Digital Health & Technology
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January 10, 2024
FDA 'Can't Do This Alone,' Wants Help Vetting AI In Healthcare
The Food and Drug Administration will almost certainly need outside help regulating the safety of artificial intelligence deployed by hospitals and healthcare organizations, the agency's commissioner said Wednesday, citing the complexity of the technology and need to track health outcomes over long periods of time.
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January 09, 2024
FDA Digital Tech Rule Faces Health Privacy, Inequity Test
A new federal road map for collecting "remote" health data in clinical investigations could help speed such technologies to the marketplace, experts told Law360, while creating new risks to patient privacy and the effort to address inequities in healthcare.
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January 09, 2024
FTC Halts Data Broker's Location Data Sharing In Novel Deal
The Federal Trade Commission has stepped up its efforts to curtail the unauthorized disclosure of consumers' sensitive location information, announcing a groundbreaking settlement Tuesday with a data broker that the agency claims unlawfully sold precise location data that could be used to track people to reproductive health clinics, religious worship centers and other sensitive places.
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January 09, 2024
Mich. Resident Sues Software Co., Provider Over Data Breach
A Michigan resident is asking a federal court to impose damages on software company Welltok LLC and Michigan provider Corewell Health East after the health information of a million patients in its database became the target of a ransomware attack.
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January 08, 2024
Orrick Client Delta Dental Of Calif. Hit With Data Breach Suit
Weeks after Delta Dental of California's law firm Orrick Herrington & Sutcliffe LLP was hit with a proposed class action over a data leak that allegedly included Delta files, the insurer was hit with a suit in Massachusetts federal court on Monday over another leak connected to the massive MOVEit data breach.
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January 08, 2024
Wash. Pediatric Hospital Asks Judge To Toss Data Privacy Suit
Seattle Children's Hospital has urged a state judge to dismiss a proposed class action alleging the hospital violated Washington privacy and consumer laws, contending the plaintiffs' own actions were to blame if any personal information was shared with Meta, the parent company of Facebook.
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January 08, 2024
Eli Lilly, Novartis Could Pump Close To $3B Into AI Drug Tech
Eli Lilly & Co. and Novartis could invest close to $3 billion in the development of artificial intelligence for drug discovery under two new agreements with a digital biology company owned by Google's parent company.
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January 05, 2024
Hospitals Want Fast End To 'Flawed' Online Tracking Rules
The American Hospital Association and others on Friday urged a Texas federal court to scrap federal guidance effectively barring certain healthcare entities from using online tracking technology as the data captured from visitors to their websites falls "far outside" the information protected by federal health privacy law.
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January 05, 2024
Eli Lilly Goes Straight To Consumers With Telehealth Platform
A new website launched by Eli Lilly & Co. will connect patients with doctors who treat obesity and offer direct home delivery of the company's obesity drug Zepbound, which the U.S. Food and Drug Administration approved in November.
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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.
Expert Analysis
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The State Of Digital Health Care's Pandemic Transformation
Two years into the COVID-19 pandemic, tech companies are helping to drive the health industry's transition into a new era of greatly expanded digital health and remote care, though some new challenges involving system compatibility and cybersecurity have arisen as well, says Carter Gage at Sheppard Mullin.
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Readying Cybersecurity Protocols For The Quantum Age
As there is a significant likelihood that quantum computers will be able to break the majority of current encryption methods within the next decade, organizations should make preparations now to transition to post-quantum security mechanisms, says Ryan McKenney at Orrick.
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2 FCA Settlements Highlight Gov't Cyber Liability Focus
Recent False Claims Act settlements with Comprehensive Health Care Services and Aerojet Rocketyne illustrate government contractors' growing cybersecurity liability, and underscore how important it is for companies to comply with new incident reporting regulations and live up to standing contractual obligations, say attorneys at O'Melveny.
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What CMS E-Records Proposal Means For Hospitals
The Centers for Medicare & Medicaid Services has proposed significant changes to the Medicare Promoting Interoperability Program — including increasing transparency through public reporting and requiring history queries of prescription drug monitoring programs — that will have far-reaching ramifications for participating hospitals, say Christine Moundas and Gideon Palte at Ropes & Gray.
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How To Protect Health Care Trade Secrets With Covenants
Post-employment restrictive covenants such as noncompetes are an effective way for health companies to protect confidential information and trade secrets, but employers must be cognizant of the rapidly changing state laws governing the enforceability of such agreements, say Erik Weibust and Katherine Rigby at Epstein Becker.
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HSR Statistics Show Increasing Scrutiny Of Health Care M&A
Recent enforcement and Hart-Scott-Rodino statistics illustrate the Federal Trade Commission's growing interest in the application of federal antitrust law to health care transactions and the FTC's ability to test novel theories of harm in this area, say Amanda Wait and Vic Domen at Norton Rose.
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New Ariz. Cyberattack Info Sharing May Be Worth The Burden
A recent amendment to Arizona’s data breach notification law, and similar state and federal cyber incident reporting rules, significantly burden companies that are attacked, but increased information sharing could help prevent and mitigate the damage from future data security incidents, say Christine Czuprynski and Kate Jarrett at McDonald Hopkins.
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Ransomware Risks For Health Cos. And How To Avoid Them
Excerpt from Practical Guidance
As the health care industry is a particularly valuable and vulnerable target of ransomware attacks, it's important for companies to understand possible attack methodologies and best steps for mitigating risks, says Nathan Kottkamp at Williams Mullen.
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What FDA Expects From Medical Device Cybersecurity Efforts
The U.S. Food and Drug Administration's latest draft guidance on cybersecurity for medical devices highlights the distinction between safeguards that are "built in" rather than "bolted on," emphasizing the importance of robust design controls, say Jae Kim and Raymond Williams at DLA Piper.
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As Cyber Risks Surge, Remember Attorneys' Ethical Duties
The prevalence of remote work and a greater threat of Russian cyberattacks should serve as a stark reminder of a lawyer's professional obligations to guard against unauthorized disclosure of client information and to protect client interests in the event of a cyberattack, says Alvin Mathews at Ulmer & Berne.
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Seeking Clarity On Medical Privacy In Fla. Class Actions
When class actions are filed in Florida courts against medical service providers, even over issues other than medical treatment, and plaintiffs seek the names of other possible class members, the federal health privacy law and Florida's right to privacy are implicated — but the issue has yet to receive sufficient attention from the courts, says Aaron Weiss at Carlton Fields.
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Navigating Ambiguities In New Cyber Reporting Law
The recently passed Cyber Incident Reporting for Critical Infrastructure Act requires increased cybersecurity defense and response disclosures, but owners and operators should take the law's lack of clarity on certain parameters into account as they prepare to comply, say attorneys at Holland & Knight.
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Preparing For New Mandatory Cyber Reporting Rules
The requirements of a new federal law mandating cyber incident reporting for critical infrastructure will not become operational for several months, but affected companies should begin assessing whether their response plans incorporate critical policies and procedures to ensure compliance, say Steven Stransky at Thompson Hine and Lacy Rex at Oswald Companies.