Decree No. 116 / 2012 Coll.

Decree on the transmission of data to the National Health Information System

Valid Effective from 06.04.2012
Contents
116
DECLARATION
of 2 April 2012
on the transmission of data to the National Health Information System
The Ministry of Health provides, pursuant to Section 120 of Act No. 372 / 2011 Coll., on health services and the conditions for their provision (Health Services Act), for the implementation of Sections 70 (6), 75 (3), 77 (3) and 78 of the Health Services Act:
§ 1
(1) Personal and other data shall be transmitted to the National Health Information System (hereinafter referred to as the Information System) in electronic form by direct entry or on the technical data carrier.
(2) The direct entry is carried out with a secure data transfer protocol through remote access to the designated electronic address indicated on the Ministry of Health website or on the websites of its authorised information system administrator
(a) by remote transmission,
(b) by online entry via a web application; or
(c) by completing the electronic form and sending it to the relevant repository.
(3) On the technical data medium, the data are transmitted to the information system in person or via the postal licence holder, which must be supported by a delivery. The transferred files must be encrypted with the administrator's public key.
§ 2
(1) The application for authorisation for access to personal data and other data held in the National Health Registers, the National Register of Providers and the National Register of Health Workers ("the Register") in addition to the formalities laid down by the Health Services Act also contains:
(a) the name of the register;
(b) the identification details of the body authorised to submit the application, the identification number of the person, the serial number and the name of the applicant body, the address and the name of the statutory authority of the body which is required to provide data to registers under the Health Services Act, and the identifier of the data box, if established and made available;
(c) the identification details of the authorised worker, namely his / her function, name and surname, academic, scientific or educational title, date of birth, expertise, type of work carried out, department of the workplace and part thereof, telephone and e-mail address;
(d) a guaranteed electronic signature of a person under an electronic signature law, authorised to act on behalf of an entity which, under the Health Services Act, is entitled to submit an application if the application is not received via a data box.
(2) The request for revocation of access to the register shall include, in addition to the particulars referred to in paragraph 1, the grounds for revocation of access to personal data and other data kept in that register.
(3) The request for remote access is placed on the Ministry of Health's website or on the website of its authorised information system administrator.
§ 3
The range of providers and other persons transferring data to registers and periodicity and the deadlines for their transmission are set out in the Annex to this Decree.
§ 4
This decree shall take effect on the day of its publication.
Minister:
Doc. MUDr. Heger, CSc., v. r.

