We wish you a Merry Christmas and Happy New Year!

December 23, 2021 | by | 2 Comments

Editor Emeritus Steve and Editor Donna wish all our Readers, commenters, contributors, former Editors, and supporters a Very Merry Christmas (in Danish or not!) and a Happy New Year.

Thank you for staying with us through the lean years of telecare and health tech to the fat, the pandemic that just won’t end, in-office and remote work, endless acronyms such as IPO, SPAC, DHSC, CDC, and POTS, analogue and digital telecom, politics, regulation, and Way Too Much Data!

Take some time to enjoy the festive season with family and friends, no matter where you may be. And remember, it’s not about the presents and the hurry, but being together. 

(Here’s the famous Rockefeller Center Christmas tree and promenade, from better days when the tree wasn’t quite as walled off and skimpy as it’s been the past two years–and there were more people in the offices!)

 

 

Further insights on and thoughts about the Oracle acquisition of Cerner

December 22, 2021 | by

HISTalk, with its focus on health IT and generally short mentions without opinion on the news, in today’s issue includes some thoughts on the Oracle-Cerner deal, including a rare “Announcements and Requests” inviting reader thoughts on the acquisition’s effect on several issues. Also rare: a lengthy anonymous comment from a healthcare CIO.

A few highlights–your Editor recommends you go to the article for more:

  • Oracle’s free cash is far less than the purchase price at $23 billion. They will need additional financing to complete the Cerner acquisition.
  • Announcements and Requests: will customers on the fence between Epic and Cerner run towards the less uncertain choice? Will the Cerner VA and DOD business be affected? How does this affect Cerner’s implementations of cloud services, currently AWS versus Oracle’s Gen2, as well as healthcare’s usage of  InterSystems Cache versus Oracle’s relational databases? And will Oracle’s Voice Digital Assistant as the user interface to Cerner Millenium really fly?
  • From Change of Control: How key to the deal was CEO David Feinberg MD, who only joined in October? No matter what, he’s now a very wealthy man.
  • From On-Demand: Oracle is buying its way into healthcare. Cerner lost a lot of ground in executive changes and a less than effective CEO. (Editor’s note: This dates back to 2017–the illness and untimely death of Neal Patterson, the co-founder and CEO, at age 67 and president Zane Burke’s departure the following year after 20 years for the CEO spot at Livongo, which undoubtedly made him a wealthy man!)
  • From Anonymous Health System CIO’s Initial Thoughts: Their biggest problems are 1) people and process.”Cerner has struggled to maintain competent staff that understand healthcare and individual customer workflows. Throughout our implementations, we had major challenges with project management, availability of experienced staff, and the ability to help us make informed decisions.”  2) “If Oracle is going to help reduce the cost of healthcare, they also need to help find savings for their customers.” 

All these should be of concern to Cerner as they–and their people–try to maintain momentum until the acquisition closes. Customer uncertainty, staff competence, and Oracle’s lack of background in how healthcare operates (including a history of pulling some ‘fast ones’ around cloud licensing, as well as understanding clinician preferences such as Dragon as a voice assistant) are undoubtedly giving some investors–and hospital systems–pause. Hat tip to HISTalk. Our earlier coverage here.

One final comment from Editor Donna: Never underestimate the power of a CEO’s ego–especially one who is routinely compared to God, at least in TechWorld–in wanting One Last Coup to burnish his escutcheon, before that Long Sail Into The Sunset on his yacht Musashi.

Does the digital telecom switchover threaten the lives of the most remote old and disabled? (UK, updated)

December 21, 2021 | by

The UK’s recent preview of winter (which officially starts today), Storm Arwen followed by Storm Barra, was yet another exposure of the downside of the digital telecom switchover. As our UK Readers know, BT Openreach has been aggressively proceeding with the full conversion to VOIP by 2025 and closing the ‘broadband gap’ in rural and remote areas. Connecting them to the internet and more feature-filled VOIP service, including telecare services, has major advantages, especially where mobile service is sketchy or blank. 

Here’s the problem–power outages. According to the Energy Networks Association, 1 million homes and businesses in the northeast of England and Scotland lost power for days after Storms Arwen and Barra in late November, making it the worst storm in 15 years. Many of these homes were in rural villages and isolated areas. Power lines in these areas go down frequently in lesser storms that don’t have 100 mph winds and snow. When the power goes out, the VOIP goes out unless you have backup power. Phone lines no longer have their own power, as in the Public Switched Telephone Network (PSTN), equivalent to the US POTS (Plain Old Telephone Service or “copper”).

