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

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.

News roundup: Current Health’s Class II, Healthware Italy’s €10 million boost, the low state of Latin America telemedicine, weekend reading on digital health in health systems

February 7, 2019 | by

Scottish startup gains FDA Class II clearance, pilots with Mount Sinai Brooklyn. Edinburgh’s Current Health has received FDA Class II clearance for its AI-enabled remote patient monitoring wearable monitors. The single arm-worn wearable sends data every two seconds on oxygen saturation, respiration rate, pulse rate, temperature, activity, and posture. Algorithms analyze the data and alert clinicians to patient status and deterioration. The Mount Sinai pilot follows on Dartford and Gravesham NHS Trust for a post-discharge monitoring program, with a 22 percent reduction in home visits plus fewer hospital readmissions and emergency department visits. Current Health is the renamed snap40. Mobihealthnews, BusinessWire release

Healthware, a Salerno, Italy-based consultancy group primarily concentrated in marketing and sales, has received a €10 million investment from Fondo Italiano d’Investimento SGR (FII Tech Growth). The investment will be used over the next two years has received to expand Healthware’s business transformation for life sciences companies and product development and services for digital health start-ups which improve health outcomes through new technologies. Release.  Hat tip to Healthware’s Antonietta Pannella

Telemedicine adoption in hospitals ranges from 65 to below 30 percent in Latin America. A study published this week in Health Affairs Global Health Policy (paywalled) looks at the different rates of hospital-based telemedicine adoption in nine Latin America countries. Leading is Chile with the aforementioned 65 percent; Argentina, Costa Rica, Mexico and Peru with less than a 30 percent. In the middle: Panama (35 percent), Uruguay and Guatemala in the 40 percent range. Despite supportive official policies in many of these countries, “Efforts to implement telemedicine are isolated and scattered, often left to the public sector or taking the form of insulated projects that are not sustained” or scaled up nationally and regionally. Mobihealthnews

For weekend reading. Intersecting with the Latin America story above is this. This Editor missed the October issue of Global Health: Science and Practice published out of Johns Hopkins, but here it is. The focus of the six articles is digital health integration into health systems in the US and internationally. Hat tip to Alain B. Labrique via Twitter

A basket of reflections, considerations on CVS-Aetna: Epic, Cerner, the model, and hospitals’ role

December 14, 2017 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/12/canary-in-the-coal-mine.jpgw595.jpeg” thumb_width=”150″ /]With the holidays and the end of the year coming in a little over two short weeks, there’s plenty of room for thoughts, reasoned speculation, and some unusual takes on the CVS-Aetna merger. This Editor remains in her belief that among us, there’s a bit of exhaustion and an attitude of ‘wait and see’ around the topic among us. The canaries have a case of the vapors….

Let’s sort through some of the more interesting POVs expressed of late by our fellow pressies, which Readers can consider in between cups of good cheer and bites of All That Food. Bear in mind that this merger has a long road to go on a hard road, with potholes marked DOJ and (in this Editor’s opinion) HHS, before it’s a done deal in 2018.

