Decree No. 373 / 2016 Coll.
Decree on the transmission of data to the National Health Information System
Valid
Order
Effective from 01.01.2017
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373
DECLARATION
of 3 November 2016
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), as amended by Act No. 147 / 2016 Coll., for the implementation of Sections 70 (6) and 78 of the Health Services Act:
(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 via remote access to the designated electronic address on the website of the Institute of Health Information and Statistics of the Czech Republic (hereinafter referred to as the Statistical Institute)
(a) by remote transmission using a data interface;
(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.
(1) The application for authorisation to access personal data and other data held in the National Health Registers, the National Register of Providers, the National Register of Health Workers and the National Register of Paid Health Services ("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 number of the body authorised to submit the application;
(c) the identification details of the person authorised by the body authorised to submit the application to act on his behalf, the name and, where applicable, the names, the academic title, the scientific grade or the scientific degree, the date of birth, the telephone number and the e-mail address;
(d) the identification of the authorised worker, the name and, where applicable, the names and surnames, the academic title, the scientific grade or the scientific degree, the date of birth, the telephone number and the electronic address.
(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.
(1) The range of providers and other persons transferring data to registers and periodicity and the deadlines for their transmission are set out in Annex 1 to this Decree.
(2) The list of groups of medical devices used by providers in the provision of health services and relevant to the availability of health services (hereinafter referred to as the "significant medical device") and the scope of their data transmitted to the National Register of Providers is set out in Annex 2 to this Decree.
(3) The data relating to the transmission of the results of the laboratory tests provided for in Section 77a (4) (a) of the Health Services Act are set out in Annex 3 to this Decree.
Decree No. 116 / 2012 Coll., on the Transmission of Data to the National Health Information System, is hereby repealed.
Transitional provision
If the fact relevant for the transmission of data pursuant to Decree No. 116 / 2012 Coll., on the transmission of data to the National Health Information System, occurred before the date of entry into force of this Order and the deadline for the transmission of such data provided for in Decree No. 116 / 2012 Coll. did not expire until the date of entry into force of the Order, the data shall be transmitted to the relevant registry within the time limit provided for in Decree No. 116 / 2012 Coll.
This Decision shall enter into force on 1 January 2017.
Minister:
MUDr.
Příloha č. 1
Annex No 1 to Decree No 373 / 2016 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 data-transmission providers:
Any provider that:
(a) has established a diagnosis; or
(b) be responsible for the treatment of newly identified disease in 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 the 10th revision (hereinafter referred to as "MKN-10")] 2), the disease evaluated as neoplasms in situ (MKN-10: D00-D09), neoplasms of uncertain or unknown behaviour (MKN-10: D37-D48) and selected non-benign neoplasms and cervical dysphagia (MKN10 - D36, N87).
1.2. Deadline for data transmission
Data on each newly diagnosed disease shall be transmitted within 3 months of the date of diagnosis including data relating to the disease.
2. National Hospital Register
2.1. Heading of data-transmitting providers:
Any provider that provides bed care, with the exception of 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. The data for each hospitalisation of a patient in a bed ward or workplace not completed at the end of the calendar year shall be transmitted by the end of January of the following calendar year.
3. National Register of Reproductive Health
3.1 A range of data-transmitting providers:
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 developmental defect or genetically conditioned disease in the foetus, child or adult;
(e) who has performed an artificial abortion or has provided treatment after abortion; or
(f) in whose medical institution abortion has been caused.
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 in the foetus, child or adult, a genetically conditioned disease in the foetus, child or adult, at the end of each period of the period of service for each calendar month, until the end of the following calendar month;
(c) for each pregnancy artificially interrupted and each pregnancy terminated by abortion for each calendar month until the 10th day of the following calendar month.
4. National registry of cardiovascular operations and interventions
4.1 A range of data-transmitting providers:
Any provider that has provided medical services to a patient in connection with cardiovascular surgery or intervention.
4.2 Periodicity and transmission deadlines:
Data shall be transmitted for each cardiovascular operation carried out and for each cardiovascular intervention carried out after the hospitalisation has been completed for each calendar month until the end of the following calendar month.
