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…)

Looking ahead with TeleSCoPE (EU)

Perhaps because we have covered the topic before, a cryptic email arrives from Malcolm Fisk, the driving force behind the development of the European Code for Telehealth Services, suggesting I consult the TeleSCoPE website and his Med-e-Tel presentation last week where “you’ll see a little announcement that indicates that things are moving forward”.

The website now includes a yellow box with the statement:

The framework for telehealth services to be assessed against the requirements of the European Code of Practice for Telehealth Services is being released on May 16th 2014. This follows collaborative work between the Telescope Partnership and DNV Healthcare. A four year cycle has been agreed that includes a Foundation Assessment followed by (mostly off-site) reviews and conformity checks. Accompanying the framework will be the new version of the Code by which the first tranche of services will become accredited.

…and the presentation includes, at the end, (more…)

When deciding which telemonitoring Code of Practice to adopt, do you use a TeleSCoPE?

As promised in our recent post, the European Code of Practice for Telehealth Services has now been published by the TeleSCoPE project. This directly responds to the European Commission COM2008:689 on telemedicine for the benefit of patients, healthcare systems and society. The particular definition of telehealth/telemedicine used here means that it covers both of what are often referred to separately as telecare and telehealth.

It therefore covers the same areas as the TSA Integrated Code of Practice.  As explained in our previous post, TSA codes are (more…)

Well someone thinks telehealth is good news!

Medtronic has just announced a $200m takeover of Cardiocom, the telehealth device maker.  If you can get through the paywall, the WSJ article is here (updated link not paywalled–Ed. Donna)FierceMedical quotes Medtronic as saying that “At-home monitoring is a proven method of reducing the rates of hospital readmission…and that translates to savings for payers, providers and governments.” First area of joint working is expected to be heart failure. Recent US regulations on Medicare, and increasingly insurance payers, penalize hospitals for 30-day same-cause repeat admissions. Medtronic press release.

Editor Donna: The announcement of Medtronic’s (#4 in worldwide revenue) acquisition of Cardiocom (both Minnesota-based companies) created quite a stir in the US as Medtronic is a ‘traditional medical device’ company best known for its implantables: cardiac shunts, stents, heart valves, pacemakers, insulin pumps and interestingly, a wide range of neurostimulators for different conditions. Now with the acquisition of Cardiocom, Medtronic moves into the post-implant/post-discharge/post-diagnosis chronic condition management continuum– not only into telehealth via Cardiocom’s devices and hubs, but also their clinical and care management systems. $200 million in cold cash is a fair bet even though Medtronic’s market cap is north of $55 billion. Medtronic has to see the opportunity to make a bottom line difference to providers and payers. It is also reacting to a narrowing in its profitable core market–medical devices are now taxed, there have been recent product defect-related ‘scandals’ tarring the industry, and there is pressure to reduce pricey device costs to fit a cost-constrained environment, driven by the new healthcare ‘scheme’ (in both the British and American English senses!) Forbes‘ David Shaywitz has a smart take on it today (though he won’t hold his breath for the pharmas to follow), as well as VC TripleTree’s Chris Hoffman ‘connecting the dots’ and coming up with what we’ve been talking about for some time–integration making sense. It is also most definitely a shot over the bow for major competitors such as Alere, Bosch and Philips plus a raft of smaller companies which have been working with a scattering of hospital discharge areas, integrated delivery systems, ACOs and home health agencies, looking nervously over their shoulder–and other leading medical device companies such as Stryker, BD, Baxter and yes….GE. (Bosch also sued Cardiocom on patent infringement this time last year [TTA 7 Aug 2012]; presumably as this suit was not announced as settled or decided, Bosch is now dealing with a company its own size!)

It also should be noted that Medtronic’s CEO, Omar Ishrak, is well acquainted with home health. Mr. Ishrak was formerly the CEO and president of GE Healthcare through mid-2011–and the driver behind making what was an ultimately failed bet in getting GEHC into home health. That was in 2008-9 with a tiny company called Living Independently Group, developer of a telecare system called QuietCare, which ultimately went to the Care Innovations JV with Intel. (Disclosure: I was head of marketing at the time of the acquisition.) Like GEHC, Medtronic is acquiring a closely-held company in a very different line of business with drivers quite unlike its own; they are retaining the former CEO as a general manager of the division but whether other management or the brand name will survive is not disclosed.

Whilst on the subject of telehealth devices, Heartwire reports a meta-analysis of 52 studies that shows that just measuring your blood pressure regularly results in a significant reduction in both systolic and diastolic levels after six months. Sadly the paper itself in the latest issue of the Annals of Internal Medicine is behind a paywall so it’s not possible to try to understand how the final comment in the synopsis of the paper on the Annals website that: “Additional support enhances the BP-lowering effect.” fits with the comment in Heartwire that “Low-strength” evidence from 13 studies comparing self-monitoring plus additional support vs self-monitoring alone “failed to support a difference” between the two strategies.”

Meanwhile back in the UK, Medvivo has become the first company to be accredited to the telehealth elements of the TSA’s Integrated Code of Practice. Sadly the TSA website will only release the Code to members (TTA isn’t one) or those aspiring to achieve accreditation (TTA fails on that one too) so it’s not possible to make meaningful comment. However the prospect of a Battle of the Codes is looking up with word from Malcolm Fisk that the final version of the European Code of Practice for Telehealth Services will be available for all to read and download on the TeleSCoPE website within a month. There has been talk of a third code being developed too…