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…)

Friday’s cyberattack is a shot-over-bow for healthcare (updated)

click to enlargeFriday’s multiple distributed denial-of-service (DDoS) attacks on Dyn, the domain name system provider for hundreds of major websites, also hit close to home. Both Athenahealth and Allscripts went down briefly during the attack period. Athenahealth reported that only their patient-facing website was affected, not their EHRs, according to Modern Healthcare. However, a security expert from CynergisTek, CEO Mac McMillan, said that Athenahealth EHRs were affected, albeit only a few–all small hospitals.

A researcher/spokesman from Dyn had hours before the attack presented a talk on DDoS attacks at a meeting of the North American Network Operators Group (NANOG)

The culprit is a bit of malware called Mirai that targets IoT–Internet of Things–devices. It also took down the (Brian)KrebsOnSecurity.com blog which had been working with Dyn on information around DDoS attacks and some of those promoting ‘cures’. According to Krebs, the malware first looks through millions of poorly secured internet-connected devices (those innocent looking DVRs, smart home devices and even security devices that look out on your front door) and servers, then pounces via using botnets to convert a huge number of them to send tsunamis of traffic to the target to crash it. According to the Krebs website, it’s also entwined with extortion–read, ransomware demands. (Click ‘read more’ for additional analysis on the attack)

Here we have another warning for healthcare, if ransomware wasn’t enough. According to MH, “even for those hospitals with so-called “legacy” EHRs that run on the hospital’s own computers, an average of about 30 percent of their information technology infrastructure is hosted (more…)

Accelerated Access Review published – well worth a read

The Accelerated Access Review is published today. Readers with long memories will recall that it kicked off in the Spring of 2015 aimed at accelerating the uptake of innovation in to the NHS. It had three technical streams – pharma, medtech & digital health, plus a patient stream. This editor, as Managing Director of DHACA, was the digital health champion.

DHACA members were heavily engaged in the consultation, so it is gratifying to see that all DHACA recommendations were accepted. Most important were recommendations that:

  • NICE broaden its reach to include more medtech & digital health recommendations, and consider other means of funding;
  • there be closer alignment of regulatory and NICE data requirements and processes (currently, there can be duplication);
  • a strategic commercial unit is established in the NHS;
  • a small amount of funding is offered to support the commercialisation of disruptive innovative technologies that significantly change care pathways;
  • products not referred to NICE should be assessed only once by NHSE;
  • the route for digital products should build on the “Paperless 2020” simplified app assessment process;
  • the Crown Commercial Service, in partnership with NHS Digital, NHS England, the Department of Health and other system and technology partners, should consider how best to develop an accessible, simple and swift competitive process for procuring digital products from SMEs;
  • NHS England, working with NHS Digital, should develop a generic framework for app prescription.

When implemented, these and all the other recommendations in the report will go a long way to (more…)

An assistive robotic glove for those with hand disabilities

click to enlarge There are many people who have lost hand mobility due to injury, stroke and other neurological conditions. Exoskeletons are a great idea, but for a small area far too bulky. At Seoul National University, research director Kyujin Cho and a group of SNU Biorobotics Lab students, working with disabled people, have developed the Exo-Glove Poly, a soft wearable robot ‘glove’ that is capable of grasping objects. Three soft, tactile fingers fit over the wearer’s thumb, index finger and middle finger, with a tendon-like routing system of wires connected to a motor which opens and closes the hand. It is waterproof, washable and reasonable looking. According to the article in AtlasoftheFuture.org, this assistive technology is scheduled for commercialization in late 2017. Exo-Glove Poly website. Hat tip to contributor Sarianne Gruber via LinkedIn.

Weapons in the Perpetual Battle of Stalingrad that is diabetes management

A major area for both medicine and for healthcare technology is managing diabetes–Type 1, Type 2 and also pre-diabetes, which is the term used to describe those who are on the path to Type 2 diabetes. Type 1 diabetics, because they have had it for years, usually since youth, have one battle and are fighting that Perpetual Battle of Stalingrad. As this Editor has noted previously, technological tools such as closed-loop systems that combine glucose sensors with insulin pumps take much of the constant monitoring load off the Type 1 person. [TTA 20 Aug, 5 Oct]

But the panel at MedCityNews’ ENGAGE touched on a point that rankles most pre-diabetics and Type 2 diabetics–the lack of empathy both healthcare and most people they know, including family, have for their chronic condition. Many feel personal shame. And digital health ‘solutions’ (a tired term, let’s retire it!–Ed. Donna) either drown the patient in data or send out, as Frank Westermann of Austria’s mySugr said, a lot of negative messaging. Adam Brickman of Omada Health, whose ‘Prevent’ programs are mainly through payers and employers, noted it was a real challenge to get people to change their lifestyle, but also change their state of mind. Their model includes peer support and health coaching, specifically to include that empathy. Home support also makes all ther difference between those who successfully manage their condition and those who don’t, according to Susan Guzman of the Behavioral Diabetes Institute. The approach is certainly not one-size-fits-all.  MedCityNews  In September, Omada received a sizable approval on its approach via a Series C round of $48 million. Current clients include Humana and Costco. Forbes attributes the size of the round to Omada’s approach in tying participant outcomes to over 50 percent of its compensation.


