Lightning news roundup: AI for health systems Olive scores $400M, VA’s sticking with Cerner EHR, Black+Decker gets into the PERS game

July 2, 2021 | by

As here in the US we are winding up for our Independence Day holiday (apologies to King George III)….

Olive, a healthcare automation company for healthcare organizations, scored a venture round of $400 million from Vista Equity Partners. To date, it’s raised $856 million through a Series G plus this round and is now valued at $4 billion according to the company release. Olive’s value proposition is automating via AI routine processes and workflows, such as benefit verification discovery, prior authorizations, and billing/payments for health systems. About 900 US hospitals have adopted Olive’s systems. Mobihealthnews.

Breaking: The US Department of Veterans Affairs will be staying with Cerner Millenium for their EHR modernization from VistA. This follows a 12-week review of the implementation following failures within the $16 billion program itemized by the Government Accountability Office (GAO) in February [TTA 19 Feb]. Secretary Denis McDonough is scheduling two further review weeks to determine additional changes to the program. The intent is to build a cloud-based system fully interoperable with the Department of Defense’s Military Health System (MHS) also built with Cerner. FedScoop, Healthcare IT News

And in the What Are They Drinking in Marketing? I want some of that, stat! department…

Black + Decker is now becoming a PERS provider with the introduction of Black+Decker Health and the goVia line of mobile and home-based PERS with optional fall extension and call center monitoring through Medical Guardian . The devices are a fairly predictable line of cellular-connected (Verizon, AT+T) with a ‘classic’ home landline unit. The units are being sold through Amazon. B+D release

From a marketing perspective, the Black+Decker name, identified for decades with home and power tools, on a PERS line is also a classic–a classic mistaken line extension like Cadbury mashed potatoes or Colgate frozen entrees. Buy a PERS, get a drill? Relevance and fit to a older, female-skewing group?  It surely looks like their parent Stanley, which is a leading company in institutional alarm and location services. offloaded this legacy business to them. (Judging from the website, someone’s in a rush as some pages still have ‘greek’ copy under headings.) Hat tip to a Reader who wishes to remain anonymous.

Telehealth usage going flat, off by 1/3 and declining: Trilliant Health study

June 30, 2021 | by

Trilliant Health, a healthcare data analytics and advisory shop based in Tennessee, has run some projections on the US healthcare market and telehealth, and they’re not as bright as many of us–and a lot of investors plus Mr. Market–have believed. It opens up on page 4 of the electronic document (also available in PDF) with this ‘downer’–that the largest sector of the largest global economy is overbuilt and unsustainable. Hospitals and health systems have operated for decades that basic economic factors–demand, supply, and yield–don’t apply, and there are more companies competing with them for the consumer healthcare dollar than they realize–with more proliferating every day. 

Sledding through their 160-page report, we turn to our sweet spot, telehealth, and Trilliant is not delivering cheerful news (pages 32-43). 

  • Unsurprisingly, demand for telehealth is tapering off. Based on claims data for face-to-face video visits, excluding Medicare fee-for-service (Original Medicare) and self-pay visits, they peaked above 12 million in April 2020 and, save for a bump up in December 2020-January 2021, steadily declined to about 9 million by March 2021.
  • Teladoc, the leading provider, is projecting that 2021 volume will only represent 4 percent of the US population–a lot more than before, but not growing as it did in 2020.
  • Telehealth’s growth was astronomical on both coasts–California, Massachusetts, Vermont, Oregon–and Hawaii–but relatively lower in middle and Southern America in places like Wyoming, North Dakota, Mississippi, and Iowa. Telehealth usage is declining sharply in that region as well but across the board in all states including California. In fact, Phoenix and Dallas had higher telehealth utilization pre-pandemic than during it.
  • Mental health drove telehealth growth during the pandemic, representing 35 percent of claims, almost four times the next group of categories at 8 percent. The largest group of diagnoses were for anxiety and depression among women 20-49. With the reopening of the US economy and children heading back to school, will this sustain or decline?
  • Women 30-39 are the largest users of telehealth–pre, during, and post-pandemic

Telehealth is not only proliferating, it is going up against now-open urgent care, retail clinics from Walgreens, Walmart, and CVS, plus tech-enabled providers that blend virtual care with home care, such as Amazon with a full rollout of Amazon Care and other employers. The cost of care is also a negative driver. FierceHealthcare analyzes other parts of the report impacting practices, health systems, and hospitals.

 

Weekend reading: 1/3 of global healthcare orgs ransomwared, 50%+ mobile privacy problems–BMJ study, med device insecurity

June 25, 2021 | by

Weekend reading to make you feel insecure, indeed. Healthcare continues to be one of the most vulnerable sectors to hacking, breaches, ransomware. (It likely was one of the top 5 on the list handed to Mr. Putin in Geneva a week ago.) It doesn’t help that many organizations from providers to payers, legacy devices to apps, figuratively have a ‘Welcome Hackers’ neon sign on their doors, virtual and otherwise.

