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.”
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!
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…)
UCL is delighted to invite you to join them at Wayra, London for their Prize and Tech Day on Tuesday 23rd February at 14.30-19.00 as part of the Rosalind Franklin Appathon- a national app competition to empower and recognise women as leaders in STEMM (Science, Technology, Engineering, Maths and Medicine).
This free event will include some short talks from the judges, UCL Provost Professor Michael Arthur and a very special guest talk from Rosalind Franklin’s sister, author and historian Professor Jenifer Glynn. We will then hear pitches from the app finalists. Winners will be announced by Baroness Martha Lane Fox (Founder of Lastminute.com), Andrew Eland (Director of Social Impact Engineering, Google) and Dame Athene Donald (Professor of Experimental Physics at the University of Cambridge). There will also be plenty of time for networking and a chance to try out some of the apps. More information can be found here .
Do join UCL in celebrating the breadth of digital talent here in the UK and the pioneering women behind some truly innovative and exciting apps by registering for the event here.
Major apps stores reported more than 165,000 mHealth apps published by 45,000 companies, and projected 3 billion downloads by close of 2015. Some other key findings from R2G do surprise:
- The target for apps is DTC–chronically ill patients–with their hospitals as #2. Physicians are important, but less so than last year’s survey.
- App publishers aims appear altruistic. 53 percent of mHealth publishers claim that their main motivation is to help people improve their medical conditions. However, 60 percent aren’t reaching their goals yet mainly due to low reach. The vast majority of apps (62 percent) mark up less than 5,000 annual downloads. (See the chart below for some possible reasons why)
- Diagnostic apps lead in anticipated business potential until 2020. And app publishers have added medical professionals to their team.
- What app publishers find works to change behavior is not gamification. What does: integration of provider feedback or dialogue.
- Yet providers, such as doctors and nurses, are seen as the most threatened group by mHealth solutions.
- A scant 3 percent of mHealth publishers generate more than $1 million–and they are far more focused on sales and brand awareness than their brethren which make little. (chart)
There is, but not what was envisioned five to six years ago. If you still think of mHealth as a subset of ‘health’ and defined by its devices as a separate strategy or ‘revolution’, it’s time to check your glasses’ prescription. Thus an article like this published in HIMSS Media’s mHealthNews that focuses on mobile devices starts off feeling antique (as in 2008-9) in its emphasis on video and direct to consumer apps and problems thereof–then fast forwards to This Modern World: the Graettinger-esque dissonance of data insecurity, the entry into the City of Glass of integration–multiple platforms, data sets and apps/tools into personalized, proactive care and clinical decision support.
At MedCity News, the snark prevails in coverage of a World Congress Boston mHealth + Telehealth World conference where participants seemed to treat mHealth as m-health–chattering on about smartphones and tablets as devices not delivery vehicles, (more…)
Yes, those same people who–gee whiz–designed computers, did their own programs in MS-DOS and went from Palm Pilots to BlackBerries to iPhones, are already over or hitting 65 (3.9 million in US in 2015)–and they aren’t happy with what’s being served up to them in healthcare tech. The Accenture study across 10 countries and over 10,000 adults points out the demand–67 percent–and the dissatisfaction–66 percent. They want independent self-care tools, wearables to monitor themselves, online communities like PatientsLikeMe, patient navigators and health record tools. Moreover, the more comfortable they are with and value technology, the more likely they are already using technology for tracking weight and cholesterol levels. Couple this with the ‘Drawn and Quartered’ Parks Associates research [TTA 11 Aug 14] and moving past the mHealth hype earlier this week, the study points out a strong market for apps, online tools and other digital health–but designed not for a peer group of most designers, nor to be ‘cool’. Helloooo designers! Wake up! Laurie Orlov does point out on AgeInPlaceTech that there’s not much new here, but that we shouldn’t move on. Accenture release, Modern Healthcare, Fred Pennic in HIT Consultant, Stephanie Baum in MedCityNews
The NHS’s National Information Board (NIB) this week published its long awaited document on its plans for personalising health and social care activities, with a strong England focus. It breaks new ground for such a document in many ways (not least that when you put ‘apps’ or ‘telehealth’ or a myriad of other terms into the search engine, you get many hits!).
Before describing at some length why this editor considers the document to be so important, it is of course important to recognise that there will be an election in six months’ time so both the funding and the priorities of the NHS may well change before it has even got beyond the very first set of commitments. A further point is that, were the NHS to meet all the commitments it has made, even in recent years, it would be a very different organisation to that that it is: commitment do not necessary result in delivery.
The document is subtitled “A framework for action” which is a good description. it contains many individual commitments. However few are are sufficiently (more…)
Adopting or Ditching It? We’re barely into September, yet the first 2015 prediction-of-a-sort is on the record from Center for Connected Health‘s Dr. Joseph Kvedar in The eHealth Blog. Does Apple HealthKit+Samsung‘s SHealth’s iterations+Google Fit+smartwatches everywhere (including LG’s G Watch R) equal $7.2 billion in wearables alone by 2018 as part of a mHealthy $49 billion by 2020? He’s optimistic, yet he hedges his bets with the caveat
“The challenge in health care is that, though we know what patients/consumers need to do to improve their health, most of them don’t want to hear about it.”
