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. 

TSA’s International Technology-Enabled Care (ITEC) Conference 16 & 17 October 2017

The TSA is holding its annual conference on 16 & 17 October – one of their key issues will be the analogue to digital phone service shift which poses huge risks and opportunities for the TEC sector. The TSA will be unveiling their white paper on the topic at the conference – a great reason to attend! 

Even if that’s not uppermost on your mind, ITEC has much to offer – from politics to health science, demographics to robotics, many factors combine to shape new models of care nationally and internationally: find out how TECS fit into the bigger picture and how the sector can flourish within this complex and uncertain landscape!

Book here.

(Disclosure, this editor is presenting at the conference on a very important topic – be sure to say hi after his presentation!)

 

TSA appoints new chair

Paul Shead has succeeded Andrew Gardner as Chair of TSA. He has worked closely with the TSA and its membership since the organisation’s inception, and has been on the TSA’s board of directors since May 2012. He will chair the board for the next 12 months, working to develop strategy, monitor performance and extend the organisation’s sphere of influence. Paul’s experience of the telecare industry spans more than 20 yearsCurrently he is Managing Director of Verklizan, supplier of the UMO telecare and telehealth monitoring platform to housing associations, local authorities and private companies in the UK.

Commenting on his appointment, Paul said: ‘Social care and health are facing unprecedented pressures. The need effectively to commission, procure and quality-assure technology enabled care (“TEC”) has never been greater. The shift of analogue to digital also presents huge opportunities and risks. The fast-changing pace of TEC means that a new audience of digital health companies is springing up alongside more traditional telecare organisations. I’m keen to ensure that TSA can support and inspire every part of the UK’s diverse technology enabled care sector. I look forward to working alongside the TSA Board, Chief Executive, President and staff to ensure that we respond effectively to challenges, make the case for TEC and work to shape future policy. We must provide our growing and diverse membership with the knowledge, intelligence and ideas to sell their products and take the sector forward.’ (more…)

Free individual advice and guidance to SMEs wanting to sell to the NHS

Here is your opportunity as an SME to get advice on selling to the NHS. Specfically, DHACA and Kent Surrey & Sussex AHSN have joined forces to help you to prepare a more compelling and comprehensive value proposition as part of your market access strategy. (SMEs don’t need either to be in the KSS AHSN catchment areas, or members of DHACA, although the latter is free to join and has lots of useful digital health resources, so why wouldn’t you?) 

There will be two sessions, both of which you should be able to attend if you apply. These will be held at the Royal Society of Medicine (close to Oxford St and Bond St tubes). That on 20th July will be about 90 minutes. In that time you will hear and be able to discuss:

  • How current NHS finances and cash flow may impact on your service/product uptake
  • How to improve your value proposition for NHS audiences

This will help you prepare for the second stage, on 27th July, which will be an individual Innovation Surgery. These will last 1 hour and cover aspects from the market access briefing. They will be specific to your product as well as covering the technical and market potential of your product/service.

More details and how to apply are available in the DHACA Briefing and Surgery Flyer

Note that although the flyer says you need to email vivienne.gray3@nhs.net by the end of Thursday 6th July to apply, Vivienne will be happy to accept late applications, though do please get them in soon!

(Disclosure: this editor is Managing Director of DHACA)

 

Some London events (to 5 July) and an opportunity to monetise your expertise

To respond to a recent contract Our Mobile Health needs to expand its pool of paid expert app reviewers. Applicants should be proficient health app users, professionally qualified, articulate and able to assess academic papers that justify app effectiveness.  Reviews are done remotely (though reviewers must use the English version of apps) and offer an opportunity for reviewers to position themselves as digital health pioneers. Apply here.

Also, if you’re free in London, here are some events you may wish to consider:

Midsummer’s DHACA Day is at the Digital Catapult Centre, Euston Road, London on  21st June. It is aimed very much at digital health developers, with presentations on IP, new business opportunities, the new medical devices and data protection legislation and much more. DHACA membership remains free; entry to the event, which starts at 10 am for 10.30 am, is just the cost of lunch. Book here.

