Medtronic reports corporate IT systems cyberattacked. 500K UK Biobank records breached. Are med device and research organizations the new hacker happy hunting ground?

April 30, 2026 | by | No Comments

Medtronic’s cyberattack apparently contained. The company reported in a corporate statement on 24 April that an unauthorized party accessed data in certain Medtronic corporate IT systems. Medtronic has not identified, to date, any effects on, as specified: products, patient safety, patient needs, connections to customers, manufacturing and distribution operations, or financial reporting systems. They are determining any intrusion into patient information. According to their most recent SEC filings, Medtronic does not anticipate any effect on its business or financial needs.

The criminal hacker organization taking credit for it is the interestingly named ShinyHunters (what, not Shiny Stockings?) which claims it exfiltrated 9 million patient records with personally identifiable information (PII), 38 million records in total, as well as “terabytes” of internal corporate data. This immediately contradicts Medtronic’s anodyne corporate statement. However, the leak is no longer published on their dedicated leak website, according to Cybernews reported in TechRadar, which may indicate that some negotiations are going on. We’ll see if Medtronic will be changing their statement.

ShinyHunters is indulging in some chest beating, bragging on its leak website that they’ve stolen data from primarily consumer companies such as Zara, Carnival, 7-Eleven, Pitney Bowes, The Canada Life Assurance Company, and Hallmark. 

This fits a pattern of major healthcare hacking. Orthopedic medical device and robotics company Stryker was caught in a massive breach, wiping tens of thousands of systems and servers across the company’s network including applications such as Intune Company Portal, Teams, and VPN clients often used on personal devices. The perpetrator, Handala, is “linked to Iran’s Ministry of Intelligence and Security (MOIS) that targets Israeli organizations with destructive malware designed to wipe Windows and Linux devices.” This makes it political as a primary reason, economic secondary. [TTA 20 Mar]

Corporate IT is more vulnerable than production or patient-facing systems, according to Ensar Seker, chief information security officer at threat intelligence platform SOCRadar, quoted in MedCityNews. Corporate systems have high-value data but are less rigorously segmented and protected. MedTechDive

Another breach with international repercussions is that of UK Biobank. UK Biobank is a non-profit research database with information on 500,000 British citizens who volunteered their history and data. That data was found for sale on three separate listings on the Chinese e-commerce website Alibaba. Apparently no entity purchased the data. Unusually, the Chinese government assisted in the listings’ removal.

Last Thursday (23 April), science minister Ian Murray told the House of Commons that the charity had informed the government about the data breach last Monday and thanked the Chinese government for assisting with the removal from Alibaba. Biobank has referred itself to the Information Commissioner’s Office. The hacker is not identified.

Dame Chi Onwurah, the Labor chair of the science, innovation and technology committee, scored her own Government, saying that it was “another blow to public confidence”, adding that it showed “little progress had been made” in protecting public data. Mr. Murray had assured her back in February that standards of public sector information security and data hygiene would improve.

The subjects joined the study over four years, 2006-2010, and at that time were between 40 and 69 years old. The information could include gender, age, month and year of birth, socioeconomic status, lifestyle habits, and measures from biological samples. The deidentified  information did not include names, addresses or contact details. 

According to the Independent (via Yahoo UK), UK Biobank is the world’s most comprehensive dataset of biological, health and lifestyle information. It is used internationally and has been used to achieve improvements in the detection and treatment of dementia, cancers and Parkinson’s. DataBreaches.net

Short takes/wrapup: fundings for Talkiatry, Heyday Health, CipherHealth; Brightside Health now 50 states for Medicare Part B; Neurabody’s sensor based posture therapy; below the radar global layoffs at Medtronic

June 27, 2024 | by

The funding spigot seems to be on, even up to a Series C.

Talkiatry closed a $130 million Series C for a total funding of $245 million. The round was led by Andreessen Horowitz (a16z) with participation from Perceptive Advisors. Debt financing was provided by Banc of California. Talkiatry’s offering in virtual behavioral or telemental health is psychiatrically-based with a national network of 300 psychiatrists performing to date over 1 million patient visits. Their differentiation is stronger outcomes and reduced utilization of higher levels of care. Their footprint is in health plans: Aetna, Blue Cross Blue Shield, United Healthcare, Cigna, and Humana, covering more than 70% of commercial lives in the US–but plans to expand to provider networks. Release, FierceHealthcare