Three articles from the always interesting Healthcare Dive, two by Rebecca Pifer and the third by veteran Greg Slobodkin, will give our Readers a quick and unsettling overview:

  • According to cybersecurity company Sophos in their 16-page report, 2020 was an annus horribilis for healthcare organizations and ransomware, with 34 percent suffering a ransomware attack, 65 percent confirming the attacks encrypted their data, but only 69 percent reported that the encrypted data was restored after the ransom was paid. Costs were upward of $1 million. Their conclusion: assume you will be hit, and at least three backups. Dive 24 June
  • The BMJ found that lax or no privacy policies were a key problem with over half of mobile health apps. 23 percent of user data transmissions occurred on insecure communication protocols and 28.1 percent of apps provided no privacy policies. There’s a lot to unpack in the BMJ study by the Macquarie University (Sydney) team. Our long-time Readers will recall our articles about insecure smartphone apps dating back to 2013 with Charles Lowe’s article here as an example. Dive 16 June
  • Old medical devices, continuing vulnerability that can’t be fixed. Yes, fully functioning and legacy medical devices, often costing beaucoup bucks, are shockingly running on Windows 98 (!), Windows XP, outdated software, and manufacturers’ passwords. It’s hard to believe that Dive is writing about this as it’s been an issue this Editor’s written about since (drumroll) 2013 when TTA picked up on BBC and other reports of ‘murderous defibrillators and pacemakers’. If too far back, try 2015 with Kevin Fu’s and Ponemon’s warnings then to ‘wash their hands’ of these systems even if they’re still working. Chris Gates quoted in the article: “You can’t always bolt-on security after the fact, especially with a legacy piece of equipment — I’ve literally handed checks back to clients and told them there’s no fixing this.” Dive 23 June

What to do?

  • If you are a healthcare organization, think security first. Other organizations in finance and BPO do, locking down to excruciating points. And yes, you’ll have to pay a premium for the best IT security people, up your budgets, and lower your bureaucracy to attract them. Payers are extremely vulnerable with their wealth of PHI and PII, yet tend to skimp here.
  • Consider bringing in all your IT teams to your home country and not offshoring. Much of the hacking occurs overseas where it’s tougher to secure servers and the cloud reliably and fully.
  • Pay for regular and full probes and audits done by outside experts.
  • If you supply a mobile app–design with security and privacy first, from the phone or device to the cloud or server, including data sharing. There are companies that can assist you with this. One example is Blue Cedar, but there are others.
  • If you supply hardware and software for medical devices, think updates, patches, and tracking every bit you sell to make sure your customers do what they need to do. Even if your customer is a past one.

(Side message to NHS Digital–don’t rush your GPDPR upload to the summer holidays. Make it fourth quarter. Your GPs will thank you.)

Suggestions from our Readers wanted! While your Editor has been covering security issues since early days here, she is not an expert, programmer, or developer, nor has stayed at a Holiday Inn Express lately.

GPDPR update: GPs must set own patient opt-out date prior to 1 September extraction (updated for ‘Data Saves Lives’)

June 24, 2021 | by

(Editor’s Note: Read till the end for Roy Lilley’s take on data and the NHS Bureaucracy. “Bureaucracy… creates delays, duplication, interfaces and costs lives.)

Is it 25 August–or earlier? Well, it depends… NHS Digital has informed GPs that, contrary to a prior announcement, the deadline for submitting those who wish to opt out of the General Practice Data for Planning and Research (GPDPR) database must be set by the GP practice, and is not 25 August. The deadline for the mass extraction remains 1 September. This puts practices into a dilemma–informing patients of their right to opt-out. setting a date for staff to process the forms, and processing the hard copy forms in time for the 1 September extraction. (And right during summer holiday time with the bank holiday on 30 August)

For patients wishing to opt-out, they must submit a type-1 opt-out form (a Word document) and send it to their GP practice via mail or email by the deadline which then submits with the data collection. If a patient wishes to opt-out after, it’s permitted but any data before the opt-out date will be collected. The National Data Opt-Out does not apply to the GPDPR. 

According to the 22 June update in Pulse,

The BMA GP Committee’s latest newsletter quoted IT lead Dr Farah Jameel as saying: ‘The public needs a clear deadline by which they can opt out, alongside clear instructions on how to do this if they so wish.

‘We have been urging the government and NHS Digital to consider making the process of opting out simpler, and in effect remove any additional burden [that] large volumes of Type 1 opt-outs could place on already under-pressure general practice.

‘We urge NHS Digital to clarify this with both the public and practices.’

Another GP from Bristol is quoted as pointing out that most opt-outs will be received last minute, jamming the practices.

