Care Innovations sells off Validation Institute. But is there more to the story? And a side of Walmart Health action.

The Health Value Institute, part of Woburn, Massachusetts-based conference organizer World Congress, announced late last week the acquisition of the Validation Institute from Care Innovations. Terms were not disclosed. The Health Value Institute and the Validation Institute recently partnered to validate the outcomes for the Health Value Award finalists and awards this past April at the 15th Annual World Health Care Congress. According to both parties, the acquisition will help to expand the membership of validated companies, and the present offerings for HR, broker, and benefit executives. Release.

The Validation Institute was launched with fanfare back in June 2014, when GE still had a chunk of the company and during the 2 1/2 year repositioning (revival? resuscitation?) led by Sean Slovenski from the doldrums of the prior Louis Burns regime. Mr. Slovenski departed in early 2016 to be president of population health at Healthways/Sharecare, which lasted a little over a year. However, this week Mr. Slovenski made headlines as the new SVP Health & Wellness of Walmart, reporting directly to the head of their US business.  The hiring of a senior executive with a few years at Humana and a short time at Sharecare, another Walmart partner, coupled with several years in healthcare tech and provider-side is certainly indicative of Walmart’s serious focus on healthcare provision. It’s a fascinating race with Amazon and CVS-Aetna–with the mystery of what Walgreens Boots Alliance will do. Also Healthcare Dive.

But back to Care Innovations. Signs of a new direction–and a loss. The case can be made that the Validation Institute, the Jefferson College of Population Health, and validating individuals and companies was no longer core to their business which is centered around their RPM platform Health Harmony (with QuietCare still hanging in there!) However, this Editor notes the prominent addition of  ‘platform-as-a-service’ advisory services for those who are developing health apps, which appears to be a spinoff of their engineering/IT services. Vivify Health, a competitor, already does this. There is a vote of confidence; in June, Roche signed on with a strategic investment (undisclosed) as well as integration of the mySugr integrated diabetes management/app solution (release).

Looking around their recently refreshed website, there is an absence–that of the two or three pages previously dedicated to the Veterans Health Administration (VA) and the press release of the VA award. This tends to lend credence to the rumors that there was a second company that did not pass the Trade Adjustment Act (TAA) requirements that knocked out Iron Bow/Vivify Health from the VA, or for another undisclosed reason CI bowed out of a potentially $258 million five-year contract. If so, that leaves for the VA Medtronic and 1Vision/AMC Health. It’s certainly a limited menu for the supposedly growing numbers of veterans requiring telehealth and a limited choice for their care coordinators–and not quite as presented to the public or the 2015 competitors in the solicitation. Who benefits? Who loses? (Disclosure: This Editor worked for one of the finalists and a VA supplier from 2003, Viterion.)  Hat tip to one of our ‘Industry Insiders’, but the opinions expressed here are her own.

News roundup: Paradromics; Cerner’s trials with DOD, VA; Medtronic; Babylon Health; NHS’ private data

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2017/12/Lasso.jpg” thumb_width=”125″ /]Connecting the brain with medical devices is Paradromic’s USP. Their brain-machine interface technology is seeking to power prosthetics to assist the blind, deaf, and paralyzed, and in future brain diseases. Their current project is to enable the paralyzed to communicate through a computer in real time. Their seed round of $7 million was led by Arkitekt Ventures and Synergy Ventures. Crunchbase. Mobihealthnews

The US Department of Defense’s replacement of the ancient AHLTA EHR with a Cerner-Leidos system, MHS Genesis, has been having a rough test period at Fairchild Air Force Base, Oak Harbor, and Naval Station Bremerton. No one is happy. Congress will exercise its right under the just-passed HR 4245 for the House Veterans Affairs Committee to review the implementation and to receive quarterly updates. POLITICO’s Morning eHealth for 6/25  Over at the VA, Cerner’s EHR will roll out starting in October in three hospitals in Washington state, to be completed by March 2020. The VA Committee has been asking some tough questions on the feedback that VA doctors have been providing, the fact that VA is under-strength on the modernization and that there is no permanent head of the implementation. POLITICO’s Morning eHealth for 6/27