Heyday Health‘s raise of $12.5 million was from Gradient Ventures (Google’s early stage fund), Lionbird, a large national payor, Great Oaks Capital, and Kate Ryder, CEO of Maven Clinic. Heyday’s technology provides 24/7 in-person’s home, telehealth, and phone visits for Medicare and Medicare Advantage beneficiaries in Ohio and Kentucky. Each person is connected to a personalized care team comprised of a physician, a nurse practitioner, and a Health Ally that works with them to design and manage care plans. The funding will be used for geographic expansion into the Cincinnati/Dayton area in Southwest Ohio and the Louisville area in Kentucky. Release, FierceHealthcare

CipherHealth received an undisclosed capital investment from Atalaya Capital Management for growth and expansion. Cipher provides communication solutions for patient engagement such as secure texting, appointment setting, rounding, and patient feedback. Release 

Brightside Health, another telemental health provider that had its own $33 million Series C in April, announced that it has expanded its reach to Medicare Part B recipients in all 50 states and the District of Columbia, making it the first and only telepsychiatry provider to do so. With this, they now have a total reach of 130 million covered lives. Older adults are an underserved market for mental health support, with 15% utilizing ERs for care, one in four recipients living with a mental illness, and those 65+ having the highest rate of suicidal ideation. Release

We don’t often hear of digital health coming out of Luxembourg, but startup Neurabody located there is combining sensor-based data with AI to address the causes of and therapy for lower back pain. The current Posture AI device is a smart posture estimation sensor and an optional posture correction ergonomic shirt that provides personalized feedback and advice on improving posture and reducing pain via a smartphone or tablet app. If the user begins to slouch, the sensor detects it and buzzes to remind the user to sit up straight. Future products in the next two years are a smart posture seat and smart lumbar support devices. Co-founder William Choi is a serial entrepreneur, an investor and founding member of BackJoy Orthotics, an Inc 500 Fastest Growing Company. Right now the app is available on Google Play and the Apple App Store. The shirts are listed at $149 but the sensor and chest strap are not listed for sale and the shirt purchase pages are not functional. The pages need some work (e.g. typos, ‘coming soon’ pages). Release

But layoffs are still with use, even for the powerful ‘giants’.

Med device giant Medtronic has been quietly proceeding with a global layoff. The only publications that have been on this are Mass Device, which initially was unable to receive confirmation but pursued, and the local Minneapolis Star-Tribune. The layoffs started in April and May, with posts from former employees on LinkedIn and on TheLayoff, which are coded in Medtronic-speak. The company confirmed earlier this month to the Strib that it was laying off staff but would not give details, from the number of employees affected to impacted business divisions or geographic locations.

At the end of 2023, Medtronic offered employees an early retirement program, usually a first sign of major layoffs. Then, at the start of 2024, Medtronic announced the closure of five manufacturing plants and six distribution centers as part of an effort to improve the company’s supply chain, but again refused to disclose where or when. Medtronic relocated to Dublin years ago but maintains an operational HQ near Minneapolis. 11,000 employees of 90,000 total work there, making Medtronic the world’s largest medical device company and still a major employer in Minnesota. None of the layoffs are showing up on state WARN sites either because they are below the thresholds or Medtronic is simply not filing, though states do not except foreign companies.

Did they really think that they could keep this on the QT and Strictly Hush-Hush in the age of social media and layoff trackers (apologies to James Ellroy)?

VA awards four remote patient monitoring companies to share in $1B Home Telehealth contract (updated)

June 9, 2023 | by

The Department of Veterans Affairs awarded on 1 May the latest contract for veteran Home Telehealth (HT) remote patient monitoring systems to four companies. They are perennial and incumbent vendor Medtronic Care Management Services, with HT newcomers Cognosante, Valor Healthcare, and DrKumo.

The duration of the Remote Patient Monitoring-HT contract is for a base period of two years and six (6) option periods. Each vendor can receive a minimum of $100,000 and maximum of $250,000,000 for a total value of all vendors in the contract of $1.032 billion, which is about the same as the previous award setup. It covers 72,000 patients with chronic care, acute care, health promotion/disease prevention, and non-institutional care (NIC) needs, and was awarded through the Office of Connected Care. This contract provisions for systems and hardware/software tools for the connected care of veterans at home. The solicitation originally came out in September 2021 and the award for multiple reasons was delayed for nearly two years.

Cognosante is perhaps the most interesting one here as an IT services company that offers telehealth and RPM as part of a main suite of diversified business process outsourcing. It already does business with the VA and the government, most recently with the VA in 2022 for support of a system used to manage referral and authorization processes for community care services (GovConWire). Former Senator Thomas Daschle is on their board of directors.

