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General Information
Legal
Issues for Medical Audit in Australia
Michael Gorton, B.Comm, LLB,
FRACS (Hon), FANZCA (Hon) College Solicitor, Partner at Russell Kennedy, Solicitors
Audit (whether self-audit or in groups) is a welcome quality assurance activity-to
monitor and improve medical competence, and to inform the debate on medical standards.
It is important that doctors are encouraged to participate in these activities,
given the benefits for the individual, and the profession as a whole.
Whilst the profession generally is in favour of open and positive participation
in quality assurance activities, some may be discouraged for fear that:
- information generated by the activity may be used in medical negligence litigation;
- disclosure of the information may cause embarrassment or adverse impact
on their practice;
- legal action may arise from third party review
of other practices.
Many doctors will be concerned that information obtained
during the audit, particularly identifying information, may be adverse to the
doctor and his/her practice. Additionally, care should be taken to avoid patient
identifying information. Even information which identified particular hospitals,
if adverse, would be a matter of some concern. Accordingly, surgeons will be reassured
if some privilege or confidentiality applies to the process.
Qualified Privilege
There are various statutory
schemes available to provide protection to medical professionals for protection
of information obtained through audit and quality assurance activities.
The Commonwealth Qualified Privilege Scheme is established under sections dealing
with quality assurance and confidentiality in the Health Insurance Act 1973
(Cth).
Quality assurance projects, medical audits and credentialling
processes can be registered under the Scheme. Application is made to the Minister
for Health for a declaration in relation to the activity or project.
Once an activity is declared under the legislation, all participants must comply
with the confidentiality requirements contained in the legislation. This means
that any person (including a participant) who acquires information which identifies
individuals or entities, which is information known solely as a result of participation
in the activity, must not disclose or make a record of that information. A breach
of the confidentiality provisions is a criminal offence to which sanctions apply.
The information cannot be disclosed in court, unless it involves a serious
criminal offence, and then only with the specific written approval of the Minister.
Registration under the Commonwealth legislation provides two important protections:
- confidentiality of information that identifies individuals or entities,
which is known as a result of participation in the activity or project;
- protection
from civil proceedings for members of committees that assess or evaluate the quality
of health services provided by others (credentialling activities).
States
and Territories also have legislation to provide protection for quality assurance
activities. However, the legislation in some States does not provide as strong
protection as the Commonwealth legislation and, in some cases, information thought
to have been protected by State legislation has been ordered to be produced publicly
by courts and tribunals. The legislation in some States is similar to the Federal
legislation and, accordingly, the choice of registration (either under State or
Federal law) will vary from state to state.
I believe that registration
under the Commonwealth legislation affords professionals, and doctors in particular,
with adequate and strong protection of confidentiality and removes the fear of
unprotected disclosure of adverse identifying information.
Patient Confidentiality
Some activities, including
medical audit, might necessarily involve the disclosure of patient identifying
information.
Patient confidentiality is, of course, a general duty attaching
to all medical professionals. Identifying patient information and patient records
should not be used without patient consent.
In many circumstances, in
hospitals, consent is given as part of the general hospital consent form, signed
by all patients on admission.
However, in the context of private practice,
patient consent should be sought for all release or use of patient identifying
information or patient records for quality assurance, medical audit, or research
purposes.
The following material in relation to privacy legislation also
deals with these issues.
Privacy Laws
Recent legislative changes dealing with privacy issues
impact on the way audit, credentialling and medical research is conducted in Australia.
The Commonwealth's Privacy Act commenced in December 2001 and regulates
the way that information is collected, used and protected. It particularly restricts
disclosure.
Private sector organisations are required to comply with
a set of privacy principles (National Privacy Principles-NPP) that set a base
line standard for the protection of personal information. Reference has been made
in other articles to requirements under privacy legislation.
Medical
organisations in particular deal with sensitive health information which will
be regulated by privacy legislation. In addition, some States have their own legislation
dealing with these issues in a similar, but not necessarily identical, way (e.g.
the Victorian Health Records Act, which commenced in July 2002). Next
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