Add to this BT’s shortage of backup batteries. Digital phone systems in the US are usually installed with a backup battery, which isn’t cheap but sustains about 24 hours of basic voice service. Older models had special ‘brick’ batteries that you ordered from your phone provider that were around $50, newer models are powered by 12 D cell flashlight batteries that at least you can buy at the supermarket. Apparently, BT’s backup units are not only unavailable due to a global shortage, but also cost £85, a substantial charge to a pensioner–unless you live in a ‘not spot’ area without mobile service, in which case it’s free.

No power, no phone, no telecare, no PERS. But plenty of danger to thousands of older isolated adults, plus the frail, alone, and disabled. No connections to friends, carers, and emergency services for days, during a late fall snowstorm which made roads impassable. The storm may be early, but if this is a galloping start, there’s a whole winter to get through.

What about mobile service as a backup? Rural areas are, in bright sunny weather, plagued by spotty service. Supposedly nearly all areas in England have a minimum of 2G service sufficient to call 999. But when the cell phone masts go down, as they did in the storm, and the power to charge the phone is out, the backup is out of commission. One unnamed resident of Grizedale in the Lake District put a molto fino point on it. “It’s embarrassing that a supposedly world-leading country has such a shonky infrastructure. I had full 4G in the mountains of Transylvania a few years ago.”

Ofcom, the regulator, positioned the storms as exceptional. “Even in those circumstances, our rules are clear that there should be protections in place for people to call the emergency services” (999). Rules are one thing, reality another. Judge for yourself as we head into winter. BBC News Hat tip to Editor Emeritus Steve Hards.

Editor’s note for our US Readers: The situation is not that different for us. Nationally, POTS service is deteriorating and not being replaced by providers, forcing changes to VOIP. (I can personally speak to this–20 miles from NYC.) And if you believe that we’re well covered everywhere by cell phone service, you haven’t been to Lancaster County, Pennsylvania, much less further west in the area the locals call ‘Pennsyltucky’. That area also skews older–18.2% of state residents are age 65+. The US also has a wide variety of extreme weather–ice storms, blizzards, ‘snow bombs’, hurricanes, tornadoes, and tropical storms.

(Breaking) Sold! Cerner to Oracle for $28.3 billion. And is Epic next?

December 20, 2021 | by

That bombshell came in fast! From the rumor mill to reality, from last Thursday to today (Monday), Oracle and Cerner announced their deal today at 9.37am ET. It is a bracing all-cash deal at $95/share plus debt assumption totaling $28.3 billion, expected to be immediately accretive to Oracle’s earnings. Closing is anticipated sometime in 2022. It is subject to considerable regulatory (SEC and likely DOJ) and shareholder approvals. It’s Oracle’s largest deal ever, but so far their share price is not appreciative of the big move.

According to the Oracle release, Cerner and its EHR plus related systems will be organized as a dedicated Industry Business Unit within Oracle. No transition information was included, although towards the end it’s stated that “Oracle intends to maintain and grow Cerner’s community presence, including in the Kansas City area, while utilizing Oracle’s global footprint to reach new geographies faster.”

Both the Oracle and Cerner releases (headlining their home page in gigantic type) are written totally from Oracle’s POV–no shilly-shallying about how Cerner will guide them into the healthcare arena or a meeting of like companies, et al. It’s all about how Oracle will transform healthcare.

Changes will be coming to Cerner. Between the lines, they are not painted in the best light. From the Mike Cecelia (EVP, Vertical Industries) quote, “Oracle’s Autonomous Database, low-code development tools, and Voice Digital Assistant user interface enables us to rapidly modernize Cerner’s systems and move them to our Gen2 Cloud. This can be done very quickly because Cerner’s largest business and most important clinical system already runs on the Oracle Database. No change required there. What will change is the user interface. (Ed. emphasis) We will make Cerner’s systems much easier to learn and use by making Oracle’s hands-free Voice Digital Assistant the primary interface to Cerner’s clinical systems. This will allow medical professionals to spend less time typing on computer keyboards and more time caring for patients.”

There is also no mention of Cerner’s challenges with the VA. What are the implications with the Cerner implementations there and with DOD?

Do anticipate much industry speculation on David Feinberg, MD, who only this fall joined Cerner as CEO, and his role in this. The most logical is that he’ll shepherd the sale till the close and exit stage left, well-rewarded, with his future (only 59) still ahead, unless Oracle sees a role for him. In its way, it broke Cerner out of a corner that they were painted into with EHRs. At the end of the day, will there be a Cerner?

