;

(b) if it is issued in the framework of periodic medical examinations carried out for the purpose of reassessment of the medical fitness of the person under consideration within the time limits laid down by implementing legislation pursuant to § 52 or 60 or, where appropriate, other legislation, the date on which such examination was to be carried out under that legislation; This is not the case if it is a medical opinion issued under Paragraph 43 (2),

(c) the date on which the legal effects of the medical opinion issued for the same purpose have occurred, unless otherwise provided for in this law or other legislation;

(d) the termination of an employment relationship, if it is an opinion under Paragraph 41 (d), unless otherwise specified.

(7) The medical opinion shall not cease to be valid under paragraph 6 (d) if:

(a) a new employment relationship with the same employer, with the same performance of the work and under the same working conditions, has been concluded by the person under consideration no more than 3 months after the date of termination of the employment relationship; or

(b) an employment relationship with an employer previously assigned to it as a user, with the same performance of the work and under the same working conditions as that assessed by the provider of the user's occupational medical services or by the provider referred to in Article 54 (2) (b), unless his health status has changed; the employer may require an initial medical examination before the employment relationship is concluded.

(8) If the medical assessment is invalid, the person to be assessed for the purpose for which he should have been medically assessed shall be considered as unfit or as a person whose medical condition does not meet the conditions or requirements for which he was assessed.

§ 45

(1) An assessor who finds that the person under assessment is no longer fit to carry out an activity or to carry out an activity on condition or that his or her health status does not satisfy the conditions or requirements for which he or she has been assessed shall notify the person under consideration and, without delay, to the person who, by applying the medical opinion, creates rights or obligations if that person is aware. The person to be assessed shall be deemed to be disabled or, where appropriate, medically fit for this activity on condition or a person whose medical condition does not meet the conditions or requirements for which he has been assessed, until the legal effects of the new medical assessment have occurred.

(2) A treating doctor who has a reasonable suspicion that a change in the patient 's health status has occurred in the course of his or her activity or that the patient' s medical condition does not meet the requirements or requirements for which he or she has been assessed shall inform the patient and the provider responsible for the medical assessment, if the provider is known to him or if his or her address has been communicated to him. The information includes information on the patient's medical condition which led to the suspicion that there was a change in medical fitness or medical condition. If the treating physician does not know the provider responsible for the medical assessment, he / she shall also notify his / her reasonable suspicion to the person who, by applying the medical assessment, creates rights or obligations if he / she is known to him or if his / her address has been communicated to him / her by the patient.

(3) In order to establish medical fitness or medical condition and to issue a medical opinion on the basis of the information referred to in paragraph 2, the person concerned shall be required to appear at the request of the provider responsible for the medical assessment or other authorised person within the designated medical examination period.

§ 46

(1) If the person or person under consideration who, by applying the medical opinion, arises rights or obligations for the improper medical assessment is the subject of a medical opinion, he may, within 10 working days of the date on which his demonstrable transfer, submit a proposal for his examination to the provider who issued the opinion. A person who, by applying the opinion, arises rights or obligations and who has been given the opinion by the person under consideration, may submit a proposal for a review of the medical opinion within 10 working days of the date of its transmission to the provider referred to in the first sentence. The right to review a medical opinion may be waived. The written declaration of surrender of the right to review a medical opinion or the record of an oral communication of surrender of the right to review a medical opinion shall be part of the medical file; the entry shall be endorsed by the person who waived the right to review the medical opinion and the health care professional who made the entry.

(2) Where a proposal to review a medical opinion has been submitted after the expiry of the period referred to in paragraph 1, the provider shall postpone the proposal. This shall be communicated in writing to the person who submitted the medical opinion and to the person who, by applying the medical opinion, arises rights or obligations, if he is aware, and to the person under consideration, not the persons who submitted the medical opinion. In demonstrating the serious reasons which the applicant or any other person authorised to submit a review proposal has objectively prevented the submission of the application within the time limit set, the provider shall forgive the delay in submitting the application. A request for remission of the time-limit for the submission of an application for review may be made within 10 working days of the date on which the reason for which the person referred to in the sentence of the second sentence has ceased to exist. The request for a period of remission shall be accompanied by a request for review, otherwise the provider shall not deal with it. If 60 days have elapsed since the date on which the application for review was to be submitted, the missing deadline may not be waived. The waiver of the delay shall be without prejudice to the time limits set for the application of the medical opinion. The provider shall immediately communicate in writing the postponement of the proposal for review of a medical opinion or the waiver of the deadline for the submission of a proposal for review or for the waiver of that period, including the grounds for such a request, to the person who made the review of a medical opinion and to the person who gives rise to rights or obligations by the application of the medical opinion, if known, and to the person concerned, not the persons who made the proposal.

(3) The proposal for a review of a medical opinion does not have a suspensive effect if it concludes that the person under assessment is unfit for the purpose for which he was assessed, disabled with or without long-term medical fitness, unless it is a condition repeated in the medical opinion issued for the same purpose and consists of the use of a particular compensated establishment or medical device.

(4) If the provider complies with the review proposal in full, the contested medical opinion shall be withdrawn without delay and, on the basis of the facts and, where appropriate, the reassessment of medical fitness, it shall issue a new opinion within the time limits referred to in paragraph 43 (1), with the period running from the date on which the review proposal was submitted. Evidence of cancellation is part of the patient's medical file.

(5) If the health review proposal provider fails in full, the file shall be forwarded to the competent administrative authority, including the relevant part of the medical file or a copy thereof, and other supporting documents necessary for the review of the medical opinion and its opinion.

(a) within 10 working days if there is a medical opinion on medical fitness;

(b) within 45 working days, if it is a medical opinion;

1. occupational diseases; or

2. pursuant to Paragraph 43 (1) (c),

(c) within 30 working days if it is a medical assessment in other cases;

from the date of receipt of the application for review. If the medical condition of the person under consideration needs to be examined or the conditions of the occupational disease checked, the time limits referred to in (b) or (c) may be extended by a further 30 working days.

(6) The application for review of a new medical opinion issued pursuant to paragraph 4 by the authorised person shall be forwarded by the provider together with the file to the competent administrative authority within the time limits laid down in paragraph 5.

(7) The provider shall immediately notify in writing the fact that the application for review of the medical opinion has been submitted to him, to the person who, by applying the medical opinion, creates rights or obligations, if he is aware of it, and to the person under consideration, not the persons who made the application. It shall likewise proceed if the proposal for a full review of the medical opinion or if the proposal for a review is submitted to the competent administrative authority. If the provider complies with the proposal for a full review of the assessment, it shall indicate in the communication according to the sentence of the first fact which led him to do so.

§ 47

(1) When reviewing the medical opinion, the competent administrative authority shall base its assessment on supporting documents submitted by the provider and determine whether:

(a) the assessment of the medical fitness or state of health of the person under consideration has been carried out and the medical assessment issued by the authorised provider and drawn up by the assessor with the relevant specialised competence;

(b) medical examinations have been carried out which are provided for by legislation or indicated by the assessor;

(c) the health status of the person assessed for the purposes of the health assessment has been established entirely to the extent provided for by the implementing legislation pursuant to § 52, 60 or 65 or other legislation24);

(d) when verifying conditions of occupational disease, it has been carried out in accordance with other legislation25); and

(e) the conclusion on the medical or health assessment is consistent with the medical status of the person under assessment at the time of the medical assessment.

(2) The competent administrative authority shall within 30 working days of the date of receipt of the application for medical examination.

(a) reject the application and confirm the contested medical opinion; or

(b) the affected medical opinion shall be revoked and returned to the provider for a new medical opinion; or

(c) the affected medical opinion shall be revoked.

The time limit referred to in the first sentence may be extended by the administrative authority for a further 15 working days in specific cases.

(3) The competent administrative authority may, to the extent necessary to review the medical opinion referred to in paragraph 1:

(a) to invite the provider to supplement the documents submitted by him, including the contract concluded pursuant to Articles 54 (2) (a) and 57a, while at the same time determining the period within which the provider is obliged to submit the documents; the provider is obliged to provide the necessary synergies;

(b) to request a professional opinion from competent persons under another legislation, where this is necessary for the proper assessment of the procedure for issuing a medical opinion on the medical fitness or health status of the person under consideration;

in such cases, the period referred to in paragraph 2 shall be interrupted.

(4) An administrative decision given pursuant to paragraph 2 shall not be appealed against. Save as otherwise provided in this law, the procedures referred to in paragraph 2 shall be governed by the provisions of the Administrative Code.

(5) If the competent administrative authority confirms the medical opinion, a new medical assessment or the medical condition of the person under assessment may be carried out only if it is clear from the medical examination that the assessment of his medical fitness or medical condition is likely to lead to a different conclusion from that of the medical opinion.

§ 48

(1) The assessment of medical fitness and the issue of a medical opinion pursuant to paragraphs 46 and 47 shall be treated in a similar manner to that provided by:

(a) The prison service, the proposal for a review of the medical assessment, shall be forwarded by the medical assessor to the director of the organization unit of the prison services in which the medical services are provided, which shall review the medical assessment pursuant to § 46; If the Director of the Prison Service Organisational Unit does not fully comply with the review proposal, it shall forward it to the Directorate-General of the Prison Service, which shall proceed in accordance with Paragraph 47,

(b) the safety information service, the proposal to review the medical assessment referred to in Article 46, shall be examined by the assessor; if the review proposal fails in full, it shall be forwarded to the Director of the Security Information Service, who shall act in accordance with Paragraph 47;

(c) the Office for Foreign Relations and Information, the proposal for review of the medical opinion referred to in Article 46 shall be examined by the medical assessor; if the application for review fails to comply in full, it shall be forwarded to the Director of the Office for Foreign Relations and to the information which shall proceed in accordance with Paragraph 47;

(d) Directorate-General for Customs, the proposal for a review of the medical opinion referred to in Article 46 shall be examined by the assessor; if the review proposal fails in full, it shall be forwarded to the Director-General of the Directorate-General for Customs, which shall proceed in accordance with Paragraph 47;

(e) the Ministry of the Interior, a proposal for a review of the medical assessment, shall be submitted by the medical assessor to the designated healthcare professional in the field of the Ministry of Interior or, where appropriate, by the organisational bodies of the State set up by him, in which the medical services are provided, which shall review the medical assessment pursuant to § 46; if the designated health care professional fails to fully comply with the review proposal, it shall forward it to the Ministry of the Interior, which shall proceed in accordance with Paragraph 47;

(f) the Ministry of Defence or the legal person set up by that Ministry, the proposal for a review of the medical assessment shall be forwarded by the medical assessor to the director or head of the health care service provider under the responsibility of the Ministry of Defence, who shall review the medical assessment pursuant to Article 46; if the proposal for a review fails in full, it shall be forwarded to the Ministry of Defence, which shall proceed in accordance with Paragraph 47.

(2) If there is a review of the medical opinion on the medical fitness of air personnel, the Civil Aviation Act shall be followed.

Common provisions for assessment and medical assessments

§ 49

(1) Paragraph 41 to 48 shall apply mutatis mutandis when assessing the health condition for the purposes of sickness insurance:

(a) evidence of a demonstrable transmission of a decision in respect of temporary incapacity for work to the person under consideration and of the need for care and care or the need for long-term care to the person who requested the health assessment shall be an entry in the medical file signed by the person under consideration or, in the case of transmission by the postal licence holder, an indication of the service on the delivery note; in the case of the use of electronic communication, proof of the dispatch of a decision in respect of temporary incapacity for work shall also be provided to the person under consideration by means of a data box or an alert stored on a computer in electronic form in the formats laid down by law with the function of authentication of stored data and a time stamp obtained through a state-recognised authority;

(b) the deadline for the submission of a review application pursuant to Article 46 (1) shall be 3 working days; the proposal has no suspensory effect,

(c) the deadline for referral of the review proposal pursuant to Article 46 (5) shall be 5 working days;

(d) the party to the review procedure shall be the provider of the decision and the person whose health is assessed; a proposal for a review of the decision may be made by that person or person who arises from rights or obligations by the application of the decision.

(2) If the patient cannot sign or refuse to sign the entry referred to in paragraph 1 (a) due to his or her medical condition, the health care professional shall record this in the medical file, indicating the reasons preventing the patient from signing; the record shall be signed by the health professional and the witness.

(3) The legislation on health assessment for the purposes of pension insurance, sickness insurance, state social assistance, assistance in kind, benefits of state social assistance and benefits for disabled persons is not affected by the provisions of this law.

