Weekend ‘Must Read’: Are Big Tech/Big Pharma’s health tech promises nothing but a dangerous fraud?

If it sounds too good to be true, it isn’t. And watch your wallet. In 14 words, this summarizes Leeza Osipenko’s theme for this article. It may seem to our Readers that Editor Donna is out there for clicks in the headline, but not really. Dr. Osipenko’s term is ‘snake oil’. It’s a quaint, vintage term for deceptive marketing of completely ineffective remedies, redolent of 19th Century hucksters and ‘The Music Man’. Its real meaning is fraud.

The promise is that Big Data, using Big Analytics, Big Machine Learning, and Big AI, will be a panacea for All That Ails Healthcare. It will save the entire system and the patient money, revolutionize medical decision making, save doctors time, increase accuracy, and in general save us from ourselves. Oh yes, and we do need saving, because our Big Tech and Big Health betters tell us so!

Major points in Dr. Osipenko’s Project Syndicate article, which is not long but provocative. Bonus content is available with a link to a London School of Economics panel discussion podcast (39 min.):

  • Source data is flawed. It’s subject to error, subjective clinical decision-making, lack of structure, standardization, and general GIGO.
  • However, Big Data is sold to health care systems and the general public like none of these potentially dangerous limitations even exist
  • Where are the long-range studies which can objectively compare and test the quality and outcomes of using this data? Nowhere to be found yet. It’s like we are in 1900 with no Pure Food Act, no FDA, or FTC to oversee.
  • It is sold into health systems as beneficial and completely harmless. Have we already forgotten the scandal of Ascension Health, the largest non-profit health system in the US, and Google Health simply proceeding off their BAA as if they had consent to identified data from practices and patients, and HIPAA didn’t exist? 10 million healthcare records were breached and HHS brought it to a screeching halt.
    • Our TTA article of 14 Nov 19 goes into why Google was so overeager to move this project forward, fast, and break a few things like rules.
  • We as individuals have no transparency into these systems. We don’t know what they know about us, or if it is correct. And if it isn’t, how can we correct it?
  • “Algorithmic diagnostic and decision models sometimes return results that doctors themselves do not understand”–great if you are being diagnosed.
  • Big Data demands a high level of math literacy.  Most decision makers are not data geeks. And those of us who work with numbers are often baffled by results and later find the calcs are el wrongo–this Editor speaks from personal experience on simple CMS data sets.
  • In order to be valuable, AI and machine learning demand access to potentially sensitive data. What’s the tradeoff? Where’s the consent?

Implicit in the article is cui bono?

  • Google and its social media rivals want data on us to monetize–in other words, sell stuff to us. Better health and outcomes are just a nice side benefit for them.
  • China. Our Readers may also recall from our April 2019 article that China is building the world’s largest medical database, free of those pesky Western democracy privacy restrictions, and using AI/machine learning to create a massive set of diagnostic tools. They aren’t going to stop at China, and in recent developments around intellectual property theft and programming back doors, will go to great lengths to secure Western data. Tencent and Fosun are playing by Chinese rules.

In conclusion:

At the end of the day, improving health care through big data and AI will likely take much more trial and error than techno-optimists realize. If conducted transparently and publicly, big-data projects can teach us how to create high-quality data sets prospectively, thereby increasing algorithmic solutions’ chances of success. By the same token, the algorithms themselves should be made available at least to regulators and the organizations subscribing to the service, if not to the public.

and

Having been massively overhyped, big-data health-care solutions are being rushed to market in without meaningful regulation, transparency, standardization, accountability, or robust validation practices. Patients deserve health systems and providers that will protect them, rather than using them as mere sources of data for profit-driven experiments.

Hat tip to Steve Hards.

The Year of the Sensor, round 2: COVID contact tracing + sensor wearables in LTC facilities; Ireland’s long and pivoting road to a contact tracing app

Wearables + sensors being used in long-term/post-acute care facilities for COVID contact tracing, decontamination. Historically ‘unsexy’ to digital health techies, long-term and post-acute care (LTPAC) came into sharp focus as the epicenter of COVID-19 deaths in the past four months. 45 percent of US COVID-19 deaths (over 54,000) occurred in nursing homes and assisted living residences, with the percentages being far higher in states like New Hampshire and Rhode Island (80%), Massachusetts and Connecticut (63%), Pennsylvania (68%), and New Jersey (48%). Freopp.org has a wealth of state-level information.

