Digital Health & Technology
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January 24, 2024
Software Co. Says Data Breach Victims Aren't Customers
NextGen Healthcare is asking a Georgia federal court to dismiss a proposed consolidated class action because the plaintiffs don't have a relationship with the software company that would make it liable for damages, even as it acknowledged their health information was compromised by a cyberattack.
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January 23, 2024
Australia, US, UK Sanction Russian Over Medibank Hack
Officials from Australia, the U.S. and the United Kingdom revealed Tuesday that they had sanctioned a Russian national believed to have played an integral role in a 2022 cyberattack that hit Australian health insurer Medibank Private Ltd., marking the first time the three nations have made such a coordinated strike.
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January 23, 2024
FDA Pilot Program Accepts First AI Health Technology
An automated depression and anxiety severity measurement tool is the first artificial intelligence-based and digital health technology-based project as well as the first neuroscience project accepted into the U.S. Food and Drug Administration's Innovative Science and Technology Approaches for New Drugs Pilot Program, or ISTAND, the agency announced Tuesday.
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January 22, 2024
NY Senate Backs Bill Bolstering Healthcare Data Privacy
New York state's Senate on Monday signed off on legislation that would require companies collecting and selling healthcare information to have user consent before selling that data to third parties, passing a bill that's part of a legislative package lawmakers say is aimed at "reproductive equity."
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January 22, 2024
Anna Jaques Hospital Sued In Mass. Over Hacked Patient Data
Anna Jaques Hospital was hit with a proposed class action on Monday in Massachusetts state court alleging the hospital failed to maintain adequate cybersecurity measures, leading to a December breach potentially involving thousands of patient records.
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January 22, 2024
4th Circ. Preview: Timberland's TM Bid Kicks Off 2024
The Fourth Circuit will kick off 2024 by probing Timberland's bid to trademark its footwear and pondering an embattled insurance mogul's attempt to escape a $524 million judgment.
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January 22, 2024
Boston Biopharma Co. Picks Industry Veteran As Next GC
Biopharma company BPGbio Inc. announced Monday the appointment of a compliance specialist and former Cooley LLP associate as its new general counsel.
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January 19, 2024
Law360 Names Firms Of The Year
Eight law firms have earned spots as Law360's Firms of the Year, with 55 Practice Group of the Year awards among them, steering some of the largest deals of 2023 and securing high-profile litigation wins, including at the U.S. Supreme Court.
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January 19, 2024
Law360 Names Practice Groups Of The Year
Law360 would like to congratulate the winners of its Practice Groups of the Year awards for 2023, which honor the attorney teams behind litigation wins and major deals that resonated throughout the legal industry this past year.
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January 19, 2024
Lawmakers Urge HHS To Make Telehealth Policy Permanent
A bipartisan group of senators and representatives on Friday pressed the U.S. Department of Health and Human Services to make permanent the temporary pandemic-era expansions in Medicare telehealth coverage before the end of the year.
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January 19, 2024
Colo. Group Seeks Damage Caps Drop, Reporting Expansion
An issue committee, supported in part by the Colorado Trial Lawyers Association, has launched an effort to place two statewide initiatives before Colorado voters in November, designed to help patients and those filing suits over catastrophic injuries and wrongful deaths.
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January 19, 2024
Becton Investors Get Initial OK Of $85M Deal Over Recall
A magistrate judge granted preliminary approval to an $85 million settlement a class of Becton Dickinson investors reached with the medical tech company over securities fraud claims that it hid regulatory problems regarding sales of its Alaris infusion pump, which Becton recalled in 2020.
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January 19, 2024
WHO Report Examines Pros And Cons Of AI In Healthcare
The World Health Organization has released new guidance on opportunities and ethical risks presented by introducing generative artificial intelligence models such as ChatGPT into the healthcare sector.
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January 19, 2024
Fla. Medical Device Co. Sued Over Data Breach That Hit 54,000
A Tampa-based medical device company has been sued over a data breach that allegedly compromised the personal information of 54,000 people, with a proposed federal class action alleging that the company was negligent in protecting its customers' private data.
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January 18, 2024
FTC Asked To Force Google To Delete Sensitive Location Data
Google hasn't kept its promise to delete sensitive location data, including records of users' visits to abortion clinics and addiction centers, a pair of tech advocacy groups told the Federal Trade Commission on Thursday, urging the commission to hit Google with penalties and block its "unlawful" data practices.
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January 18, 2024
CMS Announces State-Based Behavioral Health Model
The Centers for Medicare & Medicaid Services on Thursday launched a program it said will fund up to eight states to implement a new value-based care model designed to improve health outcomes for vulnerable populations.
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January 18, 2024
FDA And CMS Leaders Unite Over Proposed Lab Test Rule
Leaders at the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services joined forces on Thursday, stressing that the two agencies are on the same page regarding the FDA providing increased oversight of laboratory developed tests, or LDTs.
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January 18, 2024
Midwest Healthcare Group Escapes Bulk Of Data Breach Suit
An Illinois federal judge tossed most of a proposed class action alleging an anti-poverty nonprofit's careless management of clients' personal information, including sensitive health information, resulted in a data breach.
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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.
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.