First apps using Apple’s CareKit clinical care framework hit market

click to enlargeWell, that was fast! Apple’s CareKit framework, specifically for clinical care app developers, was only announced last month and opened its official doors yesterday, but three developers had early access. Their apps hit the market yesterday: One Drop (diabetes management), Iodine for Start (depression medication management), and Glow for Glow Nurture, an app for pregnant women, and Glow Baby, an app for new mothers. Four hospitals have also announced app development underway using CareKit modules: Beth Israel Deaconess (chronic condition management), the University of Rochester (Parkinson’s), Texas Medical Center (care coordination), and Cleveland Clinic (asthma and COPD).

There are four modules which developers can selectively use (pictured).

  • CareCard, which helps patients track care plans and action items
  • Symptom and Measurement Tracker, which helps patients keep a log of their experiences
  • Insights Dashboard which integrates the care plan data from CareCard with the symptom data from the Symptom and Measurement tracker to create insights about the effectiveness of treatments
  • Connect, which helps patients share data with their providers or other caregivers.

The three in market yesterday, for instance, all used Connect; Iodine and One Drop use Care Card and One Drop uses the Symptom Tracker.

The article’s comments from developers and hospitals highlight a move to a standardized framework for clinical apps, which may be wishful thinking as most of the world uses Android, but addresses the validation and certification conundrum that’s plagued health apps for years. We’ll wait and see if Apple sustains the lead here. Mobihealthnews. Apple ResearchKit/CareKit page. The Verge, Ars Technica, TechCrunch

A gallimaufry of short digital health items to start the day with

The WHO has produced an excellent report on the state of eHealth in the European region, including a review of telehealth readiness. Ericsson have produced a very interesting report confirming what I guess anyone will have realised if they’ve traveled by public transport or have children: young people downloading video content are driving a surge in data usage: there’s much detail here though. Both are well worth the read.

Mentioning Ericsson reminds that the Telegraph recently produced a summary of the 20 best-selling mobile phones of all time – takes you back, with the substantial number once produced by Nokia.

The Royal Society of Medicine has it’s fifth annual medical app conference on April 7th – numbers booked have already well exceeded last year’s sellout so they are expecting to fill this year’s much larger conference venue. The focus this year is on the many legislative, regulatory and voluntary measures being introduced that will impact medical apps – there’s still room for old favourites though, such as Richard Brady’s always-topical (more…)

DHACA visits Lancaster University on 23rd September – come and join us!

The Digital Health & Care Alliance is holding its sixth one day event on 23rd September, at the University of Lancaster.

DHACA Days are aimed at informing members, seeking feedback on DHACA activities and encouraging special Interest Group (SIG) engagement in topics of importance to members. On this occasion we have a very special SIG event which is the launching of DHACA’s medical apps regulatory process description, which looks at all the things you need to do to get a medical app fully approved. The draft is already available for members to comment on.

In addition, in the morning we will have presentations from:

  • Prof Peter Sawyer, Professor of Software Systems Engineering, University of Lancaster:sensing cognitive health through monitoring computer interaction and through ambient technology – this is a most exciting (and I guess to some a bit scary) new area of research where you can sense someone’s cognitive health from how they use smartphones and other devices.
  • Prof Jon Whittle; Head of the School of Computing and Communications,University of Lancaster: the uses for temporary digital tattoos, and how to make them – this will in part be an interactive session in which members’ suggestions and, if appropriate, future involvement will be sought.
  • Jeremy Moyse, Strategic Development Manager, SEQOL: a provider’s view of how technology will help deliver changes in the health & care world – SEQOL is a ‘spin-out’ social enterprise formed in 2011 from the NHS Transforming Community Service programme and now delivers a broad range of health & care services in Swindon; as Jeremy will explain, it has grown massively since then, and collected a cabinet full of awards.
  • Prof Awais Rashid, University of Lancaster: secure IoT use in digital health – Prof Rashid is a world expert on this topic which has become particularly important since the FDA recently withdrew approval from an infusion pump because it was too easy to hack. He will explain the critical importance of IoT security, how to assess it and how best to achieve secure solutions.

(more…)

More evidence of confusion among clinicians over medical apps (UK) + MAUDE

A paper just published in the Annals of Medicine & Surgery entitled A UK perspective on smartphone use amongst doctors within the surgical profession also sheds some interesting light on the use of mobile apps by surgeons.