This created opportunities for companies that already had relationships with LTPAC to create systems to 1) contact trace individuals and residents, 2) trace locations not only of residents and staff but also contaminated areas, and 3) help focus ongoing decontamination and sanitization efforts. Featured in this surprising TechRepublic article is CarePredict, which back in March started to develop a response to COVID spread including what they dubbed the PinPoint Toolset. CarePredict already had in place a sensor-based system for residents that consolidated sensors into a wrist-worn resident ADL tracker with location and machine learning creating predictive health analytics that appear in a dashboard form. They expanded their analytics to staff and visitor contact plus locating frequently visited area by residents and staff so that decontamination efforts can be focused there. Also featured in the article are VIRI (website) and Quuppa, a real-time locating system (RTLS) repurposed from manufacturing and security. (Disclosure: Editor Donna consulted for CarePredict in 2017-18)

Ireland’s long and winding road to a national contact tracing app is the subject of an article in ZDNet. Waterford-based NearForm was called in by Ireland’s Health Services Executive (HSE) on week 1 of the lockdown and started work immediately. They had a prototype oapp running on a mobile phone by the end of the week, nonfunctioning but giving the HSE a look at the user interface. NearForm worked on a centralized model first, which was basically terminated by Apple’s insistence on blocking BTE, then in April pivoted to the decentralized Apple-Google (Gapple? AppGoo?) Exposure Notification system, once the HSE secured beta access to the new technology. By 7 July, Ireland launched and had over a million downloads in 48 hours. Germany had a similar saga and timing. Both Ireland, Germany, and other countries moved quickly to adopt Apple and Google’s APIs, when Apple blocked their original centralized app methodology. UK and NHSX did not pivot and are In The Lurch with Test and Trace [TTA 18 June, more deconstruction in VentureBeat]. Editor’s Note to Matt: go to your neighbor island, don’t be shy, and make a deal deal’ for the app. Solves that problem. 

Can technology speed the return to office post-COVID? Is contaminated office air conditioning a COVID culprit?

Most offices in the US are still not open or only ‘essential personnel’. As this Editor noted on 19 May, a number of companies, including startups, are focusing on working with employers on return-to-work strategies. There are a raft of approaches including on-site clinics, temperature screening checkpoints, and check-in/reporting apps from Verily (Alphabet) and Fitbit’s Ready to Work. These screeners generally monitor for self-reported symptoms, but some will advise and track you to testing if you demonstrate risk, such as UnitedHealth Group and Microsoft’s ‘ProtectWell’ with a closed loop of testing recommendations that are reported to the employer. Collective Go from Collective Health goes a bit further in emphasizing up-front (molecular [PCR]) testing and continuous employee monitoring into their protocols for, apparently, every worker. OneMedical, which works with 7,000 employers, adds to their on-site management and testing additional contact tracing. FierceHealthcare

Maybe it’s in the air-conditioned air you breathe? Office building air circulation may be a culprit in the spike in Florida, Arizona, and Texas cases. The uptick in cases in Southern states where the contagion rates were initially fairly light may be due to the mostly recirculated air in office air conditioning systems. Most modern buildings don’t have windows which open. Older buildings have their own problems like mold from leaky systems and ‘soot’ (from air pollution and when people used to smoke in offices, remember when?). Newer LEED buildings are so ‘tight’ and energy efficient that air tends to be stagnant. Few buildings have good ratios of air exchange with the outside plus use HEPA filtration throughout the HVAC system. The total picture is that any virus can make its way through offices–six feet of distancing, masks, sanitization, no cafeterias, and acrylic panel separators be d****d.  (Contrast your average office building with modern commercial aircraft where about 50 percent of air is recirculated at any one time, there’s a total change about every three minutes, and HEPA filters are used! AskThePilot, a great site for all things airline)

A return-to-work readiness strategy suggested here by a Harvard Medical epidemiologist whose main area is TB spread are germicidal UV lights high in the room to catch the viruses that go up, then down. UV light for sanitization and disinfection is a technology used for several years to disinfect patient care areas (PurpleSun is one). Far-UVC, versus near-UVC, and potential uses are outlined in this Nature article from February 2018Harvard Gazette

While telehealth virtual office visits flatten, overall up 300-fold; FCC finalizes COVID-19 telehealth funding program (US)

As expected, the trend of telehealth visits versus in-person is flattening as primary care offices and urgent care clinics reopen. Yet the overall trend is up through May–a dizzying 300-fold, as tracked by the new Epic Health Research Network (EHRN–yes, that Epic). Their analysis compares 15 March-8 May 2020 to the same dates in 2019 using data from 22 health systems in 17 states which cover seven million patients. It also constructs a visit diagnosis profile comparison, which leads with hypertension, hyperlipidemia, pain, and diabetes–with the 2020 addition of — unsurprisingly — anxiety.

POLITICO Future Pulse analyzed EHRN data into July (which was not located in a cross-check by this Editor) and came up with its usual ‘the cup has a hole in it’ observation: “TELEHEALTH BOOM BUST”. But that is absolutely in line with the Commonwealth Fund/Phreesia/Harvard study which as we noted tailed off as a percentage of total visits by 46 percent [TTA 1 July]. But even POLITICO’s gloomy headline can’t conceal that telehealth in the 37 healthcare systems surveyed was a flatline up to March and leveled off to slightly below the 2 million visit peak around 15 April. 