(4) The provisions on the obligation to maintain confidentiality under another legislation shall apply in matters relating to medical care and medical assessments in such a way as not to shorten the procedural rights of the person under consideration and those who derive rights and obligations by applying it. This is without prejudice to other legislation which provides for an obligation to disclose certain facts and, where appropriate, an obligation to maintain certain facts of confidentiality.

§ 50

Paragraph 41 to 48 shall not apply when deciding on a sickness insurance institution for the purposes of sickness insurance under another legislation.

§ 51

Assessment of medical fitness for education, physical education and sport

(1) The medical fitness for education, including the simultaneous assessment of practical teaching and training, and during the course of the training, is assessed and the medical opinion on medical fitness is issued, unless otherwise specified, by the registrant of the person under assessment. Where the registrant does not have an assessor, another provider shall make an assessment; This shall be recorded in the medical file kept by the assessor and the record shall be signed by the assessor and the assessor. The medical assessor shall be a physician with specialised competence in the field of children and adolescents or in the field of pediatric medicine or general practice, unless otherwise provided for in this law or other legislation.

(2) In the case of applicants for education in schools and educational establishments established by the Ministry of Defence, they assess the medical fitness for education and the medical assessment of medical fitness is issued by the registrant. If the registrant does not have a registrant, the assessment shall be carried out and the medical assessment shall be issued by the health service provider to which the Ministry of Defence has granted authorisation to provide health services; a medical assessor is a physician with specialised competence in the field of assessment medicine, practical medicine for children and youth, pediatric or occupational medicine. An applicant for education in schools and school establishments established by the Ministry of Defence must also meet the medical requirements for the profession of a citizen in the professional service provided for by the Professional Soldier Act.

(3) Medical fitness for education, including practical teaching and practical training, shall not be assessed where the legislation governing the system of education in basic, secondary and higher vocational education does not lay down the conditions of medical fitness for education.

(4) A medical opinion on medical fitness is issued when practical teaching or practical training is carried out at the workplace of a legal or business natural person, where the person preparing for the pursuit of the profession is assigned to a risky job under the Public Health Protection Act (10), or if the activity for which the performance of the medical condition is provided for by the implementing legislation provided for in Paragraph 60 is a provider of occupational health services of that person. The medical assessor is the physician referred to in § 54 (1).

(5) The assessment of the medical fitness of a person preparing for the pursuit of a profession in the course of education before its inclusion in practical training or training referred to in paragraph 4 shall not be carried out if, in the context of practical teaching or practical training, an activity is carried out under conditions similar to those of the first and is not part of the activity for which the conditions of medical fitness are laid down in implementing legislation pursuant to § 60 or other legislation21).

(6) A pupil or a student may be sent for a medical examination in the course of education if there are reasonable doubts as to his / her fitness for education, practical instruction or practical training, at the request of a school, school establishment, pupil, student or legal representative in the case of underage pupils and students.

(7) Medical assessment on medical fitness

(a) for physical education in the framework of educational programmes for the release of teaching in the subject of physical education for at least the entire half-year of the school year, the registered provider shall:

(b) for performance sport, the registrant or provider in the field of physical medicine; performance sport means sport activity for the purposes of this Act, the main objective of which is the regular and systematic participation of an athlete in organised sports competitions,

(c) the person whose business is the exercise of sports activity is issued by the provider of physical medicine;

(d) for peak sport, the provider of physical medicine shall issue; This appropriation is intended to cover commitments remaining to be settled from previous years.

(e) for primary school education in sports and physical education classes and during teaching, the registrant or provider in the field of physical medicine, in secondary school classes in sport and physical education and during teaching is issued by the provider in the field of physical medicine;

(f) to study in a study programme carried out by a university or its Faculty of Sports and Physical Education and during the course of the study, the provider of physical medicine is issued by a provider.

(8) In the case of a medical opinion issued by a registrant, the medical assessor shall be a physician with specialised competence in the field of practical medicine for children and adolescents, pediatric or general practitioner. Where the registrant does not have an assessor, another provider shall make an assessment; This shall be recorded in the medical file kept by the assessor and the record shall be signed by the assessor and the assessor. In the case of a medical opinion issued by a provider in the field of physical medicine, the medical assessor is a doctor with special competence in the field of physical medicine.

(9) The legal person carrying out the activities of a school or a school establishment where training involving practical training or training is carried out shall be responsible for assessing the medical fitness of secondary school pupils or students of higher education, including medical examinations.

§ 52

Implementing legislation provides for:

(a) procedures for the provision of medical examinations, types, frequency and content of medical examinations necessary for the identification of the health status of the person under assessment and for the assessment of medical fitness, including the scope of the professional examinations;

(b) a list of diseases, conditions or defects which exclude or restrict medical fitness for education or during education, sport, physical education or other activities;

(c) the particulars and model of the medical opinion in relation to the activity under consideration;

(d) the details of the application for a medical examination and assessment of medical fitness for education.

Díl 2

Professional medical services, health promotion and medical assessment programmes of the person applying for employment

Professional medical services

§ 53

(1) Health services are preventive health services, which include an assessment of the impact of work, working environment and working conditions on health, carrying out occupational medical examinations which are preventive examinations, and an assessment of the health status for the purpose of assessing medical fitness for work, advice on health protection at work and protection against accidents at work, occupational diseases and diseases related to work, first aid training and regular supervision at work and performance.

(2) The employer shall provide occupational medical services for staff and persons seeking employment under the conditions laid down by this law and other legislation.

§ 54

(1) The provider of occupational medical services is:

(a) a provider of general medical practice; or

(b) a provider in the field of occupational medicine.

(2) Employer for the performance of work at his workplace, unless otherwise specified,

(a) it is obliged to conclude a written contract for the provision of occupational health services with the provider referred to in paragraph 1, if the work covered by the Act on the Protection of Public Health (10) falls within the category of first, second, second, second risk, third or fourth, or is part of the activity for which the conditions are laid down by other legislation;

(b) may, if the first category of work under the Public Health Protection Act is not part of the activity for which the conditions of medical fitness are laid down by implementing legislation pursuant to Paragraph 60 or other legislation, arrange for the conduct of occupational medical examinations, assessment of medical fitness for work and the issue of medical assessments on medical fitness for work on the basis of a written request from a provider which is a registered provider of a staff member or a person seeking employment, unless another legislation provides otherwise); other parts of the occupational medical services referred to in Article 53 (1) shall be provided by the employer, where this is justified for the protection of the health of workers, through the provider of occupational medical services with whom he enters into a contract to provide a particular service;

(c) it shall, if it is required to change the classification of a work in a category higher than that of the first, under the Public Health Protection Act or an activity whose performance is subject to implementing legislation pursuant to Paragraph 60 or other legislation, enter into a new or additional written contract with the provider referred to in paragraph 1 concerning those occupational services which it has not yet requested, no later than 3 months after the date on which the change took place.

(3) The registered provider of the staff member or person applying for employment, unless otherwise provided by other legislation20), is obliged, at the request of the employer referred to in paragraph 2 (b), to carry out an occupational medical examination, medical fitness assessment and to issue a medical opinion on medical fitness for work; for this activity, it is considered as a provider of occupational medical services (26). The obligations laid down in Paragraph 57 shall not apply to that provider of occupational medical services, except for the obligation under Paragraph 57 (1) (j).

(4) Assessment of medical fitness and occupational medical examinations, with the exception of initial medical examination, for work which is not yet classified under the Public Health Protection Act or for work which is or will be carried out in trial operations under another legislation which does not exceed 1 year, the employer shall provide the provider referred to in paragraph 2 (a) with whom he has concluded a written contract or in accordance with paragraph 2 (b) on the basis of the results of the risk assessment under another legislation. The initial medical examination shall be carried out by the employer on the basis of the data on the anticipated job placement of the person applying for the job, the type of work, the mode of work, the risk factors of the working conditions in relation to the specific work and the level of expected exposure to the risk factors of the working conditions assessed by the employer after consultation with the occupational service provider.

(5) The Agency provides occupational medical services for its staff, which it temporarily assigns to a user with whom it has concluded an agreement under the Labour Code on the temporary secondment of a staff member of the Agency to work with the user, through:

(a) providers of occupational medical services with whom they have concluded a written contract as referred to in paragraph 2 (a);

(b) the registered provider of the staff member upon written request pursuant to paragraph 2 (b); or

(c) the provider of the user's occupational medical services.

(6) At the request of the employer, the registrant is obliged to implement the provisions of Article 69 (1) (b)

(a) assessment of medical fitness for military active duty under the Law of Defense; or

(b) an occupational medical examination, an assessment of the medical fitness for the service of a soldier in reserve and a medical assessment of the medical fitness of a soldier in reserve prior to the profession of that soldier in a service under another legislation31), provided that such a service does not involve the performance of a work at risk under the Public Health Protection Act; paragraphs 2 to 4 shall not apply.

§ 55

(1) The employer shall:

(a) to allow persons authorised by the occupational health service provider, including the authorised persons of the occupational health service provider of the Agency, whose staff are assigned to such workplaces, to enter each of their workplaces and to provide them with the information necessary to evaluate and prevent risks to life or health at the workplace, including the results of measuring factors of working conditions, to provide them with technical documentation of the machinery and equipment, to provide them with information relevant to the protection of health at work, including data found in the verification of conditions of occupational diseases and, where appropriate, occupational accidents; in the case of workplaces which are subject to a special scheme by reason of state or other legally protected secrecy, only designated staff of the occupational health service provider who are obliged to comply with the special scheme shall enter those workplaces;

(b) maintain documentation on occupational medical services not related to specific staff whose content is provided for in the implementing legislation referred to in Article 60;

(c) to follow the conclusions of medical opinions on their medical fitness when including workers;

(d) when sending a staff member for an occupational medical examination, equipping him with an application for such an examination; the application shall contain the information provided for in the implementing act provided for in Article 60 and other information provided for in other legal provisions governing the requirements for medical fitness or medical detection;

(e) to send staff members for an emergency medical examination where the staff member so requested or has received an initiative pursuant to § 45 (2) or § 57 (1) (j);

(f) inform the occupational health service providers that the information provided for in the implementing legislation provided for in Article 60 for medical examinations after the end of the risk work has occurred for the employee.

(2) The employer has the right to send staff members for an emergency medical examination if he has doubts about the staff member's medical fitness to work.

§ 55a

Health Support Programme

(1) For the purposes of this Act, the Health Support Programme shall mean a set of measures which an employer may establish and offer to employees in order to enable the increased use of health prevention tools. The health promotion programme does not include measures which the employer is obliged to introduce under Part Five of the Labour Code. The employer shall evaluate the implemented health support programme at least once a year.

(2) In the event of the introduction of the health promotion programme referred to in paragraph 1, the employer shall cooperate with persons with demonstrable experience in the field of public health protection.

(3) The Ministry of Health shall establish a health prevention instrument provided under the Health Support Programme, a range of persons with whom the employer may cooperate in the provision of the Health Support Programme and a way of evaluating the Health Support Programme.

§ 56

The staff member shall:

(a) submit to:

1. occupational medical services with a provider of occupational medical services with whom the employer has concluded a written contract pursuant to § 54 (2) (a) or, where appropriate, with a provider of occupational medical services providing occupational medical services under a contract under § 57a; or

2. occupational medical examinations and medical assessments with the provider of occupational medical services pursuant to § 54 (2) (b) or § 58a (1) (a); and

3. other health services indicated by the occupational health service provider referred to in point 1 or 2 for health assessment; other health service providers shall be designated by the staff provider of the occupational medical services; other health services are part of the occupational medical services,

(b) submit to occupational medical services ordered under another legislation;

(c) to communicate to the occupational health service provider the name and address of the registrant and other providers who have taken him into custody;

(d) communicate to the occupational health service provider, at his request or on his own initiative, any known or suspected facts relating to the protection of health at work.

