We wish our Readers a happy, healthy holiday season and New Year!

December 23, 2022 | by

2022, with all its drama, is near its exhausting end. This Editor will share with Readers a sigh of relief along with some mindful drinking and eating–most of the time.

2023 with all its challenges will be here before we know it. We will be back at it after 2 January, chronicling the world of telehealth and healthcare with our usual ‘gimlety eye’.

There will be a Weekly Alert on Friday 23 December, repeating Wednesday 28 December–the easy way to catch up on the last few weeks of articles. (Subscribe here!)

We wish all of you the joy of the holiday season and a happy, healthy, and prosperous New Year.  Donna and Steve

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

December 22, 2022 | by

Readers won’t get out of 2022 without one last cybercrime…article. DDoS attacks–distributed denial of service–escalated worldwide with Russia’s invasion of Ukraine in February. (Ukraine and military aid is a hot topic this week with President Zelenskyy’s visit to the US and Congress speech.) Xavier Bellekens, CEO of Lupovis, a cybersecurity company and a cyberpsychologist (!), postulates that DDoS attacks, as nasty as they are, may be a smokescreen for far more nefarious and damaging attacks. While IT goes into crisis mode over the DDoS, other attacks and information gathering on systems preparing for future attacks are taking place. Russian cyber groups focus on large organizations and move down the line into the most vulnerable, using both manual and automated approaches. Worth reading given the vulnerability and IT short staffing in healthcare organizations. Cybernews

The fallout from Cerebral and Schedule 2 telehealth misprescribing expands. The Drug Enforcement Agency (DEA) issued a ‘Show Cause’ to online pharmacy Truepill for inappropriate filling of ADHD Schedule 2 medications, including Adderall. A ‘Show Cause’ order is an administrative action to determine whether a DEA Certificate of Registration should be revoked, which could put Truepill out of business. The red flag for the DEA: 60% of  Truepill’s prescriptions–72,000–filled between September 2020 and September 2022 were for controlled substances, including generic Adderall. Truepill was Cerebral’s primary mail order provider, though they also used CVS and Walmart. The company stopped filling Cerebral’s ADHD prescriptions in May 2022.

In the order, the DEA cites that “Truepill dispensed controlled substances pursuant to prescriptions that were not issued for a legitimate medical purpose in the usual course of professional practice. An investigation into Truepill’s operations revealed that the pharmacy filled prescriptions that were: unlawful by exceeding the 90-day supply limits; and/or written by prescribers who did not possess the proper state licensing.”

The company stated in an emailed statement that they were fully cooperating with the investigation. If it does move to a hearing, Truepill’s chances of a successful defense are statistically low.

Truepill also fills prescriptions for Hims & Hers, GoodRx and Mark Cuban Cost Plus Drug Company. It was valued in its 2021 funding round at $1.6 billion. Companies in telemental health and prescribing of Schedule 2 ADHD medications, such as Cerebral and Done Health, are under enhanced scrutiny over their business practices [TTA 1 June]. Mobihealthnews, DEA press release, HISTalk, Digital Health Business & Technology

Telehealth medical claims stabilize. FAIR Health’s latest reports for August and September report that the percent of medical claims coded as telehealth are back up to 5.4%. June and July dropped slightly to 5.2% and 5.3% respectively. Also steady are that the vast majority of claims are for mental health services. In September, they were 66% of diagnoses far ahead of ‘acute respiratory diseases and infections’ at 3.1%. In procedure codes, psychotherapy accounts for over 43%.

A patent troll Epically bites the dust. Back in the early to mid-2010s [TTA’s index here], patent trolls (technically non-practicing entities which have no active business) presented a significant threat to early and growth-stage health tech companies. One, MMR Global (which apparently no longer exists), was notorious for buying up EHR and PHR-related patents and then filing patent infringement lawsuits against both small and large healthcare organizations with similar patents–and their users–that were generally monetarily settled. But NPEs are still active. One in south Florida, Decapolis Systems, used the same techniques as MMR Global had, suing in this case multiple Epic customers for patent infringement. Epic not only defended its customers but also sued Decapolis in the US District Court, Southern District of Florida. The court found that both Decapolis patents were invalid, ending what Epic termed ‘vexatious patent litigation’. Decapolis had successfully sued 24 other entities, including other EHRs, which settled. Owned by an inventor, this company will have to find another line of honest business. Epic release, Thomson Coburg

Oracle’s message to Kansas City: no more Cerner meetings for you. And maybe more. Cerner’s site for its annual customer/partner conference since 2007 has been in Kansas City, attracting about 14,000 visitors. Not only will it be integrated into Oracle CloudWorld in Las Vegas, 18-21 September, it’s been retitled Oracle Health with no mention of Cerner. The loss to local KC business is substantial–estimated to be in the $18 million range. While it’s logical to integrate it into the massive CloudWorld conference, it’s also another message to KC after Oracle’s sudden real estate downsizing that Cerner’s presence there will shrink…and shrink..as it’s absorbed into Oracle Health, and further confirmation that the Cerner name is gradually being sunsetted. KansasCity.com, HISTalk

A new (to this Editor) specialty care telehealth company, MediOrbis, is partnering with Kahun for an AI-enabled digital intake tool. This is a chatbot capable of conducting an initial medical assessment. Based on the patient’s answers and Kahun’s database of about 30 million evidence-based medical knowledge insights, it provides a summary for the physician before the telehealth visit and highlights areas of concern. Mobihealthnews  MediOrbis also has partnered with remote care/engagement Independa to add its capabilities to Independa’s HealthHub on their LG TVs.