Where POLITICO’s gloom ‘n’ doom is useful is in the caution of why telehealth has fallen off, other than the obvious of offices reopening. There’s the post-mortem experience of smaller practices which paints an unflattering picture of unreadiness, rocky starts, and unaffordability:

  • Skype and FaceTime are not permanent solutions, as not HIPAA-compliant
  • New telehealth software can cost money. However, this Editor also knows from her business experience that population health software often has a HIPAA-compliant telehealth module which is relatively simple to use and is usually free.
  • It’s the training that costs, more in time than money. If the practice is in a value-based care model, that is done by market staff either from the management services organization (MSO) or the software provider.
  • Reimbursement. Even with CMS loosening requirements and coding, it moved so quickly that providers haven’t been reimbursed properly.
  • Equipment and broadband access. Patients, especially older patients, don’t all have smartphones or tablets. Not everyone has Wi-Fi or enough data–or that patient lives in a 2-bar area. Some practices aren’t on EHRs either.
  • Without RPM, accurate device integration, and an integrated tracking platform, F2F telehealth can only be a virtual visit without monitoring data.

Perhaps not wanting to paint a totally doomy picture (advertising sponsorship, perhaps?), the interview with Ed Lee, the head of Kaiser Permanente’s telehealth program, confirmed that the past few months were extraordinary for them, even with a decent telehealth base. “We were seeing somewhere around 18 percent of telehealth [visits] pre-covid. Around the height of it, we’re seeing 80 percent.” They also have pilots in place to put technology in the homes of those who need it, and realize its limitations.

Speaking of limitations, the Federal Communications Commission (FCC) COVID-19 Telehealth Program, authorized by the CARES Act, is over and out. The final tranche consisted of 25 applications for the remaining $10.73 million, with a final total of 539 funding applications up to the authorized $200 million. Applicants came from 47 states, Washington, DC, and Guam. FCC release. To no one’s surprise, 40 Congresscritters want to extend it as a ‘bold step’ but are first demanding that Chair Ajit Pai do handsprings and provide all sorts of information on the reimbursement program which does not provide upfront money but reimburses eligible expenditures. That will take a few months. You’d think they’d read a few things on the FCC website first. mHealth Intelligence

Telehealth, virtual, and ‘omnichannel’ health winners in CVS’ ‘Path To Better Health’ study

CVS Health’s third annual ‘Path to Better Health’ study contains both cheerful (for health tech) and distressing news (for practices). While we do have to consider the source–CVS Health definitely has an entire kennel of dogs in the fractionalization of health delivery race, HealthHUB as only one–the key findings illustrate a greater acceptance of telehealth and remote visits by the surveyed consumers. Providers seem to be shifting in the same direction, albeit not that dramatically.

Percentage results are 2020 versus the (2019 study).

Consumers are much more accepting of virtual communication:

  • Telehealth interest: 32 percent (14 percent)
  • Virtual office visit interest: 29 percent (20 percent)
  • Messaging interest: 48 percent (41 percent)
  • More women (35 percent) than men (27 percent) are interested 
  • 40 percent are interested in virtual behavioral health; 38 percent in virtual advice from a pharmacist

Providers are moving more slowly in connecting virtually with patients, though telehealth had the greatest boost:

  • Telehealth: 40 percent (22 percent)
  • Virtual office visits: 24 percent (23 percent)
  • Digital messaging through email, text and patient portals: 36 percent said they are very valuable for successful interactions with their patients

While the study does not speculate on the lagging acceptance numbers for providers except for telehealth, virtual visits (by telehealth!) and digital messaging add to workload and do not necessarily at this time have clear workflows.

Predictive analytics

  • 39 percent of providers claim that they already have or are likely/somewhat likely to incorporate predictive analytics into their practices within several years
  • 31 percent of providers are somewhat likely to incorporate predictive analytics or artificial intelligence
  • Acceptance is greater among providers with very large (450+ patient) practices (48 percent)
  • Younger providers with under 15 years of experience are also more likely to incorporate predictive analytics in their practices (50 percent), versus those over 15 years of experience (35 percent)

Mental health issues. Perhaps it was the timing of the study (March), but the need for mental health support, evidenced by social connection among those 18 to 34 and 35 to 50, was drastically on the rise–unhappiness among social connections (29-30 percent), no desire to be social (44-45 percent), not knowing where to meet new people (44-51 percent).

There is also a great deal of information on concerns around affordability of medical and drug costs, convenience, the cost of chronic disease management, mental and cognitive health, and community-based resources. In reading through the executive summary, it is easy to see how delivery of care has shifted from the primary care office and hospital to urgent care clinics, but interoperability (information sharing) is a major concern. 75 percent of physicians have a high to moderate concern of a looming physician shortage.