Medtronic, the 9,000 elephant of healthcare devices, is partnering with AI-based nutrition platform Nutrino, an AI-powered personalized nutrition platform. Nutrino’s FoodPrint Report technology will integrate into Medtronic’s iPro2 myLog app that connects to their continuous glucose monitor. Users log their food by taking a picture of each snack or meal. The patient’s sensor glucose data is integrated with the food data for a Pattern Snapshot report and a FoodPrint report. Nutrino recently gained $8 million in Series A funding. Mobihealthnews

Babylon Health passes the test–the British GP test. Babylon recreated the MRCGP (Member of the Royal College of General Practitioners) exam based on publicly available questions. Its AI system passed with a score of 81 percent. A separate test subjected Babylon and seven primary care physicians to 100 independently-devised symptom sets, and Babylon passed with an 80 score. GPs…it’s coming. Mobihealthnews 

The NHS will be partnering with a repository of private healthcare data, the Private Healthcare Information Network (PHIN), to integrate their data with NHS Digital. PHIN has committed to reporting 750,000 privately funded hospital “episodes” to NHS Digital each year through the Acute Data Alignment Programme (ADAPt), Mobihealthnews

Iron Bow’s uncertain future with $258 million VA Home Telehealth contract

Iron Bow Technologies’s setback with their VA contract confirmed. Iron Bow, which partnered last year with Vivify Health to provide telehealth services to the US Department of Veterans Affairs, received an unfavorable ruling on the US country of origin of the Vivify Health system that essentially stops the contract implementation.

Under Title III of the Trade Agreements Act of 1979, Federal suppliers must produce their products in the US or substantially transform the components in such a way that it becomes a product of the US. US Customs and Border Protection (CBP), Department of Homeland Security (DHS), makes this determination. Vivify Health contended that their Vietnam-produced tablet, because of their US-produced Vivify Health Pathways software and further US-based modifications to convert it into an FDA-regulated medical device, was transformed into a US product. In August, the CBP determined that the end product did not meet the transformation standard based on decades of precedent and the country of origin remained Vietnam. Transformation, yes, but not enough or the right kind for the CBP. Federal Register 8/22/17

An interesting Federal regulatory disconnect is that the FDA considers the Vivify tablet a regulated medical device. CBP considers it a communications device as the tablet transmits data from other medical devices but does not take those measurements itself. 

Vivify Health has publicly used in implementations with health organizations Samsung tablets. It is not known if the tablet reviewed by the CBP is manufactured by Samsung.

Both Iron Bow and Vivify Health were asked by this Editor for comments. Iron Bow’s response:

We have received an unfavorable ruling from United States Customs and Border Protection (“Customs”) regarding our proposed solution for the Home Telehealth contract. We respectfully disagree with the findings by Customs and have appealed the matter to the United States Court of International Trade. We are currently in discussions with our customer regarding the possible options for a path forward.

Vivify has not responded to date. 

Certainly, this is a sizable financial loss to both Iron Bow and Vivify if they cannot go forward with the VA, whether through a court decision or a different procurement process for the tablet to qualify it as US origin. Last February, we reported that the VA awarded the billion-dollar five-year Veterans Health Administration (VHA) Home Telehealth contract to four providers: incumbent Medtronic, Iron Bow, Intel Care Innovations, and service-disabled veteran-owned small business 1Vision. The award amount for each was $258 million over a five-year period, re-establishing the VHA as the largest telehealth customer in the US. All four awardees had in common that they were prior Federal contractors, either with the VA or with other Federal areas [TTA 1 Feb 17].

Medtronic and Care Innovations had long-established integrated telehealth systems but Iron Bow and 1Vision, as telemedicine and IT service providers respectively, did not have vital signs remote monitoring capability. In the solicitation, Iron Bow partnered with Vivify [TTA 15 Feb 17]. For 1Vision, it took nearly one year to announce that their telehealth partner was New York-based AMC Health, an existing provider of VA health services. It was also, for those in the field, a Poorly Kept Secret, as AMC Health had been staffing with VA telehealth veterans from the time of the award. (The joint release is on AMC Health’s site here.) The reason for the announcement delay is not known. AMC Health does not use a tablet system, instead transmitting data directly from devices or a mobile hub to a care management platform. They also provide IVR services.