Annex to Decree No 116 / 2012 Coll.
A range of providers and other persons transferring personal data and other data to the National Health Information System for the needs of registries and periodicity and deadlines for their transmission
1. National Cancer Registry
1.1. Heading of providers and other persons transmitting data:
Any provider that has established a diagnosis and each provider responsible for treating and monitoring diseases from the group of diagnoses of malignant neoplasms [codes C00 - C97 according to a valid version of the International Statistical Classification of Diseases and Associated Health Problems as amended by 10 revisions (hereinafter referred to as "MKN-10")] 1), a disease evaluated as neoplasms in situ (MKN- 10: D00 - D09) and neoplasms of uncertain or unknown behaviour (MKN- 10: codes D37 - D48).
1.2 Periodicity and transmission deadlines:
Data on each newly diagnosed disease shall be transmitted within 1 month of the date of diagnosis and data related to its treatment and treatment procedures shall be transmitted within 8 months of the date of diagnosis. The patient's health monitoring data shall be transmitted after the first to fifth, seventh and tenth years of follow-up; followed by an interval of 5 years and also if the patient dies.
2. National Hospital Register
2.1. Heading of providers and other persons transmitting data:
Any provider who has provided bed health care except for spa rehabilitation care and who has stopped providing such bed care to the patient.
2.2 Periodicity and transmission deadlines:
The data shall be transmitted for each completed hospitalisation of the patient in the bed ward or at the workplace for a given calendar month until the end of the following calendar month.
3. National Register of Reproductive Health
3.1. Heading of providers and other persons transmitting data:
Every provider,
(a) who has used the methods and procedures of assisted reproduction for the purpose of artificial insemination of a woman;
(b) in whose medical establishment the birth has taken place or which has carried out postpartum care on the mother;
(c) which has provided health services to the newborn in connection with childbirth or provided bed care to the newborn;
(d) which has diagnosed a birth defect in the fetus or child under 15 years of age,
(e) who has performed an artificial abortion or provided treatment after abortion;
(f) in whose medical institution a woman has died in connection with pregnancy, abortion, childbirth or 6 weeks of childbirth or who has identified such death.
3.2 Periodicity and transmission deadlines:
Data to be transmitted
(a) for each cycle of assisted reproduction, within 3 days of the date on which the relevant phase of treatment started or performed the appropriate exercise or examination;
(b) for each pregnancy terminated by birth, for each child born and found to be a birth defect of the fetus or of the child at the end of each calendar month, by the end of the following calendar month,
(c) for each pregnancy artificially interrupted and every pregnancy terminated by abortion for each calendar month until the 10th day of the following calendar month,
(d) for each death of a woman in connection with pregnancy, abortion, childbirth and six months, by the end of the following calendar month.
4. National registry of cardiovascular operations and interventions
4.1 Heading of providers and other persons transmitting data:
Any provider that has provided medical services to a patient in connection with cardiovascular surgery or intervention.
4.2 Periodicity and transmission deadlines:
The data shall be transmitted for each cardiothoracic operation carried out and for each cardiovascular intervention carried out following the release of the patient from treatment for each calendar month until the end of the following calendar month.
5. National register of joint compensation
5.1. Heading of providers and other persons transmitting data:
Any provider that has provided medical services to the patient in connection with implantation or reimplantation of artificial joint replacement.
5.2. Periodicity and transmission deadlines:
The data shall be transmitted for each artificial joint replacement implantation carried out within 30 days of the end of the patient's bed treatment.
6. National Register of Occupational Diseases
6.1. Heading of providers and other persons transmitting data:
Any provider who has recognised an occupational disease under other legislation2).
6.2. Periodicity and transmission deadlines:
The data shall be transmitted for each occupational disease or occupational disease threat which no longer fulfils the conditions for recognition of an occupational disease or an occupational disease threat no later than the 10th day of the calendar month following the month in which the judgment on the cessation of an occupational disease or the threat of an occupational disease in force or the decision on it became final.
7. National Register of Drug Treatment
7.1. Heading of providers and other persons transmitting data:
7.1.1. Any health service provider providing professional care to persons using addictive substances and to persons dependent on such substances under the law governing measures to protect against damage caused by tobacco products, alcohol and other addiction3) in the form of:
(a) outpatient care;
(b) day care;
(c) bed care;
(d) detoxification carried out under outpatient or bedside care; or
(e) substitution treatment provided by all health service providers, regardless of their field or expertise.
7.1.2. Any provider of social services (4) providing professional care to persons using addictive substances and persons dependent on such substances under the law governing measures to protect against damage caused by tobacco products, alcohol and other addictive substances, in the form of social care services, social prevention or social counselling programmes.
7.2 Periodicity and transmission deadlines for:
7.2.1. Periodicity and transmission deadlines for substitution treatment:
Data relating to substitution treatment shall be transmitted for each treatment initiated, altered or discontinued. Before initiating substitution treatment, the provider shall verify that the patient is not receiving substitution therapy from another provider. Data relating to substitution therapy shall be transmitted within 24 hours of the first dose of the substitution substance and within 24 hours of the end of or change in replacement treatment.
7.2.2. Periodicity and transmission deadlines for other forms of professional care:
Data relating to other forms of professional care shall be transmitted:
(a) at the start of the first client treatment with the provider in a given year; for outpatient programmes of the type of advice or low-threshold harm reduction interventions, data shall be transmitted at first contact with the client in a given year as soon as possible after all necessary reporting data have been established; for structured interventions, no later than 3 working days after the date of initiation of treatment, for low threshold services, generally no later than the third contact with the client,
