Digital Health & Technology
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January 11, 2024
Conn. Healthcare Co. Eyes Deal For Data Breach Class
Merritt Healthcare Advisors is working to finalize a settlement with a proposed class of consumers who claim that the company's lax security allowed cybercriminals to access their personal information, according to a paperless order entered Thursday in the District of Connecticut.
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January 10, 2024
Rex Medical Asks Fed. Circ. To Decry Slashing Of $10M Award
Rex Medical LP is asserting to the Federal Circuit that a Delaware federal judge was wrong to slash a jury's $10 million patent damages verdict in Rex's favor to just $1 over a purported lack of evidence.
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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.
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.