Valor Healthcare also is a current VA provider in operating more than 50 community-based outpatient clinics (CBOCs). Valor as prime contractor partnered with GlobalMed on the contract, with GlobalMed as the technology provider for software integration and security services. GlobalMed already provides telemedicine carts to the VA and is a contractor for virtual health services for the Defense Health Agency’s (DHA) Medical Community of Interest network.

DrKumo is the upstart, founded in 2021 by CEO Kelly Nguyen, Pharm.D and CTO Duc Pham. Their main feature is RPM for disease and chronic care management. 

All four companies prominently feature their connections with the VA and veterans, featuring the latter prominently in their management. Medtronic is the long-time (since the ’00s) incumbent and a leading vendor to the VA and the MHS in multiple areas.

The VA is a tough client, which other companies with HT contracts (and the personal experience of this Editor while marketing director of Viterion two contracts ago) can testify to. While VA may award contracts with four companies, many things can happen in the execution, such as failure to satisfy government US-origin requirements on the hardware origins, as specified in the Trade Agreements Act (TAA). Your hardware will need to be “substantially transformed” in the US or in a signatory country designated by the TAA. More than one vendor has effectively lost their contract over this; it happened to Vivify Health (now part of Optum) in 2018 and they with Iron Bow walked away [TTA 16 Jan 2018]. Another major hurdle is acceptance by VA care teams, and here all three companies are up against incumbent Medtronic.

Update 1 Nov: Another incumbent, AMC Health, which in 2022 partnered with GE HealthCare on post-hospital monitoring, switched partnerships and moved to partner with Cognosante. Partnerships are near-impossible to discern from the award notices. This is per their chief operating officer, James Considine, to the Editor. 

Becker’s, GovConWire, Valor release, GlobalMed release, SAM.gov award notice-Medtronic, SAM.gov award notice-Valor, SAM.gov award notice-DrKumo, SAM.gov award notice-Cognosante

Thursday news roundup: bet on Oracle-Cerner closing next week, VA EHR progress reports mandated, Homeward-RiteAid rural care, Medtronic-DaVita kidney JV, Withings reenters RPM, Lightbeam buys Jvion AI

June 1, 2022 | by

The Oracle acquisition of Cerner will close as early as Monday next week, no later than mid-June. Mid-June is the prediction of Seeking Alpha. They based it on Oracle-Cerner already passing Australia’s Foreign Investment Review Board, no questions posed by the UK antitrust authority, and the US waiting period expiring in February. As rumored [TTA 25 May], European Commission regulators approved it today (Barrons, paywalled) which predicts the close will be next Monday. Hat tip to HISTalk for their alert yesterday.

Scrutiny of Cerner’s $16 billion EHR implementation with the Department of Veterans Affairs by Congress ramps up. New legislation due to be signed by the president shortly will require the VA Secretary to submit regular reports 30 days after the last day of each fiscal quarter on the VA’s Electronic Health Record Modernization (EHRM) program. Content will include spending, performance metrics, outcomes, safety, transitioning from VistA to Cerner Millenium, interoperability, and progress or issues with all. Text of Senate bill, FierceHealthcare  TTA’s previous article on Cerner EHR interoperability problems with DOD and VA

Bringing healthcare to rural America is Homeward with a freshly inked deal with RiteAid. Founded by former Livongo president Jennifer Schneider, MD, Homeward will set up distinctive purple mobile van clinics at up to 700 Rite Aid location parking lots in rural communities starting Q3 this year. Michigan will be the first market. Homeward will accept regional Medicare Advantage plans and Medicare.

The company is targeting the 60 million Americans who live in rural areas and have been losing access to basic medical care as local practices and clinics close. Their technology enablement will be for appointments, checkins, telehealth, remote patient monitoring, and scheduling home visits. Homeward announced its launch at the recent ViVE2022 in March including $20 million in funding from General Catalyst. Other Livongo alumni with the new company are Brian Vandenberg, former general counsel, Amar Kendale, former chief product officer, and Bimal Shah, MD, former chief medical officer at Livongo. Nice to know that they have moved to another healthcare chapter of real need, versus cruising the Caribbean in very large yachts. FierceHealthcare, Homeward release

Medical device giant Medtronic and DaVita are establishing a joint venture by next year to advance kidney care therapies and technologies, including new products to be used in clinics and in the home. The intent of the JV is to increase the availability of kidney care including dialysis. 10% of adults worldwide–700 million people–have chronic kidney disease. 2.6 million have kidney failure. The JV is expected to be formed in early 2023 with each company owning an equal share. Initial investment is not disclosed. According to the release:

  • Medtronic will contribute its Renal Care Solutions (RCS) business including the current product portfolio (renal access, acute therapies, and chronic therapies), product pipeline, and global manufacturing R&D teams and facilities.
  • Both companies will provide an initial investment to fund the new company (NewCo) and future certain operating capital.