Vivify has moved forward with other commercial partnerships, with the most significant being InTouch Health, which itself is on a tear with acquisitions such as TruClinic [TTA 19 Dec 17].

Hat tip to two alert Readers who assisted in the development of this article but who wish to remain anonymous.

January’s Crazy Week: JP Morgan, StartUp Health, Health 2.0 WinterTech…and CES takes the cake!

This week is Crazy Week for healthcare and technology folk, with multiple major events centered in San Francisco and Las Vegas.

JP Morgan’s 36th annual healthcare conference started today 8 Jan through Thursday 11 Jan in San Francisco. It annually hosts 450 companies presenting to 9,000 attendees. It attracts hundreds of investors and is A Very Big Deal for both investors and companies angling for same. It kicked off with Medtronic‘s Omar Ishrak touting their success with Tyrx, an anti-microbial resorbable envelope for their cardiac devices to prevent post-surgical infection. In value-based care, it may not be in itself reimbursable, but improves outcomes (MedCityNews). The official hashtag for the conference is #JPMHC18 but there’s also #JPM18.

Of interest to Readers will be Teladoc’s presentation at JPM, provided by Seeking Alpha

CNBC’s tip sheet on the action. Genalyte‘s lab-on-a-chip demos their blood sampling in 15 minutes technique to MedCityNews writer. And Vive La Biotech–why American investors should be looking at French companies.

Within the event is the invite-only StartUp Health Festival Monday and Tuesday which hashtags at #startuphealth. Separately, but with many of the usual suspects, is Health 2.0’s one-day WinterTech conference in San Francisco the following day on Wednesday 10 Jan, also with an investment focus. (You can imagine the investor and company hopping between conference locations!) Alex Fair is also leading a Meetup tweetup for the week–more information here. You may also want to check out #pinksockspinksocks is an ad hoc group dedicated to health and wellness innovation and doctor-patient connectedness.

Further south, the sprawl of Las Vegas has been taken over by the sprawl of CES (aptly dubbed ‘Whoa!’) starting Tuesday 9 Jan through Friday 12 Jan. The substantial health tech focus (more…)

Some quick, cheerful updates from Welbeing, CarePredict, Tunstall, Tynetec, Hasbro, Fitbit

It’s Friday, and in search of cheerful topics, here are some updates on doings from telecare, telehealth, and related companies we’ve recently noted on TTA:

Welbeing‘s opened a new head office at Technology Business Park in Moy Avenue in Eastbourne….CarePredict‘s AI for ADL system using the Tempo wearable has new implementations at LifeWell Senior Living’s community in Santa Fe, New Mexico (their third with CarePredict) and a three-year commitment with the Avanti Towne Lake community, Cypress, Texas. Dave Muoio has an interview with CEO Satish Movva on Mobihealthnews….Tunstall is partnering with Milpitas, California-based noHold’s Albert bot to create a virtual assistant for Tunstall’s mobile Smart Hub product, currently in Australia and in trials in Europe and the USA….Tynetec (advert above) has been closely associated and fundraised with the Dementia Dog Project and DogsforGood. An article in the Express highlights both in the beneficial role of pets with Alzheimers and dementia sufferers…. In robotic pet news, Hasbro is upgrading its ‘Joy for All’ companion pets through a Brown University research program, Affordable Robotic Intelligence for Elderly Support (ARIES) to add medication reminders, basic artificial intelligence, and more (Mobihealthnews)….Fitbit continues its march to a clinicalized product touting diabetes management partnerships with Medtronic and DexCom, plus clinical trials detecting sleep apnea through its SpO2 sensor. 3rd quarter sales were up 23 percent to $244 million and 40 percent from repeat purchasers, but they took an $8 million loss from a distributor (MedCityNews).