Which indicates that Dr. Kvedar has joined our small group of Thinkers puzzling out why health apps haven’t taken off beyond their Quantified Selfer early adopters and what Parks Associates termed ‘Healthy and Engaged’ [TTA 11 Aug]. With 1/3 of the purchasers of activity trackers putting them in the drawer after six months and the unstickiness of apps (80 percent are abandoned after a shocking two weeks), the winning combination isn’t obvious. But is it ‘focus on engagement’ and ‘personal, motivational and ubiquitous’? Certainly key factors, but how do we get the ‘Challenged but Mindful’ with a chronic condition–or two or three–to track and reward their real progress, even on a bad day–which an activity tracker which constantly presses you to exceed your performance has trouble gauging. (more…)
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…)
This week the European Commission published its green paper on mHealth previously announced in the eHealth Action Plan 2012-2020, kicking off a broad stakeholder consultation on existing barriers and issues related to mHealth deployment and helping to identify the right way forward to unlock mHealth potential. To accompany it, a very short video by Neelie Kroes is available. An accompanying short (10 page) paper by the EC on the current legal position for people using health & wellbeing apps is also well worth a read. Finally, to complete the set, the EC has produced an mHealth infographic as well.
Responses to the Green Paper are required to the European Commission by 3rd July at the latest.
In view of the potential for mHealth to benefit everyone if correctly regulated and supported, all readers are urged to respond, either individually or collectively via an industry body (eg DHACA – see below), or both.
The document, at only 19 pages long, is hugely impressive, making an excellent case for (more…)
If like me you are frequently asked for a summary of what has happened recently in the world of telehealth & telecare and are forced either to sit down and cut & paste/write one or politely turn down the request, you’ll be pleased to know of the recent four-page summary produced by the Parliamentary Office of Science and Technology (POST). Written by Peter Border, it is a competent summary of recent developments in remote monitoring in the UK, including 3millionlives & ALIP, extending to mention of the regulation of medical apps.
Of course there are bits I’d have written differently. For example (more…)
The MHRA has today provided guidance on medical device software, which includes medical apps. The guidance can be found here.
Briefly, this guidance aims to:
- outline the current regulatory position
- explain what defines a medical device
- help with decisions on whether your stand -alone software or app is a medical device and give examples
- give information about the rules on classification of medical devices and how to meet the regulations
- give links to other useful websites and relevant documents.
This guidance is aimed at those working in healthcare and people who are developing devices.
Readers might wish to refer to our previous recommendations regarding medical apps.
Health apps are often in the news these days. Ofcom, the UK telecommunications regulator, commissioned Kantar Media to carry out qualitative research on attitudes and behaviours of apps users when using devices such as smart phones and tablets. The resulting report, Apps Environment, published today by Ofcom makes interesting reading.
Although the report was commissioned by the UK regulator, I think the findings are applicable to any country. What’s more, the generic nature of the conclusions make them relevant to health apps as much as to any others.
The report says that “among app users, several perceptions were found to be influencing behaviours, attitudes and the low level of concern in the app environment. These perceptions were:
• official app stores monitor and vet the apps they make available;
• well-known brands provide a safe, secure and reliable user experience, and;
• apps are safer than browsers due to their more limited and contained nature compared to browser-based internet use.”
Another finding was that many app users said they paid very little attention to permissions requested by apps – nothing new there then. How many times have you ticked that “I Agree” box to the terms and conditions without reading them?
Very few participants in the research are reported to have raised spontaneous concerns about apps. The researchers say that when prompted, in-app purchasing and advertising were of greatest concern to parents, and at most, a frustration or annoyance to others.
This shows that when it comes to more critical apps such as health apps or those that are designed to provide a safety net in a care environment a stronger regulation may be needed as well as a pro-active educational effort to emphasise the need to be aware of issues such as data privacy.
Returning from the World Economic Forum in Davos, Switzerland, where she met with several company CEOs, South Korean President Park Geun-hye has decided to promote telehealth as a new growth engine for South Korea according to the Shanghai Daily. The president wants to see the country become a global leader in telehealth with a strong domestic use of the technology.
This is particularly fortunate for Samsung, the country’s largest group of companies, which is also said to be planning biomedicine and medical equipment to be among its growth sectors with a reported 10-year total of $22 bn (US) of investment across all its growth sectors. Samsung already produces major hospital equipment such as ultrasound and digital radiography systems, currently operates a massive hospital and cancer center in Seoul and is, (more…)
Guest columnist Lois Drapin thinks so. She shares her insights on Validic, an emerging company in data integration for payers, providers, preventive wellness companies and pharma;how it evolved from its original concept in consumer health engagement, along with a few pointers its founders have for fellow entrepreneurs.
One of the keystone aspects of “ecosystems” is interoperability and this also applies to the data pipeline that flows from health apps and devices to the appropriate segment of the healthcare delivery system, and eventually, to the users—patients, consumers and/or medical professionals such as physicians and nurses or other clinicians. By now, we all know that the capture and analytics for both “big” and “small” health data are business imperatives for healthcare in the US. With data of this nature, we can embrace our understanding of behavioral change at the individual and population levels. The anticipated outcomes of behavioral change may power operational and cost efficiencies in the healthcare industry.
But data will no longer come from just inside the healthcare delivery system. In addition to the changing technology enablement within the health system, as we all know, data will flow from many things—in fact, The Internet of Things (IoT). This means that data that relates to our lifestyle, wellness and health will pour from the many types of wearable devices not now connected to the heath delivery system. In addition to our computers, tablets, phablets and smartphones, are the many sensors paired with tech innovations such as the wearables— from wristbands, smartwatches, clothing (from shoes to headbands), glasses, contacts, and pendants — to things such as refrigerators, clocks, mattresses, scales, coffee pots, cars, and even, toilets…all of which are predicted to become an important market in the coming years.
Validic, based in Durham, NC, has put itself smack in the middle of that market (more…)