Health databases: the basic legal and ethical principles

 

Most other countries contain extensive data-protection legislation in an era where data has become a commodity and personal information a valuable tool in marketing strategies, planning and research. South Africa has no data-protection legislation that could regulate the collection, storage, use and transmittal of personal information. Information legislation in existence aims to regulate requests for information, rather than the compilation and use of information. With this in mind, medical practitioners have to be extremely careful how they use, and have others use patient information.

 

Doctor-patient confidentiality is one of the cornerstones of the medical profession. Sections 12 and 14 of the South African Constitution protect this right as well. Section 12 relates to freedom and security of the person (the right to have control over one’s body and information about oneself) and section 14 entrenches the right to privacy and confidentiality. Inferences drawn from personal information such as names etc. as to the race or any other characteristic of the patient may amount to claims of unfair discrimination under section 9 of the Constitution, especially as persons also have the right to self-identify. The National Health Bill, in its current version, states that every health care user (i.e. patient) is entitled to confidentiality of all information concerning him/herself, their health status, treatment or stay in a health establishment. It also states that a health care provider may examine the records of a patient for purposes of study, teaching or research with the authorisation of the patient, the head of the establishment and the ethics committee.

 

Other relevant documents supporting the sanctity of this principle is Ethical Rule 20 of the Rules specifying the Acts or Omissions in respect of which the Council may take Disciplinary Steps promulgated in terms of the Health Professions Act of 1974 and the SAMA Code of Conduct. The new proposed World Medical Association Policy on Health Databases includes strict provisions in relation to the protection of privacy. This proposed policy is to be discussed by SAMA’s Human Rights, Law and Ethics Committee. One of the most recent proposals of the Medical and Dental Professions Board on patient records on CD includes reference to “effective safeguards against the unauthorised use or retransmission of confidential patient information”. In the international context, the OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data entrenches the following principles: openness, limitation of collection and use, purpose specification, data quality, individual participation, security safeguards and accountablity.

 

This means that a medical practitioner, or any other person or institution dealing with patient information, has to be authorised by law or court order to hand over or sell such information to a third party or has to obtain the informed consent of the patient. One such law is the Medical Schemes Act and Regulations that authorise certain patient information to be given to the patient’s fund. This however does not mean that where an intermediary handles accounts, such intermediary can sell that information to any other institution. Such information has been obtained for the purposes of submitting it to a specified medical aid fund and may only use it for that purpose, as authorised by relevant legislation. In all other cases it is advisable that the medical practitioner obtain the permission of his or her patients if the information is to be part of another database or information system, especially if that information is to be sold for profit purposes or provided to third parties. Where a practitioner want to use the information for bona fide business planning purposes, it is submitted that they are not prohibited from using patient data. However, one should be careful where that information, however de-identified it may be, goes out to any person or group of persons that is not part of the immediate health care arrangement between the patient and medical practitioner.

 

It is often stated that the information is de-identified (i.e. there is no name attached to the information) and therefore can be utilised for any purpose. This is not true, as there may be other aspects involved. One is the fact that the patient owns the information (the establishment or practitioner may own the record, i.e. the file), another is the fact that a patient may have objections to his/her information being sold or given to, for example, a certain facility, organisation or business. Where a third party requests certain aspects of patient information from a medical practitioner in private practice, it is suggested that such application should be done in terms of the Promotion of Access to Information Act, in terms of which the unreasonable disclosure of personal information is prohibited. It is better left to the requester to proof in a court of law that the information that they are requesting does not amount to an unreasonable disclosure than the medical practitioner running the risk of violating patient rights.

 

Elsabé Klinck

Human Rights, Law and Ethics Unit

SAMA

July 2001

 

These documents do not constitute official SAMA policy.

It is, however, the opinion of the legal department

and is provided without prejudice.