Next DHACA Day 9th July, London – seeking new members (psst–it’s free)

DHACA, the Digital Health and Care Alliance, with some 850 members currently, is having a new membership drive among SMEs working in the UK’s digital health & care space, following the kind offering of new sponsorship by Kent Surrey and Sussex AHSN and UCL Partners. 

The organisation’s objective is to help members develop their innovative products and services commercially, to achieve successful sales to the NHS. DHACA works right across the UK.

If you aren’t a member, you can sign up here to ensure you are kept aware of important news and of DHACA events. Membership is entirely free and members’ details will of course never be passed on to any other organisation.

Whether or not you are currently a member, booking is now open for the next DHACA Day. This event is primarily aimed at informing members working in the digital health & care sector of the major recent changes they need to be aware of, and how best to navigate them to make greater sales to the NHS and other health & care organisations. There is a small charge of £30+VAT to provide lunch, otherwise all other costs will kindly be covered by the event Sponsors, Baker Botts, in whose premises at 41 Lothbury (the opposite side of the Bank of England to the Bank Tube) it will be held.

The draft agenda includes talks by Luke Pratsides, Clinical Lead, Digital Development, NHS England about NHSX, Sam Shah, Director of Digital Development at NHS England and James Maguire, Clinical Advisor in Digital Innovation & AI at NHSX on NHS England’s digital development strategy, Mark Salmon, Programme Director, NICE on their HealthTech Connect and Evidence Standards, Neil Foster, Partner, Baker Botts on Finance for digital health start-ups, Neil Coulson, Partner, Baker Botts, on IP protection and the GDPR, Rob Berry, Commercial Director, UCL Partners on how the AHSNs can help SMEs and much more. Neil McGuire, Clinical Director of Devices, MHRA, has also been invited to update attendees on MDR implementation – a most important topic.

DHACA is keen to get members’ views on how they’d like it to be organised and governed in order to deliver what members want, so there will be time in the middle of the day for this too.

Should be a great day!

(Disclosure: this Editor is also DHACA CEO) 

 

A few short topical items: NHS Digital, DHACA, IET, more

Rob Shaw, NHS Digital’s Deputy CEO, gave a welcome talk at EHI Live on Tuesday encouraging the NHS organisations to become “intelligent” customers. To quote “We have got to make it easier for suppliers to sell into health and social care”. Let’s hope that the message is received and acted on! Until it is, the Kent Surrey and Sussex AHSN is offering help to SMEs to make that first sales – how to book, and to get more details on the event on 23rd November go here.

DHACA’s Digital Health Safety event, in partnership with Digital Health.London on 7th November is proving extremely popular, to the point where it may be oversubscribed soon, so if you want a seat for this really important event for all digital health developers and suppliers, book now.

The IET is running a TechStyle event on the evening of 22 November entitled the world of wearables aimed at people “between 14 and 114”. For today only (1 November) they are offering a special “2 for 1” deal making the already tiny cost essentially insignificant. Book here.  Hat tip to Prof Mike Short.

Prof Short has also highlighted a recent report from Agilysis looking at the role digital technology can play in delivering the vital step change our nation’s care services need. It concluded that: 

  • Leading digital professionals say lack of digital skills biggest risk to transforming care services fit for the 21st century;
  • Lack of knowledge of digital tools is largely responsible for delays in embracing new ways of working;
  • Believe digital technology could cut costs associated with social care delivery and therefore address the number one issue affecting UK social care today;
  • Digital technology can help local authorities manage both demand (improved customer satisfaction) and supply (improves multi-agency working).

There’s a great (more…)

A random selection of what’s crossed my screen recently

One of the signs of autumn for this editor is the first email from Flusurvey. This is a brilliantly simple system that sends you an email every week asking if you have flu-like symptoms, then produces a map of the UK that gives advance warnings of epidemics. It costs nothing to join and is a great contribution to public health so why not sign up?. (They also have some exciting developments that may surface soon such as a small device that you blow into the connects to a smartphone and can tell almost immediately if you have flu’.)

Increasingly of concern to this editor, due to his deep involvement in digital health regulation, is who is working out how to regulate self-learning algorithms. It is therefore good to see the issue breaking cover in the general press with this article. For what it’s worth this editor’s view is that as technology begins to behave more like humans, albeit in a much faster, and narrow, way by learning as it goes along, perhaps an appropriately adapted use of the way human clinicians are examined, supervised and regulated, might be most appropriate. Sitting next to an AHSN CIO interested in the topic at a Kings Fund event last week, I was pleased to hear him offer precisely the same suggestion, so perhaps there is a little mileage in the idea. 

