Legal roundup: Teladoc class-action suit dismissed; NextGen EHR $31M Federal settlement; significant AliveCor-Apple antitrust ‘spoiliation’ update; class action suits filed against HCA, Johns Hopkins

July 19, 2023 | by

The latest legal activity in digital health and cybersecurity:

Teladoc’s pending class action lawsuit by shareholders was tossed. This was originally filed in June 2022 after the crash of Teladoc’s shares after The Big Livongo Writeoff in May 2022. Shareholder Jeremy Schneider, represented at the time by Jeremy Alan Lieberman of Pomerantz LLP, filed a lawsuit in the US Federal Court for the Southern District, located in downtown Manhattan, representing shareholders who purchased Teladoc shares between 28 October 2021 and 27 April 2022. The lawsuit cited materially false statements that Teladoc made on its business, operations, competition, and prospects that were overly positive and inflated share value. Judge Denise Cote agreed with Teladoc’s 20 January motion to dismiss based on specific disclosures that Teladoc made in multiple SEC filings in that period from the 2020 10-K on that countered claims made in the class action lawsuit.

Reading Judge Cote’s decision, Teladoc used specific limiting and warning language (what marketers call ‘downside’ language) on the risks around the merger. Their executives in public statements indicated that operations and competition were challenging.  The class action suit failed to prove conclusively that the statements it identified were ‘materially misleading’ and would mislead a reasonable investor. Other statements made by executives were “largely non-actionable statements of opinion and/or expressions of corporate optimism”, a/k/a “puffery”. Class action suits of this type that go to Federal courts (versus state courts) rarely succeed due to the high bar of proof and volumes of case law at the Federal level.

This Editor noted that this particular class action did not include Mr. Schneider nor Pomerantz LLP. Different plaintiffs were represented by Labaton Sucharow LLP and The Schall Law Firm. Teladoc reportedly had no comment.  Judge Cote’s opinion (Casetext), Mobihealthnews, Healthcare Dive

Easier to settle for $31 million than fight the Feds. Charged with violating the False Claims Act (FCA) and providing illegal incentives for referrals (the Anti-Kickback Statute that applies to Federally funded healthcare), NextGen Healthcare decided to settle with the Department of Justice (DOJ) for a whopping $31 million. The settlement does not admit wrongdoing by NextGen, which in its defense told Healthcare Dive that the claims made were over a decade old–and they were. At the time, their EHR used an auxiliary software that was designed only to perform the certification test scripts, thereby gaining 2014 Edition certification criteria published by HHS’s Office of the National Coordinator (ONC). In this Ur-time of EHRs, fixes like this weren’t (ahem) unusual. Compounding it was that the EHR then lacked certain additional required functionalities, including the ability to record vital sign data, translate data into required medical vocabularies, and create complete clinical summaries. Making NextGen’s decision the proverbial ‘no-brainer’ was that the controversial US Supreme Court ruling in June ruled that under the FCA, defendants are now liable for claims they suspect or knowingly believe are false, versus the previous objective standard. The Anti-Kickback Statute violation was blatant.  NextGen was giving credits often worth as much as $10,000 to current healthcare customers whose recommendation of NextGen’s EHR software led to a new sale, along with incentives such as tickets to sports and entertainment events. Anti-Kickback is one of those ‘biggies’ that the average healthcare employee is trained on within their first 60 days. DOJ release

The AliveCor-Apple Federal antitrust case had a small but important split decision regarding ‘spoiliation’ in the discovery process that could impact the case’s outcome–and future litigation. This June US District Court for the Northern District of California order went against AliveCor in part of what it sought–that Apple’s deleted emails to and from Apple’s then Director of Health Strategy should be considered adverse by a jury. But Apple was then found at fault for deleting them despite their relevance to the case with a ‘duty to preserve’ that started on 25 May 2021 with the antitrust litigation. In general, emails such as these to and from relevant people are subject to a litigation hold.

  • The director departed Apple only one week prior, 14 May 2021. His emails were auto-deleted at some point in accordance with company policy. In the discovery process, through other documents, AliveCor determined over a year later that the director was, indeed, relevant to the case.
  • The order states that Apple should have preserved his emails from the start as he was an individual with potentially relevant information. From the order, “[the director] worked on strategic health initiatives, and the record shows that he regularly corresponded about the Apple Watch and AliveCor with individuals Apple did identify as relevant.” “Apple did not take reasonable steps to preserve electronically stored information that should have been preserved in the anticipation or conduct of litigation…” While it may have been “irresponsible and careless”, it wasn’t purposeful which then would have been considered for sanctions, but there is considerable strong language in the order that Apple’s counsel didn’t disclose the loss of this information even while under oath in a deposition. 
  • In the ‘adverse’ consideration, AliveCor did not gain what it wanted, which was an assumption that the lost emails were prejudicial–that they contained relevant material to AliveCor and Apple’s strategy of eliminating competition. “To the extent they existed, additional emails relevant to these topics may have been useful to enhance AliveCor’s case, but AliveCor has not shown that the absence of these emails will prevent it from proving its antitrust claims.”

AliveCor provided this Editor with a statement on the order:

“The Northern District of California judge’s description of Apple’s actions as ‘irresponsible and careless, and perhaps even grossly negligent’ in their handling of emails belonging to its former Director of Health Strategy that supported our pending antitrust case speaks to Apple’s usual playbook of shamelessly using legal tactics to steamroll innovative companies like AliveCor. Even though the judge stopped short of granting our motion to instruct the jury that they should assume the deleted emails were negative for Apple’s case, we are confident in the outcomes of our antitrust case and grateful for the outpouring of support we have received as we continue to hold Apple accountable.”

