Digital Health & Technology

  • December 20, 2023

    FDA Offers Guide On Real-World Data For Device Submissions

    Guidance from the U.S. Food and Drug Administration aims to clarify how the agency assesses real-world data and evidence when considering medical devices submitted for approval, addressing the use of data from wearable devices, among other issues.

  • December 20, 2023

    Stimwave Buyer Can Enforce Sale In 'Disturbing' Domain Row

    The buyer of Stimwave Technologies can force the medical device company's former CEO and her family to relinquish control of a domain name used to direct patients to information about faulty implants, a Delaware bankruptcy judge said Wednesday, calling the family's alleged efforts to redirect web traffic "immoral."

  • December 19, 2023

    Indicted Stimwave CEO Hit With $41M Civil Suit From SEC

    The U.S. Securities and Exchange Commission on Tuesday accused the former CEO of bankrupt medical device maker Stimwave Technologies of defrauding investors out of roughly $41 million, filing a civil suit against the embattled executive the same day federal prosecutors lodged a superseding indictment in her criminal case.

  • December 19, 2023

    Fla. Nurse Convicted Of Medicare Fraud Faces Up To 21 Years

    Federal prosecutors have asked a judge to sentence a nurse practitioner in Florida to roughly 17 to 21 years in prison for her role in a Medicare fraud ring, describing her as the nation's top prescriber of fraudulent genetic tests.

  • December 19, 2023

    Philips Unit Inks $14.7M FCA Deal For Cardiac Monitoring Bills

    Philips-owned BioTelemetry Inc. and its subsidiary will pay over $14.7 million to settle False Claims Act allegations that they inflated federal healthcare reimbursements for six years by inducing providers to bill for cardiac telemetry instead of the cheaper cardiac event monitoring services doctors had intended, the U.S. Department of Justice announced Monday.

  • December 19, 2023

    Zymergen Gets Conditional OK For Ch. 11 Asset Sales

    A Delaware bankruptcy judge on Tuesday signaled she would approve biotechnology company Zymergen's asset sales to two bidders as part of its Chapter 11 liquidation plan, under an agreement whereby the debtor's parent will acquire most of the business.

  • December 18, 2023

    Claims Court Says Military Did Not Infringe Software Rights

    A U.S. Court of Federal Claims judge has ruled that the U.S. Defense Health Agency did not infringe copyrights or breach the contract of a healthcare consulting services company because the business' registrations were invalid, and there was no proof of a deal.

  • December 18, 2023

    Optum Group To Pay $160K After Patient Records Complaints

    Optum Medical Care of New Jersey has agreed to pay $160,000 to resolve allegations it violated federal law by taking too long to release health records requested by patients and parents, federal officials say.

  • December 15, 2023

    Ky. Hospital Didn't Do Enough To Stop Data Breach, Suit Says

    A Kentucky-based healthcare system that suffered a ransomware attack in May was hit with a proposed class action alleging it irresponsibly left about 2.5 million people vulnerable to identity theft, credit card fraud and other crimes.

  • December 15, 2023

    Artis Ventures Closes $200M Fund For TechBio Investments

    Venture capital firm Artis Ventures announced Thursday that it has closed a new fund, raising more than $200 million to be invested in companies focused on using technology to solve healthcare challenges.

  • December 15, 2023

    Boston Scientific Reaches $38.5M Deal To End Investor Suit

    Investors suing Boston Scientific Inc. for touting a heart valve product that was later pulled from the market announced Friday that they have settled their stock suit against the medical device maker for $38.5 million.

  • December 14, 2023

    New HHS Rule Called 'Significant Step' For Responsible AI

    The U.S. Department of Health and Human Services finalized its rule to address artificial intelligence on Wednesday, specifically taking aim at algorithm transparency and information sharing for healthcare providers, with the national coordinator for Health IT calling it a "significant step."

  • December 14, 2023

    CVS Health, 27 Others Pledge Safe AI Use And Development

    CVS Health, Duke Health and 26 other healthcare providers and payors have pledged their commitment to the "safe, secure and trustworthy" use and purchase of artificial intelligence, according to a Thursday announcement by the Biden administration.