Telehealth two-year extensions included in US Federal ‘omnibus’ budget bill

December 22, 2022 | by

Expanded telehealth access extended for two years. The ‘omnibus’ fiscal 2023 spending bill before Congress Thursday contains extensions for four areas of improved national telehealth access developed during the COVID-19 Public Health Emergency (PHE) starting in January 2020. Because they apply to Medicare and high-deductible health plans (HDHP), they become guidelines for commercial health plans and help to cement telehealth as a permanent part of health care delivery.

The two-year extensions include:

  • Retained expanded reimbursable access to telehealth for Medicare beneficiaries put into place during the PHE
  • A two-year delay in implementing the Medicare telemental health in-person requirement
  • Extension of safe harbor provisions to offer telehealth as part of HDHPs with Health Savings Accounts (HSAs)
  • Extension of the Acute Hospital Care at Home Program. This waiver permits some emergency department and inpatient hospital patients to be treated from their homes. 

At this time, the PHE is set to expire on 11 January 2023. It has been extended every 90 days since January 2020 and may be extended again. The bill did not extend the Ryan Haight in-person waiver for the remote prescription of controlled substances, a wise move in this Editor’s view given the abuse of this waiver by certain telehealth organizations. It does request the Drug Enforcement Agency (DEA) to promulgate final regulations specifying the circumstances in which a Special Registration for telemedicine may be issued for controlled substances, and the procedure for obtaining the registration.

Another wise move on Congress’ part in this monster 4,000+ page, $1.7 trillion spending bill is to further prohibit the creation of a national patient ID for healthcare that supposedly would facilitate EHR interoperability. 

The bill is supposed to come before a lame-duck Congress at the eleventh hour before their Christmas leave on Thursday. Some opposition has coalesced due to wasteful earmarks covering pet projects that are included in the (unread by most representatives) bill and the fact that a new Congress with a change of party control in the House will be seated in January. However, for those of us in the US telehealth business, these inclusions are not controversial nor wasteful, and if the omnibus bill fails for some reason, will likely be included in any short-term extensions which are typical in keeping the government running. ATA release, POLITICO Future Pulse

Few specialty telehealth visits require in-person follow up within 90 days: Epic Research study 2020-2022

December 21, 2022 | by

35 million visits make the case that virtual visits can stand alone, even in medical specialties–but how much was the pandemic a factor? Epic Research, a public benefit corporation owned by Epic Systems Corporation, analyzed telehealth consults over 26 months in a dual team study. The study found that most patients did not require an in-person follow-up appointment in that specialty within 90 days. The dual team study (two teams working independently) reviewed US EHR data collected from 1 March 2020 through 31 May 2022.

There was an extremely wide spread by specialty both in the number of visits and in-person follow-up within the three-month window. 

Looking at the study findings:

  • The lowest in-person follow-up percentage was in genetics at 4%, followed by nutrition at 10%; the highest–unsurprisingly–was obstetrics at 92%.
  • Far and away, the specialty with the greatest number of telehealth visits, over 4.3 million, was mental health and psychiatry. Their in-person follow-up was 15% of that number. That ‘cadence of care’ cited in the study report could be in part due to state medical regulations and insurance guidelines requiring in-person review, especially when prescribing Schedule 2 (those with a high possibility of abuse and dependence) or even Schedule 4 drugs.
  • Other specialties falling below 25% of in-person follow-up were endocrinology and neurology (both with 1 million telehealth visits), plus diabetes services, nephrology, pulmonology, medication management, gastroenterology, rheumatology, and addiction.
  • Cardiology and surgery, with both at 1.4 million telehealth visits, surprisingly had follow-up percentages around 43%
  • Above 50% in follow-up are geriatrics and fertility, both of which require more in-person examination. Geriatrics also covers a broad range of chronic condition care management in patients.

In looking at the numbers, this Editor will point to three situational factors unique to the pandemic period and its aftermath that may skew these findings on in-person follow-up visits to a lower range: 

  1. Most medical offices in the US closed from the start of the pandemic (about March 2020) and did not reopen until mid-year. Many health specialty practices and psychiatric clinics did not reopen for in-person visits until the fall or even later.
  2. Online mental health consults took off like a rocket–and are coming back to earth with greater scrutiny of prescribed Schedule 2 drugs (see Cerebral Health, Talkspace, et al.)
  3. Continuing patient apprehension on in-person visits into this year
  4. The continuing of public health emergency (PHE) compensation for telehealth visits into 2022 both in Medicare and private insurance

A flaw in the article is that these points are not considered in influencing in-person visits in the future.

Rounding up fundings and startups: Override(ing) pain; brainy Synchron and In-Med Prognostics; Click off migraine; Cardiosense and CHF detection

December 17, 2022 | by

Looking at the brighter side–new companies and fundings, even the modest ones:

Override, a virtual pain management startup, emerged from stealth mode this week with $3.5 million in hand. The company’s program applies an interdisciplinary methodology to virtual pain management in a continuity from diagnosis and physical therapy through to pain coaching and mental health. According to their release, the company combines the “latest in pain neuroscience research to help patients make functional, behavioral, and movement-related changes needed to calm the nervous system and rewire pain neural pathways. The program strives to transform people dependent on opioids, chiropractors, and repeat injections into self-managers of their own pain experience and broader health.” Pain coaching is offered nationwide, while pain physicians, physical therapy, and pain psychology treatment are only available to residents in FL, Maryland, New Jersey, Virginia, and Texas. Services may be purchased à la carte or bundled. Override’s present model is direct to patients first, then piloting with employer and health system partners.

