Regulation, safety and sustainable development: three short important updates

Erik Vollebregt has just released a blog that should be read by anyone with a medical device or whose technology is likely to be classified as a medical device under the new Medical Devices Regulation (MDR – Regulation 2017/745/EU) which replaces the MDD in early 2020. It makes scary reading as to what will need doing to comply with the new regulations as approval under the MDD will no longer apply (no ‘grandfathering’). MedTech Europe has helpfully produced a flowchart describing the necessary steps. Advice from official sources given to this editor is that, as the MDR already applies in the EU, its continued application in the UK after Brexit is not in serious doubt, so UK companies should not delay.

The Digital Health & Care Alliance (disclosure; that this editor manages) and DigitalHealth.London are jointly running a digital health safety conference on 7th November. Key players in the UK are on the agenda (including the CQC, MHRA, HSIB, NHS Digital/England, Datix, Vitalpac etc.). This is a topic that requires the attention of all developers and providers of digital health, as new technology, being unfamiliar, is inherently risky. It is therefore really key for everyone involved to share experiences, understand the risks and carefully plan avoidance and mitigation.  The draft agenda and booking details are here (there is a small charge for lunch).

For those who have doubts about the benefits that mobile communications can bring at times, a read of the GSMA’s 2017 report on mobile’s contribution to the UN’s sustainable development goals will fill you full of optimism of what technology can do, for health and many other aspects of life. Beautifully presented and full of interesting facts: recommended! (If you’ve not enough time, the summary is here.) Hat tip to Prof Mike Short. 

Resources dear boy, resources – useful stuff TTA has been sent recently

During this editor’s brief holiday, the interesting reports really piled up, so here is a selection of what look to be the best, including a few that never got blogged previously:

G3ICT & AT&T have published an excellent new report entitled ‘The Internet of things: new promises for persons with disabilities

The European Parliament has produced an extremely useful compendium of articles and statistics on the silver economy: well worth reading (or at least bookmarking for writing that next EIP AHA project proposal).

If like me, use of the ‘Euro’ prefix always brings to mind the Eurosausage episode of Yes Minister, prepare to be pleasantly surprised by this new online database of digital services for carers of older people jointly produced by Eurocarers and the EC’s Joint Research Centre, and hosted by Eurocarers. This offers access to 78 good practices of digital services for older care at home.

Ofcom’s 2015 Communications Market Report is essential reading for anyone working in (more…)

RSM’s Medical Apps one-day conference 9th April – last call

The next RSM event, entitled “Mainstreaming medical apps; reducing NHS costs; improving patient outcomes” is on 9th April, where there are still a few spaces left. This one-day conference will build on the last two years’ sell-out one-day conferences on medical apps at the RSM.

This year as medical apps are coming of age, the focus is on the critical aspects of mainstreaming them, in particular the various UK and EU regulatory issues that need managing in order to enable apps to be recommended or prescribed with confidence by clinicians. This will also include examples of ground- breaking medical apps as well as the use of electronic games to promote health and wellbeing.

Speakers on the regulatory side include, from the UK Professor Gillian Leng, Deputy Chief Executive of NICE, and Jo Hagan-Brown & Dr Neil McGuire from the MHRA, and from the European Commission Pēteris Zilgalvis, Head of Unit for Health and Well-being. Julian Hitchcock from lawyers Lawford Davies Denoon will give another of his excellent talks summarising the regulatory position from a user’s point of view, Dr Richard Brady will update us on bad apps and Julie Bretland will describe progress on the National Information Board’s work on how best to evaluate medical apps.

From the patient perspective, Alex Wyke will be talking about developing guidelines for good practice in health apps and Dr Tom Lewis from Warwick (in place of Prof Jeremy Wyatt now sadly unable to attend) will be talking about how best to evidence benefits from apps.

Describing some novel apps will be Professor Ray Meddis, on how to make an iPhone a hearing aid, Professor Susan Michie from UCL on gamification of smoking cessation, Ileana Welte from big White Wall on why mental health is such fertile ground for apps, and Ian Hay describing the challenges of using Android apps to deliver artificial pancreas-like functionality for the GSMA Brussels to Barcelona bike ride.

Should be a great day, and at the RSM’s rates, a tiny fraction of the cost of a commercially-run event!

Book here

Supplier offer

For £50/table, the RSM is also offering SMEs the opportunity to demonstrate their medical apps to the professional audience during refreshment breaks and at lunch (for more information on this offer contact Charlotte on 0207 290 3942). There are just four tables left now.

Something for (almost) everyone – a digital health gallymaufry

The Association of British Healthcare Industries (ABHI) is looking for companies to share the British Pavilion at the CMEF trade show from 15th – 18th May 2015 in Shanghai, China. It is apparently the the leading Healthcare trade show in China and is now the largest Medical Equipment exhibition in the Asia Pacific region attracting over 60,000 visitors. Details here.

Still need to see some more predictions for 2015? – try these 12 for telecoms, which does include the odd interesting nod towards subjects we cover, including interconnection of wearables and connected homes.

Prompted by our mention of V-Connect in our review of our 2014 predictions, MD Adam Hoare has pointed out that his company also won the Medilink ‘partnership with the NHS’ award for their renal project with The Lister Hospital in Stevenage. Congratulations!

Accenture has produced an interesting (more…)

mHealth vs Ebola – more

Following on from our previous item that included links on how mHealth is helping in the fight against the Ebola virus, and our subsequent item on a virus-killing robot, Prof Mike Short has kindly shared some  more links with a GSMA healthcare focus.

The first of these items explains how the GSMA, the ITU and the Internet Society are joining forces to fight against Ebola. The three organizations will bring together the global telecommunications and Internet communities, to leverage their extensive reach, capacity and respective memberships to increase the effectiveness of information and communications technologies (ICTs), especially mobile communications and the Internet, for better preparedness, early warning and response.