§ 57

(1) The provider of occupational medical services is obliged to:

(a) inform employees of the possible impact of working conditions factors on their health, with knowledge of the development of their health,

(b) inform the employer of the possible impact of working conditions factors on the health status of its employees;

(c) to implement, to the extent provided for by implementing legislation pursuant to § 60 and other legislation

1. occupational medical examinations,

2. regular supervision at the employer's workplace and of the work performed by staff; if the employer is a job agency, regular supervision is carried out at the workplace of the user;

(d) to cooperate with the employer, staff, health and safety representatives at work and with competent persons under the law governing the provision of additional conditions of safety and health at work11), trade unions and health and safety inspection bodies (12);

(e) notify the employer without delay of findings of serious or recurrent facts affecting safety and health at work;

(f) initiate the inspection authorities in the field of safety and health at work12), where workers' health is at risk, to carry out supervision at the employer's workplace in order to ensure safety and health at work13), in case they find that the employer does not comply with medical opinions or, despite repeated warnings, fails to fulfil the safety and health obligations laid down by other legislation;

(g) keep documentation on occupational medical services carried out for employers, which does not apply to specific employees whose content is provided for in the implementing legislation referred to in Article 60, separately from the medical documentation kept on specific staff;

(h) to keep separate patient-based medical documentation from employee-based medical documentation when providing occupational medical services, provided that it is both a registered patient provider and a provider of occupational medical services;

(i) to ensure or carry out the collection of biological material for the determination of the biological exposure test values laid down by other legislation27) or by the public health protection authority pursuant to the Public Health Protection Act or other legislation27), including the evaluation of the results of biological exposure tests and, when exceeding their values, inform the public health authority;

(j) without delay give the employer an incentive to request an emergency occupational medical examination if he receives information from the treating physician pursuant to § 45 (2);

(k) inform the staff of the medical examination carried out in connection with the termination of the risk work (hereinafter referred to as the "exit medical examination") of their entitlement to follow-up examinations under the Public Health Protection Act (10).

1. by the registering provider,

2. by a provider authorised to recognise occupational diseases; or

3. the provider of the employer's occupational medical services in the case of the duration of the employment relationship with that employer;

on the basis of information provided by the employer pursuant to Article 55 (1) (f); at the same time, the occupational health service provider shall transmit information on the staff member's health to the extent necessary to ensure the continuity of the necessary health services to the registrant, if known, and the staff member; This fact shall be recorded by the provider of occupational medical services in the medical file,

(l) issue medical opinions on the basis of a medical assessment by a medical assessor with specialised competence in the field of general medical practice or with specialised or specific competence in the field of occupational medicine.

(2) The provider of occupational health services shall be entitled to require the employer to ensure measurement and, where appropriate, expertise, in order to analyse working conditions, working environment and the response of the workers' body, including the results of categorisation of health risks, if he suspects that there has been a change in working conditions which adversely affects or could affect workers' health. The employer is obliged to provide the measurement or expertise required by the provider according to the first sentence. If the requirement to ensure such measurements or experts does not agree, the competent public health authority shall request an opinion under the Public Health Protection Act or the State Nuclear Safety Authority, if work is carried out in an ionising radiation14). The application shall state the reasons for the refusal to provide measurements or expertise as requested by the occupational health service provider.

(3) The competent public health authority under the Public Health Protection Act or the National Nuclear Safety Authority shall examine the reason for the employer's request and communicate its opinion in writing to the employer within 15 days of receipt of the request.

§ 57a

(1) A provider of occupational medical services having a contract with an employer pursuant to Article 54 (2) (a) may provide a part of the occupational medical services referred to in Article 53 (1) through another provider of occupational medical services (hereinafter referred to as the "authorised provider") on the basis of a written contract concluded with him, provided that such procedure is agreed in a written contract with the employer; this shall not affect the procedure laid down in Paragraph 42 (1).

(2) In particular, the contract concluded between the providers of occupational medical services referred to in paragraph 1 shall specify:

(a) part of the occupational medical services to be carried out by another provider;

(b) the place of provision of occupational medical services;

(c) the way in which information on occupational medical services provided is transmitted to each other;

(d) the way in which the provider of occupational medical services, through which he provides the part of the occupational medical service, will be familiar with the working conditions and risks at the workplace before the provision of occupational medical services begins and whenever the conditions or risks at the workplace change.

(3) The designated provider carrying out the medical assessment under the contract referred to in paragraph 1 shall, in the course of that activity, issue a medical opinion on its behalf.

§ 58

The employer shall pay the occupational medical services provided under this law, except:

(a) assessment of occupational diseases;

(b) monitoring the development of health status during medical preventive examinations for occupational diseases; and

(c) the development of health status in medical preventive examinations after the end of the risk work.

§ 58a

Ensuring occupational medical services by the employer on the basis of an employment relationship or equivalent

(1) An employer who has been authorised to provide health services under the Law on health services in the field referred to in § 54 (1) (a) or (b) may provide occupational medical services for the performance of work at his workplaces through:

(a) doctors with specialised competence or professional competence in the field of occupational medicine or with specialised competence in the field of general practical medicine; and

(b) other healthcare professionals involved in the provision of occupational medical services;

with whom he has entered into an employment relationship or similar. The employer shall ensure the professional independence of the staff referred to in points (a) and (b).

(2) When providing the occupational medical services referred to in paragraph 1

(a) means the person authorised by the provider pursuant to Article 55 (1) (a) by the health care professional referred to in paragraph 1;

(b) the staff member must submit to the occupational medical services of the doctor referred to in paragraph 1 (a); the facts referred to in Article 56 (c) and (d) are communicated to the physician,

(c) only a staff member who is the doctor referred to in paragraph 1 (a) may examine the medical assessment under Paragraph 46;

(d) the employer must:

1. to fulfil the obligations referred to in Article 57 through the health professionals referred to in paragraph 1;

2. ensure that other obligations and tasks laid down by this law or other legislation are carried out only through the health service providers referred to in paragraph 1.

§ 59

Assessment of the medical fitness of the person applying for employment

(1) In the case of a person applying for a job, the assessment of his / her fitness to work shall be treated in a similar manner to that of staff members in the framework of occupational medical services, provided that:

(a) the initial medical examination shall be carried out:

1. the provider of occupational medical services with whom the employer has a written contract, or the provider of occupational medical services carrying out occupational medical examinations under a contract pursuant to § 57a;

2. a registered provider to whom the employer has sent a person seeking employment, unless otherwise provided for in other legislation20), and where the work referred to in Paragraph 54 (2) (b) is concerned; or

3. the employer's doctor referred to in § 58a (1) (a),

4. the registering provider, at the employer's request, pursuant to Article 69 (1) (b), if it is for the work referred to in Article 54 (6),

(b) the employer shall ensure an initial medical examination whenever a person seeking employment is to be assigned to a work which is categorised as second, second risk, third or fourth under the Public Health Protection Act, unless otherwise provided, or where the activity for which the medical conditions are laid down in implementing legislation pursuant to § 60 or other legislation is to be part of that work, before the establishment of

1. employment,

2. a legal relationship based on an agreement on work outside the employment relationship if the person applying for employment is to be assigned to a job which is at risk under the Law on the Protection of Public Health of Labour; or

3. the relationship of a similar relationship to an employment lawyer,

(c) the person applying for employment shall be considered to be unfit for work to which he is to be assigned if he does not undergo an initial medical examination if he is seconded to it;

(d) the employer has the right to require an initial medical examination of a person seeking work who is not at risk under the Law on the Protection of Public Health for Work and whose performance is not subject to the conditions of medical fitness laid down in the implementing legislation referred to in Article 60 or other legislation; if the employer does not require an initial medical examination, the person applying for a job shall be considered to be fit to perform the work to which he is to be assigned, until proven otherwise; If the staff member requires an entry visit, the employer shall issue a request for such an entry visit.

(2) The entry medical examination shall be paid by the person applying for the job. The employer shall pay the person applying for employment for an initial medical examination if he or she has an employment relationship with him or her. The first and second sentences shall not apply if the person applying for employment agrees to pay for the entry medical examination with any employer even in the event of failure to conclude a work relationship or similar relationship, or if the legislation provides otherwise. An initial medical examination, if it is about assessing the medical fitness of a person applying for a job at night, shall be paid by any employer.

§ 60

Implementing legislation, unless otherwise provided for by other legislation15) provides

(a) procedures for the provision and conduct of medical examinations, types, frequency and content of medical examinations necessary for the identification of the medical condition of the person under assessment and for the assessment of medical fitness, including the scope of the professional examinations;

(b) the organisation, content and scope of occupational medical services and the content of documentation on occupational medical services not related to a specific employee, managed by a provider of occupational medical services and an employer;

(c) medical fitness conditions for work or service and activities, including risk factors for the working environment and diseases, conditions and defects which, when these factors occur, exclude or restrict medical fitness for work or service;

(d) the details of the application for an occupational medical examination and medical fitness assessment;

(e) the particulars and the model of the medical opinion in relation to the activity and formalities to be considered and the model of the certificate of completion;

(f) the reasons why it is not necessary to require an extract from the health file of the registrant, or, where appropriate, a certificate of unaltered health, for the purpose of assessing medical fitness or health status;

(g) replacement procedures, organisation and implementation of occupational medical services when declaring an emergency state, a state of danger, a state of war under the Constitutional Law on the Security of the Czech Republic and the Constitution of the Czech Republic, or in the regulation of emergency measures in the event of an epidemic and the risk of its occurrence under the Act on the Protection of Public Health, provided that such conditions and measures are declared for the whole territory of the Czech Republic.

Díl 3

Occupational diseases

Oddíl 1

Assessment and recognition of occupational diseases

§ 61

(1) The health status of a person in relation to an occupational disease is ascertained and assessed by providers of occupational medical services.

(2) Occupational diseases are assessed, recognised and developed by persons with recognised occupational disease, to be monitored by providers in the field of occupational medicine who are authorised by the Ministry to recognise occupational diseases, unless otherwise specified. for these purposes, they may also carry out, where appropriate, medical examination. The medical assessor is a doctor with specialised competence or specific competence in the field of occupational medicine.

§ 62

(1) The provider referred to in Paragraph 61 (2) recognises occupational diseases on the basis of:

(a) the identification of the health status by the provider referred to in Article 61 (1), including the identification of the health status prior to the occurrence of the disease and the results of the professional examinations requested by him and his opinion;

(b) the results of further expert examinations, where justified, requested or carried out by the provider referred to in Article 61 (2); and

(c) verification of the conditions for the emergence of occupational diseases referred to in paragraph 3.

(2) The provider referred to in Article 61 (1) and the registrant for the purpose of assessing and recognising an occupational disease shall transmit to the provider referred to in Article 61 (2) a copy of the medical documentation to the extent necessary to assess the disease. Similarly, unless the disease of the person under assessment continues to satisfy the conditions for the duration of the occupational disease laid down in the implementing legislation under Paragraph 65.

(3) Verification of conditions for the emergence of diseases from the profession (16)

(a) the competent public health authorities under the Public Health Protection Act;

(b) the State Nuclear Safety Authority, if it is suspected of developing an occupational disease in connection with work under conditions of ionising radiation;

(c) the provider of occupational medical services referred to in Paragraph 61 (2), if there is a suspicion of an occupational disease occurring in the course of work abroad to which the employee has been seconded by an employer based in the Czech Republic, on the basis of a communication by the person examined and a detailed written statement by the sending employer on the conditions under which the work was carried out abroad and, where appropriate, other findings from the place of work.

The results of the verification of the conditions of an occupational disease are binding on providers of occupational disease assessment.

(4) In the case of persons resident abroad, the assessment and recognition of occupational diseases shall be based on a medical report issued in the country of residence of the person under assessment and verified by the competent authority of the country, unless the declared international agreements by which the Czech Republic is bound otherwise result; the medical report must be accompanied by an officially certified translation into the Czech language; the translation is not required if it is a medical report in the Slovak language.

(5) It must be clear from the conclusion of the medical opinion whether the disease of the person under consideration is recognised or not recognised as an occupational disease, or whether the disease of the person under examination no longer fulfils the conditions for the recognition of an occupational disease laid down in the implementing legislation provided for in Article 65. The provider referred to in Article 61 (2), which has issued a medical opinion, shall without delay ensure that it can be communicated to the persons referred to in Article 44 (1) and to other persons who, by applying the medical opinion, derive rights or obligations whose scope is defined by the implementing legislation referred to in Article 65.

§ 63

(1) The medical practitioner shall send to the provider referred to in § 61 (1) or (2) a person who, following a professional examination, has incurred a reasonable suspicion of an occupational disease or to the provider referred to in § 61 (2) if it is suspected that the disease no longer fulfils the conditions for the recognition of an occupational disease. The obligation to send a staff member to a provider referred to in Article 61 (1) or (2) shall also lie with the employer, if he has reason to suspect the occurrence of an occupational disease, or with the provider referred to in Article 61 (2), if he suspects that the disease no longer fulfils the conditions for the recognition of an occupational disease.

(2) Where the provider referred to in Article 61 (2) finds that he has been based on incorrect data in the assessment of an occupational disease, he shall inform the person concerned and the persons to whom rights and obligations arise in connection with the application of the medical opinion, if known, and shall carry out a reassessment of the health status of the person under assessment on his own initiative; on the basis of a reassessment, it shall issue a new medical opinion and arrange for its immediate transmission to the persons referred to in Article 44 (1) and to other persons whose scope is defined by the implementing legislation referred to in Article 65.