And what about Epic? A more complex picture, as Epic Systems is wholly private, on a roll, and dominated by Judy Feinberg, the founder and CEO. However, she is 78, and both personal and corporate considerations on future planning must loom large. What would Epic be worth to an acquirer? And who would it be? Amazon? IBM? (a terrible fit after the Watson Health debacle), Salesforce? Microsoft? Hmmmmm…. CNBC,  TechCrunch, HealthcareITNews   Our earlier coverage here.

News roundup: UnitedHealth Group pushes off Change closing again, Amazon’s new healthcare head, Centene’s shakeup of CEO, board, holdings

December 18, 2021 | by

Change won’t come easy, as this Editor predicted. Now the closing of the Change Healthcare acquisition by UnitedHealth Group has been pushed off to April 2022. Announced in January, it was delayed in August and October/November with the Department of Justice review of the merger under the Hart-Scott-Rodino Antitrust Act (HSR). This SEC filing by UnitedHealth is the first time a definite date target has been set. Change’s diversified health IT/data analytics/imaging/payments systems would be combined with OptumInsight. HealthcareFinanceNews

Amazon finally named a head of healthcare to oversee Amazon Care, Amazon Pharmacy, Halo and Alexa’s healthcare uses. Neil Lindsay, former head of Amazon Prime, was named senior vice president of health and brand within Amazon’s global consumer business, reporting to CEO Andy Jassy. Mr. Lindsay sits on the so-called ‘S-team’, Amazon’s most influential executive group. Take this as an indicator of the importance of healthcare to their business. The terseness of the information has been typical of Amazon. Becker’s Hospital Review, CNBC

Centene, one of the top 10 health plan companies in the US, had a major shakeup this week. Long-time CEO Michael Neidorff will retire and exit sometime in 2022. The board, now set at 14 members, retired three directors via a new age limit of 75. Five new directors will come on board, including Ken Burdick, former CEO of WellCare Health Plans, acquired by Centene in 2020, and Wayne DeVeydt, former Anthem CFO.

The shake-n-bake has been shaking since November, when activist investor Politan Capital Management started to press for changes. Other changes include a projected sale of non-core assets, including private hospitals Circle Health in the UK and Ribera in Spain, with combined revenue of $2 billion. The rather ‘shaggy’ list of Medicaid managed care, Medicare Advantage, and exchange plans–none of which carry the Centene brand–and a potpourri of other units and management services are being examined bottom up by a three-person “value creation office”, as are Centene’s extensive real estate holdings and leases, to extract savings wherever possible. One area mentioned was hybrid and at-home work, a major change to the Centene “cubie” culture.

Neidorff joined a tiny Centene as CEO in 1996 and is now 78. There is no update on the delayed Magellan behavioral health management acquisition. Healthcare Dive 14 Dec, 13 Dec. Centene releases on Neidorff’s retirement as “leadership succession plan” and governance/board changes.

Theranos, The Trial of Elizabeth Holmes closes, ch. 15: she believed! in the technology!

December 18, 2021 | by

The defense returned to their closing arguments on Friday. According to lead defense attorney Kevin Downey, not only did Holmes appoint a stellar board, but also the evidence showed that she believed intensely in the Theranos technology changing the world.

  • Holmes stayed till the end trying to save the company–because she believed in improving healthcare
  • She continued to improve the company and the technology, but after all that she didn’t realize…
  • …that the labs had problems until March 2016, when her very last lab director, Kingshuk Das, MD, invalidated 60,000 lab tests made on Theranos labs in 2014-2015.
    • This happened only after CMS sent a deficiency report notice to Dr. Das’ predecessor with the subject line  “CONDITION LEVEL DEFICIENCIES – IMMEDIATE JEOPARDY.” And that lab directors and techs had already told Holmes about problems with the Edison labs.
  • The proof of her sincerity? If she committed fraud, she would have sold her stock while it still had value, and jumped ship like a scared rat!

Interestingly, Downey made no mention of Sunny Balwani, except that Holmes fired him in 2016. No mention of all the time spent in her testimony depicting Balwani as a mentally and physically abusive Svengali, which led Holmes-as-Trilby to not be in control of herself as CEO, even after he departed.

The prosecution returned for rebuttals. John Bostic countered the defense claim of Holmes’ belief with “the disease that plagued Theranos wasn’t a lack of effort, it was a lack of honesty.” “We see a CEO of a company who was so desperate for the company to succeed, so afraid of failure, that she was willing to do anything.” Bostic also reminded the jury that they needed to put Holmes’ claims of emotional abuse by Balwani aside since there was “no evidence connecting the allegations of abuse with the actual charged conduct.” 

