General Information
 Legal Issues for Medical Audit in Australia (cont.)
Health Information
Health information includes information or an opinion about the physical, mental or psychological health of a person. It includes information about a disability, and an individual's wishes about future health services. It also includes information relating to the health services provided.

Collecting Health Information
Generally speaking, health information now collected will need individual consent. This need not be written, but should be clear, either from the express wishes of the individual or arising from the conduct or circumstances.

Information collected can only be used for the general purposes for which it was collected. In the main, this will relate to the treatment and health services to be provided to the patient or individual. It can include secondary purposes for which a doctor may need to use or disclose health information, including for research, management of health services, quality assurance, follow up with individuals or consulting with other doctors.

Research
Health information forms a special category of information which is highly sensitive. In general terms, it can only be collected and used under privacy legislation with consent. However, the NPP provide an exemption allowing for the collection, use and disclosure of health information which is necessary for research, i.e. 'relevant to public health' under particular conditions. These include circumstances where it is impracticable for the organisation conducting research to seek the individual's consent first. For example, there may be no current address for a person whose health information is being used in the research, or insufficient information to allow follow up or identification. There may be administrative and practical reasons why an individual consent in each case is difficult to obtain. Some research projects allow patients to 'opt out' of a trial or data collection project, rather than require a specific consent to participate.

However, to utilise this exemption:
  • it must be shown that the research cannot be served by 'de-identified information'-where the identity of the individual cannot be ascertained;
  • the research must take place in accordance with guidelines issued by the Privacy Commissioner.
The Privacy Commissioner may approve guidelines issued by the NHMRC, and draft guidelines have been issued for comment. The guidelines require that general ethical principles be applied to all research involving humans, as well as guidelines on specific research, participant groups and other issues.

A fundamental of the guidelines is a requirement for a Human Research Ethics Committee to review research proposals. The HREC must consider a number of matters, including whether the research proposal has sufficient expertise and understanding of the privacy issues involved, and whether or not the public interest in carrying out the research activity substantially outweighs the public interest in the protection of privacy.

Nonetheless, other National Privacy Principles should also be borne in mind when conducting research, even if approval has been received from an HREC:
  • reasonable steps must be taken to ensure that, where health information has been collected without consent, it is de-identified before it is disclosed;
  • reasonable steps must be taken to protect personal information from misuse, loss, unauthorised access, modification or disclosure;
  • reasonable steps must be taken to destroy and de-identify personal information when no longer required;
  • reasonable steps must be taken to let any person who asks, to be advised of the personal information held, for what purpose, and how the information is collected, held and used.

Other Legislation
State based legislation does, in the main, reflect the same requirements. For example, in Victoria, the Health Records Act 2001 establishes its own Health Privacy Principles (HPP), which similarly govern the collection, use, disclosure and handling of health information. The Health Services Commissioner in Victoria has also issued statutory guidelines on research reflecting similar requirements to those under the Federal legislation:

  • research must be in the public interest if it is not practicable to seek consent from patients;
  • research information should be de-identified as much as possible;
  • research should be reviewed by a Human Research Ethics Committee.
July 2002


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This page was last edited: 16 September 2003