We have a particularly information-filled edition for you this week, with my initial summary of a particularly important webinar we ran on 30th March plus news of major EU legislation proposals that will affect medical devices and much, much more. We are also in the final stages of organising two new webinars. The first, on 19th May will be at 14:00 BST as it will be a talk and live demo on penetration testing by Kryptowire based in the US – this is the service increasingly being used by the NHS and elsewhere in the UK Government. administration. The second, likely to be on 16th June will be by BSi experts on UKCA implementation at the normal time of 10:00 so do keep those times and dates free.

Changing the roles of doctor and patient

With no webinar to organise this week, my thoughts have been turning to exploiting previous webinar material, especially the event on 30th March entitled Digital health is changing the roles of doctor and patient: what does this mean for developers? As a result I have been summarising the key points made by our three speakers in a short document that will be added to the website – that document is now in draft and on its way to them to be checked for accuracy. In the meantime though I have become even more convinced of the importance of the original Lancet Digital Health piece.

The key drivers seem to be:

  • Technology is increasingly able to provide objective measures that AI/ML can interpret as a diagnosis;
  • Technology can provide continuous monitoring, filling in the gaps between clinical visits;
  • The resultant greater granularity is upending the traditional disease categorisation by subjective symptom reporting.

This in turn means that:

  • The conceptualisation of some disease is being challenged;
  • Patients are increasingly able to take responsibility for their own health;
  • Doctors no longer always need to be in the diagnosis/treatment loop.

Which raises many issues including:

  • The future role of doctors;
  • The need for a substantial increase in the evidence base for digital health usage…
  • …which goes hand in hand with how to ensure all patient data currently held by providers is accessible by patients and those they agree to receive it;
  • The acceptability of machine-originated guidance;
  • How best to develop international standards for ePROMs;
  • The need for a major regulatory change now that doctors have less oversight of machine:patient interactions.

If you want to revisit the recording of the event directly, it’s here. I hope to be able to post my summary on the website next week. In the meantime you’ll find lots of relevant items elsewhere in this newsletter on new regulation proposals responding to the impact of AI, simpler less invasive monitoring. and improvements in real world evidence gathering. We plan to keep this stream of good news up in subsequent weeks so be sure you are signed up to receive the newsletter personally.

EU proposes major regulatory change to accomodate AI

Erik Vollebregt has a masterful summary of wide-ranging proposals from the EC on change impacting both medical/IV device regulation and data privacy regulation to incorporate AI/ML considerations. This is the proposal for a a regulation laying down harmonised rules on artificial intelligence (aka the Artificial Intelligence Act, abbreviated to AIA).

“The AIA sets up a system of conformity asssessment for artificial intelligence systems, which, given the definition of AI system, will almost always double as medical device under the MDR if deployed for medical intended purpose. The conformity assessment will also involve notified bodies like under the MDR.

The ‘provider’ of an articial intelligence system will also have post-market monitoring obligations to proactively collect and review experience gained from the use of AI systems they place on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions, very much like PMS under the MDR.”

This should be essential reading for anyone contemplating or already selling dihital health devices or service in the EU. As Erik says “Dear industry, now you know – time to start preparing. This regulation will happen, one way or the other because politicians have decided it is needed and it will look a lot like this proposal. You only have yourself to blame if you wait too long.”

It seems almost certain that the UK will follow suit in some form so even if you don’t plan to sell to the EU, certainly worth engaging.

Continuous learning

There is also a useful addition in this comment in Lancet Digital Health entitled Continual learning in medical devices: FDA’s action plan and beyond. It can be tough going at times (eg “The algorithm change protocol determines the applied methodology to achieve the prespecifications.”) though well worth it, with some useful recommendations for ensuring continuous learning systems are safe,

The CONNECT Act is back!

The CONNECT for Health Act is back before Congress for a fourth time. Backers say the massive telehealth bill could cross the finish line this time on broad bipartisan support and pressure to set long-term connected health policy. The CONNECT Act (short for Creating Opportunities Now for Necessary and Effective Care Technologies) if passed would have a dramatic impact on improving US acceptance of telehealth.

Eyes are the window to the soul…and to your cardiovascular risk score

Matthew 6:22-24 had a different view in mind when the original quote from Jesus’ teaching from which the famous quote is derived was first written. However, in the most recent Lancet Digital Health, there is a paper showing remarkable ability to estimate coronary artery calcium (CAC) from retinal photographs; subsequent correlation with cardiac events is significant. The full title of the paper is Deep-learning-based cardiovascular risk stratification using coronary artery calcium scores predicted from retinal photographs which is hard to beat as a very brief summary of the method used

So yet another invasive test (in this case a specific CAC CT scan) looks likely to be replaceable by a quick non-invasive test that in this case also avoids the radiation risk from a CT scan.

Coordination On Mobile Pandemic Apps best practice and Solution Sharing (COMPASS)

This interesting German project is seeking to do what it says on the tin. The project combines existing and deployed pandemic apps in an open source modular solution and a corresponding directly usable but also configurable modular development. Further information can be found in the profile. There’s no evidence on the website just now of an interest in collaboration outside that country though, which will obviously limit its effectiveness unless there is a change of heart. It is also top-heavy with university engagement with just one supplier involved as we went to press.


The DTAC webpage has apparently been updated to take account of feedback from users. It now includes information sessions for tech developers on 12th May and 6th June, and for health and care workers on 12th & 24th May, and on 9th June.

And finally…

Based on a large-scale evaluation in East London, the Nuffield Trust’s new research highlights ten practical lessons for those integrating technology into health and social care services. Nadia Crellin also wrote an article for Digital Health about the findings, while a blog from Rachel Hutchings describes three of the main recommendations.

Thanks as always to Prof Mike Short and to Dr Nicholas Robinson for drawing my attention to items I might otherwise have missed.

Kind regards,