Submission - Secondary Use Of My Health Record Data - November 2017.
Background to Submission Author.
Dr. David G More MB, PhD, FACHI, the author of this submission, is a registered medical practitioner with an over 20 year background in Digital Health implementation and use.
Short Summary.
Overall I would just like to be sure that whatever Framework the Consultation comes up with we have strong public accountability as to who is doing what with whose data and that it is conducted under ethical supervision - assuming that we decide we agree to proceed with Secondary Use - which I remain sceptical of - given the context of reduced public trust of institutions and other risks. If Secondary Use is to proceed I also offer what I believe is a sensible and pragmatic approach to implementation.
Background To Submission.
On behalf of the Commonwealth Department of Health HealthConsult has been tasked with assisting to develop a “Framework for the Secondary Use of My Health Record Data”
Conceptually this framework is to enable use of the data in this system (which is identified clinical and administrative data) of the purposes of extraction, analysis and reporting on any manner of data elements held in the record for health related purposes and for the ‘public good’.
Apparently specifically excluded is use of the data ‘exclusively’ for commercial or administrative purposed but ‘mixed’ use is apparently permitted.
An example of mixed use might be the use by a for-profit drug company of the data to assist in locating individuals for a clinical trial – as recently discussed on RN’s AM.
See here:
It seems to me that all those who have a myHR should at the least be offered an opportunity to opt-out and any Secondary Use while retaining their myHR if so desired.
Issues That Will Need To Be Addressed In The Final Framework.
Individual Consent
There is a general privacy principle that indicates the personal information should, in general, only be used, by anyone, for the purposes it was collected. As far as the myHR is concerned this would suggest the information held in the system is to be used for the purpose of delivering or supporting the individuals health care. Clearly using this same information for research, management etc. is unrelated to the direct care of the individual and so on is not what the data was given to the myHR for.
Data Quality
The data held in the myHR is largely held in rather old fashioned data-bases in forms where the is very little quality control and where it is held in forms that makes it very problematic to actually search or use the data. This has been openly acknowledged by the ADHA.
History Of Government Attempts To Misuse Health Data.
It was public opinion in the UK that resulted in the cancellation of the so called care.data program and in Australia data releases have been withdrawn after issue with the quality of anonymization were discovered. At the very least these issues should result in extreme care and caution with the use of the data or maybe have some actual experts oversee what Government does.
If There Is Any ‘Social License’ For Unannounced Use Of Personal Health Data Held In The myHR
It can be, not unreasonably, argued that unless individuals are fully informed and provided consent for data use that use of their data is a violation of the ‘social contract’ between the individual and the Government and that it is this sort of retrospective change of ‘the rules’ that is a contributor to the current lack of trust is government as starkly revealed in my recent poll.
----- Dated 12 November, 2017:
Do You Trust Government To Keep Safe And Not Abuse Private Information You Share With It?
Yes 4% (4)
No 95% (99)
I Am Not Sure One Way Or The Other 1% (1)
Total votes: 104
There Is Internal Government Awareness Of Complexity In, and Risks Of, Allowing Access To The Data
Discussions with the ADHA have not only confirmed major data quality and accessibility issues but also significant issues with safely providing any form of individual data access or downloading.
Proposal For Ethical Use Of Data Held In The myHR If It Is To Proceed.
Given that it is important that health data be properly used (where ethically possible) for the benefit of everyone I recommend the following approach to secondary use of the data held in the myHR system.
The approach also permits linkage to other relevant data sources.
1. All use of the data be as a result of a written publicly available proposal. This can be developed with the analytic entity. (A possibility for this entity may be a unit of the Australian Institute Of Health And Welfare)
2. The secondary use proposal is formally reviewed by an independent appropriately qualified and diverse expert ethics committee, and only proceeds if approved. The details of the Ethics Committee discussion should be publicly released. There should be a clear set of guidelines developed to explain what, and what not, constitutes ethical use.
3. All data analysis and reporting done in house – at a small group or sole purpose entity expert in handling data extraction, linkage and analysis. NO raw data leaves the analytic entity.
4. Researchers are encouraged to work with the entity experts to conduct analysis and reporting – but no data actually leaves the Government controlled repositories.
5. All summary reports resulting from the research / analytics is made publicly available on a dedicated web-site which also has the research proposal and ethic committee comments.
6. The supervising analytic entity should be within Government and publicly accountable.
This approach provides maximum transparency, considerable assurance of proper use of the information, reasonable data access and high security. There can also be total public confidence in what is done being done due to mandated transparency and disclosure. Additionally since no data is actually released, except in summary report form, the need to consent is obviated.
The disadvantages may be that outcomes may take a little time and may be more costly than simply handing the data over for use (and potential misuse).
I am happy to provide more details as may be useful to assess the proposal.
It should be noted that this submission is based on the assumption that the myHR Program proceeds as presently intended by the ADHA.
To be clear, overall I do not see Secondary Use of myHR data as either inevitable or positive, especially given the fact that most of the data is held and can be used elsewhere within Government, is more accessible there, and use of those sources avoids many of the privacy concerns associated with the myHR.
David More 16/11/2017.
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