PillCam in Dublin hospital test for small bowel diagnosis (IE)

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2017/09/Pillcam.jpg” thumb_width=”150″ /]Medtronic’s PillCam is being tested by Bon Secours Hospital in Dublin, Ireland for small bowel and colon diseases. The test group is only 50 patients, which is striking as the PillCam is in wide use in the US for diagnosis of Crohn’s Disease. The PillCam SB is 1.02″ wide and in an eight-hour test can take up to 55,000 pictures (two pictures per second). After the test, it is expelled naturally but in about 3 percent of cases, it is not, so a test capsule is used in many cases, according to their US website. Images from the camera are sent to a belt-worn data recorder, which from RTÉ Health Correspondent Fergal Bowers’ personal test, you’d want to avoid train stations and airports. Images are downloaded after the test. The prep is similar to that for colonoscopy, with one extra–that you have to wait at least eight hours after! It is also in use at Tallaght Hospital. The articles imply that it may be used instead of standard endoscopy, which in the US is a prerequisite. RTÉ on the Bon Secours test. Hat tip to our Northern Ireland correspondent and former TTA Ireland editor, Toni Bunting

GE’s change at the top puts a healthcare head first

This Monday morning’s Big News was the stepping down, after 16 years, of GE‘s CEO Jeff Immelt effective August 1, and the rise of GE Healthcare’s head, John Flannery. The focus of most articles naturally was the fate of GE. Mr. Immelt may have steered the company through a severe recession starting in 2008, but he managed to lose about a third of the company’s value in the process. Expect some changes to be made in Boston. “I’m going to do a fast but deliberate, methodical review of the whole company,” Flannery told Reuters in an interview. “The board has encouraged me to come in and look at it afresh.” In an earlier call with investors, he said the review would have “no constraint.”

Mr. Flannery is a 30-year GE veteran, head of Healthcare since 2014, and previously head of GE India, its equity business in Latin America and GE Capital in Argentina and Chile. According to Fortune, GEHC is 15 percent of GE’s total business and in recent years has been smartly up in revenue. They have partnered recently with UCSF on predictive analytics, Boston Children’s Hospital on a pediatric brain scan database, and Johns Hopkins of a more efficient hospital bed allocation process. Also is an example of telemedicine remote diagnosis using a GE Health portable ECG device connected to the Tricog smartphone app to take a reading in India which was diagnosed in San Diego.

Usually healthcare CEOs become CEOs of other healthcare companies–witness the rise of one of Mr. Flannery’s predecessors, GE veteran Omar Ishrak, as CEO of Medtronic.  Fortune’s healthcare reporter interviewed Mr. Flannery two weeks ago–more of this interview will be published according to the author. (But hasn’t as of June 21!)

VA says goodbye to VistA, hello to Cerner for new EHR–and possible impacts (updated)

The new sheriff just turned the town upside down. Veterans Affairs’ new Secretary, Dr. David J. Shulkin, as expected moved quickly on the VA’s EHR modernization before the July 1 deadline, and moved to the same vendor that the Department of Defense (DoD) chose in 2015 for the Military Health System, Cerner. VA will adapt MHS GENESIS, based on Cerner Millenium. The rationale is seamless interoperability both with DoD and with private sector community providers and vendors, which base their services on commercial EHRs. The goal is to have one record for a service member through his or her lifetime and to eliminate the transition gap after discharge or retirement. (Transition gaps are also repeated when reservists or National Guard are called up for active duty then returned to their former status.) Another priority for VA is preventing the high rate of suicide among vulnerable veterans.

Updates: VA confirmed that Epic and Leidos will keep the development of the online medical appointment scheduling program, awarded in 2015 and currently in pilot, to be completed in 18 months. The contract is worth $624 million over five years. Wisconsin State Journal  The House Appropriations subcommittee on Veterans Affairs likes the Cerner EHR change. The Senate Veterans Affairs Committee is meeting Wednesday to discuss the VA budget sans the EHR transition. The EHR numbers are expected to be sooner rather than later. POLITICO Morning eHealth 

Dr. Shulkin is well acquainted with the extreme need for a modernized, interoperable system serving the Veterans Health Administration (VHA), having been on the US Senate Hot Grill for some years as Undersecretary of Health for VA. The foundation for the move from homegrown VistA to Cerner was laid last year during the prior Administration through an August RFI for a COTS (commercial off the shelf) EHR [TTA 12 Aug 16] and in later hearings. “Software development is not a core competency of VA” and it has been obvious in system breakdowns like scheduling, maintaining cybersecurity and the complex interoperability between two different systems. To move to Cerner immediately without a competition, which took DoD over two years, Dr. Shulkin used his authority to sign a “Determination and Findings” (D&F) which provides for a public health exception to the bidding process. The value of the Cerner contract will not be determined for several months.

