On Friday the Federal Government quietly released its long-awaited framework for secondary use of information contained within the My Health Record. It will generate discussion as it is controversial.
The release of the framework to guide the secondary use of My Health Record (MyHR) system data comes just months before the participation rules for the Australian national health record change from opt-in to opt-out.
Consent for secondary use is implied if consumers don’t opt out of the MyHR. In other words, people need to take action if they don’t want their health data to be used for purposes other than direct clinical care.
To stop information flowing to third parties, consumers will have to press the ‘withdraw participation button’.
Another hot topic is the use of the data by commercial organisations which, interestingly, is permitted under the framework, provided it is ‘in the public interest’.
And, as expected, one of the main purposes of secondary use is the monitoring of outcomes of care. It remains to be seen what this will mean for the interaction and relationship between consumers and health providers.
The release of data is expected to commence from 2020.
The Australian Institute of Health and Welfare (AIHW) will act as the data custodian.
A ‘My Health Record secondary use of data governance board’ will assess applications for access to MyHR data ‘based on the use of data, not the user’.
Any Australian-based entity, except insurance companies, can apply to get access to the data. The board will take a ‘case and precedent’ approach to determining what uses will be permitted and not permitted for secondary use.
Although information in the MyHR cannot be used for commercial purposes, such as direct marketing to consumers, data may be released to commercial organisations if they can demonstrate that the use is consistent with ‘research and public health purposes’ and is likely to be ‘in the public interest’.
I suspect that this backdoor will be in high demand by third parties such as the pharmaceutical industry.
The board can permit the linkage of myHR data with other data sources once the applicant’s use is assessed to be of public benefit. In an example provided in the framework, researchers link MyHR information to a database of clinical trial participants to investigate hospitalisations, morbidity and mortality.
The framework gives examples of the use of health data for secondary purposes, including:
- Evaluation of health interventions and health programs (e.g. determine if an intervention or service is generating outcomes/benefits consistent with funding approvals)
- Examining practice variations for the purposes of quality improvement or adherence to best-practice guidelines at a health service level
- Construction of clinical registries (e.g. create or supplement data in clinical registries to evaluate the effectiveness of interventions)
- Improvement of existing health services and development of new services
- Enhancing post-market surveillance insights for new products
- Improvements to patient pathways research
- Increased visibility and insights into population health matters
- Development of government health policy
- Develop/enable technology innovations
- Preparation of publications
- Recruitment to clinical trials (e.g. identify people who may be suitable for a new product/service)
- Development of clinical decision support systems (e.g. link data on individual’s health with best practice to influence treatment choices)
- Health services research relevant to public health (e.g. examine the health service utilisation patterns for potentially avoidable hospitalisations; research that leads to changes in other government policies, such as welfare, and ultimately reduces impact on the health system).
A review will be performed after two years, which may identify additional uses.
The following uses of MyHR data are not permitted:
- Determination of funds allocation for a health service (e.g. set the level of funds allocated to an individual community health service)
- Remuneration of individual clinicians (e.g. to make/modify payments)
- Individual clinician audit (note: this does not exclude examining practice variations for the purposes of quality improvement or adherence to best-practice guidelines at a health service level).
- Direct marketing to consumers
- Assessment of insurance premiums and/or claims
- Assessment of eligibility for benefits (e.g. use by Centrelink and/or the Australian Taxation Office to make determinations relating to an individual)
- Criminal and/or national security investigations, except as required by law (e.g. use to investigate the interactions of individuals with the health system as part of assessing their behaviour).
Data that has been removed or classified by consumers as ‘restricted access’ will not be retrieved for secondary use purposes. Similarly, when people cancel their MyHR record, the data will no longer be used.
Consumers can stop their data being used for secondary purposes by clicking on the ‘withdraw participation button’. It is expected that a dynamic consent model will be introduced later, which allows consumers to give consent for secondary use on a case-by-case basis (which would also open the door for the use of identified data).
In the light of the recent Facebook Cambridge Analytica Scandal I suspect that many consumers will press the button – or will be advised by health professionals to do so.