(3) Where an occupational disease is suspected or suspected that the disease no longer fulfils the conditions for the recognition of an occupational disease, the person concerned shall be required to undergo the expert examination indicated by the provider referred to in Paragraph 61 (1) or (2), with the provider designated by that provider. The provider referred to in Paragraph 61 (1) or (2) shall communicate to the designated provider the facts which led to the suspicion under the first sentence. The designated provider shall carry out a professional examination within a period agreed with the person under consideration, but not more than 30 days from the date of communication by the provider of occupational medical services.

(4) If the person concerned refuses to undergo a professional examination, he shall be regarded as not suffering from an occupational disease. That fact must be communicated by the provider in a verifiable manner to the person liable for compensation for injury and other non-material injury, if known. No medical evaluation.

(5) The assessment of an occupational disease may not be terminated at the request of a patient who is the subject of an assessment or of another authorised person, provided that the conditions of the disease for the assessment of an occupational disease have already been verified.

§ 64

The employer shall be obliged to allow the authorised staff of the provider referred to in Paragraph 61 (1) or (2) to enter the workplace where the staff member or former staff member works or has worked under the conditions under which the occupational disease under assessment arises, in order to establish further facts or to carry out a clinical test or to take a sample of the material or to obtain an audiovisual record necessary to assess the occupational disease. The employer shall also be obliged to allow the former employee to enter the workplace in order to ensure the objectivity of the investigation and to verify the conditions of the occupational disease. The employer shall also be obliged to allow access to the workplaces entrusted to the staff of the public health authority under Article 62 (3) (a) and of the State Office for Nuclear Safety pursuant to Article 62 (3) (b) for the purpose of verifying the conditions of the emergence of occupational diseases.

§ 65

Implementing legislation provides for:

(a) closer requirements for the procedure for the assessment and recognition of occupational disease;

(b) closer requirements for the procedure for the assessment of occupational disease where the disease no longer fulfils the conditions of the occupational disease;

(c) the number of persons to whom the providers referred to in Article 61 (2) transmit a medical opinion on occupational disease;

(d) conditions under which the disease can no longer be recognised as an occupational disease;

(e) the particulars of a medical opinion recognising an occupational disease or not recognised as an occupational disease.

Oddíl 2

Authorisation for the recognition of occupational diseases

§ 66

(1) The Ministry shall grant authorisation for the recognition of occupational diseases to the occupational health care provider, on the basis of his request, which shall include:

(a) the provider's identification data;

(b) a copy of the authorisation to provide health services in the field of occupational medicine;

(c) the extent and volume of health services which it is able to provide and their minimum staff security;

(d) the duration of the provision of occupational medical services, which must last at least 5 years;

(e) technical and physical equipment of the medical establishment.

(2) The provider may submit an application following a call published by the Ministry. The Ministry's invitation shall include:

(a) the place where applications are submitted;

(b) the time limit for submission of applications;

(c) the territory for which health services are to be provided;

(d) the scope and volume requirements of the required health services.

(3) The Ministry, after examining the supporting documents in individual applicants' applications and the facts set out therein, shall exclude providers that have not complied with the conditions set out in the invitation and, for the others, determine the order in relation to the territory for which health services are to be provided. The criteria for determining the ranking of applicants are the qualification assumption, the duration and extent of the practice and the scope of the services offered. Authorisations for the recognition of occupational diseases may be granted to providers in the order specified in the first sentence. The authorisation shall be granted for a period of 10 years.

(4) The Ministry may grant authorisation for the recognition of occupational diseases on the basis of a designated ranking only to the provider,

(a) providing occupational medical services for at least five years; and

(b) for which the assessment and recognition of occupational diseases are carried out by doctors with specialised competence or specific professional competence in the field of occupational medicine, the sum of weekly working hours, fixed or shorter, shall be at least 80 hours, of which 40 hours may be worked by more than one doctor.

(5) Authorisation for the recognition of occupational diseases contains:

(a) the particulars referred to in paragraph 1 (a);

(b) the definition of the territory for which health services are to be provided;

(c) the scope and volume of health services provided.

(6) The Ministry will publish the list of providers to whom it has granted authorisation for the recognition of occupational diseases in a way that allows remote access.

§ 66a

(1) The Ministry shall, on its own initiative, decide which of the providers in the field of occupational medicine holding an authorisation for the recognition of occupational diseases, taking into account its availability for patients, the assessment and recognition of occupational diseases, provided that:

(a) no provider of occupational medical services shall submit an application for authorisation for the recognition of occupational diseases pursuant to Article 66 (1) following a call by the Ministry pursuant to Article 66 (2);

(b) the condition of the assessment of occupational diseases by doctors with specialised competence or specific professional competence in the field of occupational medicine is not fulfilled by the applicant for authorisation for the recognition of occupational diseases, the sum of the weekly working hours, fixed or shorter, for such doctors being at least 80 hours, of which 40 hours may be worked by more than one doctor; or

(c) the authorisation for the recognition of occupational diseases shall expire in accordance with Article 68 (1).

(2) Ministry

(a) may only designate, by decision referred to in paragraph 1, a provider of occupational medical services who provides occupational medical services for a period of at least 5 years and for which the assessment and recognition of occupational diseases are carried out by doctors with specialised competence or specific professional competence in the field of occupational medicine, the sum of the weekly working hours, fixed or shorter, for those doctors being at least 80 hours, of which 40 hours may be worked by several doctors;

(b) in the decision referred to in paragraph 1, define the territory for which health services are to be provided, the extent and volume of health services provided and the duration of the assessment and recognition of an occupational disease.

§ 67

The provider shall notify the Ministry in writing of changes to all data and conditions under which authorisation for the recognition of occupational diseases has been granted, within 15 days of the date of origin.

§ 68

(1) Authorisation for the recognition of occupational diseases

(a) the date of expiry of the authorisation to provide health services in the field of occupational medicine;

(b) withdraw authorisation by the Ministry.

(2) Ministry of Authorisation for the recognition of occupational diseases

(a) withdraw if the provider so requests or does not provide a health service for the territory indicated in the authorisation;

(b) may withdraw if the supplier:

1. no longer fulfils any of the conditions laid down in § 66 (1) (e) or § 66 (5) (c);

2. has seriously or repeatedly infringed the obligation laid down for the recognition of occupational diseases by this law or other legislation.

(3) If a provider has not been granted a new authorisation for the recognition of occupational diseases after the end of the period for which he has been authorised to recognise occupational diseases, the provisions of the Health Services Act governing the treatment of medical documentation at the end of the period for which he has been authorised to recognise occupational diseases shall apply mutatis mutandis, with the Ministry taking over the medical documentation by the time of its transmission to the new provider responsible for the recognition of occupational diseases.

Díl 4

Common provisions for the assessment of medical fitness for work, the performance of civil service, occupational medical services and the assessment and recognition of occupational diseases among members of the Security Corps and Armed Forces and prisoners

§ 69

(1) The employer shall also:

(a) a Security Corps which exercises the rights and obligations under another legislation in respect of a natural person serving in the Security Corps (hereinafter referred to as "member of the Security Corps");

(b) the armed forces of the Czech Republic which exercise rights and obligations under another law in respect of a member of their service;

(c) prisons and institutions for the exercise of security detention, if they are persons in the execution of a prison sentence, detention or detention;

(d) a service body under the Civil Service Act.

(2) Where the Prison Service is an employer, it shall provide occupational medical services to staff and persons in custody, a custodial sentence or security detention in its healthcare establishments; If occupational medical services cannot be provided, they shall be provided by the Prison Service with another occupational medical service provider.

(3) Employee is also a member of the Security Corps or a member of the armed forces of the Czech Republic in an employment relationship or a civil servant under another legislation. Employee shall also mean persons in custody, imprisonment or security detention, if they are assigned to work.

(4) The place of work shall also mean the place provided for by other legislation.

(5) Authorisations for the recognition of occupational diseases in active duty soldiers and soldiers whose service has ceased to exist where an occupational disease has occurred during the course of their service, pupils and students of military schools are granted to a provider in the field of occupational medicine authorised to provide health services by the Ministry of Defence; Paragraph 66 to 68 shall not apply.

§ 69a

When assessing the medical fitness of a member of the service in the Security Corps or in the armed forces of the Czech Republic or of a citizen applying for admission to service to the Security Corps, or of an applicant for employment in the Armed Forces, or of a civil servant for the performance of a national service or an applicant for admission to service in a civil service, this Act shall be applied, unless otherwise provided for by other legislation.

§ 69b

The provisions of this Title shall not apply to insolvency proceedings, exceptional service professions and the pursuit of exceptional service activities; when assessing the medical fitness of a citizen and a soldier, the law of law shall be applied.

HLAVA V

Medicinal Radiation and CLINICAL AUDITS

Díl 1

Medical exposure

§ 70

(1) Medical exposure means exposure to natural persons under another legislation.

(2) For the purposes of this Act, clinical responsibility means responsibility for:

(a) a justification for medical exposure;

(b) the practical part of the medical exposure;

(c) evaluation of the quality of medical exposure;

(d) clinical evaluation of medical exposure; or

(e) physical-technical part of medical exposure.

The carrier of clinical responsibility shall be the practitioner within the scope of his professional capacity.

(3) Indicative physician means any treating physician or dental practitioner who, by means of a request under other legislation23) recommended that a patient be exposed to medical exposure; a request is not required if the same person is the indicating doctor and the practitioner with clinical responsibility for justifying the medical exposure. The physician must assess all information about the patient's medical condition relevant to the medical exposure known to him in order to avoid unnecessary exposure to the patient.

(4) An application expert shall mean a doctor, dental practitioner or other healthcare professional authorised to carry out the activities referred to in paragraph 2.

(5) National radiological standards are the procedures set out for standard health performance in the provision of health services involving medical exposure corresponding to current knowledge of science and clinical medicine ("national radiological standards'). National Radiological Standards are issued by the Ministry in agreement with the State Office for Nuclear Safety; publish them, including their updating, at least every 10 years in the Ministry of Health Bulletin and in a way that allows remote access.

(6) Radiological equipment means a medical device used for investigation or treatment in nuclear medicine, radiotherapy or radiodiagnostic equipment, which is a source of ionising radiation, imaging or detection system in nuclear medicine, or may affect the level of exposure of persons exposed to medical radiation.

§ 71

(1) A provider providing health services involving medical exposure is obliged to:

(a) to perform medical exposure only if its justification indicates that the potential diagnostic or therapeutic benefit, including the benefit to the patient's health or to society, is higher than the damage that medical exposure may cause;

(b) develop and ensure compliance with local radiological standards for all performance normally performed; the development of local radiological standards shall be based on national radiological standards, where available, specific conditions at the workplace of the medical establishment and the scope of the health services provided; in the event of the introduction of a new medical exposure method and national radiological standards not yet developed, it shall provide its local radiological standard and, where appropriate, other necessary information to the Ministry as a basis for the development of a national radiological standard without undue delay from the introduction of that method,

(c) carry out an internal clinical audit, evaluate the findings made on the basis of it, propose solutions to identified non-conformities, determine the date for their removal and remove them;

(d) ensure that an external clinical audit is carried out by authorised persons, evaluate the findings made on its basis, propose solutions to the non-conformities identified, determine and remove the date for their removal;

(e) ensure compliance with radiation protection rules and procedures in the provision of health services involving medical exposure, including:

1. provision of occupational medical services,

2. screening,

3. verification of the non-implemented method and of the biomedical research programme;

4. the provision of health services to patients who may or may have been exposed during pregnancy and breast-feeding and to minor patients.

The obligations referred to in points (b) and (d) shall not apply where there is medical exposure within dental radiodiagnostic and bone densitometry; in such cases, providers shall comply with national radiological standards, specific workplace conditions and the scope of the health services provided.

(2) The provider is also obliged to ensure that:

(a) local radiological standards are available to all healthcare professionals involved in the provision of health services involving medical exposure;

(b) in the provision of health services involving medical exposure, the relevant medical exposure-related activities were carried out only by a qualified healthcare professional and made available to that health professional at the work of the provider;

(c) optimisation of radiation protection has been carried out when providing health services involving medical exposure;

(d) follow-up theoretical and practical training of health professionals involved in the provision of health services involving medical exposure, taking into account new medical knowledge;

(e) measures are taken to prevent radiological incidents and radiological incidents;

(f) a list of application experts has been kept at the workplace.

(3) At the request of a provider providing medical treatment, a registered patient provider is required to provide written information on the patient's medical status relevant to the medical exposure. This is without prejudice to the obligation under the Health Services Act to provide the information necessary to ensure the continuity of health services.

