Digital Health & Technology

Expert Analysis

• 10 Practical Takeaways From FDA's Biopharma AI Guidance

  

  Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.

• How Health Cos. Can Navigate Data Security Regulation Limbo

  

  Despite the Trump administration's freeze on proposed updates to the Health Insurance Portability and Accountability Act security rule, there are critical cybersecurity steps healthcare organizations can take now without clear federal guidance, says William Li at Axiom.

• Rethinking 'No Comment' For Clients Facing Public Crises

  

  “No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.

• Dispelling 10 Myths About Health Provider-Based Compliance

  

  Congress appears intent on requiring hospitals to submit provider-based attestations for all off-campus outpatient hospital locations, so now is the time for hospitals to prepare for this change by understanding common misconceptions about provider-based status and proactively correct noncompliance, say attorneys at McDermott.

• Top 10 Healthcare And Life Sciences Issues To Watch In 2025

  

  Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.

• 2024 Was A Significant Year For HIPAA Compliance

  

  The Office of Civil Rights' high level of Health Insurance Portability and Accountability Act activity in 2024 and press releases about its specific focus on certain cybersecurity issues make it abundantly clear that the OCR is not going to tolerate widespread compliance complacency, says Nathan Kottkamp at Williams Mullen.

• Liability Risk For AI In Medical Devices Demands Greater Care

  

  As regulators push for legal reform surrounding artificial intelligence and cases implicating product liability for AI in medical technology continue to rise, manufacturers must adapt and implement new strategies to accommodate evolving risks, say attorneys at Crowell & Moring.

• 6 Predictions For Cyber Risk And Insurance In 2025

  

  This year is likely to bring with it some thorny and expensive cyber challenges, including increased ransomware activity, more data breach class actions and continued efforts to define business interruption loss calculations, say attorneys at Wiley.

• Health Tech Regulatory Trends To Watch In 2025

  

  With an upcoming change in administration and the release of some long-awaited rules, the healthcare industry should prepare for shifting trends, including a growing focus on health data and interest in technology-enabled delivery of healthcare, say attorneys at Orrick.

• Balancing Health Tech Advances And Clinical Responsibility

  

  To maintain their clinical responsibilities and mitigate potential legal risk, health professionals should incorporate the benefits of new medical technology powered by artificial intelligence while addressing its risks and limitations, says Kathleen Fisher Enyeart at Lathrop GPM.

• Navigating Decentralized Clinical Trials With FDA's Guidance

  

  The U.S. Food and Drug Administration's recently finalized guidance on conducting decentralized clinical trials, while not legally binding, can serve as a road map for sponsors, investigators and others to ensure trial integrity and participant safety, say attorneys at Phillips Lytle.

• What To Expect Next From Federal Health Tech Regulation

  

  Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.

• Defending AI, Machine Learning Patents In Life Sciences

  

  Ten years after the U.S. Supreme Court's decision in Alice v. CLS Bank, artificial intelligence and machine learning technology remain at risk for Alice challenges, but reviewing recent cases can help life sciences companies avoid common pitfalls and successfully defend their patents, say attorneys at Mintz.