(b) at the start of further or repeated treatment with the provider in a given year, if 6 calendar months have elapsed since the end of the previous treatment; for outpatient programmes of the type of advice or low-threshold harm reduction interventions, repeated contact with the client in a given year shall be reported if 6 or more calendar months have elapsed since the previous contact has been reported, as soon as possible after the detection of all necessary reporting data, as a rule within 3 working days of the date of the start of treatment or contact by the client,
(c) on the first visit to the provider in a given year, if the treatment of the previous year is continued by confirming the treatment by the end of January of that year at the latest, for structured interventions usually during the first 7 working days of that year,
(d) data shall be transmitted within 3 working days of the end of treatment when treatment is discontinued, if it is a structured intervention that is evident.
8. National accident register
8.1. Heading of providers and other persons transmitting data:
Every provider of bed health care that hospitalized a trauma patient.
8.2. Periodicity and transmission deadlines:
Data shall be transmitted for each hospitalised trauma patient no later than the twentieth day of the following calendar month after the date of completion of the hospitalisation.
9. National registry of people permanently excluded from blood donation
9.1. Heading of providers and other persons transmitting data:
Every transfusion provider who identified a person permanently excluded from blood donation.
9.2. Periodicity and transmission deadlines:
The data shall be transmitted for each person permanently excluded from blood donation immediately after verification of the positive result of the confirmatory examination of the person concerned to determine permanent exclusion from blood donation.
10. National registry of autopsies and toxicology tests carried out in the medical department
10.1 Heading of providers and other persons transmitting data:
Every medical facility where an autopsy and tox screen were carried out.
10.2 Periodicity and transmission deadlines:
The data shall be transmitted for each autopsy carried out, including the results of the toxicological tests obtained during the autopsy, immediately after all necessary data have been established.
11. National register of providers
11.1 Heading of providers and other persons transmitting data:
Each body referred to in Section 75 (1) of the Health Services Act.
11.2 Periodicity and transmission deadlines:
Data shall be transmitted for each health service provider within 10 working days of the date of issue or of obtaining authorisation to provide health services or on an ongoing basis in the event of a change in those data or interruption or cessation of activity.
12. National Register of Health Workers
12.1 Heading of providers and other persons transmitting data:
Each body referred to in Section 77 (1) of the Health Services Act.
12.2 Periodicity and transmission deadlines:
Data shall be transmitted for each person competent for the exercise of the medical profession of a doctor, dental practitioner, pharmacist (5) and for medical staff competent for the exercise of the medical profession without professional supervision after obtaining professional competence or professional and specialised competence (6) within 10 working days of the date of acquisition of professional or specialised competence or of the commencement, interruption or termination of the medical profession. In the event of new facts and changes to the data already mentioned, the data shall be transmitted without undue delay.
13. National registry of donors
13.1 Heading of providers and other persons transmitting data:
Every health service provider that identified a possible donor of organs, tissues and haematopoietic cells.
13.2 Periodicity and transmission deadlines:
Data shall be transmitted after a medical assessment of the potential donor, immediately after identification of the potential donor of organs, tissues and haematopoietic cells.
14. National registry of persons awaiting transplantation
14.1 Heading of providers and other persons transmitting data:
Any health service provider that has indicated the candidate to be included in or excluded from the register.
14.2 Periodicity and transmission deadlines:
The data shall be transmitted immediately after the fact that indicates the patient to be included in the waiting lists.
Information on:
(a) such changes in the state of health of persons awaiting transplantation which could jeopardise or render impossible the indicated transplant;
(b) the deterioration of the condition of a patient already registered in the National Register of Organ Transplants, which increases the urgency of the transplantation;
(c) the detection of the death of a patient registered in the National Register of Persons Waiting for Organ Transplants.
15. National registry of transplants carried out
15.1 Heading of providers and other persons transmitting data:
Every health service provider that has provided health services under the transplant law.
15.2 Periodicity and transmission deadlines:
Data shall be transmitted within 7 days of the date of transplantation.
1) Communication from the Czech Statistical Office No. 340 / 2011 Coll., on updating the International Statistical Classification of Diseases and Associated Health Problems (MKN-10).
2) For example Act No. 582 / 1991 Coll., on the organisation and implementation of social security, as amended, Act No. 373 / 2011 Coll., on Specific Health Services.
3) Act No. 379 / 2005 Coll., on measures to protect against damage caused by tobacco products, alcohol and other addictive substances and amending related laws, as amended.
4) Act No. 108 / 2006 Coll., on Social Services, as amended.
5) Act No. 95 / 2004 Coll., on the conditions for obtaining and recognising professional competence and specialised competence for the exercise of the medical profession of physician, dental practitioner, pharmacist, as amended.
6) Act No. 96 / 2004 Coll., on the conditions for obtaining and recognising eligibility for the pursuit of non-medical medical professions and for carrying out activities related to the provision of medical care and amending certain related laws (Law on non-medical medical professions), as amended.

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Regulation Information

CitationDecree No. 116 / 2012 Coll., on the Transmission of Data to the National Health Information System
Regulation Type-
Author-
CollectionCode of Laws
Date of Promulgation06.04.2012
Effective from06.04.2012
Effective until-
Status Valid
The regulation text is for informational purposes only.
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