Methodology. The US survey was taken in March. The consumer sample was 1,000 18+. CVS oversampled 12 metropolitan statistical areas (MSAs): Atlanta, Austin, Boston, Cleveland, Dallas, Houston, Los Angeles, New York City, Philadelphia, Providence, Hartford, San Francisco, Tampa plus two ethnic groups: African American and Hispanic. 400 providers were surveyed, primarily primary care physicians and specialists with at least two years’ experience, as well as nurse practitioners, physician assistants, and pharmacists.

Infographic, Executive Summary, press release. Also Fierce Healthcare. (An annoying part of the summaries is that they state changes in percentage points as percentages.)

Walgreens Boots goes big with billion-dollar medical office deal with VillageMD

Go big or go home. That seems to be Walgreens Boots Alliance’s’ theme in its 8 July announced deal with and investment in primary care provider VillageMD. They will set up 500 to 700 co-located full-service Village Medical offices in more than 30 markets over the next three to five years. The “Village Medical at Walgreens” offices will be staffed by a projected 3,600 primary care providers and fully integrated with Walgreens pharmacists for one-stop shopping. According to the release:

  • Most of the Village Medical medical offices will be approximately 3,330 square feet each, up to 9,000 square feet, and utilize existing store space. “80% will be used by VillageMD to fund the opening of the clinics and build the partnership.”
  • 24/7 care will be available via telehealth and at-home visits
  • Fees will be covered by insurance or for those without, on a sliding scale
  • Over 50 percent will be located in Health Professional Shortage Areas and Medically Underserved Areas/Populations, as designated by HHS. These would reach underserved “older, sicker, and poorer patients” without regular access to care, said VillageMD CEO Tim Barry in an interview with CNBC
  • Capacity would be 100 to 120 patients per day 

This follows on a pilot of five Village Medical clinics at Walgreens locations in Houston, and Village Medical’s eight-state expansion in the Find Care telehealth program announced in April.

Walgreens Boots Alliance will invest $1 billion in equity and convertible debt in VillageMD over the next three years, including a $250 million equity investment to be completed today which will culminate in about 30 percent ownership.

To this Editor, Walgreens is sitting at a giant poker table, stacking the $1,000 chips, and saying to its rivals, ‘see ya and raise ya’. These are full-service offices, not urgent care clinics, and they are investing in their provider. It could be transformative–or flop on executional niceties such as location, medical competition, or even COVID keeping down physical visits. The competition is also daunting on the retail side. Recently Walgreens has pared back hundreds of locations and faces the deep pockets of CVS-Aetna, which plans to open 1,500 HealthHUBs which integrate stores, MinuteClinics with nurse-practitioners, pharmacies, and health data, Amazon with PillPack aimed at its pharmacy business, and Walmart with its toe in the water with clinics. 

Village Medical, formerly Village Family Health, is a multi-state primary care provider which is part of Chicago-based VillageMD. Both include more than 2,800 physicians across nine markets, so the Walgreens deal will more than double their size. Also Forbes (Photo: Walgreens)

News roundup: Teladoc closes InTouch, Samsung bets on tele-genomics, SURE Recovery app, Optimize.health’s seed round, Walgreens’ Microsoft boost

Teladoc completed the acquisition of InTouch Health on 1 July. The purchase, announced at the JP Morgan soireé in January (and an eternity ago) took place just before the ’10 years in 2 months’ leap forward in telehealth services. InTouch’s telehealth offerings are primarily for hospitals and health systems, heavily based on multi-feature carts and camera setups. The purchase price of $150 million in cash and 4.6 million shares of Teladoc Health common stock, valued then at $600 million, may be a great bargain for Teladoc considering the rich prices that other telehealth-related companies commanded during the peak of the pandemic, and that Teladoc’s revenue boosted to almost $181 million in revenue in Q1 2020, up 41 percent versus Q1 2019. Release

Samsung makes a telemedicine bet with Genome Medical. Through its Catalyst Fund, Samsung is the lead among 15 investors in a $14 million Series B extension financing that includes LRVHealth, Revelation Partners, and Kaiser Permanente Fund. Genome Medical’s connection to telemedicine is on-demand, standard-of-care genetics and genomics through virtual health services, including counseling, patient drug response, and provider-to-provider consults through its platform. Release. CNet. Crunchbase.

Mindwave Ventures, which this Editor noted last December was opening up an office in the Leeds health tech hub, has continued its development and research with multiple platforms and apps in partnership with NHS and academic/research clients. One that came on our ever-whirling radar screen is the release of the SURE Recovery app, for those in recovery from alcohol and drug problems. It enables users to work with the SURE (Substance Use Recovery Evaluator) and SUSS (Substance Use Sleep Scale) measures, plus a personal diary, to track their recovery over time. Mindwave developed the app in conjunction with The King’s College London and theInstitute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London. The app is now available to download; search ‘SURE Recovery’ on the App Store or Google Play. The page on the Mindwave site is on their Clinical Research page–click the tab for SURE. Hat tip to Ellis Noble of KC Communications.

