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).

CVS puts a retail triple spin on telemedicine

A definite boost to telemedicine providers American Well, now-publicly traded Teladoc and Doctor on Demand is retail drugstore CVS Health piloting their services through CVS MinuteClinics, starting in 2016. CVS’ release is disappointingly heavy on company quotations, light on specifics, but what can be determined is that CVS will test various arrangements, including onsite telemedicine in stores, through CVS ‘digital properties’ (presumably online or through apps) and MinuteClinic provider consults with telemedicine provider doctors. It carefully avoids referring to the three companies as ‘partnerships’ though it generically refers to them deep in the release. CVS currently has 1,000 MinuteClinic locations in 32 states and plan to grow by 50 percent by 2017; they have been testing telemedicine in about 50 clinics in Texas and California.

Annoyingly, both CVS and the three companies improperly use ‘telehealth’ in describing their services when correctly they provide only doctor-patient video consults, or telemedicine. The clinic providers (or individuals) may be reporting vital signs data as part of the visit, but tools are not integrated. Equally annoying is CVS, in the release and in conferences, citing a paywalled study (at the not inconsiderable sum of $39.95 / €34.95 / £29.95!) in the Journal of General Internal Medicine (JGIM) of their results. If you are touting that “95 percent of patients were highly satisfied with the quality of care they received, the ease with which telehealth technology was integrated into the visit, and the timeliness and convenience of their care.” –well, with results like that, make some arrangements and grant access to the study! CVS release, Medscape, FierceHealthIT

Alphabet action versus diabetes with Life Sciences’ contact lens and Sanofi

click to enlarge Monday’s Big Story. As previously reported [TTA 25 Aug], the new Google holding company Alphabet is bringing the Life Sciences group formerly under Google X into its own company, with a new name TBD. On Monday, Life Sciences and Paris-based pharma Sanofi announced a partnership on projects related to diabetes monitoring and treatment. According to BioSpace, “at least part of the partnership will be focusing on helping Life Sciences create small, Internet-based devices that either automatically adjust insulin levels, or make suggestions based on real-time monitoring. ”

Clearly Life Sciences’ raison d’etre includes a focus on this disease, others that may relate to it, and in developing devices that others may market. Your Editors have been tracking their research for well over a year. A roundup of Life Sciences’ partnerships include more than diabetes:

**Novartis division Alcon for the glucose sensing contact lens [TTA 17 July 14, patent report 27 Mar 15 ]

** DexCom to develop a Band-Aid sized wearable for glucose monitoring, announced 15 August

**A 10 year deal with Abbvie for age-related disease exploration (which relates to the accelerated aging associated with diabetes)

**Biogen for multiple sclerosis (MS) treatments

We continue to have doubts about the practicality of the contact lens and the viability of embedded sensors in lenses, as the eyes are extremely sensitive and especially vulnerable for those with diabetes. But directionally on this disease, which is expanding almost uncontrollably worldwide, the research and devices which Life Sciences can develop for a variety of companies looks promising. Business Insider, Re/Code, Digital Trends

A trip back in time to telecare, circa 2009–and maybe the future

click to enlargeAs the season winds down, our thoughts turn backwards. Your Editor remembers Jersey Shore vacations, travel, great airshows, collector car shows, old friends and good times. She also remembers When Telecare Was New (2006-9) with Living Independently Group (now Care Innovations), helping to pioneer the QuietCare system in senior housing. At that time, universities like Virginia and Florida were on the cutting edge in developing smart homes and pioneering systems for monitoring health in older adults and the disabled. Those smart homes and research initiatives vanished years ago, replaced by incubators, accelerators, the size of your funding round, Big Data, wearables, IoT….

