News roundup: ONC recommends ‘nutrition labeling’ for healthcare AI apps but Google moves forward; CVS’ health services rebranding as Healthspire (updated); Clover Health repots out of ACO REACH

December 6, 2023 | by

Straining toward a model for AI app information? The latest grope by Federal regulators towards the “trustworthy use of artificial intelligence”, as the American Telemedicine Association terms it, is a labeling system that has been likened to ‘nutrition labeling’. This near-incomprehensible analogy to food labeling was proposed back in April by the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC), now headed by Micky Tripathi, Ph.D. This disclosure would consist of how the app was trained, how it performs, how it should be used, and how it shouldn’t, which does not sound onerous at all. The disclosures are designed to forestall issues around performance and bias that have previously appeared, such as Epic’s AI system designed to predict sepsis risk and an algorithm designed to flag patients needing assistance with complex treatment regimens. 

An optional proposed disclosure around how the app was trained and tested would be important to healthcare organizations but potentially problematic to developers. There are quite a few caveats expressed by Silicon Valley investors around hurting startups and even giants like Epic through over-disclosure of proprietary information, enabling reverse engineering and poaching of intellectual property. Everyone likes transparency, trust, safety, and efficacy, but the conundrum is to disclose what is needed for proper and cautious use without providing an entreé to IP. Wall Street Journal, Becker’s, ATA release and AI principles 

Google, predictably, damns the torpedoes, full speed ahead with healthcare AI. And intends to write the rules. They’ve deployed AI tools already with Mayo Clinic and HCA Healthcare–Mayo for medical records and research papers, HCA for clinical notes. EHR Meditech is using Google’s AI for clinical documentation and to summarize patient histories. Bayer is also working with Google. Their products include a licensed algorithm for breast and lung cancer detection, a tool for diagnosing diabetic retinopathy, and a question-answering bot. Google makes no secret that they plan to influence Federal efforts at setting standards by hiring lobbyists, most of whom are out of the Food and Drug Administration (FDA), and playing a large role in industry groups such as the Coalition for Health AI (CHAI).  If you believe that Google, Microsoft, Amazon (playing catchup), or other healthcare service companies like UnitedHealth Group’s Optum will twiddle their thumbs and wait for the Feds to set standards and (good grief) enforce disclosure on AI tools, this Editor has several lovely bridges for sale. POLITICO, Becker’s

CVS Health grouping health services and multi-payer assets under CVS Healthspire. Monday’s announcement at the Forbes Healthcare Summit will roll up new $20 billion acquisitions Oak Street Health and Signify Health along with 1,100 MinuteClinics, the CVS Caremark pharmacy benefit manager (PBM), CVS Specialty, and its new Cordavis operation that works with pharmaceutical companies to bring to market  biosimilars. The rebranding, a clever melding of ‘health’ and ‘inspire’, will start this month into 2024. It’s not revealed whether the current names will be sunsetted for CVS Healthspire, or whether they will keep their established brand names. The parallels are with Evernorth (Cigna), Optum (UnitedHealth Group), and Carelon (Elevance, the former Anthem) in creating a vertically integrated healthcare company. At Investor Day, CVS Pharmacy announced a cost-plus arrangement for retail prescriptions built on the cost of the drug, a set markup, and a fee that reflects the care and value of pharmacy services–clearly in competition with Mark Cuban CostPlus.  Forbes, FierceHealthcare, CVS release, Investor Day release  

Clover Health exits the advanced value-based primary care program, ACO REACH. Clover’s exit at the end of the 2023 performance year after two years disbands their practice arrangements for CMS’ advanced original Medicare shared savings program, formerly Direct Contracting, and provision of beneficiary services after completing their required wrapups and reporting. It is part of their recent moves to become profitable, focusing on their Medicare Advantage business and Clover Assistant management. They outsourced their Medicare Advantage plan administration to UST HealthProof for a savings of $30 million and laid off 10% of staff as part of restructuring. A 2021 SPAC on Nasdaq debuting above $16 that survived investigations by the SEC and DOJ now has shares trading currently under the $1.00 minimum for listing. Clover also finally settled seven shareholder lawsuits over its non-disclosure of the DOJ investigation at the time of the SPAC. Cleaning house is all part of living to fight another day, like other ‘insurtechs’ such as Oscar Health. Clover release, FierceHealthcare  Also: Looking back at insurtechs and their ‘disruption’,  Insurtechs in the widening gyre

Monday roundup: Envision files Ch. 11, who’s to blame for Meta Pixel abuse?, CVS Health to shut clinical trials unit, Amino Health scoops $80M, DocGo flat but optimistic, Owlet way down in revenue

May 16, 2023 | by

What was envisioned last week came to pass for Envision Healthcare on Sunday. The hospital and physician staffing company filed for Chapter 11 reorganization five years after it was taken private by investment company KKR. At the time of that massive buyout, the value of the company was pegged at $10 billion. Things started to go south for Envision after 2020 with the pandemic drying up patient volumes for two years, with the added factors of regulations kicking in on ‘no surprise’ billing, inflation, staffing shortages, and major fights with health plans around out-of-network inflated charges plus a huge claims dispute with UnitedHealthcare [TTA 12 May]. Ironically, Envision won the main dispute with UHG; that $91 million won in arbitration in an insider’s view would have staved off the bankruptcy this year.

KKR will apparently lose its $3.5 billion equity in the company as $8 billion in debt restructuring takes place. What’s before the court is that the Envision staffing operation will be separated from the AmSurg surgical clinics. Senior lenders will have their debt rearranged into equity into one or the other company. Junior lenders, bondholders, and KKR will receive zero, or as we say locally, bupkis. It’s envisioned (sic) that the restructuring will take about three to four months.  Financial Times, Envision release

The hospitals, that’s who! If you believe Meta, it’s the hospitals that abused those poor Pixels, making them do things against their wishes to tattle all sorts of PHI and PII to Big Bad Meta which sends patients all those Nasty Intrusive Ads. Meta is being sued by parties from the ACLU to patients in class action lawsuits on how the Pixel was used on hospital patient portals and scheduling websites. Meta’s argument is that the health systems’ developers could but did not control how the ad trackers were used and that “Meta did not implement or configure” the Pixels used on the health systems’ websites. In fact, Meta claims that they have filtering tools that screen out sensitive data and that would alert the developer. “It’s ultimately the developer, not Meta, that controls the code on its own website and chooses what information to send,” according to the May 5 filing in that busy US District Court of Northern California.