What is also intriguing is that Override is a family affair–David Shulkin, MD, former VA Secretary, and his daughter, Jennie Shulkin, a lawyer who is herself a chronic pain sufferer. Dr. Shulkin is also experienced in this via the VA’s opioid treatment program. Seed funding of $3.5 million was raised from 7wireVentures and Martin Ventures, joined by SignalFire and Confluent Health. Prior to coming out of stealth, Override used the funding to purchase pain management coach Take Courage Coaching. Something very needed for the estimated 50 million Americans with chronic pain. Hat tip to HISTalk 16 Dec.

Recent fundings rounded up concentrate on the brain and heart:

The largest is brain-computer interface (BCI) developer Synchron with an oversubscribed Series C of $75 million. Lead investor was ARCH Venture Partners, joined by heavy hitters such as Gates Frontier, Bezos Expeditions, Reliance Digital Health Limited, and 11 others. Synchron’s value proposition is centered on a minimally invasive, surgically inserted brain implant (Synchron Switch) for what they term Neurointerventional Electrophysiology (Neuro EP). FDA granted them Breakthrough Device designation in 2020 for the Stentrode device, an implant delivered to the brain through blood vessels to give paralysis patients the ability to control digital devices with their thoughts. It is currently in human clinical trials in the US and Australia. The fresh funding will be used for additional development. A number of these funders have made public their interest in BCI for other uses for which thought tracking and action might be useful. Mobihealthnews, Crunchbase, VC News Daily 

Speaking of brains, Pune, India’s In-Med Prognostics has received $2.13 million in a seed round from Exxora and other angel investors. In-Med has developed AI diagnostics to aid in the assessment and early detection of neurological disorders such as dementia, Alzheimer’s, and Parkinson’s. The funding will further develop their NeuroFlow analytics platform; NeuroShield, an app powered by NeuroFlow that provides ethnicity-specific volumetric brain analysis within 20 minutes; and VivoShield Sports for performance analysis. Currently, they are marketed in Africa but In-Med has offices in Australia and San Diego.  VCCircle (India), Mobihealthnews 

And for that pain in the head known as migraine, Click Therapeutics has received FDA Breakthrough Device Designation for its prescription digital therapeutic for episodic migraine. CT-132 is being developed as an adjunctive preventive treatment for episodic migraine in patients aged 18 years+. In April, Silicon Valley Bank loaned them $15 million to retire an earlier term loan from K2 Health Ventures. Release 16 Dec, Release 15 April, Mobihealthnews

Moving from the head to the heart, Cardiosense garnered a $15 million Series A for its AI-based detection of cardiovascular disease. In February, it received Breakthrough Device designation from FDA for combining monitoring of  seismocardiogram, electrocardiogram and photoplethysmogram readings from the CardioTag wearable sensor with AI algorithms to determine pulmonary capillary wedge pressure (PCWP). PCWP is a measure of congestive heart failure (CHF) that at present can only be assessed through catheterization. The new funding will speed up other products in its portfolio as well as studies to further refine and validate the CHF algorithm over a diverse population. Leading the Series A were Broadview Ventures and Hatteras Venture Partners joined by four others.  Release, FierceBiotech

Smart lighting that detects and reports falls in older adults–and more–debuts in UK and Ireland

December 16, 2022 | by

The Nobi lamp (left), is, to this Editor’s knowledge, the first ceiling light that 1) provides illumination in bedroom or bathroom based on general motion detection, 2) can detect and document a fall, 3) can summon help. According to its website, it is programmable to do more, such as detecting motion and providing light to help prevent falls in darkness. If a fall does happen, it will alert help first, open the door if linked to a smart lock, then connects the person who has fallen with a family member or caregiver for reassurance. Optional capabilities include: taking photos so that the person’s location and type of fall can be confirmed; and some remote patient monitoring via connection to other ‘smart’ devices such as scales and blood pressure monitors. RPM information can be transferred to medical or residential records. Their AI algorithms can also determine sleep patterns inferred from motion and location in the bedroom.

Nobi was developed by a Belgian company that won the 2021 Editor’s Choice Award at CES. It recently became available in the UK and Ireland primarily for housing/assisted living/residential care use. The ceiling pendant lamp comes in two sizes and coverage capabilities–the larger Nobi covers a 10 m x 10 m area and the damp-resistant Nobita for smaller spaces such as kitchens and bathrooms with 5 m x 5 m coverage. The lamps use conventional wiring and Wi-Fi, taking about one hour to install. The information can be directed to the assisted living/care facility’s platform or to a family member/caregiver if in home use.

UK distribution is via Porters Care and Ireland via Medguard. Beyond the UK and Ireland, Nobi is also marketed in the US, Canada, Belgium, the United Kingdom, Netherlands, Sweden, Norway, Finland, Hungary, Germany, Austria, Switzerland, and Hong Kong, though the website covers only US, France, Netherlands, Denmark, and Hungary. Building Better Healthcare   Big hat tip to Roy Lilley and his nhsManagers.net newsletter and Editor Emeritus Steve Hards.

