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Friday, October 19, 2018

It Seems To Me The TGA Has A Lot Of Catching Up To Do As A Medical Device Regulator.

This appeared a few days ago:

TGA to reform regulation for software as medical devices as apps, AI and 3D printing in healthcare boom

Lynne Minion | 11 Oct 2018
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.
Lots more here:
There is also coverage here:

TGA to update regulation for health apps

By Simon Sharwood on Oct 11, 2018 10:48AM

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.”
More here:
There is also some related information here:

Results of Australia’s health panel survey on recommendations and regulation of smartphone apps for health and wellness

2 Oct 2018
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.
Here is the link:
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.
See here
Follow this link and you will discover the TGA started monitoring these mesh products in  - wait for it – 2008.
Here is the link:
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….

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