(4) The justification for the medical exposure shall be carried out by the indicating physician and the practitioner with clinical responsibility for the justification of the medical exposure; This justification is based on the indicative criteria which are part of national radiological standards. In specific cases where the justification for a medical exposure cannot be based on the indication criteria in the first sentence, it may be performed provided that a net benefit to the patient's health is demonstrated in comparison with the damage that the medical exposure may cause; the assessment of the patient's net benefit is carried out by the main practitioner in accordance with § 73 (1) (a). When performing the medical exposure referred to in the second sentence, procedures corresponding to national radiological standards shall be used as far as possible.

(5) Where the Ministry receives from the provider a local radiological standard and related information for the new medical exposure method referred to in paragraph 1 (b), it shall assess its accuracy and novelty and, on the basis of that assessment, draw up a national radiological standard or inform the provider that it has not found any reason for such a procedure on the basis of the evidence submitted by it. If the Ministry finds that the documents referred to in the first sentence are incorrect, it shall inform the provider without undue delay of this fact and recommend measures to remedy it.

(6) Medical exposure under preventive care must be carried out in accordance with an optimisation study in accordance with Section 73 (2) (g) which has shown that the social benefits of the examination are higher than possible.

§ 72

(1) The medical exposure used in the verification of the non-established method may be performed only in specially justified cases and using appropriate techniques in such a way that procedures are used as far as possible in line with national radiological standards.

(2) The provisions on the verification of non-established methods shall apply mutatis mutandis to the exposure of healthy persons or patients in the framework of voluntary participation in a biomedical research programme, including those which are not intended to benefit directly from health benefits for persons undergoing exposure, unless the medical exposure has already been assessed by the Ethics Commission under another legislation.

(3) The implementing act provides for:

(a) the rules and procedures for radiation protection in the provision of health services involving medical exposure, including verification of the non-established method and of the biomedical research programme and the provision of health services to patients who may or may have been or have been exposed during pregnancy and breastfeeding, and to minor patients;

(b) the content of the activities of indicating doctors, practitioners and other staff involved in the provision of medical exposure services, as referred to in Article 70 (2);

(c) the scope and manner of optimisation of radiation protection in medical exposure pursuant to Article 71 (2) (c);

(d) the rules for carrying out the internal clinical audit referred to in Article 74;

(e) requirements for minimum staff security of external clinical audit, the rules for its implementation and the way in which it is assessed pursuant to § 75 (3) (d) and (e).

§ 73

(1) National radiological standards include at least:

(a) the requirements for the professional, specialised, specific and specialised competence of health professionals involved in medical exposure, the description of their activities and the clinical responsibility for medical exposure, including the identification of the principal practitioner for the type of medical exposure;

(b) the technical parameters of the radiological devices used for medical exposure and the way in which they are set up and used;

(c) radiological procedures and requirements for the course of the provision of health services involving medical exposure;

(d) requirements for patient preparation prior to the provision of medical services involving medical exposure.

(2) Furthermore, national radiological standards may include:

(a) a description of the procedure for justifying medical exposure;

(b) requirements for the content of the requisition in excess of those laid down by other legislation23);

(c) indication criteria for the justification of medical exposure;

(d) contraindication to medical exposure,

(e) the method of determining the radiation burden on patients and the requirements for supporting evidence necessary for the estimation of the dose, the method of evaluation and the evidence;

(f) diagnostic reference level32), the method of their determination and treatment when assessing the optimisation of medical exposure;

(g) an optimisation study to perform medical exposure in preventive care.

Díl 2

Clinical audits

§ 74

(1) The objective of the internal clinical audit is to verify and assess whether medical services included in the medical exposure are carried out in accordance with local radiological standards, whether the rules and procedures of radiation protection laid down in the implementing legislation for their provision are complied with and whether the non-conformities identified during the external clinical audit have been remedied.

(2) Internal clinical audit shall be carried out through healthcare professionals with specialised competence in the area in which the internal audit is to be carried out who are involved in the provision of health services involving medical exposure at least once,

(a) the year in which medical exposure is carried out in the field of radiation oncology or in the framework of the provision of medical care in the field of nuclear medicine;

(b) 2 years, if it is a computational tomography, a nuclear medicine facility with hybrid devices or if it is an intervention medical performance using medical exposure; if not carried out in accordance with point (a),

(c) 6 years of dental radiodiagnostic and bone densitometry,

(d) 3 years if it is about performing medical exposure in cases not covered by points (a) to (c).

(3) The provider shall keep a record of internal clinical audits carried out, recording the date of the audit, the findings made on the basis thereof in relation to the objective set out in paragraph 1 and, where appropriate, the name and surname of the persons who carried out the internal clinical audit, including information on their fitness to pursue the medical profession.

§ 75

(1) The objective of the external clinical audit is to verify and evaluate compliance with local radiological standards and radiation protection rules and procedures laid down in the implementing legislation for the provision of medical exposure services with a view to improving the quality and results of healthcare provided. In the context of an external clinical audit, medical radiological activities, procedures and results are compared with national radiological standards, taking into account the local conditions and scope of the health services provided, and with good practice rules. Where appropriate, the providers in the framework of an external clinical audit shall be recommended to remedy measures. The provider of medical services involving medical exposure shall be required to undergo an external clinical audit at least once after:

(a) 5 years, when it comes to performing medical exposure in the field of radiation oncology or in the provision of medical treatment in the field of nuclear medicine,

(b) 6 years, if it is a computer tomography workplace, a nuclear medicine facility with hybrid devices or if it is an intervention medical performance using medical exposure; if not carried out in accordance with point (a),

(c) 7 years if it is about performing medical exposure in cases not referred to in (a) or (b).

(2) An external clinical audit may be carried out by a legal person authorised by the Ministry to carry out this activity on the basis of a consistent binding opinion of the State Office for Nuclear Security on personnel security and the rules for carrying out an external clinical audit on the medical exposure for which the authorisation is to be granted. The Ministry shall request a binding opinion before issuing a decision granting authorisation to conduct an external clinical audit. The authorisation to carry out an external clinical audit may not be transferred or transferred to another legal person.

(3) The Ministry shall authorise the legal person to carry out an external clinical audit at his written request if:

(a) is not a provider or member or member of a statutory or supervisory body of a legal person which is a provider or health insurance undertaking;

(b) a member of its statutory or supervisory body is not at the same time a member or a member of the statutory or supervisory body of another provider and is neither a provider;

(c) does not act in conformity with the provider or health insurance undertaking or otherwise do not act in conformity with the provider or health insurance undertaking members of its statutory or supervisory body;

(d) it has detailed rules for carrying out external clinical audits for the various areas of medical exposure for which authorisation is sought; medical exposure areas means:

1. radiodiagnostic,

2. radiation oncology,

3. nuclear medicine,

4. intervention radiology,

5. interventional cardiology; and

(e) is staffed to carry out an external clinical audit to the extent that authorisation is sought.

§ 76

(1) The application for authorisation to carry out an external clinical audit, in addition to the formalities laid down in the administrative rules, must include the area of medical exposure for which the authorisation is to be granted.

(2) The applicant shall attach to the application for authorisation to carry out an external clinical audit:

(a) a declaration that it fulfils the conditions set out in Article 75 (3) (a) and (c);

(b) a declaration by the members of the statutory or supervisory body that they fulfil the conditions laid down in Article 75 (3) (b) and (c);

(c) proof that a legal person has been established or established if it is not registered in a commercial or similar register or if the registration has not yet been carried out; where the applicant is a legal person having its registered office outside the Czech Republic, he shall attach an extract from a commercial or similar register held in the State of the registered office which may not be more than 3 months old;

(d) a list of the persons through whom the external clinical audit will be carried out, specifying the name and, where applicable, the names and surnames, including evidence of their fitness to pursue the medical profession and experience achieved, provided that such practice under the implementing legislation is a condition for carrying out an external clinical audit; the list shall also specify which persons will be responsible to the applicant for carrying out an external clinical audit of the medical exposure for which the authorisation is to be granted,

(e) the rules for carrying out an external clinical audit in the field of medical exposure for which authorisation is to be granted; the rules must comply with the requirements of this law and the principles of good practice.

§ 77

(1) The decision to grant an authorisation to carry out an external clinical audit, in addition to the formalities laid down in the administrative rules, includes the areas of medical exposure for which the authorisation is granted.

(2) The Ministry shall send a copy of the written copy of the decision granting the authorisation to carry out an external clinical audit within 30 days of the date of the acquisition of the legal authority of the decision to the locally competent tax administration of income tax, the locally competent local social security administration and the State Office for Nuclear Security.

(3) The Ministry shall publish a list of persons authorised to carry out an external clinical audit, indicating the information referred to in paragraph 1 in a manner that allows remote access.

§ 78

(1) A legal person authorised to carry out an external clinical audit is required to publish the rules for carrying out an external clinical audit in accordance with Article 76 (2) (e) in a way that allows remote access within 15 days of the date on which the decision granting the authorisation to carry out an external clinical audit becomes final. Where such rules are amended, that legal person shall publish their current wording in the same manner within 15 days of the date of the change.

(2) A legal person who has been authorised to carry out an external clinical audit is required to notify the Ministry in writing of any changes to the information contained in the authorisation decision, the application for authorisation and the documents submitted with that application, and to provide evidence of such changes with appropriate evidence. Amendments to the data referred to in the first sentence shall be notified within 15 days of the date on which they occurred.

(3) Where an amendment to the data referred to in paragraph 2 concerns:

(a) the extension of the list of persons through which an external clinical audit will be carried out pursuant to Article 76 (2) (d); or

(b) the rules for carrying out the external clinical audit referred to in Article 76 (2) (e);

Paragraph 75 (2) shall apply mutatis mutandis, provided that the conditions laid down for carrying out an external clinical audit continue to be fulfilled, the Ministry shall issue a certificate of compliance; until such time as this certificate is issued, a legal person authorised to carry out an external clinical audit shall proceed in accordance with the existing rules for carrying out an external clinical audit pursuant to Section 76 (2) (e) and may only carry out an external clinical audit through natural persons not affected by changes in the document referred to in Section 76 (2) (d).

(4) Where the change referred to in paragraph 2 relates to other data not specified in the decision granting authorisation to carry out an external clinical audit and the conditions laid down for carrying out an external clinical audit continue to be fulfilled, the Ministry shall record that change in the file; in other cases, the Ministry shall decide, as the case may be, to amend the authorisation or to withdraw it.

§ 79

(1) The authorisation to carry out an external clinical audit is no longer valid

(a) the disappearance of a legal person who has received such authorisation;

(b) the removal from the Commercial Register of legal persons having their registered office outside the Czech Republic;

(c) a decision by the Ministry to withdraw the authorisation.

(2) The Ministry shall withdraw the authorisation to carry out an external clinical audit if the legal entity which has been granted:

(a) no longer fulfils any of the conditions laid down in Paragraph 75 (3); or

(b) request the withdrawal of the authorisation.

(3) The Ministry may withdraw the authorisation to carry out an external clinical audit if a legal person has seriously or repeatedly infringed any of the obligations referred to in § 78 (1), (2) or (3) or has carried out an external clinical audit through a person excluded from carrying out an external clinical audit under § 81 (3).

§ 80

The Ministry shall send a copy of the written copy of the decision amending or withdrawing the authorisation to carry out an external clinical audit within 30 days of the date on which the decision is taken to the authorities referred to in Article 77 (2).

§ 81

(1) The legal person authorised to carry out an external clinical audit shall carry out an external clinical audit on the basis of a contract concluded between the provider and that person.

(2) The legal person carrying out an external clinical audit is obliged to:

(a) proceed impartially;

(b) comply with the rules for carrying out an external clinical audit in the field of medical exposure referred to in Article 75 (3) (d);

(c) carry out external clinical audits only through the persons listed in Section 76 (2) (d).

(3) An external clinical audit shall exclude a person who is in a legal or similar relationship with the provider for whom the audit is to be carried out or who is an expert representative for that provider or is a member of that provider, its statutory body or a member of the statutory authority or its supervisory authority.

§ 82

(1) A legal person who has carried out an external clinical audit shall issue a report to the provider on the conduct of an external clinical audit (hereinafter referred to as the "report") and send it on request to the Ministry within 30 days of the date of receipt of the Ministry's written request.