10 reasons for a new trial? Elizabeth Holmes’ legal team files appeal, delay in prison start (updated)

December 15, 2022 | by

Elizabeth Holmes and her legal team continue their campaign to keep her out of Federal prison. On 2 December, on the deadline from two weeks of sentencing but just made public, her three-page appeal was filed with the US Court of Appeals for the Ninth Circuit.  She has until 3 March to file legal briefs in the 9th Circuit Court of Appeals in California. In addition, her legal team has requested from Judge Edward Davila that she remain free until her appeal is concluded due to not being a flight risk, citing close family ties and pregnancy. Holmes was scheduled to report to Federal prison (still to be determined by the US Bureau of Prisons) on 27 April 2023.

The 10 reasons for a new trial are not fully enumerated in the SiliconValley.com article, but include purported errors by Judge Davila during the trial. These include allowing the jury to hear about regulatory action against Theranos and the company’s voiding of all test results from its Edison lab machines. The filing argues that those events took place after she made any “relevant” statements to investors. Another reason was the sudden visit by former lab director and key prosecution witness Dr. Adam Rosendorff to her home [TTA 26 Oct, 20 Oct]. Dr. Rosendorff reaffirmed in the court hearing that he testified truthfully and honestly, the visit took place during a moment of distress, and that he continued to believe that Holmes needed to pay her debt to society. 

Legal experts mostly agree that Holmes presents little to no flight risk, as she is known everywhere, and is no threat to her community. Where they are split on whether she will remain free during the full process of the appeal, which could be a year or even more. Appeals have low rates of success at the Federal level. To these observers, Judge Davila has been scrupulous–‘bent over backwards’–to be fair to both prosecution and defense during the trial. He has already heard and rejected defense arguments for new trials and acquittals. He did not permit the prosecution to run wild or overcharge either. The decision of another jury on COO Sunny Balwani on all 12 counts, the same as Holmes, also conducted by Judge Davila, may very well factor into an appeal to the judges, unfavorably for the defense. One wild card factor is that the jury convicted her on but four out of 11 counts (acquitting or deadlocking on the rest; Count 9 was dropped due to a prosecution error). The jury for her trial proved 1) difficult to select and 2) difficult to retain, going through three alternates of the five.

Still pending are monetary damages. Updated: checking Judge Davila’s calendar, this will take place after January as his calendar is filled.

It does look like Holmes may enjoy freedom through 2023–but her chances of reversing her conviction and going free are as small as that nanotainer she is modeling. FoxNews, Ars Technica

Mid-week roundup: Wisconsin’s Marshfield Clinic zeros out telehealth staff; Komodo Health lays off 9%; epharmacy Medly’s Ch. 11, PharmEasy layoffs; OneStudyTeam releases 25%

December 15, 2022 | by

Year-end brings reckonings and reorganizations….and may leave you feeling like Pepper.

Marshfield Clinic, located in rural north central Wisconsin, eliminated its 18-person telehealth department on 1 December. It is not clear from reports whether telehealth is being eliminated (HISTalk) or whether this is being maintained by current IT staff. This follows news of ongoing financial difficulties in this network of 12 community and rural hospitals and 65 clinics. In August, they renegotiated some loans in the wake of losing $25 million that month–and their CFO departed. The health system is also in the throes of replacing a 30-year-old homegrown EHR with Cerner. Like most rural hospital systems, Marshfield has been keelhauled between increasing wage and supply costs plus the ending of CARES Act subsidies. It has had ongoing merger discussions with Minnesota’s Essentia Health. WSAW-TV 7 (Wausau WI)

Recently fast-growing Komodo Health is laying off 9%, or 78, staff.  The layoffs were positioned as a ‘restructuring’ to remaining employees. Interestingly, Komodo has about 40 positions recently posted and listed as open on LinkedIn, not including its CFO who is departing at end of this year.

Komodo is reportedly planning to IPO in 2023. In early November, it completed a structured equity infusion of $200 million from Coatue and Dragoneer. Reportedly, Komodo’s annual recurring revenue is $150 million but is not yet profitable. Last March in its Series E, it was valued at a rich $3.3 billion. 

Komodo is in the complex analytics business of creating data maps out of de-identified patient data. From this, they create software applications that reveal patient behaviors, can guide treatment, highlight care gaps, and, in their words, ‘reduce the global burden of disease’. Like mapping patient health journeys, everyone agrees it is valuable, but then debates on how to apply it. Is it the whole truth and nothing but? Or are my patients different? Whether strapped health systems and health plans see that Komodo’s applications are necessary, given their in-house data, with the knock-on cost of integrating it into their systems, is entirely another question that influences Komodo’s growth. TechCrunch, FierceHealthcare, Mobihealthnews  

Two epharmacy operations have run into significant financial difficulties.

  • Brooklyn’s Medly filed for Chapter 11 bankruptcy reorganization on 9 December, closing 20 stores. A scrappy upstart founded in 2017 that grew from a storefront in Brooklyn to over 20 physical locations in New York, New Jersey, and Philadelphia plus four same-day prescription delivery centers, they went through a cash crunch in August that derailed their filling prescriptions for close to one month. Precipitating this was their purchase of Boulder-based integrative pharmacy Pharmaca in late 2021 to add 21 locations in 20 markets across nine states, first-half losses of $35 million, and failure to obtain over the summer a $100 million loan. Medly owes about $121 million plus $47 million in trade debt, unpaid salaries, and other unsecured debt. A bidder, MedPharmaca Holdings Inc., will have an opening bid of $18.5 million at a bankruptcy auction for almost all of Medly’s assets, including the Pharmaca stores.