DHACA (disclosure: run by this editor) has just renewed its website after a long delay, and will be updating content over the next few weeks. First off is the events page advertising:

Our Digital health safety conference on 7th November at Cocoon Networks, London, is being run jointly with DigitalHealth.London – the MHRA has now confirmed they will present so we have almost all the relevant organisations and experts in the UK speaking at this event which should be essential attendance for all involved with the development and use of digital health & care. Attendance has increased substantially in the past few days so do book soon to be sure of securing a place. Much more, including an almost-finalised agenda, is here.

DHACA Day XV – we are back to our usual location at the Digital Catapult Centre on 10th January where are building an agenda of some extremely interesting speakers. To check out the agenda development and to book in advance, go here.

(more…)

Accelerated Access Review published – well worth a read

The Accelerated Access Review is published today. Readers with long memories will recall that it kicked off in the Spring of 2015 aimed at accelerating the uptake of innovation in to the NHS. It had three technical streams – pharma, medtech & digital health, plus a patient stream. This editor, as Managing Director of DHACA, was the digital health champion.

DHACA members were heavily engaged in the consultation, so it is gratifying to see that all DHACA recommendations were accepted. Most important were recommendations that:

  • NICE broaden its reach to include more medtech & digital health recommendations, and consider other means of funding;
  • there be closer alignment of regulatory and NICE data requirements and processes (currently, there can be duplication);
  • a strategic commercial unit is established in the NHS;
  • a small amount of funding is offered to support the commercialisation of disruptive innovative technologies that significantly change care pathways;
  • products not referred to NICE should be assessed only once by NHSE;
  • the route for digital products should build on the “Paperless 2020” simplified app assessment process;
  • the Crown Commercial Service, in partnership with NHS Digital, NHS England, the Department of Health and other system and technology partners, should consider how best to develop an accessible, simple and swift competitive process for procuring digital products from SMEs;
  • NHS England, working with NHS Digital, should develop a generic framework for app prescription.

When implemented, these and all the other recommendations in the report will go a long way to (more…)

Catch-up: what you may have missed whilst on holiday

This was the month when the UK Press seemingly finally woke up to the existence of STPs (Sustainability & Transformation Plans). This article by Derek du Preez and this in Digital Health are two one of a few that pick out the hope that digital health can help with making the NHS more sustainable. Sadly the headlines were grabbed with concern over closing hospital beds, which politicians in the UK still seem to consider to be a Bad Thing. Even though hospital beds have been reduced in most European countries over recent years, and those such as Denmark now trumpet reductions in hospital beds as progress, we have still to break the connection in people’s minds in the UK that beds are a good surrogate for health service delivery volume, (even though when pressed no individual seems keen to spend longer in hospital than absolutely necessary, or would prefer a treatment as an inpatient over treatment as an outpatient.)

Though not directly connected, the NHS offered over £100m to acute care trusts for “global digital excellence” – in line with the previous comments, perhaps the money could alternatively be spent on the UK building on its excellent primary care IT with the specific intention of moving more treatment out of hospitals…and follow that up with a proposal to put the hospital that is judged to be the least “globally digitally excellent” (more…)

The Accelerated Access Review – a personal journey

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/02/AAR-logo.jpg” thumb_width=”200″ /]The Accelerated Access Review (AAR) aims to speed up access by NHS patients to innovative medicines, medtech and diagnostics, and digital health. Of these, digital health is the newest, and because it enables care to be delivered in a far more efficient and patient-centric way, offers great hope for the future of improved patient outcomes and controlled costs.

As someone outside government who was drawn into the digital health stream of the AAR, this blog aims to capture key learnings from the experience.

Challenges

The initial list of obstacles to innovation in the NHS was depressingly long, until carefully differentiated. Top of the pile were items like the NHS’s asymmetric attitude to risk – successful innovations are forgotten, unsuccessful innovations are a life sentence for those involved – which are soluble only by those at the very top.

