TTA’s Brrrrr Season 3: Oracle Cerner limps again, ransomware fizzles, research on blood microsamples and post-traumatic biomarkers, Dollar General clinics, Google antitrust, more!

 

 

Weekly Update

A potpourri of news this week from Google’s antitrust lawsuit (and 6% layoff) to Dollar General’s clinic pilot with DocGo mobile vans. Ransomware attacks by AlphV/BlackCat fizzled and the DOJ knocked out Hive. Significant research on microsamples of blood and post-traumatic biomarkers published. Oracle has more VA/MHS problems, engineering head departs. Some funding and grants. And did Elizabeth Holmes really attempt to flee the country?

Rounding out week: Oracle Health engineering head departs; Hive ransomware KO’d by DOJ; Google sued by DOJ on antitrust, lays off another 12,000; Pearl and Precision Neuro raise, Enabled Healthcare ADAPT grant
Mid-week news roundup: CVS Health Virtual Primary Care launches, VA’s two-day Oracle Cerner EHR slowdown, and microsampling blood + wearables for multiple tests (Not quite a return for the Theranos concept)
Healthcare cyberattack latest: NextGen EHR ransomwared by AlphV/BlackCat, back to normal – 93% of healthcare orgs had 1-5 ransomware incidents (Expect more of this–it’s a movable war)
Using wearables to monitor biomarkers related to neuropsychiatric symptoms post-traumatic event (Significant research)
Theranos Holmes trial updates: did she book a one-way flight to Mexico last year, or were the prosecutors reckless and wrong? (You decide)
CVS, Walgreens, Walmart….Dollar General health clinics? (A low-risk toe in the clinic water)

It must be Mid-Winter Blues, but the news was fairly light this week–even from the JPMorgan health conference, a soggy SFO affair indeed. (At least the streets were cleaned.) Babylon feels ‘misunderstood’, Teladoc lays off 6%. CVS keeps funding and KillNet keeps threatening IT Havoc. Good news from UKTelehealthcare with TECS help for the digital switchover. Plus ISfTeH’s annual meeting now set for Winnipeg and news from ATA.

Industry org news: ISfTeH International Conference call for presentations, new leaders for ATA Policy Council (Good news!)
UKTelehealthcare launches TECS consultancy in partnership with TECS Advisory (Expert help on the digital switch)
Interesting pickups from JPM on CVS, Talkspace, Veradigm backs Holmusk, ‘misunderstood’ Babylon Health; six takeaways (News from a damp, dreary, insane JPM)
Teladoc laying off 6%, reducing real estate, in move to “balanced growth” and profitability (Nice move if they can do it)
‘KillNet’ Russian hacktivist group targeting US, UK health info in Ukraine revenge: HHS HC3 report (Healthcare becomes a side battle)

A mulligan stew of a week. CVS moving in on primary care with (possibly) Oak Street, funding Carbon Health in-store clinics while the latter downsizes. Walgreens’ VillageMD closed on Summit Health and Teladoc paints a brighter revenue picture with BetterHelp. Rock Health quantified a deflated 2022 year in funding, but M&A/VC investment still proceeds in its ‘boring’ way. Verily, Alphabet’s wandering ‘bet’, finally gets a needed trim. And Theranos is still in the news from appeals to post-prison requirements.

Weekend short takes: Theranos’ Holmes post-prison mental health + more on Shultz and Balwani; global M&A, funding roundup
Rock Health puts a kind-of-positive spin on digital health’s ‘annus horribilis’ 2022–a boring 2023
Mid-week roundup: Teladoc gets BetterHelp to boost Q4 ’22 revenue; fundings for Array, Paytient, Telesair, three others; layoffs hit at Alphabet’s Verily, Cue Health
CVS works their plan in Oak Street Health buy talks, Carbon Health $100M investment + clinic pilot; VillageMD-Summit finalizes (updated)
Theranos trial updates: Holmes’ freedom on appeal bid opposed; Balwani files appeal to conviction

Two surprises not under the Christmas tree or New Year’s hat. The ITC upheld AliveCor patents and damages versus Apple, pending their PTAB appeal, and Amazon got its first state approval for One Medical. As expected, telehealth’s national Medicare reimbursement was extended for two years, setting policy for health plans. And NHS advanced rapid stroke diagnosis with Brainomix trial in 22 hospital trust trial, tripling near-full recoveries to 48%.

Weekend news roundup: GE Healthcare spins off, adds CTO; Allscripts now Veradigm; NHS Brainomix AI stroke trial success; Withings home urine scanner; Careficient buys Net Health EMR; CommonSpirit’s class action suit on data breach
Amazon-One Medical gains conditional OK in Oregon–a preview of coming scrutiny?
(What happens at the big state and Fed level?)
Telehealth extensions signed into US law with Federal FY 2023 omnibus bill (Major breakthrough to widen nationally reimbursed telehealth)
Split decision! ITC rules that Apple violated AliveCor patents; enforcement held for PTAB appeal (David v Goliath continues!)

A potpourri of news wraps 2022, starting with confirming how telehealth can stand on its own even in specialty care visits and its continued strength in mental health. In the US, most telehealth expansion is confirmed for two years. But as predicted, DEA is going hard after ADHD misprescribing — a unicorn may lose its horn as a result. Oracle is erasing Cerner’s home town presence as Epic stomps a patent troll. And beware of DDoS–it may distract from more nefarious cybercrimes.

We wish our Readers all the happiness of the season, as we look forward to the start of the New Year. We’ll be back with new articles after 2 January. 