In addition, each GP practice has more work to do before the extraction–a data protection impact assessment (DPIA).

The problems of patient awareness, particularly during the summer, obtaining the form, and submitting it in time remain. So, what’s the rush? This Editor closes once again with the thought that the fourth quarter would be far better timing both for the surgeries and NHS Digital.

Our prior coverage 11 June and 2 June.

Addendum: Roy Lilley’s eLetter on ‘Data Saves Lives’ (draft publication here) is a Must Read. It is a most interesting take on how the NHS is botching the opportunities around health data by drowning it in bureaucracy. The latest example is a draft document titled ‘Data Saves Lives’. A course in obfuscation where even a casual look will reveal its true awfulness. Mr. Lilley has counted 96 commitments, 10 new organizations, and six major pieces of legislation. “It is bad, bad, bad and a perfect example of why the NHS’ relationship with the IT sector is so bad.” The GPDPR gets one–one–mention in this document. Sounds like some imports from the US Congress wrote it! In any case, if you’re in UK healthcare, you should be subscribing to this free eLetter. ‘Data Saves Lives’ NHS news release may go down easier

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…)

The Theranos Story, ch. 74: defense questionnaire trimmed; Holmes loses attorney-client privileges on 13 emails, doctor/patient testimony allowed

June 18, 2021 | by

This week’s update as Elizabeth Holmes’ Federal trial nears its 31 August start. 

The defense’s 112-page whopper of a jury selection questionnaire was, as most expected, nixed by Judge Edward Davila. He provided the defense with a slimmed-down version that apparently, from press reports, edited the media coverage issues. The prosecution had previously objected to the length, intrusiveness, and over-specificity around juror media usage. Judge Davila remarked in Tuesday’s hearing that jurors could be asked about their sources of news in an open-ended response. According to the Fox Business report, “He said both sides might be surprised to see how many potential jurors don’t know anything about the case.” Impartiality is also an issue in high-profile cases, but “impartiality does not require ignorance,” in the words of a previous Federal decision in the Enron CEO’s criminal case.

The jury will also hear testimony from patients and doctors who used Theranos tests and said they got inaccurate results. The testimony will be limited to facts about the inaccurate test and the money they lost by paying for it. Emotional and physical harm will be off-limits. Fox Business  What won’t be admissible, at least for now, is how Theranos “destroyed” its Laboratory Information System, or LIS, database. The defense argued that the prosecution took years to acquire it and then sat on the evidence. Judge Davila reserved the right to revisit that issue if appropriate. Fox Business

Elizabeth Holmes cannot keep her 13 emails with law firm Boies Schiller Flexner LLP out of the trial on attorney-client privilege grounds. US magistrate Judge Nathanael Cousins ruled that it did not apply to these emails since Boies Schiller was the corporation’s legal counsel and not hired by her personally. According to the Wall Street Journal (partial article as paywalled), the receiver who wound down Theranos after it closed in 2018 waived the company’s privilege to the documents, yet another factor. Boies Schiller represented Theranos up to 2016. Managing partner David Boies was a Theranos board director and a bulldog of an advocate from the company until then. Mr. Boies is now aged 80 and remains chairman of the law firm. (One wonders if the well-seasoned litigator, or his deposition, will be part of the trial.)

Judge Davila has also set the trial schedule–three days per week from late August into December, earlier disclosed as Tuesdays, Thursdays, and Fridays, with relatively short days to fight ‘juror fatigue’. Since Elizabeth Holmes will also have delivered her child by the time the trial starts, there will be a “quiet room” in the courthouse provided for her special needs during the trial.

TTA’s previous coverage of Theranos

Disruption or giveaway: Amazon Care signs on employers, but who? Amazon Pharmacy’s 6 months of meds for $6. (updated)

June 16, 2021 | by

Is this disruption, a giveaway, or blue smoke requiring IFR? An Amazon Care VP, Babak Parviz, said at the Wall Street Journal’s Tech Health virtual event that all is well with their rollout of virtual primary care (VPC). Washington state is first, with VPC now available nationally to all Amazon employees as well as companies. However, Mr. Parviz did not disclose the signed-up companies, nor a timetable for when in-person Amazon Care practices will be expanding to Washington, DC, Baltimore, and other cities in the coming months.

Mr. Parviz also provided some details of what Amazon Care would ultimately look like:

  • Clinician chat/video connected within 60 seconds
  • If an in-person visit is required, a mobile clinician arrives within 60 minutes, who can perform some diagnostic tests, such as for strep throat, provide vaccinations and draw blood for lab work. For other diagnoses, that clinician is equipped with a kit with devices to monitor vital signs which are live-streamed to remote clinicians.
  • Medication delivery within 120 minutes

FierceHealthcare

The timing of the Amazon Care rollout has not changed since our coverage of their announcement in March. This Editor noted in that article that Credit Suisse in their overview was underwhelmed by Amazon Care as well as other efforts in the complex and crowded healthcare space. Amazon Care also doesn’t integrate with payers. It’s payment upfront, then the patient files a claim with their insurer.