This could influence outcomes in the multitude of lawsuits being filed against health systems like Kaiser Permanente, UCSF Health, and LCMC Health in New Orleans plus Willis-Knighton Health in northwest Louisiana (Healthcare Dive). If the District Court finds that Meta, and possibly other ad trackers such as those from Google, Twitter, or Bing were not inherently liable for personal health data violations that monetized PHI, then the health systems are 100% on the hook for the data breaches (or ‘wiretapping’ in a creative use of terminology). It also makes the potential paydays possibly less lucrative–in the eyes of this Editor, as Meta and Google have far deeper pockets than any ol’ health system. SC Media, Paubox   The Meta Pixel backstory here

CVS Health to shut its clinical trials unit by December 2024. CVS, like Walgreens and Walmart, jumped into the clinical trials business during the Covid-19 pandemic, seeing a need in the market with pharmaceutical companies and a ready-made, 100 million deep diverse base of patients among their pharmacy users. CVS cited to Healthcare Dive that the shutdown was to better concentrate on core business. Current active trials on the website include narcolepsy, rheumatoid arthritis, and kidney health. No disclosure as to profitability but CVS has a lot to digest with new buys Signify Health and Oak Street Health.

Amino Health’s $80 million funding is a bright spot in this sideways spring. With a digital guidance model that works with employers and health plans to help 1.6 million members navigate their care, their new funding will be used for technology scaling. Equity and debt financing were led by Transformation Capital, which will be joining the Amino board, and Oxford Finance LLC. Amino is being boosted by the Federal Transparency in Coverage (TIC) Rule which makes pricing disclosure a key part of plan navigation. Amino originally started with a direct-to-consumer model but shifted to enterprise, including brokers and third-party administrators. Amino’s total raise is now $125 million (Crunchbase). Mobihealthnews, Amino release

DocGo’s two services, mobile health and medical transport, essentially swapped revenue this quarter in a better-than-average picture. Their mobile health services area in Q1 fell 19% to $72.9 million from $90.1 million in Q1 2022, while transportation services grew 44% to $40.1 million from $27.8 million in Q1 2022. This added to total revenue of $113 million with a net loss of $3.9 million. Their 2023 revenue guidance remains at $500-$510 million with adjusted EBITDA guidance of $45-$50 million. 

What’s promising here is that it’s a SPAC that didn’t crack like practically every other. DocGo pointed out in their release that they have a backlog of $205 million in total contract value over approximately three years and they have doubled their RFPs. Their patient target for 2023 is 50,000. Share price today on Nasdaq ticked up to $8.77. Considering their high last year of $11.08, they are not doing badly in this time at all. Mobihealthnews .We last saw DocGo providing mobile clinics in a Tennessee pilot with Dollar General [TTA 24 Jan] which now is tied in with the state of Tennessee, plus a pilot in NY and NJ with Redirect Health. They provide services in 26 states and the UK.  

This Editor is trying to be as cheerful as the baby at left about baby sock/monitor Owlet, which has had a rough ride in the past two years. Their revenue dropped to $10.7 million in Q1 2023 versus $12 million in Q4 2022 and $21.5 million in Q1 2022. Owlet ended 2021 with a nastygram from the FDA that pulled their original Smart Sock off the market [TTA 4 Dec 2021] but rebounded early in 2022 with the Dream Sock and Dream Duo [TTA 16 Feb 2022] that avoided the claims that sent them into 510(k) Marketing Neverland.  Still, they were delisted by the NYSE in December 2022. On the positive side, Owlet wound up 2022 with $69.2 million in revenue and a good-sized private placement of $30 million in February [TTA 18 Mar]. It has submitted to FDA for two products, including the steep de novo climb on an enhancement to the Dream Sock. Now a much smaller company than it was last year, they have reduced operational expenses to $15.1 million from $24.1 million in Q4 2022 to get to breakeven by end of this year and to be relisted on the NYSE in the future. Having followed them since the early ‘telehealth for the bassinet set’ days of 2012-2013, this Editor wishes them bonne chance. Owlet release, Mobihealthnews

Rounding out week: Oracle Health engineering head departs; Hive ransomware KO’d by DOJ; Google sued by DOJ on antitrust, lays off another 12,000; Pearl and Precision Neuro raise, Enabled Healthcare ADAPT grant

January 28, 2023 | by

Oracle Health engineering executive VP Don Johnson ankles after six months. Mr. Johnson, who was a nine-year veteran of Oracle, came up through the cloud infrastructure area starting in 2014, after a previous stint from 2005 at Amazon Web Services. He led product strategy, engineering, and operations before shifting over to Oracle Health. Oracle’s Cerner acquisition has been one Tower of Trouble, a Mound of Misery, even before it closed last June. Being barked at by Congress and the GAO over the VA and MHS, plus eroding relationships with health systems over EHR problems, and with the pressure from the tip-top to fix it fast and get on with the transformation of healthcare, could lead one to consider a long trip to a Remote Pacific Island. The Register. Hat tip to HISTalk.

In one for our side, the Department of Justice (DOJ) announced that the international ransomware network known as the Hive was shut down. Its servers in Los Angeles and darknet sites were seized. The DOJ continues to pursue charges against Hive members. The Hive ransomware was used in attacks on an estimated 1,300 companies worldwide since June 2021, yielding about $100 million in ransom payments. Hospital systems attacked were numerous, including Memorial Hermann Health System in Houston and a Louisiana health system.   DOJ release 26 Jan, Healthcare IT News, HealthITSecurity

The problems at Google continue with a DOJ civil antitrust lawsuit released earlier this week accusing Google of monopolizing multiple digital advertising technology products. For those of us in marketing who came up with a choice of multiple search engines and ad technologies, Google’s monopoly of the “ad tech stack” that website publishers depend on to sell ads and that advertisers rely on to buy ads is very real, and very expensive. You live and die by Google algorithms on your search ranking, both natural search and optimization. In other words, you deal with Google or nobody. So the DOJ lawsuit, joined by eight states, is, in this Editor’s view, overdue. Few are drawing a line between this antitrust suit and the layoffs of 12,000 Google staff (6%) last week plus the cutbacks at Verily, but this Editor will. DOJ release, CNBC

