Decree No 470 / 2003 Coll.
Decree determining the scope and manner of provision of information by medical devices to the National Health Information System
Valid
Order
Effective from 31.12.2003
Text versions:
31.12.2003
470
DECLARATION
of 15 December 2003
determining the scope and manner of the provision of information by medical devices to the National Health Information System
According to Section 67c (2) of Act No. 20 / 1966 Coll., on the Care of People, as amended by Act No. 260 / 2001 Coll. and Act No. 285 / 2002 Coll.:
(1) Healthcare establishments provide information to the National Health Information System (1) to the extent set out in the Annex.
(2) Medical establishments shall provide the information referred to in paragraph 1 to the National Health Information System in written or electronic form.
This Decree shall take effect on 31 December 2003.
Minister:
Dr. Součková v. r.
Annex to Decree No 470 / 2003 Coll.
Scope and provision of information by medical devices to the National Health Information System for the management of National Health Registers
1. National Cancer Registry
For the needs of the management of the National Cancer Registry (NOR), the National Health Information System (NZIS) provides information to every medical facility that has diagnosed, treated or disseminated a disease from a group of malignant neoplasms (C00 - C97), a disease evaluated as neoplasms in situ (D00 - D09) and neoplasms of uncertain or unknown behavior (D37 - D48), to the extent:
1.1. Personal data needed to identify the patient (birth number, name and / or name, surname, address of place of residence),
1.2. Data relating to the patient's medical condition, namely the patient's personal and family history related to the disease,
1.3. Data on the disease (course and treatment),
1.4. Data on the patient's dispenserisation,
1.5. the data needed to identify the health care establishment reporting, treating and dispatching, and the name of the department (hereinafter referred to as the department name).
After 25 years of death, personal data are anonymized.
Health care facilities shall provide information on the disease to NZIS in electronic form within 30 days of diagnosis and information on the course of the disease and treatment of the disease in question at intervals of 1, 2, 3, 4, 5, 7, 10 and beyond 5 years or in the event of death.
2. National Hospital Register
For the needs of the management of the National Hospital Register, the NZIS provides information to every hospital in the health care facility, except for spa treatment and recovery facilities, for every completed hospitalisation of the patient in the hospital's bedside department, to the extent:
2.1. Personal data needed to identify the patient (birth number; municipality of residence),
2.2. Data relating to the patient's admission,
2.3. Data related to the patient's medical condition in relation to hospitalisation, namely diagnostic data on the course and treatment of the disease; the condition of the patient on release and the need for further healthcare,
2.4. Data needed to identify the hospital providing institutional care and the name of the department.
At the end of 5 years from the year of termination of the bed care, personal data are anonymized.
Medical devices shall provide information to the NZIS in writing (in person or in delivery) within 5 days of the end of each calendar month or in electronic form within 30 days of the end of each calendar month.
3. National Register of Parents
For the purpose of the management of the National Parent Register, the NZIS provides information to every health facility that has carried out the birth or postpartum treatment of the parent and newborn to the extent:
3.1. Personal data needed for the identification of the parent (birth number, name or, where applicable, name, surname, town of residence),
3.2. data relating to the health of the parent in relation to pregnancy and childbirth and to the health of the child born, namely the course of pregnancy and childbirth; the state of the mother and the child born on release; the health characteristics of the born child,
3.3. the data needed to identify the health care institution that carried out the birth or postpartum treatment of the parent and the name of the ward.
After 10 years of birth, personal data are anonymised.
Medical devices shall provide information to the NZIS in writing (in person or in delivery) for each completed calendar month no later than the 10th day of the following calendar month or in electronic form for each completed calendar month no later than the end of the following calendar month.
4. National Register of Newborns
For the purpose of managing the National Register of Newborns, the NZIS provides information to each health facility that has carried out the birth or postpartum treatment of the parent and newborn to the extent:
4.1. Personal data needed to identify the mother and newborn (birth number, name and, where appropriate, surname, town of residence),
4.2. Data relating to maternal and newborn health, namely birth data,
4.3. Data relating to the state of the newborn and its treatment,
4.4. Data on the state of health of the newborn (child) when released from the medical institution,
4.5. the data needed to identify the medical institution where the child was born or where the child was provided with bed care and the name of the ward.
After 10 years of birth, personal data are anonymised.
Medical devices shall provide information to the NZIS in writing (in person or in delivery) for each completed calendar month no later than the 10th day of the following calendar month or in electronic form for each completed calendar month no later than the end of the following calendar month.