Existing players are already established in large chunks of what Amazon wants to own.

  • Both Amwell’s Ido Schoenberg [TTA 2 April] and Teladoc’s Jason Gorevic (FierceHealthcare 12 May) have opined that they are way ahead of Amazon both in corporate affiliations and comprehensive solutions. Examples: Amwell’s recently announced upgrade of their clinician platform and adding platforms for in-home hospital-grade care [TTA 29 Apr], Teladoc’s moves into mental health with myStrength [TTA 14 May].
  • Even Walmart is getting into telehealth with their purchase of a small player, MeMD [TTA 8 May].
  • CVS has their MinuteClinics affiliated with leading local health systems, and Walgreens is building out 500 free-standing VillageMD locations [TTA 4 Dec 20]. CVS and Walgreens are also fully integrated with payers and pharmacy benefit management plans (PBM).

Another loss leader is pharmacy. Amazon is also offering to Prime members a pharmacy prescription savings benefit: six-month supplies of select medications for $6. The conditions are that members must pay out-of-pocket (no insurance), they must have the six-month prescription from their provider, and the medication must be both available and eligible on Amazon Pharmacy. Medications included are for high blood pressure, diabetes, and more. The timing is interesting as Walmart also announced a few days earlier a similar program for Walmart+ members. Mobihealthnews.

crystal-ballThis Editor’s opinion is that Amazon’s business plans for both entities and in healthcare are really about accumulating data, not user revenue, and are certainly not altruistic no matter what they say. Amazon will accumulate and own national healthcare data on Amazon Care and Pharmacy users far more valuable than whatever is spent on providing care and services. Amazon will not only use it internally for cross-selling, but can monetize the data to pharmaceutical companies, payers, developers, and other commercial third parties in and ex-US. Shouldn’t privacy advocates be concerned, as this isn’t being disclosed? 

Telemental Health Care Access Act introduced in US Senate to repeal in-person requirements for mental telehealth care

June 16, 2021 | by

Eliminating the Medicare requirement for an in-person visit prior to telehealth used for mental health services. Yesterday, the Telemental Health Care Access Act of 2021 (PDF link) was introduced in the US Senate. It is a bipartisan bill sponsored by four senators, Bill Cassidy, MD (R-LA), Tina Smith (D-MN), Ben Cardin (D-MD), and John Thune (R-SD). It specifically amends Title XVIII of the Social Security Act to ensure coverage of mental health services furnished through telehealth without a prior in-person visit.

The 2021 Consolidated Appropriations Act on one hand removed the geographic restrictions for Medicare, but on the other imposed a restriction that requires physicians to see their mental health patients in-person at least six months prior to a Medicare-reimbursed telehealth visit. It’s significant as Medicare and the Physician Fee Schedule (PFS) [TTA 3 Dec 20] set the standards for commercial payers on coverage and reimbursement. The bill, so new it does not have a number yet, is designed to eliminate that requirement.

In the US, there is an acute shortage (at least 6,000) of mental health providers, particularly psychiatrists. Back in 2013, 70 percent of psychiatrists were over the age of 50 and due to retire. As to the top of the funnel, few medical graduates choose psychiatry due to compensation issues (paying for expensive medical education). Those who do are trained in residencies and tend to stay near large cities, further exacerbating the existing geographic imbalance. It’s a situation that hits this Editor close to home as her own brother is one of those semi-retired psychiatrists. He apparently has not been replaced in the clinic practice in which he worked for over 20 years and his private practice is self-limited. Most of the psychiatrists in his suburban area are retiring as well. Psychiatric mental health advanced practice registered nurses (PMH-APRN) fill only part of this gap. (For a further discussion of APRNs and their role in mental health practice, see this issue of Psychiatric Times)

Telemental health can fill some of the gap in rural areas, for continued support in mental health counseling and medical management, and for those who would benefit from cognitive therapies, a burgeoning area for telehealth companies.

The bill is supported by the American Telemedicine Association (ATA), the American Psychiatric Association, the American Psychological Association, and at least 30 companies (including the leading telehealth providers such as Teladoc and Doctor on Demand) and non-profit organizations such as the American Foundation for Suicide Prevention. ATA release and overview of present in-person requirements;  Senator Bill Cassidy release.

The Theranos Story, ch. 73: the defense tries to stack the jury deck in Holmes’ favor, prosecutors say. And Theranos swag and memes are hot!

June 10, 2021 | by

Law and Order Proceeds. For those of us who follow US trials, or have served on a local or county jury, smart attorneys do a fair amount of ruling jurors in–and out. The voir dire process in high-profile trials is critical. Jury consultants make comfortable livings creating profiles of their ‘ideal juror’.