Editor’s note: she thanks an AliveCor representative for sharing this information along with the redacted court order. Apple is free to contact this Editor with its own statement.

Recent AliveCor versus Apple coverage on patents: ITC presidential review, ITC vs. PTAB, PTAB decision

Last but certainly not least, a class action lawsuit against HCA. To no one’s surprise, it was filed last week (12 July) in the US District Court for the Middle District of Tennessee, as HCA is headquartered in Nashville. The plaintiffs are named Gary Silvers and Richard Marous, two HCA patients living in Florida, and was filed by two law firms, Shamis & Gentile and Kopelowitz Ostrow Ferguson Wieselberg Gilbert. The suit claims that HCA failed in their duty of confidentiality to protect sensitive information– personally identifiable information (PII) and protected health information (PHI)–that was contained in the hacked records. While HCA has released that the records did not include the most sensitive clinical information as it was used for email communications, the volume of 27 million rows of data that was apparently unencrypted potentially affects 11 million individuals [TTA 12 July]. The suit charges HCA with failure to safeguard ‘Private Information’ as a reasonable expectation using reasonable security procedures in light of current regulations (HIPAA, FTC), plus the susceptibility of healthcare organizations to cyberattacks which is well known. It seeks monetary damages plus injunctive and declaratory relief. This lawsuit is likely the first of many. Healthcare Dive, Healthcare IT News, HIPAA Journal

These lawsuits based on hacking and cybersecurity responsibility are becoming routine. On 7 and 10 July, Johns Hopkins was sued twice. This was for a May ransomware data breach on a software vulnerability called MOVEit that was exploited by a Russian ransomware group called CLOP. This may have compromised, according to the first suit, tens to hundreds of thousands of records, including sensitive PHI. Both suits allege negligence, breach of fiduciary duty, breach of confidence, invasion of privacy, breach of implied contract, and unjust enrichment. They seek monetary damages and injunctive relief. Both were filed in US District Court for the District of Maryland.  Becker’s, Healthcare Dive, HIPAA Journal

Breaking: AliveCor wins presidential review on ITC Final Determination on Apple patent infringement

February 22, 2023 | by

Enforcement held for PTAB appeal decision. As anticipated after the International Trade Commission (ITC) decision, finding that Apple Watches infringed three AliveCor patents on ECG readings [TTA 3 Jan], the Final Determination issued 22 December 2022 has passed the 60-day mandatory presidential review and is now in effect.

The penalty in the bond assessed against Apple–$2 per watch–applies to Apple Watches with the ECG feature imported or sold during the presidential review period. It is the first Limited Exclusion Order (LEO) with a cease and desist order against Apple. However, the penalty cannot be enforced until AliveCor’s appeal of the US Patent and Trademark Office’s Patent Trial and Appeal Board’s (PTAB) ruling is decided. PTAB’s ruling in early December 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 as unpatentable: 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.

The PTAB appeal is in progress. AliveCor also has a separate action against Apple through its Federal antitrust case in the Northern District of California. That will not go to trial until early 2024. AliveCor has about 170 patents, but the loss of any patents is important to a company’s IP and ultimately, funding. It’s also a clear signal to innovative companies that a David can win against a Goliath. AliveCor release

Split decision! ITC rules that Apple violated AliveCor patents; enforcement held for PTAB appeal

January 3, 2023 | by

David v. Goliath slugfest continues. The International Trade Commission (ITC) confirmed its Initial Determination [TTA 28 June] that Apple Watches infringed AliveCor patents on ECG readings. This Final Determination counters the US Patent and Trademark Office’s Patent Trial and Appeal Board’s (PTAB) December ruling that found not only in favor of Apple’s patents but also invalidating AliveCor’s three patents in question [TTA 8 Dec].  

The ITC’s findings come under a 60-day presidential review from 22 December. The penalty on Apple comes under a Limited Exclusion Order (LEO), a cease and desist order. It sets a bond in the amount of $2 per unit of infringing Apple Watches imported or sold during this review period. However, enforcement of the ruling will be delayed until the review of AliveCor’s appeal of the PTAB ruling wends its way through that process in the Northern District of California, which is expected to take place in early 2024, a year from now.

A running dispute since 2020. Once upon a time, AliveCor and Apple worked together to give ECG functionality to the Apple Watch. This ended after the Apple Watch 4 incorporated ECG readings. This resulted in court actions related to patents starting in early 2021 [TTA 29 Apr 21, 9 July 21]. Apple is now up to the Watch 8, incorporating more and more cardiac and health monitoring features. AliveCor has also moved on with financing with a GE Healthcare-backed Series F this past August, the KardiaMobile 6L, and the KardiaMobile Card. As of today, it has over 170 patents.

As this Editor remarked in December, going after a rival’s patents is an often necessary but risky business that can backfire. Right now, David has moved Goliath to a draw now, with further matchups this year into next. AliveCor release, Mobihealthnews      Hat tip to Dr. Dave Albert, founder and Reader.

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. 