5. National register of congenital defects
For the purpose of the management of the National Register of Congenital Diseases, the NZIS provides information to every health facility where the congenital defect of the fetus or child has been diagnosed, to the extent:
5.1. Personal data needed to identify the mother and child (birth number, municipality of residence),
5.2. Data on the father of the child (year of birth, employment),
5.3. Data relating to the state of health of the mother and child, namely the personal and family history of the mother, diagnostic data and the course of pregnancy, identified by the birth defect of the child,
5.4. Data needed to identify a medical facility that diagnosed the birth defect and the name of the department.
After a period of 5 years from the year of the 15-year-old birth, personal data are anonymised.
Health care facilities shall provide information to the NZIS in writing (in person or in delivery) for each completed calendar month no later than the 10th day of the following calendar month or in electronic form for each completed calendar month no later than the end of the following calendar month.
6. National register of users of medically indicated substitution substances
For the purpose of maintaining the national register of users of medically indicated substitution substances, with the consent of the user to the NZIS, each medical facility responsible for providing substitution treatment shall provide information to:
6.1. Personal data needed to identify the user (family number, surname, surname or, where applicable, name, permanent residence, nationality, state, health insurance company, insured person number, if this number is not the birth number),
6.2. Data relating to the health status of the user of the substitution substance,
6.3. Data on treatment, modification or cessation of substitution therapy,
6.4. The data needed to identify the medical institution and the physician transmitting the user's medical documentation,
6.5. Data on the health care facility to which the user's medical file has been transmitted on termination or change of substitution treatment (organisation identification number).
At the end of 20 years from the year of completion of the substitution treatment, personal data are anonymous.
Medical devices shall provide information to the NZIS in written form (in person or in delivery) within 24 hours of the first dose of the substitution substance and within 24 hours of the end or change of the replacement treatment.
7. National Abort Register
For the purpose of maintaining the National Abdominal Register, the NZIS shall provide information to each medical institution where the abortion was carried out, or a woman treated for abortion or ectopic pregnancy, to the extent:
7.1. Personal data needed to identify a woman (birth number, municipality of residence),
7.2. data relating to the state of health of the woman in relation to abortion, namely personal history,
7.3. data on abortion carried out (about the type of abortion, health reasons),
7.4. foetal data (age, weight, length),
7.5. Data needed to identify the medical establishment where the performance was performed and to identify the medical establishment which performed the performance.
After 10 years of abortion, personal data are anonymized.
The medical establishment shall provide information to the NZIS in writing (in person or in delivery) for each completed calendar month no later than the fifth day of the following calendar month or in electronic form for each completed calendar month no later than the 10th day of the following calendar month.
8. National Registry of Vascular Surgery
For the needs of the National Registry of Vascular Surgery, it provides information to NZIS of each medical facility in which the vascular reconstructive operation (s) has been performed, to the extent:
8.1. Personal data needed to identify the patient (birth number, name, or surname, if applicable),
8.2. Data relating to the patient's medical condition in relation to the disease, namely pre-operative information (personal and family history),
8.3. information on the treatment and progress of the disease, reason and type of operation, operational information (date of operation, identification of the surgeon, professional details of the operation carried out) and post-operative information (professional details of post-operative complications, release from the medical institution and, where appropriate, death of the patient),
8.4. the data needed to identify the medical facility in which the vascular reconstruction operations and the name of the department were carried out.
After 5 years of death, personal data are anonymised.
Medical facilities shall provide information to the NZIS in electronic form within 30 days of the end of hospitalisation in connection with the reported performance.
9. National register of joint compensation
For the purpose of maintaining the National Register of Joint Refunds, the NZIS shall provide information to each health care facility performing artificial hip joint replacement implantation to:
9.1. personal data needed to identify the patient (birth number, name or surname, if applicable),
9.2. data related to the patient's medical condition in relation to the disease, preoperative information (personal and family history),
9.3. data on the treatment and course of the disease, reason and type of operation, operational data (date of operation, identification of operator),
9.4. details of the operation carried out, including detailed identification of all components of the artificial joint replacement used,
9.5. the data needed to identify the medical facility where the implantation was carried out and the name of the separation.
After 5 years of death, personal data are anonymised.
The medical facility shall provide information to the NZIS in electronic form within 30 days of the operation.
10. Register of doctors, dentists and pharmacists
For the management of the registry of doctors, dentists and pharmacists, it provides information to the NZIS system for each medical facility to the extent:
10.1. personal data needed to identify the doctor, dental practitioner and pharmacist (birth number, name and / or surname and title if applicable),
10.2. data on education and specialisation,
10.3. data on the working or similar ratio,
10.4. the data needed to identify a medical institution to which a doctor, dentist or pharmacist has an occupational or similar relationship; the size of the time.