Funding raises in seed, Series A and B are the most common–two of note in Series B this past week:

  • Pearl Health raised a $75 million Series B of $55 million in equity capital and an anticipated $20 million in a line of credit. The round was led by Andreessen Horowitz’s Growth Fund and Viking Global Investors. Pearl is a developer of services and software for independent providers to enable them to better participate in value-based care through consolidating healthcare data and then using that information to create personalized patient care plans.  Release, MedCityNews 
  • Precision Neuroscience raised $41 million, also in a Series B.  Precision is another brain-computer interface technology like Synchron [TTA 17 Dec 22], in this case focused on treatment of neurological illnesses and events such as stroke, traumatic brain injury, and dementia. Leading the round is Forepont Capital Partners. Mobihealthnews 

In even earlier-stage companies, grants from accelerators are still present and are significant. Enabled Healthcare is a startup that has received a grant of $50,000 from Village Capital’s ADAPT program, It is one of four receiving an equity-free, peer-selected grant. ADAPT, funded by MetLife Foundation, supports innovation and development of solutions for key issues related to climate change, healthcare and wellness, and economic mobility. Enabled was selected from over 130 startups. Enabled combines in-person and virtual monitoring approaches to better coordinate care for those with complex needs on Medicare and Medicaid, and will go live in March. Release 

Facebook Meta Pixel update: Nemours Children’s Health using 25 ad trackers on appointment scheduling site

June 21, 2022 | by

The Meta Pixel tracker study gets a little worse–this time, it’s information on appointments for children. The Markup’s investigation on healthcare use of ad trackers continues with an examination of Nemours Children’s Health, a Delaware-based multi-state health network with 97 locations in Delaware, Pennsylvania, New Jersey, and Florida that serve about 500,000 families. Once again, Meta Pixel and other ad trackers were found to capture personal information and patient/family details entered by an adult on the appointment scheduling site to Facebook that may constitute protected health information.

Meta Pixel was recorded as tracking:

  • IP addresses
  • Scheduled doctor and his or her specialty
  • In some cases, the first and last name of the child being scheduled

It is not this information alone, but in combination with other information that Facebook possesses, that can profile any user’s health conditions, link specific conditions to individuals and parents, and thus constitute a privacy violation. IP addresses are one of the factors that HIPAA cites as when linked to other information, create a violation.

The Markup used a tool called Blacklight to scan Nemours’ websites.

What was Nemours thinking in building their website? In addition to Meta Pixel, the scheduling site is riddled with 25 ad trackers and 38 third-party cookies. These are coded in by Facebook, Amazon, Google, and The Latest Healthcare Transformer, Oracle. Oracle claims it has healthcare data on 80% of US internet users, and one can assume this is how they get it. Ad platforms MediaMath and LiveRamp also captured data. The Markup’s team could detect the trackers, but not determine what information these ad trackers were capturing. 

In addition to the trackers on the scheduling site, Blacklight picked up a session recorder from Mouseflow. This is code that can potentially track what people click on a page. Mouseflow states on its Legal Hub that in order to transmit HIPAA-protected information to a third party, a business associate agreement (BAA) must be in place. Mouseflow did not confirm a BAA agreement to The Markup, but in a statement to them insisted that Mouseflow does not permit the transmission of PII or PHI and masks that information.

Not all health data transmitted constitute HIPAA violations, but capture of appointment scheduling information is right on the line of HIPAA violations, though not 100% conclusive.

Elsewhere on the Nemours website, there were nine ad trackers and ten third-party cookies. 

Even after they were notified by The Markup, Nemours persisted in using Meta Pixel. While many of the trackers on the scheduling site were removed, trackers from Facebook, Google, and Salesforce remained. Facebook’s Meta Pixel was removed after last week’s story.

This is certainly another gap between the suits in the suites and the IT/developers rowing in the galley.

Feel the Fitbit burn (literally)–1.7 million Ionic models recalled due to battery burn hazard

March 4, 2022 | by

It’s those lithium-ion batteries again. Reminiscent of Samsung’s exploding Galaxy Note 7 (and recently on fire Galaxy A21), Google’s Fitbit on Wednesday recalled 1.7 million Fitbit Ionic watches worldwide. In the US, there were 115 incidents reported with 78 burn injuries, including two reports of third-degree burns and four reports of second-degree burns. Internationally, there were 59 overheating incidents reported with 40 burn injuries.

The popular Ionic fitness and smartwatch sold about 1 million in the US and 693,000 internationally from September 2017 to December 2021. Fitbit stopped producing the Ionic in 2020. There are four models in four color combinations, including an Adidas edition. According to the US Consumer Product Safety Commission (CPSC) recall notice, owners should stop using the Ionic and contact Fitbit to receive pre-paid packaging to return the device. Upon receipt, owners will be refunded $299 with a discount code for 40% off five select Fitbit devices and accessories available through Fitbit’s discount store for a limited time. Original cost of the watch ranged online and at retail outlets from $200 to $330. 

The Fitbit help page has the details on where to mail the watches, refund, and discount. And disposal if one doesn’t care to return it. 

Do expect there will be some kind of a class-action suit against Google/Fitbit–the combination of injury and deep pocketed defendants is a magnet. Fox Business News

How Big Data failed public health during COVID

January 20, 2022 | by

Once upon a time, say about 2012, Big Data and Massive Crunching was going to show us The Way. Better health, diagnosis, prevention, behavior, and a whole lotta other things. Doctors, nurses, engineers, and marketers feared that their jobs would be taken over by the handsome specimen to the left.

So at the start of the COVID pandemic, the hope was that Big Data was going to map the outbreaks and contact trace so that people could go into self-lockdown after a ride on a bus or subway, inform distancing measures, and identify hot spots for public health organizations, no matter how remote. Academic researchers and nonprofit partners mobilized into the non-profit Covid-19 Mobility Data Network that started by analyzing smartphone location data shared by tech companies. The intent was that public health officials could analyze it for insights based on hard data rather than 6′ guesstimates. It would then be expanded with additional data from Big Tech and grow, grow, grow.