NICE is launching a new evidence tool for “medtech product developers” on 3rd July at the Royal Society of Obstetricians and Gynaecologists, 27 Sussex Place, London. Attendance is free though expect it to sell out soon! Book here.

The next Health Technology Forum meeting near Bank tube in London is on 5th July at 6.15 pm for 6.30 pm, starting with Giovanna Forte’s epic story of how to sell to the NHS – it’s really not to be missed! There’s also an important digital health dimension as she is looking for a partner to develop her innovation into an integrated service. This is followed by a talk on using digital health to provide acute paediatric care remotely. It’s free to attend though, if you book here, do please come along as otherwise it messes up our host Baker Botts’ kind and generous hospitality arrangements.

(Disclosure: this editor has an involvement in the majority of the above.)

 

Winston Churchill Memorial Trust – 2018 Travelling Fellowships

Here’s a great opportunity to get funding to go and investigate a health & care innovation elsewhere in the world – there are plenty of them!

Do you have the drive and determination to undertake global research? If so the Winston Churchill Memorial Trust funds UK citizens to investigate ground-breaking practice in other countries and return with innovative ideas for the benefit of people in the UK. Whatever your background, they can help you bring positive change to your community, sector, or profession.

They are looking for people who are passionate about making a difference in their field – that means just about every TelecareAware reader! (Though note sadly only UK citizens can apply.)

Grants cover return and internal travel, daily living and insurance within the countries visited. Apart from UK citizenship, there are no other required qualifications.

Categories include (directly health-related in bold):

  • Environment, Conservation and Sustainable Living
  • Education
  • Health and Wellbeing
  • Mental Health – Community Based Approaches
  • Migration – Living Well Together
  • New Approaches to Social and Affordable Housing
  • Nursing and Allied Health Professions
  • Science, Technology and Innovation
  • Supporting Vulnerable Children following Bereavement

Apply before 5pm on 19th September 2017.

For more details please go here.

Digital health & insurance: perfect partners?

The BMA is claiming at their annual conference today that GPs are struggling with workload. Once upon a time, everyone thought digital health alone was one answer to reduce that workload. However until we have better algorithms to sort the signal from the noise, many doctors claim that more data is contributing to the problem rather than solving it. So how to get patients to use digital health data to take more responsibility for their own health? In technical terms, how to raise their patient activation measure (PAM)?

One way of improving the effectiveness of digital health might therefore be to add incentives to become more activated; insurance could provide such an incentive. The Royal Society of Medicine has therefore put together, as a ‘first’, an event on 1st June to explore this combination (disclosure: organised by this editor).

The speakers have been chosen to cover the full spectrum of participants in this field. Beginning with the software, Caty Ebel Bitoun from the Netherlands will describe software she builds to support health insurers, and Justin Lawler from We Savvy in Ireland will describe how that software can be configured to deliver maximum benefit.

Guy Gross will explain how careful segmentation of insured populations by PAMs can substantially reduce (more…)

Two London events worth considering

A quick blog to draw your attention to two events at the Royal Society of Medicine that this editor has been involved in setting up, and that should be of interest.

The first is the Future of Medicine: the Doctor’s Role in 2027, on May 18th, which has a host of excellent speakers looking at how technology is likely to change the way medicine is practised in ten year’s time, to help clinicians, healthcare managers, academics and suppliers prepare for those changes to ensure maximum improvement in patient outcomes. Book here

The second event, in partnership with the IET, Digital Health and Insurance: a Perfect Partnership? on June 1st brings in a wide range of international speakers to explore how, by giving insurers precision over the risks they are taking, digital health is transforming health insurance, both for humans and for pets, and in the process may well result in a fundamentally different way of providing, and paying for, health in the future. Not to be missed! Book here.

As has been said before, the RSM has medical education as one of its charitable objects (the other is promoting medical advances) so their events are extremely attractively priced.

Calling all digital health people in the North of the UK (and the South)

Sadly the DHACA Day in Leeds on 27th April had to be cancelled because of competing events on that day – readers are reminded of the next DHACA Day now in London on 21st June – agenda still to be set.