Rounding up the week with good news: AliveCor’s Series F round, Scotland’s Smplicare gains £750K for fall research

August 19, 2022 | by

AliveCor has moved to a Series F round led by GE Healthcare. In this funding-parched environment, this is impressive though the funding amount is (sigh) not disclosed. The round was joined by NGK-NTK (through a CVC partnership with Pegasus Tech Ventures) and existing investors including Khosla Ventures, Bold Capital Partners, Qualcomm Ventures, and WP Global Partners. The fresh funding will be used to advance new innovations, their AI roadmapping, and existing ones such as introducing subscription services, KardiaCare and KardiaComplete for patients, payers and employers, and KardiaPro for physicians. KardiaCare has 165,000 members, claiming 2 million users and 160 million ECGs to date. GEHC and AliveCor currently partner on integrating KardiaMobile 6L’s ECG data directly into GE Healthcare’s MUSE Cardiac Management System.  Release. Hat tip to Dr. Dave Albert, founder and Reader.

The UK funding environment is also perking a bit in the public/private area. Edinburgh-based startup Smplicare now has £750,000  to explore how commercially available wearable technologies can predict the risk of falls and other age-related health issues. Funding came from private investors and UK Research & Innovation (UKRI)’s Healthy Ageing Challenge, with the goal of adding five years of healthy, independent living for everyone by 2035. Overall, the challenge has seven themes and an extensive list of partnerships worth referencing if your technology, platform, or social enterprise is in this area of keeping older people active, productive, and in their communities. Smplicare’s tech uses a questionnaire to easily determine levels of clinical fraility, then a dashboard to project trends. Their project is to monitor 300 individuals 55+ and with a history of falls agreeing to wear a mainstream wearable for six months. What this will enable Smplicare to do is to have enough data to create an AI-powered algorithm that will predict the likelihood of a fall, possibly saving the NHS more than £4.4 billion annually. The research is led by Smplicare’s chief innovation officer, Dr. Adrian Smales, an award-winning PhD in health informatics. Support comes from the analytics team at Data Lab, Scotland’s innovation center for data and AI, and on the clinical side, Dr. Atul Anand, an NHS and University of Edinburgh geriatrician with experience in big data clinical studies. Insider.co.UK, The Scotsman

US International Trade Commission initial determination: Apple infringed AliveCor’s patents (updated)

June 28, 2022 | by

If affirmed, a David versus Goliath win. AliveCor, the developer of the KardiaMobile ECG devices, announced late today that Administrative Law Judge (ALJ) Cameron Elliot of the US International Trade Commission (ITC) issued an Initial Determination that Apple infringed certain AliveCor technology patents. If affirmed by the full ITC in a Final Determination by 26 October (!), it could lead to an exclusion order barring the importation of certain Apple devices infringing on AliveCor patents from the US.

The initial complaint was filed in May 2021 [TTA 29 April] concerning Apple’s infringement in the Apple Watch 4, 5, and 6 of three AliveCor ECG technology US patents: No. 10,595,731 (“the ’731 patent”); No. 10,638,941 (“the ’941 patent”); and No. 9,572,499 (“the ’499 patent”). Last February, AliveCor successfully moved with the ITC to have the investigation terminated on certain claims on the three patents, but a considerable number remained. This is what ITC terms an “unfair import” or Section 337 investigation. These regard intellectual property rights, including “allegations of patent infringement and trademark infringement by imported goods.”

Updated for links: AliveCor press release, ITC Public Notice which details what parts of what patents have been infringed. Both the 731 and the 941 patents have been found to be infringed under Section 337. The 499 patent has not been violated. This Editor will assume we have to wait till October for any exclusion orders.

ATA conference roundup: a new board chair, a digital app review pilot, and company announcements

May 5, 2022 | by

The American Telemedicine Association (ATA) 2022 conference and expo is a wrap, after starting on Sunday through to Tuesday. While your Editor could not attend due to other commitments that precluded a trip to Boston, one industry insider who visited the expo–his first in-person event in two years–reported that after a slow start on Sunday, the floor busied up on Monday. Business was being done, finally and not virtually. What were the busy booths and what was ‘hot’? Companies in the areas of telemental health and remote patient monitoring (RPM). (Did you attend? What was your impression? Leave comments below.)

ATA had two major announcements of its own during the conference:

  • Kristi Henderson, DNP, NP-C, FAAN, FAEN, has been named as Chair of the ATA Board for a two-year term. Henderson is the CEO of Optum Everycare, where she leads a team building digital and virtual health solutions to improve quality outcomes and experiences for patients and providers. She has served on the board since December 2020. As Chair, she is succeeding Joseph Kvedar, MD and Professor at Harvard Medical School among other positions. Dr. Kvedar will become Immediate Past Chair and Senior Advisor to the ATA. Announcement
  • ATA, the American College of Physicians (ACP), and ORCHA, the Organization for the Review of Care and Health Applications,  announced a framework for the assessment of professional and consumer digital health technologies, including mobile apps and web-based tools. ACP and ORCHA, which has experience assessing compiling libraries of apps, will be piloting a test of the framework against a database of digital health tools. The goal of the pilot is to “determine how the library can be useful to physicians in recommending high-value digital health tools to their patients, and what other barriers to wider adoption of digital health tools may exist.” Announcement

Quite a few company announcements were made during ATA–a selection:

  • Johns Hopkins Bloomberg School of Public Health highlighted the publication of a major scientific study (full text) documenting telehealth outcomes in JAMA Network Open. This Johns Hopkins-based research was partially supported by the ATA. The study followed a national cohort of 40.7 million commercially insured persons from July to December 2021 and included 21 chronic and non-chronic conditions. Fourteen-day follow-ups for persons with an initial telehealth visit were compared to persons receiving in-person care. On average, patients participating in an initial telehealth consult for a new health condition did not require more unplanned hospitalizations or follow-up ED visits within 14 days of their initial consult compared with patients making an initial in-person visit. The exception was respiratory conditions. Release
  • BioIntelliSense, which last year scored $45 million in funding for its on-body sensors, announced two major collaborations for remote patient monitoring (RPM) with UC Davis Health and Houston Methodist.
  • CDW Healthcare and Caregility announced a strategic partnership to expand their virtual care capabilities, including Caregility’s new Inpatient Virtual Engagement solution (IVE), also launched during ATA. 
  • Connect America, which snapped up Lifeline last year, launched Connect America Home, a single health and safety platform connecting (PERS) and remote patient monitoring (RPM) with supporting services, including AI-enabled virtual health assistance and Social Determinants of Health (SDoH) support, along with analytics. Release.
  • AliveCor announced the launch of KardiaComplete, a comprehensive heart health enterprise solution designed to drive improved health outcomes and reduce the cost of cardiac care. The service will be available through self-insured employers, health insurance plans, and health systems to those diagnosed with hypertension and arrhythmias, like atrial fibrillation.
  • Withings launched Withings RPM, the company’s most advanced remote patient monitoring solution designed to enhance the patient experience. It is a single platform that enables clinicians to order and send Withings RPM devices, manage data from multiple patients with automated alerts and reminders, communicate via SMS, phone, and in-app video calls, billing, sleep tracking, and more. 

TTA was a media partner of ATA 2022.

Thursday news roundup: Walmart hiring 50K workers including health, Anthem name-changing, GE Healthcare-AliveCor partner, IPO for Komodo Health amid slowdown?

March 17, 2022 | by

In the midst of war, inflation, and the contradiction of a tight labor market, it’s somehow reassuring that Walmart needs to hire 50,000 new workers–and fast, by end of April. According to reports, some of those new hires will be bolstering the health and wellness areas. In the past, Walmart has hired heavily in their in-store pharmacies. Many of these jobs are lower-end–delivery drivers for direct-to-fridge InHome groceries, in-store workers, and supply chain staff. One higher-level worker area that points to health is global tech, creating offices in Toronto and Atlanta, with Walmart planning jobs for 5,000 engineers, data scientists, analysts, and tech experts. Additional hires will go to increasing its advertising business which is based in the New York metro area. Especially for those high-skill positions, six weeks is not quite plausible in this market. But you have to admire them for trying. CNBC, Becker’s

Anthem changing its name–again. Health insurer giant Anthem, Inc. has announced a renaming to Elevance Health. According to the release, the name is a combination of elevate and advance, presumably for health but as they say in their release, vaulting beyond healthcare into the rarefied air of ‘whole health’. It also reflects vaulting beyond the health plan business, as they fully savor the rarified air of healthcare diversification like fellow giants UnitedHealth Group, Centene, and CVS Aetna.

The parent company of Anthem Blue Cross Blue Shield plans, Anthem owns non-Blues Amerigroup, Integra Managed Care in NY,  pharmacy benefits manager IngenioRx, plus a $25 million investment in digital health hub Sharecare. Plan and product names, along with organizations will not change at this time–these are major changes that usually require state department of insurance approvals.

To this Editor’s Gimlet Eye, the coined name Elevance feels pharmaceutical and not in a good way–it’s very close to an old anti-depressant, Elavil. A return to WellPoint, a name the company had up to 2014, would have accomplished the same ends. But there’s always the shock of the new, the opportunity to change the tired signage, and behind this, someone making a point for themselves. Undoubtedly the shareholders will agree at the 18 May annual meeting, since they always do, and it will start to be used–presumably with a logo and new graphics they don’t have now–at end of Q2. Another gimlety view–it takes a certain myopia to announce a name change given what’s happening in the world. Healthcare Dive

In time for HIMSS, GE Healthcare and AliveCor, developer of the KardiaMobile ECG, announced their partnership to transmit KardiaMobile 6L data directly into GE Healthcare’s MUSE Cardiac Management System for clinical evaluation. MUSE is used by 87 percent of the top cardiac hospitals in the US. The direct integration of KardiaMobile 6L data that is taken anywhere into the MUSE workflow and then into an EMR, targeting atrial fibrillation but also other cardiac monitoring, is a big validation and win for AliveCor. Release

Analytics software company Komodo Health is preparing an IPO as early as this summer. Goldman Sachs and SVB Securities are rumored to be the lead bookrunners. Timing will depend on markets and financing. Komodo completed last March a $220 million Series E for funding to date of $314 million [TTA 25 Mar 2021]. With a valuation now topping $3 billion, Komodo may be the ‘IT’ company of healthcare IPOs in a market much tamer than last year’s Wild West Rodeo. What they do isn’t easy to explain, but they feed their 325 million patient encounter database drawn from EHR, pharma, lab, and government data into proprietary software to map patient journeys, providing analytics on more than 325 de-identified, real-world patient insights. These are used to drive better health outcomes across therapeutic areas. The primary markets for their data are life sciences and pharma for R&D, clinical trials, and medical affairs, but are seeking to expand to providers and payers.