Where it ran a cropper was the ad tech companies’ incompatibilities in data gathering, reluctance to share proprietary granular information, and privacy–an international battleground. Facebook turned out to be clueless in mapping mobility as a proxy or input to calculate contact rates, since it released only percent changes in movement or staying at home. The professors also didn’t figure on proprietary non-compatible systems and peculiarities stemming from business needs. Facebook, for instance, released data that mapped only eight-hour chunks in UTC which didn’t, of course, take into account normal bedtimes. Google would state that trends in staying home were up, versus Facebook data that indicated downward trends. Contact tracing, as Readers know, turned out to be a gigantic flop.

While the Covid-19 Mobility Data Network has evolved into a broader project called Crisis Ready, with the goal of creating data-sharing agreements that activate during a public health crisis, closing the gaps in data for epidemiological research remains elusive in areas such as urban versus rural and with specific demographics. STAT, PLOS Digital Health

Google joins the behavioral health wars, adds new senior executive from Headspace

October 28, 2021 | by

Google, having disbanded Google Health as a unit and scattered their products and teams internally, has decided that behavioral health is worth spending on across business lines. Megan Jones Bell, Psy.D., formerly chief strategy and science officer of Headspace, recently purchased by Ginger, rejoins Google this week as their first clinical director of consumer and mental health. 

She will be overseeing Google’s approach to mental health, supervising a team of clinicians, as well as coordinating primarily consumer-facing products such as the controversial verification of health information on Google-owned YouTube, across Google Search, Maps, Fitbit, and Cloud, medical products like the Care Studio EHR search app, depression screeners, and for employee health and safety. FierceHealthcare, Becker’s HealthIT

At least initially, Google does nothing in a small way. At HLTH21, Google’s chief health officer Karen DeSalvo, MD boasted that “Our get up every morning, raison d’être, is impact. It’s helping billions around the world be healthier.” Then followed broad and ambitious statements about social determinants of health (SDOH) and advancing health equity. Both have become a standard script for executive speeches at these conferences, virtual and in-person.

When scattered across multiple lines of business, it’s a little difficult to track ROI. And perhaps, that is the real Googly Goal. This Editor is of the opinion [TTA 24 Aug] that health is only a part-time pursuit for Big Tech, and that the real game is monetizing data–on people and what can be sold to healthcare organizations. When Big Tech tries to solve the problem of health by itself–which surely sounds what Dr. DeSalvo is about–it stumbles. Just ask David Feinberg, who decamped for Cerner after many frustrations at Google.  

News and deal roundup: Zus Health’s $34M ‘back-end in a box’, Bright Health’s IPO, Lyra Health’s $200M done, Valo Health’s $2.8B SPAC; UK’s Alcuris, Clarity Informatics, GTX test; Google’s health blues, Facebook’s smartwatch

June 18, 2021 | by

Athenahealth founder’s latest health tech venture lays track. Jonathan Bush’s new venture, Zus Health, is being pitched to tech founders as providing a ‘Lego’ like back-end for startup digital health companies. Variously compared to ‘Build-A-Bear’ or track laying, it’s an ‘in a box’ setup that provides a data record back end, a software development kit (SDK) with tools and services, and a patient interface. Presumably, this will also assist interoperability. Mr. Bush has enlisted an all-star team and is basing outside of Boston in the familiar area of Watertown, Massachusetts. Andreessen Horowitz (a16z) led the $34 million Series A, joined by F-Prime Capital, Maverick Ventures, Rock Health, Martin Ventures, and Oxeon Investments. The financing will be used for engineering the tech stack. Current clients developed in stealth include Cityblock Health, Dorsata, Firefly Health, and Oak Street Health. Not a breath about the revenue model other than ‘partnership’. Make sure you pronounce Zus as ‘Zeus’ (Athena’s father for those who aren’t up on their Greek myths). Zus release, FierceHealthcare

This week’s IPO filing by insurtech/clinic operator Bright Health with the Securities and Exchange Commission (SEC) confirmed earlier reports that the offering will crest over $1 billion [TTA 28 May]: 60 million shares with an initial valuation of $20 to $23 is at a minimum of $1.2 billion. Company valuation is estimated at $14 billion which is about midpoint of earlier estimates. It will trade on the NYSE under BHG. The cherry on the cake is a 7.2 million 30-day share purchase option to their underwriters at the initial IPO price. Timing is not addressed in the release but expect it soon. BHG release, Mobihealthnews

Lyra Health banks an additional $200 million. This week the corporate mental health therapy provider completed their Series F $200M financing backed by Coatue, new investor Sands Capital, plus existing investors, for a total of $675 million to date (Crunchbase). Valuation is now estimated at $4.6 billion. Mental and behavioral health tech remains warm, with the thundercloud on the horizon Teladoc’s myStrength app [TTA 14 May]. Lyra’s strong corporate footprint puts them, along with Ginger, in a desirable place for acquisition by a telehealth provider or payer. Lyra release, FierceHealthcare

Drug discovery and development company Valo Health is going the SPAC route with Khosla Ventures. The special purpose acquisition company (SPAC) Khosla Ventures Acquisition Co. will form with Valo Health a new company (KVAC) with a pro for­ma mar­ket val­ue of approx­i­mate­ly $2.8 bil­lion with an initial cash balance of $750 million including a $168 million PIPE led by Khosla Ventures. Valo’s flagship is the Opal Computational Platform that creates an AI-based platform for drug discovery. The current pipeline has two clin­i­cal-stage assets and 15 pri­or­i­tized pre-clin­i­cal assets across car­dio­vas­cu­lar meta­bol­ic renal, neu­rode­gen­er­a­tion, and oncol­o­gy fields. Khosla has been largely absent from digital health investments. The SPAC route to IPOs has also cooled. Valo release, Mobihealthnews  

And short takes on other news… (more…)

Google’s Care Studio patient record search tool to pilot at Beth Israel Deaconess Medical Center

April 9, 2021 | by

A cleaned-up Project Nightingale? Beth Israel Deaconess Medical Center (BIDMC) in Boston announced their participation in a pilot with Google of Care Studio, described in the BIDMC press release as “a technology designed to offer clinicians a longitudinal view of patient records and the ability to quickly search through those records through a single secure tool.” In other words, it’s like Google Search going across multiple systems: the BIDMC proprietary EHR (WebOMR), core medical record system, and several clinical systems designed for specific clinical specialties. All the clinician need do is type a term and the system will provide relevant information within their patient’s medical record from these systems, saving time and promoting accuracy. (See left)

The BIDMC pilot will use a limited group of 50 inpatient physicians and nurses, to assess the tool’s quality, efficacy, and safety of its use. Technical work starts this month.