Judge Edward Davila, in winding up 14 weeks of trial, then charged the jury to avoid consideration of or speculation on the abuse, and to disregard both public opinion and Holmes’ place in society. They could consider whether Holmes had a “good faith belief” in the truth of her statements. The jury will return Monday morning to start deliberations. The fraud charges include conspiracy between Holmes and Balwani against patients and investors. Two more charges are related to patients receiving erroneous test results on HIV infection and prostate cancer. One is on fraudulent marketing and advertising. Six more charges are about investor fraud. 

AP, Mercury News (paywall–refresh to read)

Because it’s the weekend, your Editor will include two extra articles. The Verge article reads something like a screed against our legal system valuing money fraud over patient medical fraud. The NY Times article is on the latest Holmes makeover. During the trial, she changed from hard-edged, black turtleneck, red-lipsticked Lady Steve Jobs to suburban-junior-manager-working mom in off the rack wrinkled skirts, peachy pink lip color with curled but messy hair, carrying an inexpensive baby bag. All calculated by her defense to create an illusion of innocence and, this Editor would add, incapability of any dastardly acts, such as financial and medical fraud.

To be continued…

TTA’s earlier coverage: Chapter 14, Chapter 13, Chapter 12, Chapter 11, Chapter 10, (10-13 recap the Holmes testimony); Chapter 9, Chapter 8, Chapter 7, Chapter 6, Chapter 5, Chapter 4 (w/comment from Malcolm Fisk), Chapter 3, Chapter 2, Chapter 1

Oracle in negotiations to buy Cerner for $30B (sold!)

December 17, 2021 | by

2021 may go out with a bang! The Wall Street Journal (paywalled) reported late Thursday that software colossus Oracle was in discussions with EHR giant Cerner to buy it, lock stock dropdown menus and workflows. And soon, according to the WSJ‘s sources. The reported amount is $30 billion.

It would be Oracle’s most expensive purchase ever, much more than PeopleSoft (HR) in 2005 and NetSuite in 2016. Given their valuations, Cerner is a snack at $23 billion for Oracle at $280 billion. But Cerner gives Oracle four-star entree to healthcare and practice systems. Oracle has long seen healthcare as a growth area for cloud computing services targeted to payers, hospitals, and health systems, and has clients like Cleveland Clinic and Kaiser. Back in June 2020, they launched a cloud service collecting clinical data from sensors, patient apps, EHRs, and labs supporting therapy development. 

As our Readers know, David Feinberg, MD left Google Health to join Cerner as president and CEO on 1 October [TTA 21 August] in a $34.5 million compensation package [TTA 24 August]. An acquisition by Oracle, in such a short time, can be interpreted as either a coup he engineered for the shareholders (and for his benefit, as change of control usually vests the package!), or he can be viewed as a placeholder for the top spot on a previously moving deal. Both are mature companies. While Cerner has been losing market share to Epic and has had many woes with its $18 billion VA Cerner Millenium implementation [TTA 3 Dec, 28 July], it also generates $1 billion per year in free cash flow and Oracle can institute operational efficiencies to increase profit margins. In the view of some, Oracle is returning to an aggressive market strategy that most felt it left behind.

Oracle shareholders didn’t like it much today, with shares declining over 6% on Friday to $96.67. But Cerner’s liked it a lot, increasing price nearly 13% to $89.77. Kansas City-based Cerner also had 150 layoffs in November in its 28,000 employee staff. Oracle recently relocated from California to Austin, Texas, shrinking its office footprint. Seeking Alpha 17 Dec, 17 Dec AM; Kansas City Star, Becker’s HealthIT

Updated–see our short article on the sale for $28.3 billion here.

Theranos, The Trial of Elizabeth Holmes closes, ch. 14: was it fraud over business failure–or building a company, not a criminal enterprise?

December 17, 2021 | by

The flat spin starts as the trial winds up. On Thursday, the prosecution presented its closing argument to the jury, and the defense began its summary which will finish on Friday.

The key prosecution points made by Assistant US Attorney Jeffrey Schenk were:

  • Elizabeth Holmes’ decisions were all hers. She first defrauded investors, then deceived patients.
  • “She chose fraud over business failure. She chose to be dishonest with investors and with patients.”
  • Elizabeth Holmes was not a young, naive CEO. She had headed Theranos for nearly a decade. But it was ‘a house of cards.’
  • A decision about Sunny Balwani’s abuse is not pertinent to the case and does not have to be made to reach a verdict. 
  • That has to be made on whether this was deliberate investor and patient fraud.“Ms. Holmes knew these honest statements would not have led to any revenue,” Schenk said. “She chose a different path.”