Other IPOs rumored to be on tap are Included Health (the former Grand Rounds/Doctor on Demand) [TTA 20 Oct 2021] and Tempus Labs in precision medicine.

AliveCor releases KardiaMobile ECG in the convenient credit card size

February 2, 2022 | by

AliveCor, the parent company of KardiaMobile mobile ECG devices, is releasing for sale the KardiaMobile Card, a credit card-sized single-lead ECG. It was FDA cleared in November. It’s mighty for its size, detecting six of the most common arrhythmias: atrial fibrillation, bradycardia, tachycardia, PVCs, sinus rhythm with SVE, and sinus rhythm with wide QRS. The pricing is $149 and includes the $99 annual KardiaCare subscription, which renews after the first year. 

In a price and product comparison, the standard KardiaMobile single lead, which is a strip with two press sensors, remains on sale for $169 and the 6L, which has a slightly bulkier sensor but is clinically equivalent to a six-lead ECG, is $239. KardiaCare includes advanced determinations, cardiologist reviews, heart health reports, and more. Owners of older smartphones should review compatibility before buying, however. Release, Mobihealthnews

As of 1 February, there is no update on AliveCor’s legal actions against Apple on patent infringement in the Apple Watch: April’s patent infringement complaint filed with the US International Trade Commission (ITC) [TTA 29 Apr 21] and their late May Federal antitrust suit in the Northern District of California [TTA 9 July 21].

News roundup: AliveCor’s latest FDA clearance plus antitrust vs. Apple, VRI on the market, Walgreens’ ‘tech-enabled future’ indefinite plus VillageMD status, monthly telehealth usage drops 12.5%

July 9, 2021 | by

AliveCor disclosed its latest FDA 510(k) clearance for the KardiaMobile 6L, for calculation of patients’ QTc interval by the patient remotely or in the office with a physician or other clinician. QTc interval is, for those of us who aren’t cardiologists, is the total time from ventricular depolarization to complete repolarization. If too long (prolongation) or too short (congenital short) for the heart rate, it can indicate a dangerous ventricular arrhythmia or atrial or ventricular fibrillation. The manual measurement takes 30 seconds. AliveCor also has clearance on software (InstantQT) that measures QT intervals quickly and accurately to detect potentially dangerous QT prolongations in patients. Prolongations can be triggered by medications including anti-arrythmia drugs, anti-fungals, antibiotics, and some psychiatric drugs. AliveCor release. In other recent news, in June they acquired CardioLabs, a monitoring and cardiac diagnostic service provider based in Tennessee, to expand their clinical servies. Release.  

And in David Sues Goliath–Again–News, AliveCor also filed, in that quiet week right before Memorial Day, a Federal antitrust suit in the Northern District of California. This lawsuit is over Apple’s exclusion of other heartrate analysis providers from the Apple Watch, harming AliveCor and consumers, and seeks damages plus an injunction to cease the exclusion. Release  This is in addition to their US International Trade Commission (ITC) complaint on infringement of AliveCor patents held for heart monitoring on the Apple Watch 4, 5, and 6. That seeks to bar importation of Apple Watches [TTA 29 Apr]. No update on that so far. 

‘Insider’ report: VRI on the market. PERS Insider, our newly discovered source for news about the emergency response device market, reported on 22 June that VRI, a PERS and remote patient monitoring provider, is up for sale. It has been majority-owned by Pamlico Capital, a private equity company, since 2014. VRI does not sell direct to consumer but concentrates on health insurance, government programs, and other B2B through its dealer network. No reasons for sale given, but with all things telehealth and most things remote healthtech fetching hefty sums post-pandemic, perhaps Pamlico senses a fortuitous time to test the waters for an exit. Article. (Subscribe here to their weekly free letter)

Walgreens Boots Alliance’s new CEO promises a ‘tech-enabled’ future for the chain, sans details. The incoming CEO, Rosalind Brewer, fresh from her COO position at Starbucks, on WBA’s Q3 earnings call mentioned a buildout of a “previously communicated tech-enabled healthcare initiative” but no further information, as still reviewing the company. Stefano Pessina has retired from the long-held CEO position, but retains the executive chair title in addition to being WBA’s largest individual shareholder. Forbes’ breathless report. More to the profit point, the latest on Walgreens and VillageMD’s full-service Village Medical practices at Walgreens locations: 29 new locations in Houston, Austin and El Paso, Texas this year, staying on track for 600 primary care practices in more than 30 markets over next four years. Business Wire

National telehealth usage dips to 4.9% of US claims in April, a 12.5% drop from March. Analyzing regional and national insurance claims data, non-profit health analytics company FAIR Health in its monthly report tracks telehealth receding as patients return to in-person care. Telehealth is now dominated by mental health procedure codes, accounting for 58.65% of diagnoses, with all other conditions at 3% or lower. Regionally, the Northeast is even higher at 64.2% and the Midwest above 69%. Monthly National report, Monthly Regional Tracker page

David sues Goliath: AliveCor claims patent infringement by Apple–ITC filing requests bar on Apple Watch US importation

April 29, 2021 | by | 1 Comment

Slingshot battle! AliveCor, developer of the Kardia Mobile electrocardiogram (ECG) and connected heart rhythm devices, filed a complaint with the US International Trade Commission (ITC) alleging Apple’s infringement of three AliveCor ECG technology patents for the Apple Watch 4, 5, and 6. The filing seeks to bar the importation of Apple Watches into the US and their sale.