(2) The report shall contain:

(a) details of the legal person who carried out the external clinical audit, the business firm or the name and address of the registered office and the identification number, if any;

(b) details of the provider:

1. in the case of a natural person, name, surname and address of the place of permanent residence in the Czech Republic or, in the case of a natural person without a permanent residence in the Czech Republic, address of residence outside the Czech Republic and, where applicable, place of registered residence in the Czech Republic, identification number, if assigned, and date of birth,

2. in the case of a legal person, the commercial firm or the name, address of the registered office and identification number, if assigned;

(c) the areas of medical exposure for which an external clinical audit has been carried out and the place or places of provision of health services;

(d) a description of the progress and findings of the external clinical audit, an evaluation of these findings in the light of the objectives set out in Article 75 (1) and corrective measures, if recommended;

(e) the date of issue of the report.

(3) A legal person who has carried out an external clinical audit shall, upon request, issue a certificate to the provider to carry out an external clinical audit. The certificate shall contain the information referred to in points (a) to (c) and (e) of paragraph 2.

(4) A legal person carrying out an external clinical audit shall keep records of the providers for which it has carried out an external clinical audit.

(5) In addition to the provider for which an external clinical audit has been carried out, the report is only accessible to legal persons who have carried out an external clinical audit

(a) a legal person carrying out a subsequent clinical audit with the provider;

(b) the Ministry,

(c) persons authorised by the State Office for Nuclear Security to carry out checks under other legislation33).

HLAVA VI

WITHDRAWAL

§ 83

(1) Protective treatment is carried out on the basis of a final decision by the Court of First Instance on the imposition of protective treatment (the "judgment of the Court") as a protective treatment of the constitutional treatment carried out in the form of bed care or as a protective treatment of outpatient treatment carried out in the form of specialised outpatient care.

(2) Protective treatment imposed by a court may also be carried out during the execution of a prison sentence in the health facilities of the Prison Service, namely protective treatment of constitutional treatment carried out in the form of stationary care and protective treatment of outpatient treatment carried out in the form of specialised outpatient care. The conditions for the performance of protective treatment shall not affect the conditions for the execution of the prison sentence.

(3) In the exercise of protective treatment, there are only such restrictions on human rights as are provided for in the law and to the extent necessary to achieve the purpose of protective treatment, unless that purpose can be achieved otherwise.

(4) When performing protective treatment, the patient's individual health service provider shall determine the risks for which his or her residence is dangerous; therapeutic interventions are aimed at affecting these risks.

(5) The identified risks referred to in paragraph 4 shall be assessed regularly in the context of the evaluation of the patient 's course of treatment, after initiation, during performance, during change and cessation of protective treatment.

§ 83a

(1) Supervision of compliance with the law in the performance of the constitutional protective treatment carried out in the form of bed care is carried out by the district attorney's office in whose district the protective treatment is carried out.

(2) In the exercise of supervision, the prosecutor shall be entitled to:

(a) at any time visit the places where protective treatment is carried out and enter all premises where patients carrying out protective treatment may be present;

(b) even without the consent of the patient, consult medical and other documentation and obtain extracts and copies thereof;

(c) to talk to patients without other persons present,

(d) request from the staff of the health service provider in whose health care facility the necessary explanations, the presentation of files, decisions and other documents relating to the exercise of the protection treatment;

(e) verify that the decisions and procedures of the provider providing protection treatment comply with the legislation;

(f) issue orders for the maintenance of legislation relating to the exercise of protective treatment;

(g) order that the patient who is being held illegally in the course of protective treatment be released immediately.

(3) A provider providing protective treatment shall be required to carry out the orders of the public prosecutor without delay.

(4) The complaint to investigate torture, cruel, inhuman or degrading treatment or punishment or any other ill-treatment brought by the patient or his representative shall be dealt with by the prosecutor without undue delay. The patient or his representative shall have the right to consult and comment on the complaint.

(5) The supervision of the Prosecutor's Office referred to in paragraph 1 is without prejudice to the inspection activity provided for under other legislation34).

§ 84

(1) Providers are required, unless otherwise specified, to provide protective treatment outside the execution of a custodial sentence where they are entitled to provide health services in the field in which they belong.

(2) In addition to the rights laid down by the Health Services Act, a provider providing protective treatment outside the execution of a custodial sentence shall be entitled to refuse admission of a patient to protective treatment if acceptance of the patient would exceed the workload.

(3) In addition to the execution of a prison sentence, protective treatment is carried out by a provider in a prison health facility provided that the conditions laid down in the Health Services Act are met for the provision of health services. The prison service medical facility is part of the prison.

§ 85

(1) A provider providing protective treatment outside the execution of a custodial sentence may:

(a) exceptionally prohibit:

1. specific patient visit,

2. use of the phone by a patient or other means of communication or recording, including accessories and components thereof; or

3. the transmission of correspondence to the patient,

if there is reason to believe that they would seriously interfere with individual treatment; it can therefore also control patient packages; the reasons for the prohibition or control of packages shall be recorded in the patient's medical file; the patient cannot be prohibited from visiting his / her legal representative or a representative of an organisation providing advice to patients and the use of the phone and from having written contact with such representatives,

(b) not allow a patient to leave the medical facility for a short period.

(2) The restriction of correspondence or the control of correspondence between a patient and a court appointed by a guardian, between a patient and a legal representative or a representative of an organisation providing advice to patients, between a patient and a public authority, the Ombudsman, the guardian of children's rights or their representative or a diplomatic mission or consular office of a foreign State, or between a patient and an international organisation which, under an international convention to which the Czech Republic is bound, is competent to discuss initiatives relating to the protection of human rights, is inadmissible. This correspondence shall be sent to the addressee and delivered to the patient without delay.

(3) A provider providing protective treatment outside the execution of a custodial sentence shall ensure that the patient is clearly aware of his rights and obligations relating to the provision of health services in a health care facility in the course of protective treatment, as well as individual treatment procedures, of the internal rules of the health care establishment (hereinafter referred to as the "internal rules'), unless the submission of such information precludes his health status. In the next course of treatment, the provider referred to in the sentence of the first patient shall clearly identify the expected duration of treatment and the possibility of changing the form of healthcare referred to in Section 83 (1) in which the protective treatment is carried out. A record of familiarisation of the patient with his / her rights and duties is included in the patient-led medical file. The record shall be signed by the patient, the health professional and the witness who was present with the information. The obligation to provide the patient with information on his medical condition and the health services proposed under the Health Services Act is not affected by the first sentence procedure. Any patient's disagreement with the proposed individual treatment procedure shall also be recorded in the medical file.

(4) The provisions of paragraphs 1 to 3 shall also apply to protective treatment provided in addition to the execution of a custodial sentence, unless otherwise provided by other legislation.

§ 86

(1) A provider providing protective treatment outside the execution of a custodial sentence may, upon request, authorise a patient to leave the medical establishment for a short period, after assessing the patient's health status. To that end, he will be given a pass.

(2) The release may be made if the patient's medical condition is stabilised and if it is reasonable to assume that there will be no change in the course of the short-term departure of the medical establishment leading to a failure of behaviour in respect of which protection has been ordered. The authorisation of a short-term departure from a healthcare facility shall not conflict with the purpose of protective treatment and shall not interfere with individual treatment procedures.

(3) The patient's application referred to in paragraph 1 shall include the reasons for leaving the medical establishment for a short period, the period for which the authorisation is requested and the address of the patient's whereabouts. The leave shall contain the name and, where appropriate, the name, surname of the patient, the date of his birth, the period for which he is issued and the address of the place where the patient will stay. The written application or record of oral administration and a copy of the pass is part of the patient's medical file. If the provider refuses to issue a pass, the health file shall include a refusal record indicating the reasons for the refusal.

(4) If the provider refuses to issue a pass, the patient may submit a new application not earlier than 7 days after the date of refusal of the original application.

§ 87

(1) A provider providing protective treatment other than the execution of a custodial sentence may, where the patient seriously violates an individual treatment procedure, submit a proposal to the court which ordered the protective treatment to change the manner in which he is treated. Where protective treatment is provided in addition to the execution of a custodial sentence, the court shall submit an application to change the manner in which protective treatment is carried out by the Director of the Prison Service Organisational Unit.

(2) A provider providing protective treatment outside the execution of a prison sentence shall notify the court which ordered the protective treatment that:

(a) cannot ensure that the patient is admitted to protective treatment on the grounds referred to in Paragraph 84 (2); Part of this notification is the justification for the refusal to accept the patient and the indication of the expected deadline for its possible admission;

(b) a patient who has been ordered to receive protective treatment in the form of:

1. bed or outpatient care, within the period prescribed by the court, has not taken up protective treatment,

2. bed care, contrary to the conditions of the prescribed protective treatment from the medical facility, has withdrawn,

3. outpatient care, without proper apology, did not show up for medical examination within the prescribed time limit,

(c) the patient has been transferred to another workplace of the provider of the protection treatment or to another provider's healthcare facility, on the basis of a sudden change in the health status not related to the protective treatment carried out in the form of bed care; If the patient has been appointed guardian by the court, the provider shall also notify him of this fact.

(3) A provider providing protective treatment outside the execution of a custodial sentence shall also be required to notify the facts referred to in paragraph 2 (a). (b) The police of the Czech Republic.

(4) The provider shall make the notification referred to in paragraphs 2 and 3 within 24 hours of the date on which the event referred to in paragraph 2 occurred.

§ 87a

The provider ensuring the protective treatment of a constitutional minor in the form of bed care shall notify the competent body of the social legal protection of children of the facts referred to in Section 87 (2) and the upcoming release of the minor from the protective treatment of the constitutional. The provider allows that body to monitor compliance with the rights of a minor in the exercise of protective treatment of a constitutional patient under § 85 and 86.

§ 88

(1) In addition to the obligations laid down by the Law on health services in the performance of protective treatment, the patient is obliged to:

(a) undergo an individual treatment provided for protective treatment, including any health performance that is part of an individual treatment; This is without prejudice to the right of the patient to choose from possible alternatives to treatment or its right to consent under the Health Services Act for individual medical performances which are not directly related to the fulfilment of the purpose of protective treatment,

(b) undergo a personal examination on the basis of a reasoned request from the treating physician in order to ensure the internal rules and to avoid carrying a case which would undermine individual treatment; the same-sex person shall be inspected,

(c) to allow employees designated by the provider to check their personal effects;

(d) in the event of a short-term departure from the health establishment, notify the address at which it will be present and comply with this place of residence; if it refuses to disclose this fact, the provider shall not issue a pass.

(2) The provider shall record the procedure referred to in paragraph 1 (b) or (c) and any follow-up to the patient's medical file.

§ 89

(1) Costs related to the performance of protective treatment for persons not participating in public health insurance in the Czech Republic are borne by the State from the State budget chapter of the Ministry.

(2) The bill referred to in paragraph 1 shall be sent by the provider to the Ministry no later than the 15th day of the following calendar month after the calendar quarter in which the health services were provided.

HLAVA VII

AGRICULTURAL AND AGRICULTURAL SERVICES

§ 89a

Definition of alcohol and toxic containment services

(1) An alcohol and antitoxic detention service (hereinafter referred to as the "detention service") is a health service provided by a person who, under the influence of alcohol or other addictive substances, does not control his behaviour and thereby directly endangers himself or another person, property or public policy.

(2) The detention service is provided at an alcohol and antitoxic detention centre (hereinafter referred to as "detention centre"). The capture station is a medical facility.

(3) The detention service shall include an examination of the person in order to determine whether his or her location in the detention centre is not excluded for the reasons set out in Section 89b (2) (a), and a stay at the detention centre, including the necessary care to avoid any health risk directly related to acute intoxication.

(4) The capture service provides for a region within its territory under separate jurisdiction.

§ 89b

Location in detention station

(1) A person who, under the influence of alcohol or other addictive substances, does not control his behaviour and thereby immediately endangers himself or another person, property or public order and cannot be averted otherwise, is obliged to undergo an examination and stay at a detention centre, including the necessary care to prevent the risk of health directly related to acute intoxication for a period of essential but less than 24 hours.

(2) No person can be placed in the detention centre

(a) endangered by life failure of vital functions, unconscious, with untreated injury, massive bleeding or a person showing signs of a disease immediately requiring care that cannot be provided at the detention centre; or

(b) under 15 years of age.

(3) A person may be placed in a detention centre only with the consent of a doctor designated by the detention service provider and subject to the conditions laid down in paragraphs 1 and 2.

(4) If a person who is provided with a detention centre directly endangers himself or another person or harms the property of the detention centre provider and the provider of the detention centre cannot prevent this by itself, the latter may request the necessary cooperation of the police of the Czech Republic, the Military Police, if it is for a person called for an orientation examination or medical examination under the Law on the Protection of Health from the Harmful Effects of the Addictive Layer (22), a military officer, a municipal police and, in the case of persons in charge of custody, security detention or prison detention.