Thus it should not be a surprise that Elizabeth Holmes’ spare-no-expense-or-strategem defense would file in May with the court an over-the-top 41-page, 112 question jury document. Their rationale is to screen jurors for issues related to the extensive news coverage around la scandale Theranos, Holmes herself, and even the pandemic (!).

In the prosecution’s view, questions such as “Do you have investments?”, “Do you have health insurance?”, and inquiries about social media use, were “untethered” from pretrial publicity and the coronavirus pandemic.

By comparison, the prosecution presented to Judge Edward Davila a modestly sized nine-page questionnaire with a scant 51 questions. Typically, many of these questions are routine, such as reading about the case and if they had any pre-existing opinions which would prevent that person from a fair judgment of the facts presented in the case. On pandemic issues, the prosecution drew from previously used questionnaires that addressed them, though this Editor cannot see how the pandemic is pertinent to this case.

Holmes is facing 12 felony fraud charges. The trial will start 31 August and will be held on Tuesdays, Thursdays, and Fridays through 17 December, according to a filing last week by Holmes’ legal team. She faces maximum penalties of 20 years in prison and a $2.75 million fine, plus possible restitution. East Bay Times

Attention eBay Shoppers!  According to CNBC, original Theranos-labeled items are fetching real coin on auction sites like eBay and Poshmark. An original Theranos lab coat is supposedly listed for $17,000. Over at Etsy and Redbubble, which sell artist-created items, logo-printed t-shirts and masks, including those with Holmes’ face and the Silicon Valley meme, ‘Fake It Till You Make It’, “Girl Boss” signs, throws, posters (left), and greeting cards. (Good things? Yeesh!) are all over. The funniest is a sweatshirt with ‘Theranos Testing–A Guaranteed Result’. Over on Etsy, a merchant’s most popular Theranos item is a mug emblazoned ‘Theranos Early Investor’. (Is it cracked?) Perhaps Holmes could put her Theranos trinkets and trash online to defray a few costs. Or copyright her image like Bogart?

NHS Digital GPDPR medical database plans criticized by Royal College of GPs, privacy advocates (updated 8 June)

June 2, 2021 | by | 2 Comments

What our UK Readers may have missed on the long bank holiday weekend. And why this matters outside the UK.  NHS Digital is being roundly criticized by privacy advocates, the Royal College of GPs (RCGP), the Doctors’ Association UK (DAUK), and individual GP surgeries on plans for creation of the General Practice Data for Planning and Research (GPDPR).

The GPDPR will compile information on 55 million patients–every patient in England registered with a GP surgery–into a database available to academic and commercial third parties for research and planning purposes. NHS has been collecting patient data on patients in a database, the General Practice Extraction Service (GPES), for the past decade. The GPDPR will replace it. Data collection on patients in England starts 1 July. What will be collected is at the end of this article as background.

The objections center on the sensitivity of the data, the short window of notification to patients, the lack of a clearly notified opt-out with sufficient time, and how it will be used.

  • The data apparently can include mental and sexual health data, criminal records (!), and other sensitive information. 
  • The short time–six weeks–between the announcement in late April (a low key affair with Matt Hancock-signed blog posts on the NHS Digital website, YouTube videos, and flyers at GP surgeries), and the start of data collection from the surgeries
  • How many patients are actually aware that this is happening and of their options is debatable. (See next two bullets)
    • If a patient didn’t pick up on it in the six-week window ending on 23 June (and go to the page with the Type 1 Opt-Out), a patient can opt out for data going forward, but cannot withdraw any data collected into the database prior to that date.
    • If a patient is in the National Data Opt-out program, their medical data will be collected anyway, since it applies to only identifiable and confidential patient information.
  • Many GPs are concerned about further erosion of the physician-patient relationship and the lack of communication to patients on how the data will be used, the ethical questions around the organizations to which it will be sold, and how patient privacy will be preserved.

The blackest mark here on NHS Digital is that the groups ostensibly involved in the development of the database–the RCGP and the British Medical Association (BMA)–are the ones sounding the alarm, along with the aforementioned DAUK and privacy groups such as MedConfidential and Foxglove. There is also a rebellion starting among London GPs. Reportedly, 36 doctors’ surgeries in Tower Hamlets, east London, will withhold data. An email is circulating to about 100 surgeries in north London questioning the legitimacy of the NHS data collection. This is despite penalties if they don’t submit.

