Digital Health & Technology
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January 30, 2024
NC Hospital Says It Didn't Share Patient Data With Meta
A North Carolina hospital system scoffed at allegations that it shared patient information with Facebook without consent for years in response to a proposed negligence class action brought by three patients and after a state business court allowed the action to move forward.
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January 30, 2024
Stryker Can't Slip California Workers' Wage Suit
Medical device company Stryker cannot escape former workers' wage claims, a California federal judge ruled Tuesday, saying it was unclear whether the company was the workers' employer because it still retained some authority over workers employed by the company's subsidiaries.
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January 29, 2024
Reps Want More From VA On AI Transparency, Enforcement
Members of the House of Representatives on Monday grilled officials from the U.S. Department of Veterans Affairs on how they plan to protect veterans' privacy and ensure transparency in the development and deployment of artificial intelligence models.
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January 29, 2024
Meta Must Keep Battling Trimmed Health Tracking Privacy Suit
A California federal judge on Monday refused to throw out a trimmed version of a lawsuit claiming that Meta Platforms Inc. illegally collected patients' health information using a Facebook data tracking tool, ruling that their latest complaint has addressed some of his prior concerns.
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January 29, 2024
Texas AG Seeks Transgender Patients' Data, Ga. Clinic Says
Georgia-based telehealth clinic QueerMed said Monday that Texas Attorney General Ken Paxton is asking for medical records for patients seeking gender-affirming care, saying the request appears intentional to deter out-of-state clinics from providing such care.
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January 29, 2024
FDA Seeks Input On Reporting Race, Ethnicity In Drug Trials
The Food and Drug Administration asked the healthcare industry Monday for comment on updated guidance that outlines the agency's expectations for collecting race and ethnicity data in drug and medical device research.
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January 29, 2024
Imperative Care Names O'Melveny Deals Partner As CLO
Silicon Valley's Imperative Care announced Monday that an O'Melveny deals partner will take over as chief legal officer, joining a revamped leadership team at the medical tech company.
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January 26, 2024
23andMe Users Say Hackers Targeted Jewish, Chinese Data
Hackers who pushed their way past 23andMe's security systems in a data breach last year were after the personal information of Jewish and Chinese customers, but the biotechnology company hid that detail when notifying 7 million affected customers, according to a proposed class action filed Friday in California federal court.
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January 26, 2024
Bills Aim To Halt Cash To Chinese Cos. Over Genetic Data
Lawmakers on Capitol Hill have introduced legislation to block Chinese biotech companies from receiving federal funding if they have ties to the Chinese Communist Party, saying the goal is to prevent such companies and the party from stealing America's genetic data.
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January 26, 2024
Ex-Goodwin Procter Life Sciences Atty Joins DLA Piper In NY
DLA Piper announced it has hired an experienced life sciences transactional attorney from Goodwin Procter LLP as a New York-based partner in its corporate practice.
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January 25, 2024
Morgan & Morgan Beats Firms To Lead Zoll Data Breach Row
A Massachusetts federal judge on Thursday tapped Morgan & Morgan PA to lead a proposed class action by customers of Zoll Medical Corp. alleging the company failed to protect their private information in two data breaches, rejecting a competing bid by Hausfeld LLP and DiCello Levitt.
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January 24, 2024
Med Device Employee Gets 1 Year For Forging FDA Clearance
A former worker for a medical device maker was sentenced Wednesday to a year in prison after pleading guilty to his role in selling medical equipment that did not have governmental approval.
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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.
Expert Analysis
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FTC's Health Privacy Actions Offer 5 Advertising Takeaways
The Federal Trade Commission's recent enforcement actions against GoodRx and BetterHelp highlight the need for any company engaging in common online advertising practices to pay close attention to the personal information they collect and share with third parties, say Kate Black and Sam Castic at Hintze Law.
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States Shouldn't Fear HIPAA When Improving Gov't Services
As the looming end of the COVID-19 public health emergency motivates states to streamline their processes for individuals seeking public benefits, they should generally not have to worry about violating the Health Insurance Portability and Accountability Act when sharing data across government services, says Jodi Daniel at Crowell & Moring.
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5 Data Privacy Practices Cos. Should Implement Now
Businesses that are not subject to a comprehensive data privacy law should nevertheless consider implementing privacy practices that are consistent with current norms to help mitigate both common law exposure and an expensive rush to compliance if a federal law is passed, say John Rolecki and Alexander Thibodeau at Varnum.
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Privacy Lessons From FTC's BetterHelp Consent Decree
The Federal Trade Commission's recent enforcement action against BetterHelp highlights the growing risk associated with the use of third-party cookies and pixels on websites for companies that offer health services, say Rachel Marmor and Shannon Hartsfield at Holland & Knight.
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118th Congress: Investigative Priorities And Rule Changes
Attorneys at Gibson Dunn lay out what companies and individuals can expect with regard to congressional investigations in the 118th Congress, from political priorities to new rules and authorities.
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Emerging Trends In Electronic Health Record Enforcement
As electronic health record systems become increasingly ubiquitous in health care, recent Anti-Kickback Statute and False Claims Act cases involving EHR systems provide a helpful list of issues that tech-savvy relators and government investigators might identify, say Ellen London at London & Stout and former Assistant U.S. Attorney Li Yu.
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FTC's GoodRx Action Highlights Risks For Digital Health Cos.
The Federal Trade Commission's first-of-its-kind enforcement action against GoodRx for unlawfully sharing sensitive customer information is indicative of regulators' growing interest in the digital health space and heightens the importance of taking proactive compliance steps, say attorneys at Ropes & Gray.
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What DOJ's 2022 Recovery Stats Say About FCA Enforcement
Despite showing a decline in False Claims Act recoveries in fiscal year 2022, the U.S. Department of Justice's recently released statistics should lead companies to expect a continued rise in government-initiated investigations, pandemic-related fraud enforcement and FCA cases involving new technology, say attorneys at Crowell & Moring.
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Medicare Developments Ahead For Remote Health Monitoring
Stakeholders interested in remote monitoring services should keep an eye on an upcoming multijurisdictional contractor advisory committee meeting that may lead to a new local coverage determination affecting Medicare coverage for remote monitoring devices, say attorneys at McDermott.
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Calif. Privacy Law Holds Implications For Mental Health Apps
California is leading the way in privacy regulation with its amended Confidentiality of Medical Information Act, which has important compliance repercussions for mental health app developers and could serve as a model for similar laws in other states, say Christine Moundas and Elana Bengualid at Ropes & Gray.
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New Clinical Trial Law Promotes Diversity And Modernization
The Food and Drug Omnibus Reform Act, signed into law last month, will likely encourage more equitable subject recruitment and enrollment in clinical trials, and also could create a pathway toward clarifying ambiguities that have historically been left for regulated entities to piece together, say attorneys at Ropes & Gray.
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Evaluating The Legal Ethics Of A ChatGPT-Authored Motion
Aimee Furness and Sam Mallick at Haynes Boone asked ChatGPT to draft a motion to dismiss, and then scrutinized the resulting work product in light of attorneys' ethical and professional responsibility obligations.
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2022 Law And Policy Highlights In Digital Health Care
This year, federal regulators made good on several commitments to create new opportunities for digital health innovators, and a number of promising cybersecurity bills are on the horizon, but not all virtual health care law and policy developments have been positive, say attorneys at Arnold & Porter.