We wish our Readers a happy, healthy holiday season and New Year!
News roundup: DDoS attacks may be ‘smokescreen’, DEA slams Truepill with ‘show cause’, telehealth claims stabilize at 5.4%, Epic squashes patent troll, Cerner meeting exits KC, MedOrbis, Kahun partner on AI intake (From cybercrime to Cerner, c-c-c-changes roll)
Telehealth two-year extensions included in US Federal ‘omnibus’ budget bill (Tucked into a Moby Dick-sized whale of a bill)
Few specialty telehealth visits require in-person follow up within 90 days: Epic Research study 2020-2022 (Findings, though, may be pandemically skewed)

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Telehealth & Telecare Aware: covering the news on latest developments in telecare, telehealth, telemedicine, and health tech, worldwide–thoughtfully and from the view of fellow professionals

Thanks for asking for update emails. Please tell your colleagues about this news service and, if you have relevant information to share with the rest of the world, please let me know.

Donna Cusano, Editor In Chief
donna.cusano@telecareaware.com

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Healthcare cyberattack latest: NextGen EHR ransomwared by AlphV/BlackCat, back to normal – 93% of healthcare orgs had 1-5 ransomware incidents

Cyberattacks on healthcare continue their drip-drip-drip. The latest is on an EHR/practice management platform used by small to enterprise-sized specialty practices, NextGen Healthcare. The hacker group associated with the AlphV/BlackCat ransomware moved into the system on 17 January. For a short time, they reportedly exhibited NextGen information on their extortion site but later took it down. NextGen reported a short-term disruption to operations. A NextGen spokesperson stated that “We immediately contained the threat, secured our network, and have returned to normal operations,” the spokesperson said. “Our forensic review is ongoing and, to date, we have not uncovered any evidence of access to or exfiltration of client data. The privacy and security of our client information is of the utmost importance to us.”  NextGen has also stated to this Editor that no patient data was affected.

NextGen is used by about 2,500 practices in the US, UK, India, and Canada, including over 20 specialties.

The group behind AlphV/BlackCat ransomware has an infamous history. Reputedly, the gang has been kicking around since 2012 and was the same group of charmers that attacked the Colonial Pipeline in 2021, using the Darkside ransomware in May 2021 that dried out gas stations across the US East Coast. Their next ransomware edition, BlackMatter, targeted agriculture during fall 2021. Healthcare IT News, The Record/Recorded Future News

More severe attacks affecting 93% of healthcare organizations. While NextGen contained the attack quickly, both the Censinet/Ponemon Institute and Fortified Health Security’s 2023 Horizon Report tracked 2022 healthcare data breaches and concluded that while the number of incidents didn’t change much, their severity ramped up. More according to SC Media in these reports: 

  • Over a dozen of the biggest incidents in 2022 each impacted well over 1 million records
  • Nearly half of the respondents experienced a ransomware attack in the last two years
  • 93% faced between one to five ransomware-related incidents
  • Outages lasted upwards of 35 days

The common ground with NextGen is danger to patient safety, because electronic record damage can translate quickly into unavailable patient care.

Updated PharmaCare Services, a pharmacy management company based in Texas, is listed as a victim on BlackCat’s extortion site. They were exhibited with NextGen and remained when NextGen’s listing was challenged and then taken down. PharmaCare is staying mum on any ransomware disruptions, according to GovInfoSecurity.

One ray of hope is improved medical device security, included in the ‘omnibus’ budget package approved in late 2022. FDA will be required to enforce new standards for premarket device submissions. One is a software bill of materials, adequate evidence to demonstrate the product can be updated and patched, and a description of security testing and controls. This was before Congress in the Protecting and Transforming Cyber Health Care (PATCH) Act which didn’t go far, but elements of which found their way into the omnibus. A needed change for medical devices and long expected by manufacturers. SC Media

Owlet gets back into the baby zzzzz’s market with Dream Sock and Dream Duo–but now not medical devices!

Without a splash or fuss, Owlet reintroduced its baby monitoring sock as the Dream Sock last month. Formerly known as the Smart Sock, Owlet got into FDA Hot Water in October [TTA 4 Dec 21] with their marketing the Smart Sock, which monitored sleep patterns, blood oxygen saturation, and pulse rate, as a medical device that would fall under 510(k) marketing clearance requirements, including premarket approval (PMA). The Smart Sock and Smart Duo were pulled from market on 22 November.

The Dream Sock, according to Owlet’s product page, is all about baby sleep, measuring sleep quality indicators, including wakings, heart rate, and movement. It provides a sleep quality score via a sleep coaching app. The difference between the old sock and app is that the blood oxygen saturation (SpO2) measuring capability is deleted. The SpO2 monitoring and the claims they were making were likely causes of the FDA’s warning.

The web store listing is for $299 for a Dream Sock fitting up to 18 months, with the Dream Sock Plus, which fits 0-5 years, at $359. The Dream Duo adds the Cam video baby monitor to the system for babies up to 18 months for $399. Sales are restricted to the US at this time. The products can also be found on the usual web stores.

On both the home page and on the product pages, the disclaimer statement is loud and clear:

WARNING: Owlet products are not medical devices. They are not intended for use as medical devices or to replace medical devices. They do not and are not intended to diagnose, cure, treat, mitigate, alleviate or prevent any disease or health condition, or investigate, replace or modify anatomy or any physiological process. [snip]

Digging into the website, Owlet states that they are “actively pursuing submitting a medical device application to the FDA to bring the Smart Sock technology to medical and consumer markets in the future.”