At the end of the BIDMC release, it’s carefully explained that the tool is “designed to adhere to state and federal patient privacy regulations, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and industry-wide standards related to protected health information. BIDMC and Google Health have entered into a Business Associate Agreement (BAA) to ensure that both parties meet patient privacy obligations required under HIPAA. BIDMC patient data will be stored and maintained in a protected environment, isolated from other Google customers.” (Editor’s emphasis) The BAA was inked in 2018.

Without referring to it, it addresses the controversy surrounding Google’s Project Nightingale and Ascension Health, a major privacy kerfuffle pre-COVID that broke in early November 2019. From the TTA article, edited: “Google’s BAA allowed them apparently to access in the initial phase at least 10 million identified health records which were transmitted to Google without patient or physician consent or knowledge, including patient name, lab results, diagnoses, hospital records, patient names and dates of birth.” Ascension maintained that everything was secure and Google could not use data for marketing or other purposes not connected to the project, but handling was under wraps and Google employees had access to the data. Ascension’s core agreement was about migration of data to Google Cloud and providing G Suite tools to clinicians and employees. But apparently there was also a search tool component, which evolved into Care Studio.

Health and Human Services (HHS) Office of Civil Rights, which governs privacy, announced at the time an investigation. The only later reference this Editor was able to locate was in HIPAA Journal of 5 March 2020 regarding the request of three Senators from both sides of the aisle demanding an explanation on the agreements and what information Google employees accessed. The timing was bad as then COVID hit and all else went out the window. In short, the investigations went nowhere, at least to the public.

It would surprise this Editor if any questions were raised about Care Studio, though BIDMC’s goal is understandable and admirable. Also Becker’s Hospital Review, FierceHealthcare

News Roundup: Doctor on Demand’s $75M Series D, Google’s Fitbit buy scrutinized, $5.4 bn digital health funding breaks record

July 9, 2020 | by

More evidence that telehealth has advanced 10 years in Pandemic Time. Doctor on Demand, estimated to be the #3 telemedicine provider behind Teladoc and Amwell, announced a Series D raise of $75 million, led by VC General Atlantic plus their prior investors. This increases their total funding to $240 million.

Unlike the latter two, DOD actively courts individual users in addition to companies and health plans. In May, they announced that they were the first to be covered under Medicare Part B as part of the CMS expansion of telehealth services in response to the pandemic (and for the duration, which is likely to be extended past July), which would reach 33 million beneficiaries. Other recent partnerships include a pilot with Walmart for Virtual Primary Care in three states (Colorado, Minnesota, Wisconsin) in conjunction with Grand Rounds and HEALTHScope Benefits as well as with Humana for On Hand Virtual Primary Care (regrettably only a video clip on the DOD press site with the noisome Jim Cramer). DOD covers urgent, chronic, preventative care, and behavioral health and claims about 98 million users, doubled the number of covered lives in 1st half 2020, and passed 3 million visits. Crunchbase News,  Mobihealthnews

Google’s Fitbit acquisition scrutinized by EU and Australia regulators, beaten up by consumer groups in US, EU, Canada, Australia, and Brazil. None too happy about this acquisition is a swath of powerful opponents.

  • EU regulators have sent 60-page questionnaires to both Google and Fitbit competitors asking re the effect the $2.1 bn acquisition will have on the wearables space, whether it will present disadvantages to competitors in Google’s Play store, and how Google will use the data in their advertising and targeting businesses. While #2 and 3 are no-brainers (of course it will present a competitive disadvantage! of course, they’ll use the data!), it signals further investigation. The next waypost is 20 July where EU regulators will present their decision.
  • The Australian Competition and Consumer Commission (ACCC) announced in mid-June their concerns in a preliminary decision, though they don’t have the jurisdiction to block it. “Buying Fitbit will allow Google to build an even more comprehensive set of user data, further cementing its position and raising barriers to entry to potential rivals,” according to ACCC Chairman Rod Sims. This adds to the controversy Down Under on how Google and other internet companies use personal information. Final statement is 13 August. Reuters
  • The US Department of Justice is also evaluating it, as is the Federal Trade Commission. But an acquisition like this doesn’t easily fall under antitrust regulation as Google and Fitbit aren’t direct competitors. Fitbit has only about 5 percent of the fitness wearable market. However, this plays into another related investigation by DOJ — Google’s abuse of advertising data and its dominance of the market in tech tools such as Google Ad Manager in the US. DOJ asked competitors for information at the end of June. There are separate investigations by state attorneys general and also by Congress of Google and Apple. Reuters. 
  • The consumer group opposition rounds up the usual suspects like Open Markets Institute, Omidyar Network, Center for Digital Democracy, Open Knowledge and Public Citizen in the US, and in the EU Open Society European Policy Institute and Access Now. Their grounds expressed in a letter to regulators in the above countries are the usual dire-sounding collection of “exceptionally valuable health and location datasets, and data collection capabilities.” Sound and fury….

It will keep Google’s attorneys in DC, Brussels, and elsewhere quite busy for a lot longer than perhaps Google anticipated. Meanwhile, Fitbit is in the Twilight Zone. The Verge, Android Authority, FierceHealthcare 

US digital health companies smash funding records in 1st half 2020. Despite–or because of–the pandemic, US digital health investment funding tracked by Rock Health is at a torrid pace of $5.4 bn–$1.2 bn above the record first half posted in 2019.  That is despite a pullback in 1st Q + April.

Investors came roaring back in May and June, spurred by telehealth success and a rallying market, closing 2nd Q with $2.4 bn in investment. That was 33 percent higher than the $1.8 bn quarterly average for the prior three years. And the deals were big: on average $25.1 million, with the big boosts in Series C and bridge financing. M&A is still cloudy, but what isn’t? Notably, Rock Health is not projecting a final year number, a good move after they stubbed their collective toe on last year’s final investment total, down from both forecast and 2018. [TTA 7 Feb]

The big moves of 1st half in real digital health (not fitness) were Teladoc-InTouch Health (just closed at $600 million stock and cash) and Optum-AbleTo (at a staggering $470 million, which has apparently not moved past the ‘advanced talks’ state). Two of last year’s Big IPOs–Phreesia and Livongo— are doing just fine; Health Catalyst not so much. The bubble bath we predicted turned out to be a cleansing one–but there’s six months more to go. Also Mobihealthnews

Breaking: NHSX COVID contact tracing app exits stage left. Enter the Apple and Google dance team.