  • December 13, 2023

    6 Biggest Healthcare Fraud Cases Of 2023

    This year saw a rare False Claims Act jury trial that netted a $490 million verdict, a $172 million settlement from Cigna to settle healthcare fraud allegations, and emerging fraud schemes from developing technologies. Here, Law360 takes a look back at six significant healthcare fraud enforcement actions from 2023.

  • December 12, 2023

    Ex-Dow Jones Atty Joins Weight Loss Co. Noom As GC

    An attorney who provided in-house counsel to Dow Jones for over two decades has joined weight loss company Noom, where he will lead compliance efforts as general counsel.

  • December 12, 2023

    Point32Health Promotes Veteran Healthcare Atty As CLO

    Susan A. Kee is the new chief legal officer at Massachusetts-based Point32Health, a not-for-profit health services organization formed three years ago from the merger of Tufts Health Plan and Harvard Pilgrim Health Care.

  • December 08, 2023

    New Drug Patent Proposal Sparks Worry Over Gov't Overstep

    The Biden administration's proposal to seize drug patents if the prices of the medicines are deemed unreasonable is expected to face significant legal pushback, and the potential effects on the pharmaceutical industry may not be what the administration had in mind, experts say.

  • December 07, 2023

    NC Radiology Group, Broker Strike Deal In Cyberattack Row

    A North Carolina radiology practice told a federal court Thursday it struck a deal with its insurance broker resolving its suit alleging it lost more than $1 million as a result of a ransomware attack that occurred shortly after the broker allowed cyber liability coverage to lapse.

  • December 06, 2023

    Wellness or Medical? Device-Maker Attys Look for Answers

    To be or not to be a medical device? That is the question attorneys are navigating with healthcare entrepreneurs seeking to market innovations incorporating artificial intelligence and digital technologies, and one that may help them avoid conflicts with U.S. Food and Drug Administration guidelines.

  • December 06, 2023

    Hospital Group Explores 'Responsible' Health Data Privacy

    The Joint Commission, a healthcare accreditation nonprofit, launched a new health data privacy certification program on Wednesday that aims to train hospitals on protecting patient privacy while transferring the data to third-party organizations for secondary use.

  • December 06, 2023

    HHS Offers Plan To Bolster Hospital Defenses In Cyberattacks

    The Centers for Medicare and Medicaid Services will propose new cybersecurity requirements for hospitals in an effort to implement greater accountability in the healthcare industry, the federal government announced Wednesday.

  • December 06, 2023

    NC Biz Court Trims Suit Claiming Hospital Sold Data To Meta

    North Carolina's business court allowed a proposed class action against WakeMed Health & Hospitals to move forward after finding the plaintiffs adequately alleged claims of common-law negligence, breach of implied contract and breach of fiduciary duty in a suit claiming the hospital system sold patient data to Meta Inc. without consent.

  • December 05, 2023

    Massive Hack At 23andMe Got Health, DNA Ancestry Data

    Hackers accessed data from about 6.9 million users of the DNA testing company 23andMe Inc., the company confirmed Tuesday. The breach got a wealth of sensitive information, including health and DNA ancestry profiles.

  • December 04, 2023

    Patients Sue Nevada Healthcare Vendor For Exposing Data

    Two patients of an Illinois healthcare system filed a proposed class action against a Nevada medical transcription firm, alleging that the company failed to protect sensitive health information, even though the healthcare sector is a favorite target for hackers.

  • December 04, 2023

    Blank-Check Co. Aimei Health Technology Prices $60M IPO

    Aimei Health Technology, a blank-check company focused on healthcare targets, priced its initial public offering at $60 million on Friday ahead of its Monday listing on the Nasdaq, offering 6 million units at $10 apiece.

Expert Analysis

  • Anti-Kickback Safe Harbors May Be Less Safe After Medtronic

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    A California federal court's recent order denying dismissal in U.S. v. Medtronic improperly acknowledges intent as a liability factor in a suit alleging violations of the Anti-Kickback Statute, which is likely to erode certainty in statutory AKS safe harbor protections, says Scott Landau at Abell Eskew.

