Digital Health & Technology

Expert Analysis

• 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.

• BIPA, Meta Pixel Suits Could Reshape Cybersecurity Litigation

  

  Businesses and attorneys should watch several pending electronic privacy cases that revolve around disclosure of protected personal information and health data, which may shape how courts handle damages and class actions in the future of cybersecurity litigation, say Kelly Johnson and Melanie Condon at Goldberg Segalla.

• The Double-Edged Sword Of Using ChatGPT In Health Care

  

  While ChatGPT has shown promising potential in health care, one of the key challenges for players in this space is balancing patient privacy and data protection with the benefits of utilizing this technology, say attorneys at Sheppard Mullin.

• Addressing Legal Issues Raised By AI Use In Health Care

  Excerpt from Practical Guidance

  

  With the usage of artificial intelligence and machine learning in health care likely to be governed by a patchwork of state laws for the near future, industry actors should build flexibility into products to meet evolving regulatory concerns, including monetization of patient data and professional licensing questions, say Sara Shanti and Phil Kim at Sheppard Mullin.

• New Health Data Compliance Considerations For Pa. Lawyers

  

  Given the regularity with which attorneys handle private health information, it is important for Pennsylvania firms to understand recent significant amendments to the state's data breach law, which address information not currently covered by federal law, says Mark Mattioli at Post & Schell.

• Mitigating Risks Of Developing Drugs And Devices With AI

  

  As the use of artificial intelligence in drug and medical device development advances, companies should implement five key steps to identify and mitigate areas of potential risk before regulatory frameworks catch up, say attorneys at King & Spalding.