Owlet shares (OWLT:NYSE) have taken a massive value drop since it completed its SPAC with Sandbridge Acquisition Corporation and parked in the Unicorn Lot last July. It opened at $8, crested to over $10 in mid-August, then started to drop precipitously before Labor Day. It closed on Tuesday at $1.83. If only for the Cute Factor, one wishes them luck.

Owlet sock pulled from US distribution after FDA warning letter

Awwww turning to Owwwww! High-flying Owlet has lost some altitude due to the consequences of a 5 October FDA warning letter. The outcome, at least for now, is that Owlet cannot sell its Smart Sock in the US. The Smart Sock measures sleep patterns, blood oxygen saturation, and pulse rate through pulse oximetry. FDA is now considering it a medical device that falls under 510(k) marketing clearance requirements, including premarket approval (PMA). Effective 22 November, the Owlet app will no longer be downloadable, although current owners who have downloaded the app for the Smart Sock and the Cam will not be affected. There are Owlets in the reseller pipeline, such as Amazon, which have now been rendered non-working. The Owlet Smart Sock can be sold outside the US, but not from the website.

What is surprising from the FDA letter is that they have had this issue with Owlet for five years. From the letter: “Since 2016, the FDA has corresponded with Owlet that the Owlet Smart Sock meets the definition of a device under the FD&C Act and does not fall under the compliance policy for low-risk products that promote a healthy lifestyle (General Wellness guidance).” The latter is a catch-all that has enabled various tech products to go to market with statements such as “not intended to diagnose, cure, treat, alleviate or prevent any disease or health condition”. It may have been either an escalation of monitoring capabilities, of marketing, or of the FDA deciding after the SPAC that Owlet needed to be treated differently. Owlet came to market in 2013.

Owlet’s letter to customers alludes to the FDA warning letter and that no safety issues were raised. They promise here and on the website that they will “transition to a new app and consumer wellness product that addresses FDA’s concerns”. The website continues to sell the Owlet Cam and Dream Lab, with ‘Coming Soon’ in January for the new Dream Sock and Dream Duo, but with no details. What’s not known are any details on their capabilities, whether they will fall under ‘general wellness’, and whether Owlet has begun the laborious and long process of filing as (likely) a Class II device.

Owlet enjoyed a SPAC during the summer [TTA 23 July] that nabbed it $135 million and a valuation of over $1 billion. It traded then at $8. Today’s close was $3.95. Its market cap is now less than half. It’s disappointing to this Editor that Owlet didn’t file with FDA well before the SPAC. They now have the opportunity to get FDA clearance, but the more likely outcome is that, at least for now, they will market a less capable device that falls under ‘general wellness’. Deseret News, FierceBiotech, CNET, The Verge

Good news! Eight software functions no longer classified as medical devices under FDA.

Good news for medical device designers. FDA is amending classification regulations as a result of changes made by the 21st Century Cures Act to the Federal Food, Drug, and Cosmetic Act (FD&C Act). These remove certain software functions from the definition of a device  “including software functions that are solely intended to transfer, store, convert formats, or display medical device data and results, including medical images or other clinical information.” The changes apply to software in the following devices and systems:

Calculator/Data Processing Module for Clinical Use
Continuous Glucose Monitor Secondary Display
Automated Indirect Immunofluorescence Microscope and Software-Assisted System
Medical Device Data Systems
Home Uterine Activity Monitor
Medical Image Storage Device
Medical Image Communications Device
Picture Archiving and Communications System (PACS)

Read more in the Federal Register. Hat tip to HISTalk Monday Morning Update

2021 predictions: telehealth law and if at all possible, stay away from FDA (US)

crystal-ballFoley & Lardner rolls out five predictions for telehealth/digital health law and policy in the US:

1. Licensing: More Efforts to Increase Reciprocity and Reduce Barriers. During the current PHE, HHS and states waived many telehealth requirements, including HIPAA and licensing. As the PHE does not look to be ending anytime soon, look for this to continue and eventually be part of Federal policy as soon as the fall. The status quo in Medicare is rural telehealth only–and that restriction is being recognized as absurd. (Related TTA article on the 2021 Physician Fee Schedule [PFS])

2. Modalities: Technology-Neutral State Laws that Prioritize Quality of Care. States are all over the place with telehealth. Currently, changes have been through legislation with others by executive order or regulation. The American Telemedicine Association published a guide to standard practice and terminology language mid-last year (revised in September) to help guide state lawmakers. One can only hope they follow this recommendation from the ATA. 

3. Privacy: Greater Sensitivity to Patient-as-Consumer in Digital Health. Increased privacy regulations will run up against interoperability and data sharing. In this Editor’s view, this will continue to be a battleground, as in data sharing, there’s Gold In Them Thar Hills and Big Tech has its eye on it.

4. Enforcement: OIG/DOJ Will Build on Prior Investigations. This is the area of Medicare overpayment, wrong payment, and fraudulent tele- and TV marketing of medications, genetic testing, and DME. This massive takedown including opioids made headlines last year [TTA 2 Oct] and included $4.5 bn in fake telemedicine claims. It’s kind of a no-brainer that with the expansion of telehealth, this will continue. It’s always been on the Fed’s radar screen.

5. Payment: Continued Expansion of Telehealth Reimbursement. Again, a ‘Captain Obvious’ with the changes in the 2021 PFS plus resistant states like NY and Massachusetts finally on board with parity (ATA on NY and MA). There are some interesting adds that employers will increasingly pay for tele-primary care, behavioral health, and specialty care like fertility, which again is a no-brainer when your workforce is remote and you want to keep them online. Where telehealth needs a permanent boost is in Federal value-based care programs run by CMS, like shared savings and Primary Care First.

