Digital Health & Technology

  • February 01, 2024

    Device-Maker Attys Talk FDA Nondevice Rule At Conference

    Over a year after the FDA issued its Clinical Decision Support Software guidance for nonmedical devices that describes the agency's approach to medical device software functions, attorneys working in the medical device regulation space are still grappling with the guidance and learning how the FDA is enforcing the regulation.

  • February 01, 2024

    FTC Puts Cap On Blackbaud's Data Retention In Breach Deal

    Blackbaud Inc. has agreed to delete personal data that it doesn't need anymore and boost its data security to resolve the Federal Trade Commission's claims over a 2020 ransomware attack that affected millions of consumers, the commission announced Thursday, marking the latest regulatory action the software provider has settled over the data breach. 

  • February 01, 2024

    Drug Cos. Not Ready for 'Deep End' of Remote Trials

    Enthusiasm among drug companies and federal officials about increasing diversity among clinical subjects through "decentralized" trials is being tempered by unknowns about the regulatory landscape, a group of experts said Thursday.

  • February 01, 2024

    HHS OKs Telehealth, At-Home Flexibility For Opioid Treatment

    Federal authorities plan to permanently extend pandemic-era rules that allow patients in opioid treatment programs to take methadone at home and obtain prescriptions for buprenorphine during telehealth visits, as part of an effort to combat opioid addiction.

  • January 31, 2024

    FDA Has More Cyber Guidance Planned For Device Makers

    A U.S. Food and Drug Administration official said Wednesday that further guidance is likely in store in 2024 as the agency marks its first year with the new authority to require device makers to submit cybersecurity compliance plans with applications to bring new healthcare devices to market.

  • 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. 

Expert Analysis

  • Top Trends And Challenges For Health Care Financing In 2022

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    Rising inflation, interest hikes, supply chain issues and public market disruption are just some of the factors that made 2022 a challenging year for financing health care deals, and all indications point to continued headwinds next year, say Stephanie McCann and Samantha Koplik at McDermott.

  • 2022 Data Privacy Suits Tested New Liability Theories

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    In the absence of a comprehensive federal data privacy law, plaintiffs lawyers are testing new theories of liability under state laws, and a look at recent lawsuits against online companies that have resulted in large settlements shows these attempts are more frequently being met with success, say attorneys at Quinn Emanuel.

  • How EU's New Pharma Incentives May Affect US Cos.

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    Geneviève Michaux and Georgios Symeonidis at King & Spalding examine Europe's recent revisions to its General Pharmaceutical Legislation and the Orphan and Paediatric Legislation, and consider the European Commission's related policy proposals, with an emphasis on pharmaceutical incentives and impacts for U.S. pharmaceutical developers and manufacturers that market products in Europe.

  • HHS Bulletin Raises HIPAA Risks For Online Tracking Vendors

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    A new bulletin from the U.S. Department of Health and Human Services clarifies how the Health Insurance Portability and Accountability Act applies to information collected by tracking technology on websites and mobile apps, creating new compliance considerations for online tracking vendors that may be unfamiliar with HIPAA, says Mason Fitch at Hintze Law.

  • Compliance Considerations For Virtual Ketamine Clinics

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    In the wake of investigations into several online prescribers of controlled substances, it is more important than ever that virtual clinics providing off-label ketamine treatment for mental and behavioral health issues consider five key aspects to staying compliant with medical practice and controlled substance regulations, say attorneys at Goodwin.

  • State Regulation Compliance Tips For Telehealth Employers

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    Nondisclosure, onboarding and reimbursement challenges are behind many remote work-related telehealth employment lawsuits, but with advance planning and knowledge of the state's requirements where practitioners are located, telehealth employers can avoid costly mistakes from the inception through the end of employment, say attorneys at Foley & Lardner.

  • 9 Legal Ethics Considerations In Natural Disaster Preparation

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    Since natural disasters like Hurricane Ian do not relieve lawyers of their ethical obligations to clients, law firms should focus their preparedness efforts on specific areas crucial to continuity of representation and ethics compliance, like business and communications contingency planning, record redundancy and more, says Mark Hinderks at Stinson.

  • NY Data Breach Penalty Expands Regulatory Requirements

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    The New York Department of Financial Services’ recent consent order with EyeMed is an aggressive reading of state regulation that arguably expands current requirements, which could increase the complexity of the risk assessment process and may serve as a precedent for other privacy and data security regulators, says Rick Borden at Frankfurt Kurnit.

  • Cybersecurity Expectations Intensify For Medical Device Cos.

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    A recent FBI industry notification and U.S. Food and Drug Administration draft guidance highlight urgent compliance considerations for medical device manufacturers, and contrasts with how federal regulators have previously treated health care players as victims in cybersecurity incidents, say attorneys at Morrison Foerster.

  • Risk Mitigation In Face Of Rising Legal Malpractice Claims

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    As the recent rise in frequency and cost of legal malpractice claims is expected to continue amid global high inflation and economic uncertainty, law firms and insurers would be wise to evaluate key risk areas and consider six steps to minimize exposure, say Nicole Shapiro and Cory Stumpf at Atheria Law.

  • Unpacking FDA's Final Clinical Decision Support Guidance

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    The U.S. Food and Drug Administration's latest guidance on clinical decision support software introduces new concepts, questions and ambiguities, and may be challenging to implement in practice, say attorneys at Covington.

  • How Cos. Can Adapt To Global AI Regulation Trends

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    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.

  • 4 Strategies For Drafting Effective Consumer Breach Notices

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    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.