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

June 17, 2020 | by

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 ?

June 17, 2020 | by

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

June 12, 2020 | by

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

June 12, 2020 | by | 1 Comment

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

May 30, 2020 | by

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

May 29, 2020 | by

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

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

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

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

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

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

May 27, 2020 | by

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)

Reflections of a TechForce19 Participant

May 23, 2020 | by

Ever wonder what it’s like to successfully apply for, and then to deploy your program, as part of a high-stakes challenge? Reader Adrian Scaife, Business Development Manager of Alcuris Ltd., has been on an eight-week merry-go-round on hyperdrive (to mix a few metaphors). We invited him to tell us what it was like after the reports were handed in, and his impressions follow. Thank you, Adrian!

Now the Rapid Feasibility stage has been completed and outcome reports submitted, it’s a good time to sit back and take stock of the last 8 weeks.

It all started in late March when Matt Hancock asked for innovative tech companies to support vulnerable people during the Covid crisis around three themes, Optimising Staffing in Care and Volunteering Sectors, Mental Health and Remote Care. The funding available totalled £500,000 and was planned to be shared across 20 companies.

Even at the start the ambition, the scale and the pace of the initiative were very clear.

Looking back, it is apparent that the initiative has become a brand–TechForce19 – a great name, logo and its own website. The benefit to all is a set of unifying objectives, direction, urgency, and something that people and organisation can come together to support.

The sheer number of organisations involved in the initiative was breath-taking. Funding was from the Department of Health and Social Care along with the Ministry of Housing, Communities and Local Government. It was run by NHSX supported by Public Ltd., the Academic Health Science Networks including the Health Innovation Network in London and other experts from a variety of organisations.

The application process was at speed with a launch date of 24th March and application submission by noon 1st April (and that was the extended deadline!). The application form was thorough in the questions asked particularly around how you would conduct a two-week test to demonstrate that you can solve the challenge(s). We also knew it was going to be scored based on Solution feasibility, Company credibility, Impact, and Digital maturity.

The selection process was equally fast with feedback on the next stage due Friday 4th April. Friday came and went, and we feared the worst. Little did we know at the time that over 1,600 applications had been received. Just before midnight on Saturday an email was received announcing we were through to the interview stage and ours was on Monday. 60 interviews were completed over the next few days.

Just over a week later, confirmation that our proposal had been accepted, one of just 18 participants. Time to deliver on our plan. Just 10 days to plan the project in detail, provide partner training, deliver the hardware, for our partners to collect their referrals and then to deploy the Memo Connected Care Suite. Two weeks of live running. Evaluation and an outcomes report to be submitted by the 18th May.

I must give enormous praise and thanks to our partners for their commitment to deliver when all around them the pressures on their services due to Covid were unbelievable.

So now the Feasibility and Outcomes report has been submitted. We have received some terrific feedback both from families and Social Care staff. Did the project go according to plan? Well not entirely but when do they ever, especially during a national crisis.

One surprise that I shall never forget is Nasdaq, the American stock exchange, wanted to applaud digital innovators globally who were supporting the Covid fight. They promoted the work of TechForce19 on their seven storey Nasdaq Tower in Times Square, New York by highlighting each of the 18 participants.

TechForce19 is an NHSX Covid-19 response initiative, supported by PUBLIC and the AHSN Network. The views expressed in this article are those of the author and not necessarily those of NHSX or its partners.

PUBLIC’s website has profiles on the 17 other TechForce19 participants, including many names familiar to our Readers, such as Just Checking and Buddi. Our earlier article is here.  Hat tip to Reader Alistair Appleby.

 

 

Post-COVID back to work: for workplace screening, testing, contact tracing, there’s an app for that

May 19, 2020 | by

If you’re looking forward to going back to the office without the children and the dog barking, and seeing people other than your family, don’t expect to go back to “The Office” Normal with kibitzing over the divider and in the kitchen/break room. Chances are the latter will be locked, and the nearest person over the divider will be six feet away. There will not only be serious physical changes to the office, starting with many fewer people there, but also apps to track your health and who you come in contact with. Your employer will be managing your potential risk for infection of yourself and others.