So you’re introducing a telehealth platform or device that you’d like to say ‘FDA-cleared’. This may not be the time to deal with FDA.  Bradley Merrill Thompson of Epstein Becker & Green, P.C., well known to be one of the leading lights in telehealth law and advocacy since Ur-Days, makes a very convincing case to avoid the FDA 510(k) process–if you can. 1) FDA is jammed. 2) it’s a long haul, nearly a year as of 2019, probably longer for 2020 and 3) if you are de novo without any predicate device, you have maybe a 50 percent chance of success.  His anecdotal take is that FDA clearance doesn’t lead to a boost in revenue. Mr. Thompson has also studied the fearsome Warning Letters, and the few for 2020 mostly involved exaggerated or unproven claims around COVID-19. None involved unapproved claims for a digital health product. 

In this Editor’s view, customers won’t be hung up on an FDA clearance if you do what you say you’re going to do at the price they want to pay. Investors need to know this. Some markets do require FDA clearance, however. This Editor experienced this working for her first digital health company, Living Independently Group, where GE Healthcare before acquiring insisted that we take the system through an unnecessary Class I (!) approval. In dealing with vital signs monitoring and Federal purchasing, our Class II filing at Viterion was required. His advice is to watch your claims and work on your business model. Much, much more from Mr. Thompson in Mobihealthnews.

The Theranos Story, ch. 61: Elizabeth Holmes as legal deadbeat

Did her lawyers expect otherwise? This weekend’s news of Elizabeth Holmes’ legal team at Cooley LLP withdrawing their representation services due to non-payment should not have caused much surprise. Cooley’s attorney team petitioned the court to withdraw from the case, stating that “Ms. Holmes has not paid Cooley for any of its work as her counsel of record in this action for more than a year.”

Cooley was representing Ms. Holmes in a class-action civil suit in Phoenix brought against her, former Theranos president Sunny Balwani, and Walgreens, charging fraud and medical battery. (When they withdraw, will she seek public representation based on poverty?)

Perhaps Ms. Holmes is the one who’s setting priorities, as the civil suit would be for monetary damages, and no money means there will be none for the plaintiffs to collect. The DOJ charges are a different story. She is on the hook for nine counts of wire fraud and two counts of conspiracy related to her actions at Theranos. Conviction on these could send her to Club Fed for 20 years plus a fine of $250,000 plus restitution for each charge. [TTA 16 June]

Last Wednesday, both Ms. Holmes and lawyers for her and Mr. Balwani were in Federal court in San Jose on the wire fraud and conspiracy charges, demanding that the government release documents from the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that allegedly would clear them. After an hour, Judge Davila set 4 November as the next hearing date. 

Defending oneself does not come cheap, but after your company’s value crashes to $0 from $9bn, one might be looking for change in your Roche-Bobois couch and wondering if your little black Silicon Valley-entrepreneur formal pantsuit/white shirt ensembles will last through the trial. CNBC 2 Oct, CNBC 4 OctFox Business, Business Insider

Events coming up soon–and in the autumn: Hunter College 13 May, Aging 2.0 London 21 May; NYeC’s November Gala, Connected Health Summit (16-18 Oct) poster call

Health Tech and the FDA: What You Need To Know, Monday 13 May, from 5-7pm is a discussion on what you need to know if your health or medtech service or device needs FDA approval. The main presentation is by Rebecca Wood, Partner at Sidley Austin LLP and former Food and Drug Administration Chief Counsel, and moderated by Charles Platkin, PhD, JD, MPH, the co-executive director of the Hunter College Center for Health Technology. Tickets are free but registration is required here (Eventbrite). Location is Hunter College, 2180 Third Avenue @ 119th Street, Main Auditorium (on 2nd Floor), NYC. Hat tip to Sonia K. Gonzalez in the Health 2.0 NYC Community.

And in London 21 May, conveniently the evening before the Digital Health and Care Congress, warm up at Aging 2.0 London to learn how age-tech “Zebras” (Z) a/k/a businesses, can take advantage of age-tech advances and hear from a panel of five from start ups, investors and government on the opportunities, challenges and realities of the UK tech business. Hurry–the website indicates only 25 tickets left. London, 21 May, 5.30 pm at Google for Startups London Campus, 4-5 Bonhill Street London.

Save the date, and plan ahead! The New York eHealth Collaborative, a regional non-profit organization that promotes the integration of health information through exchanges (HIEs), hosts an annual Gala that is one of the major events on the local New York healthcare business calendar. This year, the Gala will be the evening of 20 November at the Edison Ballroom in Manhattan. Your Editor attended in 2017 (missed 2018) and it was a memorable event. It annually honors three to four national healthcare executives who are also leaders in healthcare technology. If you are at all engaged with healthcare systems and technology in the New York metro area, it’s worth your time and fisc to attend this event to be the company of over 250 C-suite executives, leaders, and policymakers. Gala and Awards website  

Your Editor still misses their conferences, the last of which was one of the best she ever attended in (unbelievably) 2016 [TTA 17 Jan 17]. In 2014, their conference was also the site of an epic Eric Topol/Ezekiel Emanuel ‘face-off’ of radically diverging visions. That was hard to top! Their Executive Director Valerie Gray shares NYeC updates on YouTube including updates on Federal health tech initatives: TEFCA enabling nationwide health information exchange, and two similar proposed rules from CMS and ONC on interoperability, both with comment periods ending in June. 

