Sunday, May 13, 2018

The Commonwealth’s Framework To Guide The Secondary Use of MyHR Patient Data – Any Good?

This was announced – as one would expect on Friday (of Budget Week) by Minister Hunt.

Framework to guide the secondary use of My Health Record system data

The Framework to guide the secondary use of My Health Record system data (the Framework) has been developed.
Page last updated: 11 May 2018
The Framework outlines key principles that will be used to establish the governance mechanisms and implement transparent processes that are needed to guide decisions about releasing data to suitable applicants for secondary use purposes.
On the 11th May 2018 the Minister, The Hon Greg Hunt MP Minister for Health announced the release of the Framework.
The development of the Framework was informed by a national public consultation process. A Community Consultation Summary Report was developed to reflect the findings of that process.
An Implementation Plan will be developed during the second half of 2018 by the Department of Health, the Australian Institute of Health and Welfare and the Australian Digital Health Agency in collaboration with key stakeholders and project partners. The Implementation Plan will be published here once it has been completed.

Related Links


Here is the page link:
Most valuable to me is what the consultation found people wanted (Consultation Report – link above):

Executive Summary

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.
A thematic analysis of the findings from the consultative process is presented in the Chapters that follow.  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 de-identified 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.
----- End Extract:
However what we got from Government does not quite meet what was asked for by the majority in a number of areas:
Here is what came out:

Guiding principles of the Framework

The Framework outlines a series of guiding principles that will be used to guide the release of data for secondary use purposes. Table 1 below contains a summary of the principles that are discussed in more detail throughout the chapters of the Framework.
Table 1:               Summary of guiding principles within the Framework
Chapter 1: Governance model for secondary use of My Health Record system data
1.1       The Australian Institute of Health and Welfare (AIHW) is the Data Custodian for the purposes of the Framework.
1.2       The My Health Record (MHR) Secondary Use of Data Governance Board (the Board) will implement the Framework.
1.3       The Board has no role around primary use of the MHR system data—this is the responsibility of the System Operator.
1.4       The Board will comprise representatives from the AIHW, the Australian Digital Health Agency (as the System Operator) and a range of independent experts, including representatives from population health/epidemiology, research, health services delivery, technology, data science, data governance and privacy, and consumer advocacy.
1.5       The Chair of the Aboriginal and Torres Strait Islander Peoples’ Advisory Panel will be a member of the Board.
1.6       The Board will oversee development and operation of all secondary use infrastructure.
Chapter 2: Consumer control of data in the My Health Record system
1.1       Consumers can opt out of having their MHR data used for secondary purposes.
Chapter 3: Applying to access My Health Record system data for secondary use
3.1       The Board will assess applications primarily based on the use of data, not the user.
3.2       The Board will take a ‘case and precedent’ approach to determining what uses will be permitted and not permitted for secondary use.
3.3       Any Australian-based entity (except insurance agencies) can apply to access MHR system data for secondary use, subject to meeting the criteria set out in this Framework.
3.4       Applicants that are not based in Australia may, in limited circumstances, be involved in the use of MHR system data for secondary purposes.
3.5       The Board will use the ‘Five safes’ principles to assess applications.
3.6       MHR data that has been made accessible for secondary use must not leave Australia; however, there is scope for data analyses and reports produced using MHR system data to be shared internationally.
Chapter 4: Access to, or release of, data for secondary use
4.1       The Board will ensure that, where data is in other public datasets, the principles applied to access are consistent with those applied in the other datasets.
4.2       The Board will use a ‘case and precedent’ approach to determine what is ‘solely commercial use’ of data.
4.3       The Board will give specific consideration to use of data pertaining to Aboriginal and Torres Strait Islander people and communities.
4.4       Where an applicant seeks access to data from another repository—for example, Medicare Benefits Schedule or Pharmaceutical Benefits Schedule data—they will be referred to the data custodian for those systems.
Chapter 5: Process for requesting and accessing data
5.1       For applications involving identified data, subject to the provisions of the My Health Records Act 2012 and the Privacy Act 1988, the Board will require ethics approval to be obtained by the AIHW Ethics Committee before data can be accessed or released.
5.2       For applications involving de-identified data, the Board may require ethics approval to be obtained before data can be accessed or released.
5.3       The Board will work with related government bodies, data custodians and ethics committee(s) that also have an interest in the particular application to minimise as much as is possible unnecessary duplication of effort, additional cost and/or delays in processing an application.
5.4       Prior to data being released, the Board will require the approved applicant to agree to the Conditions of Use Agreement (CUA).
Chapter 6: Data linkage
6.1       The Board can permit the linkage of MHR system data with other data sources once the applicant’s use is assessed to be of public benefit.
6.2       Specific processes will apply for data linkage involving identified data for Aboriginal and Torres Strait Islander people.
Chapter 7: Processes to ensure protection of the privacy of individuals
7.1       De-identification of data is acknowledged to be a dynamic and ongoing process.
7.2       The Board will strive to stay abreast of changes in technology and data science as they evolve so that, as far as possible, it may anticipate new privacy threats and use this knowledge to inform assessment of applications for the use of data.
7.3       Proven methods will be used to reduce the risk of breaching an individual’s privacy to very low levels.
7.4       The Board will regularly reconsider the privacy protection processes around secondary use of MHR system data. Particular consideration will be given to circumstances where there is already data in the public domain about individuals.
7.5       As part of the ongoing process of reviewing the Framework (with the first review occurring after two years of operation), the list of permitted and not permitted uses will be reconsidered and amended with reference to the ‘case and precedent’ experience of the Board (see Chapter 3, ‘Applying to access My Health Record system data for secondary use’).
Chapter 8: Preparing and making data available, and data quality
8.1       The Board will ensure that individuals’ privacy is protected in the processes of preparing and making data available for secondary use.
8.2       The Board will ensure that any data made available is of sufficient quality to expect that the objectives of the project, as stated in the application, can be achieved.
Chapter 9: Monitoring and assurance processes
9.1       The Board will put in place a set of processes to provide assurance to stakeholders and the public that successful applicants use MHR system data only for approved secondary purposes.
9.2       The higher the assessed risk of a project, the more detailed the monitoring activities that will be required in the Conditions of Use Agreement (CUA).
Chapter 10: Risk mitigation strategies and imposed penalties
10.1    The Board will ensure that the risk of a breach of privacy for an individual is reduced to an acceptable level by minimising the risks associated with each application for secondary use and recommending penalties where applicable.
----- End Extract:
The two huge issues I note is that Secondary Use has been made ‘opt-out’ and that there is no recognition of the incompleteness and unknown quality of the data in the myHR to say nothing of how easy it is to access and use.
Of course I am sure that many will think that the whole question is moot as no generalised secondary use of private health data should be permitted at all, except with specific individual consent!
I am sure others will have additional issues so comment away!
David