  • UnitedHealth Group and Microsoft’s ‘ProtectWell’ app will screen your health everyday (using Microsoft’s COVID-19 triaging Healthcare Bot and Azure. If there’s a risk of exposure or if you are exhibiting symptoms, it will direct you to a COVID-19 testing process that enables closed-loop ordering and reporting of test results directly back to employers, managed (of course) by UnitedHealth. The app will also provide guidelines and resources for a safer work environment, including physical distancing, personal hygiene, sanitation, and more. UHG and Microsoft are furnishing the app to employers at no charge. UHG has already implemented this ‘contact tracing lite’ for frontline workers and will roll out to its over 320,000 employees; Microsoft will do the same for its US-based workers. Release
  • Enterprise software company Appian released Workforce Safety and Readiness, an app to enable HR departments to plan and maintain a return to work for employees and to maintain a safer workplace. This ’employee re-entry’ app as their CEO Matt Calkins put it, is not for every company. The app will quiz employees on factors such as health data, possible virus exposures, and details about their jobs to determine when and how they should return, based on their jobs plus CDC and state guidance, both of which keep shifting; state and local guidance in particular is keeping more than one law firm quite busy. The app can then push information to workers about their new hours, area, and similar. When the employee is back to work, they can then use the app to provide feedback on crowding and lack supplies such as hand sanitizer or wipes. The app is built on a HIPAA-compliant system and originated with a self-reporting disease app. Appian is targeting larger companies with thousands of employees on a $5,000 per month subscription model. Appian page, The Protocol
  • Companies large and small have devised their own mass testing procedures for current workers and those returning, as early as the next two weeks. This next article from Protocol details several approaches, mostly around detecting the imminently ill.
  • PWC has already set up a contact tracing system for returning workers, an app that tracks contacts with the phones of others of a person who self-reports being ill. While the privacy seems pretty robust–it works on employee self-reporting and his or her AD ID on my phone, then all the other phones it had contact with over the past X days via Bluetooth. As PWC’s David Sapin of their connected solutions area put it, “But if you’re going to come back into the workplace, you need to accept having this type of app on your phone.”
  • For a really dystopian view, see this article in Bloomberg. You may be scanned thermally, have an elevator operator (back to the past!), and lots and lots of sensors monitoring your comings and goings. Facilities departments will be retrofitting for anti-microbial surfaces and plexiglass guards. Before you are allowed to return, if you are allowed to return, you may be pre-assessed for risk before you are allowed to, with bonus point for antibodies. And when you’re back in your ‘six feet office’, you’ll have many more rules governing daily desk coverings, how you interact with your colleagues, walk in the hall, go to the bathroom. Hint: buy acrylic polycarbonate manufacturer stock. ZDNet

Of course, one wonders if Unintended Consequences will be to very firmly establish a remote workforce, which is anathema to some companies, or encouraging further outsourcing of work to offshore entities.

The Theranos Story, ch. 63: 12 new wire fraud, conspiracy, forfeiture charges for Holmes, Balwani

May 13, 2020 | by

The Fraud That Is Theranos manages to stay in the news, despite a global pandemic, with more fraud charges. Only a few weeks ago, things were looking up for former executives Elizabeth Holmes (left, in the Female Steve Jobs days) and ‘Sunny’ Balwani. The defense insisted that they couldn’t prepare a proper defense without breaking shelter-in-place executive orders, which built their case for delaying the original August trial date. Prosecutors are requesting 27 October; the defense 2021. In February, the nine counts of wire fraud and two counts of conspiracy were reduced by the judge, who dismissed the two conspiracy charges related to defrauding patients who did not pay directly (e.g. insurance payment) and directing doctors to misrepresent Theranos to patients. 