A complication–employees are also suing the company in a class action lawsuit for mass layoffs. 1,100 of 1,900 employees were not given up to 90 days written notice, as required by Federal and NY State Worker Adjustment and Retraining (WARN) Acts. WARN act notices were posted after the layoffs, according to the lawsuit. Employees also lost salary, commissions, bonuses, accrued holiday pay, and 401(k) contributions. Oddly, their website lists about 20 open positions, but this Editor is sure that is due to the website manager also being laid off.  FierceHealthcare, Boulder Daily Camera, Digital Health Business

  • Nearly 8,000 miles away, PharmEasy of Mumbai, India has laid off an undisclosed number of people in a second round of layoffs, primarily in product technology, quality analytics, and support verticals. Their problems, reported in India’s Inc42, center on mounting losses, a funding crunch, and a shelved IPO. India’s Business Standard reported that the layoffs will go into the hundreds. PharmEasy is an online store covering most of India that delivers everything from medications and lab tests to doctor referrals and Dettol. 

And last in this (depressing) roundup is Boston’s OneStudyTeam’s 25% layoff of 160 employees with the usual “restructure our team going into 2023” and “streamline operations” statements, despite being used by 70% of biopharma companies.  OneStudyTeam has a clinical trial workflow platform that enrolls and manages patients. As part of clinical trials holding company Reify Health, it is a sister company to Care Access, a decentralized research organization (DRO). In April, Reify added $220 million in Series E funding for $479.6 million in total, increasing its valuation to $4.8 billion. Mobihealthnews, Crunchbase

Theranos’ Balwani gets an unlucky 13 year sentence, restitution to come

December 8, 2022 | by

Today, in the US District Court, Northern District of California, Ramesh ‘Sunny’ Balwani, the former president of Theranos, was sentenced to 155 months, or 12.9 years, in Federal prison. Balwani had been convicted on all 12 counts of fraud and conspiracy, including two for patient fraud, in July. The prosecution had asked for 15 years, as they had with Elizabeth Holmes, who was sentenced by Judge Edward Davila to 11.25 years on four counts. Balwani will be required to surrender on 15 March. None of the coverage indicates that he will appeal. 

The hearing today was about six hours and was far less of a media ‘event’ than Holmes’ hearing. 

Like Holmes, Balwani’s defense requested a sentence of home confinement of four to 10 months, citing that Balwani was an investor ($5 million), was not CEO but COO for six years to May 2016 before the company went out of business, wasn’t involved in key decision-making by Holmes, and gave money to charitable causes. The probation officers’ recommendation was, also like Holmes, nine years. Judge Davila again went with standard sentencing guidelines to produce a result that was far less than most observers, including your Editor, expected given the 12 counts and his direct management of the Theranos lab.

US Attorney Jeff Schenk, who spoke for the prosecution, said “Mr. Balwani knew that Theranos was not generating, and would not generate, any meaningful revenue by being honest with people. So he chose a different path.” The opposite view from his defense attorney, Jeffrey Coopersmith: “Mr. Balwani never wanted anyone to be harmed. He would never harm a fly. Instead, he wanted to give…He’s deserving of a lenient sentence. He’s not Ms. Holmes. He did not pursue fame and fortune.”

However, Balwani was key in making deals and withheld what was really happening in the lab. According to TechCrunch, “During the trial, a Walgreens executive testified that he worked closely with Balwani on the deal. The prosecution also displayed evidence of a text from Balwani to Holmes stating that he deliberately didn’t tell Walgreens that they were using different machines.” He did not testify in his own defense or speak at the hearing on his own behalf.

According to reporter Dorothy Atkins, covering for Law 360, Judge Davila “won’t give Balwani a tougher sentence for leading the conspiracy, but he found Balwani recklessly put patients at risk, since he led the lab.” By his own text to Holmes, “I am responsible for everything at Theranos.” and had, according to the judge, “significant autonomy” in the lab–where the machines did not work. In the judge’s words, as she reported, “Defendant chose to go forward with deception, I’ll call it, and continued to perpetuate the fraud….” After sentencing, his defense requested that he serve in a minimum security prison. At the end, “Balwani packed his things and whispered something to his family members. He didn’t get any hugs, and there were no visible tears in the courtroom.”

On restitution, the prosecution wants Balwani to pay $804 million to defrauded investors, which happened to be the same amount requested bu the prosecution as Holmes. Judge Davila calculated total investor loss as $120 million. A final determination will be made at a later date to be determined.

