EXPLANATORY STATEMENT
ISSUED BY THE AUTHORITY OF THE MINISTER FOR HEALTH
HEALTH INSURANCE ACT 1973
Health Insurance (Quality Assurance Activity) Declaration 2018 (No. 5)
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. 5) (the Declaration) is to declare the Emergency Medicine Events Register, also known as EMER, to be a quality assurance activity to which Part VC of the Act applies.
The body authorising this activity is the Australasian College of Emergency Medicine Limited (ACEM). The activity will be undertaken by ACEM.
The EMER project is an online incident reporting platform for emergency medicine physicians, including emergency medicine trainees, practicing in Australia and New Zealand to report adverse events, or ‘near-miss’ events that occur during their practice. Other allied health care professionals and health care consumers can also access the platform to report an event.
Users may report incidents across a spectrum of incident severity, ranging from ‘near misses’ to severe harm, by using an online portal (www.emer.org.au). Users are asked to respond to closed-ended and open-ended questions and provide information about each incident in free-text fields. At the completion of each reported incident, a brief de-identified summary of the incident reported is provided to the reporter. An incident identification number is provided for clinician-reporters to use to record continuing professional development points. No information that may identify a person is contained in the summary or incident identification number.
Any information that may identify a particular site, individual or individuals either expressly or implicitly is removed by an appropriately qualified designated EMER data custodian appointed by the ACEM within 72 hours of each incident reported. As this process de-identifies the data and removes any personal information, users will not be required to consent to their personal information being used for the purpose of the quality assurance activity.
ACEM personnel categorise each incident according to patient safety issues, human contributory factors, system resilience, and how far downstream an error travels before it is detected.
Persons who request access to EMER data must obtain low risk ethics approvals from relevant institutional human research ethics committees and ACEM. Once all approvals are obtained, ACEM data personnel extract the data from the EMER database and check all potentially identifiable information is removed before the data is released to the person and used for further analysis. The data is then securely released to the data requester.
The ACEM has the following security measures to ensure safe and secure storage, protection and access to the data:
- The EMER will be on a dedicated virtual server hosted on Amazon Web Services (AWS). Amazon Web Services is an Australian Signals Directorate Cloud Certified Provider. In this context, “dedicated” means the server would not host any other website.
- Implement a web application firewall to mitigate against un-authorised access and other attacks.
- Submit the site for ‘HSTS (HTTP Strict Transport Security) preload’, which instructs all browsers to only ever connect to EMER via a secure connection and removes the ability of any compatible browsers to use the same HTTP.
ACEM will only ever release de‑identified, aggregated data from the EMER to produce reports for journal publications, e-newsletters, magazines, and peer reviewed publications, and for presentations at safety and quality related conferences, professional development and learning programs and workshops. Data will only be released where there is a minimum cluster of at least five similar cases and presented on a quarterly basis or as a sufficient number of similar cases becomes available, for example biannually or annually.
Data from EMER that are used for quality assurance activities will be securely held and retained from the last data of data entry for a period of seven years and then securely destroyed using a double deletion process. The deletion process will be double audited to ensure that all artefact data and back up data are securely removed from the AWS dedicated virtual server.
Details of the Declaration are set out in Attachment A.
CONSULTATION
ACEM, 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 EMER program conducted by ACEM.
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. 5)
Section 1 – Name
This section provides for the Declaration to be referred to as the Health Insurance (Quality Assurance Activity) Declaration 2018 (No. 5) (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 Emergency Medicine Events Register (EMER)’. It also describes the quality assurance activity as a program that allows emergency health professionals practising in Australia to record critical emergency-related incidents across a spectrum of incident severity—from ‘near misses’ to severe harm—through an online incident reporting system, known as EMER.
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. 5)
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. 5) (the Declaration) declares the Emergency Medicine Events Register conducted by the Australasian College of Emergency Medicine 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 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. Although some personal data may be initially collected, the data will be promptly de-identified to remove any personal information and ensure that no individual or individuals are identifiable. The de-identified information is then analysed, securely disclosed to appropriate data requesters and used to inform the improvement of emergency medicine practice.
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