EXPLANATORY STATEMENT
ISSUED BY THE AUTHORITY OF THE MINISTER FOR HEALTH
HEALTH INSURANCE ACT 1973
Health Insurance (Quality Assurance Activity) Declaration 2018 (No. 1)
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 that are 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. 1) (the Declaration) is to declare the Australian Otolaryngology Head and Neck Quality Assurance Network (AOQAN) to be a quality assurance activity to which Part VC of the Act applies. The activity is undertaken by the Australian Society of Otolaryngology Head and Neck Surgery Limited (ASOHNS). ASOHNS is the representative organisation for Ear, Nose and Throat Head and Neck surgeons in Australia.
The activity consists of a web‑based system that collects and collates potentially sensitive information from otolaryngology head and neck surgeons about their patient’s head and neck cancer diagnosis and staging, treatments including surgical and non-surgical interventions, and follow-up appointments. The system will later expand to include additional modules covering rhinology and otology.
The objectives of the activity are to provide information on current surgical techniques to provide knowledge related to the complications and successes of surgery, including patient outcomes.
Prior to any information being collected, patients are asked by their surgeon to consent to participate in the activity and are advised their data will be recorded in the registry and de-identified to be used for quality assurance purposes. If the patient consents, the surgeon uses a unique login and password to access the web based system and enters the relevant information collected from their patient. Each surgeon has secure access to their own information using their unique login and password.
The information collected is stored in a database hosted in a secure Microsoft Azure environment. Microsoft Azure is a “Platform as a Service” cloud‑based model that is certified by the Australian Signals Directorate. This platform enables ASOHNS to use web applications and proprietary software specifically designed to securely host data collected by the Activity.
Further, only system administrators employed by ASOHNS will have access to information about individual surgeons and patients relating to the information provided through the activity. Any data collected for the purpose of undertaking this quality assurance activity will be held only while the Declaration is in force, and thereafter destroyed.
The activity includes analysis of outcome data by a Data Sub-Committee of ASOHNS. The Committee is comprised of otolaryngology head and neck surgeons with the necessary medical knowledge to make informed assessments of the data collected, as well as one member with expertise in statistics and data analysis. To access the data for analysis, the Data Sub-Committee must request a report of the data within specific parameters, such as data related to certain medical procedures or data fields. Surgeons define the data sets to provide useful information for evaluation purposes and meaningful reporting will be distributed to users of the system on a regular basis. The system administrator then accesses the database using a secure login and extracts the data into a report according to the request. As part of this process any information that may identify, expressly or by implication a particular individual, or particular individuals is removed prior to analysis.
ASOHNS publishes the data annually. These reports provide recommendations based on data to enable clinicians to engage in evidence based outcomes. Regular publication of reports are used to monitor the implementation and effectiveness of any recommendations made.
The data held in each registry will not be used for any purpose other than for research in a de-identified, aggregated manner in accordance with the descriptions set out in the Declarations. In line with the legal requirements of qualified privilege, any information that may identify an individual patient surgeon, either expressly or by deduction will not be publicly disclosed.
Examples of information AOQAN collates are:
- patient details (name, gender, year of birth) as well as co-morbidities;
- surgeon details;
- hospital/clinic;
- date of diagnosis for the tumour;
- details of the tumour properties (site, classification, histology, diagnosis confirmation, risk factors);
- therapy decision and planned treatment;
- follow up reminders incorporated in the system;
- follow-up appointments for head and neck cancer patients recorded for ASOHNS to assess treatment plans that have the most effective survival rates; and
- reporting, benchmarks and monitoring of results.
The database uses the International Union Against Cancer / American Joint Committee on Cancer TNM (Tumour, Node, Metastasis) classification of malignant tumours, the international standard for all tumours in all sites in the body. This classification is used by every cancer service in the world to standardise staging of tumours, record the tumour, make appropriate treatment decisions, record in all databases and report in scientific papers and in all text books.
Details of the Declaration are set out in Attachment A.
CONSULTATION
ASOHNS, as the applicant for declaration of the activity, was consulted prior to the finalisation of the Declaration. Wider consultation was not considered necessary as the quality assurance activity only relates to the gathering of information for the AQOAN, as conducted by ASOHNS.
The declaration of this activity will not result in any direct or substantial indirect effect on business.
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. 1)
Section 1 – Name
This section provides for the Declaration to be referred to as the Health Insurance (Quality Assurance Activity) Declaration 2018 (No. 1) (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 Otolaryngology Head and Neck Quality Assurance Network’. It also describes the quality assurance activity as the collection of sensitive information about surgical procedures and patient outcomes from Otolaryngology Head and Neck surgeons through a web-based system.
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. 1)
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. 1) (the Declaration) declares the Australian Otolaryngology Head and Neck Quality Assurance Network Registry conducted by the Australian Society of Otolaryngology Head and Neck Surgery Limited 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 Right 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 collected as part of the quality assurance activity will be de-identified to ensure that no individual or individuals are identified prior to analysis or disclosure of the information.
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