Sigh. Your Editor is in Error. The University of Missouri is still at it 12 years later with its sensor-based behavioral/activity/proactive care system in the Tiger Place assisted living community near Columbia. And it seems much the same: bed and residential motion sensors, fall detection tracked by a variety of sensors, gait analysis and analysis of activity changes (changes in behavior=changes in health, which still doesn’t excite those in senior care the way it should) . You have to admire the persistence of vision the founders/researchers have had (Marilyn Rantz, professor emeritus with the School of Nursing, and Marjorie Skubic, a professor with MU’s College of Engineering). Their research model has now spread to 13 communities and hospitals in Missouri, and they are commercializing it with a former student, George Chronis, with Foresite Healthcare to convert it into a reliable, robust assisted living/hospital monitoring/care transition system with a simpler, affordable ‘health at home’ version. Besides the nostalgia and supporting fellow ‘true believers’, what they have designed is still needed AND not achieved by RFID (a big fizzle) or ancient PERS. We can all wish them luck in a competitive and much changed market. MU researchers taking sensor system from lab to marketplace (Columbia Daily Tribune)

Previously in TTA: Quantifying early detection capabilities of telecare (July 2012) and Editor Steve’s first look in October 2009 at ‘magic carpet falls’.

Telemedicine, telehealth underutilized in pediatric care

In focusing on older adults on Medicare and secondarily the disabled, the use of telemedicine and telehealth is being overlooked for chronically ill children, especially those living at distance from specialized care. Children’s hospitals Many of these seriously ill children are either covered by parents’ employer plans or, if the family is low income, state Medicaid programs. This interview with Andrey Ostrovsky, MD, an attending physician at Children’s National Medical Center in Washington DC, notes the lack of incentive for innovative care which could utilize healthcare technology profitably. There is also a Medicaid waiver approval for telehealth reimbursement used for older person care, called the 1915(c) waiver for home-based and community services, which can be used for children. FierceHealthIT

Is the fitness tracker eventually going to lose to the smartwatch? (Updated)

click to enlargeclick to enlargeWhich one would you prefer? 

The interest in fitness bands has quantifiably and substantially diminished since January, according to Argus Insights’ survey of online consumer reviews (!)–and since the debut of Apple Watch. And while Fitbit maintains its leadership in the band category (sorry Jawbone, though Editor Charles won’t be), the rising preference is for smartwatches like the Apple Watch and Android wear such as the Moto 360 and the LG Watch Urbane (pictured). While there’s a substantial price difference between smartwatches (~$350 versus under $150), and both Apple Watch and LG’s watches (versus LG bands) have limited fitness capability, there’s few new developments in fitness bands to create excitement. There have been enough problems with fitness band reliability, breakage, rising prices and a boredom with design to diminish interest while new brands enter the market, and smartwatch prices come down slightly. For the price, users also want more out of their watches. Neil Versel in MedCityNews.

Updated: Apple Watch, with 3.6 million units sold in 2nd quarter was immediately behind Fitbit with 4.4 million, according to IDC’s Worldwide Quarterly Wearable Device Tracker. 2 of every 3 smart wearables (capable of running third-party apps) was an Apple Watch. Another sign of the coming divide between fitness bands (which will be sold on price and fitness focus) and smartwatches (which will be sold on versatility as well as fitness justifying the higher price).  IDC release

Also by Mr Versel is a memorial to telemedicine pioneer  Dr ‘Red’ Duke. As a surgical resident at Parkland Hospital, he was on the team which saved the life of Texas Governor John Connally, shot with President John Kennedy in November 1963.

Integrating inexpensive lab testing, imaging to EHR–and vice versa

In the Dr Eric Topol patient-driven world, personal lab testing would be walk in, keep retail hours and not even need a doctor’s order. That is the model for Theranos, a well-funded low cost blood testing company operating 43 centers in California, Arizona (no doctor order needed) and one Pennsylvania Walgreens. Their latest alliance is with EHR physician practice giant Practice Fusion, which claims about 112,000 doctors actively using its cloud-based, ad supported platform, claims to be the fastest growing US EHR with at present 100 million patient records. The Theranos reporting app, which also connects patients with doctors who can help interpret the results (MD Connect) integrates with other EHRs (though not listed) and now the results will also show in their Practice Fusion patient record. Practice Fusion is also integrating imaging center RadNet‘s results.

