EXPLANATORY STATEMENT
STATUTORY RULES 1984 NO. 289
EPIDEMIOLOGICAL STUDIES (CONFIDENTIALITY) ACT 1981
EPIDEMIOLOGICAL STUDIES (CONFIDENTIALITY) REGULATIONS (AMENDMENT)
Issued by the authority of the Minister for Health
Section 13 of the Epidemiological Studies (Confidentiality) Act 1981 (‘the Act’) provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters required or permitted by the Act to be prescribed or necessary or convenient to be prescribed for carrying out or giving effect to the Act.
The purpose of the Act is to provide for the confidentiality of information collected in prescribed epidemiological studies conducted by, or on behalf of, the Commonwealth.
Sub-section 3(1) of the Act defines a ‘prescribed study’ as, inter alia, a Commonwealth epidemiological study declared by the regulations to be a study to which the Act applies. Sub-section 3(1) also defines a ‘Commonwealth epidemiological study’ as an epidemiological study conducted by, or on behalf of, the Commonwealth.
The purpose of the regulations is to declare the epidemiological study in relation to Acquired
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Immune Deficiency Syndrome (AIDS), which commenced in 1983 and is being conducted on behalf of the Commonwealth by the National Health and Medical Research Council, to be a prescribed study under sub-section 3(1) of the Act.
The National Health and Medical Research Council (NH & MRC) is a research body constituted by an Order-in-Council pursuant to sub-section 9(1) of the National Health Act 1953. One of NH & MRC’s functions, as provided for under paragraph 9(a) of the establishing Order-in-Council is to enquire into, advise and make recommendations to the Commonwealth and the States on matters of public health legislation and administration and on any matters relating to health, medical and dental care and medical research.
AIDS in Australia was initially examined by NH & MRC at its 95th Session in June 1983. As a consequence, the NH & MRC established the Working Party on AIDS in order to ensure that AIDS is kept under constant review.
The purpose of the Commonwealth study into AIDS is that details of cases of AIDS, AIDS-related complex and Lymphadenopathy Syndrome are reported to the NH & MRC Working Party on AIDS thus enabling it effectively to monitor any spread of AIDS and advise on containment of the disease. Information provided
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includes details of patients’ medical condition and information on their travel, sexual activities and intravenous drug abuse. Because of the nature of the information sought from patients and the publicity that cases of AIDS attract, it was regarded as desirable that the study be prescribed in regulations under the Act.
Regulation 3 of the Epidemiological Studies (Confidentiality) Regulations was repealed and a new regulation 3 made which has included AIDS in the categories to which sub-section 3(1) of the Act applies.
Overview
The Epidemiological Studies (Confidentiality) Act 1981 was enacted to address the need for ensuring the confidentiality of information gathered during epidemiological studies conducted by or on behalf of the Commonwealth. The Act was introduced by the Parliament of Australia to safeguard sensitive data collected during these studies, which often include personal health information. The policy objective of the Act is to maintain the confidentiality of such information to protect the privacy of individuals while still allowing for critical public health research and monitoring.
The Epidemiological Studies (Confidentiality) Regulations (Amendment) was issued under the authority of the Minister for Health, with the aim of declaring specific studies, such as the National Health and Medical Research Council's study on Acquired Immune Deficiency Syndrome (AIDS), as prescribed studies under the Act. This amendment ensures that sensitive information collected during the study, including details about patients’ medical conditions and personal activities, is protected, thereby facilitating effective monitoring and research into the spread and containment of the disease.
Scope and Application
The Epidemiological Studies (Confidentiality) Act 1981 applies to the confidentiality of information collected in prescribed epidemiological studies conducted by or on behalf of the Commonwealth, ensuring that such information is kept confidential to protect the privacy of individuals. The Act applies to any entity involved in conducting these studies, specifically including the National Health and Medical Research Council (NH&MRC), which is conducting the study on Acquired Immune Deficiency Syndrome (AIDS) on behalf of the Commonwealth. The geographical reach of the Act is national, as it pertains to studies conducted across Australia by or on behalf of the Commonwealth government. The Act does not specify any exclusions or exemptions but rather focuses on establishing a framework to maintain the confidentiality of sensitive epidemiological data. The Act’s application is extended through the regulations, which were amended to include the AIDS study as a prescribed study, thus bringing it under the confidentiality provisions of the Act.
Key Provisions
The Epidemiological Studies (Confidentiality) Regulations (Amendment) under the Epidemiological Studies (Confidentiality) Act 1981 (the Act) make significant amendments to ensure the confidentiality of information collected in prescribed epidemiological studies, particularly focusing on Acquired Immune Deficiency Syndrome (AIDS). Regulation 3, which has been amended, now includes AIDS among the categories of studies to which the Act applies, thereby ensuring that information related to this condition is protected. This amendment aligns with the Act's purpose to maintain confidentiality in epidemiological studies conducted by or on behalf of the Commonwealth.
The obligations imposed by these regulations primarily focus on ensuring that any information collected in the study on AIDS is handled with strict confidentiality. This includes protecting the sensitive personal data of patients, such as medical conditions, travel history, sexual activities, and intravenous drug use, which are integral to the study's effectiveness. Entities involved in the study, such as the National Health and Medical Research Council (NH&MRC), must adhere to the confidentiality provisions of the Act, which means they cannot disclose any information that could identify an individual without their consent, except under specific circumstances permitted by the Act.
Failure to comply with the confidentiality requirements of the Act and the regulations can lead to significant consequences. For instance, unauthorised disclosure of confidential information can be considered an offence. Under section 11 of the Act, individuals found guilty of disclosing confidential information can face penalties, including fines. The maximum penalty for such offences is specified in section 11(1) of the Act, which sets out the potential financial penalties for breaches. Additionally, any breaches may also result in civil liability for damages caused by the disclosure, reinforcing the importance of adhering to the confidentiality requirements.