I do hope you can join us next Wednesday for what will probably be our only webinar in June on the incredibly important issue of how UK regulation is developing following our departure from the EU (except N Ireland of course).

Member involvement opportunities

 

Digital Health Regulation and how the BSI is supporting it – Wednesday 16th June 10:00

Most members will be aware that when the UK left the EU we adopted a different regulatory environment for medical devices to the Medical Devices Regulation (MDR) that the EU implemented on May 26th. The UK Conformity Assessment (UKCA) covers a wide range of goods and services so for this webinar we will be focusing only on its provisions for medical equipment, where it is very similar to the old EU Medical Devices Directive (MDD). There are though some important differences, and a need to register devices to a timetable driven by existing classification levels.

A key element of both pieces of EU legislation is the concept of Notified Bodies – organisations that do the heavy lifting to ensure regulatory compliance, the largest of which in the UK, and one of the largest in the EU, is the BSI. It is therefore particularly welcome that Vishal Thakker, Regulatory Lead for Regulatory Services (Medical Devices) at BSI and Dr Fiona Dunn, Senior Technical Specialist & Scheme Manager-Active Devices, have kindly agreed to speak to us on Wednesday June 16th starting at 10:00 and ending by 11:30.

I’d add that I’ve had a sneak peek at their presentation slides which look to be superbly focused on helping digital health SMEs to understand regulation and to know what to do to achieve regulatory approval for their software and hardware. It is not to be missed!

Go here for the DHACA website page, or here to book directly.

The Future of Health Regulation – Tuesday 15th June 15:00

On 15th June at 15:00 (ending 16:30) Taylor Wessing is organising a discussion on the future of health regulation for which I have been asked to join the panel. Conclusions will be input to the review of UK regulation that I understand is underway. Do sign up, support me, and have your say here!

An opportunity to influence the assessment of digitally enabled psychological therapies

ABHI and MedCity have been commissioned by NHS England to provide input into assessment criteria for digitally enabled psychological therapies. Andrew Davies from ABHI (andrew.davies@abhi.org.uk) would like to interview you if you would – please contact him direct though cc me in as I like being able to boast how helpful DHACA members are!

A date for your diary – the return of the DHACA (half) Day

Talking to Sarah Melaney, a partner at sponsors Brown Rudnick (and ex Baker Botts, one of our previous sponsors) today, we have tentatively agreed to run a DHACA (half) Day on the morning of 15th September, also to invite Psephos to present on how they help with UKCA and MDR compliance. If you’d like to present then, or have a particular presentation you’d like someone else to give, do please let me know so we can arrange it before holiday torpor sets in

Other items that should be important to members

Babylon to go public

At last we hear that Babylon Health is planning to go public, in the second half of 2021. The vehicle being used to do this is a SPAC. If you’re planning to have a flutter, do please check out the risks associated with IPOs and SPACs in particular.

ADA secures £63m investment to enhance assessment tech

Meanwhile an organisation that has always impressed me greatly, Ada (named after the first ever computer programmer) has secured an additional $90m to enhance their existing, and already excellent, diagnostic technology. When I was organising events at the Royal Society of Medicine, I invited Dr Claire Novorol, a co-founder of ADA, to give presentations at three separate events, all of which were very well received; the range of diseases covered and the stories of identification of that had baffled senior clinicians were extremely impressive. In contrast to the previous item, Ada’s business model was always less clear though – this injection of cash is starting to remedy that.

This could undoubtedly be one of the main drivers towards the vision of a changed patients/doctor relationship as per our Webinar on 30th March, the write-up for which now includes my five-page summary of what was said.

Wearables going mainstream

Another key feature of the vision described in the previous item is the greater use of wearables so it is interesting to see that IDC figures showed.Q1 2021 shipments were above 100m for the first time, driven by uptake of devices from smaller vendors and demand for newer form factors, That is 34.4 per cent higher than Q1 2020.

Adding to this, Ageing and Technology Watch has a report on the future of wearables for older people, and a series of other useful links.

There’s an excellent Viewpoint article in a recent Lancet Digital Health entitled The hopes and hazards of using personal health technologies in the diagnosis and prognosis of infections which is a good summary of progress to date and of the challenges still to be overcome.

There’s also an interesting contribution from Future Care Capital drawing a parallel between how black boxes linked to car insurance have encouraged young drivers to be more careful and so how wearables tied to health insurance might encourage healthier living (so more appropriate in countries running the Bismarkian care provision model that is insurance-based, than the UK Beveridgean model). I like the term “stealthcare”.

As we were about to press send, the news came through of the three way deal between Orange, Axa and Moroccan-based Dabadoc to digitise health care access across Africa, which fits well with the previous item and is potentially most significant.

Apple has just announced, too, an extension to their health offering, adding real-time assessment of walking stability and fall risk, additional context for lab test results, new tools for tracking health trends for individuals as well as caregivers, and new integrations with major EHR vendors. Their Watch, meanwhile, is adding updated mindfulness and meditation features, new workout types and respiratory rate tracking in the sleep app.

All in all, this is very much driving towards the vision painted by Dr Sarah Goodday on 30th March though, as she said, and I included in the write-up, there are many other significant challenges to overcome before we truly can transition to a new health paradigm.

Exciting times!

Paediatric Health’s Growth Spurt: The Next Phase of Digital Disruption

7 Wire Ventures has produced an excellent summary of digital health for children and adolescents, including a periodic-table-like scan of existing (mainly US) competing offerings. As the heading suggests they think that this will be a higher  than average digital health growth sector.