Given the recent advice to members by the RCP against the use of apps that are medical devices though not CE certified, the following finding is of especial interest, as it is widely considered that many clinical calculators meet the EU legal definition of a medical device:

…when looking specifically at senior doctors, the most common type of app utilised was clinical calculators followed by reference guides/handbooks and then drug reference guides.

The paper also confirms findings by this editor and others that clinicians are confused by the wide range of apps available and lack guidance on the effectiveness & efficacy of individual apps.

The majority of participants did not have any relevant suggestions for app development, which may suggest that there is an uncertainty over the catalogue available. Given concerns voiced in both our study and the work of others questioning the reliability of available resources, a possible solution would be the creation of a UK based app directory to outline availability with verification of performance and validity. However given the complexity of this regulation, peer review specific to the UK may have to suffice.

A short & interesting read that very much supports the need for a reference source for clinician-facing apps, and an objective measure of the benefits they deliver: recommended.

Whilst writing, Prof Mike Short has also drawn my attention to a related, very short, article entitled To Be or not to Be a Medical Device: Is the Regulatory Framework a Safety Rope or a Fetter? which thankfully concludes that:

Certainly, adhering to the standards listed <in the article> massively increase administrative overhead in research and development, extend the “time to market” and causes increased costs. However, this is the price to pay for success to reach the goal: Impact on patient care. Therefore, the answer to the question in the title of this article is: Software can be a medical device and from this point of view, we have to accept administrative overheads – and the regulatory framework can be a useful guide-line.

Perhaps more interestingly though it includes reference to the FDA’s ‘Manufacturer and User Facility Device Experience (MAUDE) which records product problems (obviously in the US), including those for medical software. Wouldn’t it be great if the EU had such a database for medical apps?

BSI publishes medical apps code of practice – PAS 277

After some six months of consultation and hard work, the BSI has produced PAS 277, which can be downloaded free, here. The purpose of the code, which is not mandatory, is to provide guidance to app developers on the key issues to be aware of when developing and delivering medical apps. This editor, as Managing Director of DHACA, was a member of the team developing the code.

PAS stands for Publicly Available Standard – to quote Wikipedia, the objective of a Publicly Available Specification is to speed up standardization. PASs are often produced in response to an urgent market need.

Again representing DHACA, this editor is now also a member of the drafting committee of the EU’s voluntary code focusing (more…)

Important: DHACA’s response to the RCP advice on medical apps

The Royal College of Physicians has just published app guidance that, according to EHI “doctors should only use medical apps with an official CE mark”. EHI goes on to clarify that the guidance “applies to medical apps that can be classed as medical devices, which are bound by EU law to carry the mark.”

The Digital Health & Care Alliance (DHACA), of which this reviewer is Managing Director, is extremely concerned that this advice may seriously impact on the beneficial use of medical apps in the UK as it places the onus of deciding whether an app is a medical device on individual clinicians, a decision that at times even experienced MHRA personnel can equivocate on.

As the original research done by this editor on the topic of medical app take-up demonstrated, clinicians (more…)

Medical apps & medication adherence: two key reports from the UK Academy of Medical Sciences

This editor was involved in the development of two events at the Academy of Medical Sciences that took place at the end of 2014, the reports of which have just been publicised.

The first, on medical apps, brought together a wide range of stakeholders to:

  • Explore the current and proposed regulatory frameworks for health apps;
  • Hear case studies of the development of health apps and of the regulation and oversight of software development in other medical, nuclear and automotive sectors;
  • Discuss the current and future challenges faced in the oversight of health apps and devise solutions to these issues.

Particular issues raised during the day included: (more…)

‘Separating the wheat from the chaff’ in medical apps daunting: JAMA

Medical apps may not be strangers to doctors’ offices anymore but they also realize that apps are difficult to recommend responsibly to patients or even to find, because there is no real guidance or validation. This current article in JAMA online confirms the perception and the need for care integration that both Editors Charles especially and Donna have pointed out lo these many years. However this Editor is quite disillusioned at the attempts to date to ‘curate’ apps with the Happtique failure and the relatively low profile to date of IMS Health’s AppScript and professional review site iMedical Apps and the stated intentions of SocialWellth which purchased Happtique. The reality is that the numbers are against it–IMS Health in their study estimated 40,000 medical apps–in 2013. For apps that want to take the high road, it’s economically difficult, but could be rewarding in the long term. The WellDoc BlueStar diabetes tracking and management support app did with FDA clearance and prescription-only use, but few so far can see a revenue model there. Also MedCityNews.