FierceBiotech, Medtronic release

Withings reenters remote patient monitoring with Withings RPM. Their initial entry was with MedProCare back in 2019 but apparently in the repositioning of the company since the buyback from Nokia in 2018, it was back-burnered. The new RPM will be based on an app that will:

  • track time for CMS-compliant billing reports and uploadable to the provider EHR
  • support billing for CMS codes 99453, 99454, 99457, 99458
  • a digital patient-facing assistant
  • full connectivity to Withings devices such as scales, blood pressure monitors, and sleep monitors
  • implementation support by their Health Solutions teams

Withings RPM page, Outsourcing-Pharma

Looking hard for an M&A that relates to us in this very quiet market, Lightbeam Health Solutions, a population health software company, is acquiring Jvion Inc. Jvion has AI-enabled prescriptive analytics and social determinants of health (SDoH) solutions which will be combined with Lightbeam’s health analytics and outcomes for payers and providers. Terms of the acquisition and leadership transitions were not disclosed. Lightbeam release

News Roundup of acquisitions, funding: Health Catalyst-Vitalware, Change Healthcare-Nucleus.io, Medtronic-Companion Medical, Cecelia Health; Proteus Health sale contested, but sold (updated 20 Aug)

August 19, 2020 | by

Spin that lasso, round up the dogies, because we’re going to the rodeo! Data and analytics company Health Catalyst is acquiring Vitalware, which provides ‘chargemaster’ revenue workflow optimization and analytics SaaS technology to healthcare organizations. The deal is expected to come in at about $120 million with a $30 million earnout, funded by stock and cash, and close later this year.  Health Catalyst is on a buying tear, having acquired Healthfinch, a prescription refill management and visit planning platform to close care gaps, for $40 million in cash and shares in July. Health Catalyst went public in July 2019 and is trading at a market cap of nearly $1.3 bn (Unicorn Status isn’t what it used to be!). They’ve also inked a partnership deal with Northwell Health, the largest provider in New York State, to expand Northwell’s enterprise data and analytics capabilities with EHR integration. Health Catalyst releases on Vitalware, Healthfinch, and Northwell Health. Also FierceHealthcare.

Updated. Another major 2019 IPO, Change Healthcare, is acquiring Nucleus.io, a  cloud-based imaging and workflow platform, from San Diego-based developer NucleusHealth. This is a significant move, fitting into their Enterprise Imaging area and accelerating their implementation of a complete cloud-based, end-to-end solution within their Enterprise Imaging Network. Nucleus.io serves over 7,500 organizations and will add to Change Healthcare’s imaging customer base. Change is acquiring the Nucleus.io technology and team. NucleusHealth will continue to operate under its own name; they also operate a teleradiology platform, StatRad. Terms were not disclosed. Release. HealthcareITNews (Updated to clarify that the Change Healthcare acquisition is the Nucleus.io technology and not NucleusHealth the company)

Medtronic, which insiders dub the 9,000 lb. elephant of medical devices and remote patient management, has been quiet of late, but that doesn’t mean the elephant isn’t moving and sitting where it wants to sit. Continuing to build in diabetes care, they have just acquired Companion Medical, developer and marketer of the InPen, a insulin pen with a companion app, which was FDA cleared in 2016 and remains the only ‘smart insulin pen’ system. Eli Lilly and K2 Health Ventures were Companion’s major funders. Closing is expected within two months. Terms were not disclosed. Medtronic is clearly constructing a closed-loop diabetes management system through acquisitions such as Companion as well as diet-management startups Klue and Nutrino.  Release, Mobihealthnews. 

