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Expert Analysis

• Concerns For 510(k) Sponsors After FDA Proposes Major Shift

  

  While there may be public health benefits from modernizing the 510(k) process for clearing medical devices, recent draft guidance from the U.S. Food and Drug Administration's Center for Devices and Radiological Health leaves meaningful open questions about the legal and regulatory implications of the new approach, and potential practical challenges, say attorneys at Covington.

• Address The Data Monopoly, Otherwise Tech Giants Control AI

  

  It is likely that we will experience a severe monopoly on artificial intelligence systems and patents by the largest players in the tech industry, so the way we treat data needs to change, whether through the legislature, the courts or tech companies, says Pranav Katti at Barclay Damon.

• Companies Must Dig Up Old Laws To Stay Privacy-Compliant

  

  Despite the recent focus on new privacy and data security laws, companies cannot ignore existing rules that have recently been revived, amended or reinterpreted to address emerging privacy and data security challenges, says Julia Kadish at Sheppard Mullin.

• 8 Ways Life Sciences Cos. Can Adapt To The Social Media Era

  

  As pharmaceutical and medical device companies harness the powerful promotion potential of social media, they must navigate legal, regulatory and reputational risks that can be particularly challenging due to the complex framework of rules that apply to the life sciences industry, say attorneys at Troutman Pepper.

• HHS Neuromonitoring Advisory May Have Broad Relevance

  

  The Health Department Office of Inspector General's recent advisory opinion rejecting a neuromonitoring service's proposal for a shell arrangement isn't surprising, but it could be a harbinger of more warnings against problematic joint venture arrangements to come, says Mary Kohler at Kohler Health Law.

• For Radiation Oncology Units, Cyber Vigilance Is Crucial

  

  Recent cyberattacks highlight the unique cybersecurity challenges faced by radiation oncology departments and the importance of implementing policies and procedures to safeguard operations and patient data, says Paul Schmeltzer at Clark Hill.

• How Merger Review Overhaul Could Affect Health Industry

  

  For those in the health care industry considering growth and expansion strategies, the antitrust agencies' recent proposals for new Hart-Scott-Rodino rules and more complex merger guidelines will increase deal timelines, the merging parties' burden, and overall uncertainty and potential antitrust risk as to the outcome, say attorneys at Husch Blackwell.

• What Circuit Split May Mean For FCA Kickback Liability

  

  The recent circuit split on the meaning of the resulting-from provision in False Claims Act kickback cases could have significant ramifications for FCA liability, as it could affect the standard of causation that plaintiffs must meet to establish liability, say former federal prosecutors Li Yu, Ellen London and Gregg Shapiro.

• How Health Cos. Can Brace For Tracking Tech Scrutiny

  

  A joint letter sent by the U.S. Department of Health and Human Services Office for Civil Rights and Federal Trade Commission last month highlights the agencies' concerns about tracking technologies, and may foreshadow a spike in enforcement actions, say attorneys at Moses Singer.

• Unpacking CMS' Latest Proposals For Telehealth Flexibilities

  

  The Centers for Medicare and Medicaid Services' calendar year 2024 proposed rule includes a number of important extensions to telehealth flexibilities, acknowledging the importance of these temporary policies, but permanent certainty will require further legislative action and agency rulemaking, say attorneys at Baker Donelson.

• Wash. Class Actions Are Coming After My Health My Data Act

  

  With its expansive scope and private right of action — including possible class actions — for damages, Washington state’s recently enacted My Health My Data Act will be the basis for a great deal of litigation, and companies should be mindful that plaintiffs will need to prove actual, monetary harm, says Tom Nolan at Quinn Emanuel.

• SEC Cybersecurity Rule Presents Burden For Health Care Cos.

  

  A new rule from the U.S. Securities and Exchange Commission aims to increase cybersecurity resiliency, but may only force regulated entities — particularly those in the health care space — to face a far more complicated environment with increased strategic and litigation risks, say Bess Hinson and Angad Chopra at Holland & Knight.

• Comparing US And EU Approaches To Health AI Regulation

  

  Victoria Larson and Julia Cotney at Verrill Dana compare current U.S. and EU regulatory frameworks for artificial intelligence and machine learning in the healthcare industry and highlight key principles that providers and developers should be aware of.