Balwani is 57, which means that if he serves the typical 85% of his Federal sentence, he will emerge from Club Fed aged 68.  Washington Examiner, NBC, NBC Bay Area, Scott Budman of NBC’s Twitter feed

AliveCor loses Patent Office ruling with Apple; three patents invalidated

December 8, 2022 | by

Apple prevails in the patent infringement suit by AliveCor–and got three AliveCor heart monitoring patents invalidated as ‘unpatentable’. In the duel of patent infringement claims dating back to May 2021 between AliveCor and Apple, the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) not only ruled that Apple did not infringe on AliveCor’s patents, but also threw out the AliveCor patents that were the basis for the infringement. AliveCor had sued Apple for patent infringement on their ECG technology in three US patents: No. 10,595,731 (“the ’731 patent”); No. 10,638,941 (“the ’941 patent”); and No. 9,572,499 (“the ’499 patent”) in their Apple Watches 4, 5, and 6. [TTA 29 Apr 21, 9 July 21] 

The term ‘unpatentable’ is used when the PTAB deems the patent, even when granted in the past, too obvious or too general. When the PTAB finds that, they throw out the patent and it is no longer valid.

Apple of course crowed that they developed their own patents fully on their own, and not from the time when AliveCor’s ECG monitoring was incorporated into earlier Apple Watches. Apple is up to the Series 8. AliveCor has already announced it will appeal and await the pending ruling from the International Trade Commission (ITC) to block the import of Apple Watches. The ITC’s initial determination in June was positive [TTA 28 June] and AliveCor of course is ‘cautiously optimistic’ on the Final Determination due in a few days (12 December). With the PTAB’s finding, it is far less likely that the ITC will impose an import block when AliveCor’s patents have been invalidated.  9to5Mac, Mobihealthnews

AliveCor has moved forward with its KardiaMobile series, including a credit card-sized device (left), and has enjoyed substantial investment, with an August Series F (amount undisclosed) round led by GE Healthcare. 

Patent invalidation is a danger in any patent infringement lawsuit. In 2015, Bosch Healthcare, which had bought HealthHero, an early RPM platform marketed as Health Buddy, and ViTelNet, was a serial patent challenger. They went after Philips, Viterion (while owned by Bayer), both to a draw, and won against a slew of barely-out-of-the-cradle companies forgotten by nearly all of us such as Alere Health, MedApps, Waldo Health, and Express MD Solutions. Then they sued Cardiocom in 2012 with the same expectation. Except that a year later, Cardiocom was acquired by Medtronic. Deep-pocketed Medtronic fought back hard–and by 2015, the PTAB invalidated most of Bosch’s key patents. Bosch withdrew from the US market abruptly in 2015. TTA 19 June 2015, 7 September 2015 primarily about the ongoing Teladoc-Amwell dustups

Given their funding and device development, AliveCor will likely not face Bosch’s fate, but such invalidations have consequences yet to be determined and litigated. 

News (and robot) roundup: ElliQ companion robot upgrades, named to 2022 TIME list; Robin the Robot introduced for older adult care; Utilita acquires Canary Care (UK)

December 7, 2022 | by

ElliQ, a desktop companion robot targeted to older adults and those with assistive needs, announced an upgrade to their software, a new 2.0 edition of their hardware (left), and a communication app for caregivers. In March, when Intuition Robotics launched it, this Editor noted its unusual shape, versatile small size, controlled by a small tablet with a simplified interface, and its ability to combine both chat interactivity and wellness tracking, including appointments and med reminders.

  • The new software enhances interactivity with deeper conversations, and more content, such as museum exhibit tours, virtual travel, and the recording of memories to send to loved ones. The software upgrades are supported on ElliQ 1.0 and the new 2.0 hardware.
  • The 2.0 hardware is at a significantly larger scale with improvements such as simpler tablet charging, a better screen, and higher quality far field microphone performance. 
  • The new companion app for family members, friends, and caregivers expands capabilities into video calls, text/image/video messages, remote reminder setting, and updates on wellness changes. The free app is available shortly on the Apple Store and Google Play.

ElliQ was also named to TIME’s 2022 list of Best Inventions in the Accessibility category, for innovation in helping seniors live happier and healthier with the use of easy-to-use AI and technology.

In May, ElliQ entered a partnership with the NYSOFA (New York State Office for the Aging) program with 800 older adults in care. Based on their impact study from the first six months of distribution, ElliQ has had some impressive results, such as reducing loneliness in 80% of users and helps 82% stay mentally active. Release (PDF)

Another TIME winner in 2021 for robotics, Robin the Robot, has been introduced in care for older adults at Riverwalk Post-Acute in Riverside, California. Robin’s design is child-sized at 4 feet and mimics a child of about seven years. Most of the Robin pilots are in pediatric hospitals such as UCLA Mattel Children’s Hospital, augmenting care through interacting with the child, providing social support through telepresence and unobtrusive patient monitoring. This new initiative in older adult post-acute care not only monitors emotional state by observing patient facial expressions, but also provides companionship and mental stimulation through playing games and conversation at a ‘grandchild’ level. Expper Technologies, a seed-stage company also in California, in October won a $2 million round led by Starta VC with its co-investing platform Liqvest and Formula VC. HealthLeadersMedia  More on Robin’s use in this type of care is in this blog post.

In the UK, Canary Care has been acquired by energy ‘challenger’ provider Utilita. Oxfordshire-based Canary Care expands Utilita’s home services area into assistive technology with wireless sensors that monitor activity, temperature, and portal accessible by family and caregivers. Transaction cost is not disclosed. Canary Care will continue as a separate entity, but will be working with Utilita’s tech arm, Procode, on research and development. Utilita supplies energy and also energy control such as smart meters and monitoring apps. Release (PDF). 

Perspectives: Could the telehealth VIMPRO model save the NHS from drowning in demand?

