Apologies for a larger-than-usual newsletter this week – ! hope you’ll agree though that there’s lots of important stuff in here.

You need to understand medical device regulation basics!

As I have said in many audiences to many people, the single biggest problem with investment proposals I am asked to assess is a failure to recognise the importance of medical device regulation. The greatest failure is not recognising that your proposal is a medical device at all so it’s great to see that the BSI has recently republished their easy-to-follow guidance on this: essential stuff!

Of course once you realise it is, then there’s much more to get your head around so we have a webinar with the BSI on 16th June 10am at which they will be explaining the key requirements of the UKCA as it affects digital health, and what you need to do to comply. Booking is now open here.

In addition, we will be running a webinar with Psephos on September 15th who will focus particularly on the many different regulatory regimes in the world – note that like all DHACA webinars, this one will be free to attend.

One last event to mention – we will be participating with the ABHI in an online event exploring UK digital health regulation and how companies and the public would like to see this shaped for the future to ensure that products are developed that are safe, efficacious and ethical. I have been holding this newsletter for details of how to book though have now been told that the mooted date of 9th June has been postponed to some time the following week, to be finalised. I’ll Tweet the date (from @DHACA_org) when it’s announced and add it to our events page.

The introduction of AI into medical devices seems to have created immense amounts of smoke – witness that no self-respecting online event now is without its AI sessions – yet very little fire – as shown by the lack of real substance in most of these sessions. That apparently is about to change shortly with the FDA being asked to approve the first continuously learning medical device. There’s a comment piece in the current Lancet Digital Health briefly describing the FDA’s planned approach. For me the most interesting fact revealed is that Tesla continuously updates its cars’ autopilots on the basis of data feedback aggregated from its fleet of approximately 500 000 vehicles, so there is experience in continuous updates in high risk systems.

Separately Google has just released details of its AI-driven app to diagnose skin conditions, Derm Assist. It is quoted as having a “C.E. mark as a Class I Medical Device in the E.U.” although it’s not clear whether that relates to the MDD, or the MDR, which came into force today (26th May) in the EU. If the latter, Rule 11 states that “Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa…” which perhaps underlines the point made in the Forbes article that “Google is quick to assert that what the app provides you with is not the final diagnosis nor a definitive answer by any means, but a realistic set of possibilities after it has searched more than 288 skin conditions in its database.”

Note that long term DHACA member Skin Analytics offers a much stronger diagnostic steer with a clear focus on whether lesions are likely to be malignant – they also already call their service Derm AI, which may lead to confusion, unintentional or otherwise. Coincidentally I was sent a flyer by Miiskin claiming a new Mole Sizing measurement system, although both the links in the flyer are invalid and the Miiskin website doesn’t mention it directly.

On a different tack, this is the first time I’ve seen a medical device company promoting CE certification as an advantage over unregulated competition. In this item from Sooma, the final sentence is “These devices must now comply with the MDR regulation or they will not be observant to EU regulations and therefore, cannot be sold on European markets.”

Finally on this important topic, there is one thing that only the most engaged regulatory enthusiasts will want. At 1156 pages, it looks like it offers a pretty comprehensive coverage of overall EU legislation in the area. Enriched MDR and IVDR by Erik Vollebregt is €413 in electronic formats, with a discount for updated versions as they become available.

Horizon Europe funding opportunities

The UK remains a full member of Horizon Europe so members are particularly encouraged to get stuck in to the new programme, find partners and bid. I’ve participated in four previous Horizon projects and can highly recommend them as a way of seeing the bigger picture of what you are working on, building last relationships across Europe, and developing technologies that will make a real difference to people’s lives.

The KTN has a great summary of the programme and the Health Cluster on their website. A draft of the Horizon Health Work Programme was published by the European Commission (EC) and is available here. The EC is currently planning an information event about the Health Cluster on the morning of 2nd July 2021, now confirmed, although as yet  no link to the event has been provided. A Health Cluster partnering event will be arranged by the network of Health NCPs around Europe/beyond, probably in early July. The publication of the final versions of most Horizon Europe Work Programmes has been delayed and is now expected to be adopted in mid-June. The 2021 Health Call is expected to open the following week, so in late June. The EC apparently does not currently intend to move the 2021 Health Call deadline from 21st Sept 2021. All of the above timings are all still subject to change.

The UK National Contract Points (NCPs) in collaboration with the KTN Global Alliance are keen to invite potential applicants (in the UK, Europe and beyond) to participate in the Horizon Europe consortia building event series #UKinHorizon. These events are not information dissemination events; they will focus on pitching of project ideas and brokering partnerships for European Research and Innovation collaborations and networking. The events are ideal for those who have identified specific call topics or at least areas of interest, and are ready to take the next steps, discussing concrete project ideas with potential partners and going forward to a proposal submission. Go here for further information and registration for the Health Cluster consortia building on 14th June.