June 18, 2020 | by | 1 Comment

Breaking News: The NHS finally abandoned the NHSX-designed COVID contact tracing app in favor of the app based on the Apple and Google API.

The NHSX version had issues, seemingly intractable, on the BTE features on distancing and contact duration between devices, as well as the app being inaccurate on the iPhone.

The “Gapple” app is already in use in Italy, Switzerland, Denmark, Latvia, and Poland. As this Editor noted on Tuesday, Austria is in test, Germany just launched their ‘Corona Warning App’ and reported 6.5 million downloads in the first 24 hours. 

The BBC reported that the lead on the NHSX app, Matthew Gould and Geraint Lewis, are “stepping back” and former Apple executive Simon Thompson is joining NHSX to manage it

Depending on reports, the NHS either rejected the Gapple app in April or were working on it in tandem from May. More likely, they revived the latter with the NHSX problems. The Gapple version is decentralized in storing information about user contacts on individual phone handsets because of issues over user privacy, versus the NHSX centralized app.

According to the FT and TechCrunch, the government is de-emphasizing the utility of the app, and relying on its small army of contact tracers. 

But what about all those folks on the Isle of Wight?

More on this: Digitalhealth.net, TechCrunch, Financial Times     Hat tip to Steve Hards for alerting this Editor at the end of a busy day!

News roundup: LabCorp CRO boosts Medable, Propeller Health gains 510(k), EU’s 34 medtech startups, Amazon’s healthcare moves, Google’s Arizona privacy lawsuit

May 29, 2020 | by

It does seem ages since our last one! One major winning category for digital health is clinical trials. LabCorp has one of the largest CROs (contract research organization), Covance. LabCorp has partnered with startup Medable, a Palo Alto-based company that decentralizes the gathering and analysis of clinical trial data from recruited participants through apps and telemedicine. Mobihealthnews  Confirming this trend: earlier this month, Medable cleared a $25 million venture round from GSR Ventures. Crunchbase  This does make rival CRO PRA Health Science’s pickup of Care Innovations from Intel late last year, for an undisclosed amount, look like a prescient (and likely a bargain) purchase.

Propeller Health, which specializes in digital respiratory health with sensors connected to inhalers and apps, gained 510(k) FDA clearance for a sensor/app for use with AstraZeneca’s Symbicort inhaler. This medication is used for asthma and COPD. It does not seem that long ago (2014) that the startup was at trade shows like NYeC and mHealth Summit with an exceedingly modest display of popups and brochures. Their 2019 acquisition by ResMed for the stunningly premium price of $225 million made news in late 2018. Mobihealthnews

In Europe, COVID-19 has boosted at least 34 medtech startups, including 11 in UK alone, followed by Switzerland and Sweden. This is based on a study by Oxford University data visualization spin-out Zegami. One of them happens to be Zegami on a project in using a limited dataset to distinguish between x-rays of COVID-19 infections and infections caused by viral or bacterial pneumonia, as well as images of healthy lungs. On the list are (naturally) Babylon Health and the slightly mysterious Medopad. Sweden’s Kry (LIVI in the UK) is also on the list. Kry/LIVI last made some news when Juliet Bauer of NHS Digital ankled to Kry in early 2019, Med-techInnovationNews, Mobihealthnews

Amazon’s latest stretches into healthcare are noted in a brief Becker’s Health IT article which notes AWS’ deals with Cerner and addition of healthcare-specific features with hospitals using AWS. Mayo Clinic has partnered with Alexa for voice responsive ‘Mayo Answers’. Some Amazon employees now have access to telehealth benefits (this Editor wonders why not all, beyond those Seattle warehouse workers). Industry research company CB Insights is projecting that Amazon’s next move will be a benefits marketplace for employers and payers. Meanwhile, their partnership with JP Morgan Chase and Berkshire Hathaway, Haven, has stumbled with its CEO Atul Gawande, MD, leaving the post to return to practice after less than two years. Executive turnover has been high, and the company has yet to announce a major initiative. FierceHealthcare 

Meanwhile, Arizona’s attorney general has sued Google for violating state privacy laws. Seems like Android users are trackable, even if they turn off location on their phones, through Google apps like Maps and Weather. The lawsuit also charges that Google changed its default tracking settings without informing users, using data for targeted ads. Becker’s Health IT 

News roundup: Kompaï debuts, Aging Tech 2020 study, Project Nightingale may sing to the Senate, Amwell, b.well, Lyft’s SDOH, more on telehealth for COVID-19

March 13, 2020 | by

Believe it or not, there IS news beyond a virus!

France’s Kompaï assistance robot is finally for sale to health organizations, primarily nursing homes and hospitals. Its objective, according to its announcement release, is to help health professionals in repetitive daily tasks, and to help patients. It’s interesting that the discussion of appearance was to achieve a ‘slightly humanoid’ look, but not too human. The development process took over 10 years. (Here at TTA, Steve’s first ‘in person’ with the developers was in May 2011!) Kompaï usage mentioned is in mobility assistance and facility ‘tours’ and public guidance. Here’s Kompai in action on what looks like a tour. Press release (French/English)

Not much on robotics here. Laurie Orlov has issued her 2020 Market Overview Technology for Aging Market Overview on her Aging and Health Technology Watch, and everyone in the industry should download. Key points:

  • In 2020, aging technologies finally nudged into the mainstream
  • The older adult tech market has been recognized as an opportunity by such companies as Best Buy, Samsung, and Amazon. Medicare Advantage payers now cover some tech.
  • Advances plus smart marketing in hearing tech–one of the top needs in even younger demographics–is disrupting a formerly staid (and expensive)
  • The White House report “Emerging Technologies to Support an Aging Population” [TTA 7 March] first was an acknowledgment of its importance and two, would also serve as a great source document for entrepreneurs and developers.

The study covers the demographics of the older adult market, where they are living, caregiving, the effect of data breaches, optimizing design for this market, the impacts of voice-driven assistants, wearables, and hearables.