For those sentimental about VistA, he acknowledged the pioneering role of the EHR back in the 1970s, but that calls for modernization started in 2000 with seven ‘blue ribbon’ commissions and innumerable Congressional hearings since. He understated the cost in the failed efforts on interoperability with DoD’s own AHLTA system, VA’s own effort at a new architecture, and modernizing the outpatient system. This Editor tallied these three alone at $3 billion in GAO’s reckoning [‘Pondering the Squandering’, TTA 27 July 13]. 

It is still going to take years to implement–no quick fixes in something this massive, despite the urgency.

  • Both MHS and VA will be running two systems at once for years (more…)

Iron Bow partners with Vivify Health for $258 million VA telehealth contract

One mystery solved! Iron Bow Technologies announced that its telehealth delivery partner for their award of $258 million in the Veterans Affairs Home Telehealth program is Plano, Texas-based Vivify Health. As noted in our original article [TTA 6 Feb] on the much-delayed VA remote patient monitoring award, Iron Bow was an existing contractor in other VA Telehealth services, Clinical Video Telehealth (video conferencing) and Store-and-Forward (clinical imaging review), but did not have vital signs RPM capability. The addition of Vivify with its mobile and tablet-based solutions and integrated peripherals adds that capability.

Vivify structures its main telehealth solutions based on escalating patient ‘risk’: 1) healthy and ‘at risk’ (may have early stage disease), 2) rising risk (has complex chronic disease) and 3) high risk (for hospitalization). The approaches are scaled up from engagement on BYOD mobile and web for (1), to vital signs monitoring and telemedicine clinician visits via mobile and tablet (2), to the highest level of an integrated kit with tablet and integrated peripherals (3). These further divide into five ‘pathways’ which are more product-oriented.

Cost is, of course, a factor, with VA a very demanding client in this regard as individual VISN (region) budgets are tight. Medtronic, the incumbent, has not only been using the venerable Cardiocom Commander Flex hub, but also provides VA with Interactive Voice Monitoring (IVR) which is an inexpensive patient management solution. (Ed. note: having worked with IVR in the past, it can work well if used with primarily lower-risk patients, is structured/implemented properly and integrated with live clinical check-ins.) Vivify’s system is all new–and not inexpensive, especially at the high-risk level. From their website, Vivify uses BYOD for the lower levels and the integrated kit for the highest and poorer outcome patients. This Editor notes they offer a voice telephony care solution which presumably is IVR. This gives them a welcome flexibility in price, but also a complexity which will be a training issue with VA care coordinators.

Other factors affect mobile-based solutions. Many at risk at-home veterans are older and thus don’t have smartphones or tablets. Reliable broadband connectivity is also an issue. Many don’t have Wi-Fi, which is a prerequisite for tablet use, and may live in areas with poor cellular reception.

The other work and labor-intensive parts for Vivify and Iron Bow are to integrate their reporting platform into VA’s complex and secure systems, which also involves a highly structured updating process: CPRS (computerized patient record systems), the VistA EHR and whatever replaces it (Epic is being trialed in Boise, Idaho–scroll down to ‘Big Decisions’ and Dr Shulkin).

Founded in 2009, Vivify has compiled an impressive track record with CHRISTUS Health (TX), RWJ Health (NJ), Trinity Health (MI), Centura Health (CO) and other large systems plus home care. It has also been conservative in its venture funding, with $23.4 million to date and its last big round from LabCorp and others in 2014 (CrunchBase).

Release. Hat tip to Vivify’s Bill Paschall via LinkedIn.  P.S. Stay tuned for an announcement of 1Vision’s partner. 