Connected Health Symposium to merge with PCHAlliance conference

One of the earliest conferences in healthcare tech, the Connected Health Symposium organized annually in Boston by Partners HealthCare, is merging with the Personal Connected Health Alliance (PCHAlliance)‘s Connected Health Conference to stage one conference in 2017. Joseph C. Kvedar, MD,  who is VP Connected Health at Partners HealthCare, will be a senior advisor to PCHAlliance, a featured speaker at this year’s PCHA CHC in December and will be the Program Chair for the newly combined event. To this Editor, it’s a logical move as when both of these conferences were pioneering nearly a decade ago, there were few venues beyond the traditional (and boring) Big Health meetings. Now there are multiple meetings, large and small, expensive and popularly priced, every month in many cities. In the release there is no information on when and where the joint event will be. The Symposium was in October and the 2016 PCHA CHC will be 11-14 December at the Gaylord National Harbor near Washington DC. TTA is a media partner of the PCHA CHC for the 8th year, starting in 2009 when it was the brand new mHealth Summit.

Cerner’s takeoff delayed on DOD’s new EHR, MHS Genesis

The new $4.3 billion US Department of Defense EHR, jointly developed by Cerner and Leidos, has taken another delay from the aggressive rollout schedule set in April.  The original test start date was 6 December at the Fairchild Air Force Base hospital in Spokane, Washington (state) and the Oak Harbor Naval Hospital on Washington’s Whidbey Island. Back in early September, it was reported that it would be delayed by at least a few months for technical reasons (Federal News Radio and Healthcare IT News). The rara avis in the latter is a mention of major dental supplier Henry Schein–along with Accenture, they were part of the award, but very much a junior partner in providing the dental EHR. (Leidos release)

The latest update on the start of MHS Genesis is February 2017 for Fairchild AFB and June for Oak Harbor. Healthcare IT News

Population health is everywhere (US)

Last week, CMS published the ominously dubbed Final Rule on MACRA (the Medicare Access and CHIP Reauthorization Act of 2015) which utterly changes how physicians are compensated by Medicare and the various monetary incentives they have in quality and patient-centered care. This Editor is not going to get into interpretation of 2,300+ pages, but her belief is that this will not be effective in 2017 as designed, as literally it is over-complex and not understood by those who implement patient care. The dizzying models include Merit-Based Incentive Payment System (MIPS) and for the daring, the Advanced Alternative Payment Model (APM). All great business for the 100 or so ‘value-based consultants’ ready to help those expensively organized ACOs which thought they’d be rich from Meaningful Use. Oh, and what about the patient and their well-being in the meantime?? Healthcare Dive, Healthcare IT News and here  Don’t hunt for CMS’ fact sheet–it’s here. Don’t look for much about telemedicine and remote monitoring, which apparently was included in the law but not in the Final Rule for MIPS but is a part of the Advanced APM. Congress may act to expand Medicare’s payment policy on telehealth, but don’t hold your breath for it happening this year. POLITICO Morning eHealth 19 Oct

But population health and the data analytics that’s needed to get a handle on both large-scale patient health trends to allocate care where it is needed, and the financial metrics that organizations need, is hot. Verily Life Sciences (Alphabet-Google’s ever versatile healthcare tech arm) is allying itself with 3M Health Information Systems. (This Editor bets that you never thought that the Post-It Notes company was in health information!) According to the article, 3M’s part has to do with its business in coding, classification and risk-stratification methodologies. Verily will bring to the party data analytics, algorithms and software development. Healthcare IT News

This Editor also noted IHS Markit’s analysis of MACRA mixed with a bit from ATA’s Fall Forum. One insight: And now CMS plans to tie 90 percent of traditional Medicare fee-for-service payments to value-based payments in 2018. A lagninappe: “MACRA will help telemedicine to simply become another modality within healthcare delivery.” The wrapup is quite illuminating.