Intended use determines degree of health app regulation–and also how you communicate your attributes and performance claims. Bradley Merrill Thompson, who performs an invaluable service by advising our field on regulation, compliance and interacting with FDA, demonstrates how a developer can determine where the intended use of an app might fall (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…)

Urgent NICE consultation: a great opportunity (UK)

This is a plea for any reader interested in the future success of medical apps in the UK to take a few minutes over Christmas to respond to a consultation request from the National Institute for Health & Care Excellence (NICE), which this editor has just been made aware of. The triennial consultation on the role of NICE opened in early December and closes on 2nd January – a very short time-frame as it covers the Christmas period!

Details are here. There is a form to download so it is not a challenging task to respond.

Many readers will be aware of this editor’s campaign following extensive research, to widen the remit of NICE to include reviewing the efficacy of medical apps. This is so that doctors can confidently recommend and indeed prescribe (NICE approved) medical apps without fear of liability, in the same way that they currently do for drugs. In addition, when discussing treatments with patients, doctors can then compare the efficacy of apps and of drugs for those conditions – such as depression, anxiety and pain relief – where apps can likely do the job better, at lower cost, with no side-effects. At a stroke this would reduce the cost of drugs to the NHS and take the UK to the forefront of the mobile health revolution.

If you can spare the time over Christmas you would give one person a very Happy Christmas; many thanks in anticipation.

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…)

Post-market device surveillance – boring though very important

Thanks to Claudia Pagliari for passing me a news item from the Diabetes Technology Society, announcing that the Steering Committee has been assembled for its Surveillance Program for Cleared Blood Glucose Monitors. To quote:

“This program is intended to identify poorly performing blood glucose monitoring products on the market.   This surveillance program will provide an independent assessment of the performance of cleared blood glucose monitors following Food and Drug Administration (FDA) clearance.  The program will generate information that can assist patients, healthcare providers, and payers in making informed product selections.  The information will also be provided to FDA, which is the government agency that regulates these products.”

So why is this so important? Well one of the things this Editor discovered when doing research into how to encourage GPs to recommend medical apps is that none of the existing organisations that evaluate medical apps appear to recognise adequately that every change of operating system, every upgrade in functionality needs to be carefully checked to ensure the app is still as safe and effective as it was when the app was first evaluated. For example, some apps such as Mersey Burns check that the mobile is running the required operating system superbly; most don’t.

“After a product has been cleared for use by the FDA, there is currently no systematic post-market surveillance program that monitors for ongoing product quality post-clearance. Poorly performing BGM system can interfere with the ability of people with diabetes to reliably monitor their blood glucose levels, and make correct decision based upon the readings.  Inaccurate readings can lead to incorrect actions and therefore to adverse outcomes. Ongoing efforts by the FDA to improve accuracy standards for pre-market clearance would be undermined if performance was not maintained post-market.  Therefore, a post-market surveillance program is critically important to ensure the accuracy of cleared products for people with diabetes.”

So hats off to the Diabetic Technology Society – let’s hope others pick up this excellent initiative, particularly for medical apps. As David Klonoff, M.D., founder of Diabetes Technology Society and a Clinical Professor of Medicine at University of California, San Francisco said “This surveillance program will provide a significant benefit to both patients and manufacturers”.

 

RSM apps conference – save over 90%…and a day! (UK)

I try not to abuse my position as a contributing editor to TTA by pushing the Royal Society of Medicine’s conferences too hard.  However, having just received an email encouraging me to attend a commercial health apps event in London at the end of April which would cost me £1698 to attend (on an earlybird rate!), I feel that loyal TTA readers should be reminded that the RSM is also running an event on the same topic – entitled Playing games, using apps, promoting wellbeing – on 10th April.

As the RSM is a charity dedicated to medical education and the advancement of medical care, we try to keep prices as low as possible whilst getting the most prestigious speakers. The charges therefore – starting at just £45 for the day – are not expected to cover the cost of running the event….and many of the speakers are the same. A further plus is that we have crammed everything into a single day.

Last year’s apps event sold out before the event, as did our recent digital health held in February, so I’m glad to be able to report that there are still just a few places left for those fast movers keen to save money, and time.

Reflections on the NHS Innovation Expo (UK)

Editor Charles visited the Expo in Manchester on Tuesday 4th March – here are his personal reflections.

I decided to devote the one day I had to visit the NHS Innovation Expo to visiting stands to try to spread the word about DHACA that was launched last week.

The first thing I noticed about the event was that it seemed less crowded than previous ones. When passing them, I never saw the main auditoria full either, very much in contrast to earlier Expos.

The other principal observation was that (more…)