The sharing of mobile phone data is particularly important as (more…)

The sun is in his heaven and all’s well with the world?

It’s tempting to think that nothing much has changed in the world of telehealth & telecare recently. For example the quality of healthcare PR looks to be unchanged, if the recent announcement by Telehealth Sensors is anything to go by. They claim to have developed  an incontinence sensor that is “a revolutionary advancement in the home healthcare and post-acute care monitoring market.” Careful reading suggests this “revolutionary advancement” is based on the property of water, apparently only recently recognised by Telehealth Sensors,  that it conducts electricity (especially if its impure) – so advanced in fact that such sensors with a rather longer lifetime than the 30 days claimed by Telehealth Sensors, have (more…)

A salmagundi of (mainly free) opportunities to learn more about health technology this autumn (UK)

UKTI Belgium is running an excellent webinar series on eHealth & the European Union. Dates/times are:

  1. Thu, Nov 13, 2014 11:30 AM – 12:00 PM GMT
  2. Tue, Dec 2, 2014 11:30 AM – 12:00 PM GMT

During these webinars they will discuss tools that will enable you and your organisation to react to EU opportunities and challenges. For more information and to register go here.

TechUK and the BCS are running another of their very successful Healthtech Startup Schools, starting on Monday 20 October, ending on Monday 08 December. It is at techUK London , 10 St Bride Street, London , EC4A 4AD. Registration is here.

The University of Bath’s Assisted Living Action Network (ALAN) is holding an evening meeting in Bristol on 22nd October entitled on the flyer “Digital Health Apps: Insider views on the Challenges and Opportunities”, and on the website “Understanding the new regulatory and information environment for health apps”. It is being addressed by many worthies including Rob Turpin of BSI and Graham Worsley, recently retired from the TSB and now assembling a portoflio of really interesting roles. Book here

The GSMA has announced a whole bunch of awards for 2015 – entries are now open. Don’t dismiss them without checking each one out first – for example the Best Connected Life Award has eight categories, each with an award, including Best Mobile Innovation for Health. (If you wonder why this is under opportunities to learn (more…)

mHealth: a salmagundi of items

Overloaded with Horizon2020 proposal adjudication and conference management (including the first DHACA members’ day on 11th July), this editor has been unable to do much Telehealth & Telecare Aware blogging. However the interesting items have continued to attract my attention and Prof Mike short (especially), Alex Wyke and Nicholas Robinson have continued to add further to the pile (huge thanks to all). So much seems worth highlighting: where to start? Perhaps with the 18 factors to make telemedicine a success, enumerated by the EU-funded Momentum project. Telecare Aware readers will be unsurprised by all 18, which look pretty basic. However many will notice obvious absences, such as the need to adduce evidence of the success of the intervention. Gluttons for punishment will find much more (more…)

Aerotel’s HeartView ECG goes mobile and personal

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2014/02/aerotel-heartview-p128-mobile-feb14.jpg” thumb_width=”150″ /]For those attending GSMA Mobile World Congress in Barcelona next week and interested in how a more traditional telehealth provider incorporates mobile technology, stroll over to the Israeli Pavilion (Hall 5, Booth #5C81) to see Aerotel‘s new (debuted at Medica Dusseldorf last November) HeartView P12/8 Mobile, an extension of their existing 12-lead ECG line that incorporates a 3G module for patient data transmission to either a call center or to a physician’s email. Aerotel claims that it is the smallest and most accurate 12-lead mobile monitor on the market. We thank Boaz Babai of ARPU~UP,  Aerotel’s marketing agency, for the heads-up–but it would have been helpful to have a link to the (nonexistent?) product web page. Release (finance.yahoo.com).

Additional views on the mHealth Summit

HISTalk:I’ve been at the conference for two days and it still doesn’t have a clear identity in my mind. Others told me the same thing – it’s unfocused and hard to describe, much like “mHealth” itself.” The anonymous editor of this hospital HIT-oriented blog scores the conference for lack of provider-oriented content and participants, being a ‘speed-dating’ event for companies and investors (the original governmental/NGO/non-profit focus utterly swamped by the commercial), and the event management (which is largely out of the organizers’ hands and in the site’s). Part of the confusion may well be the fact that mHealth is 1) exploding and 2) transitioning (‘m’ going the way of ‘e’ in Health). A second article underneath the main from an anonymous CIO criticizes many of the sessions for being mislabeled, the Executive Breakfast for being underserved–and Tuesday was an improvement over Monday. Food a major complaint!

You do have to wonder if the GSMA writer attended a different conference because he resolutely focuses on wireless and NGO/social organization mHealth frameworks. An interesting but limited perspective. And the article includes a major error: Paul Jacobs of Qualcomm did not deliver the opening keynote as originally listed, but Rick Valencia of Qualcomm Life. One Qualcomm as good as another? Commercial Models to the Forefront: Key trends at mHealth Summit 2013 (GSMA.com)

Sunday’s WIPJam (Wireless Industry Partnership) with 20+ speakers seems to have been the in place for the mobile developer crowd, with Mobile Development 101, mobile trends, 10 ways to fail in first-time app development and more. Seventeen of these presentations are available to view at a Dropbox link here.

GSMA Mobile World Congress & mHealth

The GSMA has announced details of its upcoming World Congress in Barcelona on 24-27 February 2014 which will include a significant mHealth stream as part of the new “mPowered Industries” programme.

Meanwhile the mHealth Grand Tour from Brussels to Barcelona is continuing, demonstrating advanced the real-time monitoring of diabetes.

Elsewhere a new (and pricey) report by RnR Market Research on the mHealth market  (more…)