Call for Poster Abstracts starts 27 May for the Connected Health Conference in Boston 16-18 October. Now a joint presentation of PCHAlliance and Partners HealthCare, the Call for Abstracts for Posters starts on 27 May and ends 27 June. The 2019 theme is Designing for Healthy Habits and Better Outcomes. For more information and application, see here. Winners receive a complimentary registration to the conference for the presenting author and discounted tickets for co-authors. TTA has been a past media sponsor of both the Connected Health Conference and NYeC’s Digital Health Conference.

The Theranos Story, ch. 59: there’s life left in the corporate corpse–patents! And no trial date in sight.

You can get blood out of this. Really! The US Patent and Trademark Office (USPTO) awarded five–count ’em, five!–patents to Theranos in March and April. All of them were filed between 2015 and 2016, when the whispers of fraud were getting louder, as were the legal threats.

The five patents are:

1. Systems, devices, and methods for bodily fluid sample collection, transport, and handling
2. Systems, devices, and methods for bodily fluid sample transport
3. Systems and methods for sample preparation using sonication
4. Systems and methods for sample preparation using sonication (cell disruption)
5. Rapid measurement of formed blood component sedimentation rate from small sample volumes

The CB Insights Research article has the details on what they cover, including patent application illustrations. It’s not stated, but looking back to TTA’s many articles, in this Editor’s judgment, the heir to these patents cannot be Elizabeth Holmes or her many investors now feeling the lint in their pockets, but the company holding the last note, the $65 million (not $100 million) loan from Fortress Investment Group LLC, part of Japan’s SoftBank Group [TTA 28 Dec 17]–collateralized by the portfolio of over 70 patents. Hat tip to HISTalk 19 April

If you hunger for a deep dive into the design of Theranos’ blood analyzers that never really worked, and can appreciate that the miniLab was what “one expert in laboratory medicine called “theater … not science”, this Design World article is for you: Schadenfreude for Theranos — and satisfaction in how engineering doesn’t lie

Meanwhile, back in the US District Court in San Jose, California, we learn that the trial of Ms. Holmes (now engaged to William “Billy” Evans, a 27-year-old heir to the Evans Hotel Group, which has three West Coast resort properties and who is also a techie) and former Theranos president Ramesh ‘Sunny’ Balwani has been delayed indefinitely. Originally reported to be summer entertainment with a start date of 8 July, the judge set the next status conference for the case for 1 July, but refused to set a trial date, which means that the trial may not begin till next year. According to the San Jose Mercury News, the defense is seeking materials from the FDA and CMS, which are, according to defense lawyer, lawyer Kevin Downey, are “in many instances exculpatory.”

Ms. Holmes’ lawyers are also seeking information on the communications between John Carreyrou of the Wall Street Journal, the FDA, and CMS. In a motion filed last week, they accused Mr. Carreyrou under the guise of investigative journalism of “exerting influence on the regulatory process in a way that appears to have warped the agencies’ focus on the company and possibly biased the agencies’ findings against it.” Stat

The bubbly Ms. Holmes and Not-So-Sunny Balwani are facing Federal charges of two counts of conspiracy to commit wire fraud and nine counts of wire fraud. They each face a maximum of 20 years in prison and up to $2.7 million in fines.

A selection of short digital health items of potential interest

Editor Charles has taken time off recently from assessing mHealth apps to give us a selection of short news items and event notifications.

CE and FDA certification

This editor recently stumbled over the first list he’s ever seen of approved digital health medical devices. As of today there are some 151 products on there which is hugely impressive. One of the reasons for the relatively poor showing of CE certifications on the list is that there is no official list yet: latest forecasts for Eudamed, which will provide this, are Spring 2020 amid much uncertainty about whether enough Notified Bodies will be approved to certify to the MDR in time. Immediately spotted as a CE certification missing is Walk with Path’s Path Finder device for helping people with Parkinson’s to avoid a freezing of their gait (though CE certification is well hidden on their website) and doubtless there are others. Clearly the list points up potential benefits were it ever possible to harmonise the approval process across the Pond.

Longevity 

The first Longevity Leaders event took place on Monday, perhaps the first large event in the UK on that topic. Based on the enthusiasm of attendees, clearly it won’t be the last. Doubtless in due course it will fragment into a myriad of specialist topics though currently it is a fascinating combination of almost every medical/pharmaceutical and digital discipline, plus housing and a range of other considerations. Timescales varied widely too – for example I talked about the immediate benefits of digital health including keeping people in their own homes, thus minimising sarcopenia from being confined to a hospital bed and avoiding exacerbating dementia by a change of environment, whereas others spoke of how best to make DNA immortal and whether the first person destined to live to 1000 had already been born.

Clinical  Homecare

From the sublime (last item) to the The National Clinical Homecare Association‘s conference on 31st January, where this Editor also spoke on how digital health could help people to be treated in their own homes. Notable was the absence of any Twitter handle for the Association, no hashtag for the conference and just two people it seemed out of 250 using social media. Clearly there are huge opportunities here for digital health suppliers, particularly as so much of what was said by other speakers, and what was being shown in the exhibition was very much manually-intensive stuff: join the NCHA and start a revolution in clinical homecare! 