  • How Health Care Cos. Can Prepare For DOJ's Cyberfraud Push

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    Enforcement of the U.S. Department of Justice’s new cyberfraud initiative will initially occur largely through civil investigations that broadly apply the False Claims Act, so health care organizations should ensure that their practices can withstand hacks, whistleblowers and government scrutiny, say Katie McDermott and Mark Krotoski at Morgan Lewis.

  • How Investors Can Navigate A Vibrant Digital Health Market

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    With investment activity surging across the digital health care industry, investors must balance their interest in transformative technologies with the inherent risks of platforms and models that have yet to be fully proven, says Brian Gordon at McDermott.

  • What Cos. Can Learn From The 2021 FCA Recovery Statistics

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    Attorneys at Winston unpack the recently released U.S. Department of Justice False Claims Act recovery statistics for fiscal year 2021, discuss how they compare to prior years and what companies in an expanding array of industries should expect next.

  • Expect Aggressive Life Sciences Enforcement In 2022

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    This year, life sciences companies should prepare for heightened activity from the U.S. Department of Justice and U.S. Food and Drug Administration, which will likely target illicit opioid distribution, clinical trial fraud and other key areas, say attorneys at Ropes & Gray.

  • The Rising Demand For Commercial Litigators In 2022

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    Amid broken supply chains, pandemic-induced bankruptcies and a rise in regulation by litigation, strong commercial litigators — strategists who are adept in trying a range of tortious and contractual disputes — are becoming a must-have for many law firms, making this year an opportune moment to make the career switch, say Michael Ascher and Kimberly Donlon at Major Lindsey.

  • Health Care Policy Priorities To Watch In 2022

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    The Build Back Better Act is at the forefront of Congress' lengthy health care agenda this year, but there are a number of other issues that health companies and their legal teams should watch closely, including the pandemic's continuing impact on telehealth licensure requirements, surprise-billing regulations and increasing scrutiny of market consolidation, say Miranda Franco and Robert Bradner at Holland & Knight.

  • The State Of FDA Regulation Of Software As A Medical Device

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    Though the U.S. Food and Drug Administration has accelerated activities related to software as a medical device, developers should carefully consider guidance gaps and challenges regarding transparency and change management in software that utilizes artificial intelligence and machine learning, says Nicholas Diamond at C&M International.

  • What DOJ's Cyberfraud Initiative Means For Health Cos.

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    Though the U.S. Department of Justice's new cyberfraud initiative does not single out the health care industry, health and life sciences companies may be subject to heightened scrutiny under the False Claims Act and should prepare accordingly, say attorneys at Ropes & Gray.

  • How Medical Device Cos. Can Limit Enforcement, Legal Risks

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    With recent cases highlighting the myriad consequences that compliance failures can bring to medical device manufacturers, it is imperative that companies take proactive steps to avoid U.S. Food and Drug Administration enforcement and pay particular attention to keeping warning letters out of evidence in product liability suits, say attorneys at Phillips Lytle and Compliance Team.

  • How Growing Cyber Scrutiny Affects Corporate Compliance

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    In the face of overlapping cybersecurity initiatives at the U.S. Departments of Justice and Health and Human Services, health care companies and government contractors should prepare for microscopic scrutiny by ensuring specific components are included in compliance programs and being mindful of reporting obligations under existing corporate integrity agreements, say attorneys at Verrill Dana.

  • Choosing The Right IP Protections For Telehealth Innovations

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    Telemedicine and digital health innovations are likely to stay after the COVID-19 pandemic ends, so inventing companies must decide on a comprehensive intellectual property strategy, considering the goals, risks and upfront requirements offered by both patent and trade secret protections, say Eric Sophir and Matthew Horton at Foley & Lardner.

  • A Phased Approach To In-House Legal Tech Adoption

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    In-house legal departments that adopt new technologies too quickly often face frustration or failure, so to help ensure a smooth transition, companies should consider a multistep approach, depending on where they stand with respect to modernizing legal processes, says Tariq Hafeez at LegalEase Solutions.