Digital Health & Technology
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January 05, 2024
Split 9th Circ. Revives Antitrust Suit Against Catheter Maker
A split Ninth Circuit panel sided with Innovative Health LLC on Friday and revived its antitrust suit against Biosense Webster Inc. in a dispute over the market for catheters, saying Innovative provided sufficient evidence to defeat summary judgment in its claim that Biosense tied the sale of catheters to clinical support services.
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January 05, 2024
Barley Snyder Promotes Health, Estate Attys To Partnership
Barley Snyder has announced the addition of an experienced healthcare lawyer and an expert estate planner as its first new partners of the year.
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January 05, 2024
Ga. Board Restores Telehealth Rx For Controlled Substances
A Georgia medical oversight group has relented and restored doctors' ability to prescribe controlled substances, including painkillers and attention-deficit medications, via virtual visits.
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January 05, 2024
IQVIA Drops Healthcare Ad Deal After Court Pause
Healthcare data company IQVIA has abandoned its planned purchase of Propel Media after the Federal Trade Commission convinced a court to pause the deal over concerns about the cost of advertising that targets doctors and other healthcare professionals.
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January 04, 2024
Birth Control Clips Hurt Women When They Move, Suit Says
The Filshie Clips birth control device may move around after implantation, a hazard the clips' manufacturers did not warn the public or healthcare professionals about, according to a Connecticut federal lawsuit from a woman who says she was injured by them.
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January 04, 2024
Merck And Insurers Settle $1.4B Cyberattack Coverage Case
Merck has reached a settlement with its insurers over whether the pharmaceutical giant's "all-risk" property insurance covered $1.4 billion in losses stemming from the 2017 NotPetya attack or if its "hostile/warlike" exclusion applies.
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January 03, 2024
AHA Says Data-Blocking Penalty Threatens Rural Hospitals
A proposed federal rule that establishes monetary penalties for information blocking may threaten the financial viability of small and rural hospitals, according to the American Hospital Association.
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January 03, 2024
ACTS Retirement Data Breach Suit Settlement Gets Initial OK
A Pennsylvania federal judge gave preliminary approval Tuesday to a deal inked by ACTS Retirement Services Inc. to settle claims it failed to protect the personal information of nearly 21,000 people exposed in an April 2022 data breach.
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January 03, 2024
BioXcel Execs Face Investor Suit Over Alzheimer's Drug Probe
Top brass at artificial intelligence-driven biopharmaceutical company BioXcel Therapeutics Inc. have been hit with a shareholder derivative suit alleging they took too long to disclose a U.S. Food and Drug Administration probe of its development of an Alzheimer's treatment and its lead clinical trial investigator's compliance issues.
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January 03, 2024
FDA Seeks Comment On Ideas To Improve Agency Guidance
The U.S. Food and Drug Administration asked pharmaceutical companies, healthcare providers and others Wednesday to weigh in on how the agency can more quickly provide guidance on its interpretation of federal laws and regulations.
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January 02, 2024
Colo. Doctor Says Biz Partner Stole Software For Own Co.
A Colorado doctor filed a lawsuit Tuesday against his former business partner over a failed medical software startup, alleging the business partner developed a competing platform and diverted revenue from the shared startup to his own company.
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January 02, 2024
Lawsuit Says 23andMe Dragged Its Feet In Data Leak
A proposed class action in California federal court claims ancestry tracking company 23andMe took too long to respond to a data breach that affected millions of customers and targeted Ashkenazi Jewish users.
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January 02, 2024
Chancery Dissolves Biomed Co. For 'Egregious' Conduct
Delaware's chancellor has ordered the dissolution of a company whose CEO and founder "lied, cheated, destroyed evidence and repeatedly ignored court orders" in a dispute pitting one brother against another over repayment of a $1.8 million loan for purportedly "Nobel Prize-worthy" biomedical research.
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January 01, 2024
Sunset Of CMS' Remote Supervision Policy Draws Concern
As part of their New Year's resolutions, some leaders at U.S. healthcare associations are planning to push the federal government to restore a policy that allowed teaching physicians to remotely supervise residents as they care for Medicare patients in every part of the country.
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December 28, 2023
Apple Watch Import Ban Put On Hold By Fed. Circ.
The Federal Circuit on Wednesday temporarily suspended a U.S. International Trade Commission ruling that banned imports of the Apple Watch in a patent dispute with Masimo Corp.
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December 26, 2023
White House Won't Veto ITC Apple Watch Import Ban
The Biden administration said Tuesday that it will not veto a U.S. International Trade Commission decision banning imports of the Apple Watch in a patent dispute with Masimo Corp., days after the tech giant stopped selling some models of the popular devices due to the ruling.
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December 21, 2023
5th Circ. Urged To Reject Retrial In DOJ's $140M Fraud Suit
A former medical device sales representative accused of running a $140 million healthcare fraud scheme in Houston with four other men told the Fifth Circuit on Thursday that he shouldn't be forced to face a retrial, writing that the government "knew or should have known" about alleged prosecutorial misconduct that forced a mistrial the first time around.