Recent developments in AI

Since this editor stopped active involvement in conference organisation for the Royal Society of Medicine it is encouraging to see that the younger generation has picked up the baton and is running even harder, such that the above event, on 26th February, has proved so popular that it has been moved to the largest (300 seater) lecture theatre at the Society, and on current sign-up rate will sell out.  Speakers from Babylon, Ada Health, DeepMind, Kheiron Medical, BenevolentAI, UCL Life Sciences & Alan Turing AI partnership, and many more will ensure that delegates gain a comprehensive understanding of how AI is being used across healthcare. Book here to experience the delights of the new RSM all-new website which makes signing up for an event so much easier than in the past. Fear not though: the RSM’s legendary low ticket costs are maintained!

Wayra and Novartis

A most exciting event this week was the announcement of the joint Wayra and Novartis health call now looking for their next cohort of remarkable start-ups to join their new programme called The Health Hub. This is built together with their new partner Novartis, one of the leading pharma companies. Their focus is on how healthtech can be used drastically to innovate long-term disease management. Apply here, by February 17th. Hat tip to Professor Mike Short for this item and other observations in this post .

Rewired Pitchfest

Early health tech entrepreneurs should consider taking part in the Rewired Pitchfest at the Digital Health Rewired Conference and Exhibition, Olympia London on 26 March. Sponsored by Silver Buck, this provides the opportunity for early stage digital health start-ups to showcase their disruptive ideas and prototypes to NHS IT leaders. Applicants will compete before a judging panel featuring investors and successful start-up founders. It’s a great way to gain significant exposure and make connections with a diverse range of UK digital health leaders…and the winner will be announced, and congratulated, by Matt Hancock himself! There is also the chance of winning a mentoring programme with the experts on the judging panel and PR features in Digital Health News. (Disclosure: this editor is on the Programme Committee of Rewired, as well as being a Pitch judge)

Punning headlines

It’s rare that a single item is worthy of its own paragraph on TTA these days however an exception must surely be made for one of the few punning headlines to be found in digital health, especially as it’s for such an old – and until now undelivered – idea: “Smart toilet seat is flush with possibilities to monitor patients’ health”

The Theranos Story, ch. 52: How Elizabeth Holmes became ‘healthcare’s most reviled’–HISTalk’s review of ‘Bad Blood’

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2018/07/holmes-barbie-doll-1.jpg” thumb_width=”125″ /]A Must Read, even if you don’t have time for the book. During the brief Independence Day holiday, this Editor caught up with HISTalk’s review of John Carreyrou’s ‘Bad Blood’, his evisceration of the Fraud That Was Theranos and The Utter Fraud That Is Elizabeth Holmes. Even if you’ve read the book, it’s both a lively recounting of how the scam developed and the willingness–nay, eagerness!–of supposedly savvy people and companies to be duped. The reviewer also reveals that Mr. Carreyrou wasn’t the first to raise questions about Theranos after raves in the press and kudos from the prestigious likes of Eric Topol. Mr. Carreyrou’s first article was in October 2015 [TTA 16 Oct 15] whereas Kevin Loria wrote the first exposé in Business Insider on 25 April 15 which raised all the fundamental questions which Theranos spun, hyped, or otherwise ignored–and Mr. Carreyrou eventually answered. (Our blow by blow, from him and other sources, is here.)

The review also picks out from the book the scabrous bits of Ms. Holmes’ delusions; her makeover to become the blond Aryan female Steve Jobs mit Margaret Keane-ish waif eyes–something she took far too literally; the affair between her and Sunny Balwani, certainly in violation of the usual ethics–and her Hitler in the Bunker, April ’45 behavior as Theranos collapsed around her. 

The review concludes by telling the healthcare community something we need said plainly, often, and written in 50-foot letters:

Theranos is a good reminder to healthcare dabblers. Your customer is the patient, not your investors or partners. You can’t just throw product at the wall and see what sticks when your technology is used to diagnose, treat, or manage disease. Your inevitable mistakes could kill someone. Your startup hubris isn’t welcome here and it will be recalled with great glee when you slink away with tail between legs. Have your self-proclaimed innovation and disruption reviewed by someone who knows what they’re talking about before trotting out your hockey-stick growth chart. And investors, company board members, and government officials, you might be the only thing standing between a patient in need and glitzy, profitable technology that might kill them even as a high-powered founder and an army of lawyers try to make you look the other way.

In other words, what you (the innovator, the investor) is holding is not a patient’s watch, it could be his heart, lungs, or pancreas. (Musical interlude: ‘Be Careful, It’s My Heart’)

The Theranos Effect is real in terms of investment in small companies out there on the ‘bleeding edge’. The cooling is mostly salutory, and we’ve been seeing it since late last year (see here). But…will we remember after it wears off, after the fines are collected, the prison time is served?

The Theranos Story, ch. 46: “F for Fake.” SEC’s fraud charges force Elizabeth Holmes out (finally).

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]Our New Year’s 2018 prediction (after December’s $100 million loan from Fortress Investment Group): “Ms. Holmes will be removed and replaced, then the company will be reorganized and/or renamed.”

Fortress did not have to wait long or get their hands dirty. Today, the Securities and Exchange Commission (SEC) charged both founder and now former CEO Elizabeth Holmes and past CEO/president Ramesh ‘Sunny’ Balwani with securities fraud. While Mr. Balwani will fight the charges, Ms. Holmes escaped trading her black turtleneck for an orange jumpsuit by agreeing to pay a penalty of $500,000 to the SEC, give back 18.9 million shares to the company, give up her uniquely Silicon Valley perk of super-voting equity rights, and is now barred from serving as a public company director or officer for 10 years. From the Theranos release: “As part of the settlement, neither the Company nor Ms. Holmes admitted or denied any wrongdoing.”