3 comments:

Anonymous said...

I agree the relaxation of providing consent through actionable thought and process by indervidual is a disappointment, if not patronising. One could surmise this is a recognition by the department that the MyHR has very little value to consumers and unlikely to find people engaged with the system. Again they are playing on this disinterest by forcing people to opt out. Now if the MyHR has a big red button that clearly states push to opt out then that might be a satisfactory trade-off.

I am pleased the ADHA has been sidelined though. They have proven to be an unsafe pair of hands and there is little trust in the CEO when it comes to handle personal information of our citizens.

Anonymous said...

The Board will comprise representatives from the AIHW, the Australian Digital Health Agency (as the System Operator) and a range of independent experts, including representatives from population health/epidemiology, research, health services delivery, technology, data science, data governance and privacy, and consumer advocacy.


Sounds familiar, the ADHA board was supposedly made up of expertise, not convinced that has created a disciplined, expert led success story. While these ‘boards’ remain puppets of the Department and the organisations lead by Department placements I fear we will progress nowhere other than down a dangerous road.

Bernard Robertson-Dunn said...

Two observations:

First, what the framework doesn't cover:

"The Framework does not apply to uses described in the MHR Act, such as for the purposes of law enforcement or System Operator functions. For a full description of all the circumstances in which identified MHR data can be released, refer to sections 61 to 70 of the MHR Act."

The key part being this bit of section 70:

70 Disclosure for law enforcement purposes, etc.

(1) The System Operator is authorised to use or disclose health information included in a healthcare recipient’s My Health Record if the System Operator reasonably believes that the use or disclosure is reasonably necessary for one or more of the following things done by, or on behalf of, an enforcement body:

(c) the protection of the public revenue;

(d) the prevention, detection, investigation or remedying of seriously improper conduct or prescribed conduct;

Does robodebt ring a bell? One wonders why they added this little clause to the legislation recently

"13A System Operator may arrange for use of computer programs to make decisions

(1) The System Operator may arrange for the use, under the System Operator’s control, of computer programs for any purposes for which the System Operator may make decisions under this Act."

Second, there was much discussion about two issues:

1. The lack of useful data in the system

2. The use of pdfs which makes getting at data difficult – especially data that could become timeseries data

The team doing the consultation said they knew these things made secondary use difficult but they expected that, over time, things would improve.

Neither the consultation summary nor the framework document mention these issues. It would appear ADHA is desperate to talk up the supposed usefulness of myhr to patients, without mentioning problems, costs or risks.

From what I've seen and heard, ADHA and the government will be "enhancing" myhr and getting (persuading? insisting that?) GPs upload much more data.

What's the betting there will not be much discussion about planned changes to the system during the opt-out period? So much for informed decisions.