Editor’s clarification: The VA Home Telehealth contract is structured as a one-year base period, followed by four one-year optional periods, for five years total. The awarded amount over the five-year period is $258 million for Iron Bow/Vivify. It is the same amount/term for each of the three other awarded companies, totaling just over $1 billion for the five-year program. This is comparable to the 2011 five-year program value of $1.3 billion divided over six awardees. Thanks to Josie Smoot of Iron Bow Technologies’ press office.

VA awards over $1 billion in Home Telehealth contracts–at long last (updated)

Breaking News, Updated  The Department of Veterans Affairs (VA) on 1 Feb issued over $1 billion in awards to four companies to provide Home Telehealth vital signs monitoring technologies to veterans in home care and monitoring. The four companies are Medtronic, Care Innovations, Iron Bow Technologies, and 1Vision LLC. The $1 billion is split evenly between the four ($258 million for each company over the five-year duration). The contracts are for an initial year (31 Jan 2018 end date listed on GovTribe.com), renewable annually for five years total. The bid process started in 2015 and the award had originally been scheduled for early-to-mid 2016.

On the suppliers:

  • Medtronic is the incumbent as a supplier since 2011, dating back to Cardiocom’s 2011 award for its home monitoring units (Cardiocom was acquired in August 2013). Medtronic is a Dublin, Ireland HQ’d company with a US headquarters in Minnesota.
  • Care Innovations is well known to our Readers as the developer of Health Harmony and the acquirer of the QuietCare telecare/behavioral monitoring used in senior housing. Their parent is Intel.
  • Iron Bow Technologies is a supplier to VA in other healthcare areas (telemedicine and store-and-forward) and is a large, privately held IT company with multiple Federal contracts and deep Federal contractor roots. Their revenue has been reported at over $462 million (Washington Technology Top 100 2016).
  • 1Vision LLC is a new company formed as a joint venture between HMS Technologies, Inc. and MBL Technologies, Inc. Neither are previously engaged as home telehealth providers, but both are Federal contractors. According to their individual websites, HMS is an IT systems integrator and MBL is engaged primarily in cybersecurity.

The question for this Editor is how Iron Bow and 1Vision, which are not telehealth (vital signs) monitoring companies but telemedicine and IT service providers respectively, will execute Home Telehealth with the VA. Have they partnered with yet-to-be disclosed providers in providing home telehealth services to the VA? (Watch this space)

While the award is the largest in US telehealth, the VA is, by this Editor’s experience in her last position with Viterion Corporation, extremely demanding on its service providers and will be even more so in the future. The future reasons are clear: 1) President Trump has put a Klieg light on the VA and 2) he’s named a new VA secretary, Dr David Shulkin, who is currently VA Undersecretary for Health (confirmation hearing notes courtesy of POLITICO, nomination approved by the Senate committee Tuesday, and easily confirmed Monday night 13 Feb), who has been highly engaged with HIT issues, including both the VistA EHR modernization/replacement and initiatives such as the recently unveiled Digital Health Platform [TTA 12 Jan]. (more…)

IBM Watson Health computes into diabetes management, UK care budgeting (US/UK)

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/10/SugarIQ2-712.jpg” thumb_width=”250″ /]IBM Watson Health, the advanced cognitive computing division of IBM, with Medtronic has developed an app that may, when marketed after FDA approval, help to ease for diabetes patients their daily ‘Battle of Stalingrad’. Sugar.IQ is an app that finds patterns in diabetes data through combining Watson’s cognitive computing capabilities with diabetes data from Medtronic and other sources. The app then uses continuous glucose monitoring data from Medtronic insulin pumps and glucose sensors to give specific, personalized information to the patient on their health trends and how to better manage their diabetes. The analytic features are impressive. Glycemic Assist lets the patient ask the app to follow specific food or therapy-related actions and events to see their exact impact. The Food Logging feature can track specific foods in a diary to determine the effects of specific foods. It is being tested presently on 100 MiniMed Connect users. Previewed at last week’s Health 2.0 conference. HealthcareITNews (photo), Medtronic blog post, Medtronic release (PDF) (This MiniMed Connect is not to be confused with the Medtronic MiniMed 670G artificial pancreas–hybrid closed-loop insulin delivery system for type 1 diabetes patients–just approved by FDA. MedCityNews)

