This blog is totally independent, unpaid and has only three major objectives.
The first is to inform readers of news and happenings in the e-Health domain, both here in Australia and world-wide.
The second is to provide commentary on e-Health in Australia and to foster improvement where I can.
The third is to encourage discussion of the matters raised in the blog so hopefully readers can get a balanced view of what is really happening and what successes are being achieved.
Quote Of The Year
Timeless Quotes - Sadly The Late Paul Shetler - "Its not Your Health Record it's a Government Record Of Your Health Information"
or
H. L. Mencken - "For every complex problem there is an answer that is clear, simple, and wrong."
Search the database for questions placed on notice during estimates hearings, and the answers provided. The database contains information for the Community Affairs Legislation Committee from the 2018–19 budget estimates hearings.
To view answers to questions on notice from Budget estimates 2017-18 or later estimates rounds, please use the questions on notice search function on the Senate estimates webpage. To view answers to questions on notice from estimates rounds prior to Budget estimates 2017-18, please see the links to estimates rounds below.
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Note: Each link is followed by a title and few paragraphs. For the full article click on the link above title of the article. Note also that full access to some links may require site registration or subscription payment.
Ex-minister speaks of ‘horror’ of having to digitise the NHS with no plan
A former life sciences minister has reportedly spoken of the ‘horror’ of being awarded significant money to create a digital NHS with no plan as to how to do it.
Hanna Crouch. 9 October 2018
Despite being responsible for promoting the use of technology in healthcare, George Freeman told a fringe meeting at the Conservative Party conference last week that he was frozen out of the spending talks in which new investment in a paperless NHS was agreed.
Instead, Freeman and his civil servants were told to set out how they would spend the money once it had already been allocated.
The Food and Drug Administration issued a cybersecurity alert on two Medtronic devices that could allow a hacker to hijack the software update process to change the device’s function. Medtronic disabled the online software update to eliminate the flaw.
IMPACT
Following a review of potential security vulnerabilities around the internet connection, the FDA found 34,000 CareLink cardiac implantable electronic devices are at risk. If exploited, a hacker could change the programmer’s functionality or the device itself during the implantation or follow-up visits.
The flaw is found in the internet connection between the CareLink 2090 and Encore 29901 Programmers, used for downloading software from Medtronic’s Software Distribution Network. The programmers are used by providers to adjust the cardiac device settings and collect locally stored data.
UK Biobank contains a wealth of data on genetics, health and more from 500,000 participants. A detailed overview of the biobank and an analysis of its brain-imaging data show the value of this resource.
Huge sample sizes are often needed to discover the genetic variants that contribute to disease. Meta-analyses of many genome-wide association studies (GWAS), which test for such links, are now beginning to search for associations between DNA variants and common diseases in more than one million individuals1. But perhaps equally important is detailed clinical and biological information about the participants, which enables researchers to better test for more associations — including those that give insight into disease mechanisms. Writing in Nature, Bycroft et al.2 and Elliott et al.3 describe a huge resource called UK Biobank that marries large-scale genomic and detailed clinical data for 500,000 people. The biobank promises to aid the discovery of relationships between genome variation and common human diseases, and to improve our understanding of the mechanisms that underlie those associations.
October 12, 2018 - Penn Medicine recently launched an initiative intended to transform EHR systems into more interactive, intuitive tools to ease provider burden, improve patient health outcomes, and boost clinical efficiency.
“We recognize that EHRs are no longer just part of how clinical care is documented, but they are central to how clinical care is delivered,” said University of Pennsylvania Health System Executive Vice President J. Larry Jameson, MD.
“Increasingly, health information technology plays a foundational role in each domain of our work: patient care, educating the next generation of physicians and scientists, and biomedical research,” he continued. “Electronic health records innovations are key to advancing our impact in each of those missions.”
Health apps, diagnostic AI systems and the 3D printing of body parts are among the tech innovations that could soon be subject to strengthened oversight, with the Therapeutic Goods Administration planning to put forward regulatory amendments for the emerging technologies.