Then there were the surmountable challenges – for example the fear, uncertainty and doubt over digital health regulation was overcome by (more…)

Three of the best – digital health events at the Royal Society of Medicine for 2016

The Royal Society of Medicine has two unbeatable benefits to offer conference attendees: virtually every world expert is keen to present there and, because it is a medical education charity, charges are heavily subsidised. As a result you get the most bang for your buck of any independent digital health event, anywhere!

And just now the offer is even more attractive as if you book for all three in the next 14 days (ie by 12th February) the RSM will give you a 10% discount on all three!

On February 25th, the RSM is holding their first 2016 conference: Recent developments in digital health. This is the fourth time they have run this popular event which aims to update attendees about particularly important new digital heath advances. For me the highlight will be Chris Elliott of Leman Micro who plans to demonstrate working smartphones that can measure all the key vital signs apart from weight without any peripheral – that includes systolic & diastolic blood pressure, as well as one-lead ECG, pulse, respiration rate and temperature. When these devices are widely available, they will dramatically affect health care delivery worldwide – particularly self-care – dramatically. See it first at the RSM!

I’d also highlight speakers such as Beverley Bryant, Director of Digital Technology NHS England, Mustafa Suleyman, Head of Applied Artificial Intelligence at Google DeepMind (who’ll hopefully tell us a bit about introducing deep learning in to Babylon), Prof Tony Young, National Clinical Director for Innovation, NHS England and Dr Ameet Bakhai, Royal Free London NHS Foundation Trust. It’s going to be a brilliant day!

Book here.

On April 7th the RSM is holding Medical apps: mainstreaming innovation, also in its fourth year. Last year the election caused last minute cancellations by both NICE & the MHRA, who are making up for that with two high-level presentations. Among a panoply of other excellent speakers, I’m personally looking forward especially to (more…)

Apps and wearables – developments over the summer

Trying at least temporarily to distract this editor’s attention from his recent unfortunate experience with Jawbone technology, here are some interesting app and wearables snippets received over the summer.

We begin with news of the first CE certified mole checking app, SkinVision which rates moles using a simple traffic light system (using a red, orange or green risk rating). The app lets users store photos in multiple folders so they can track different moles over time. It aims to detect changing moles (color, size, symmetry etc.) that are a clear sign that something is wrong and that the person should visit a doctor immediately.

This contrasts with the findings of a paper published in June examining 46 insulin calculator apps, 45 of which were found to contain material problems, resulting in the conclusion that :”The majority of insulin dose calculator apps provide no protection against, and may actively contribute to, incorrect or inappropriate dose recommendations that put current users at risk of both catastrophic overdose and more subtle harms resulting from suboptimal glucose control.”, which to say the least of matters is worrying. (more…)

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.

2015: a few predictions (UK-biased)

As intimated in our review of last year’s predictions, we feel little need to change course significantly, however some are now done & dusted, whereas others have a way to go. The latter include a concern about doctors, especially those in hospitals, continuing to use high-risk uncertified apps where the chance of injury or death of a patient is high if there is an error in them. Uncertified dosage calculators are considered particularly concerning.

Of necessity this is an area where clinicians are unwilling to be quoted, and meetings impose Chatham House rules. Suffice to say therefore that the point has now been well taken, and the MHRA are well aware of general concerns. Our first prediction therefore is that:

One or more Royal College/College will advise or instruct its members only to use CE-certified or otherwise risk-assessed medical apps.

The challenge here of course is that a restriction to CE-certified apps-only would be a disaster as many, if not most, apps used by clinicians do not meet the definition of a Medical Device and so could not justifiably be CE-certified. And apps are now a major source of efficiencies in hospitals – (more…)

Looking back over Telehealth & Telecare Aware’s predictions for 2014

Looking back over our predictions made on 31st December last year, it’s hard to quibble with any, and worth hanging on to those that didn’t come good this year.

Our first was

Security and data privacy issues will become a serious mHealth issue in 2014; developers failing to take great care over security and privacy issues will risk very adverse publicity and worse.