In the UK, Harrow Council in northwest London is using IBM Watson Health’s Care Manager for social care service matching and budgeting. Using “cognitive technologies that provide personalised insight and evidence based guidelines”, Watson will match individuals’ needs and budgets to providers, and will be further able to manage costs over the ten-year agreement by “control(ling) the contract and payments between the individual commissioning for support, and social care providers competing to supply the service.” It’s not entirely clear to this Editor how the individual flexibility of care and services works with the recipient, however. The IBM Watson Health announcement follows on last May’s announcement with Alder Hey Children’s NHS Foundation Trust and the Hartee Centre to transform Alder Hey into the UK’s first “cognitive hospital”. DigitalHealth.net  Hat tip to reader Paul Costello of Viterion Digital Health

A review of digital health patent slugfests and Unintended Consequences

Mobihealthnews provides a recap of the past four years of patent actions pitting company against company in the hushed but deadly rings of the US Patent and Trademark Office (USPTO) and the US International Trade Commission. On the fight card: the never-ending American Well-Teladoc bout (Teladoc winning every decision so far by a knockout [TTA 18 June]–a second American Well patent being invalidated on 25 August); CardioNet vs MedTel, which the former won but has had to chase the latter out of the arena and down the street to collect; Fitbit-Jawbone which has gone both ways [TTA 27 July]; and the long trail of blood, sweat and Unintended Consequences around Bosch Healthcare’s heavyweight IP pursuit against mainly flyweight early-stage companies (not noting, as we did, their apparent ‘draws’ vs Philips and Viterion, then owned by Bayer).

The Reader will note our tracking Bosch’s activities go back to 2012 (here, here and here). Moreover, with Mr Tim Rowan of Home Care Technology, we broke the news of Bosch’s demise in June 2015, drawing the conclusion that their offense versus Cardiocom’s patents (now in Medtronic’s cardiac division) directly led to the invalidation of their key patents, IP–and the very basis of the company’s existence. See the 19 June 2015 article and our recap one year later in reviewing AW-Teladoc. (Any similar phrasing or conclusions within the Mobihealthnews article, we will leave to our Readers to decide!)

Medtronic’s moves in post-acute cardiac care management, monitoring

Medical device giant (and inverted to Dublin) Medtronic announced today the launch of their Beacon Heart Failure Management Service in the US. It combines their implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices with post-acute patient monitoring from Medtronic Care Management Services (MCMS). The patients are checked both through their recorded cardiac device diagnostics and what they called ‘branching logic’ questions which collect daily qualitative, biometric and symptom information, plus provide patient education. Care managers then review the data along what they term ‘established clinical pathways’ check for growing risk factors and alert providers if needed.

What is interesting is that the in-home delivery and collection platform or hub is not specified. Medtronic happens to own one of the telehealth pioneers, a company which used to be called Cardiocom–which is now part of Medtronic Care Management Services in their Cardiac and Vascular Group (CVG).

No launch clients/partners are mentioned, save a quote from a cardiologist at The Stern Cardiovascular Foundation in the Memphis TN area. ReleaseFierceMedicalDevices

In other Medtronic news, earlier this week they announced the acquisition of cardiac device company HeartWare for $1.1 billion. HeartWare has developed small implantable (more…)

Can expanding telehealth help VA solve veteran access crisis?

The Department of Veterans Affairs (VA) has been both one of the largest US users of telehealth in various forms–and widely criticized for practices including veteran patient wait lists for care, a lack of accountability, a scheduling system full of problems, an ancient EHR (VistA), and an inability to meet interoperability and modernization goals set over years. Telehealth is, in fact, one of VA’s bright spots with store-and-forward imaging, clinical video telemedicine and home telehealth.

At the American Telemedicine Association ATA 2016 meeting Monday, Under Secretary for Health and VA Chief Executive Dr. David Shulkin noted that the crisis has pushed VA into other options for achieving the goals set for the end of year: every VA medical center provides same day primary care services and same day mental health services. One area of focus is telemental health. Dr Shulkin announced in his plenary speech the opening of five new Mental Health Telehealth Clinical Resource Centers this summer, located in Charleston, Salt Lake City, Pittsburgh, and a consortium of facilities in Boise, Seattle, and Portland, Oregon. West Haven, Connecticut is already open as a specialty hub focused on the most severe and complex mental health issues, such as chronic depression and bipolar disorder. Other VA telemedicine initiatives include kiosks and text messaging to help with medication adherence and chronic condition management. (We’ve reported on their partnering with nhssimple to develop ANNIE, a sister of NHS’ Flo in text messaging to encourage patients in their health monitoring, TTA 2 Dec 15.)