According to AliveCor’s carefully worded release, their filing in the ITC “is one step, among others, AliveCor is taking to obtain relief for Apple’s intentional copying of AliveCor’s patented technology—including the ability to take an ECG reading on the Apple Watch, and to perform heartrate analysis—as well as Apple’s efforts to eliminate AliveCor as competition in the heartrate analysis market for the Apple Watch.”

This follows on the first shoe–AliveCor’s December lawsuit, filed in the US District Court for the Western District of Texas, alleging that the Apple Watch 4, 5, and 6 infringed on the same patents. The timing was interesting, as FDA cleared the latest update of the Apple Watch’s ECG monitoring at about the same time [TTA 10 Dec 2020]. In November, AliveCor cleared a Series E of $65 million.

The irony is that in 2017, the KardiaBand was the first FDA-cleared medical device accessory for Apple Watch. It was an ECG-reader that clipped onto the watch. AliveCor pulled it from the market after Apple introduced its own ECG feature in the Apple Watch 4.

AliveCor has their entire business riding on this. The mass-market Kardia Mobile, their six-lead medical-grade KardiaMobile 6L, and their KardiaCare platform with monitoring and evaluations are their business, unlike Apple for which ECG is only a feature.  Mobihealthnews, FierceHealthcare, MDDIOnline

Deal and news roundup, 17-18 Feb: Sharecare goes SPAC for hefty $3.9 bn valuation; Humana Care Support pilots; AliveCor, AstraZeneca partner on renal, cardiac; Current Health RPM in clinical trials

February 18, 2021 | by

Sharecare, a free/paid app platform that enables users to consolidate all their health and wellness data in one location and use proprietary health management tools, is going the SPAC route with Falcon Capital Acquisition Corp. It will trade on NASDAQ under SHCR. Initial enterprise value is expected to be $3.9 bn with approximately $400 million in growth capital. Closing is expected to be in Q2 of this year.

Founded in 2010 by celebrity doctor Mehmet Oz, MD (now on the board and not in active management) and WebMD founder Jeff Arnold, the current CEO, Sharecare will also have an undisclosed investment by strategic partners Anthem and Digital Alpha. Anthem is looking at the AI value plus consumer engagement and personalized care. Helping to fund both the public equity and cash position is a fully committed private investment in public equity (PIPE) of $425 million at $10.00 per share which is below market value. Falcon Capital will retain about 20 percent of the company. Mr. Arnold will join the board and be retained as CEO. After the closing, Sharecare and Falcon will donate about $4 million in stock to Sharecare’s charitable foundation.

Sharecare sells the platform to enterprises such as providers, employers, health plans, government organizations, and communities, as well as individuals on their free apps. Release, FierceHealthcare, Becker’s

Rival health plan Humana is also adding to its care management tools with a pilot of the Humana Care Support program. The platform creates an integrated, personalized experience for members, including a multi-disciplinary care team and SDOH integration. The pilot targets select groups of Medicare Advantage members in Kentucky, Pennsylvania, and West Virginia with multiple chronic conditions, complex congestive heart failure, and diabetes, with multi-disciplinary care teams. Humana Care Pilot is built on Salesforce’s Health Cloud platform for viewing the patient’s medical history and integrating clinician workflows. Its analytics are powered by Microsoft’s Azure and Power BI. The goal is lowering costs and improving outcomes for this high-cost group of patients. If successful, the program will roll out to other markets this year. Humana release, FierceHealthcare

AliveCor, the developer of the KardiaMobile mobile ECG/EKG, and AstraZeneca are partnering on research for new disease management solutions in cardiovascular, renal, and metabolism (CVRM) therapeutic areas. This will use AliveCor’s monitoring system for blood potassium. The Kardia-K AI platform uses ECG/EKG neural network analysis to measure a patient’s potassium levels without a patient blood draw. Hyperkalemia (elevated blood potassium) is linked to renal issues and kidney disease as well as cardiac issues. Kardia-K received Breakthrough Device Designation status from the FDA to screen for elevated levels of blood potassium in September 2018, and was validated in a study with Mayo Clinic published in 2019. Release, Mobihealthnews

Current Health, a monitoring and care management RPM system for enterprise-level health organizations, announced its “Community” initiative to build diverse longitudinal datasets for decentralized clinical trials. Their platform is FDA-cleared and used at scale in phase III and phase IV drug trials by major pharmaceutical organizations for remote endpoint collection and for virtual trial delivery. Monitoring is performed through wearables and sent to the electronic data capture (EDC) vendor for the clinical research organization (CRO). Current Health is using Community for its own COVID-19 study to predict hospitalizations and inform clinical treatment. The study is recruiting US participants diagnosed with the virus in the last 48 hours. Current has locations in Edinburgh, London, Boston, and San Francisco according to their website. Mobihealthnews

News roundup: Cera hits £89.5M revenues, Alcove Carephone in new elder housing, Everlywell home test kits raise $179M; FDA clears Lucira’s all-in-one COVID test kit, Apple Watch new ECG feature

December 10, 2020 | by

Farringdon, London-based Cera announced a high point in its revenues of £89.5 million ($120 million) since their 2016 launch. While it is primarily a home care company d/b/a-ing under Cera Care (and seeks to hire an additional 5,000 staff, mostly professional carers), we noted back in March their £52 million ($70 million) raise and the launch of SmartCare, a sensor-based analytics platform that uses machine learning and data analytics in real-time on behaviors to personalize care and detect health risks with a reported 93 percent accuracy. Cera also has a proprietary app to connect families with Cera on visits and progress. Unfortunately the Cera website is singularly uninformative on company news and SmartCare. Mobihealthnews