Mr. Schenk reviewed the testimony of all 29 witnesses and statements made by Holmes herself, with the specific aim of refuting every defense point made about her not being aware that the technology didn’t work, or that she was not in charge of the marketing, advertising, business development, partnerships, and finances. He put a very fine and obvious point on it with a chart for the jury entitled “Knowledge of falsity,” which listed her false statements alongside exhibits.

Enter the defense, represented by Kevin Downey. He started by telling the jurors that they had a high burden of proof in finding Holmes guilty “beyond a reasonable doubt”and that crucial information was left out of the government’s case. It was ‘incomplete’ and that their opinion would change with his review of the evidence. Holmes acted ‘in good faith’. In that review, Downey provided illustrations of 11 successful partnerships Theranos had with drug companies. As to the board, he pointed out that they were not cronies who one would expect in a fraudulent enterprise; “She appointed these people, an incredibly illustrious group of people.”

The defense continues on Friday. The jury will be given instructions after the defense concludes, and it’s expected they will have over the holidays to deliberate. MercuryNews (paywalled but refresh repeatedly to view), CNBC, The Guardian

To be continued….

TTA’s earlier coverage: Chapter 13, Chapter 12, Chapter 11, Chapter 10, (10-13 recap the Holmes testimony); Chapter 9, Chapter 8, Chapter 7, Chapter 6, Chapter 5, Chapter 4 (w/comment from Malcolm Fisk), Chapter 3, Chapter 2, Chapter 1

Short takes: £150 million for UK social care tech out of £1 billion, bias by design in medical device use investigated, Netsmart buys Remarkable Health, Vinehealth seed rounds £4.1 million

December 8, 2021 | by

The Department of Health and Social Care (DHSC) has presented to Parliament a £1 billion, three-year healthcare system reform plan. The white paper, People at the Heart of Care, highlights the following as part of a larger 10 year program:

  • £300 million in housing investment for supported housing
  • new technology and digitization backed by at least £150 million to improve care quality and safety, support independent living and allow staff to provide focused care where it is needed 
  • £500 million for 1.5 million adult social care workforce career training and qualifications 
  • £70 million to assist local authorities and improve the delivery and standard of care
  • up to £25 million to support unpaid carers

Part of the tech upgrading includes 80% of social carers having digitized care records that connect to a shared care record by March 2024. The improvements will be funded through the 1.25% Health and Social Care levy. Gov.uk, HealthcareITNews

The UK DHSC is investigating whether the design and use of medical devices such as pulse oximeters could be potentially biased by race. This stems from the disproportionate death rate during COVID-19 of blacks, Asians, and other minorities. The review announced will look at whether AI tools can be biased in their algorithms and whether pulse oximeters may be inaccurate due to darker skin color. HealthcareITNews

Behavioral health continues its hot streak, with specialty EHR provider Netsmart acquiring Remarkable Health, a practice management software developer for behavioral health. Their CT|One electronic health record (EHR) and Bells, the first virtual clinical documentation solution created for behavioral health and human services organizations, will be integrated into Netsmart’s EHRs. Acquisition cost and management transitions were not disclosed. Release

UK-based Vinehealth, an oncology support app that also gathers patient-reported outcome (PRO) data for drug development and clinical trials, closed a seed round of $5.5 million (£4.1 million). Expansion plans include an introduction in the US. Funders were led by Talis Capital with participation from previous investors Playfair Capital and Ascension, plus an extensive list of angel investors including KHP MedTech Innovations, a collaboration between King’s College London, King’s College Hospital NHS Foundation Trust, and Guy’s and St Thomas’ NHS Trust. The Vinehealth app has had 15,000 downloads since January 2020. TechCrunch, 

Theranos, The Trial of Elizabeth Holmes, ch. 13: a crescendo of ‘I don’t knows’ and ‘I don’t remembers’…and the defense rests! (updated)

December 8, 2021 | by

Elizabeth Holmes returned to the stand in her own defense today, continuing with cross-examination by the prosecution’s Robert Leach. From the coverage published so far of six hours of questioning, Holmes has done everything to deny key statements she made multiple times to writers and investors, just short of ‘taking the Fifth’ (Amendment, which is a Constitutional guard against self-incrimination). 

Starting with the now-infamous 2014 Fortune cover story authored by Roger Parloff, Holmes admitted to Leach that the claim of 200 tests using the equally infamous nanotainers was incorrect, but used what marketers call ‘weasel words’: “I believe that now.” Did she not believe that then? She then proceeded not to remember that she forwarded the article via email to investors on 12 June 2014. “I think I could have handled those communications differently.” 