December 6, 2022 | by

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion area. Today’s Perspectives is from Adam Hunter, CCO at Phlo Connect, an API-driven pharmacy infrastructure platform to deliver enhanced patient and clinician experiences. Phlo Connect integrates with prescribing technologies and digital health platforms used by the NHS and by private healthcare providers, from the initial consult and prescribing, and processes the request through to patient delivery. This article discusses how Vertically Integrated Micro-Providers (VIMPRO) can work in partnership to streamline NHS services using technology and telehealth.

Interested in being a Perspectives contributor? Contact Editor Donna. 

The NHS is in crisis: with staff vacancies currently exceeding 130,000, elective care waiting lists are predicted to exceed 10 million by March 2024, and up to 22,000 appointments are cancelled every single day.

Speaking at a King’s Fund conference in London earlier this month, NHS Chief Executive Amanda Prichard told delegates that demand on national health and care providers is rising so quickly that patients are not always getting the level of care they deserve. Highlighting a projected £7bn NHS budget shortfall, she went on to emphasise that “We’ve got to shift the model of care from one that does late diagnosis and expensive treatment to one that does faster diagnosis, better treatment and better value for the taxpayer in the process.”

Such a model, where all patients can access timely, preventative care without exorbitant cost, is one that every developed national healthcare system aspires to adopt. Navigating the practicalities and finding the capacity for transformation has to date stalled the full realisation of this. However, gathering pace in the past decade has been the VIMPRO model of healthcare delivery, which is increasingly proving to be a successful way of meeting the needs of underserved patient groups and alleviating pressures. At this time of critical need, could this model save struggling public systems from drowning in demand?

The VIMPRO model explained

A Vertically Integrated Micro-Provider (VIMPRO) is a telehealth provider focused on delivering an end-to-end service to a specific patient group. VIMPROs are characterised by excellent user experience and personalised clinician-led care, and are increasingly entering into partnerships with national healthcare providers (including the NHS) to help bridge gaps in service delivery.

One example of a successful existing VIMPRO model operating in partnership with the NHS to meet a previously unmet patient need is Leva Clinic. They are UK leaders in chronic pain management and medical cannabis treatment. The majority of their users pay to use their digital platform, where they access psychology consultations, nurse appointments, physiotherapy advice, prescription and direct-to-door medication delivery.

This is a big step in the right direction towards meeting the needs of the UK’s underserved pain patients, many of whom have spent years with inappropriate support owing to a shortage of pain specialists and lack of personalised treatment options.

Patient and system benefits

From the perspective of NHS leaders, the benefits of the VIMPRO model are multiple. Firstly, they provide an alternative point of access to care for patients who’d otherwise need to be seen by GPs and referred on to NHS consultants. This frees up system capacity and cuts wait times and workloads. Secondly, VIMPROs provide the education and information that their specific patient group needs to manage their condition and improve their outcomes. This reduces the burden of ill health on the NHS further down the line. And thirdly, when VIMPROs are integrated properly with NHS systems, all the information about the patient’s care can be tracked in their electronic record without adding to practitioners’ admin burden. 

The VIMPRO model also offers multiple benefits to patients. Convenience and timeliness of access to healthcare are primary amongst these, as they remove the barriers of geography and waiting lists that obstruct care in the NHS. Patients can be quickly connected to leading specialists and prescribers anywhere in the county, and don’t even have to leave their homes to collect their medication. In addition, accessing remote care through a VIMPRO model means that patients who are reluctant to engage with local services for support – perhaps because of stigma around their condition – are offered an alternative source of care that’s entirely virtual and distinct from other NHS services. Finally, VIMPROs often take on the responsibility of creating education materials and championing the needs of their patient vertical. For example, men’s health VIMPRO Numan hosts a medically-reviewed blog delivering advice on weight management, erectile dysfunction, hair loss, mental health and other under-discussed men’s health issues.

The future of NHS care delivery?

There is no single solution that can fix the problems facing the NHS and other public health systems around the world. Replacing the core of NHS services with a network of VIMPROs is an unrealistic proposition that would be extremely difficult to achieve. However, carefully planned VIMPRO partnerships have already proven to be effective at redirecting patient demand to where it can be successfully dealt with.

If the right streamlined system integration and tailored digital infrastructure is put in place, patients and clinicians can enjoy seamless and convenient experiences. This means no clunky transition between platforms and service providers: from first consultation to the arrival of medication on the doorstep of the patient. 

Global health needs, and our expectations of healthcare, are constantly evolving. Only by constantly evolving the models of care delivery will we be able to keep up, and right now, that means embracing the opportunities of the VIMPRO model and making it work as well as we possibly can.

Optum Labs creates and funds digital health research hub at Cornell Tech NYC

December 6, 2022 | by

Optum Labs, the research and development arm of Optum/UnitedHealth Care, is allying with Cornell University to create a collaborative health research hub at the university’s NYC-Roosevelt Island campus, Cornell Tech. The initiative, funded by Optum Labs, is targeted to develop precision behavioral health and advance equity. According to the release, it will drive innovative research in precision behavioral health, extended reality for aging in place, and equitable human and algorithmic decision-making. A large part of this is incorporating new types of health data from wearables and IoT devices, Also this joint venture will seek to create new types of remote intervention and care delivery using augmented reality and virtual reality actuation technologies with computational techniques. (Whew!)