As identified during a recent consumer survey conducted by IHS Markit on digital health trends in the US, patients are interested now more than ever in sharing their healthcare data, and provider communication is at a low: (more…)

NYeC Digital Health Conference (NY)

NYeC Digital Health Conference, 6-7 December 2016 | New World Stages, New York, NY
The New York eHealth Collaborative’s Digital Health Conference brings together 500 senior-level healthcare industry leaders to learn about new innovations and to foster dynamic conversation addressing how healthcare is being redefined through technology.

Keynote speakers:
• Robert Wachter, MD, Professor and Interim Chairman of the Department of Medicine, University of California, San Francisco, author of “The Digital Doctor: Hope, Hype and Harm at the Dawn of Medicine’s Computer Age” [TTA 16 Apr 15]. (To this Editor, this is a must-see keynote!)
• Steven Johnson, PBS Host and Bestselling Author, “How We Got To Now” and “Where Good Ideas Come From”

Some other speakers: Carol Raphael, the former CEO of Visiting Nurse Service of NY; Kristopher Smith of Northwell Health; James Mault of Qualcomm Life and Aron Gupta of Quartet Health. This year a who’s who of New York’s healthcare and health tech community will gather for two days of networking, lively intellectual exchange, and exploration to see what’s new, what’s cutting edge and what will shape the future of healthcare.

It’s worth taking the trip to NYC for this right before the holidays! For more information, click here for the website.

Telehealth & Telecare Aware Readers receive a 10% registration discount. Click on this link or the sidebar advert. Important–use code TTA when registering. For updates, @NYeHealth. TTA is a conference partner/media partner of the NYeC DHC.

Breaking news – an NHS innovation failure

As a sad indication of the NHS’s – and the UK health & care system in general’s – inability to innovate, v-connect, previously known as Red Embedded, has made the following announcement:

“It is with great regret that we are discontinuing the v-connect service as of the 31st October 2016. I am sure that the reasons will be understandable to you but here is a short summary. The video technology has been in development for more than eleven years. The efforts to commercialise the technology, in care, have been in progress for more than seven. In that time we have developed many features that support people to live independently at home supported by a personalised set of connections and facilities matched to their needs. We were guided by the continual calls for integrated care, personalisation and care closer to  home. We have been somewhat successful in obtaining project and grant funding to facilitate this. (more…)

The Theranos Story, ch. 21: the denouement of tears, fears and lawsuits

click to enlargeFinally, Theranos sinks its labs, Wellness Centers…and 340 employees. Since founder/CEO/controlling shareholder Elizabeth Holmes has been banned by CMS from running any labs for the next two years, shutting ’em down makes total sense in terms of saving her job. (Of course, if you are one of those fired employees in Arizona, California or Pennsylvania, it doesn’t. But hey, you may be worth more than Ms Holmes!) What she’s betting what is left of the company on is the miniLab, which hasn’t exactly come heartily out of the gate. It was Gimlet Eyed at the AACC annual meeting in Philadelphia, then shortly thereafter she withdrew from FDA review a Zika test using the miniLab due to lack of a patient-safety protocol approved by an institutional review board. (Tsk, tsk–Ed.)

Now the news of a lawsuit by a major investor will, in its process, reveal more of the Bubble That Was Theranos and possibly put the banana peel under the pivot. Investors sank over $800 million into the company, and one of them, Partner Fund Management, wants its $96 million back like Lee Marvin as Walker in Point Blank. According to the Wall Street Journal, which originally wielded the needle, the charges are that they and other funds were lured in by fraudulent claims and various misrepresentations of the Edison technology and its effectiveness–in other words, that they had labs and tests that actually worked. The SEC continues to investigate, including subpoenaing Partner and possibly other investors.  ABC News, Wall Street Journal (search on title ‘Major Investor Sues Theranos’ if you hit the paywall), Gizmodo 30 Aug, 11 Oct (a wonderfully Gimlety take by Eve Peyser), and a series of acid flashbacks in Forbes

See here for the 20 previous TTA chapters.

