AIMS Declared for the Third Time as a Quality Assurance Activity in June 2006

Note: the following applies only to Australia

In June 2006 AIMS was declared for the third time by the Minister for Health and Aged Care (Australia) under Part VC of the Health Insurance Act (HIA) 1973 as a Quality Assurance Activity. This declaration provides specific protection to health care professionals participating in quality assurance activities and provides penalties for anyone who divulges protected information. The aim of the protection is to encourage health care professionals to fully participate in quality assurance activities.

As the protection is provided at the Commonwealth level, clients wishing to invoke Qualified Privilege must take legal advice to determine how laws in the local jurisdiction affect Part VC of the Health Insurance Act (HIA) 1973. AIMS clients in Western Australia, South Australia, the Northern Territory and the Australian Capital Territory have used Qualified Privilege for several years without a single successful challenge to the protection.

The most recent declaration has been altered to accommodate the increasing diversity of use of AIMS. Stakeholders require the AIMS database to be a single point of entry for the recording of adverse event-related data as well as event data often captured in separate systems. In addition to streamlining information capture, this also allows data to be collected just once and then used for multiple purposes.

The new declaration differentiates between data that ought and the data that ought not to be protected. This is done by breaking down the description of AIMS data into three discrete components, or phases, and confining the request for declaration to only one of those phases. There are, broadly speaking, three key features, activities, or phases, within the AIMS system:

1. The notification phase of reporting whether it is via paper, electronic or narrated to a call centre is not protected.
2. The investigation and analysis phase of the incident is protected.
3. The recommendation phase is not protected.

Therefore declaration (or protection) applies only to the second phase - investigation and analysis of data obtained from the notification.

It is recognised that when all adverse events are recorded through a single database; many of the matters recorded do not necessarily require or justify protection under the Part VC of the Health Insurance Act - or indeed under any other system of so-called qualified privilege or statutory immunity. The declaration states that the statutory protection should not be granted to data or activities that do not satisfy these public interest considerations, nor should protection be granted to data or activities that are inadvertently caught by the mere fact that they are in some way caught up in a protected mechanism/tool/activity. Indeed, we accept that  the propensity for such activity to protect more data than is justified on the public interest analysis countenanced by the HIA is in fact one basis for not granting the sought after protection at all. Activities that are not performed for Quality Assurance purposes do not fall under the umbrella of the act. Examples of activities that may be considered as not justifying protection under the HIA are consumer complaints and occupational health and safety events.

Scope of the Quality Assurance Declaration
Excerpts from the Department of Health and Ageing website page describing the Commonwealth Qualified Privilege Scheme (December 2006)

The Commonwealth Qualified Privilege Scheme encourages health professionals to undertake quality assurance activities in connection with the provision of certain health services.

The scheme has been designed to provide important safeguards by protecting certain information from disclosure and protecting persons involved in the activity from civil liability.

To be covered by the Commonwealth legislation (Part VC of the Health Insurance Act 1973), a quality assurance activity must involve one of the following:

• an assessment or evaluation of the quality of health services
• a study of the incidence or causes of conditions or circumstances that may affect the quality of health services
• the making of recommendations about the provision of health services as a result of an assessment, evaluation or study
• the monitoring of the implementation of a recommendation about the provision of health services.

The Commonwealth legislation can only have effect where the health services to which the activity relates involve Commonwealth funding, namely:

• Medicare Benefits
• Public Hospital Services
• Health Program Grants
• Prescribing of pharmaceutical products under the Pharmaceutical Benefits Scheme.

The Commonwealth legislation is designed to complement, not override, similar legislation that may be in place in the States and Territories. It is designed to be used when a quality assurance activity takes place in more than one State or Territory. However, there are occasions when the Commonwealth legislation may be applied to an activity taking place in only one State or Territory.

In order for the privilege provided by the Commonwealth legislation to apply, the Minister for Health and Ageing must make a declaration in relation to the specific activity.

The Commonwealth Qualified Privilege Scheme provides two main areas of protection for specific quality assurance activities. These areas are:

1. Confidentiality of information that identifies individuals
Declaration of a quality assurance activity protects the confidentiality of information that identifies individuals that becomes known solely as a result of declared quality assurance activities by:

• making it an offence to make a record of that information or to disclose that information to another person or to a court; and
• specifying that a person cannot be required to disclose, or produce documents containing, such information to a court except in certain limited circumstances.

2. Assessment of other health care providers
A declaration offers protection from civil proceedings (apart from those relating to the breach of rules of procedural fairness) to people who participate in activities that involve the assessment or evaluation of the quality of health services provided by others. This protection applies if:

• the relevant person engaged in the review process in good faith;
• the review process adversely affects the rights or interest of a person who provides health services;
• the relevant person participates in the review process as a member of a committee for the purpose of making an evaluation or assessment of the services provided by a health care practitioner; and
• all or a majority of the members of the committee are health care professionals belonging to the same health care profession as the person who provides health services.

Responsibility of participants of declared activities
As a participant of a declared activity, you must not divulge information that identifies individuals that became known solely as a result of your activity. If you do not comply with this requirement the maximum penalty under the legislation is imprisonment for two years.

Areas not covered by a Declaration
In the past there has been some misunderstanding about the purposes and scope of protection provided by a declaration. For example:

(a) Patient Consent
One misunderstanding is that a declaration overrides the general law relating to confidentiality and patient consent and thereby obviates any requirement that may exist to seek patient consent for a patients medical records to be viewed by other than a treating doctor. A declaration is irrelevant to the issue of whether or not patient consent is required.

(b) Disclosure of Information
Another misunderstanding is that all information generated as a result of a declared activity can be kept confidential. This is not the case. The only information protected by a declaration is that which identifies individuals. In fact, the legislation requires participants of declared activities to report on the progress and outcomes of the activity (without identifying individuals).