Why does this matter if you’re not in England? Medical data–collecting, manipulating it, connecting it, finding insights, and selling it–is the Gold Rush of the 2020s. Pharma and payers as markets are just the start. Nearly every Roundup or deal this Editor covers has companies with a chunk of this gold rush. Why are telehealth companies worth their IPO/SPAC/funding prices? Why is McKesson ‘big banging’ four separate businesses into one division? Why do we follow ‘data warehouses’ like Sensyne [TTA 26 May],  Mayo Clinic’s big bet on a multi-line Remote Diagnostics and Management Platform [TTA 23 Apr], and virtual pharmacies like Capsule?  Why are insurtechs like Oscar and Bright Health hot? Why is it the #1 target of hackers?

It’s not altruistic. Services can be duplicated. Companies can be a hair away from failure. But ah, their data…the data has huge market value, even if its potential is not fully understood yet. Ask any data analytics person. Ask China, probably the most aggressive nation in collecting the health and personal data of its citizens, with Chinese capital for years now leading investment in global health tech companies.

In an article back in October 2015, this Editor described the many ways that deidentified patient data, in this case genomic data, can be identified by researchers through cross-checking via research database “beacons”, a network of servers. Referring to the 23andme and Ancestry.com collection of innocently given genomic data from consumers, this Editor proposed a Genomic Bill of Rights in 2018 and again in 2020. If this Editor, no data geek, can deduce it (hat tip to Toni Bunting back in 2015), this information has to be well known to researchers and to privacy advocates.

The controversy is just starting to ramp up. And it should. It’s about time there was a reckoning. The Guardian 30 May, 1 June

More background. According to the NHS Digital page on the GPDPR, patients will be anonymized by a process where de-identification software will replace their NHS Number, date of birth, and full postcode with unique codes produced by de-identification software. The data collected from GPs in England starting 1 July will be on: (more…)

News and deals roundup: CoverMyMeds ‘big bang’, Noom’s $540M Series F, insurtech Bright Health’s IPO, Grand Rounds-Included Health, GoodRx, Cedar-OODA, Huma, Bluestream Health’s outreach

May 28, 2021 | by

McKesson shmushes four units into CoverMyMeds. McKesson’s Big Bang combines four McKesson business units–RelayHealth (pharmacy networking), McKesson Prescription Automation (software), CoverMyMeds (medication access for patients), and RxCrossroads by McKesson (therapeutic and drug commercialization). They are being reassembled into one massive unit under the CoverMyMeds name. The unit will have about 5,000 people and will be headed by Nathan Mott. More here in a blog post/announcement posting that’s short on information and long on cheerleading.

And the funding rounds keep marching down the alphabet. Noom, the weight loss app, gained a generous Series F of $540 million led by Silver Lake with participation from Oak HC/FT, Temasek (Singapore), Novo Holdings, Sequoia Capital, RRE and Samsung Ventures. Valuation is now at $4 billion. Adam Karol, a managing director at Silver Lake, and former TaskRabbit chief executive Stacy Brown-Philpot will join Noom’s board. The fresh funding will be used to expand into areas such as stress and anxiety, diabetes, hypertension, and sleep.

Noom had a banner year in 2020, with $400 million in revenues as people tried to shed Pandemic Pounds (aided by a near-ubiquitous ad push). The app has had 45 million downloads to date in 100 countries, largely in the US, UK, Canada, Australia, Ireland, and New Zealand. According to a (paywalled) Bloomberg News report, feelers are out for an IPO which may be valued at $10 billion. TechCrunch, Reuters, FierceHealthcare

Bright Health Group filed its S-1 registration statement with the Securities and Exchange Commission (SEC). Their rumored $1 billion IPO will be on the NYSE and trade under the symbol BHG. Timing, share value, and number of shares are to be determined. It’s speculated that the valuation at that point is expected to be between $10 and $20 billion. Bright Health is an insurtech operating exchange and Medicare Advantage (MA) health plans under Bright HealthCare  in 14 states and 50 markets, covering over 620,000 lives. They also have a separate care delivery channel called NeueHealth, 61 advanced risk-bearing primary care clinics delivering in-person and virtual care to 75,000 unique patients. Last month, they purchased Zipnosis, adding their white-labeled telemedicine for large health systems business. Bright Health Group release, Mobihealthnews

Short takes:

Doctor on Demand and Grand Rounds, which finalized their merger earlier this month, have agreed to acquire Included Health. Terms and timing were not disclosed. Included Health specializes in care concierge and healthcare navigation services for the LGBTQ+ community. FierceHealthcare, Release

GoodRx acquired rival RxSaver for $50 million in cash in late April to bulk up against Amazon. FierceHealthcare

Medical billing and pre-visit tech company Cedar is acquiring payer workflow tech company OODA Health for $425 million deal in a mix of cash and equity. It’s expected to close at end of May. OODA’s co-founder, chairman, and co-CEO is Giovanni Colella, MD, also co-founded Castlight Health and founded RelayHealth (see above), so another successful exit for him. FierceHealthcare, HISTalk