And in diabetes management, Cecelia Health (the renamed Fit4D), scored a healthy $13 million in Series B funding. Rittenhouse Ventures and Endo Investors co-led the round, with participants Boston Millennia Partners, SustainVC, G100 Capital and others, for a total of $22.4 million in funding (Crunchbase). Fit4D developed clinical virtual coaching with certified diabetes educators, and partners with health plans, self-insured employers, medical device and pharma companies. The funding will go to developing a first-in-kind ‘Virtual Clinic’ for diabetes, which will offer continuous glucose monitoring (CGM) training, education on medication adherence and lifestyle and behavior change, mental health screening and counseling. These will be then supported by algorithms recommending necessary dosage and titration changes that will be reviewed and approved by Cecelia Health’s Certified Diabetes Care and Education Specialists (CDCES) and endocrinologists.  Release, Mobihealthnews  A few days before the funding, Cecelia announced their participation with the Jaeb Center for Health Research Foundation in Tampa in their research to develop a virtual specialty clinic model, funded by a $5 million grant from the Helmsley Foundation. Release

Updated for Proteus sale. The troubled ‘smart pill’ pioneering company and one-time unicorn Proteus Digital Health, which filed for Chapter 11 (reorganization) bankruptcy on 16 June [TTA 17 June], planned to exit it with a $15 million ‘stalking horse’ deal with Otsuka Pharmaceuticals in advance of a bankruptcy auction. ‘Stalking horse’ deals set a floor at an auction and essentially set a minimum price. Investors, including Novartis and two Hong Kong funds, contested that fire sale earlier this week, claiming the sale to Otsuka was undervalued and if the IP and other assets were divided, a higher price would be obtained. One could understand their feelings, as Proteus raised nearly $500 million from them which essentially has vanished.

On Wednesday 19 August, the US Bankruptcy Court for the District of Delaware approved the sale to Otsuka, which was filed on Thursday. A key part of the hearings was Proteus’ investment banker, Raymond James & Associates, fruitlessly reaching out to over 240 potential buyers. What scared them off was Proteus’ burn rate–between $2 million and $2.5 million a month–with no clear prospect of positive cash flow or profitability (the latter quite elusive even in public companies). The purchase by Otsuka, which was deemed fair in the ruling with the opportunity for others to provide higher offers, covers information technology assets, intellectual property, and equipment, including equipment used to design and manufacture wearable sensors. Related court documents.

Otsuka was Proteus’ last major partnership for Abilify MyCite that ended suddenly in January. From the case documents schedule, this will be wrapped by end of September. FierceHealthcare 12 Aug, 27 July    STAT+ (paywalled) 20 Aug, HealthcareITNews

The last news roundup for 2019: ACA mandate unconstitutional, more $ for health research, PartnersHealthcare rebrands, Hackensack Meridian pays ransom, breaches>heart attack deaths, telepsychiatry merger, more

December 19, 2019 | by

Well, it’s happy trails for 2019, until we meet again in 2020, paraphrasing a well-known Roy Rogers tune (Roy was a movie and TV cowboy singer in the US; his eponymous roast beef sandwich chain was an advertising client for one of this Editor’s first jobs). So we’ll round up the news as we and I trust most of our Readers will be off for most of the next two weeks to be observing the holidays with family, friends, de-stressing, defrosting, or attempting to catch up on work while it’s quiet before January Madness hits. It’s hard to believe that This Year of Grace is almost over.

Breaking News: In a somewhat split decision, the Fifth Circuit Court of Appeals ruled Wednesday evening that the (Un) Affordable Care Act’s (ACA)’s individual insurance mandate, compelling everyone to signup Or Else, is unconstitutional. Congress zeroed out the mandate charge in 2018’s tax law. A decision regarding severability of the mandate from the ACA law has been remanded to the District Court. FierceHealthcare, Healthcare Dive

Also here in the US, we have both an impeachment of a President (a House action which will fail utterly in the Senate, and regarded by ordinary folks as a political annoyance) and a Federal budget running out on Friday that hardly anyone notices because it’s been extended since October by two continuing resolutions (CRs). The new budget that has to be signed by President Trump on Friday is, according to this POLITICO report today, chock full of health research dollars for NIH, the All Of Us genomics initiative directed by Eric Dishman, the Patient-Centered Outcomes Research Institute, or PCORI. and more. There’s some coal dust in the stocking for the national patient identifier initiative. Separately, CMS’ Blue Button 2.0 is offline due to a bug.