More not knowing or remembering. Were Theranos labs being used on military medevacs, as witnesses from Walgreens and Safeway, among others, have testified? Was Walgreens told of difficulties with the Theranos labs? Did or didn’t she dismiss concerns raised by Erika Cheung and Tyler Shultz to John Carreyrou of the WSJ as coming from disgruntled employees? Did she present a 2015 revenue projection of nearly $1 billion to investors, especially as the internal estimate was much lower and there were no contracts with pharma companies? Did she listen to her lab directors about problems with the tests?

But regrets, she had a few. The WSJ investigation, for instance. And slapping pharma company logos on Theranos reports.

It all comes down to who the jury believes. The prosecution either will close today or tomorrow (Wednesday). The defense will return to wrap up, either with Holmes or with expert witnesses such as Mindy Mechanic and, possibly, others. The defense will return to the 3 Ds–diffusion, deflection, and diminished capacity. The luridly resonant theme of Sunny Balwani as an abusive Svengali, which led her to be not in control of herself even after he departed, will be the coda. The Guardian, CNBC

Wednesday Update. Boy, was your Editor wrong. The defense rested today (Wednesday).

  • Dr. Mindy Mechanic, the defense’ expert on relationship violence, will not be testifying about the nature of the Balwani-Holmes relationship. By not calling Dr. Mechanic, the prosecution cannot call their psychiatrists who also spoke with the defendants. For his part, Balwani has consistently defended himself from these charges of relationship abuse. The prosecution is also seeking to strike Holmes’ testimony of being sexually assaulted while a freshman at Stanford as now being irrelevant to the case, but it is hard for a jury to unhear it.
  • Holmes was, of course, the star witness in her own defense, joined in minor roles by paralegal Trent Middleton from Williams & Connolly, Holmes’ law firm, who summarized evidence in the case, then former Theranos board member Fabrizio Bonanni, who testified that Holmes attempted to remedy Theranos’ problems–but only after it came under regulatory scrutiny, which was late in the game. He had been offered the COO position but declined as ‘too old for that’.
  • Holmes returned in her final testimony to Balwani. Sunny, she said, was her most important advisor though she was, admittedly, the decision-maker. He was volatile. She “tried not to ignite” Balwani in emails and frequent texts. “Sunny would often blow off steam or vent through text,” Holmes said. “I was trying to be supportive.”
  • Returning to tugging on the heartstrings of the four women on the jury, she stated that breaking up with him was a ‘process’. He’d just show up at places she would go, like church and The Dish near Stanford. 
  • Holmes explicitly denied ever trying to mislead investors, Her own summary was restating her original ‘healthcare vision’ and the impact the company would make on healthcare.

Summaries by the prosecution and defense will be next up. Mercury News (partial paywall), CNBC

To be continued…

TTA’s earlier coverage: Chapter 12, Chapter 11, Chapter 10, Chapter 9, Chapter 8, Chapter 7, Chapter 6, Chapter 5, Chapter 4 (w/comment from Malcolm Fisk), Chapter 3, Chapter 2, Chapter 1

Owlet sock pulled from US distribution after FDA warning letter

December 4, 2021 | by

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

News and deal roundup: Best Buy’s $400M for Current, VA’s Cerner restart 2022, CVS-Microsoft product deal, and Athenahealth (finally) sold for $17B

December 3, 2021 | by

Whew! Best Buy revealed on its quarterly earnings call that they paid $400 million for Edinburgh/Boston-based RPM developer Current Health [TTA 13 Oct]. It’s near the end of the call transcript published on the Motley Fool. There will be no impact on their financial performance this year and will have a slightly negative impact on the Q4 non-GAAP operating income. Hat tip to HISTalk. 

Also today in HISTalk is a nifty summary of the Department of Veterans Affairs (VA) Cerner implementation timing and restaffing. There’s a graphic on the 2022-23 (FY 2022-24) rollout plus the new organization. VA has appointed a new Program Executive Director, Terry Adirim, MD, MPH, MBA, moving from Acting Assistant Secretary of Defense for Health Affairs, and established a new EHR Integration Council. VA release. VA also published a 10 page analysis on what went wrong with the initial tests and lessons learned, such as creating an EHR ‘sandbox’ for clinician training.