Alcove is partnering with Cornell Court in Saffron Waldon, Essex, an extra-care community developed and run by L&Q Living, to fit out apartments with their in-residence Carephone tablet. Having the access to the tablet, residents can easily initiate a group video call with family members, as well as attend virtual care and therapy sessions and activities including bingo and exercise classes. There is also access to a ‘virtual concierge’. The combination of onsite services and the Carephone access helps with resident independence. All helpful as the UK remains on a non-virtual lockdown in most places and Christmas looks distinctly un-festive this year, especially for older adults. Local Authority Building & Maintenance (LABM) Online.

COVID-19 has certainly been a boom of a boon for at-home testing companies.

  • Everlywell just raised a hefty Series D of $179 million. They market and process over 30 FDA-cleared kits, including (of course) symptomatic COVID-19 (SARS-CoV-2, lower nasal swab) with a follow up from the lab in 24-48 hours via their app coupled with a telehealth consult. Other kits include thyroid, indoor/outdoor and food allergies, and hepatitis C, at prices ranging from $49 to a comprehensive food sensitivity test at $259. Prediction: Everlywell and similar companies will be 2021’s 23andMe/Ancestry.com.  Fierce Biotech
  • An equally intriguing ‘home run’? FDA cleared the first ‘all-in-one’ home test for COVID-19 under an EUA (Emergency Use Authorization). The Lucira Health molecular test from a nasal swab sample is completed by a battery-powered handheld unit that includes all the reagents needed to process the test. The unit then shows the result with a green light for positive or negative. Average time: 2 minutes. Molecular tests are more sensitive and accurate than the current quick tests of antigens. Go-to-market of the single-use test kit is expected early spring 2021, at a cost of $50. The by-prescription test can also be performed in point of care settings. The company will be filing early next year to have as an option prescription via telehealth. Sutter Health in Northern California and Cleveland Clinic Florida in Miami-Ft. Lauderdale participated in the trials and will be first on distribution. Fierce Biotech, Lucira press release, FDA release

Remember when any burp from Apple was Major News, breathlessly awaited? Now ho-hum. FDA cleared the latest update of the Apple Watch’s ECG monitoring. Now the feature enables heart rate detection up to 150 beats per minute and adds a classification category called A-Fib with high heart rate. The Apple Watch has been used in some studies to monitor for atrial fibrillation. No release date is set for the watch. However, AliveCor is suing Apple on patent infringement of three patents, from the Apple Watch Series 4 and later devices, so stand by. Mobilhealthnews

AliveCor, OMRON announce cardiac monitoring strategic alliance, equity investment

April 30, 2020 | by

You know it’s a step towards a more normal state of affairs when this Editor can cheerfully announce something which has really nothing to do with a virus, pandemic, or something ending in 19, although there’s the expected COVID spin. Almost getting lost in All That was the announcement last week of a global strategic alliance between AliveCor, the developer of KardiaMobile, and OMRON Healthcare, the Kyoto-based cardiac health and wellness company. Cardiac monitoring was around well before this virus and with a focus on mobile monitoring, is a major up-vote for an innovative company like AliveCor.  What’s in the release is the announcement of a global alliance, technology integration, and at the very end of the release, closing of an undisclosed equity investment by OMRON Corporation (OMRON Healthcare’s parent). This is actually the second equity investment which OMRON has made in AliveCor, with the first being in March 2017 with the Mayo Clinic. Hat tip to co-founder and ever-dapper Dave Albert, MD via Twitter

After the COVID Deluge: a Topol-esque view of what (tele)medicine will look like

April 10, 2020 | by

A typically cheery view by Eric Topol, MD of what medical practice will look like after COVID is over. With the full court press to go remote in hospitals and practices worldwide, telehealth and telemedicine has gone fast forward in a matter of under two months. But what will it look like after it’s over? Most of what the good doctor is prognosticating will be familiar to our Readers who’ve followed him for years–certainly he was right on mobile health overall and especially AliveCor/Kardia Mobile— but not so on point with mobile body scanners (anyone remember VScan?)

When the high tide recedes, what will the beach look like?

  • “Telemedicine will play the role of the first consultation, akin to the house-call of yore.” (Terminology note–interesting that Dr. T still uses ‘telemedicine’ versus ‘telehealth’–Ed.)
  • Chatbots will serve as screeners–once they are proven to be effective (a ways to go here, as the Babylon debate rages on)
  • Smartphones will be the hub, connecting with all sorts of monitoring devices (the ‘connected health’ Tyto Care and Vivify Health model–which makes the Editor’s former company, the late Viterion Digital Health, even more of a pioneer that died crossing the Donner Pass of 2016)
  • Smartwatches are also part of this hub (this Editor remains a skeptic) 
  • Now is the time to harness technology by both health systems and individual practices, but multiple barriers remain. (This Editor can speak to the difficulties for both primary care and specialty practices in not only practice but also reimbursement–and acceptance by patients.) Device expense is also a problem for the non-affluent.