5. National register of joint compensation
5.1. Heading of data-transmitting providers:
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 data-transmitting providers:
Any provider who has recognised an occupational disease under other legislation3).
6.2. Periodicity and transmission deadlines:
Data shall be transmitted for each:
(a) recognised occupational disease or occupational disease threat;
(b) an occupational disease or an occupational disease which no longer fulfils the conditions for the recognition of an occupational disease or an occupational disease risk;
not later than the 10th day of the calendar month following the month in which the medical opinion on the recognition or termination of an occupational disease or the threat of an occupational disease has gained legal effects.
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 under Section 27 of the Law on Health Protection against the harmful effects of addictive substances (4), if it is for health services.
7.1.2 Each provider of social services (8) providing professional care under Section 27 of the Law on Health Protection from the harmful effects of addictive substances (4), if it is about social services5).
7.2 Periodicity and transmission deadlines:
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. 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 treatment of the client with the professional care 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 professional care 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 professional care 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 data-transmitting providers:
Every bed care provider who hospitalized a trauma patient.
8.2. Periodicity and transmission deadlines:
Data shall be transmitted for each hospitalised accident patient no later than the end of the following calendar month following the date of completion of the hospitalisation.
9. National registry of blood donors and people permanently excluded from blood donation
9.1. Heading of data transmission providers:
Each blood transfusions provider or component thereof and each blood donation provider that has identified a person permanently excluded from blood donation.
9.2. Periodicity and transmission deadlines:
The data shall be transmitted for each blood sample or component immediately after collection and for each person permanently excluded from the blood donation immediately after verification of the positive result of the examination or diagnosis in that person.
10. National registry of autopsies and toxicology tests carried out in the medical department
10.1 Heading of data-transmitting providers:
Any provider in the field of forensic medicine for which an autopsy has been 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 Diabetology Register
11.1 A range of data-transmitting providers:
Any provider that:
(a) has established a diagnosis,
(b) is responsible for the treatment and clinical monitoring of disease in the E10-E16 diagnosis group according to MKN-10; or
(c) perform the determination of laboratory values of patients with disease in the diagnosis group E10-E16 according to MKN-10.
11.2 Periodicity and transmission deadlines:
The diagnosis and clinical monitoring data shall be transmitted for each calendar year by the end of February of the following calendar year. Data on the determination of patient laboratory values shall be transmitted for the calendar month concerned by the end of the following calendar month.
12. National Intensive Care Register
12.1 Heading of data-transmitting providers:
Any provider of bed care that provided the patient with intensive or subsequent intensive care during hospitalization.
12.2 Periodicity and transmission deadlines:
Data shall be transmitted for each completed hospitalisation of the patient in an acute bed care bed of intensive or subsequent intensive care for a given calendar month at the latest by the end of the following calendar month.
13. National Register of Health Service Providers
13.1 Heading of providers and other persons transmitting data:
Each body referred to in Section 75 (1) of the Health Services Act; If significant medical devices are involved, the data shall be transmitted by each provider using them in the provision of health services.
13.2 Periodicity and transmission deadlines:
13.2.1 Data, with the exception of data on significant medical devices, shall be transmitted for each provider within the time limit set in Section 75 (3) of the Health Services Act.
13.2.2. Data shall be transmitted for each social service provider providing health services under:
(a) the Social Services Act in social care establishments; and
(b) the Health Services Act without authorisation to provide health services;
within the deadline provided for in Section 75 (3) of the Health Services Act, except for the indication of significant medical devices.
13.2.3 Data on major medical devices used for the period 1 January to 30 June and for the period 1 July to 31 December of the calendar year shall be transmitted by the end of each calendar month following that period.
13.2.4. Data on the number of beds are transmitted according to the form and field of health care, or the type of healthcare according to § 5 (2) (f) to (i) of the Health Services Act. Data on occupancy of beds are transmitted in the following structure:
(a) Form of care:
- acute bed care intensive,
- acute bed care standard,
- subsequent bed care,
- long-term bed care.
(b) Equipment for beds:
- apparatus for supporting and maintaining respiratory oxygen or other oxygen supply equipment,
- instruments for supporting and maintaining the respiratory system,
- instruments for supporting and maintaining the circulatory system,
- dialysis apparatus,
- instruments for monitoring vital functions.