Elsewhere, Nesta has updated its European Digital City Index, showing the position at the end of 2016
of the top 50 cities in Europe for start-ups. Not digital health-specific though very interesting, nevertheless. TechCity have produced a more detailed website exploring why the UK is the Tech Nation of Europe, which is excellently animated. Though with little mention of digital health it is nevertheless an excellent read, and resource…and something to make those of us who are involved in the UK digital scene proud of our achievements. And if you are a supplier looking for opportunities to capitalise on the UK’s standing, what better than to attend Healthcare UK and NHS Digital’s International Digital Health Opportunities event in London on 25th April?

If you are still feeling international though less interested in exporting, perhaps you might like to attend (more…)

CHANGED DEADLINE Calling all diabetes prevention apps: may be your chance for greatness!

Our Mobile Health is seeking to identify the best digital behaviour change interventions aimed at helping people diagnosed as pre-diabetic to reduce their risk of onset of Type 2 Diabetes. They are working with NHS England and the Diabetes Prevention Programme to identify the best 4-5 of these that are suitable for deployment to around a total of 5000 people across England. The aim is to build up an evidence base for digital behaviour change interventions for people diagnosed as pre-diabetic.

Organisations with suitable digital behaviour change interventions are invited to submit their solutions for inclusion. These should be either actually deployed or will be ready to be deployed within three months. They should be suitable to be, or have been, localised for the UK market, and they should not be dependent on any further integration with the UK health system for deployment.  Shortlisted digital behaviour change interventions will be invited to participate in Our Mobile Health’s assessment process; the final selection will be made based on the results of that assessment.

The deadline for submissions, which can be made directly online is midday on Wednesday 15th March.  NOTE THIS IS A CHANGE FROM THAT PREVIOUSLY ADVISED. There is more about the programme on the NHS website.

(Disclosure: this editor has been asked to assist with the assessment process referred to above)

A cornucopia of events and opportunities (UK/EU)

This editor has been extremely busy of late representing DHACA members’ interests in Brexit discussions, finalising RSM events and researching technology to help carers. However the requests to promote events have continued to arrive so here is a very brief summary:

Innovate UK is looking for new assessors – click here for more information.

On 7th March ADASS is holding its Care Apps Showcase and Conference event in Central Birmingham. Book here.

The Wearable Technology Show is on 7th & 8th March at Excel, and for the first time will include within it the Digital Health Technology Show. This editor is presenting. Readers can get free entry to the exhibition and cut-price entry to the conference sessions (quote DHTDHAC17).

On 23rd March, the London Health Technology Forum has its annual pitch session. If you fancy trying your hand at pitching your start-up, or your new idea, we want you! There’s no guarantee that winners will get funded. However there are lots of finance people coming, and winners will certainly get some nice champagne…and bag lots of useful experience. Book here. Contact marie.carey@bakerbotts.com if you want to pitch.

The RSM’s Apps event is in its fifth year and on 4th April. We have a veritable constellation of who’s who in mHealth apps presenting this year: I hate the expression “must see” though it’s very appropriate in this case. Book here. These are incredible value events because one of the charitable objects of the RSM is education: compared with commercial events they are a steal, and the quality is superb.

PwC has a 13 week startup growth programme for revenue generating health companies, entitled ‘future of health’ starting 6th March. They still seem to be taking enquiries though, more details here.

Aging (sic) 2.0 has come to London and holds a global startup search event on 11 April. If you want to register on their startup database,  perhaps to participate in that event, go here.

The DigitalHealth.London Accelerator is now open again for applications. Closing date is 12 midnight on Thursday 20 April

EHTEL have their Symposium in Brussels on 15-16 March – apply here.

The RSM is working with the IET in partnership for the third year to offer you Future of Medicine; the role of Doctors in 2027 on 18th May with the now-expected array of iconoclastic presenters telling us how different the delivery of care will be in ten years. Book here.

More shortly.

Events dear boy, events…

Here is a selection of events you may wish to engage with that have crossed this editor’s PC recently:

Nominate someone for a Digital Pioneer Award – nominations close on 2 December.