The impacts of Covid-19 on LTCs and lessons for the future

A recent PPP meeting identified two, linked, reports sponsored by Abbvie. The first, highlighting impact, is a brilliant read, with presentation slide-type summaries of how things developed during the pandemic – the only weakness of the report, albeit in my eyes an upsetting one, is to put three “s”s in “focuses”. Data sources vary so if you want to know whether a table refers to all the UK, or just England, a visit to the appendix is pretty essential.

The second, with the PPP imprimatur, describes lessons for the future, which personally I found poorly put together – picking one recommendation at random (no 4), in the summary at the beginning this reads: “Integrated Care Systems should prioritise the co-design of services.” However in the text it reads: “Co-design of services to embed self-management and shared decision-making should be built into the priorities of Integrated Care Systems.”…which says something much more specific although to my mind it’s still lacking in advice about what actually to do.

There’s a box in there entitled “Examples of apps validated by ORCHA” though no link in the text to it. Even items that the pandemic proved dramatically to improve care delivery like Total Triage, that longstanding DHACA members will be aware we have been promoting for two years now, don’t get a mention. There also seems to be confusion with the statement “NICE, for example, is working increasingly closely with innovators so that the regulatory approval process moves from being a series of hurdles to a collaboration’…” Surely that’s the MHRA (although I’m told they aren’t)?

Baroness Blackwood kindly invited me to ask a question at the end of the presentation, however by then I’d begun to see it being quietly filed away in the NHS alongside many other similar tomes: an opportunity lost.

That sinking feeling Part II

Following on from my moan last week that the NHS doesn’t seem to have learned from the care.data fiasco of seven years ago, the FT on Friday had a headline NHS hit by legal threat over GP data ‘grab’  GP has a more direct heading Dozens of GP practices to block extraction of data from patient records

Apparently the UK government is being threatened with legal action if it does not pause plans to collate the full medical histories of 55m patients in England into a single database from July 1. The campaigners it seems have warned that “rushing this major change through with no transparency or debate violates patient trust, and that doing so without patient consent is unlawful”. Unease among many clinicians and other working in the NHS is palpable.

NHS Digital to the fore again

As regular readers will be ware, DHACA is a huge fan of NHS Digital who perhaps don’t get all the credit for the great work they do. A particularly good example,of great importance to members, is their revamping of their guides and documentation for developers. It’s brilliantly clearly written (or at least what I read was) – the onboarding process for APIs was the area that I was pointed to by a DHACA member as being especially meritorious.

Carer’s tech

Longstanding members will be aware of the work we did in partnership with Carers UK on how best to promote technology to help carers to look after their loved ones with less stress. It included an excellent specially commissioned (by Carers UK) video which I really like. There’s now a very different, still excellent, take on the use of technology to help older people, starring a Samsung interactive display. It’s well worth watching (and very short).

And finally…

  • The MWC’s IOT summit on 30th June in Barcelona is offering a limited number of free passes – looks like you need to email ngordon@gsma.com with the subject Free Discovery Pass for MWC Barcelona 2021 if you’re interested;
  • AF patients using wearables go to hospital more often than those not using wearables although outcomes are very similar according to a recent Jama paper. “Our cohort study is among the first studies to systematically characterize the use of wearable use among individuals with AF as a part of routine health care delivery. Individuals who used wearables were younger, healthier, and socioeconomically better off than those who did not use wearables. We found no difference in clinic-measured pulse rates between the two groups but higher health care use rates among individuals who used wearables,” the authors of the study wrote. That’s a blow!
  • The IOT Forum is running a virtual two hour Innovation Forum on Telehealth and mHealth, on July 15th starting 8:30 PST. Attendance starts at $200 (unless you are a Telecom Council member). Makes you realise what good value DHACA’s free webinars are!
  • Rich Corbridge, CIO at Walgrens Boots Alliance (WBA) and Sue Hargreaves, Global IT Capability Senior Manager at WBA will give a 45 minute webinar on how the WBA Academy enabled the reskilling and upskilling of over 2000 employees in order to keep up with the pace of change in technology at 13:30 BST on 9th June. Click here to book.
  • A cartoon introduction to bioinformatics coding is a little light relief, with some serious messages.
  • How to grow your business: a Nature podcast that has some excellent advice.
  • The rise of telehealth and its impact on strategy is doubtless a topic that will be occupying the minds of many – this US contribution includes important consideration of health equity, including translation, when appropriate.
  • A recent item in Telehealth and Telecare Aware is a dire warning to all suppliers of what happens if you are not perceived to have complied with the contract you have signed up to. (Note that the piece relies heavily on translation from Swedish so that may have added inaccuracies, including in word placement in the sentence, as for example in the statement that “In Luleå, a woman who sounded the alarm died in vain (sic) several times.”)
  • Another warning comes from the resignation of iRhythm’s CEO after just four months in the aftermath of the decision by CMS in the US to pass on giving long-term cardiac monitoring services national Medicare pricing in a final rule. This underlines the importance of early clarification – and ideally commitment –  that your customer wants what you can provide at a price you can profitably provide it at. (I would add that this is no criticism of iRhythm where circumstances conspired to prevent a successful outcome.)
  • The KTN has just produced what looks like a really useful report entitled A transformative roadmap for neurotechnology in the UK
  • AWS now offers telehealth as a standard option although the picture on the home page of a doctor in white coat complete with stethoscope does rather undermine the concept of telehealth.
  • UK Telehealthcare is running its next Digital Forum on 15th JUNE 11:00 – 13:00.  Registration Link

Many thanks this week to Prof Mike Short, Sean Key and Dr Nicholas Robinson for pointing me to items I might otherwise have missed.

Kind regards,

Charles