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December 21, 2023
Becton Investors Seek OK Of $85M Deal Over Alaris Recall
A class of Becton Dickinson investors asked a New Jersey federal judge Thursday for his initial blessing on an $85 million settlement resolving securities fraud claims that the medical technology maker hid looming regulatory setbacks affecting the sales of its Alaris infusion pump, which Becton voluntarily recalled in 2020.
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December 21, 2023
Top Government Contracts Of 2023: A Year In Review
This year saw the federal government conclude a $60 billion IT program for the U.S. Department of Veterans Affairs and a previously stalled $5.7 billion enterprise technology deal for the U.S. Air Force. But fatal errors with the VA's new $16 billion health records system forced it to pause the program. Here, Law360 takes a look back at some of the biggest government contracts from 2023.
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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.
Expert Analysis
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4 Strategies For Drafting Effective Consumer Breach Notices
Businesses should consider key strategies when drafting consumer breach notification letters, such as knowing their audience and what is on their mind, and prioritizing user-friendliness and tone, say attorneys at Troutman Pepper.
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How Contractors Can Avoid Cybersecurity FCA Violations
Recent U.S. Department of Justice settlements and remarks underscore heightened focus on cybersecurity liability under the False Claims Act, so government contractors should consider compliance measures such as conducting periodic risk assessments, being responsive to employee concerns, and more, say attorneys at WilmerHale.
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EU Regulation Highlights AI Issues For Digital Health Cos.
As the regulation of artificial intelligence is high on the agenda for EU and U.K. policymakers and regulators, and likely imminent in the U.S., now is the time for providers in the digital health space to consider how compliance may need to change, and safeguard their position in the market, say Chris Eastham and Olivia Morgan at Fieldfisher.
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What DOJ Enforcement Shift Means For Life Sciences Cos.
Though monitoring life science company compliance has historically been the domain of the U.S. Department of Health and Human Services, recent trends suggest that the U.S. Department of Justice may be assuming a primary role going forward, raising interesting questions for the industry, say attorneys at Skadden.
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Ransomware Payment Lessons Amid DOJ Recovery Success
The U.S. Department of Justice’s recent successes clawing back ransom payments made to hacking groups provide companies an additional factor to consider when deciding whether to engage with law enforcement after experiencing a breach, whether to pay a ransom demand, and whether to try to recover the payment, says Tyler Bridegan at Wiley.
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What's Next For DOJ's COVID Enforcement In Health Care
As we enter the end of the third year of the pandemic, a few fraud-related trends and risks have emerged, necessitating important steps that health care and life sciences companies should take in light of continuing U.S. Department of Justice scrutiny, say attorneys at Arnold & Porter.
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How To Minimize Risk When Launching Smart Medical Devices
Prior to launching a smart medical device, there are several critical steps that companies can take in order to protect their intellectual property, get approval from the U.S. Food and Drug Administration and ensure the safety of their data, say attorneys at Crowell & Moring.
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Health Issues To Watch In Inflation Act, Other Policy Initiatives
The newly signed Inflation Reduction Act includes a number of significant drug pricing reforms, and the future holds a wider array of health issues that may be addressed in pending legislation when Congress returns in September, says Miranda Franco at Holland & Knight.
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DOJ Filing Reawakens Fraud-On-The-FDA Theory Of Liability
The U.S. Department of Justice’s recent statement of interest in U.S. ex rel. Crocano v. Trividia Health before a Florida federal court represents a substantial attempt to revive a False Claims Act liability theory involving misstatements to the U.S. Food and Drug Administration, potentially leading to increased scrutiny of medical products, say attorneys at Duane Morris.
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Digital Health Cos. Should Expect More Scrutiny Amid Growth
As the digital health market continues to flourish, the privacy and security of patient data has become a focus of legislative, regulatory and interest group action, and developers should be motivated to reassure both regulators and consumers that users' data is adequately protected, say attorneys at Kirkland.
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Anti-Kickback Circuit Split Holds Implications For Defendants
The Eighth Circuit's recent decision in U.S. v. D.S. Medical represents a significant step toward holding plaintiffs to more exacting burdens of proof in Anti-Kickback Statute False Claims Act suits, and the outcome of the resulting circuit split could decrease estimated damages for defendants, say attorneys at Gibson Dunn.
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Post-Dobbs HHS Guidance Brings Privacy Considerations
The U.S. Supreme Court's recent decision in Dobbs v. Jackson Women's Health Organization, and ensuing guidance from the U.S. Department of Health and Human Services, will create new privacy compliance issues for health care providers and other companies collecting personal information concerning the use of reproductive health services, say attorneys at Ropes & Gray.
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HHS Fraud Alert Is A Major Warning To Telehealth Industry
The U.S. Department of Health and Human Services recently issued a rare fraud alert, indicating potential changes in telemedicine enforcement, and suggesting that digital health entities are likely to face subpoenas, civil investigative demands and other inquiries, say attorneys at Hooper Lundy.