  • A big win for Epic. Currently the EHR for CVS’ MinuteClinics and most recently the care management programs of CVS Specialty, Epic is bullish on the opportunities in what their VP of population health termed the ‘gray space’ in the patient experience outside of the traditional sites of care. In October, CVS added Epic’s Healthy Planet population health analytics platform to learn more about drug dispensing patterns and medication adherence–this Editor believes in preparation for merger talks. The open question this Editor has after all the glow in this article is how Aetna’s varied systems (e.g. ActiveHealth, Medicity, and others) would integrate into Epic, and the price of poker, because with Epic it’s never free. Ask any hospital. Healthcare IT News.
    • Certainly, their main competitor Cerner is feeling the heat after a slowdown in its VA plans, the single largest EHR implementation ever. Congress has held up initial funding making the contract effective (Washington Technology). It is geometrically more complicated than their simultaneous DoD implementation, with $10 billion estimated over 10 years (FCW). Other wrenches in the works: a fresh CliniComp lawsuit against Cerner based on infringement against their 2003 patent on remote hosting, and their appeal of the no-bid award to Cerner [TTA 23 Aug] against VA. Kansas City Business Journal, Healthcare IT News
  • Is it going to increase cost? It might. And what about info sharing with providers? A Harvard Medical School professor opined to Marketplace that instead of self-treatment at home for a cold, the patient might actually traipse to a MinuteClinic for care, thus driving up healthcare costs. This resembles the RAND logic around telemedicine consult expense we deflated in a series of articles back in the spring. Information sharing with regular providers is a bigger issue which urgent cares, telemedicine, and clinics already are dealing with. The paradox is that integration with a payer, with a retailer’s ability to track ancillary purchases such as OTC meds and DME purchases, might actually help that issue. But will it? Will a combined CVS-Aetna share information or hoard it, further disempowering patients? This Stat article calls on Mark Bertolini to promote shared information, engagement, and accountability to balance the scales.
  • Do we really need hospitals? If they don’t change, we might need a lot less of them except for highly specialized treatment. And this is likely a good thing. The HBR points out that CVS-Aetna is hardly the only threat to the traditional hospital–there’s Johns Hopkins’ Hospital at Home program for older adults, UnitedHealthcare’s growing network of providers under OptumCare, including the recent deal for DaVita dialysis centers, and free-standing, low-cost “neighborhood” hospitals, almost like pop-up stores. The article doesn’t mention ‘consult stations’ like Europe’s H4D, which is proving that the kiosk idea isn’t dead. 

The reality is that we won’t know what this merger entails until it actually happens, if it happens–and its final shape will take years to mold. Related: CVS-Aetna: the canary says that DOJ likely to review merger, Analysis of the CVS-Aetna merger: a new era, a canary in a mine–or both?, CVS’ bid for Aetna–will it happen, and kick off a trend? (what will Amazon and other retailers, including supermarkets, do?)

Telemedicine’s 25 things to know better–and Better

July 17, 2015 | by

For those of us who have been Terminology Warriors going back to the oughts (see founder and EIC emeritus Steve Hards’ summary in ‘What is Telecare’), this is a useful summary of not only what is telemedicine and who is authorized to perform it, but also how it is developing (US focus) in state law and reimbursement (private and Medicare). Despite being published earlier this month, it is already dated as reimbursement parity laws have been passed in Connecticut and Delaware [TTA 10 July]. The richly IPO’d Teladoc is omitted on the provider list in point #21; Better is anomalous as it is less telemedicine than a personal health assistance service.  25 things to know about telemedicine (Becker’s Health IT and CIO Review)

About Better: they have joined with Johns Hopkins’ Sibley Memorial Hospital Innovation Hub to provide support for orthopedic episodes of care. These generally are for a 90 day period which extends from scheduling the procedure through post-discharge recovery, and are usually tied into a bundled payment from an insurer or Medicare. Johns Hopkins press release Hat tip to CEO Geoff Clapp.

Is the ‘last mile’ of app certification efficacy metrics?

December 15, 2013 | by

News and announcements around app certification definitely were hot topics in the past week or so, but are they more heat than light? Do these certifications adequately address efficacy? Stephanie Baum, in her follow-up to the Happtique kerfuffle in MedCityNews, opens up the discussion with the proposition: “It seems like there needs to be some way to prove that apps actually help people.” Bradley Merrill Thompson of Epstein Becker & Green points out “It’s certainly useful to know that an app works from a software perspective reliably, but it is even more valuable to know that the app can actually improve health.” While Happtique certification standards have a gap here, this Editor would point out that they were evolved nearly two years ago when the reporting/analysis needed for this was largely not available. Newer programs such as Johns Hopkins’ mHealth Evidence and the new IMS Health AppScript [TTA 15 Dec] can dip into the ‘big data’ pool far more effectively. Will Happtique be able to address this, or leave the ‘last mile’ to others? And what is the real and quantifiable demand for app certification anyway? Health app prescribing by physicians is a question mark in this Editor’s observation; the larger market may be health plans and programs such as Partners HealthCare’s Wellocracy, Cigna’s GoYou  and Aetna’s CarePass.