The health care facility shall provide information to the NZIS in written or electronic form per calendar year at 31.12.
11. National Cardiothoracic Register
For the needs of the management of the National Cardiothoracic Register, the NZIS provides information to each medical facility in which cardiac surgery was performed, to the extent:
11.1. personal data needed to identify the patient (birth number, surname, first name, or names, if applicable),
11.2. data related to the patient's medical condition in relation to the disease, preoperative information (personal and family history),
11.3. Treatment and course data, reason and type of operation,
11.4. operational information (date of operation, professional details of operation carried out, identification of operator),
11.5. post-operative information (expert data on the care provided in the intensive care unit of the medical institution, post-surgical complications, release from the medical institution, or the cause of death),
11.6. the data needed to identify the medical institution in which the cardiothoracic surgery and the name of the department were performed.
After 20 years of death, personal data are anonymized.
Medical facilities shall provide information to the NZIS in electronic form within 30 days of the end of hospitalisation.
12. National registry of cardiovascular interventions
For the purpose of managing the National Registry of Cardiovascular Interventions, it provides information to the NZIS of each medical facility in which the cardiovascular intervention (performance) was carried out, to the extent:
12.1. personal data needed to identify the patient (birth number, surname, first name, or names, if applicable),
12.2. data relating to the patient's medical condition in relation to the disease and date of the cardiovascular intervention of coronary blood vessels by catheterization (indications, history of difficulties, personal history, angiography results, description of performance including procedures and associated performance),
12.3. data on possible coronary vascular interventions (extremities),
12.4. the data needed to identify the medical institution in which the intervention was carried out and the name of the department;
12.5. Information needed to identify the doctor who has carried out the intervention (name, name, surname, working grade, if applicable).
After five years of death, personal data are anonymized.
Medical devices shall provide information to the NZIS in electronic form within 30 days after the cardiovascular intervention.
13. National Register of Occupational and Occupational Diseases
For the purposes of the management of the National Register of Occupational Diseases and Occupational Diseases, the NZIS shall provide information to any health establishment which is the centre of occupational diseases to the extent:
13.1. personal data needed to identify the patient (birth number; name or, where applicable, surname; place of residence; date of death in relation to deaths related to occupational disease),
13.2. data relating to the health of the patient in relation to occupational disease or to the threat of occupational diseases (date of detection of occupational disease, diagnosis of disease, corresponding item of the list of occupational diseases referred to in the specific legislation, 2) date from which the disease is no longer an occupational disease),
13.3. the data needed to characterise the risk or conditions of the development of occupational diseases or of the threat of occupational diseases (employment in which the performance of the occupational disease has occurred, risk factor of working conditions, 3) which has caused the occupational disease, risk factor exposure rate, category of work),
13.4. the information required for the identification of the employer (registered office and identification number of the organizational unit of the State, region or municipality or organisation identification number, if assigned, business company or name, registered office, address of the organizational unit of a foreign person in the territory of the Czech Republic, or name, name, surname, surname or address of the declared residence of a foreign person in the territory of the Czech Republic, or address of the place of permanent residence of a foreign person in the territory of the Czech Republic, or place of residence in the foreign territory and place of business, in the case of an employer who is a natural person, sectoral classification of economic activity),
13.5. the data needed to identify the medical institution which has recognised the occupational disease or the threat of occupational diseases;
13.6. the information needed to identify a doctor who, on behalf of the competent medical institution, issued a medical opinion on the recognition of an occupational disease or a threat to an occupational disease (name or, where appropriate, names, surname and title, professional title); the date of detection of the occupational disease.
After 40 years of reporting of an occupational disease or a threat to an occupational disease, personal data are anonymised.
Health care establishments shall provide information to the NZIS in written form on a prescribed form for each recognised occupational disease or occupational disease threat monthly by the 10th day of the following month in which the medical opinion on the recognition of an occupational disease or occupational disease threat has acquired legal authority.
1) Sections 67c (1) and 67d (1) of Act No. 20 / 1966 Coll., on the Care of People, as amended by Act No. 260 / 2001 Coll. and Act No. 285 / 2002 Coll.
2) Government Decree No. 290 / 1995 Coll., establishing a list of occupational diseases.
3) Decree No. 89 / 2001 Coll., laying down the conditions for classifying works into categories, the limit values of the biological exposure test indicators and the formalities for reporting work with asbestos and biological agents.
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Regulation Information
| Citation | Decree No. 470 / 2003 Coll., determining the scope and method of providing information to medical institutions in the National Health Information System |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.12.2003 |
|---|---|
| Effective from | 31.12.2003 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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