(5) The service provider shall recommend professional care to the persons located in the detention centre.

§ 89c

Transport to detention station

(1) The transport of a person to a detention centre shall be ensured by the person who requested the person for an indicative examination or medical examination under the law on the protection of health against harmful effects of addictive substances.

(2) If a person who is transported to a detention centre when providing a medical emergency service or medical transport service is directly endangering himself or another person or harms the property of a medical emergency service provider or a medical transport service provider and a medical emergency service provider or a medical transport service provider cannot prevent this by itself, that provider may request the necessary cooperation of the Police of the Czech Republic, the Military Police, if it goes to a person called for an indicative examination or medical examination under the Law on the Protection of Health against the Harmful Effects of Drugs by a military police officer, a municipal police officer and, in the case of persons in charge of custody, security detention or a prison sentence.

§ 89d

Notification obligation

(1) The investigation and residence of the person in the detention centre shall be notified by the detention service provider to the registry provider, if known.

(2) The investigation and residence of the minor in the detention centre is also notified by the provider of the detention centre.

(a) to its legal representative or, where appropriate, to another person responsible for raising it; and

(b) a social protection body.

(3) If he is a person of limited capacity, his examination and residence in the detention centre shall also be notified to his guardian.

§ 89e

Reimbursement of costs for the detention service provided and transport to the detention centre

(1) Where the presence of alcohol or other addictive substances is demonstrated, the provider of the detention service shall bear the costs of the detention service provided by the person to whom the detention service has been provided; the person shall also bear the costs of transport to the detention centre to the person who incurred the costs. Where a detention service has been provided to a minor who is not fully qualified, the costs shall be borne by his legal representative.

(2) If the presence of alcohol or other addictive substances is not demonstrated, the detention service provider shall pay the cost of the detention service provided by the police of the Czech Republic, the Military Police, the Municipal Police, the Prison Service, the Probation and Mediation Service, the facilities for the performance of constitutional education or protective education28), the employer, the supervisory authority or the health service provider, under whose responsibility the call for guidance or medical examination has been made under the law on the protection of health against addictive substances. Those who cover the costs shall also bear transport costs to the detention centre.

(3) Where, in the context of the provision of a detention service, it is necessary to communicate with the person to whom the detention service is provided in a manner based on interpretation by the other person and where the presence of alcohol or other addictive substance is demonstrated, the costs of interpretation shall be borne by the person to whom the detention service has been provided. Where a detention service has been provided to a minor who is not fully qualified, the costs of interpretation shall be borne by his legal representative. Where the presence of alcohol or other addictive substances is not demonstrated, the interpretation costs shall be borne by the person carrying the costs referred to in paragraph 2.

HLAVA VIII

TRANSFERS

§ 90

(1) The provider commits an offence by:

(a) does not ensure that the patient is informed in accordance with Article 15 (2) before carrying out sterilisation;

(b) establish an expert commission whose composition or relationship of its member to the provider is contrary to Article 13 (3) or (4), if it is a sterilisation;

(c) implement:

1. in contravention of § 14 without the written consent of the patient for medical reasons sterilisation,

2. without a written request from a patient pursuant to § 17 (4) (a) or the positive opinion of a Panel of Experts pursuant to § 17 (4) (b) or without a written request from a patient pursuant to § 17 (5) (a) or the positive opinion of a Panel of Experts pursuant to § 17 (5) (b) or the consent of a court pursuant to § 17 (5) (c) castration pursuant to § 17 (2) or (3),

3. without a written request from a patient pursuant to § 21 (3) (a) or a positive opinion of the Panel pursuant to § 21 (3) (b), a change in the sex of a transsexual patient pursuant to § 21 (2); or

4. without the written consent of the patient under § 24 (2) (a) or the positive opinion of the Panel under § 24 (2) (b) or without the written consent of the patient under § 24 (3) (a) or the positive opinion of the Panel under § 24 (3) (b) or the consent of the Court under § 24 (3) (c) of the Psychosurgical Performance under § 24 (1);

(d) implement:

1. without the written consent of the legal representative of the patient or the guardian of the patient pursuant to § 13 (2) (a), the positive opinion of the Panel of Experts pursuant to § 13 (2) (b) or the consent of the court pursuant to § 13 (2) (c) of sterilisation for health reasons;

2. without a written request from the legal representative of the patient or the guardian of the patient pursuant to § 21 (4) (a) or the positive opinion of the Panel pursuant to § 21 (4) (b) or the consent of the court pursuant to § 21 (4) (c) to change the sex of transsexual patients pursuant to § 21 (2); or

3. without the written consent of the legal representative of the patient or the guardian of the patient pursuant to § 24 (4) (a) or the positive opinion of the Panel pursuant to § 24 (4) (b) or the consent of the court pursuant to § 24 (4) (c) of the psychosurgical exercise,

(e) carry out sterilisation, castration or psychosurgery for reasons other than those provided for in Section 13 (1) or (2), if it is about sterilisation, or § 17 (2), (3) or (5) if it is about castration, or in Section 21 (2), (3) or (4) if it is about the sex change of a transsexual patient, or § 24 (2), (3) or (4) if it is about psychosurgery,

(f) provide, sell or donate, contrary to Paragraph 29 (2), the results of the genetic examination of the patient to third parties;

(g) make it possible to intervene in the human genome for reasons other than those provided for in Paragraph 30 (1), or to create conditions for such intervention;

(h) in contravention of Paragraph 30 (2), allow the implementation of procedures designed to create a human being or create conditions for the implementation of such procedures or allow the creation of a new human being;

(i) allow procedures contrary to Article 30 (3) or create conditions for the implementation of such procedures;

(j) it draws blood in contravention of § 31 (2) or does not comply with § 31 (3) before blood collection is carried out;

(k) issue a medical opinion for which it is not authorised to be issued pursuant to Paragraph 42 (2), or review a medical opinion for which it is not authorised to be examined under § 46 (1) or § 47 (1);

(l) shall not issue an opinion within the time limit set in Paragraph 43 (1);

m) will not submit a proposal for review of the medical opinion within the time limit set in Paragraph 46 (5);

(n) in contravention of Article 47 (3) (a), does not submit the supporting documents to the competent administrative authority following its call or fails to comply with the specified deadline;

(o) recognise an occupational disease even if it is not entitled to recognise an occupational disease as referred to in Article 61 (2); or

(p) it shall not send, in accordance with Article 63 (1), a person who, following a professional examination, has incurred a reasonable suspicion of an occupational disease or if it is suspected that the disease no longer fulfils the conditions for recognition of an occupational disease to the competent provider.

(2) The provider performing assisted reproduction methods shall commit an offence by:

(a) carry out the destruction of human embryos in breach of Article 9;

(b) contrary to Article 10 (1), ensure that the anonymity of the anonymous donor and the infertile couple and the anonymity of the anonymous donor and of the child born from assisted reproduction is not maintained;

(c) in contravention of Article 10 (2), it shall not retain data on the state of health of an anonymous donor for a period of 30 years after artificial insemination.

(3) A provider verifying non-established methods shall commit an infringement by:

(a) carry out verification of the method not implemented, even if it has not been authorised by the Ministry to implement it;

(b) carry out verification of the non-implemented method in breach of Article 33 (4) or (5);

(c) shall not terminate the verification of the non-established method if the authorisation for verification has been withdrawn pursuant to Article 36 (5);

(d) in contravention of Paragraph 37 (a), it shall not establish or establish an ethics commission in a composition contrary to Article 38 (2);

(e) in breach of Paragraph 37 (b), it shall not conclude an insurance contract;

(f) in contravention of Paragraph 39 (1) (a), it shall not submit a report on the stage of verification of the non-established method;

(g) in contravention of Article 39 (1) (b), it shall not immediately interrupt or suspend the verification of the non-established method;

(h) fails to comply with the notification requirement under Paragraph 39 (1) (c);

(i) in contravention of Paragraph 39 (1) (d), does not allow persons entrusted by the Ministry, the State Institute for Nuclear Security or the members of the Ethics Committee to carry out an inspection; or

(j) in contravention of Paragraph 39 (2), it shall not submit a final report on the outcome of the verification of the non-established method.

(4) The provider of occupational medical services commits an offence by:

(a) fails to comply with the notification requirement under Paragraph 57 (1) (e);

(b) not give an initiative to the supervisory authorities in the field of safety and health at work pursuant to Article 57 (1) (f);

(c) contrary to § 57 (1) (i)

1. do not provide or perform biological material sampling for the determination of biological exposure test values;

2. does not carry out an evaluation of the results of biological exposure tests; or

3. fails to fulfil the information obligation;

(d) does not give the employer the incentive to apply for an emergency occupational medical examination under Paragraph 57 (1) (j); or

(e) in contravention of Paragraph 54 (3), for works classified as first under the Public Health Protection Act, it shall not carry out a medical examination, an assessment of fitness to work or issue a medical opinion on medical fitness to work.

(5) A provider providing medical services involving medical exposure shall commit an offence by:

(a) perform a medical exposure contrary to Article 71 (1) (a);

(b) in breach of Article 71 (1) (b), it shall not develop or ensure compliance with local radiological standards or provide the Ministry with a basis for the development of a national radiological standard;

(c) in contravention of Article 71 (1) (c), carry out internal clinical audits or evaluate findings made on the basis thereof, or does not propose a solution to the non-conformity identified, or set a deadline for its removal or remove them;

(d) does not, contrary to Article 71 (1) (d), arrange for an external clinical audit to be carried out or evaluate findings made on the basis of it, or propose a solution to the non-conformity identified, or fix a deadline for its removal or remove them;

(e) in breach of Article 71 (1) (e), does not ensure compliance with radiation protection rules and procedures;

(f) in breach of Article 71 (2) (a), it shall not ensure that local radiological standards are available to all healthcare professionals involved in the provision of health services involving medical exposure;

(g) in the provision of health services involving medical exposure, it is in breach of Article 71 (2) (b);

(h) in contravention of Paragraph 71 (2) (c), does not optimise radiation protection;

(i) carry out medical exposure under the biomedical research programme in breach of Article 72 (1);

(j) in carrying out an internal clinical audit, in breach of Paragraph 74 (2); or

(k) the breach of § 74 (3) does not lead to a record of internal clinical audits.

(6) A provider providing protective treatment shall commit an offence by:

(a) does not provide protective treatment outside the execution of a custodial sentence, even if the conditions laid down in Article 84 (1) and not the procedure laid down in Article 84 (2) are met,

(b) in contravention of Paragraph 85 (1) (a), it shall not record in the patient's medical file the reasons which led to the prohibition or control of packages;

(c) does not provide the patient with the information referred to in Section 85 (3); or

(d) fails to comply with the notification requirement under Paragraph 87 (2).

(7) A penalty may be imposed in respect of an offence:

(a) 1 000 000 CZK if it is an offence referred to in paragraph 1 (g), (h) or (i);

(b) 500 000 CZK if the offence referred to in paragraph 1 (f) or (o), paragraph 2 (a) or paragraph 3 (a), (c), (e) or (g) is committed;

(c) 300 000 CZK if the offence referred to in paragraph 1 (a), (c), (d), (e), (k) or (p), (3) (b), (d) or (j), (5) (a), (b), (c), (d), (e), (g), (h), (i), (j) or (k) or (6) (a) is committed;

(d) 200 000 CZK if the offence referred to in paragraph 1 (b), (j), (l), (m) or (n), (f), (h) or (i), (4) (a), (b), (c) or (d) or (6) (d) is committed; or

(e) 100 000 CZK if the offence referred to in paragraph 2 (b) or (c), paragraph 4 (e), paragraph 5 (f) or paragraph 6 (b) or (c) is committed.

§ 91

(1) A legal person commits an offence by carrying out an external clinical audit even if he is not authorised to carry out it under Paragraph 75 (2).

(2) A legal person authorised to carry out an external clinical audit shall commit an offence by:

(a) it shall not publish the rules of the evaluation process contrary to Paragraph 78 (1);

(b) fails to comply with the notification requirement of Paragraph 78 (2) or, after notification of the amendments, in breach of Paragraph 78 (3);

(c) in breach of Paragraph 81 (2) (a), in carrying out an external clinical audit, it shall not proceed impartially;

(d) in breach of Article 81 (2) (b), in carrying out an external clinical audit, fail to comply with the rules of the evaluation process;

(e) in contravention of § 81 (2) (c), carry out an external clinical audit through a person not listed under § 76 (2) (d);

(f) in contravention of Paragraph 81 (3), carry out an external clinical audit by the person excluded from this evaluation;

(g) in breach of Paragraph 82 (1), it shall not issue a report to the provider on the conduct of an external clinical audit or send it to the Ministry; or

(h) it does not keep records of providers for which it has carried out an external clinical audit, contrary to Paragraph 82 (4).