Connected to telehealth and RPM is provider reimbursement. Optimize.health is an early-stage company which provides a turnkey setup for practices for its remote patient monitoring platform, with the usual features such as patient engagement, integrated devices with the platform, and call center support. The apparent difference is the emphasis on sharing data and simplifying reimbursement, the hard part of any RPM or telehealth platform. Announced this week: a $3.5 million seed round led by Bonfire Ventures. A small boost to this part of the telehealth field which has not had the great success of virtual consults. Release.

Back in January 2019, Walgreens Boots announced a partnership with Microsoft to migrate their IT over to the Azure platform. It took a while for results to manifest to the public. When COVID happened, they rolled out a COVID-19 risk assessment tool on its website and mobile app based on Azure. Their Find Care platform doubled the number of virtual care providers and services available. Walgreens also provided a link to COVID-19 clinical trials through the Find My Clinical Trial program on its mobile app. This article in FierceHealthcare touts how they are maneuvering to stay even with CVS Aetna and Amazon, which is hardly waiting for its partners in the gone-pearshaped Haven.

Hackermania runs wild…all the way to the bank! Ransomware strikes Crozer-Keystone, UCSF med school, others

News to make you livid. After surviving (to date) the COVID pandemic, health systems and medical schools are being attacked by ransomware criminals. Both the small Crozer-Keystone Health System and the globally known University of California San Francisco School of Medicine have been attacked by the ever-so cutely named Netwalker (a/k/a MailTo). Yes, this criminal hacker gang isn’t outside banging pots for first responders or donating money, or even sticking to a brief truce (Emsisoft), but figuring ways to spread malware into healthcare organizations for fun and profit. 

And profitable it’s been. UCSF paid Netwalker the princely sum of $1.14 million (£910,000) in 116.4 bitcoins after an attack starting 1 June that was also (to add insult to injury) published on Netwalker’s public blog. In the timeline presented by BBC News, it was negotiated down (professionally) from $3 million; BBC also obtained some key parts of the negotiation via an anonymous tipoff, and it’s fascinating reading. Netwalker leads the victim to a dark web ‘customer service’ site where there’s a countdown to double payment or deletion of your now-encrypted data. They are also able to live chat with the victim.

UCSF was able to limit the malware encryption damage to servers within the School of Medicine (according to the BBC, literally unplugging computers; according to UCSF, isolating servers) but decided to pay the ransom to unlock the encrypted data and return data they obtained, stating in its public release “The data that was encrypted is important to some of the academic work we pursue as a university serving the public good”. They will work with the FBI on the incident and have brought on board outside expert help.

According to FierceHealthcare, Netwalker was also behind the attack on the Champaign-Urbana Public Health District (Illinois) website in March and Michigan State University’s network in May.

Paying ransom is contrary to the advice of the major world security services such as the FBI, Europol, and the UK’s National Cyber Security Centre, on the simple basis that it encourages them. It’s a true damned-if-you-do, damned-if-you-don’t situation, as Brett Callow, a threat analyst at cyber-security company Emsisoft, said to the BBC: “But why would a ruthless criminal enterprise delete data that it may be able to further monetise at a later date?” 

Crozer-Keystone to date has refused to pay ransom. On 19 June, bitcoin publication Cointelegraph published a screenshot of Netwalker’s dark web auction page of the data. Apparently it is all financial and not medical records or PHI. Crozer also isolated the intrusion and took systems offline. Crozer is a small system of four hospitals in suburban Philadelphia (Delaware County) and serves parts of the state of Delaware and western New Jersey.

Neither Crozer nor UCSF have gone public with the source of the breach, but it is known that the main lure during the pandemic has been phishing emails with COVID-19 results or news, loaded with malware downloads.

As this Editor wrote back in May 2018 on the anniversary of WannaCry, it’s not a matter of if, but when, at highly vulnerable organizations like healthcare and academia with high-value information records. Right now, the Hakbit spear-phishing ransomware connected to an Excel spreadsheet macro is targeting mid-level individuals at pharma, healthcare, and other sectors in Austria, Germany, and Switzerland, according to tech research firm Proofpoint. TechGenix

More: Becker’s 22 June on Crozer-Keystone, 29 June on UCSF, 12 largest healthcare breaches to date, 10 healthcare system incidents for June, Kroger hacking incident exposing 11,000 health records. DataBreaches.net news page.

