Digital Health & Technology
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December 21, 2023
Top North Carolina Cases Of 2023
A newly elected Republican majority on North Carolina's Supreme Court came out swinging early in 2023, overturning a decision by the previous year's liberal regime that held the state's election maps were gerrymandered and unconstitutional.
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December 20, 2023
11 Deals That Shaped Healthcare And Life Sciences In 2023
The healthcare industry's appetite for mergers and acquisitions waned considerably this year, with both the number and size of deals falling well short of recent years. But that didn't make for a slow 2023, with segments like hospital systems showing renewed activity and major announcements in biotech that signaled a careful but growing appetite from the biggest players.
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December 20, 2023
ITC Rejects Apple's Bid To Put Apple Watch Ban On Hold
The U.S. International Trade Commission on Wednesday denied Apple's request to stay an order that will soon halt imports of Apple Watch models found to infringe Masimo Corp. patents, unless it is vetoed by the White House.
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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.
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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."
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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."
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
Expert Analysis
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FTC's Hasty Health Data Rule Change Could Cause Confusion
The Federal Trade Commission's recent policy statement expanding the scope of its Health Breach Notification Rule appears to bypass appropriate administrative processes and may delay effective privacy and security policies that can advance interoperability and health innovation, says Jodi Daniel at Crowell & Moring.
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'McMorris Factors' Create Obstacles For Data Breach Plaintiffs
The factors for evaluating standing in the context of data breach allegations set forth by the Second Circuit in McMorris v. Carlos Lopez & Associates earlier this year may be difficult, if not impossible, for plaintiffs to satisfy, but the standard varies from circuit to circuit, say David Topol and Pamela Signorello at Wiley.
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Telehealth Providers Must Beware Of Fraud As Industry Grows
A recent fraud charge against a telehealth executive highlights the rise we're seeing in telefraud scams during the industry's pandemic growth, and there are some steps that all health providers should take to stay clear of potentially illegal arrangements, says LaTawnda Moore at Dinsmore.
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The Regulatory Growing Pains For Digital Health Companies
The meteoric rise of digital health services during the pandemic has been matched with increasing regulatory scrutiny in the U.S. and abroad, resulting in a patchwork of laws and approaches that could leave a damper on the industry's growth, say attorneys at Kobre & Kim.
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Policyholder Best Practices As Cyberattacks Escalate
As ransomware attacks increasingly target corporate victims, policyholders should enhance cybersecurity and privacy efforts to avoid regulatory hot water and mitigate the effects of rising insurance premiums and coverage restrictions, say Lee Epstein and Krishna Jani at Flaster Greenberg.
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Navigating Asia-Pacific Health M&A In The Wake Of COVID
Bernard Lui and Vanessa Ng at Morgan Lewis discuss new legal considerations for participants in health care mergers and acquisitions with entities in Singapore and elsewhere throughout the Asia-Pacific region as the pandemic continues.
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Life Sci Cos. Should Prep For Enforcement After COVID Pause
With the U.S. Food and Drug Administration and other federal agencies beginning to turn their sights back to pre-COVID-19 agendas, now is the time for life sciences companies to proactively address certain key areas that are likely to draw enforcement action, including physician speaker programs and data integrity, say attorneys at Buchanan Ingersoll.
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4 Considerations In Light Of Cyber Incident Notification Bill
Following the recent introduction of a bipartisan bill that would require government contractors and critical infrastructure operators to report cyber intrusions to the federal government within 24 hours, companies should take several steps to assess their preparedness for identifying vulnerabilities and mitigating the risk of cyberattacks, say attorneys at Squire Patton.
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What COVID-19, Social Issues Mean For Pharma Case Juries
Recent surveys of actual and potential jurors suggest that the turbulence of this time will likely affect the attitudes of juries in pharmaceutical and life science cases in at least five different ways, say Buffy Mims and Rachel Horton at DLA Piper, and Rick Fuentes at R&D Strategic Solutions.
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Health Cos. Must Prepare For Growing Ransomware Threat
Health companies are a prime target for ransomware attacks due to their sensitive data and relative vulnerability, so they will need compliance and resilience to guard against the increasingly varied ways that hackers can attempt to extract funds, say Alaap Shah and Stuart Gerson at Epstein Becker.
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Medical Device Cases Show Increased Sunshine Act Scrutiny
Recent U.S. Department of Justice and Centers for Medicare & Medicaid Services settlements with two medical device manufacturers signal ramped-up enforcement of the Sunshine Act, highlighting a departure from a historically gentler approach, say Jaime Jones and Brenna Jenny at Sidley.
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Compliance Considerations For Pharma Co. Testing Programs
Diagnostic tests sponsored by pharmaceutical companies can provide real benefits to patients, but should be carefully structured to mitigate compliance risks related to possible fraud and patient privacy, say Eve Brunts and Alison Fethke at Ropes & Gray.
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Gov't Authorities Should Assist Ransomware Targets
As more companies make the prudent decision to pay ransoms following cyberattacks — recently demonstrated by Colonial Pipeline's decision to make a multimillion-dollar payment — governments should use these opportunities to identify and punish perpetrators, rather than simply admonishing victims, say attorneys at Clifford Chance.