14. National Register of Health Workers
14.1 Heading of providers and other persons transmitting data:
Each body referred to in Section 77 (1) of the Health Services Act.
14.2 Periodicity and transmission deadlines:
Data shall be transmitted for each person who is competent for the exercise of the medical profession of a doctor, dental practitioner, pharmacist (6) and for health professionals who are eligible for the non-medical medical profession following the acquisition of professional competence or professional and specialised competence or specific competence (7) within the period referred to in Section 77 (4) of the Health Services Act.
15. National registry of donors
15.1 Heading of data-transmitting providers:
Every provider who identified a possible donor of organs, tissues and blood cells.
15.2 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.
16. National register of persons awaiting organ transplantation
16.1 Heading of data-transmission providers:
Any provider who has indicated the candidate to be included in or excluded from the registry.
16.2 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.
17. National registry of transplants carried out
17.1 Heading of data-transmission providers:
Any provider that provided medical services under the transplant law.
17.2 Periodicity and transmission deadlines:
Data shall be transmitted within 7 days of the date of transplantation.
18. National register of covered health services
18.1 Heading of health insurance undertakings and providers submitting data:
(a) all health insurance companies under the Act governing the General Health Insurance Company of the Czech Republic and the Act governing the department, branch, business and other health insurance companies;
(b) a provider which has carried out the required laboratory tests pursuant to § 77a (4) (a) or (b) of the Health Services Act and has reported this medical service to the health insurance company.
18.2 Periodicity and transmission deadlines:
18.2.1 Data on the scope of health services under Section 77a (2) (c) of the Health Services Act and data on personnel and material and technical equipment pursuant to Section 77a (2) (d) of the Health Services Act shall be transmitted for each quarter by the end of the second calendar month of the following quarter.
18.2.2 Data on the definition of health services under Section 77a (2) (e) of the Health Services Act, for which reimbursement has been made, data on the amount of remuneration under Section 77a (2) (f) of the Health Services Act, the type of remuneration under Section 77a (2) (g) of the Health Services Act, and the period under Section 77a (2) (h) of the Health Services Act, shall be transmitted for each half-year in the accounts as at 30 June and 31 December of the calendar year concerned, by the end of the second calendar month of the following half.
18.2.3 The data referred to in Section 77a (3) of the Health Services Act shall be transmitted for each quarter until the end of the second calendar month of the following quarter.
18.2.4. The data referred to in Section 77a (4) of the Health Services Act shall be transmitted within 14 days after the health service provider has reported a requested laboratory examination to the health insurance undertaking.
The data transmitted shall always include the data referred to in Section 77a (2) (a) and (b) of the Health Services Act.
18.3. Data on results of laboratory tests carried out:
The data relating to the transmission of the results of the laboratory tests carried out pursuant to Section 77a (4) (a) of the Health Services Act are set out in Annex 3 to this Decree.
19. National register of preventive and screening tests
19.1 Heading of data-transmission providers:
Any provider who has been involved in preventive or screening programs published by the Ministry in the Ministry of Health Bulletin.
19.2 Periodicity and transmission deadlines:
Data shall be transmitted within one month of the provision of the health service.
Příloha č. 2
Annex No 2 to Decree No 373 / 2016 Coll.
List of groups of major medical devices and the scope of data transmitted to the National Register of Health Service Providers
1. List of groups of major medical devices
Groups D.1.1 - D.1.3, D.1.4.1, D.3.1, D.4.1.4., D.5.3.1.2, T.1.1 - T.1.4, T.2.2.2.1, T.3.1.1.2., T.3.2.1., T.3.3.1, T.3.4, T.5.6.4, T.5.9., T6.1 and O.3. according to the classification of categorisation of medical technicy9).
2. Scope of data transmitted on major medical devices
Name, additional description, alphanumeric code according to the classification of the medical technology categorisation, date of acquisition of the significant medical device and address of the medical facility where the significant medical device is used.
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Regulation Information
| Citation | Decree No. 373 / 2016 Coll., on the Transmission of Data to the National Health Information System |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 16.11.2016 |
|---|---|
| Effective from | 01.01.2017 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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