Now Federal prosecutors have filed 12 fresh counts of wire fraud and conspiracy against Holmes and Balwani, plus forfeiture, in the Federal US District Court, Northern District of California, in San Jose. The superseding information (link to PDF) filed on 8 May details the very public splash and claims on their capabilities made by Holmes to the media, on their website, in their Walgreens partnership, and in advertising, from 2013 to 2015. Revealed today (12 May), the expansion of charges include 12 counts of:

  • Wire fraud against Theranos investors, including conspiracy to defraud investors through false representations of their revenue, financial models, and technology, going back to 2010
  • Wire fraud against Theranos patients, through representing to doctors that the tests were accurate while knowing they were not
  • Six additional charges of wire fraud through using electronic media and electronic transfers of funds
  • Four additional charges of wire fraud in transmitting through phone and internet laboratory and blood test results, plus payments for the purchase of nearly $1.3 million in ads targeting patients and doctors for the Wellness Centers

Wrapping this up is a demand for forfeiture of proceeds (which were at least $700 million).

These felony charges carry a potential sentence of 20 years imprisonment, a $250,000 fine, three years supervised release, plus a $100 special assessment (ahem), in addition to whatever proceeds can be clawed back in what is now a worthless company.

The actual indictment needs a grand jury to be convened, which cannot happen until 1 June or later.

Additional information on The Register, BioSpace, and Fox Business.

Theranos’ fraudulent blood testing is even more relevant in this Age of COVID with reports of the proliferation and uneven performance of virus and antibody tests. Tyler Shultz, who worked at Theranos and was related to investor/advisor George Shultz, warned on 2 May that Theranos would have thrived in this hothouse. The UK alone ordered millions of kits from China, only to send them back due to poor sensitivity (ability to avoid false negatives) and specificity (ability to avoid false positives). Rapid testing kits have come under particular fire. The US opened the gates to non-FDA cleared tests in March, only to close them shut a few days ago. Only Belgium, with the highest rate of fatalities per 1,000 infections, has banned the rapid tests. Other tests are more accurate but they take more time to return results and cannot be administered at home. Many believe that they already had COVID and anxious to see if they have the antibodies (IgG) floating about in their plasma. Bloomberg

Important UK government guidance on safer workplaces during and after the COVID-19 pandemic

May 13, 2020 | by

The UK Department for Business, Energy & Industrial Strategy has issued on Gov.UK specific advisories on workplaces and to keep workers healthy during and after the peak of this pandemic. In addition to those who’ve had to work on-site through the lockdown, as we return to business, this guidance will be helpful in assessing risk and engaging staff in changes such as physical distancing, reconfiguring offices, creating barriers, and reconfiguring work teams.

Eight work situations are identified: 

  1. Construction and outdoor work
  2. Factories, plants, and warehouses
  3. Labs and research facilities
  4. Offices and contact centres
  5. Other people’s homes
  6. Restaurants offering takeaway and delivery
  7. Shops and branches
  8. Vehicles

While not strictly digital health, this is pertinent information for us in our businesses to keep safe, particularly #3-5. Most of us won’t be working remotely forever, and quite a few of us visit homes and other offices. For our US readers, this type of guidance will also be useful–and hasn’t been seen by this Editor from the state or Federal level.

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

May 7, 2020 | by

Malcolm Fisk, whom our Readers know as Senior Researcher at the De Montfort University in Leicester, was kind enough to forward information on a recent video interview with André Martinuzzi of the Living Innovation Project, a Europe-wide innovation group with 14 partners ‘co-creating the way we will live in 2030’.

This 17:30-minute video covers a lot of ground on the UK response to the coronavirus (the uncertainty as of mid-April), how the UK, US, and Australia have used telehealth in response, and how telehealth can ‘stick’ after the crisis, but only if we design an inclusive infrastructure. You can view the video on the Living Innovation page by clicking on ‘View Video’ on the upper right hand side, or go directly to YouTube.

There’s a brief preview in the video of Dr. Fisk’s paper (awaiting publication, co-authored with Anne Livingstone and Sabrina Pit) on ‘Telehealth in the Context of COVID-19: Changing Perspectives in Australia, the United Kingdom and the United States’. Telehealth was very rapidly put into use for diagnosis, monitoring, and home treatment of COVID patients. Restrictions were lifted and investments made in communicating the availability of telehealth. However, the infrastructure for telehealth is strained, especially in the US with a mixed, primarily private model dependent on payers or individuals paying per virtual visit. In the UK, health trusts have encouraged the use of telephonic and audio/video models. In Australia, telehealth, particularly in remote areas, is well established. TTA will keep Readers posted on the publication of this paper. A big hat tip to Malcolm Fisk.