Artificial intelligence with IBM Watson, robotics pondered on 60 Minutes

click to enlargeThis Sunday, the long-running TV magazine show 60 Minutes (CBS) had a long Charlie Rose-led segment on artificial intelligence. It concentrated mainly on the good with a little bit of ugly thrown in. The longest part of it was on IBM Watson massively crunching and applying oncology and genomics to diagnosis. In a study of 1,000 cancer patients reviewed by the University of North Carolina at Chapel Hill’s molecular tumor board, while 99 percent of the doctor diagnoses were confirmed by Watson as accurate, Watson found ‘something new’ in 30 percent. As a tool, it is still considered to be in adolescence. Watson and data analytics technology has been a $15 billion investment for IBM, which can afford it, but by licensing it and through various partnerships, IBM has been starting to recoup it. The ‘children of Watson’ are also starting to grow. Over at Carnegie Mellon, robotics is king and Google Glass is reading visual data to give clues on speeding up reaction time. At Imperial College, Maja Pantic is taking the early steps into artificial emotional intelligence with a huge database of facial expressions and interpretations. In Hong Kong, Hanson Robotics is developing humanoid robots, and that may be part of the ‘ugly’ along with the fears that AI may outsmart humans in the not-so-distant future. 60 Minutes video and transcript

Speaking of recouping, IBM Watson Health‘s latest partnership is with Siemens Healthineers to develop population health technology and services to help providers operate in value-based care. Neil Versel at MedCityNews looks at that as well as 60 Minutes. Added bonus: a few chuckles about the rebranded Siemens Healthcare’s Disney-lite rebranding.

Telehealth in China: the largest market of them all?

click to enlargeIs China ready for telehealth, and the needed investment? It turns out that according to this article, the market does strongly resemble Western, Latin America and APAC countries in its needs and aging, dispersed population. The numbers (left) say yes. The market divides into three for the writer:

  1. A supplement to the public community care system, which has motivated most of the interest the Chinese government has in telehealth to care for millions (defined in the article as patient-doctor video consults, but doesn’t appear to exclude remote patient vital signs monitoring) as well as EHRs, scheduling, online access to diagnostic test results, and e-prescribing.
  2. Rural health care, not as unique as the writer seems to believe. Virtual consults and telehealth are used, and paid for, by CMS in US rural areas and on Native American reservations by the Indian Health Service. We also wrote about it in Brazil [TTA 27 Feb].
  3. Second opinions by Western physicians desired by high net worth individuals and upper middle class families. Again, not that unusual as this resembles the health tourism practiced by the affluent in Latin America and the adoption of video consults. This is denoted as the narrowest and chanciest of the three markets.

Chinese patients in (1) and (2), for the most part, would see any of these as an improvement. Their experience is that they get little time with a physician, don’t have a personal relationship with one or more doctors, and don’t expect much of a personal relationship with their doctor. So telehealth and RPM would be huge upgrades for China.  From Healthintelasia. Illustration from Analysis Group

Tunstall Americas adopts belle

We haven’t heard much from Tunstall Healthcare in the past two months, but Tunstall Americas has announced that the belle PERS unit has been added to the US line of products which now . The belle is on the AT&T GSM cellular network for two-way voice communication with their 24/7 call center and GPS location technology. The pendant has a rechargeable battery that can last up to 30 days on a single charge, and can be either worn or carried in pocket or purse. Also new in the line is the Tunstall flood detector which signals the call center through the Vi+ and CEL.  Release, Tunstall Americas website.

Who’s hiring? 3rings (UK)

Steve Purdham, who is the Chairman of 3rings, is advising our readers of two new Business Development Manager opportunities with his company.

The ‘Internet of Things’ is going to change the future of care and 3rings is at the centre of this fantastic opportunity. Due to expansion in its operation, 3rings, is looking for two ambitious BDM’s to join our digital team. If you have passion to change things then contact Steve on steve@3rings.co.uk

Full details @ https://news.3rings.co.uk/?p=237

3rings has developed and markets an electrical plug that, when the appliances are used, tracks a person’s activities of daily living. The information is delivered to the 3rings app so that family, friends and neighbors not only know of normal behavior but also when something is ‘off’. (Our past two years of coverage is here.)

Call for project presentations for the King’s Fund Digital Health & Care Congress 2017

The King’s Fund is looking for projects to be presented at the Digital Health and Care Congress 2017.

To be accepted, projects must show progress and improvements in at least one of these areas:

  • enabling patients to take an active role in their health and care;
  • improving data sharing and interoperability across the health and care economy;
  • demonstrating the benefits and improving productivity;
  • using technology and data to improve experience and quality of care.

Acceptance is via submission of an abstract, which should not be a sales pitch. Presentations should focus on digital health and care in practice. If you’re a commercial organisation working in partnership with an NHS organisation, you should ensure your NHS partner is available to present.

Note that in a change from previous years, single speakers will not be required to pay congress fees; for projects accepted for presentation, there will be one free speaker place allocated.

More details here.

The Congress will be on 4th & 5th July 2017.

The deadline for abstract submissions is Friday 9 December 2016.

Disclosure: this editor is on the organising committee of the Congress.