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

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 (updated): Proteus files Ch. 11, VA’s EHR tests now fall–maybe, making US telehealth expansion permanent, Rennova’s rural telehealth bet, Oysta’s Lite, Fitbit’s Ready to Work jumps on the screening bandwagon

Proteus Health, the company which pioneered what was initially derided as a ‘tattletale pill’, filed Chapter 11 bankruptcy today (16 June). As early as December, their layoffs of nearly 300 and closure of several sites was a strong clue that, as we put it, Proteus would be no-teous without a big win. Exactly the opposite happened with the unexpected early end of their Otsuka partnership with Abilify [TTA 17 Jan]. Proteus had raised about $500 million in venture capital from Novartis plus technology investors and family offices. Their combination of a pill with an ingestible sensor, a patch that detects ingestion and that sends information to a smartphone app was ingenious, but in a business model was meant for high-cost medications. Proteus’ current partnerships include TennCare (TN Medicaid), plus Xealth and Froedtert to integrate medication information into electronic health records. At one point, Proteus was valued at $1.5 bn by Forbes, making it one of the early healthcare unicorns.  CNBC, FierceHealthcare

VA further delayed in implementing Cerner-Leidos EHR. POLITICO’s Morning eHealth earlier this month reported from congressional sources that further testing would be delayed to the fall at the earliest and possibly 2021. The project to replace VistA stands at $16 bn. Contributing to delay was an April COVID outbreak in Spokane at a veterans’ home, which pushed patients into the VA medical center. 

In further DC news, several senators are advocating that the relaxing of restrictions on telehealth during COVID should largely be made permanent. According to the lead senator, Brian Schatz (D-HI), Medicare beneficiaries using telehealth services increased 11,718% in 45 days. Many telehealth requirements were waived, including geographic, coding of audio-video and telephonic telehealth billing, and HIPAA platform requirements. Other senators are introducing bills to support remote patient monitoring programs in community health centers’ rural health clinics. FierceHealthcare

The climate for telehealth has improved to the point where smaller players with side bets are now betting with bigger chips. Rennova Health, a mid-South healthcare provider with a side in software, is merging its software and genetic testing interpretation divisions, Health Technology Solutions, Inc. (HTS) and Advanced Molecular Services Group, Inc., (AMSG) with TPT Global Tech. The combined company will be called InnovaQor after an existing subsidiary of TPT and plans to create a next-generation telehealth platform targeted to rural health systems. Release, Becker’s Hospital Review

Oysta Technology has launched the Oysta Lite with an SOS button, GPS, safety zone mapping for travel, and two-way voice. The SOS connects to their IntelliCare platform which provides status monitoring, reporting, and device management plus connecting to the telecare service provider. They are specifically targeting post-lockdown monitoring of frail elderly.  Press flyer/release.

Fitbit jumps on the crowded COVID workplace screening bandwagon with Ready to Work, a employer-sponsored program that uses individual data collected via the Fitbit device such as resting heart rate, heart rate variability and breathing rate. Combined with self-reported symptoms, temperature, and potential exposure, the Daily Check-In app then provides guidance on whether the employee should go to work or remain at home. According to the Fitbit release, a higher heart rate–as little as two beats a minute–can be indicative of an immune system response before the onset of symptoms. TTA has earlier reported [19 May] on other COVID workplace screeners such as UHC/Microsoft’s ProtectWell app, Appian, and (in-house) PWC. FierceHealthcare also lists several others on the cart: Castlight Health, Collective Health, Carbon Health, VitalTech, and Zebra Technologies. However, at this stage, few employees are leaving remote work for in office, and fewer still may even return to the office.

Where in the world is the NHS COVID contact tracing app? Apps rolling out globally, but will they roll out before it’s treatable ?

It does seem that the NHS contact tracing app, debuted after various tests on 5 May in the Isle of Wight, has vanished from the radar screen. A scan of recent news indicates that the app is further delayed in favor of a manual track and trace system with 25,000 contact tracers, starting 28-29 May A Telegraph article indicates that the app had the Bluetooth blues, with further detail from Wired UK around emerging worries within NHSX about BTE’s ability to accurately calculate the distance between two users.

Folks in the Isle of Wight, who enthusiastically adopted the app (Week 1’s 52,000 downloads), would like to know how they’re doin’, in the immortal words of a real NYC Mayor, Edward Koch. That data about contacts and alarms seems to not be forthcoming from the NHS–as well as an updated app with more questions about symptoms and test requests and results integrated into the process, according to BBC News today 16 June. Yes, it was an odd choice, but often beta tests take place in relatively small and isolated places, not big cities where factors can’t be controlled. But the app appears not to be moving forward in favor of the manual system. Nevertheless, the sound of crickets is deafening.

Some articles like Wired’s blame the NHS’ centralized approach, where a report of COVID goes straight to the NHS server, with outbound messages going to those with whom the person was in contact, defined by BTE tracing within 6 feet for 15 minutes +. Observers like our own Editor Emeritus Steve Hards noted in comments on the 29 May article that “It will only take a few well-publicised malware or phishing incidents to make the job of the genuine trackers unworkable and for any trust in the app to evaporate.”

