Digital Health & Technology
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January 17, 2024
Apple Drops Blood Oxygen Tech From New Watches After Ban
After the Federal Circuit ruled Wednesday that Apple can't import Apple Watches that include a blood oxygen sensor found to infringe two Masimo patents, Apple said the feature will be dropped from its flagship watch models sold beginning Thursday.
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January 16, 2024
Hospital Groups Nationwide Slam Online Tracking Restrictions
Federal guidance restricting the use of online tracking technology in healthcare has disrupted the ability of hospitals to reach underserved communities and connect the public with accurate medical information, 17 state hospital associations told a federal court.
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January 16, 2024
Crowell Adds Moses Singer Health Trio In New NYC Office
Crowell & Moring LLP announced Tuesday that it has hired a team from Moses & Singer LLP with rare expertise in regulatory and compliance issues related to clinical trials for biotech and health tech companies.
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January 15, 2024
Apple Cleared To Avoid Import Ban With Redesigned Watch
U.S. Customs and Border Protection has found that redesigned versions of the Apple Watch without a blood oxygen monitor are not subject to an import ban in a patent dispute with Masimo, according to a Monday court filing by Masimo.
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January 12, 2024
Healthcare Co. HealthEC Hit With Data Breach Suit
Healthcare software company HealthEC has been hit with a lawsuit alleging that a July 2023 data breach affected nearly 4.5 million patients and that the company failed to comply with Federal Trade Commission guidelines and industry standards.
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January 12, 2024
Lab Says COVID-19 Test-Maker Owes $30M Over Faulty Kits
A California-based manufacturer of COVID-19 testing kits has been hit with a $30 million suit alleging it sent defective tests to an independent clinical lab, causing the lab to receive false positive results and subsequently get banned from testing sites.
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January 11, 2024
Quest Fertility Biz Reaches $1.25M Deal In Data Breach Case
A Quest Diagnostics fertility treatment unit has reached a $1.25 million settlement, according to a Wednesday filing in Massachusetts federal court, after a 2021 ransomware attack and accusations that a slow response by Quest left sensitive information unguarded.
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January 11, 2024
Electronic Waveform Says Travelers Owes It $1.3M
A Minnesota medical device manufacturer has told a federal court that insurer Travelers has been intentionally down-coding a pain management device popular among professional athletes in order to underpay the company, resulting in a loss of $1.3 million.
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January 11, 2024
FCC Issues Final Rule On Rural Telehealth Discount
The Federal Communications Commission on Wednesday issued an update to the Rural Health Care program, changing it to allow healthcare providers with conditional eligibility to request funding and compete for bidding.
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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.
Expert Analysis
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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.
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Bracing For The Next Wave Of Health Care Enforcement
Health companies should take proactive steps against a coming wave of federal enforcement, in light of massive new health funding, agencies' desire to protect COVID-19 relief funds, increased use of data analytics and a likely rise in qui tam suits, say attorneys at Foley & Lardner.
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Indoor Air Pollution Fix Will Require New Laws, New Tech
The COVID-19 pandemic, an aging population and changing workplace dynamics all foretell more exposure to indoor air pollutants, so a multidisciplinary policy approach combining technology, insurance, funding and regulation will be needed to improve indoor air quality and health, says Ann Al-Bahish at Haynes and Boone.
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How Justices' AMG Ruling Affects Privacy And Cybersecurity
The U.S. Supreme Court's recent ruling in AMG Capital Management v. Federal Trade Commission removes the regulator's ability to seek monetary damages that discouraged privacy and cybersecurity breaches, and as a result, companies should reassess their exposure in these areas, say attorneys at Orrick.
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COVID's Int'l Trade Impact Holds Health Co. Legal Implications
Pandemic-prompted changes to international trade are highlighting novel legal issues related to the health care industry's reliance on an international supply chain, the proliferation of counterfeit supplies, and risks associated with offshoring administrative support, say Brett Johnson and Claudia Stedman at Snell & Wilmer.