Digital Health & Technology

Expert Analysis

• 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.

• Why Privacy And Trade Secret Law Are On A Collision Course

  

  The conflict between the legal regimes of trade secret law and data privacy law is growing as companies increasingly collect and use data about their customers, making it key for organizations to find ways to comply with both laws in order to protect their intellectual property and the privacy of their customer, says Jenny Colgate at Rothwell Figg.

• Negotiating AI-Life Sciences Partnerships To Minimize IP Risk

  

  When life sciences companies and AI companies form partnerships to foster innovation, the parties should align interests as well as mitigate intellectual property risks by strategically identifying and addressing the unique AI-related legal issues, such as training data, AI model and output, say attorneys at Finnegan.

• Parsing Through The FTC's Proposed Health Privacy Updates

  

  The Federal Trade Commission's recently proposed updates to its Health Breach Notification Rule contain subtle but significant changes to key terms that help modernize the agency's health app regulation and provide stakeholders an important opportunity to help shape the future of virtual health care, say attorneys at Arnold & Porter.

• Regulating AI: An Overview Of Federal Efforts

  

  The U.S. has been carefully managing a national policy and regulatory ecosystem toward artificial intelligence, but as AI technology continues to expand into our everyday lives, so too has its risks and the need for regulation, says Jennifer Maisel at Rothwell Figg.

• Compliance Takeaways From HHS Information Blocking Rule

  

  A recently finalized rule from the U.S. Department of Health and Human Services' Office of Inspector General demonstrates a renewed focus on investigating practices that may interfere with patients' access to their electronic health information, and should encourage renewed compliance efforts across a range of processes, say attorneys at Ropes & Gray.

• Life Sci Cos. Should Work With FDA To Shape AI Regulation

  

  Due to the rapidly evolving nature of potentially long-term regulatory paradigms for artificial intelligence, drug and biologic manufacturers looking to leverage AI should engage strategically with the U.S. Food and Drug Administration to ensure clarity surrounding compliance obligations, say Lowell Zeta and Blake Wilson at Hogan Lovells.