Since the late 2000s, Practice Fusion has historically been the game changer in cost (one of the first in the cloud) and in catering to smaller practices. They are good at managing their hype, but as Neil Versel points out, there’s been a CEO ‘change-lobsters-and-dance’, there are questions about revenue and their awaited IPO seems far away, especially given the recent market upset. Hospital EHRs Cerner, Epic and NextGen now all have lower-cost practice versions that integrate with hospital versions. An American College of Physicians (ACP) 2014 survey identified that Practice Fusion is third (and tied with others) among most used practice EHRs behind Epic and eClinical Works, though strongest in solo practices. On the polar opposite of Mr Versel’s skeptical article is this breathless Forbes piece which confuses partnerships with acquisitions. Perhaps self-made billionaire Theranos CEO Elizabeth Holmes may decide to buy Practice Fusion!

Two events of interest, especially to digital health entrepreneurs

Prof Mike Short has drawn my attention to two events taking place in October:

‘The cupboard is bare: how technology can address key unmet needs in mental health’ – Cambridge Wireless Healthcare SIG event – this half day Cambridge event om 13th October, hosted by Philips Research Laboratories and jointly sponsored by TTP and Plextek, will explore the needs from the perspective of the healthcare professional and patient. More details here; book here.

6th Discovering Start-Ups Competition – a brilliant opportunity to win some really valuable prizes to get your start-up really started up, pitching to an elite panel of business leaders from Deloitte, Google, BT, IBM, Cambridge Angels, London Business Angels, Qualcomm Ventures, Samsung and more. Finals will be held at Deloittes in London on 21st October. Note entries have to be submitted by 14th September at the latest.

 

Apps and wearables – developments over the summer

Trying at least temporarily to distract this editor’s attention from his recent unfortunate experience with Jawbone technology, here are some interesting app and wearables snippets received over the summer.

We begin with news of the first CE certified mole checking app, SkinVision which rates moles using a simple traffic light system (using a red, orange or green risk rating). The app lets users store photos in multiple folders so they can track different moles over time. It aims to detect changing moles (color, size, symmetry etc.) that are a clear sign that something is wrong and that the person should visit a doctor immediately.

This contrasts with the findings of a paper published in June examining 46 insulin calculator apps, 45 of which were found to contain material problems, resulting in the conclusion that :”The majority of insulin dose calculator apps provide no protection against, and may actively contribute to, incorrect or inappropriate dose recommendations that put current users at risk of both catastrophic overdose and more subtle harms resulting from suboptimal glucose control.”, which to say the least of matters is worrying. (more…)

Another Tunstall Americas distributor acquisition

click to enlargeAnother press release from Tunstall Healthcare Group is also about Tunstall Americas, in this case the acquisition of Syracuse NY (Central NY State)-based Health Care Monitoring Systems (HMS). This continues this year’s strategy of purchasing or partnering with local home care providers. Like Mountain Home and Kupuna Monitoring (previously in TTA), HMS’ website prominently features a competitor–Philips Lifeline. Notable in the spare release is that the HMS founder notes “strong relationships with referral partners and government agencies.”  Release

Anyone want to do a PhD in digitising paper-based systems? (Swansea)

The University of Swansea is advertising for a computer science/IT PhD student to convert an existing paper-based system into an electronic version, for managing mental health. A scholarship exists to provide full student fee paid and £14k annual bursary for the student. Interviews are required by 11 September. Apparently no-one’s applied yet, so here’s your chance! Full details here.

Unicorns to Series A–health tech funding gained in (perhaps) the nick of time

click to enlargeMoney, money everywhere–unicorns get the headlines, but the companies are still (largely) small

Up until early August, this Editor would have assumed that our Readers would look at this funding roundup as a bracing windup to a largely positive eight months and a veritable Corvette Summer for healthcare technology funding. We may have to give back the keys a little sooner than we imagined. Will the dropping market affect digital health as 2008-9 did–‘out of gas’ for years? Or will it barely affect our motoring onward? Despite the Dow Jones average hitting an 18 month low today, we hope it’s closer to the latter than the former. though the new and big entrant to digital health investing is the country most affected, China.