A great deal of fuss has been made of other countries adopting contact tracing apps that actually work. Most of these are built on a platform developed by Apple and Google. These have been used in Italy, Switzerland, Latvia, and Poland. Austria is in test, Germany just launched. Japan’s is on a Microsoft platform. Countries that launched earlier have had their wrinkles. Italy is feuding over issues of data privacy. Norway’s Smittestopp app, which used both GPS and BTE to advise those contacted to self-isolate, was stopped by the Norwegian Data Protection Authority on disproportionate intrusion into users’ privacy. A bug in the programming affects Australia’s CovidSafe iPhone users in logging matches when the other iPhone is locked. Singapore, after seeing only one-quarter of the population adopting the app,  is going the wearable dongle route that you hand over if you test positive. BBC News

By the time the apps are developed, debugged, and rolled out, the lockdowns will have ended, and the virus will have abated or mutated for next season. Meanwhile, progress has been made on treatment protocols. HCQ, zinc, azithromycin, vitamins C and A in early-stage treatment are already well known, like Tamiflu for the first few days of the flu. In later treatment, nasal oxygen (not ventilators), high dose vitamin C, heparin (a common blood thinner to prevent lung clotting), methylprednisolone (a steroid) and also HCQ were published by the Front Line COVID-19 Critical Care Consortium as early as 6 April. Now another BBC News report reveals that the University of Oxford’s RECOVERY Trial is mass-testing several approaches, including an inexpensive steroid, dexamethasone ($1 a dose). Sadly, they estimate that 5,000 lives in the UK could have been saved. Between cheap and common HCQ, heparin, steroids like dexamethasone and methylprednisolone, and high dose vitamins like A, C, and zinc, let’s hope that the spread in Africa and Latin America, especially Brazil, can be quelled.

Another COVID casualty: a final decision on the Cigna-Anthem damages settlement

Remember Cigna and Anthem, a Merger Made In Hell? This Editor loves to follow up a good public slugfest which has been going on in Delaware Chancery Court since May of 2017. As our Readers may recall, the Doomed To Fail merger, finally pounded into the ground by the Federal courts, soon degenerated into what a former VP of your Editor’s would call a ‘Who Shot John’ scenario. Anthem would not pay Cigna the breakup fee of $1.85 bn. Cigna then demanded an additional $13 bn in a ‘Funny Valentine’ of damages, accusing Anthem of harming Cigna’s business. Anthem then in turn claimed $20 bn in damages. Three years later, other than a blip of news in March 2019, the imminent decision was to be at the end of February or even March this year (Axios, Reuters). We all know what happened in March–a pandemic that shut the courts. The timing could not be worse, as COVID has bitten hard into payer profits, and a settlement could bite even harder, putting either company into the red–going back years.

Whatever company wins may, after legal fees, may have enough money to buy one of these–before the concours restoration.

 

Telehealth and the response to COVID-19 in Australia, UK, and US: the paper

Published last week in the Journal of Internet Research (JMIR) is the study by Malcolm Fisk, PhD which TTA previewed last month on telehealth’s part in the two-week response, starting 12 March, in response to COVID-19 in Australia, UK, and the US. Malcolm Fisk, PhD, who our readers know as Senior Researcher at the De Montfort University in Leicester, led a group from Australia in comparing these three countries in including telehealth in their responses to the pandemic. It looks at how telehealth models were used, awareness of the role of telehealth in response, and how restrictions previously in place were dealt with. 

The study’s conclusions, briefly summarized:

  • Australia: immediately funded on 11 March with AUS $100 million (US $68 million) a “new Medicare service,” at no cost for patients, for telehealth consultations. Telehealth in Australia is well developed, particularly in rural areas, for health and social care needs. The added funding will aid in the rollout.
  • UK: at the same time, the UK was in a ‘containment’ phase with the PM’s admission that “many more families will lose loved ones before their time”. At that point, telehealth was not in the plans, but the Imperial College projections and recommendations on home quarantining and ‘social distancing’ severely affected the most vulnerable, older people. COVID wound up being quite a jolt to the NHS since telehealth is underdeveloped in most of the UK with the exception being Scotland. Clinicians to this point did not see a need, and many older people do not have access to smartphones, tablets, or the internet. Intents are good–NHSX and the Topol Report setting a framework for telehealth–but to this point telehealth rollout is limited.
  • US: 17 March could be called ‘Telehealth on Steroids’ Day, as CMS announced the ‘dramatic’ expansion of telehealth services via non HIPAA compliant platforms such as Skype and Facetime for Medicare, retroactive to 6 March. Telehealth mushroomed starting 11 March in hospitals first, reporting 15 and 20-fold increases in telehealth consults. Then CDC and the AARP got on board. The US has an uneven system, between differences in state parity reimbursement, Medicare concentrating on rural health, state Medicaid, private pay, and integrated hospital systems’ approaches. What holds telehealth back are providers and areas in the US that simply do not have the internet connectivity that telehealth consults demand.