Within its new business plan for 2018-19, the TGA said software as a medical device – such as the recently announced Apple Watch 4, which includes an atrial fibrillation-detecting algorithm and an ECG – will soon need to jump through custom-fit hoops.
In response to the “complicated and dynamic” healthcare landscape, the TGA is chasing the health tech pioneers to put in place rules that manage risk and weed out the cowboys.
“Scientific advancements such as new cancer treatments and new technologies such as 3D bio-printing continue to bring opportunities for Australians,” the business plan said.
“They also require a regulatory framework that is contemporary, adaptable and supports innovation. Our challenge is to capitalise on advancements in technology while ensuring that regulation is appropriate to manage risk.”
The TGA said it will continue to implement regulatory reforms, including those recommended by the Expert Panel Review of Medicines and Medical Devices Regulation, and will also “implement a number of other major and necessary reforms to the regulatory system”.
Within those reforms it will propose “regulatory amendments for the emerging technologies of software as a medical device and the medical application of 3D printing (cognisant of international harmonisation)”.
Efforts to improve rigour and speed in regulatory processes to contend with the explosion in digital health innovations is a worldwide scramble.
Or as medicos call them, “software as a medical device”.
The Therapeutic Goods Administration (TGA) will update regulations for “software as a medical device” – including health apps - and embark on additional internal software development work in the coming year.
The Administration’s newly-published 2018/19 business plan (pdf) states that the agency will soon “Propose regulatory amendments for the emerging technologies of software as a medical device and the medical application of 3D printing”.
Software as a medical device is currently defined as “products that have a role in diagnosing or managing illness using software that analyses clinical data, such as the results of blood tests or ECGs”. Such packages are considered to be medical devices and therefore come under the TGA's purview.
And the TGA believes that mobile apps are among the devices it must regulate.
News of revised regulations for apps is therefore likely to have quite an impact, given the proliferation of such apps and their increasing links to wearable devices.
Apple’s Series 4 Watch, for example, has features said to offer “heart rhythm classification” and to be capable of determining “if the heart is beating in a normal pattern or whether there are signs of Atrial Fibrillation (AFib), a heart condition that could lead to major health complications.”
Consumers want support in finding accurate, effective smartphone apps for health and wellness, and they should be subject to an authoritative regulatory system that rates them for efficacy.
As consumers increasingly turn to health apps to aid and monitor their health and treatment, there’s clearly a need for people to know whether they can trust the apps, and whether they offer the best health option available and are worth the investment in time and money.
Our survey results highlight the growing public demand for credible and effective oversight of health apps given their accelerating reach into every aspect of health care.
Respondents trust their GPs most when it comes to recommendations for apps, but also do their own research and look to other sources for information;
There is a role for the government to play in regulating health and wellness apps, with nearly 90% of respondents to our survey say that either the government should review and rate health apps (58%), or should fund another organisation to do it (31%);
There is a healthy scepticism towards trusting sources like Google or even recommendations from peers completely; and
Respondents trust non-government health organisations to provide sound advice.
My problem with all this relates to the long term history of the TGA as a regulator and the difficulty it must face trying to regulate in the ecosystem of mobile apps.
I would suggest that the TGA is a regulator most likely to need a serious touch up after the debacles we have seen from ASIC and APRA at the Financial Services Royal Commission. To me they look to have been totally captured by the various arms of the Medicines Industry to a really unhealthy level, and not to really focus on patient benefit and safety to the exclusion of all else as I believe they should.
On devices, the approval of the use of vaginal mesh has had devastating consequences for thousands of women and a month or so ago Health Minister Mr. Hunt apologized to all the victims for pain and suffering.
Hardly the example of a vigilant fast acting regulator! Maybe a larger budget and more staff as well as a clean out of those who have taken too long to act?
How they will go regulating apps will be fascinating to watch….
The committee recommends that record access codes should be applied to each My Health Record as a default and that individuals should be required to choose to remove the code. The committee further recommends that the ability to override access codes in the case of an emergency should only be available to registered healthcare providers for use in extraordinary and urgent situations.
Recommendation 2
The committee recommends that the Australian Government amend the My Health Records Act 2012 to protect the privacy of children aged 14 to 17 years unless they expressly request that a parent be a nominated representative.