Our roundup of the August Action includes ZocDoc, Fitbit, Alphabet, PillPack, Owlet and more, along with a few comments:

**ZocDoc, a NYC-based online medical care appointment service that matches patients with doctors by location and schedule, had the most sensational round with last week’s Series D funding of $130 million, giving it a valuation of $1.8 bn. It took over a year after the filing (June 2014) and was led by two foreign funds (London-based Atomico and Edinburgh-based Baillie Gifford) with additional funding from Founders Fund, which previously participated in raises of $95 million.

Though it claims 60 percent coverage in the US  and ‘millions of users’ (numbers which have been quoted for some years), ZocDoc won’t disclose profitability nor volume–metrics that would be part of any IPO.

Direction? Points given for deciphering this windy statement (quoted from Mobihealthnews): (more…)

September-October digital health events (US)

While enjoying the last weeks of the Lazy Hazy Crazy Days of Summer (thank you Nat Cole, BBC clip), it’s time to put the fall’s upcoming events on the calendar, if you haven’t already. A selection starting with our partners:

  • Parks Associates’ Connected Health Summit (9-10 September)–see banner advertising above or here
  • ATA Fall Forum (16-18 Sept)-see sidebar or here
    • If you are attending and would like to report on either conference, email Editor Donna (her schedule unfortunately does not permit her to attend)

Others of interest:

And in London, our partners at The King’s Fund have a wealth of events on their calendar into 2016.

Tunstall Americas allies with Apria Healthcare (US)

click to enlargeTunstall Americas continues its home care provider-centric strategy through an expanded product marketing relationship with Apria Healthcare. Apria, in addition to home care services, markets directly to customers a range of medical devices and durable medical equipment; they will be selling Tunstall’s brands under their medical alert category. This is the first we’ve seen in the US the Tunstall Vi and iVi pendant, along with the CEL cellular PERS unit. Tunstall will also be providing Apria with custom branded products, along with call center, ordering and fulfillment services.  Apria is the US’ fourth largest home care provider (2014 Home Care Market Outlook) with 1.6 percent of a highly fractionated market. Our sources tell us that the initial relationship precedes the Tunstall acquisition of AMAC.  PR Web

Is wearable IoT really necessary–and dangerous to your privacy?

click to enlargeBut does the average person even care? This Editor senses a groundswell of concern among HIT and health tech regarding the highly touted Internet of Things (IoT) and the dangers it might present. Our previous article reviewed the possibilities of hacking, system vulnerabilities in IoT networks and software bugs ‘bricking’ everyday objects such as refrigerators and cars. But what about wearables and the unimaginable amount of data they generate? Is it as unidentifiable as wearables makers claim? Columbia University computer science student Matthew Piccolella focuses in his article on healthcare ‘things’, primarily fitness trackers like Editor Charles’ favorite, Jawbone, but also clothing and even headsets that measure brain waves (Imec). Their volumes of data are changing the definition of healthcare privacy, which in the US has been synonymous with HIPAA. The problem is that health metadata are increasingly identifiable in a ‘big data’ world. (more…)

Resources dear boy, resources – useful stuff TTA has been sent recently

During this editor’s brief holiday, the interesting reports really piled up, so here is a selection of what look to be the best, including a few that never got blogged previously:

G3ICT & AT&T have published an excellent new report entitled ‘The Internet of things: new promises for persons with disabilities

The European Parliament has produced an extremely useful compendium of articles and statistics on the silver economy: well worth reading (or at least bookmarking for writing that next EIP AHA project proposal).

If like me, use of the ‘Euro’ prefix always brings to mind the Eurosausage episode of Yes Minister, prepare to be pleasantly surprised by this new online database of digital services for carers of older people jointly produced by Eurocarers and the EC’s Joint Research Centre, and hosted by Eurocarers. This offers access to 78 good practices of digital services for older care at home.

Ofcom’s 2015 Communications Market Report is essential reading for anyone working in (more…)