Project Nightingale may be singing to some US Senators. The 10 million Ascension Health identified patient records that were transferred in a BAA deal to Google [TTA 14 Nov 19], intended to build a search engine for Ascension’s EHR, continue to be looked into. They went to Google without patient or physician consent or knowledge, with major questions around its security and who had access to the data. A bipartisan group of senators is (finally) looking at this ‘maybe breach’, according to Becker’s. (Also WSJ, paywalled)

Short takes:  b.well scored a $16 million Series A for its software that integrates digital health applications for payers, providers, and employers. The round was led by UnityPoint Health Ventures….Lyft is partnering with Unite Us to provide non-emergency patient transportation to referred health appointments. Unite Us is a social determinants of health (SDOH) company which connects health and community-based social care providers….What happens if you’re a quarantined physician due to exposure to the COVID-19 virus? Use telehealth to connect to patients in EDs or in direct clinic or practice care, freeing up other doctors for hands-on care. 11 March New England Journal of Medicine….American Well is finally no more, long live Amwell. Complete with a little heart-check logo, American Well completed its long journey to a new name, to absolutely no one’s surprise. It was set to be a big reveal at HIMSS, but we know what happened there. Amwell blog, accompanied with the usual long-winded ‘marketing’ rationale They are also reporting a 10 to 20 percent increase in telehealth consults by patients (Becker’s)….Hospitals and health systems such as Spectrum Health (MI), Indiana University Health, Mount Sinai NY, St. Lukes in Bethlehem PA, and MUSC Health, are experimenting with COVID-19 virtual screenings and developing COVID-19 databases in their EHRs. The oddest: Hartford (CT) Healthcare’s drive-through screening center and virtual visit program. Is there an opportunity to cross-market with Wendy’s or Mickey D’s? After all, a burger and fries would be nice for a hungry, maybe sick, patient before they self-quarantine.

Considering 2019’s digital health investment picture: leveling off may be a Good Thing

February 7, 2020 | by

2019 proved to be a leveling-off year for digital health investment. The bath may prove to be more cleansing than bubbly.

We noted that the always-fizzy Rock Health engaged in some revisionist history on its forecasts when the final numbers came in–$7.4bn in total investment and 359 deals, a 10 percent drop versus 2018. When we looked back at our 2019 mid-year article on Rock Health’s forecast [TTA 25 July], they projected that the year would end at $8.4 bn and 360 deals versus 2018’s $8.2 bn and 376 deals. That is a full $1bn under forecast and $0.8 below 2018. Ouch!

In their account, the 10 percent dip versus 2018 is due to average deal size–decreasing to $19.8M in 2019–and a drop in late-stage deals. Their analysts attribute this to wobbliness around some high-profile IPOs, citing Uber, Lyft, and Slack, as well as the near-collapse of WeWork right before its IPO towards the end of 2019.

New investors and repeat investors increased to 627 from 585 in 2018, with no real change in composition.

The headliners of 2019 were:

  • Amazon’s acquisition of Health Navigator adding symptom-checking tools to its health offerings
  • Google’s buy of Fitbit
  • Optum’s purchase of Vivify Health, which gives it a full remote patient monitoring (RPM) suite (right when CMS is setting reimbursement codes for RPM in Medicare)
  • Best Buy’s addition of Critical Signal Technologies for RPM
  • Phreesia, Livongo’s and Health Catalyst’s IPOs. For Livongo and Health Catalyst, current share prices are off from their IPOs and shortly after: past $25 for LVGO and $31 for HCAT. Phreesia closed today at a healthy $33, substantially up from PHR’s debut at $15. (Change Healthcare, on the other hand, is up a little from its IPO at $16, which isn’t bad considering their circumstances on their financing.)

Rock Health only counts US deals in excess of $2 million, which excludes the global picture, but includes some questionable (in this Editor’s estimation) ‘digital health’ players like Peloton, explained in the 25 July article.

Rock Health’s analysts close (and justify their revisions) through discussions with VCs expecting further headwinds in the market–then turn around and positively note the Federal backing of further developments in building the foundation for connected health as tailwinds. No bubbly forecasts for 2020–we’ll have to wait.

Is this necessarily bad? This Editor likes an occasional dose of reason and is not displeased at Rock Health’s absence of kvelling.

Confirming the picture is Mercom Capital’s analysis which also recorded a 6 percent dip 2019/2018: $8.9bn with 615 deals, dropping from the $9.5bn and 698 deals in 2018. Their ‘catchment’ is more global than Rock Health, and encompasses consumer-centric and patient-centric technologies and sub-technologies. Total corporate funding reached $10.1bn.

News roundup: Proteus may be no-teous, DOJ leads on Google-Fitbit, HHS’ mud fight, Leeds leading in health tech, malware miseries, comings and goings

December 12, 2019 | by

Proteus stumbles hard, cuts back. The original ‘tattle-tale pill’ company, Proteus Digital Health, plans to lay off 292 people in the San Francisco Bay Area and to permanently close its three Redwood City and Hayward locations, starting 18 January, according to notices sent to California state and local offices, including the state employment development department. It is unclear where Proteus will be located after the closures.

This followed after Proteus failed to launch a twelfth funding round of $100 million. According to reports, they furloughed most of their employees for two weeks in November and are reorganizing. This is after a substantial number of investors have put in about $487M in funding through a Series H (Crunchbase), including a game-changing investment by Novartis dating back to 2010.  Proteus achieved unicorn status about three years ago, but its high-priced pill tracking technology with a pill sensor tracked by a skin-worn monitor reporting into a smartphone has a built-in limited market to expensive medication. Otsuka Pharmaceutical in 2017 partnered with Proteus for an FDA-cleared digital medicine system called Abilify MyCite that basically put an off-patent behavioral drug back into a more expensive tracking methodology. But Proteus remains a great idea on tracking compliance in search of a real market, and may not have much of a future. San Jose Mercury News, CNBC

But ingestible detectable pills are still being tested. On Monday, as Proteus’ bad news broke, eTectRx announced its FDA clearance of the ID-Cap System and its testing at Brigham and Women’s Hospital and Fenway Health, focusing on HIV medication when used for treatment and prevention. Release, HISTalk

Department of Justice taking the lead on scrutinizing Google’s Fitbit acquisition. The Federal Trade Commission also sought jurisdiction over the transaction. According to the New York Post, “both agencies are concerned that a Google-owned Fitbit would give the search giant an even bigger window into people’s private data, including sensitive health information, sources said. Under the Hart-Scott-Rodino Act, all large mergers must file proposals with both the DOJ and the FTC, but only one antitrust agency reviews the merger.”