London-based Huma, raised $130 million in a Series C. Leaps by Bayer and Hitachi Ventures led the round. The former, mysterious Medopad now seems to have settled on a platform that supports ‘hospital at home’ plus pharma and research companies in large, decentralized clinical trials. There’s an add-on of $70 million to the Series C that can be exercised at a later date. Release, HISTalk

White-label telehealth provider Bluestream Health is partnering with The Azadi Project to provide virtual care services to refugee women and girls fleeing from countries like Afghanistan, Iran, Iraq, and Syria for safety in Greece. “Bluestream Health has teamed with The Azadi Project to provide a virtual care platform that stretches around the world. The women fleeing war-torn and conflict-affected countries have suffered unspeakable abuse, and while seeking safety in Greece, they are further exposed to terrible living conditions and hostility.”  said Matthew Davidge, co-founder and CEO of Bluestream Health.  Release

An unappreciated long term pandemic health effect? Increased frailty among older adults.

May 27, 2021 | by

Some of the universal effects of the COVID-19 pandemic and the prolonged lockdown, lifting in practically all of the US and starting to lift in the UK, is weight gain (‘pandemic pounds’), a changed perception of ‘maintenance’, and in some, a certain reluctance to get back to what was normal life. We are reading that younger workers are reluctant to leave 100 percent remote work and go back to offices at all. Even older workers want to limit in-office time to once or twice a week, having lived free of brutal commutes. Anti-social has become fashionable, based on a simple search of t-shirts for sale (!).

But for the older adult battling to keep engaged and mobile, the toll of prolonged ‘sheltering in place’ has been far greater and less reversible, if at all. A thought piece in Kaiser Health News found that “Large numbers of older adults have become physically and cognitively debilitated and less able to care for themselves during 15 months of sheltering in place.” This includes older adults who did–and did not–have COVID-19.

Doctors are seeing combinations of:

  •  Weight gain–and weight loss due to lack of interest in eating, not eating or hydrating well
  • Depression from lack of contact with family and the outside world
  • Cognitive difficulties
  • Physical deconditioning, leading to severe lack of mobility and falls. Lack of activity leads to muscle mass loss of up to 20 percent in as little as five days.
  • Exacerbation of chronic illnesses such as diabetes, congestive heart failure and chronic obstructive pulmonary disease (COPD)

For those in assisted living, a comeback is made even more difficult with restrictions still in place. Many have deteriorated so much that rehabilitative therapies do little good. The rest of the article describes rehabilitative outreach to those living at home, ranging from in-home physical therapy, to combinations of phone/video/in-home outreach, peer advocates, and encouraging older adults to go see their doctors in person. A follow-up article gives tips for older adults to reemerge in the post-pandemic world, with an emphasis on slowly increasing physical activity, reestablishing routines and social contacts, plus minding one’s diet.

The Theranos Story, ch. 72: a little lifestyle and celebrity is admissible at trial–but not too much. And no profanity, please!

May 27, 2021 | by

The long-awaited update from the US District Court in San Jose. Judge Edward Davila ruled last Friday limiting the specifics on Elizabeth Holmes’ lifestyle that the prosecution wanted to present as evidence. Only general evidence of Elizabeth Holmes’ Silicon Valley CEO lifestyle would be admissible. The prosecution, in his words, “Each time Holmes made an extravagant purchase, it is reasonable to infer that she knew her fraudulent activity allowed her to pay for those items,” but that “Evidence of Holmes’s wealth can be construed as ‘appeals to class prejudice’ which are considered ‘highly improper’ because they ‘may so poison the minds of jurors even in a strong case that an accused may be deprived of a fair trial.” To the judge, evidence of Holmes’ wealth and fame are not even moderately related to the intent to defraud, the last of which is the heart of the charges.

The prosecution therefore has to walk a very fine line. It’s apparently fine to say that Holmes enjoyed a luxurious lifestyle equivalent to her Silicon Valley peers, with the usual perks. But details on brands of clothing, hotels, and other specifics “outside the general nature of her position as Theranos CEO,” is beyond the scope of the trial.

Judge Davila may be doing the prosecution a large favor by limiting this evidence. Too much reliance on lifestyle as the main motive to defraud is a crutch that could backfire with the jury, especially when they see in August a modestly dressed new mother Holmes. It could also open up an appeal on the basis of prejudicing the jury. To this Editor, there is abundant direct evidence of fraud of patients and investors in a technology that didn’t work, never could work, and the coverup. No need to overegg the pudding. Mercury News

And no profanity in the court! The jury will be spared the infamous employee meeting chants telling a rival testing company (Sonora Quest) and John Carreyrou of the Wall Street Journal to do something unprintable in a business article with themselves. The defense won the argument that these chants were the Silicon Valley Norm to motivate employees. Even the prosecution admitted that these might be “somewhat inflammatory”. Colorful, but inadmissible.  Mercury News

And lest we forget. Holmes is facing maximum penalties of 20 years in prison and a $2.75 million fine, plus possible restitution. The trial starts 31 August. Earlier chapters of this saga are here.