As to the rest, it is pretty much what we’ve heard from Dr. T before.  The Economist

Your Editor will add:

  • Easy to use, secure platforms that don’t put users through multiple security steps remain a concern for users. This Editor’s concern is that easy to use = insecure. Skype and Zoom are inherently insecure–Skype’s user unfriendliness and insecurity outside enterprise platforms and Zoom’s major security problems on its platform and user flaws are well-known (ZDNet).
  • Reimbursement, again! CMS has done a creditable job in broadening reimbursement for telehealth a/v and telephonic services, but coding remains a nightmare for practices struggling to remain open and with some lights on. After COVID, will CMS and HHS get religion, or put it right back in its rural bottle? Covered in the CARES Act passed at the close of March, $200 million sounds like a lot from the FCC to bankroll telecom equipment for providers, but these funds will go quickly. At least they are not delayed in endless rule making, as the Connected Care Pilot Program has been for two years. Mobihealthnews 

News roundup: Proteus may be no-teous, DOJ leads on Google-Fitbit, HHS’ mud fight, Leeds leading in health tech, malware miseries, comings and goings

December 12, 2019 | by

Proteus stumbles hard, cuts back. The original ‘tattle-tale pill’ company, Proteus Digital Health, plans to lay off 292 people in the San Francisco Bay Area and to permanently close its three Redwood City and Hayward locations, starting 18 January, according to notices sent to California state and local offices, including the state employment development department. It is unclear where Proteus will be located after the closures.

This followed after Proteus failed to launch a twelfth funding round of $100 million. According to reports, they furloughed most of their employees for two weeks in November and are reorganizing. This is after a substantial number of investors have put in about $487M in funding through a Series H (Crunchbase), including a game-changing investment by Novartis dating back to 2010.  Proteus achieved unicorn status about three years ago, but its high-priced pill tracking technology with a pill sensor tracked by a skin-worn monitor reporting into a smartphone has a built-in limited market to expensive medication. Otsuka Pharmaceutical in 2017 partnered with Proteus for an FDA-cleared digital medicine system called Abilify MyCite that basically put an off-patent behavioral drug back into a more expensive tracking methodology. But Proteus remains a great idea on tracking compliance in search of a real market, and may not have much of a future. San Jose Mercury News, CNBC

But ingestible detectable pills are still being tested. On Monday, as Proteus’ bad news broke, eTectRx announced its FDA clearance of the ID-Cap System and its testing at Brigham and Women’s Hospital and Fenway Health, focusing on HIV medication when used for treatment and prevention. Release, HISTalk

Department of Justice taking the lead on scrutinizing Google’s Fitbit acquisition. The Federal Trade Commission also sought jurisdiction over the transaction. According to the New York Post, “both agencies are concerned that a Google-owned Fitbit would give the search giant an even bigger window into people’s private data, including sensitive health information, sources said. Under the Hart-Scott-Rodino Act, all large mergers must file proposals with both the DOJ and the FTC, but only one antitrust agency reviews the merger.”

Coal from stockings being thrown about at HHS. According to POLITICO and the New York Times, the disagreements between Seema Verma, the head of the Centers for Medicare and Medicaid Services (CMS), and the Cabinet-level Secretary of Health and Human Services (HHS), Alex Azar, have boiled over, enough to have to be settled by the President’s acting chief of staff, Mick Mulvaney. According to the Times, both President Trump and VP Mike Pence have told them to find a way to work together. Both are administration appointees, but President Trump has not been reluctant to cut a mis-performing or overly contrary appointee loose. The latest salvo from those obviously not on Ms. Verma’s side was the revelation that she requested compensation for jewelry stolen on a business trip, contrary to government policy of course. She was compensated for other items which is standard. (Isn’t that what homeowners’ insurance is for? And what sensible person actually travels with valuable jewelry?) Under Ms. Verma, CMS has been quite progressive in developing new business models in Medicare fee-for-service, moving providers to two-sided risk, and innovating in both Medicare and Medicaid. It will either be settled, or one or both will be gone. Pass the popcorn.

Leeds picks up another health tech company. Mindwave Ventures is opening an office there, as well as appointing Dr Victoria Betton and Dr Janak Gunatilleke to the roles of chief innovation officer and chief operating officer. Mindwave develops technologies around digital products and services in healthcare and health research. Leeds reportedly is home to over 250 health tech companies and holds an annual Leeds Digital Festival in the spring [TTA 11 April].

Ransomware attack hits Hackensack Meridian. Systems were down for about a week. While this large New Jersey health system hasn’t admitted it, sources told the Asbury Park Press that it was ransomware. And if it’s not ransomware, its Emotet and Trickbot. Read ZDNet and be very apprehensive for 2020, indeed, as apparently healthcare is just one big target.

Comings and Goings: There may be some end of year bombshells, but after last week’s big news about John Halamka, it’s been fairly quiet. Paul Walker, whom this Editor knew at New York eHealth Collaborative, has joined CommonWell Health Alliance as executive director. Mr. Walker was most recently Philips Interoperability Solutions’ vice president of strategy and business development. CommonWell’s goal is improving healthcare interoperability and its services are used by more than 15,000 care provider sites nationwide. Blog release, Healthcare Innovation ….Dr. Jacqueline Shreibati, the chief medical officer for AliveCor, is joining Google Health in the health research area. Mum’s the word when it comes to Fitbit (see above). CNBC ….Peter Knight has pleaded guilty to falsifying educational credentials to gain his position as chief information and digital office at Oxford University Hospitals NHS Foundation Trust. He held that position from August 2016 until September 2018. BBC News