Coal from stockings being thrown about at HHS. According to POLITICO and the New York Times, the disagreements between Seema Verma, the head of the Centers for Medicare and Medicaid Services (CMS), and the Cabinet-level Secretary of Health and Human Services (HHS), Alex Azar, have boiled over, enough to have to be settled by the President’s acting chief of staff, Mick Mulvaney. According to the Times, both President Trump and VP Mike Pence have told them to find a way to work together. Both are administration appointees, but President Trump has not been reluctant to cut a mis-performing or overly contrary appointee loose. The latest salvo from those obviously not on Ms. Verma’s side was the revelation that she requested compensation for jewelry stolen on a business trip, contrary to government policy of course. She was compensated for other items which is standard. (Isn’t that what homeowners’ insurance is for? And what sensible person actually travels with valuable jewelry?) Under Ms. Verma, CMS has been quite progressive in developing new business models in Medicare fee-for-service, moving providers to two-sided risk, and innovating in both Medicare and Medicaid. It will either be settled, or one or both will be gone. Pass the popcorn.

Leeds picks up another health tech company. Mindwave Ventures is opening an office there, as well as appointing Dr Victoria Betton and Dr Janak Gunatilleke to the roles of chief innovation officer and chief operating officer. Mindwave develops technologies around digital products and services in healthcare and health research. Leeds reportedly is home to over 250 health tech companies and holds an annual Leeds Digital Festival in the spring [TTA 11 April].

Ransomware attack hits Hackensack Meridian. Systems were down for about a week. While this large New Jersey health system hasn’t admitted it, sources told the Asbury Park Press that it was ransomware. And if it’s not ransomware, its Emotet and Trickbot. Read ZDNet and be very apprehensive for 2020, indeed, as apparently healthcare is just one big target.

Comings and Goings: There may be some end of year bombshells, but after last week’s big news about John Halamka, it’s been fairly quiet. Paul Walker, whom this Editor knew at New York eHealth Collaborative, has joined CommonWell Health Alliance as executive director. Mr. Walker was most recently Philips Interoperability Solutions’ vice president of strategy and business development. CommonWell’s goal is improving healthcare interoperability and its services are used by more than 15,000 care provider sites nationwide. Blog release, Healthcare Innovation ….Dr. Jacqueline Shreibati, the chief medical officer for AliveCor, is joining Google Health in the health research area. Mum’s the word when it comes to Fitbit (see above). CNBC ….Peter Knight has pleaded guilty to falsifying educational credentials to gain his position as chief information and digital office at Oxford University Hospitals NHS Foundation Trust. He held that position from August 2016 until September 2018. BBC News

News roundup: Philips allies with Humana for pop health, Dexcom’s outage outrage, Halamka ankles Lahey for Mayo, Google and NHS Wales changes, Agfa’s health sale, Victrix/WhatsApp, more

December 5, 2019 | by

Insurer Humana is identifying high-acuity and chronic CHF Medicare Advantage members and deploying two support programs utilizing Philips PERS and remote patient monitoring (RPM) systems. The first program identifies at-risk older people with chronic conditions and offering them Philips Lifeline with AutoAlert, Lifeline’s fall detection technology, and their CareSage predictive analytics. Philips Lifeline is already offered in select Humana Medicare Advantage plans. The second is a pilot with telehealth RPM to monitor a select group of CHF patients. This will use a Philips interactive tablet and connected measurement devices for care teams to actively monitor congestive heart failure patients. The rationale in the press release is centered on population health management, quality of care, and positively influencing patient outcomes, with “more efficient resource utilization” a/k/a lowering cost of care. Philips release.

Health tech is great, when it works–and Dexcom found out how serious it can get when it doesn’t. Dexcom, a continuous glucose monitoring system, experienced a server outage over the US Thanksgiving holiday weekend into Monday. It knocked out its updates in the Follow feature, frequently used by parents to monitor Type 1 diabetic children, and those with artificial pancreas devices that adjust insulin based on monitored BG levels. Dexcom was not only blasted by users on the server outage, which they attributed to ‘overload’, but also on its communications of the problem to users which depended on Facebook postings and not on real-time direct contacts or messaging. It was a ‘big surprise’ to their CEO, who also dismissed the possibility of a data breach, which seems a bit premature. Both Google and Microsoft provide cloud and tech services to Dexcom. CNBC 12/2, 12/3

Comings and goings: HIT pioneer, strategist, and general guru John Halamka is following the AI Star, leaving Boston’s Beth Israel Lahey Health to head up a machine learning/AI initiative at the Mayo Clinic in Minneapolis. Mayo this fall announced a 10-year high-level partnership with Google Cloud to store patient data and analysis. Modern Healthcare  According to the Healthcare IT News article, he’ll be returning on weekends to the Bay State to his 250-acre working farm….Also moving on to Google Health is Facebook’s Hema Budaraju, a product management director. Business Insider has annoyingly hid the news behind its paywall, leading to speculation in Mobihealthnews that she will be engaged in Google’s “social and environmental impact” efforts as she was at FB…And speaking of Google, founders Larry Page and Sergey Brin are stepping down at long last from active management. Google CEO Sundar Pichai will now be running Google and its corporate parent, Alphabet. See their letter on the GoogleBlog.…DigitalHealth reports on changes at the NHS Wales Informatics Service. Helen Thomas is now interim director as NWIS director Andrew Griffiths is departing this month. NWIS is also transitioning to a new Special Health Authority….Agfa’s Healthcare Information Solutions and Integrated Care, plus their imaging division, are definitely going to Italy’s Dedalus Holdings S.p.A. for €975 million. It awaits approval from various authorities, their employee groups, and the usual closing conditions. Release, DigitalHealth.

UK healthcare analytics company Victrix Socsan has signed a licensing agreement last month with WhatsApp. Victrix will use Whats App for communications with beneficiaries as part of their furnishing proactive preventive care services and provide secure information. Release.