Has the ‘river of knowledge’ reversed its natural course? A lighter look at technology’s other effects.

May 7, 2020 | by | 1 Comment

A long-time TTA Reader, John Boden, takes a rueful glance at how ‘smart’ technology has not just disrupted the phone and computing markets, but has disrupted the ‘natural order’ between generations today. A virus-free look at a phenomenon that’s changed a natural dynamic.

As I am writing my experiences, and thinking about my grandparents and parents, I remember how many of the little things they taught me. It is not the big lessons I am talking about, but the details. A few examples: how to sharpen a knife; how to ground a sparkplug without getting shocked; how to tie a bowline; how to saw a board; how to chop down a tree, and hundreds of other skills. The most amazing change has taken place today. Now, so many times it is the grandchildren teaching the grandparents. The advent of technology is the cause. Cell phones, e-readers, Google, directions to anywhere from anywhere, Amazon shopping, Uber, movies, music, and on and on. All came screaming into our lives in the last decade or two, like an avalanche filling those little machines we hold in our hand.

The acquisition of the new skills needed is no longer based on the experience and hard-learned lessons that were passed down from one generation to the next, from the master craftsman to the apprentice, from parent to child, as has always been the way.

Suddenly we elders were having to learn new ways of doing things and it felt like we were drinking from a firehose. We finally gave in and bought ourselves one of those new phones we can carry around with us and flip open to use wherever we are, and then, BAM, there is a newer one, and then a newer one, and now it is much more than a phone. It is a map with a guide that tells you directions and even insists on telling you when to turn. It is a record player, a camera, a mailman that delivers immediately and you can even answer back immediately.

WHOA – WHOA – WHOA, this is too much. I cannot even get it out of my pocket before it stops ringing. Then, which button do I push to see who called? Oops, did they leave a message? Why is this screen blinking? Icon? What icon? (And what’s an icon anyway?) Do I push? Oops! Tap! Do not push! And this is just the phone part of the thing.

Where have all the dials gone? Where are the gauges with needles that told us how everything was working? What do you mean I just walk up to my car and it will know who I am and unlock the doors so I can get in? How can all this stuff that did not exist even a few years ago have so completely taken over our lives?

Ah, the instruction manual, that will explain it all! Where is it? What do you mean it is on the phone? I cannot see it. Where is it? Just go to the URL, we are told. The URL? What is that? Is it in the bathroom near the URinaL?

At about at this point that there is only one way out of the mess. Call a child or grandchild to help lead you out of this technology maze we have found ourselves in. Right now there never seems to be a skill that we have learned in our many years of experience that they need. So, today the river of knowledge seems to be in reverse of how it has been for centuries, flowing uphill.

Pretty soon our employment laws will be saying only those under the age of 16 are allowed to do this type of work!

Contact tracing app ready for Isle of Wight trial this week: Hancock. But is it ready for rollout? (updated)

May 5, 2020 | by

Announced today was what in normal times we’d call a beta test of the contact tracing app [TTA 25 April] developed by NHSX on the Isle of Wight. Transport Secretary Grant Shapps announced it Sunday to Sky News. BBC News detailed today that council and healthcare workers will be first to try the contact-tracing app starting Tuesday at 4pm, with the rest of the island able to download it starting Thursday. Gov.UK  The Isle of Wight has approximately 80,000 households.

Update: How the Isle of Wight residents reacted to the app. BBC News

How the app works: if someone reports COVID-19 symptoms through the app, that information goes to the NHS server and the server downloads that tracking information. The app then notifies the other app users that the person has been in contact with over the past few days, contact being defined as within 6 feet for 15 minutes. This can include someone a person has sat next to on public transport. The tracking in the app is via Bluetooth LE to other mobile phones. The app then alerts contacts with the app and gives advice, including how to get a test to confirm whether or not they do have COVID-19. Users will be able order tests through the app shortly.

Use of the app is voluntary and personal data is limited to postal code and what the user opts in to. So the intent of the app is to warn and test to reduce future outbreaks, as full lockdown is not and cannot be a permanent state. Mr. Shapps stated to Sky that the goal is 50 to 60 percent of the country using the app.