PartnersHealthCare rebranding, investing $100 million. Now called Mass General Brigham to better align with its parents (Massachusetts General Hospital and Brigham and Women’s Hospital, the Boston Globe reported that MGB will be spending $100 million for the first 18 months of a digital health initiative to improve the patient experience and the efficiency of care. Much will be around patient convenience, for example the ability to book appointments online, communicate with care providers via video and text, and providing online access to their medical records through OpenNotes. Efficiency initiatives will be focused on analytics and AI to manage patient flow and track revenue. The strategic plan and rebranding is promoted as a five-year project. Partners has been a pioneer in the field, with other large health systems following such as Novant Health (NC) and Mount Sinai (NY) with innovative partnerships and investments. FierceHealthcare

Hackermania in Hackensack continues. TTA reported last week that local New Jersey media identified Hackensack Meridian Health had been the victim of a ransomware attack starting on 5 December. The health system confirmed on Friday that it was a ransomware attack and they paid an undisclosed sum covered by insurance. The attack forced them back to paper records in all 17 of their hospitals, so with the insurance–and against law enforcement advice–they decided to pay up. Asbury Park Press, Healthcare IT News,Health IT Securitywhich also mentions the November attack on Oahu (Hawaii) Cancer Center. International hacker and ransomware attacks on vulnerable healthcare organizations are the subject of these year-end roundups: CISOMag, Becker’s Hospital Review.

Cyberbreaches increase fatal heart attacks? A Vanderbilt University study has also traced an uptick in patient mortality after heart attack to delayed care due to breaches. A survey of 3,000 Medicare-certified hospitals, about 10 percent of which had experienced a data breach, led to 36 additional deaths per 10,000 heart attacks. Krebs On Security blog

Short takes: the Sutter Health-Aetna partnership is adding home visits via Heal and telemedicine via 98point6 in Sutter’s Northern California area….Medtronic snapped up eating behavioral health startup Klue to reinforce a hybrid closed loop system to simplify diabetes management….Telepsychiatry is still niche, but InSight Telepsychiatry and Regroup Telehealth, two of the larger companies in the field, agreed to combine to be the single largest with a few hundred centers. Both American Well and Teladoc are encroaching on this area. 

We wish our Readers a Festive Holiday Season, whether you celebrate the week of Hanukkah, Christmas, Kwanzaa, or

another holiday. Rest, reflect, and our best wishes for a happy, healthy New Year. We will be off except for perhaps an occasional article until after 2 January.

 

News roundup: NeuroPace’s brain study, Welbeing’s Liverpool win, VA’s Apple talks, Medtronic’s diabetes move

December 6, 2018 | by

imageNeuroPace, which developed an implanted brain-responsive neuromodulation system for patients with refractory and drug-resistant epilepsy, announced the result of their nine-year long-term treatment study.

  • Approximately 3 out of 4 patients responded to therapy, achieving at least 50% seizure reduction
  • 1 in 3 patients achieved at least 90% seizure reduction
  • 28% of patients experienced seizure-free periods of six months or longer; 18% experienced seizure-free periods of one year or longer
  • Median seizure reduction across all patients was 75% at 9 years
  • Quality of life improvements (including cognition) were sustained through 9 years, with no chronic stimulation-related side effects.

The study included 256 patients across 33 epilepsy centers with nearly 1,900 patient implant years of follow-up on the RNS System. Release.

Liverpool Mutual Homes (LMH) sheltered housing awarded its emergency alarm contract to Welbeing, a Doro Group company. Welbeing has added 1,200 LMH residents to their alarm services. Release (PDF).  Hat tip to Welbeing’s Charlene Saunders.

It appears that the VA is talking with Apple about a mobile EHR. VA patients would be able to transfer their records to their iPhone — likely through Apple’s Health Records app. No time frame is mentioned and it’s hard to expect a quick turnaround given the VA’s stringent IT and security requirements. Another factor is that VA is making the long transition from VistA to Cerner’s MHS Genesis, bumpily. Mobihealthnews picking up a paywalled Wall Street Journal article.

Medtronic, otherwise known as the 9,000 lb Elephant that Sits Where It Wants, will acquire long-time diabetes partner Nutrino, an AI powered personalized nutrition platform. In June, Medtronic integrated Nutrino’s FoodPrint Report technology that connects meal and glucose variability into Medtronic’s iPro2 myLog app. Terms and timing were not disclosed. It fits in Medtronic’s recent strategy of smaller acquisitions and beefing up its diabetes business. Mobihealthnews.

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

July 17, 2018 | by

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

June 28, 2018 | by
[grow_thumb image=”https://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

January 16, 2018 | by

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!

January 9, 2018 | by

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 #pinksocks—pinksocks 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

November 10, 2017 | by

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)

September 6, 2017 | by
[grow_thumb image=”https://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

June 13, 2017 | by

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)

June 7, 2017 | by

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

February 15, 2017 | by

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.