The ‘related funding section’ of the KTN and NCP webpage is also worth checking out as not all health-related funding opportunities come under the Health heading (when I was bidding, many health-related projects came under the ICT heading).

Sign up for information as it is published here. Once you’ve signed up you will be taken directly to the “what it is and how to apply for funding” page (that still refers to the programme by its original name of Horizon 2020).

The European Research Council (ERC)

The ERC’s Advanced Grants call closes on 31 August 2021. Advanced Grants fund an exceptional Principal Investigator and their team in any field of research. The UK ERC National Contact Point also recently held webinars about how to write a successful proposal. The recordings are available online.

The ERC recently celebrated the 10,000th researcher being awarded an ERC grant. Christina Miller, Director of the UK Research Office (UKRO, one of UKRI’s offices in Brussels) published a blog post which included the statement that “Of the 10,000 ERC grantees over 2,000 choose to be hosted by UK organisations.  We are delighted that the UK’s association to Horizon Europe means that UK researchers and organisations continue to be fully eligible to participate in all ERC grant schemes, including hosting principal investigators and team members.”

Other EU events

  • The European Commission webinar ‘Funding and Tenders Portal for beginners’ is on 27th May 9-11.30am BST. The funding and tenders portal is the IT system used for Horizon Europe grant applications. Further information.
  • European Commission webinar ‘All you need to know about dissemination and exploitation of results under Horizon Europe’ is on 9th June, 8.30-11.30 BST. Further information.
  • Discover how to make your data Findable, Accessible, Interoperable and Reusable (FAIR) on 26th May 2021, 1-2pm BST. The EU-funded FAIRplus project aims to develop guidelines and tools to allow you to make your data FAIR. It’s flagship resource called the ‘FAIR Cookbook’ that this webinar introduces. Their website also has useful information.
  • Innovative Medicines Initiative (IMI) Impact events are on 8th June on Diabetes, 9th June on Data and 15th June on Dementia. Further information.
  • European Partnership (EP) for Personalised Medicine Information Day is on 31st May 2021, 12-15.30 BST. The aim of the information day is to engage with national and regional authorities, funders and stakeholders interested in promoting and implementing personalised medicine approaches in their countries and regions to foster personalised diagnostics, therapy and prevention for the benefit of patients and citizens. A Guide to a European Partnership for Personalised Medicine was also recently published.
  • A webinar entitled “What can MSCA under Horizon Europe do to Boost Your Business?” will take place on 1st June, 11:00am-12:30 BST. The UK Research Office (UKRO), in its capacity as UK National Contact Points (NCPs) for Marie Skłodowska-Curie Actions (MSCA), in collaboration with EURAXESS UK and the UK NCPs for SMEs, will be holding this webinar. Info and registration.
  • European Commission consultation on European Health Data Space (EDHS) closes on 26 July 2021.
  • The European Commission has recently published a legal framework on Artificial Intelligence (AI) here.
  • For the €1 billion Team Europe initiative on manufacturing and access to vaccines, medicines and health technologies in Africa see further information.

The Independent Expert panel on effective ways of investing in health has adopted an opinion on public procurement in healthcare systems. Further information is available about the expert panel.

Chip shortage

We’ve all been hearing about the chip shortage affecting the likes of car companies, however it seems it is also impacting closer to home – a little bird told me that pager production has been seriously affected, and push-button pendants may be next. Neither register on my personal digital health innovation meter.

NHS launches UK’s first COVID test drone delivery service, in Scotland

In 2009 I was heavily involved with implementation of telehealth to the Isle of Bute, ahead of almost all the rest of the UK, so it’s good to see that Argyll & Bute Health & Social Care Partnership (HSCP) has begun carrying COVID test samples and other medical materials on drone delivery flights between medical facilities in the Argyll & Bute region. Following a proof-of-concept phase last year, the three-month initiative, which aims to help improve COVID-19 related logistics to and from remote locations, has now been expanded and is fully operational.

That sinking feeling

As a veteran of the care.data era, when the public were really turned off health data sharing by thoughtless behaviour, it saddens me to see that the FT is now saying that “55m patients have until June 23 to opt out of having their health data scraped into a new database”. Good data sharing is so critical for successful training of machine learning algorithms and medical research that it needs to be handled incredibly sensitively to avoid another disaster.

A new organisation, Foxglove, has now weighed into the debate with what look to be sensible thoughts.

And finally…

Plus a reminder of other events…

There are a number of events that we have been asked to alert members to, in some cases in exchange for publicity to their attendees. These currently include:

Thanks to Prof Mike Short, Dr Nicholas Robinson, Robert Pocknell, Tram Trinh, Giovanna Forte and Alistair Appleby for pointing me to items I might otherwise have missed.