DigitalHealth.London in collaboration with NHS England is hosting the Digital Pioneer Awards. They are seeking out within the NHS individuals at any rank and in any role, who are deserving of an award for any of:

  • Digital leadership
  • Digital Innovation, or
  • Sustainability through digital (which means that they have been instrumental in making sure a digital implementation has been sustained enough to a point of delivering benefit).

Med-e-Tel, the Luxembourg event,  has a call out for abstracts with a deadline of 4 December.

The NHS England Clinical Entrepreneur Programme have launched recruitment for their second year cohort. Applications for all doctors will close on 9 December 2016. This intake apparently “will have limited places” (don’t they all?). Interviews will be held in March 2017 and the programme will commence in autumn 2017.

The West Midlands Health Informatics Network (WIN) will be holding its third (free) annual digital healthcare conference on 24 January 2017 at the University of Warwick. The keynote and guest speakers are:

  • Professor Theodoros N. Arvanitis, Chair in eHealth Innovation and Head of Research at The Institute of Digital Healthcare
  • John Crawford, Healthcare Industry Leader, Europe, at IBM
  • Noel Gordon, Chairman of NHS Digital
  • Harpreet Sood, Senior Fellow to the CEO at NHS England
  • Jenny Wood, Director of Adult Social Care at Solihull Metropolitan Borough Council

The aims of the conference are to:

  • showcase innovation and research in digital health, care and wellbeing;
  • enable the sharing of good practice and experience from those working in this area; and
  • promote collaboration across various settings.

The day will consist of exhibitions, poster presentations, talks/panels delivered by stakeholders, and networking sessions. With the keynote/guest speakers they have lined up, this is set to be their highest profile event to date, therefore, they ask that people should register as soon as possible here.

The Royal Society of Medicine is holding its highly popular Recent developments in digital health conference on 28 February. Speakers this year include Ali Parsa, Dame Fiona Caldicott, Shafi Ahmed,  and Sir Mark Walport – it’s going to be another great event. Last year there were disappointed late bookers because it sold out, so worth getting in early by booking here, now!

Hat tip to Prof Mike Short for some of the events.

 

You wait for ages for a new meaning for JAM then two come along together

Anyone tuning in to the Chancellor’s Autumn statement will be only too well aware of the JAMs – just about managing. However there also another JAM – the JAM Card and app which is a brilliant idea to flag to impatient people that you just need a little more time – Just A Minute, in fact – whether due to age, infirmity or disability. Now there’s an app to go with it too so you can record whether people responded well or not to you flashing the card at them.

So simple…so brilliant!

Hat tip to Prof Mike Short.

Last call for London Health Technology Forum Thursday, early bird RSM mHealth 2017

On the evening of Thursday 24th November, the London Health Technology Forum holds its last event of the calendar year on “Intellectual property & licensing”. This is a really critical area that this editor has seen more people lose money on because of not handling properly than in any other aspect of early start-up management – it truly is vital to think through very early on, to stop people stealing your ideas and paying an appropriate price to license them. Attendance is free; booking is here.

(The RSM’s mHealth app conference on 4th April 2017 is just about to end its early bird prices too – worth booking here anyway now, at it’s usually a sellout).

When is an app not an app? (When it’s a conundrum)

It all started so simply. In DHACA under the leadership of Rob Turpin (BSI) we produced the definitive guide to app regulation in the UK. Sure it was 44 pages long (and will shortly need updating) however we all knew that an app was standalone software and that none other than MEDDEV 2.1/6, the ultimate definitive guide to when an app is a medical device defined software as:

…a set of instructions that processes input data and creates output data.

However doubts began to creep into this editor’s mind when he heard that app developers in the US were avoiding (US/FDA) medical device classification as that would rule them out as service providers, which can reduce future  reimbursement benefits – as we quoted Ralph-Gordon Jahns of research2guidance in 2014 “profitable developers… rely on service sales as their primary source of revenue.”

Things got more complicated when it emerged at the UK Health Show this autumn that PHE was considering listing digital GP services as (more…)