Digital Health & Technology

  • January 31, 2024

    FDA May Have To Cut Activities As Need to Regulate AI Grows

    The U.S. Food and Drug Administration may have to pare back functions if Congress doesn't grant it the budget increase it has requested while the agency tries to keep up with rapid developments in the use of artificial intelligence in healthcare.

  • January 31, 2024

    FDA, Health Experts Talk Int'l 'Harmonization' of AI Regulation

    Cross-border compatibility of rules for artificial intelligence-powered medical devices is critical for device makers looking to globalize their products in an evolving regulatory landscape, legal and governmental experts said Wednesday.

  • 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.

  • 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.

  • 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. 

  • 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.

  • 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.  

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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. 

  • 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. 

  • 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.

  • 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."

  • 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.

  • 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.

Expert Analysis

  • FTC's Health Privacy Actions Offer 5 Advertising Takeaways

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    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.

  • States Shouldn't Fear HIPAA When Improving Gov't Services

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    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.

  • 5 Data Privacy Practices Cos. Should Implement Now

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    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.

  • Privacy Lessons From FTC's BetterHelp Consent Decree

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    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.

  • 118th Congress: Investigative Priorities And Rule Changes

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    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.

  • Emerging Trends In Electronic Health Record Enforcement

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    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.

  • FTC's GoodRx Action Highlights Risks For Digital Health Cos.

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    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.

  • What DOJ's 2022 Recovery Stats Say About FCA Enforcement

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    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.

  • Medicare Developments Ahead For Remote Health Monitoring

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    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.

  • Calif. Privacy Law Holds Implications For Mental Health Apps

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    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.

  • New Clinical Trial Law Promotes Diversity And Modernization

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    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.

  • Evaluating The Legal Ethics Of A ChatGPT-Authored Motion

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    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.

  • 2022 Law And Policy Highlights In Digital Health Care

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    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.