Digital Health & Technology
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January 31, 2024
Northwell Health Sued Over Breach Of 3M Patients' Data
Northwell Health Inc., New York state's largest health care system, breached its duty to protect sensitive information by failing to keep safe the data of over 3 million individuals in a breach, according to a proposed class action filed Tuesday.
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January 31, 2024
Teladoc Illegally Sends Users' Personal Info To Meta, Suit Says
Teladoc users have filed a putative class action in New York federal court accusing the virtual healthcare giant of privacy invasion for allegedly using a tracking pixel on its website to secretly wiretap their communications and activities, then subsequently sharing their personal information with Facebook without their permission.
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January 31, 2024
Lab Says $7M Stolen Data Is Property And Should Be Covered
A national medical testing lab told a Pennsylvania federal court that patient treatment records and at least $7 million of billing data allegedly hijacked by its software contractor was property and should therefore be covered by its insurer.
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January 31, 2024
Fla. Man Avoids Jail In Telemedicine Fraud Suit
A Florida resident did not receive prison time during a federal court hearing Wednesday and instead was sentenced to a period of supervised release for his role in a company that prosecutors say was built to scam insurers into paying millions of dollars for prescriptions that patients didn't need.
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January 30, 2024
CareFirst Judge Mulls Class OK In Trimmed Data Breach Row
A D.C. federal judge on Tuesday appeared open to the possibility of certifying a class of CareFirst policyholders that would seek only nominal damages against the health insurer for a 2014 data breach that exposed personal information belonging to roughly 1.1 million customers.
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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.
Expert Analysis
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How Cos. Can Adapt To Global AI Regulation Trends
Companies can prepare for the future of artificial intelligence regulation by monitoring proposed and existing regulations both in the U.S. and abroad, tailoring their internal compliance architecture for AI-specific risks, and looking for opportunities to lead on governance issues, says Nicholas Diamond at Jackson Walker.
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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.