(3) A penalty may be imposed in respect of an offence:

(a) 1 000 000 CZK if it is an offence referred to in paragraph 1;

(b) 300 000 CZK if the offence referred to in paragraph 2 (a), (b), (c), (d), (e), (g) or (h) is committed; or

(c) 200 000 CZK if the offence referred to in paragraph 2 (f) is committed.

§ 92

Transfers under this law

(a) the competent administrative authority, if any, in accordance with Paragraph 90 (1), (2), (4) and (6);

(b) the Ministry, if it is an infringement pursuant to Articles 90 (3) and 91,

(c) State Office for Nuclear Safety, if there are offences pursuant to Paragraph 90 (5).

§ 92a

(1) A natural person commits an offence by not undergoing an examination, residence or necessary care at a detention centre in breach of Paragraph 89b (1).

(2) A fine of up to 10 000 CZK may be imposed for the offence referred to in paragraph 1.

(3) The offence referred to in paragraph 1 shall be dealt with by the municipality in its delegation. The authority of the Police of the Czech Republic or the municipal police may also discuss the offence with an on-the-spot order.

(4) The fine shall be collected by the authority which imposed it, with the exception of the Ministry of Defence, the Ministry of Interior and the Ministry of Justice.

HLAVA IX

COMMON, TRANSITIONAL AND FINAL PROVISIONS

Common provisions

§ 93

The scope laid down by this Law to regional authorities is the exercise of the delegation.

§ 94

The activities of members of expert commissions established under this Act are another act of general interest (18), in which they are entitled to compensation for salary or wages. Members of professional commissions who are not in employment or a similar employment relationship but are employed shall be entitled to compensation for the loss of earnings for the period during which they took part in the work of the Commission, at the level shown by them, but not more than the average wage on the national economy declared and published by the Ministry of Labour and Social Affairs in the Collection of Laws and International Employment Contracts. 19). The members of the expert panels shall also be responsible for the reimbursement of the expenditure shown.

Authorisation provisions

§ 95

(1) The Ministry shall issue a decree implementing Sections 52 (a), 52 (c) and (d), 55a (3) and 60.

(2) In agreement with the Ministry of Education, Youth and Sports, the Ministry will issue a decree implementing § 52 (b).

(3) In agreement with the Ministry of Labour and Social Affairs, the Ministry will issue a decree implementing Section 65.

(4) In agreement with the State Office for Nuclear Safety, the Ministry will issue a Decree implementing Section 72 (3).

Transitional provisions

§ 96

(1) If, before the date of entry into force of this Act, an application for the performance of the health performance covered by this Act has been submitted, the examination of that application shall be completed in accordance with existing legislation. If, before the date of entry into force of this Act, a health performance regulated by this Act has already been initiated, the date of entry into force of this Act shall be followed, if it is in favour of the patient.

(2) Providers verifying the non-established method under existing legislation are required to submit a request for approval to verify the non-established method under this Act to the Ministry within 3 months of the date of entry into force of this Act. Providers may verify the non-implemented method until the time of the request decision.

(3) The provider may, in accordance with the procedure laid down in Article 9 (2), ensure the disposal of frozen human embryos produced before the date of entry into force of this Act, provided that a period of at least 10 years has elapsed since their establishment.

§ 97

(1) The Ministry shall publish national radiological standards pursuant to Paragraph 70 (5) within 6 months of the date of entry into force of this Act.

(2) The provider providing health services involving medical exposure is obliged to:

(a) develop local radiological standards pursuant to Article 71 (1) (b) within 1 year of the date of publication of the national radiological standards;

(b) carry out the first internal clinical audit in accordance with § 74 (2) within 2 years from the date of publication of the National Radiological Standards;

(c) conclude a contract pursuant to Paragraph 81 (1) to carry out an external clinical audit at all of its medical exposure centres within 1 year from the date of publication of the list referred to in Article 77 (3).

§ 98

(1) Medical services may be provided according to existing legislation governing the provision of preventive care for racing for a maximum period of 1 year from the date of entry into force of this Act. This is without prejudice to the employer's obligation to pay for preventive care for racing to the extent provided for in this Act for occupational services, from the date on which the Act takes effect.

(2) If, before the date of entry into force of this Act, a medical opinion has been requested and has not yet been issued, it shall be carried out in accordance with this Act.

(3) Medical opinions issued before the date of entry into force of this Act shall be reviewed in accordance with existing legislation.

§ 99

(1) The Ministry will publish the first call for an application for authorisation to recognise occupational diseases within 3 months of the date of entry into force of this Act.

(2) The examination of occupational diseases initiated before the authorisation for the recognition of occupational diseases under this Act is completed in accordance with existing legislation.

(3) Providers of occupational health services listed in the Annex to Decree No 342 / 1997 Coll., laying down the procedure for the recognition of occupational diseases and issuing a list of medical establishments which recognise those diseases, as effective until the date of entry into force of this Act, recognise those diseases in the publication of the list referred to in Article 66 (6). The Ministry shall communicate to them the date of publication of the list at least 30 days before the publication of the list pursuant to Paragraph 66 (6).

(4) Providers referred to in paragraph 3 shall complete the recognition of occupational diseases in cases which began before the date of notification referred to in paragraph 3.

Efficacy

§ 100

That law shall take effect on the first day of the fourth calendar month following its publication.

Germany

Klaus v. r.

Nausea v. r.

1) Council Directive 2013 / 59 / Euratom of 5 December 2013 laying down basic safety standards for the protection against exposure to ionising radiation and repealing Directives 89 / 618 / Euratom, 90 / 641 / Euratom, 96 / 29 / Euratom, 97 / 43 / Euratom and 2003 / 122 / Euratom. Council Directive 89 / 391 / EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work. Directive 2003 / 88 / EC of the European Parliament and of the Council of 4 November 2003 on certain aspects of the organisation of working time.

2) Act No. 296 / 2008 Coll., on ensuring the quality and safety of human tissues and cells intended for human use and amending related laws (Act on Human tissues and cells), as amended.

3) Act No. 227 / 2006 Coll., on research on human embryonic stem cells and related activities and amending certain related laws, as amended.

5) ČSN EN ISO 15189 Medical laboratories - Quality and competence requirements.

6) Act No. 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain laws, as amended.

7) Act No. 277 / 2009 Coll., on Insurance, as amended.

8) Act No. 187 / 2006 Coll., on sickness insurance, as amended.

10) Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws, as amended.

11) Act No. 309 / 2006 Coll., which regulates other requirements of safety and health at work in employment relations and on ensuring health and safety in the activity or provision of services outside employment relations (Act on other conditions of safety and health at work), as amended.

12) For example Act No. 251 / 2005 Coll., on Labour Inspection, as amended, Act No. 258 / 2000 Coll., as amended, Act No. 18 / 1997 Coll., on the Peaceful Use of Nuclear Energy and Ionising Radiation (Atomic Act) and on the Amendment and Addition of Certain Acts, as amended, Act No. 61 / 1988 Coll., on Mining Activities, Explosives and on State Mining Administration, as amended.

13) For example, Act No. 262 / 2006 Coll., Labour Code, as amended, Act No. 309 / 2006 Coll., as amended, Decree No. 361 / 2007 Coll., as amended.

14) Act No. 18 / 1997 Coll., as amended.

15) Act No. 361 / 2003 Coll., on the service ratio of members of the Security Corps, as amended. Decree No. 393 / 2006 Coll., on medical fitness, as amended by Decree No. 407 / 2008 Coll. Act No. 221 / 1999 Coll., on professional soldiers, as amended. Act No. 585 / 2004 Coll., on the Defence Obligations and its Assurance (Defense Act), as amended. Decree No. 103 / 2005 Coll., on medical fitness for military active duty.

16) Government Decree No. 290 / 1995 Coll., issuing a list of occupational diseases, as amended by Government Decree No. 114 / 2011 Coll.

18) § 200 et seq. of the Labour Code.

19) Act No. 435 / 2004 Coll., on Employment, as amended.

20) For example, § 247 of the Labour Code.

21) For example, Act No. 49 / 1997 Coll., on Civil Aviation, as amended, Act No. 219 / 1999 Coll., on the Armed Forces of the Czech Republic, as amended, Act No. 221 / 1999 Coll., on Occupational Soldiers, as amended, Act No. 361 / 2000 Coll., on the Assessment of Liability on Road Traffic and on Changes to Certain Acts (Road Traffic Act), as amended, Act No. 361 / 2003 Coll., on the Service Ratio of Members of the Safety Corps, as amended, Act No. 585 / 2004 Coll., Act No. 493 / 2002 Coll., on the Assessment of Liability to Issue, as amended, Decree No. 260 / 2023 Coll.

22) Paragraph 18 (2) of Act No. 300 / 2008 Coll., on Electronic Acts and Authorised Conversion of Documents. Article 6 (1) of Act No. 297 / 2016 Coll., on Trust Services for Electronic Transactions.

22) Article 21 of Act No. 65 / 2017 Coll., on the protection of health against harmful effects of addictive substances.

22a) Act No. 292 / 2013 Coll., on Special Judicial Procedures.

23) Decree No. 98 / 2012 Coll., on Health Documentation, as amended.

24) For example, Decree No. 277 / 2004 Coll., on the medical fitness to drive motor vehicles, as amended, Decree No. 101 / 1995 Coll., which issues the Order on the medical fitness of persons in the operation of railway and railway transport, as amended, and Decree No. 393 / 2006 Coll., on medical fitness, as amended.

25) For example, Government Regulation No. 361 / 2007 Coll., laying down conditions for the protection of health at work, as amended, Government Regulation No. 272 / 2011 Coll., on the protection of health against the adverse effects of noise and vibration, and Government Regulation No. 291 / 2015 Coll., on the protection of health against non-ionising radiation.

26) Paragraph 103 (1) (d) of the Labour Code.

27) For example, Government Regulation No. 361 / 2007 Coll., laying down conditions for health protection at work, as amended, or Decree No. 432 / 2003 Coll., laying down conditions for the classification of works into categories, limit values for biological exposure test indicators, conditions for the collection of biological material for the conduct of biological exposure tests and reporting of asbestos and biological agents, as amended.

28) Act No. 109 / 2002 Coll., on the performance of constitutional education or protective education in educational establishments and on preventive educational care in educational establishments and amending other laws, as amended.

29) Annex No 3 to Decree No. 143 / 2008 Coll., laying down closer requirements for ensuring the quality and safety of human blood and its components (the Human Blood Ordinance), as amended.

30) Point 9 of the Annex to Act No. 372 / 2011 Coll., on Health Services and the Conditions for their Provision (Health Services Act), as amended.

31) Act No. 45 / 2016 Coll., on the service of soldiers in reserve, as amended.

32) Paragraph 60 (2) (d) of Act No. 263 / 2016 Coll., Atomic Act.

33) For example, § 107 (1) (e) of Act No 372 / 2011 Coll.

34) For example, Act No. 349 / 1999 Coll., on the Ombudsman, as amended, and Act No. 372 / 2011 Coll., as amended.

Date of Promulgation	08.12.2011
Effective from	01.04.2012
Effective until	-
Status	Valid

Citation	Act No. 373 / 2011 Coll., on Specific Health Services
Regulation Type	Law
Author	-
Collection	Code of Laws

Act No. 373 / 2011 Coll.

Law on Specific Health Services

Contents

HLAVA I

§ 1

§ 2

HLAVA II

Díl 1

§ 3

§ 4

§ 5

§ 6

§ 7

§ 8

§ 9

§ 10

§ 11

Díl 2

§ 12

§ 13

§ 14

§ 15

§ 16

Díl 3

§ 17

§ 18

§ 19

§ 20

Díl 4

§ 21

§ 22

§ 23

Díl 5

§ 24

§ 25

§ 26

§ 27

Díl 6

§ 28

§ 29

§ 30

Díl 7

§ 31

§ 32

HLAVA III

§ 33

§ 34

§ 35

§ 36

§ 37

§ 38

§ 39

§ 40

HLAVA IV

Díl 1

§ 41

§ 42

§ 42a

§ 43

§ 44

§ 45

§ 46

§ 47

§ 48

§ 49

§ 50

§ 51

§ 52

Díl 2

§ 53

§ 54

§ 55

§ 55a

§ 56

§ 57

§ 57a

§ 58

§ 58a

§ 59

§ 60