EXPLANATORY STATEMENT
ISSUED BY THE AUTHORITY OF THE MINISTER FOR HEALTH
HEALTH INSURANCE ACT 1973
Health Insurance (Quality Assurance Activity) Declaration 2018 (No. 4)
Part VC of the Health Insurance Act 1973 (the Act) creates a scheme to encourage efficient quality assurance activities in connection with the provision of health services. Those activities help to ensure the quality of health services funded by the Government, including through Medicare benefits, the Pharmaceutical Benefits Scheme, and Health Program Grants. The scheme encourages participation in such activities by protecting certain information from disclosure, and also by providing some protection from civil liability to certain persons engaged in those activities in good faith, in respect of those activities.
Subsection 124X(1) of the Act provides that the Minister may, by legislative instrument, declare a quality assurance activity described in the declaration to be a quality assurance activity to which Part VC applies.
The purpose of the Health Insurance (Quality Assurance Activity) Declaration 2018 (No. 4) (the Declaration) is to declare the Australian Corneal Graft Registry (ACGR) to be a quality assurance activity to which Part VC of the Act applies. The activity will be engaged in by Flinders University.
The ACGR collects patient and surgeon data related to corneal transplantation in Australia. These data are aggregated and analysed to provide de-identified performance information back to ophthalmic surgeons, eye banks, the international transplantation community, the Australian Government Organ and Tissue Authority, and other interested parties regarding the outcomes of corneal graft procedures and factors that may affect outcomes after the procedure.
Corneal graft recipients agree to participate on a voluntary basis. The ophthalmic surgeon seeks consent from the corneal graft recipient at the time of surgery to register data about their graft on the ACGR. These data are provided to the ACGR following the completion of a paper form, which captures demographic data about corneal graft recipients, limited data about cornea donors, and information about the surgical procedures performed. Information from follow-up appointments is collected at 12–18 month intervals after the surgery. To ensure the rigour of the dataset, the data held on the ACGR is provided confidentially to Australian Institute of Health and Welfare for linkage with the National Death Index approximately every five years. This process is an integral component of the quality assurance activity and checks whether any graft recipients have died since being registered.
The paper registration forms are sent to Flinders University and data is entered into the ACGR database, which is only accessible by Flinders University staff and resides behind a secure network firewall. Two back-up copies of the database are held on password-protected external hard drives, and the original paper records are scanned and held on another password-protected hard drive. The paper records are archived in a secure records facility.
The ACGR is an ongoing project, and as such all data is retained indefinitely on the ACGR in an identifiable format to allow for reactivation of records in the instance that a graft recipient experiences complications with their graft years or decades after the initial transplantation. If the ACGR is discontinued, the data will be retained for a further five years before being destroyed in accordance with Flinders University ethics requirements and all paper records will be destroyed by shredding.
All data intended for publication is de-identified prior to analysis and disclosure. Flinders University staff assigns random non-identifying letters to surgeons and eye banks to ensure they cannot be identified in publications. Outcomes for individual recipients and donors are not published; instead, outcomes are published in a de-identified and aggregated format to investigate factors that may influence the probability of graft survival. This manner of reporting ensures it is not possible to identify individual recipients, donors, eye banks or surgeons either directly or by implication.
Using the de-identified data, Flinders University publishes major registry reports approximately every two to three years about the outcomes of corneal graft procedures. The ACGR data is also used to contribute papers to the international scientific literature, and to make presentations to the Australia and New Zealand Cornea Society & Eye Bank at annual meetings.
Individual surgeons are also provided with analyses of data relating to their own surgical performance. These analyses do not identify patients, eye banks or cornea donors. Surgeons can use this information to benchmark or audit themselves against the de-identified and aggregated results of all surgeons who contribute data to the ACGR.
Details of the Declaration are set out in Attachment A.
CONSULTATION
Flinders University, as the applicant for declaration of the activity, was consulted in relation to the content of the Declaration. Wider consultation was not considered necessary as the quality assurance activity relates only to the gathering of information for the ACGR, as conducted by Flinders University staff.
The Declaration commences on the day after registration on the Federal Register of Legislation.
The Declaration is a legislative instrument for the purposes of the Legislation Act 2003.
Authority: Subsection 124X(1) of the
Health Insurance Act 1973
ATTACHMENT A
Details of the Health Insurance (Quality Assurance Activity) Declaration 2018 (No. 4)
Section 1 – Name
This section provides for the Declaration to be referred to as the Health Insurance (Quality Assurance Activity) Declaration 2018 (No. 4) (the Declaration).
Section 2 – Commencement
This section provides that the Declaration commences on the day after it is registered on the Federal Register of Legislation.
Section 3 – Authority
This section provides that the Declaration is made under subsection 124X(1) of the Health Insurance Act 1973.
Section 4 – Repeal
This section provides that the Declaration is repealed on the day at the end of 5 years after it was signed. Subsection 124(4) of the Health Insurance Act 1973 provides that a declaration of a quality assurance activity ceases to be in force at the end of 5 years after it is signed, unless sooner revoked.
Section 5 – Schedule
This section provides that the activity described in the Schedule is declared to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 applies.
Schedule – Declaration of quality assurance activity
The Schedule provides that the name of the activity is ‘The Australian Corneal Graft Registry (ACGR)’. It also describes the quality assurance activity as the collection and analysis of information from eye banks, ophthalmic surgeons and other health professionals about corneal transplantations in Australia.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Quality Assurance Activity) Declaration 2018 (No. 4)
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The Health Insurance (Quality Assurance Activity) Declaration 2018 (No. 4) (the Declaration) declares the Australian Corneal Graft Registry (ACGR), conducted by Flinders University, to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 (the Act) applies. Information known solely as the result of the activity, or documents created solely for the purposes of the activity, will be covered by qualified privilege.
Human rights implications
This Declaration engages the right to health as set out in Article 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The Qualified Privilege Scheme established by Part VC of the Act is aimed at encouraging participation in quality assurance activities that help ensure the highest possible health care standards are maintained. The quality assurance activity described in this Declaration will provide participants with a greater degree of confidence and security that their participation is solely for the benefit of establishing and improving outcomes of the community health care.
This Declaration also engages, but does not limit, the right to privacy as contained in article 17 of the International Covenant on Civil and Political Rights by involving the collection, storage, security, use, disclosure or publication of personal information. Data are not registered with the ACGR without patient consent, and all information published as a result of this activity is de-identified prior to disclosure.
Conclusion
This Declaration is compatible with human rights as it promotes the right to health and does not limit the right to privacy.
Prof. Brendan Murphy
Chief Medical Officer
Department of Health