CVS Health and Microsoft continue with a new partnership, this time for digital health products. The five-year deal will include development in two areas: personalizing health recommendations that direct consumers to when and where they need a CVS, and operationally to leverage technology and machine learning for automation to reduce waste. Microsoft release, Healthcare Dive, HealthcareFinanceNews

And in the biggest non-surprise of the past few days, Athenahealth’s (or as they prefer, athenahealth) sale closed before the end of the year in a deal valued at $17 billion. The buyers were, as expected [TTA 19 Nov], Bain Capital and Hellman & Friedman, along with Singapore’s sovereign wealth fund GIC and a wholly-owned subsidiary of the Abu Dhabi Investment Authority. The 24 year-old Athenahealth, one of the EHR pioneers, was acquired by Elliot Investment Management’s PE arm Veritas and Evergreen Coast Capital in 2019 for about $5.7 billion. Its base is down to about 140,000 ambulatory care providers, having exited the small hospital market some time back. In the EHR market dominated by Epic and Cerner, surely Veritas and Evergreen are relieved to be at least getting some cash back. But there’s Misery Sharing, as they are both retaining a minority investment. (A small hint from a marketer–never lower-case the first letter in any part of your name. You make yourself unimportant and it hasn’t been ‘modern’ for a loooong time. It wasn’t lucky for British Airways, either. Perhaps the new majority owners will get this.)  Healthcare Dive, Business Wire

Theranos, The Trial of Elizabeth Holmes, ch. 12: all bucks stop with the CEO (updated)

December 2, 2021 | by

Tuesday was the last day this week of Elizabeth Holmes’ cross-examination by Federal prosecutors. Despite Monday’s excursion by the defense into how emotional and physical abuse by her live-in partner and corporate president could have warped her business judgment (a ‘me-too’ variation on the infamous Twinkie Defense relating to diminished capacity), and perhaps concealed from her the depth of Theranos’ problems, the cross-examination returned to the essentials. Who was the boss? Assistant US Attorney Robert Leach drew from her this: “Ultimately all roads led to the CEO?” “Yes,” she replied. “The buck stops with you.“ “I felt that.” 

The prosecution was highly effective in drawing out of her how Holmes controlled the company, and despite her claims of not knowing its finances, she knew what to say to round up funding. This countered the emotional drama of the prior day around ‘Svengali’ Balwani’s abuse and controlling actions. Holmes confirmed that she was the New Elizabeth in her hands-on role in altering pharma company reports, marketing materials, investor presentations, knowing their financials–and trying to kill unfavorable stories:

  • She added logos to Theranos’ pharma reports about partnerships with Pfizer and Schering-Plough to make it appear that the documents came from them. Add to these an altered analysis that came from GlaxoSmithKline (GSK), where Holmes admitted adding a logo but couldn’t recall deleting the conclusion “finger prick/blood draw procedure was difficult (needed larger lancet and better syringe system).”
  • She hired lawyers to review the Theranos website for claims at the time of the Walgreens launch in 2013. The language drew quite the critical eye for its language in their report to her. Our Readers will recognize these walk-backs on superiority claims: replacing “highest quality” with “high quality,” “highest levels of accuracy” with “high levels of accuracy,” and “more precise” to “precise.” Claims made needed to be substantiated. It’s not clear from the articles whether these were made.
  • Where walk-backs on these claims were most certainly not made were the investor presentations, including not disclosing that most testing was done on third-party machines, leaving the impression that Theranos labs were capable of running 1,000 tests.
  • Texts between Balwani and Holmes confirmed she knew that Theranos was in critical financial shape throughout 2013, burning through funding like tinder. 2014 was ‘fake till you make it’ time with sunny (sic) revenue projections–convincing to PFM Management and the DeVos family office, kicking in funds totaling close to $200 million, and then a cascade of funds following them. All of whom should have known better, admittedly.

In 2015, Holmes went directly to one of her investors, Rupert Murdoch, CEO of News Corporation and owner of the Wall Street Journal, to have John Carreyrou’s investigative reports killed. To Murdoch’s great credit, not only did the stories run, but also Carreyrou was legally defended against the mad-dog attorneys of Boies Schiller snapping at his heels. Boies Schiller also harassed and tracked former employees-turned-whistleblowers Erika Cheung and Tyler Shultz. Holmes also approved hiring the killer ‘oppo’ research of Fusion GPS. The latter became infamous a year later in sourcing and promoting now-debunked ‘evidence’ of Russian ties to then-candidate Donald Trump.

To counter the rising tide of negative news, Holmes went on CNBC’s ‘Mad Money’, hosted by, in this Editor’s opinion, the ever-credulous, often unhinged, and in recent years de trop Jim Cramer, and bald-face lied that “Every test we run on our laboratory can run on our proprietary devices.”–when only 12 did, not even the 15 Carreyrou documented.