Connect America acquires Philips’ Aging and Caregiving, including Lifeline

May 14, 2021 | by | 4 Comments

Connect America is purchasing Royal Philips’ Aging and Caregiving (ACG) line of business, including one of the top basic personal emergency response system (PERS) device providers, Lifeline. The acquisition is expected to close in a few weeks. Purchase terms, including staff, were not disclosed. The release by Connect America contains two unusual statements: both companies will remain competitive until the closing and that Philips will retain an equity stake in the company.

In the World of PERS and safety for older adults, this is big news. Our Readers will remember that Connect America, a medical alert company located in suburban Philadelphia, purchased Tunstall Americas in January 2019. Readers who follow the PERS taxonomy will recall that in 2011, Tunstall acquired AMAC, the third-largest PERS company, yet after multiple presidents and acquisitions, failed to make much of a dent in the competitive US and Canada markets. Connect America now has the major ‘name’ brand in PERS, other than Life Alert, famous for the ‘I’ve fallen and can’t get up’ TV commercials of yore and the real pioneer of the PERS pendant. Lifeline itself dates back to 1974 and was acquired by Philips in 2006. Of late, Philips has been on a divestiture tear, especially in North America.

The news hasn’t exactly made the headlines that it would have only a few years ago. One could say that the parade has passed traditional PERS pendants and home units. Replacing them are mobile and smartphones tied to assistance–GreatCall’s 5 Star services. There are bands and wristwatch forms, such as Buddi in the UK and UnaliWear’s Kanega, The latter haven’t yet the market penetration in the US but all three have in common one selling factor–none of them scream ‘old and frail at risk’ like a white pendant around the neck does. Classified now with PERS are more sophisticated but bulky devices mobile-based systems such as GreatCall’s Lively MobilePlus and Lively Wearable2, also listed as an AARP member benefit.

Connect America has been in business 35 years and has amassed a portfolio of PERS brands, traditional home and mobile devices including fall detection, plus 24/7 monitoring services. It claims to be the nation’s largest independent provider of medical alert systems under various brand names, with more than 1,000 healthcare network partners, and cumulatively over 1 million customers. Their other business is remote patient monitoring under the ConnectVitals brand and a cellular-connected device for medication management.

Another big win for Connect America is Lifeline’s agreement with AARP, marketed as part of their extensive member benefits, and other products that Philips has in this category. 

There are millions who still use traditional and mobile PERS pendants, including in the huge market of assisted living, and a multiplicity of brands, which indicate the size of the market and its longevity. The stats haven’t changed much since this Editor was with QuietCare, attempting to make PERS obsolete back in the mid-oughts. According to Freeus, the average customer is a woman, 78 years old, and keeps it for about 39 months–a little over three years. Not all of them, nor their families, feel comfortable with a smartphone which can be hard to use, break, or simply not be handy in the bathroom or bedroom. So the market is still there, albeit not a headline-making one. Hat tip to a UK Reader who wishes to remain anonymous.

‘Most Reputable’ healthcare technology companies ranked

April 21, 2021 | by

RepTrak has a mission–quantifying reputation, brand, and ESG (environmental, social, and corporate governance) performance for their clients. Their product is software and algorithms that monitor real-time perception data for companies to increase reputation intelligence. A way to market themselves is to issue a Top 100 list (PDF link) of top-scoring companies primarily in mass-market and luxury brands, plus automotive, retail, financial, media and entertainment, and technology companies. Becker’s Health IT picked out health tech-related companies as follows:

Bosch (#4)
Microsoft (#10)
Philips (#13)
Google (#15)
3M (#20)
Apple (#46)
Hewlett Packard Enterprise (#49)
IBM (#54)
Salesforce (#89)
Amazon (#92)

These companies in the Top 100 averaged 74.9 in Global Reputation Scores, a composite of products and services, innovation, workplace, governance, citizenship, leadership, and performance. 

This Editor was surprised that Becker’s missed Samsung (#17), in medical imaging monitors, dedicated smartphones, monitors, and in many of the tablets that are used in remote patient monitoring and telehealth; LG (#67) in the same lines of business; Dell (#72) in computing, cloud, and monitors; and Honeywell (#77). 

Pharma and related companies were in the lower-ranked group: Lilly (#82), Roche (#87), BristolMyers Squibb (#94), and BASF (chemicals for pharmaceuticals and vitamins).

Notably, healthcare service companies such as health plans were not included in the ranking. Are they RepTrak clients? (Do they dare?)

The top three companies? Lego, Rolex, and Ferrari. The last only before the repairs come needing replacement parts!

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