Unfortunately, many of the most vulnerable–older, sicker, and poorer adults–won’t have the smartphone, much less the app, and even with the smartphone, won’t be able to download the app or use it. It’s dependent on self-reporting, which may or may not be reliable. Phones can turn off Bluetooth LE. Another consideration, and one this Editor hopes has been tested, are extremes: extreme density in population and contact areas, and extreme distance, as in rural areas. Additional from BBC News, including a short Matt Hancock clip from the Monday briefing with an almost-touch of his nose or mouth right at the start (!)

The Guardian brings up privacy concerns as well as a Health Service Journal (HSJ) report that the app was ‘wobbly’ and had cybersecurity concerns which would exclude it from the NHS’ own app store. The HSJ story quoted their source stating that the government is “going about it in a kind of a hamfisted way. They haven’t got clear versions, so it’s been impossible to get fixed code base from them for NHS Digital to test. They keep changing it all over the place”.  The reporting data also will reside on NHS servers, not individual phones, but pushes out the alert from the server.

Worldometer gives the current UK statistic as total of 190,584 with 28,734 deaths. While case diagnosis continues to increase, fatalities have been steeply declining. There is concern that COVID is yet to spike in rural areas, as cases have concentrated in Greater London, the Midlands, and the North West. New York and New Jersey alone in the US have over 456,000 cases with just under 32,900 fatalities attributed to COVID-19, 3/4 of which have been in NY–almost as much as the entire UK. (However, the fatality statistic is widely questioned as not screened for contributing causes, since there are certain incentives for attribution.)

In other NHS news, NHS Digital, the information and tech side of NHS (not the innovation unit) has named a new deputy chief executive. Pete Rose will also take on the role of chief information security officer for the Health and Care System, including live services, cybersecurity, solutions assurance, infrastructure, and sustainability.

10 years in 2 months: prognosticating the longer-term effect of COVID-19 on telehealth, practices, and hospitals

May 2, 2020 | by

crystal-ballThis Editor recounted last night in the article below on The TeleDentists’ fresh agreements with Cigna and Anthem the observation of a former associate who has been in the thick of the remote patient monitoring wars for some years that telehealth/telemedicine has progressed 10 years in 2 months. Seema Verma, the head of the Centers for Medicare and Medicaid Services (CMS), stated to the Wall Street Journal (paywalled),  “I think the genie’s out of the bottle on this one. I think it’s fair to say that the advent of telehealth has been just completely accelerated, that it’s taken this crisis to push us to a new frontier, but there’s absolutely no going back.” Even in a short period of time, CMS-reported telehealth visits as of 28 March trebled from 100,000 to 300,000. When the April numbers are in, it would not be surprising to see it grow well into seven figures.

The genie may be out of the bottle, but what will the genie do? Genies are, after all, unpredictable, and fly around.  Out of the smoke, some educated guesses:

  • Insecure, non-HIPAA compliant audio/video platforms will be the first which should be struck from CMS approval. Zoom has become a hackfest, with all sorts of alerts from mobile providers like Verizon on how to secure your phone. (An organization of which this Editor is a member had a panel this week completely disrupted by a hacker in five minutes.) Skype’s problems are well known. The winners here will be telehealth platforms that integrate well with EHRs, population health platforms (or may be part of population health platforms), and have robust security.
  • Primary care practices and specialists, who’ve been surviving on non-F2F visits, will be adjusting their practices to patient demand, and integrating telehealth with physical visits in a way that their patients will prefer. This means a search for integration of EMRs/EHRs with secure platforms and reconfiguring areas such as care coordination. If planned correctly, this could create better management of patients with multiple chronic conditions.
  • Actual physical visits will rebound, creating financial pressure on Medicare, hospitals, and private payers. How many people’s health has declined in two-three months is key. Small practices, who may see this first, will see another level of pressure, because they will be held to their Medicare quality metrics in value-based models even if adjusted. Hospitals will also rebound–if they are able. The dark side: private payers may run the numbers and scale back on benefits for the 2021 year especially if COVID is projected to make a return.
  • Behavioral health may benefit, yet drive individual practices and a wave of retirements, or a consolidation into clinic or group settings. There’s a reason why Optum is buying out AbleTo; we may see a wave of competitor acquisitions in this area with the emphasis will be on cognitive health and short courses. Why retirements? Many psychiatric practices are still independent, concentrated geographically, and the average psychiatrist is over 50. Psychiatric EHRs are both costly and not particularly suited to practices. If faced with technological challenges, a lot of MDs and senior clinical psychologists may very well exit–threatening clinics which need MDs to legally operate.
  • Rural health’s failure accelerated. USA Today’s analysis pinpointed at least 100 rural hospitals to close within the year. They already operated on thin margins, but with COVID expenses for additional equipment, the closing down of more profitable elective procedures and dependence on Medicaid, the over 1,100 unprofitable hospitals, over half of which are the only hospital in their county, have received a body blow. HHS allocated $10 billion to rural hospitals and clinics of the $100 billion aid package, but it may be too little and too late. Becker’s Hospital Review continues to track the bankruptcies and closures. Here there are no easy solutions from the digital health area.
  • A culture of cleanliness should accelerate. If the genie pulls this out of the bottle, one major benefit will be that hospital-acquired infections will decline. Effective sanitization methods that reduce human application and scrubbing will be the ones to look at: disinfecting foggers and UV full room or area systems–or combinations of same. Cleanliness and lack of virii and bacteria may become a new metric. Look and bet on companies that can provide this, from rooms to computers/mobile tablets and phones.

Readers can help with these prognostications and especially how they will play out not only in the US, but also in the UK, Europe, and worldwide.

CEO to CEO: TSA’s Alyson Scurfield interview with Tunstall CEO Gordon Sutherland (updated)

April 25, 2020 | by | 1 Comment

If you are following the changes at Tunstall Healthcare, TSA’s Alyson Scurfield’s talk with Gordon Sutherland has some significant news. The investment from Barings, M&G, and the lender group has been confirmed as a change of ownership. It could be inferred from the release, but was not explicit.

From Mr. Sutherland: “The change in ownership deal is now subject to several legal steps including a European Commission review regarding Competition Law. We expect to be able to address any issues and the deal to be signed in late June/July.” Checking back on the Charterhouse website, Tunstall is still categorized as an unexited portfolio company (or ‘unrealised’ in a more delicate term).

Another reveal in this conversation is a strategic statement that segments care and presumably the company’s direction into four parts, somewhat like Roman Gaul (which was three or five, depending on the history you’re reading):

  1. Reactive care: for instance an alarm bell or PERS press
  2. Proactive care: reactive plus social care and well checks
  3. Predictive care: sensor-based tracking in the home. Presumably this would be rules-based (i.e. time) on ADLs.
  4. Tunstall has added to this Cognitive Care or “Intelli-Care” which would combine presumably #2 and #3 along with other healthcare data from the user which would be analyzed to deliver social or health ‘nudges’. While in its ‘infancy’ according to Mr. Sutherland, this type of system would also detect changes in vital signs which require intervention.

#3 and especially #4 referred to as in ‘infancy’ leave this Editor puzzled. Back in 2006-9, the QuietCare system (still sold by Care Innovations) had changes in ADLs based on a normative model baselined over two weeks pretty much nailed down. There are more advanced systems such as CarePredict that take that motion and movement and have put it on a wrist-based sensor system that is now sold for individuals at home as well as in group living–with fall prediction and a PERS for good measure. Vital signs monitoring can also be done with other personal devices, watches, and smartphone/tablet reporting, but medical grade monitoring is another step further with far more complex integration.

Part 2 of the conversation will discuss what are the anticipated changes to health and social care service sectors and the proposed strategic direction of TSA. Hat tip to one of our Readers

Updated 25 April: A further snippet on how the new investment will play out at Tunstall is found on healthcare business intel provider Laing Buisson’s Care Markets website. In their view, the Barings/M&G investment will be “supporting the restructure, which will see the business recapitalised and debt reduced to £180m….” The rest is unfortunately only available to Care Markets newsletter subscribers, of which we are not. Again, no mention of Charterhouse.