The digital health hub will be led by Deborah Estrin, an Associate Dean and a Robert V. Tishman ’37 Professor at Cornell University, and Tanzeem Choudhury, Ph.D., Senior Vice President at Optum Labs, and a Roger and Joelle Burnell Professor in Integrated Health and Technology at Cornell University. The funding amount is not disclosed. To this Editor, this seems like an effort to restore the New York area as a digital health hub and regain momentum lost since 2020. Cornell release, 

Optum has been reaching out on multiple fronts. The RVO Health joint venture brought over media and Healthgrades doctor ratings [TTA 14 July], UHG inking a 10-year deal with Walmart Health starting with Florida locations, and of course the Change Healthcare wrap into OptumInsight [TTA 20 Sept, 4 Oct] though still being contested by DOJ post-closing. All a part of Keeping Up With the CVS Health/Aetnas, Walgreens/VillageMDs, Amazons, and fellow payers like Cigna and Elevance. HealthcareFinanceNews

Who’s buying, selling, funding wrapup: athenahealth IPO deux?, NextGen EHR buys reseller TSI for $68M, Cloudwave buys Sensato; fundings for Lumen, UpStream, Aide Health

December 3, 2022 | by

athenahealth may go public a second time. This was teased by CEO Bob Segert in the Boston Globe (paywalled) earlier this week. He claimed in the article that since the company went private in 2019, they have added nearly 2,000 clients each year of the past three and that revenues are in the billions. Healthcare IT News recaps some of their moves from going from public to private and downsizing to today. Their other news is that they have instituted a clinical advisory board of 30 members (!) to provide feedback and guidance on clinical features and direction to athenahealth’s product team. One hopes that the sharper members advise a change in the first letter of their name from the oh-so-twee lowercase to an uppercase ‘A’. 

NextGen Healthcare, an EHR/EMR and revenue cycle management software provider for medical/dental practices, is acquiring reseller partner TSI Healthcare. The agreement is for $68 million in cash upfront, with a contingent consideration of up to $22 million in cash if TSI meets certain goals by March 2025. TSI has been a NextGen reseller for 16 years. The acquisition will enable NextGen to expand in key specialties including rheumatology, pulmonology, and cardiology. No mention is made of management or staff transition, nor of SEC review as NextGen is a publicly traded company on Nasdaq. Hat tip to HISTalk 2 Dec. Release, BusinessJournals Triangle

Massachusetts-based Cloudwave is acquiring Sensato Cybersecurity to increase cybersecurity capabilities. Cloudwave provides cloud services hosting with cybersecurity capabilities exclusively to healthcare organizations. Sensato adds cybersecurity-as-a-service (CaaS) to manage security needs, determine where security gaps are, and threat intelligence. Transaction price and details were not disclosed, but Sensato’s founder John Gomez will join CloudWave as chief security and engineering officer. Healthcare IT News  Cybersecurity continues to be top-of-mind for healthcare organizations. The latest Big Data Breach at CommonSpirit Health system hospitals got even worse, with the third-party breach of an undisclosed number of patient records at their Franciscan Health hospitals in September and October. This followed the ransomware attack on other CommonSpirit system hospitals’ EHRs in October. Healthcare IT News

As we near the end of the year, funding is wrapping up with a flurry in some surprising areas such as optimizing metabolism and care coordination for chronic conditions, reducing burden on primary care practices/GPs. One is for an early-stage company in the UK for the latter.

  • Lumen’s $62 million Series B was led by Pitango Venture Capital with Hanwha Group and Resolute Ventures.   Lumen measures metabolism via a handheld, breathalyzer-like device equipped with a CO2 sensor that analyzes whether the body is burning fats or carbs for fuel which can promote weight loss, energy for fitness, and sleep. With that data, the app delivers to users personalized meal plans and nutrition along with when to eat. The new funding will be used to expand these nutrition and lifestyle coaching services. The device is sold direct to consumers, with the app services sold on a SaaS basis: three yearly plans with a range of services from $249 to (on sale) $349.  Mobihealthnews, MedCityNews
  • Another Series B raise of $140 million went to UpStream, for total funding of $185 million. UpStream is in the decidedly unsexy area of care coordination, workflow, and financial platform technology for groups of advanced primary care practices enrolled in value-based full-risk care models, most of which are centered around Medicare and Medicare Advantage. They also deploy pharmacist-led care teams into primary care practices. Their platform and services are free to the practice, with a risk-sharing agreement that pays UpStream through savings (upside risk) but also holds them accountable if savings are below the benchmark (downside risk). Practices are paid on quality during the performance year versus having to wait for CMS to pay in Q3-4 of the following year. This is an MSO (management services organization) ‘in a box’ versus organizing ACOs that is mainly technology-based, a new wrinkle for this Editor who used to be in marketing this area. MedCityNews, Mobihealthnews
  • Aide Health is a clinician-to-patient platform for better management of chronic conditions now bolstered with £1 million in pre-seed funding. Founded by Ian Wharton, CEO, and Brian Snyder, COO, the platform measures physical, mental, and social wellbeing markers for more proactive care. Aide is piloting with the NHS for asthma or Type 2 diabetes with a cohort aged 18 to 75.  Funding was led by Hambro Perks through its EIS fund, with participation from Fuel Ventures, 1818 Ventures, and APX. BusinessCloud (UK)