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Position No. 1/2000


POSITION No. 1/2000

December 2000

First of all we need to say that, although the keeping of records on patients in the health care system is not treated in the best possible manner by the existing laws and regulations, it is possible to find provisions which, after proper interpretation, can give us the answer to whether doctors are subject to information duty under Article 11 and notification duty under Article 16 of the Act No. 101/2000 Coll.

In this field, probably the only law which explicitly (expressis verbis) stipulates the obligation to keep records is the Act No. 160/1992 Coll. on Health Care in Non-governmental Health Care Facilities, as amended (Article 5, Para. 2, letter d) of the Act).

However, the obligation to keep medical records ensues from many other laws of which some contain the requirement explicitly though it is always limited to the respective field regulated by each of them. For example, for all health care facilities or doctors this duty is stipulated by the Act No. 258/2000 Coll. on Public Health Protection and on the Amendment of Related Laws. This law stipulates the duty to record in the patients' files all data concerning inoculation as well as the contents of the instruction concerning the so-called "confirmation test" (Article 46-47 and Article 74). Another law which mentions the records is the Act No. 582/1991 Col. on the Organisation and Administration of Social Security Benefits, as amended, whose Article 16 stipulates that health care facilities are obliged to lend the doctors working for social security administration the necessary medical documentation. The duty to keep medical records is expressed also in Articles 32-33 of the Act No. 167/1998 Coll. on Addictive Substances and on the Amendment of Certain Other Laws, as amended. The law stipulates that health care facilities are obliged to keep records and preserve documentation on the use of addictive substances. The Act No. 123/2000 Coll. on Medical Devices and on the Amendment of Related Laws, imposes on all natural or legal persons authorised to provide health care the duty to register in the medical records all accidents resulting in death or injury of the patient. The keeping of medical records is relied on also by the Ministerial Decree No. 343/1997 Coll. on Medicaments and by certain other decrees.

Indirect reference to the duty to keep medical records can be found also in the Act No. 20/1966 Coll. on People's Health Care, as amended, which authorises the employees of the state health care administration to study documentation on the state of the patients' health and copy parts of the text or make extracts from it. Such reference is contained also in other laws authorising the monitoring bodies to study the documentation

To the latter we should add also the long-established interpretation of Articles 11 and 55 of the already quoted People's Health Care Act, under which the keeping of medical records forms an integral part of medical care and of the duties of health care facilities and health care workers. Also the Ministerial Decree No. 221/1995 Coll. on Expert Committees, developing the provisions of the aforementioned Act, stipulates that the work of the committee and its verdict on whether health care was administered lege artis (using the right methods and procedures) should be based on medical records of the case.

From the above summary it is evident that the law requires doctors and medical facilities to process personal data. Whether the law imposes the duty to keep records explicitly (as in the Act No. 160/1992 Coll.), or whether the obligation is expressed in some other manner, i.e. in connection with the definition of other duties, does not seem to be of great importance as long as the wording of the respective law is sufficiently clear. The different manner of expressing the obligation is due rather to the insufficient co-ordination of the legislative efforts than to material reasons. This conclusion is supported also by the fact that the laws or regulations sometimes use different terms, although what is meant in all of the cases is clearly medical documentation.

If we tried to interpret the law differently, taking into account only the literal meaning of the relevant legal provisions, we would have to conclude that the information duty applies only to doctors in state-owned facilities, and not to the personnel of the facilities not owned by the state which would clearly contradict the principle of equality of rights and responsibilities.

Conclusion: Doctors, or health care facilities whether or not they are owned by the state, are not subject to information duty under Article 11 of the Personal Data Protection Act, neither to notification duty under Article 16 of the Act No. 101/2000 Coll. on the condition that the data in question are personal data referred to in the aforementioned laws and regulations.



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