Job done: that certainly proved correct, with many being exposed as either selling or potentially selling private information. Clinicians were not immune from privacy invasion eitherHere is a US summary of the issues. Attention was drawn to an EU Article 29 data protection opinion (actually published in 2013) that sought to clarify the legal framework applicable to the processing of personal data in the development, distribution and usage of apps on smart devices, and the obligations to take adequate security measures.   Many apps got hacked too, including FDA-approved ones. There were also items, such as this one, demonstrating how complex the law is in this area in the US. In the EU, the arrival of the Data Protection Regulation in 2015 (now some say 2016) will undoubtedly improve data privacy significantly, though the failure to treat data used for health purposes differently from (more…)

Soapbox: Why an app isn’t like a book

The suggestion has been made recently at a couple of events that this editor attended that there is an unnecessary fuss over regulation of medical apps because they are just like medical books; as there is no regulation of books, why the need to regulate medical apps? . In order to try to move to a consensus, this post puts the opposite point of view, to stimulate debate. In summary the arguments of why they are different are:

  • We are familiar with books and have worked out how to deal with them;
  • Books give formulae and leave users to compute; apps do it all, often without showing their working;
  • Tablets and, especially, smartphones have screens that are smaller than books so require a different design.

This issue of course only relates to serious medical apps – something like 99.5% of all health apps available are very unlikely to do serious harm, helping people as they do record things like their fitness and their weight, and so do not require such detailed scrutiny. It is the ones that get close to, or meet, the test of being a medical device that are of particular interest here. The goal is that once clinicians are comfortable prescribing medical apps, and patients are comfortable using them, the NHS will save substantial sums by, for example replacing drugs with apps for a range of diseases where both are effective and apps are far cheaper. There are also huge benefits for clinician-facing apps – properly certified medical apps like Mersey Burns and Mersey Micro are already massively improving patient outcomes and significantly reducing NHS costs.

In more detail, books have been with us for many centuries so we are familiar with their structure, with the processes for their removal from publication if they give dangerous advice, and with the idea of specialist publications accessible by appropriate experts only – the same is not true of apps. In the event that advice in a book was dangerously wrong, (more…)

A few observations from September’s Health Technology Forum London

On Wednesday 17th September, Health Technology Forum members gathered at Baker Botts’ office in London for a couple of key presentations on legal aspects of medical software.

The first, by Joe Hagan-Brown, Regulatory Affairs Specialist at the MHRA, covered the EU’s medical device-specific regulation. The second, by Alex Denoon of Lawford Davies Denoon, was a presentation on the EU’s data protection regulation.

Readers with long memories will recall that I summarised medical device-specific regulation a while back; much of what Joe said added colour to that summary. A few comments he made are perhaps worthy of repetition (more…)

A free event for all those interested in medical apps (UK)

On Wednesday 17th September the Health Technology Forum in London is meeting again at Baker Botts’ head office at the back of the Bank of England to hear presentations from:

Joe Hagan-Brown, Regulatory Affairs Specialist at the Medicines and Healthcare products Regulatory Agency (MHRA) who has very kindly agreed to present on a huge range of app-related issues including:

The Medical Devices Directive – definition of a medical device; Software- qualification as a medical device; A brief background to software in the context of medical device legislation; Meddev 2.6/1; The market for Apps; MHRA guidance on software as a medical device; Five categories of apps; Classification; Conformity assessment; Telehealth; Vigilance/Post market surveillance; General requirements; Specific considerations

Alex Denoon, from Lawford Davies Denoon who has very indly agreed to talk to us on the impact of the proposed Data Protection Regulation on biomedical research. The talk will cover the (largely unintended) potentially catastrophic effects on matters are diverse as biobanks, personalised medicine, e-health and the development of new medicines.

The plan is to give both speakers plenty of time both for their presentations and to respond to questions, whilst still enabling all present to enjoy Baker Botts’ legendary hospitality for the networking session afterwards.

There are currently 12 spaces left. More details, and how to book are here

Healthcare Apps 2014 – a few impressions

This event was held on April 28th-30th in Victoria in London. It was organised by Pharma IQ and clearly had a strong pharma focus (including the charge which at £1995 for industry attendees clearly discriminated in favour of those with big-pharma sized budgets). It was also held just a few days after the significantly lower-priced Royal Society of Medicine event, and in the middle of a London Tube strike, all of which doubtless contributed to the relatively modest attendance (26 paid). I am most grateful to the organisers for kindly inviting me as one of speaker Alex Wyke’s guests.

As mentioned in an earlier post, there was a similarity with the RSM agenda, so I won’t repeat comments made by the same speaker before. The first up was the 3G Doctor, David Doherty, who gave another of his excellent presentations, although the sound engineer sadly made some of it inaudible. After a review of how we had got to where we are, he suggested that the Internet is about to become a device-dominated network. He drew a parallel between (more…)