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…)

FDA Workshop: Collaborative Approaches to Medical Device Cybersecurity

20-21 January 2016, FDA White Oak Campus, Silver Spring Maryland

Attend this free and public two-day workshop hosted by FDA on cybersecurity and medical devices highlighting “past collaborative efforts, increase awareness of existing maturity models (i.e. frameworks leveraged for benchmarking an organization’s processes) which are used to evaluate cybersecurity status, standards, and tools in development, and to engage the multi-stakeholder community in focused discussions on unresolved gaps and challenges that have hampered progress in advancing medical device cybersecurity.” Registration required (information and form here), but there is also a webcast (link available after 13 Jan) if you cannot make it to FDA.

Avoiding the FDA health IT-medical device regulatory trap for general IT companies (US)

If you are an IT company in the US or internationally with services which could be useful to healthcare companies or practitioners, it’s easy to be overly specific and stray into FDA-regulated territory. The always-informative Bradley Merrill Thompson of the Epstein Becker Green law firm delineates the fine regulatory line that general purpose IT companies must observe when working with healthcare customers. First there is intended use, based on how the manufacturer intends its customer to use the product; if the customer uses it for the diagnosis or treatment of disease or other conditions, FDA will regulate it as a medical device. This is less clear than it seems, and Mr Thompson explores where a general IT company can, in the old PR adage, ‘say it safely’ and avoid falling into the unwanted medical device trap by avoiding medical feature and advice claims, and keeping the context away from medical use. The Journal of mHealth (August)–online version, optional PDF download. Hat tip to Mr Thompson via the Continua LinkedIn group. Other articles of interest in the JMH are: Scottish company HCi Viocare and its ‘smart insole’ pressure sensors for foot ulcer detection following, Northwestern University’s research around patterns of smartphone usage detecting depression (page 19) and a lengthy article on transforming patient data into actionable insights (page 34).

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?

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…)

Driving up medical app usage in the UK – part I

Our recent post on ‘the last mile’ for medical apps in the US is a great introduction to some work I have been doing over the past three months: attempting to answer the question of how best to improve the perception by clinicians and patients of the efficacy of health-related apps. This work has been done for the i-Focus project, part of the Technology Strategy Board’s dallas programme.

As the research is quite detailed, and as I’m keen to get as much feedback as possible, I have split the work into three parts, to be delivered over the week – comments to this article or a direct email to me (on charles.lowe@btinternet.com) on errors, omissions or additions would be hugely gratefully received.

This post aims to answer the question of what regulations affect the development, sale and usage of health-related apps and, in particular, when an app is a medical device. (more…)

Mainly mHealth: a few predictions for 2014, and some speculation

Editor Charles on what to watch for in 2014

As we have covered previously (and here), there’s no shortage of forecasts that the mHealth market will continue to grow faster, or of penetrating comments like that that won Research2guidance a What in the Blue Blazes award that smartphone user penetration will be the main driver for the mobile health (mHealth) uptake. mHealth apps continue to proliferate – there’s even shortly to be a Pebble apps store. There are a few straws in the wind that not is all well though – for example, as we covered recently, Happtique ceased, at least temporarily, its apps approval process, citing security concerns.  Elsewhere Fierce Mobile described serious data privacy issues with the iPharmacy app, and the ICO recently produced security guidelines for app developers in the UK.  The EU is also strengthening data privacy, moving from individual country directives to a pan-EU regulation. This leads us to our first prediction (more…)

Interesting Yale University model for med device development

At Yale University, a college (undergraduate) course, ‘Medical Device and Innovation’ , perhaps is pointing to the 2014 future of medical device development in the academic setting. The course was co-taught by the assistant director of Yale’s Center for Engineering Innovation and Design (CEID) and an associate research scientist at the Yale School of Medicine; the original device ideas were pitched by doctors at Yale Medical; and the development teams included engineers, physicists, chemists, school of management students and environmental studies students. The four projects which were developed to the point of early prototype were: (more…)

Telehealth Soapbox: Medical device tax finally under fire; implications many (US)

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2013/09/gizmodo-the-top-10-rube-goldberg-machines-featured-on-film-rube-goldberg.jpg” thumb_width=”180″ /]A key part of the Rube Goldberg (or Heath Robinson)-esque funding of the Accountable Care Act (ACA, a/k/a Obamacare) is a punitive medical device tax of 2.3 percent levied on gross sales (not profits) of hip, knee, cardiac implants, many dental materials, diagnostics such as scanners, radiotherapy machines, catheters and more. Since it went into effect on 1 January, it has raised $1 billion according to the Medical Imaging & Technology Alliance, the Advanced Medical Technology Association and the Medical Device Manufacturers Association in July–for a program that does not start till 2014. According to The Hill, senior Senators Orrin Hatch, Barrasso and Hoeven are pushing for a repeal amendment to be attached to the stopgap spending bill. The reasons why the tax deserves to be tossed out on its ear are: (more…)

Medtronic confirms forecast direction change, the market reacts, and brains are stimulated

The ‘reasons why’ we (and others like David Shaywitz in Forbes) proposed back on 12 August for Medtronic’s purchase of Cardiocom were fully confirmed by their CEO Omar Ishrak in Bloomberg (21 August) and an analysis in Forbes (24 August). However, the Forbes article continues on to dump a bucket of cold water on Mr. Ishrak’s  ‘solutions provider’ strategem (so reminiscent of 2008-9 with different companies), positing that telehealth belongs with wireless/mobile companies (Qualcomm), companies further downstream (Allscripts, a major US pharmacy benefits manager) or other technology/monitoring companies. Mr. Market held the roses though (Deutsche Bank’s reiterated hold rating in Benzinga reflecting the consensus in Yahoo Finance).

What is interesting are their advances in brain stimulation to relieve pain in two areas. (more…)