This penalty may seem puny in the light of other securities fraud cases, but it appears that Ms. Holmes took little salary out of the company, with most of her long-gone billions in presently worthless remaining stock. 

The exact meaning of fraud, as determined by the SEC in cases like these, is not casual. We can say that we never believed the Edison or miniLabs would work despite the press hype. We can observe that patients and doctors were misled in test results, resulting in major human cost (our Ch. 22).  The fraud here is directly tied to representations made to investors that enabled Theranos’ massive funding, in multiple rounds, of over $700 million between 2013 to 2015. These misleading representations included demonstrations, reports on the functioning of its analyzers, inflating its relationships such as with the DOD, and its regulatory status with the FDA.

It also does not matter that all the funds were privately raised. The SEC in its statement firmly stated that it will treat private equity as it does public when it comes to investments (pay attention, health tech companies): (more…)

Breaking: FDA approves the first drug with a digital ingestion tracking system

Not many drug approvals warrant an FDA press release, but this one did and deservedly so. The US Food and Drug Administration (FDA) approved a version of the psychiatric drug Abilify (aripiprazole) equipped with the Proteus Digital Health ingestible tracking system. Abilify MyCite has been approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. It is the first approved commercial version of a drug equipped with the Proteus Discover system, which tracks the ingestion of the pill from a sensor in the tablet activated by gastric juices to a patch worn by the patient and then to a smartphone app. The patient, caregivers, and physicians can track medication usage (timing and compliance) through the app, adjusting dosage and timing as needed.

The Proteus press release states that the rollout is gradual through select health plans and providers, targeting a limited number of appropriate adults with schizophrenia, bipolar I disorder, or major depressive disorder. It is contra-indicated for pediatric patients and adults with dementia-related psychosis.

Abilify, developed by Japan’s Otsuka and originally marketed in the US with Bristol-Myers Squibb (BMS), has been generic since 2015. This Editor finds it interesting that Proteus would be combined with a now off-patent drug, creating a new one in limited release. Proteus’ original and ongoing tests were centered on combining their system with high-value (=expensive) drugs with high sensitivity as to dosage times and compliance–for instance, cardiovascular and infectious disease (hepatitis C, TB). Here we have a focus on managing serious mental illness and treatment. 

Editors (Steve and Donna) first noticed Proteus as far back as September 2009. Looking back at our early articles, Proteus has come a long way from ‘creepy’ and ‘tattletale’. With nearly half a billion dollars invested and a dozen funding rounds since 2001 (Crunchbase), approvals were long in coming–nine years from submission of patch and tablet sensor to the FDA (2008), seven years from the patch approval (2010), five years from the tablet sensor approval (2012), to release of a drug using the Proteus system. The only thing this Editor still wonders about is what happens to the sensors in the digestive tract. They contain copper, magnesium, and silicon–copper especially can be toxic. If the sensors do not dissolve completely, can this be hazardous for those with Crohn’s, colitis, or diverticulitis/diverticulosis?  Hat tip to Bertalan Meskó, MD, PhD, via Rob Dhoble, on LinkedIn.

Also, if you can stand it, a lengthy article from the New York Times with lots of back and forth about the existential threats of monitoring drugs, potential coercion (preferable to injected Abilify), how some with schizophrenia already manage, and Proteus as a ‘biomedical Big Brother’. (Some commenters appear to have the very vapors about any digital trackers, including AiCure and etectRx.)

A random selection of what’s crossed my screen recently

One of the signs of autumn for this editor is the first email from Flusurvey. This is a brilliantly simple system that sends you an email every week asking if you have flu-like symptoms, then produces a map of the UK that gives advance warnings of epidemics. It costs nothing to join and is a great contribution to public health so why not sign up?. (They also have some exciting developments that may surface soon such as a small device that you blow into the connects to a smartphone and can tell almost immediately if you have flu’.)

Increasingly of concern to this editor, due to his deep involvement in digital health regulation, is who is working out how to regulate self-learning algorithms. It is therefore good to see the issue breaking cover in the general press with this article. For what it’s worth this editor’s view is that as technology begins to behave more like humans, albeit in a much faster, and narrow, way by learning as it goes along, perhaps an appropriately adapted use of the way human clinicians are examined, supervised and regulated, might be most appropriate. Sitting next to an AHSN CIO interested in the topic at a Kings Fund event last week, I was pleased to hear him offer precisely the same suggestion, so perhaps there is a little mileage in the idea. 

DHACA (disclosure: run by this editor) has just renewed its website after a long delay, and will be updating content over the next few weeks. First off is the events page advertising:

Our Digital health safety conference on 7th November at Cocoon Networks, London, is being run jointly with DigitalHealth.London – the MHRA has now confirmed they will present so we have almost all the relevant organisations and experts in the UK speaking at this event which should be essential attendance for all involved with the development and use of digital health & care. Attendance has increased substantially in the past few days so do book soon to be sure of securing a place. Much more, including an almost-finalised agenda, is here.

DHACA Day XV – we are back to our usual location at the Digital Catapult Centre on 10th January where are building an agenda of some extremely interesting speakers. To check out the agenda development and to book in advance, go here.

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The Theranos Story, ch. 28: when the SecDef nominee is on the Board of Directors

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/12/jim_mattis.jpg” thumb_width=”150″ /]Does ‘Mad Dog’ ‘Warrior Monk’ James Mattis, General, USMC (ret.) have a blind spot when it comes to Theranos? President-Elect Donald J. Trump has selected him as the next Administration’s nominee for Secretary of Defense. A remarkable leader and, yes, scholar (check his background in various sources), but he has some ‘splaining to do, in this Editor’s opinion.

