Epidemiological Studies (Confidentiality) Amendment Regulations 2000 (No. 1) 2000 No. 225
EXPLANATORY STATEMENT
STATUTORY RULES 2000 No. 225
Issued by authority of the Minister for Health and Aged Care
Epidemiological Studies (Confidentiality) Act 1981
Epidemiological Studies (Confidentiality) Amendment Regulations 2000 (No. 1)
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.
Subsection 3(1) of the Act defines a "prescribed study" as:
(a) the Vietnam Veterans Study; or
(b) a Commonwealth epidemiological study declared by the Regulations to be a study to which the Act applies.
Regulation 3 of the Epidemiological Studies (Confidentiality) Regulations identifies those Commonwealth epidemiological studies declared to be a "prescribed study" for the purposes of the Act.
The Act restricts the use that may be made of information or documents relating to a prescribed study. Section 5 of the Act enables the Minister to authorise the release of documents prepared or obtained in the conduct of a prescribed study to persons assisting in the conduct of another prescribed study.
The purpose of the Regulations is to include a new study as a "prescribed study" defined under the Act, in order for the Minister to authorise the grant of access to data from another prescribed study for use in the new study.
The new study, to be conducted by the Department of Veterans' Affairs, involves compilation of a nominal roll and the conduct of mortality and cancer incidence studies of Australian participants in the British atomic tests performed at Monte Bello Islands, Western Australia, and Emu Claypan and Maralinga, South Australia between 1 January 1952 and 31 December 1967. This study will be based on data and other information, held by the Departments of Health and Aged Care and Industry, Science and Resources, from a study currently prescribed under the Act.
The data from both studies will be protected in accordance with provisions in the Act and Regulations.
Details of the Regulations are as follows:
Regulation 1 provides that the Regulations may be cited as the Epidemiological Studies (Confidentiality) Amendment Regulations 2000 (No. 1) Regulation 2 provides that the Regulations would commence on gazettal.
Regulation 3 provides that the Epidemiological Studies (Confidentiality) Regulations are amended by Schedule 1.
Item 1 of Schedule 1 amends regulation 1 of the Regulations to change the citation of the Regulations.
Item 2 of Schedule 1 amends subregulation 3(j) to replace the full-stop at the conclusion of the paragraph with a semi-colon.
Item 3 of Schedule 1 inserts a new subregulation after 3(j) describing the new study which will, as a result, become a "prescribed study" for the purposes of the Act:
"(k) the epidemiological study in relation to persons affected by the Atomic Weapons Test Programme conducted by the United Kingdom in Australia at the Monte Bello Islands, Western Australia, and at the Emu Claypan and Maralinga, South Australia, between 1 January 1952 and 31 December 1967, being the study conducted on behalf of the
Overview
The Epidemiological Studies (Confidentiality) Amendment Regulations 2000 (No. 1) were introduced to amend the Epidemiological Studies (Confidentiality) Act 1981 by including a new epidemiological study as a "prescribed study". This was done to enable the Minister for Health and Aged Care to authorise the release of data from existing studies to the new study, which involves the compilation of a nominal roll and the conduct of mortality and cancer incidence studies of Australian participants in the British atomic tests performed at Monte Bello Islands, Western Australia, and Emu Claypan and Maralinga, South Australia between 1 January 1952 and 31 December 1967. The regulations were enacted to address the gap in existing legislation by ensuring that the data from both the new and existing studies are protected in accordance with the Act and Regulations. The policy objective of the Act is to ensure the confidentiality of information or documents relating to prescribed studies, and the Regulations aim to facilitate the use of such data in a manner that aligns with this objective.
Scope and Application
The Epidemiological Studies (Confidentiality) Amendment Regulations 2000 (No. 1) amends the Epidemiological Studies (Confidentiality) Regulations to incorporate a new study as a "prescribed study" under the Epidemiological Studies (Confidentiality) Act 1981. This amendment allows the Minister for Health and Aged Care to authorise the release of documents and information from existing prescribed studies to be used in the new study. The Act applies to information and documents relating to epidemiological studies, particularly those deemed "prescribed studies" as defined under section 3(1) of the Act, which include the Vietnam Veterans Study and any studies declared by regulations to fall under this category. The Act restricts the use of such information and documents to authorised purposes only, providing a legal framework to protect the confidentiality of study participants. The amendment extends the application of the Act to include a new epidemiological study conducted by the Department of Veterans' Affairs, focusing on the mortality and cancer incidence of Australian participants in British atomic tests conducted between 1952 and 1967 at Monte Bello Islands and Maralinga. The geographic scope of the Act and its amendments is national, as it pertains to epidemiological studies conducted across Australia. The Regulations are applicable to all Commonwealth epidemiological studies that fall under the Act's purview and do not include specific exclusions or exemptions beyond what is already stipulated in the Act.
Key Provisions
The Epidemiological Studies (Confidentiality) Amendment Regulations 2000 (No. 1) primarily serves to include a new epidemiological study as a "prescribed study" under the Epidemiological Studies (Confidentiality) Act 1981. This new study, as defined in subregulation 3(k) of the amended Regulations, pertains to individuals affected by the Atomic Weapons Test Programme conducted by the United Kingdom in Australia between 1 January 1952 and 31 December 1967 at specific locations such as the Monte Bello Islands, Western Australia, and at Emu Claypan and Maralinga, South Australia. The inclusion of this study as a prescribed study enables the Minister to authorise the release of documents and information from other prescribed studies for use in the new study, thereby facilitating the necessary research and analysis by the Department of Veterans' Affairs.
The obligations imposed by these Regulations on the parties involved primarily revolve around the handling and use of sensitive data obtained from epidemiological studies. The Act and the Regulations together ensure that information related to prescribed studies is kept confidential and is only used for the purposes intended by the Act. Specifically, Regulation 3(k) mandates that the data from the new study must be protected in the same manner as other prescribed studies, which includes stringent confidentiality measures. Furthermore, Regulation 5 allows the Minister to authorise the release of documents and data from one prescribed study to another, provided it is for the purpose of conducting further research or analysis under the Act.
Breach of the confidentiality provisions stipulated in the Epidemiological Studies (Confidentiality) Act 1981 and the Regulations can lead to significant consequences. According to Section 10 of the Act, unauthorised disclosure of information relating to a prescribed study is an offence. Such offences can attract criminal penalties, including fines and imprisonment, depending on the severity of the breach. The maximum penalties for contravening the confidentiality provisions can include substantial fines and imprisonment for up to two years, as outlined in the Act. Civil penalties may also apply, and individuals or entities found in breach of these provisions could face legal action, including injunctions or damages claims. The stringent measures are in place to ensure the integrity and confidentiality of the data collected in these sensitive epidemiological studies.