Can I start by wishing all our members a very Happy New Year. We have a particularly exciting newsletter for you this week, so I do hope you will have time to read to the end!

Note that when checking all links were correct, three persistently failed so, if they continue to fail in the version you receive, please scroll down to the bottom of the newsletter where they are given in full for you to cut and paste into your browser.

Important: DTAC

Standing for Digital Technology Assessment Criteria (no “s” please as criteria is plural) these, currently in draft, are the new way in which digital technology will be assessed by the NHS. They will replace the DAQs that were used to assess the apps in the NHS Apps Library, which is now transferring to NHSX and will become much more focused on apps being sponsored by local NHS organisations. Shortly before Christmas DHACA participated in a couple of workshops where some important points were raised:

  1. the risk of duplication as local NHS staff repeat the assessment for every contract
  2. the time elapsed because assessments are done during a procurement;
  3. how apps and other digital health technologies will get approved if they are “sponsorless” though still needed (like Fitbit or SOS QR);
  4. how reassessment will be timetabled;
  5. the role of assessment experts like ORCHA and IQVIA.

My email to the DTAC Duo of Lauren and Rhod has not yet been responded to so I have resent it. You can see it here. I did take great care to consult as many DHACA members as possible before sending it, so especially if you disagree, do please let me know as soon as possible.

Medical Device regulation in 2021

Erik Vollebregt, perhaps the single most knowledgeable lawyer on the topic in Continental Europe, has produced a whole series of useful pronouncements on important issues, all introduced with a 12 minute Vlog. Key items for me are:

  • A link to the MHRA’s page describing the new regulatory regime in the UK – of course you’ve seen it here before, however none of the bid writers of proposals i’ve been asked to review recently seem to have so perhaps it’s worth another outing.
  • His views on Brexit, particularly making the point that tangible goods are the main items covered by the initial treaty – I have also been pushing for the DIT to start including software and services in their helpful webinars. He also explains that  the UK is “fully in the Schrems II boat” as a non-EU jurisdiction, talking about which:
  • The EU Court’s Schrems II judgement – there is an urgent need for companies to revisit international personal data transfer mechanisms.
  • All the guidance available on the documentation necessary for Class I self-certification, which presumably will also apply to the UKCA initially at least. Note if you are selling in the EU the MDR comes in on 25th May of this year, after which most devices that are assessed as Class I will, if not already on the market, require a Notified Body for certification at Class IIa due to the MDR’s Rule 11.

The UK has now introduced the Medical Device Information System (MDIS) that all devices need to be registered on (at a cost of £100/device). The latest registration dates for each category are here. Mobihealthnews has supportive comment.

NICE consultation

NICE has just released its draft guidance on shared decision making. Amongst a host of other sensible suggestions, the following section from page 5 speaks to the digital agenda on patient decision support:

“Review how information systems might support shared decision making. This could be by providing ready access to patient decision aids or information about risks, benefits and consequences during the consultation. It could also provide the healthcare provider and the person using services with knowledge of that person’s past decisions, past preferences, values, and other information discussed during appointments (for example through a patient-held record).”

Max Jones• 1st Managing Partner (Health) at Agilisys asksDoes this go far enough though? Should it more fully recognise the fact that patients are sometimes expert in their rare condition too? Should we consider AI/decision support tools the third member of the decision making team?

To contribute your comments you need to sign in to your NICE account or register for one if you don’t yet have one. The consultation closes on Tuesday, 9th February 2021 at 5 pm.

Remote patient monitoring

There seems to have been a particular splurge recently on what RPM/telehealth can do including:

 …and finally:

  • After a long drawn-out malaise, Amazon’s Haven is finally being closed down. See this piece by Fiercehealthcare. The FT has a rather better analysis of what went wrong behind their firewall – it seems that the original announcement triggered a strong consolidation response from the existing players that, combined with some high profile hires better at writing than managing, meant they never found a uniting purpose. The FT still thinks Amazon will have a major healthcare impact in due course though. (I can share the article for free a few times so get in contact if you want to read it and are asked to pay.)
  • WHO’s 10 global health issues to track for 2021.
  • The OECD has produced its latest Health at a glance: Europe 2020 (that’s 230 pages of glances). It has also commented on Europe’s unpreparedness for the current wave of the virus.
  • New kid on the block Tekihealth Solutions (bit close in name to my alma mater Telehealth Solutions?) offers “Powerful, portable, intuitive remote diagnostic solutions” for remote provision of clinical services – not only the hardware, also the doctors to deliver the service remotely.
  • The Personal Connected Health Alliance, the home for Continua seems to have shrunk since the HIMSS takeover. There’s useful resource there though.
  • Liva has just raised €24.5m Series B. “The funds will be used to drive European leadership in digital chronic disease prevention and management.”
  • The UK Government has just launched its AI roadmap.
  • The Kings Fund has a free webinar on 28th January entitled What’s in store for health and care in 2021
  • The FT ‘s (free to access) coronavirus tracking hub is getting better & better at visualisation…and scarier.
  • I learnt a new word this week researching DHACA member Steve Smith’s move to CEO of Novara Therapeutics – “theranostic” – i’m sure we’ll hear it increasingly in the digital health world.
  • Innovate UK Smart Grants January 2021: an opportunity for UK registered organisations to apply for a share of up to £25 million to deliver game-changing and commercially viable R&D innovation that can significantly impact the UK economy. Opens: Thursday 21 January, closes: Wednesday 26 May 2021 11:00am.
  • Commentary: Digital health companies should stay away from FDA in 2021 – Bradley Merrill Thompson‘s sage advice on medical device regulation in the US which of course is different than in the UK/EU though there are some helpful thoughts there.
  • UKTelehealthcare is running its next Bonus Digital MarketPlace on Tuesday 19th January 2021 (11.00-13.00) though they don’t have a URL for it yet so check here in a few days.
  • Pegasus Funding has appointed two technology-focused funding experts due to a spike in demand for tech start-up and growth finance: Alexander Jaye and Kirstie Heneghan. They will focus on helping digital health and clinical entrepreneurs to succeed in the areas of health, wellbeing and preventative technologies. Alex said: “We help them to develop their market proposition, prepare them for fundraising and then connect them to relevant investors.”  Find out more here.
  • The AHSN Network’s next excellent Market Insight Briefings are on January 13, February 11 and March 11. For more info and to book, email kssahsn.bridgingthegap@nhs.net

My thanks in particular to Professor Mike Short, who has alerted me to many items that  might otherwise have missed.

Happy New Year again – let’s hope that the great push that Covid-19 has given to the greater use of technology to deliver improved healthcare will in the future at least make up for some of the inconvenience and tragedy we have suffered personally during the past year.