This Editor leads with this question because those who have been following the Continuing Saga (which, like the Nordics, seems never-ending) know that Theranos stuffed its Board of Directors (BOD), prior to last October, with a selection of Washington Luminaries, often of a great age: Henry Kissinger, George Shultz, Sen. Sam Nunn, Sen. Bill Frist (the only one with an MD), William Perry and Gary Roughead, a retired U.S. Navy admiral. It also reads like a roster of Hoover Institution Fellows except for Sen. Frist, who sticks to the East Coast. Another interesting point: Hoover is based at Stanford University, an institution from which Elizabeth Holmes dropped out to Follow Her Vision. Obviously, there was an accompanying Vision of Washington Pull.

Also joining the BOD as of July 2013, well before The Troubles, and shortly after his retirement, was Gen. Jim Mattis (also a Hoover Fellow, photo above). When the Washington Luminaries were shuffled off to a ‘board of counselors’ after the Wall Street Journal exposé hit in October, Gen. Mattis remained on the governing BOD. Unlike his fellow Fellows, he had actually been involved with a potential deployment of the lab testing equipment. As we previously noted, as commandant of US Central Command (CENTCOM is Middle East, North Africa and Central Asia), he advocated tests of the Theranos labs under in-theatre medicine conditions in 2012-13. Leaked emails cited by the Washington Post (in Gizmodo) and also in the Wall Street Journal indicate the opposition from the US Army Medical Research and Materiel Command at health-intensive Fort Detrick MD, which oversees medical research, based on the undeniable fact that the equipment and the tests weren’t FDA-cleared, which remained true two years later…and which Gen. Mattis tried to get around, being a good Marine. Nonetheless, the procurement of Theranos equipment was halted. DOD permitted him to join the BOD after retirement as long as he was not involved in any representations to DOD or the services. (Wikipedia bio)

Yesterday, Theranos also announced that it is dissolving (draining?) the ‘board of counselors’. They led with a BOD shuffle, with Daniel J. Warmenhoven, retired chairman of NetApp, replacing director Riley P. Bechtel, who is withdrawing for health reasons. (Warmenhoven also serves on the Bechtel board, so they are keeping an eye on the estimated $100 million they invested). Gizmodo and Inc. While effective January 1, the Theranos website has already scrubbed the counselors and updated the BOD.

However, Gen. Mattis remains a director, until such time as he actually becomes Secretary of Defense, which is not a lock for Senate approval by a long shot. First, he requires a Congressionally approved waiver demanded by the National Security Act of 1947, as he has been retired only four years (as of 2017) not the required seven. Second, his involvement with Theranos has already been questioned in the media. After all, it is a Federal Poster Child of Silicon Valley Bad Behavior: censured by CMS, under investigation by SEC and DOJ. It is a handy, easily understandable club with which to beat him bloody (sic). WSJ’s wrapup.

In this Editor’s opinion, the good General should have left in October, but certainly by April when CMS laid the sanctions down, banning Ms Holmes and Mr Balwani from running labs for two years in July. What is going on in the ‘Warrior Monk’s’ mind in sticking around? Is there anything to save? 

If the WSJ articles are paywalled, search on ‘Gen. James Mattis Has Ties to Theranos’ and ‘Recent Retirement, Theranos Ties Pose Possible Obstacles for Mattis Confirmation’.  Oh yes…see here for the 27 previous TTA chapters in this Continuing, Consistently Amazing Saga.

A tricorder one step closer: Tyto Care gains FDA clearance for its digital stethoscope (US)

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/Mom_using_on_child_ear.jpg” thumb_width=”150″ /]Only a few years ago, the Star of the Future of Digital Health was the ‘tricorder’–that all-in-one vital signs device that Bones on Star Trek wielded with such élan (when he wasn’t uttering ‘He’s dead, Jim’). We haven’t heard much from Scanadu since early last year when it raised $35 million for its Series B and when it teamed with with Northern Ireland’s Intelesens as a finalist for the seemingly never-ending Qualcomm Tricorder XPRIZE. (Seven finalists are now in consumer testing with awards in early 2017.)

In the meantime, others have been proceeding in bringing their devices into reality far sooner, for real people with everyday health problems who want to examine a child, another family member or even themselves at home. One of these companies is Israel’s Tyto Care (picture above at left), which received FDA 510(k) Class II clearance for its digital stethoscope snap-on to the main device to monitor heart and lung sounds. The device also includes a digital imaging otoscope for ear exams, a throat scope, a skin camera and thermometer swipe. The Tyto home device includes video guidance instructions as part of the smartphone or tablet platform to enable a correct reading. It connects to an online platform to send the information, either in real time or store-and-forward, to a primary care physician the user selects. Tyto Care has been in investigational marketing in the US as well as Israel, bolstered by over $18 million in international investment. They are targeting home DTC as well as professional markets through practices, payers, virtual visit providers and possibly retail (one of their investors is Walgreens Boots). Release If you are attending MEDICA 2017 in Düsseldorf on 16 November, you can see Tyto Care demonstrated at the 5th Annual MEDICA App Competition.

Another all-in-one device is Las Vegas-based MedWand, which is still in pre-marketing. MedWand seems to feature clinic and ‘group’ packages as well as the individual device which includes a pulse oximeter. They received another round of undisclosed financing from Maxim Ventures, the venture arm for semi-conductor developer Maxim Integrated Products at end of September. Release.