Recommendation 3
The committee recommends that the Minister for Health amend the My Health Record Rule 2016 to extend the period for which a My Health Record can be suspended in the case of serious risk to the healthcare recipient, such as in a domestic violence incident.
Recommendation 4
The committee recommends that data which is likelytobeidentifiable from an individual's My Health Record not be made available for secondary use without the individual's explicit consent.
Recommendation 5
The committee recommends that the current prohibition on secondary access to My Health Record data for commercial purposes be strengthened to ensure that My Health Record data cannot be used for commercial purposes.
Recommendation 6
The committee recommends that no third-party access to an individual'sMy Health Record be permissible, without the explicit permission of the patient, except to maintain accurate contact information.
Recommendation 7
The committee recommends that the Australian Government amend the My Health Records Act 2012 and the Healthcare Identifiers Act 2010 to ensure that it is clear that an individual's My Health Record cannot be accessed for employment or insurance purposes.
Recommendation 8
The committee recommends that access to My Health Records for the purposes of data matching between government departments be explicitly limited only to a person's name, address, date of birth and contact information, and that no other information contained in a person's My Health Record be made available.
Recommendation 9
The committee recommends that the legislation be amended to makeexplicit that a request for record deletion is to be interpreted as a right to be unlisted, and as such, that every record is protected from third-party access even after it is deleted, and that no cached or back-up version of a record can be accessed after a patient has requested its destruction.
Recommendation 10
The committee recommends that the Australian Digital Health Agency revise its media strategy to provide more targeted comprehensive education about My Health Record.
Recommendation 11
The committee recommends that the Australian Digital Health Agency identify, engage with and provide additional support to vulnerable groups to ensure that they have the means to decide whether to opt out, whether to adjust the access controls within their My Health Record and how to do this.
Recommendation 12
The committee recommends that the Australian Government commit additional funding for a broad-based education campaign regarding My Health Record, with particular regard to communicating with vulnerable and hard to reach communities.
Recommendation 13
The committee recommends that the Australian Government extend the opt-out period for the My Health Record system for a further twelve months.
Recommendation 14
The committee recommends that the My Health Record system's operator, or operators, report regularly and comprehensively to Parliament on the management of the My Health Record system.
The ALP and LNP have some additional ideas and disagreements at the end of the report.
Comments welcome.
David.
Addendum:
The LNP do not support recommendations 1,4 and 13 and believe it is important to think carefully about No 2. The other 10 recommendations they seem to be comfortable with.
Labor wants a pause and an OAIC / Privacy Commission Inquiry so sort out consent issues in addition to not rejecting any of the 14 recommendations. Given they are likely to be the Government at some time in less that 12 months this is relevant. Here is the relevant text. Labor Additional Comments 1.1 Labor Senators share the privacy and security concerns expressed in the Chair's report. In particular, we agree that the Government's botched implementation of an opt-out model means 'an unreasonable compromise has been struck between ensuring the utility of the system … and safeguarding the privacy and safety of healthcare recipients'. 1.2 Labor Senators therefore urge the Government to commission an independent review of the My Health Record system by the Privacy Commissioner and the Office of the Australian Information Commissioner, which has itself called for further consideration of several privacy and security concerns. 1.3 In particular, the Privacy Commissioner and OAIC should consider: • the appropriate balance between utility for clinicians, patients and others (such as carers), and privacy and security for individuals; • the difficulty of ensuring informed consent in an opt-out model, and measures to encourage consumer engagement and informed choice; • changes to default access settings that are necessary because of the shift to an opt-out model (from an opt-in model, where informed consent was assured); • particular protections for vulnerable people, including minors aged 14-17 and families fleeing domestic violence; and • further legislative, policy and system changes that are needed to achieve these aims. 1.4 In the meantime, the Government must suspend the opt-out rollout until the Privacy Commissioner and OAIC report, the Government makes necessary changes, and public confidence in this important reform is restored.
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Sadly major technology change seems to have been ruled out because of cost - so in the longer term I believe the system is doomed! Sadly legislators only do legislation - not technology! D.