VA delivered 2.1 million episodes of telehealth care last year (FY 2015), in 45 specialty areas of care, including 400,000 telemental health visits. They also reduced bed days by 56 percent, reduced readmissions by 32 percent, and decreased total psychiatric admissions by 35 percent, maintaining high user satisfaction scores at 89 percent.

Dr Shulkin also noted that four generations of veterans are served by VA–WWII, Korea, Vietnam and Desert Shield through current Iraq/Afghanistan–and all four have different delivery requirements. He closed with what is, for VA which has been very proud of their ‘home grown’ solutions from the time of Dr Adam Darkins in the early 2000s on, something unusual: “We’re looking to learn, we’re looking to work with all of you who are innovating to help take better care of veterans.” (Next on tap: the award of the next five-year round of home telehealth providers, which is presently down to two Grizzled Pioneers, Medtronic (Cardiocom) and Viterion.) MobihealthnewsVA press release

Artificial pancreas for Type 1 diabetics may be closer

A victory in this perpetual Battle of Stalingrad? Three universities, plus Dublin-based Medtronic, are developing devices that may bring a commercial artificial pancreas for Type 1 diabetics to market within the next few years. Medtronic is estimating that their system could be in market by 2017. The University of Virginia‘s Center for Diabetes Technology has a final clinical trial this summer on the inControl system which is being commercialized by start-up company TypeZero Technologies. Other research programs are underway at Cambridge University and Boston University, on a product that will measure both insulin and glucagon. Type 1 diabetics produce no insulin, making their lives literally dependent on close glucose monitoring and correct insulin delivery. These are “closed-loop” systems, consisting of a pump worn outside the body, a continuous glucose monitor, which measures glucose from fluid under the skin, and a device that runs continuous algorithms to determine insulin delivery. Much of this research has been funded by the Juvenile Diabetes Research Foundation (JDRF). Perhaps there will be a better and safer way soon to fight this perpetual Battle of Stalingrad for those with Type 1 diabetes. CNBC

Medtronic favoring early-stage acquisitions, diabetes; American Well and Teva

Medtronic plc, now firmly planted in the Auld Sod of Ireland, reported a tidy $7.304 bn in its 4th quarter global revenue closing 24 April versus a prior year of $7.257 bn, with a net loss of $1 million. Their report yesterday (2 June) was primarily centered around the integration of Covidien and the foreign currency loss. Results were especially strong in the US with an 8 percent gain in fourth quarter. Earlier speculation that the major Covidien acquisition in addition to Corventis, Zephyr Technologies (through Covidien) and telehealth provider Cardiocom would slow future investments seems to be the direction CEO Omar Ishrak is taking, based on his comments during the analyst call. The Covidien strategy of making early-stage company acquisitions is to his liking and with new revenues from Covidien (and a more favorable tax domicile) certainly there is not a lack of funds despite a small loss in fourth quarter revenues. Another change from being a cardiac-centric device company is apparent in the growth area of global diabetes, shifting from pumps to diabetes management. They have a minority investment in diabetes manager Glooko, a partnership with IBM Watson Health for diabetes management, and acquired a Dutch clinic and research center, Diabeter. Jonah Comstock at Mobihealthnews has more on that call.

In a surprising move, Israel’s Teva Pharmaceuticals is putting a reported ‘tens of millions of dollars’ into American Well and their telemedicine (virtual consult) platform. The pharma interest at once may be narrow in utilizing these consults in clinical trials, but as we have seen with Merck’s telemedicine clinics in Kenya, there’s also a focus on monitoring critical medication at long distances. Late last year American Well completed an $81 million Series C, but it is not clear whether Teva is a part of this and the news is just now catching up. MedCityNews, Globes (Israeli business website)