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).

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…)

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…)

Seven safeguards for your mHealth app

With cyberattacks from all sources on the rise, and mHealth apps being used by providers in care coordination, telehealth, patient engagement and PHRs, Practice Unite, which has some experience in this area through designing customized app platforms for healthcare organizations’ patient and clinician communications, in its blog notes seven points for developers to keep in mind:

1. Access control– unique IDs assigned to each user, remote wiping of the mHealth app from any user’s device.
2. Audit controls
3. Authentication
4. Integrity controls, such as compartmentalization, to ensure that electronically transmitted PHI is not prematurely altered or corrupted
5. Transmission security: data encryption at rest, in transit, and on independently secured servers protects PHI at each stage of transmission
6. Third party app integration–must fully comply with HIPAA safeguards
7. Proprietary data encryption

But all seven points need backing from the top on down in a healthcare organization. (More in the article above)

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?

FDA final guidance on mHealth eases regulation of MDDS, mHealth (updated)

As anticipated, FDA issued final non-binding recommendations for guidance yesterday (Monday) that ease regulatory oversight of medical device data systems (MDDS), including image storage and communication devices, and mHealth devices.

In the MDDS guidance document, “(FDA) does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health.” It defined MDDS as “a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) The electronic transfer of medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) The electronic display of medical device data.” along with their hardware and software. It specifically excludes devices that are used in active patient monitoring.

Mobile health apps were covered in a separate and highly detailed guidance document, “Mobile Medical Applications”.

  • FDA will regulate only “those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.” (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…)