The summary report by HealthConsult for the national Department of Health regarding Development of a framework for the secondary uses of My Health Record Community Consultation comments
HealthConsult, as leader of a Consortium consisting of two commercial Firms and eight subject matter experts, was engaged on 24th June 2016, by the Department of Health (the ‘Department’) to: “develop a Framework for the secondary use of data in My Health Record system ” A key task in developing the Framework was to design and conduct a consultation process to facilitate a public conversation about the future possible secondary uses of MHR system data (there is currently no secondary use). Stakeholders engaged strongly with the consultation process, with 714 individuals attending webinars (159), workshops (256), interviews (25), or completing a written survey (274); and 80 organisations/individuals making a written submission. This document summarises the key themes that emerged under each of the consultation questions (grouped as appropriate). It is only a report of the consultation process, and it should not be read as the likely content of the Framework.That's a useful caveat given the likely disconnect between the Department's development processes, the outcome and the consultation.
The summary report (the full report doesn't appear to be available) states
Key conclusions that can be drawn from the consultation process are:
• There is strong support across all stakeholder groups for the secondary use of MHR data, with a common view being that this emerging public asset must be used for public benefit
• Stakeholders support a wide range of research, policy, program and service development uses, but use for solely commercial or non-health purposes is not supported by the vast majority
• Stakeholders do not support the secondary use of MHR data for the purposes of remunerating or for audits or other processes aimed at evaluating the performance of clinicians
• There is some support for secondary use of MHR data by commercial Firms as long as there is a public health benefit, but there are also some who oppose any secondary use by a commercial Firm
• There is some support for allowing secondary use of MHR data by overseas users (to support international research collaborations), but the prevailing view is that data must be stored in Australia
• Stakeholders have provided guidance on a wide range of principles to be applied to guide the release of MHR data for secondary use, and strongly advocated drawing from the best of existing approaches
• There is strong support for an independent body to govern the secondary use of MHR data, but there is also support for governance by the Department of Health, Australian Institute of Health and Welfare (AIHW) and, to a lesser extent, Australian Digital Health Agency (ADHA)
• Whatever the governance authority, stakeholders want membership of the governance committee to include independent experts, as well as strong consumer and Indigenous representation
• Most stakeholders believe that ethics approval should be obtained for secondary use of deidentified MHR data, and applications for data access should demonstrate a public benefit
• In addition, for secondary use of identified MHR data, most stakeholders believe that informed consumer consent should be obtained
• There is strong support across stakeholders for data linkage of MHR data to other (particularly health) data sets to be done by an Accredited Integrating Authority, to further leverage benefits from the MHR system
• Stakeholders believe that privacy protection is paramount and a ‘privacy by design’ approach should be adopted in developing the Framework
• Stakeholders have provided guidance on a wide range of approaches to privacy protection and advocated that a ‘best of breed’ approach is taken in developing the Framework
• Stakeholders believe that MHR data should be released for secondary use using a variety of mechanisms determined using a risk based approach, ranging from publication of key statistics, through to the release of controlled data (data cubes), through to access to unit record data in a secured environment • Stakeholders strongly support a robust range of monitoring and assurance process from users signing confidentiality undertakings through to random audits of users to ensure that any MHR data released for secondary use is only used for the approved purposes
• Stakeholders have provided guidance on risk mitigation strategies around secondary use of MHR data that includes users meeting minimum standards for data security infrastructure, users being trained and/or accredited, and users providing annual and end-of-project compliance reports
• Stakeholders strongly support a public register that includes details of requests for access to MHR data for secondary use as well as publications reporting the outcomes of the secondary use
• Stakeholders have a mixed view of penalties for misuse of MHR data with some considering the existing arrangements adequate and others advocating a stronger penalty regime
• Stakeholders believe the current policy/legislative environment is complex, and they would like to see changes to harmonise the various polices/legislation to be explicit around secondary use of data
Overall, the stakeholder engagement process has generated considerable and very valuable input into the development of the Framework. There is a widespread recognition of the public good benefits that can be obtained through the secondary use of MHR data. There is also a strong understanding of the risks, and it is clear that the initial Framework must take a cautious approach to ensure that the existing social (and cultural) licence to use the MHR data for secondary purposes is not eroded. Subsequent updates to the Framework may take a more liberal approach, once processes, procedures, mitigation strategies, and so on have been tried, tested and refined. To this end, an evaluation of the effectiveness and impact of the initial Framework after two years or so of operation would be a very worthwhile endeavour.
The stakeholder engagement process also generated a variety of inputs on the next steps in the Framework development process, which can be summarised as:
• Stakeholders advocate the release of a draft Framework for further public consultation, and many of them have expressed a desire to be involved in that process
• Stakeholders advocate much stronger engagement with the Indigenous sector in the development of the Framework, specifically the consideration of a separate Framework and separate governance process for the secondary use of MHR data about Indigenous people
• There is a widespread view amongst stakeholders that development of the Framework should take into account the Government’s response to the recommendations of the Productivity Commission’s Inquiry into Data Availability and Use (it is understood that this response is not yet available)
• Stakeholders believe that the question of charges for access to MHR data for secondary use should be directly addressed in the Framework
• Stakeholders believe that consumers should be offered the opportunity to expressly consent (dynamic consent is preferred) to, or opt out of, the use of their MHR data for secondary purposes, and that implied consent through an opt out process around primary use is inferior
• A number of stakeholders believe that the final draft Framework should be subject to a full Privacy Impact Assessment
• Many stakeholders advocate for a communications campaign (with tailoring as required for Indigenous and CALD communities) to make the public aware of the intended use of MHR data for secondary purposes (and the associated benefits).HealthConsult will proceed to develop the draft Framework with regard to the input generated via the stakeholder engagement process. Advice on the process issues raised by stakeholders will be appreciated.