Good reading. Telehealth in the Context of COVID-19: Changing Perspectives in Australia, the United Kingdom, and the United States Hat tip to Dr. Fisk for sending it our way!

Babylon Health leads a $30 million Series B for Higi health kiosks, continuing US push

Here’s an interesting investment by Babylon Health. Earlier this week, diagnostic/symptom checking app Babylon Health was reported to lead a $30 million Series B investment in Higi. Higi has about 10,000 health monitoring kiosks (Smart Health Stations) placed in various US retail locations like supermarkets (Stop & Shop, Shop Rite), pharmacies (Walgreens), workplace and community locations. A user can check their blood pressure, pulse, weight, and BMI for free, along with uploading data from one of 80 connected devices and apps. What then happens is that Higi stores that data on their platform for the user, who can log in and access it from the Higi app on their computer or smartphone.

Higi claims 62 million people have used a Higi device for a total of 372 million tests. This Editor has seen them in some local stores, usually in a corner, sitting forlornly or with an out-of-service sign. (Sanitization, of course, is a real concern.) 

So what is Babylon’s interest in Higi? The US health data, of course, which Babylon can put into their database and improve their modeling. Babylon also is gaining a foothold in the US with high-profile partners such as Mount Sinai in NYC and with health plans in Missouri, New York, and California. For Higi, the tie with Babylon increases their clinical data information base and adds access to a symptom checking app. 

In the Series B, Babylon Health was joined by Higi’s Series A investors, 7Wire Ventures, Flare Capital Partners, Jumpstart Capital, Rush University System for Health, and William Wrigley Jr. Confusingly, on Crunchbase, these investors are listed as a Series C,  not a Series A. They list a B funding round with lead partner Blue Cross Blue Shield Venture Partners, without a funding amount, with the previous round as venture, so possibly the Series B failed. Higi’s funding to date is over $61 million not including the new round. TechCrunch, Higi blog

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

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 

Why ‘masking up’ isn’t such a great idea–more than a false sense of security, a possible gateway to harm

The signs and reminders to wear a mask outside the home, lest those COVID-19 germs get in (or out), are everywhere. You could be strolling on the beach, with hardly anyone in sight, or in a park with everyone more than 6′ away, and you’re made to feel guilty for wanting to breathe fresh, unimpeded air. This Editor has seen people driving cars solo–with masks on, steaming up their glasses, and restricting their vision (and apparently hearing as one hears mainly one’s breathing) for a dangerous combination in driving safety. And even in a short visit to a supermarket, a fabric mask of the type most common to us civilians can make you feel a little light-headed, as you breathe in less O2 and more of your own CO2, like breathing in and out of a paper bag–as you touch the cheese and the detergent. It all begins to appear a little less than logical, a belief shared with medical professionals with whom I’ve spoken.

Along comes the BMJ to confirm exactly these concerns–and add a few more. A team from University College London and UCL Institute of Epidemiology and Health Care responded to a BMJ editorial that advised that “surgical masks should be worn in public to prevent some transmission of covid-19 [sic], adding that we should sometimes act without definitive evidence, just in case, according to the precautionary principle”. The authors of the ‘Rapid Response’ article note that the ‘precautionary principle’ also should prevent the neglect of potentially harmful side effects of any intervention, including the wearing of masks in public.

The two acknowledged (by most) side effects are: a false sense of security that may lead some to neglect proven infection control measures like hand (and face–Ed.) washing and inappropriate use of a face mask including facial touching and infrequent washing. The writers added five others:

  • Speech is compromised, leading people to come closer simply to hear each other, and increasing contact risk
  • The face mask propels exhaled air into the eyes, leading a person to touch their eyes and possibly contaminate them
  • “Face masks make breathing more difficult. For people with COPD, face masks are in fact intolerable to wear as they worsen their breathlessness.” The rebreathed CO2 also may increase breathing frequency and deepness, thus more contaminated air exhaled in the infected, and conversely increasing their viral load.
  • If face masks are already infected, these points are amplified
  • Reduction in innate immunity that limits the spread of pathogens through the body. “If face masks determine a humid habitat where the SARS-CoV-2 can remain active due to the water vapour continuously provided by breathing and captured by the mask fabric, they determine an increase in viral load and therefore they can cause a defeat of the innate immunity and an increase in infections.”

In short, despite all the ‘stay safe’ and ‘mask up’ admonishments, there are both positive and negative effects of mask-wearing–and risks –and they certainly are not the cure-all for COVID spread. (We will, of course, see if COVID outbreaks in the next few weeks appear in the cities where demonstrations have been rampant and mask-wearing/physical distancing have been noticeably absent.–Ed. Donna)