It isn’t known yet whether Holmes will return to the stand next week for more cross-examination or a rebuttal by the defense. What is most likely is that the defense will continue with the themes of diffusion and deflection, creating cognitive dissonance in the jurors’ minds that while Holmes acted in control and committed fraudulent acts, Balwani had so thoroughly emotionally abused her that she was not in control of herself even after he departed. Look for expert testimony from Mindy Mechanic, an expert on intimate partner violence and abuse, to show that words of ‘love’ in 500-odd texts isn’t love at all. (Cue ‘What’s Love Got To Do With It’)

The Verge, CNBC, Yahoo Finance, Ars Technica

Updated: Theranos junkies (Judge Davila’s pronunciation of which is the subject of an entire Mercury News article) may want to follow John Carreyrou’s podcast, epically titled Bad Blood: The Final Chapter. He’s up to 11 episodes and close to 11 hours, so if you think your Editor is focused on this…it’s a deep dive indeed from the reporter who found that Theranos should have been spelled with an F for Fake. The link here is to the ThreeUncannyFour player, but Sony Media has made it available on other podcast platforms such as Spotify.

To be continued…

TTA’s earlier coverage: Chapter 11, Chapter 10, Chapter 9, Chapter 8, Chapter 7, Chapter 6, Chapter 5, Chapter 4 (w/comment from Malcolm Fisk), Chapter 3, Chapter 2, Chapter 1

 

Perspectives: How enhanced digital communications can improve patient engagement

December 2, 2021 | by

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion area. Today, we have a contribution from Dave O’Shaughnessy, Avaya’s Healthcare Practice Leader for EMEA and APAC. The subject is the hot button of patient engagement–how telehealth and virtual care systems can be used to connect patients to providers, improve patient understanding, and increase both patient and provider satisfaction.

Interested contributors should contact Editor Donna. (We like pictures and graphs too)

For most of us, the term “patient engagement” seems straightforward. Patients who come in for their annual exams or patients with a chronic disease who regularly take their prescribed medications are considered engaged patients. But what about the rest of us who feel reluctant to contact our GP when we have health concerns or don’t take our prescribed medicine when we should. If these people were better engaged, their patient experience and outcomes would be improved.

Communications technology that was once considered cutting-edge is now holding healthcare back and one of the most significant obstacles to building an engaged patient experience is the traditional calling-centric communication model. Today, implementation of virtual care systems (telehealth), especially via cloud-based software-as-a-service (SaaS) applications that can be accessed from smartphones or tablets, improves patient engagement levels, and directly contributes to their overall health and outcomes.

So, what should a healthcare provider look for in a modern cloud communication and customer engagement solution? Here are four vital components for starters:

A unified communications platform

A unified communications and patient engagement platform in the cloud provides seamless connections across modes of communication (voice, messaging, chatbots, online meetings, and video), as well as devices (desktop, mobile, and tablet devices). Because it’s all integrated, patients get to use their communication channel of choice over their device of choice, and providers get the features they need to ensure that patients can engage a suitable person when they get in touch. In addition, self-service capabilities such as automated messages for appointment reminders and confirmations help to dramatically reduce time-wasting no-shows for healthcare organisations.

Real-time communications and collaboration

Provision of care requires constant and intuitive access to clinical information and the ability to effectively and efficiently communicate across dispersed teams to exchange critical information throughout care-coordination workflows. Effective and secure real-time collaboration across all communications channels helps staff reach the right people across the organisation at the right time using the most appropriate mode of communication. Most critically of all, these communication services for clinical staff must be easy-to-use, leveraging features like Single Sign-on authentication across multiple apps on a mobile device and offering intuitive click-to-call or team-calling abilities helping teams collaborate easily and rapidly.

Follow-up Patient Engagement

When patients aren’t engaged, they are less likely to follow instructions, resulting in more frequent readmissions. Cloud-based communications solutions with features such as click-to-chat and click-to-video allow patients to keep informed of what, and when, they need to take action for positive health outcomes. Providers can also add automated outbound patient notifications using SMS or Chatbots to follow up on patient satisfaction surveys, freeing critical staff to focus on in-office patients and higher priority, higher quality services.

A Secure and Flexible Platform

To avoid the security pitfalls of Bring Your Own Device (BYOD), healthcare provider staff need a “one-device, two numbers” experience that enables them to securely use one device for both personal and business. And lastly, a communications solution should be able to seamlessly integrate with the most common digital systems used by healthcare professionals.

With the cloud, communication and collaboration can become integrated into one solution that works the way patients and providers work—across any device, anytime, anywhere. Most importantly, the flexibility of cloud communication—particularly when it comes to solutions with open platforms—means providers can add new capabilities in minutes, with almost immediate access to the latest innovations. Look to partner with a solutions provider that has proven experience in patient engagement and experience solutions.