Expert Analysis

• Unpacking FDA's Final Clinical Decision Support Guidance

  

  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

  

  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

  

  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.

• How Contractors Can Avoid Cybersecurity FCA Violations

  

  Recent U.S. Department of Justice settlements and remarks underscore heightened focus on cybersecurity liability under the False Claims Act, so government contractors should consider compliance measures such as conducting periodic risk assessments, being responsive to employee concerns, and more, say attorneys at WilmerHale.

• EU Regulation Highlights AI Issues For Digital Health Cos.

  

  As the regulation of artificial intelligence is high on the agenda for EU and U.K. policymakers and regulators, and likely imminent in the U.S., now is the time for providers in the digital health space to consider how compliance may need to change, and safeguard their position in the market, say Chris Eastham and Olivia Morgan at Fieldfisher.

• What DOJ Enforcement Shift Means For Life Sciences Cos.

  

  Though monitoring life science company compliance has historically been the domain of the U.S. Department of Health and Human Services, recent trends suggest that the U.S. Department of Justice may be assuming a primary role going forward, raising interesting questions for the industry, say attorneys at Skadden.

• Ransomware Payment Lessons Amid DOJ Recovery Success

  

  The U.S. Department of Justice’s recent successes clawing back ransom payments made to hacking groups provide companies an additional factor to consider when deciding whether to engage with law enforcement after experiencing a breach, whether to pay a ransom demand, and whether to try to recover the payment, says Tyler Bridegan at Wiley.

• What's Next For DOJ's COVID Enforcement In Health Care

  

  As we enter the end of the third year of the pandemic, a few fraud-related trends and risks have emerged, necessitating important steps that health care and life sciences companies should take in light of continuing U.S. Department of Justice scrutiny, say attorneys at Arnold & Porter.

• How To Minimize Risk When Launching Smart Medical Devices

  

  Prior to launching a smart medical device, there are several critical steps that companies can take in order to protect their intellectual property, get approval from the U.S. Food and Drug Administration and ensure the safety of their data, say attorneys at Crowell & Moring.

• Health Issues To Watch In Inflation Act, Other Policy Initiatives

  

  The newly signed Inflation Reduction Act includes a number of significant drug pricing reforms, and the future holds a wider array of health issues that may be addressed in pending legislation when Congress returns in September, says Miranda Franco at Holland & Knight.

• DOJ Filing Reawakens Fraud-On-The-FDA Theory Of Liability

  

  The U.S. Department of Justice’s recent statement of interest in U.S. ex rel. Crocano v. Trividia Health before a Florida federal court represents a substantial attempt to revive a False Claims Act liability theory involving misstatements to the U.S. Food and Drug Administration, potentially leading to increased scrutiny of medical products, say attorneys at Duane Morris.

• Digital Health Cos. Should Expect More Scrutiny Amid Growth

  

  As the digital health market continues to flourish, the privacy and security of patient data has become a focus of legislative, regulatory and interest group action, and developers should be motivated to reassure both regulators and consumers that users' data is adequately protected, say attorneys at Kirkland.

• Anti-Kickback Circuit Split Holds Implications For Defendants

  

  The Eighth Circuit's recent decision in U.S. v. D.S. Medical represents a significant step toward holding plaintiffs to more exacting burdens of proof in Anti-Kickback Statute False Claims Act suits, and the outcome of the resulting circuit split could decrease estimated damages for defendants, say attorneys at Gibson Dunn.