Digital Health & Technology

Expert Analysis

• After Chevron: FDA Regulations In The Crosshairs

  

  The U.S. Supreme Court's overturning of the Chevron doctrine is likely to unleash an array of challenges against the U.S. Food and Drug Administration, focusing on areas of potential overreach such as the FDA's authority under the Federal Food, Drug and Cosmetic Act, say attorneys at Debevoise.

• After Chevron: Expect Few Changes In ITC Rulemaking

  

  The U.S. Supreme Court's opinion overruling the Chevron doctrine will have less impact on the U.S. International Trade Commission than other agencies administering trade statutes, given that the commission exercises its congressionally granted authority in a manner that allows for consistent decision making at both agency and judicial levels, say attorneys at Polsinelli.

• 5 Critical Factors Driving Settlement Values In Cyber Litigation

  

  Recent ransomware incidents and their legal repercussions offer five valuable insights into the determinants of settlement values in cyberattack-related litigation, and understanding these trends and their implications can better prepare organizations for the potential legal fallout from future breaches, says Peter Kamminga at JAMS.

• PBM Takeaways From Proposed Telehealth Flexibility Bill

  

  The U.S. House of Representatives' proposal to extend certain telehealth flexibilities signals a robust commitment to expanding telehealth access, though its plan to offset additional expenses through pharmacy benefit manager reform could lead to some industry consolidation, say attorneys at Mintz.

• Unpacking NY's Revised Hospital Cybersecurity Rule Proposal

  

  The New York State Department of Health's recently revised hospital cybersecurity rule proposal highlights increased expectations and scrutiny around cybersecurity in the healthcare sector, while adapting to both recent industry developments and public comments, say Christine Moundas and Gideon Zvi Palte at Ropes & Gray.

• FDA's Data Monitoring Guidance Reveals Future Expectations

  

  As the world of clinical research grows increasingly complex, the U.S. Food and Drug Administration's recent draft guidance on the use of data monitoring committees in clinical trials reveals how the agency expects such committees to develop, say Melissa Markey and Carolina Wirth at Hall Render.

• 'Food As Health' Serves Up Fresh Legal Considerations

  

  The growth of food as medicine presents a significant opportunity for healthcare organizations and nontraditional healthcare players to improve patient outcomes and reduce costs, though these innovative programs also bring compliance considerations that must be carefully navigated, say attorneys at McDermott.

• Key Takeaways From FDA Final Rule On Lab-Developed Tests

  

  Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.

• Examining Illinois Genetic Privacy Law Amid Deluge Of Claims

  

  After a federal court certified an Illinois Genetic Information Privacy Act class action in August, claims under the law have skyrocketed, so employers, insurers and others that collect health and genetic information should ensure compliance with the act to limit litigation risk, say attorneys at Squire Patton.

• Del. Ruling Highlights M&A Deal Adviser Conflict Disclosures

  

  The Delaware Supreme Court recently reversed the Court of Chancery's dismissal of challenges to Nordic Capital's acquisition of Inovalon, demonstrating the importance of full disclosure of financial adviser conflicts when a going-private merger seeks business judgment rule review, say attorneys at Debevoise.

• Are Concessions In FDA's Lab-Developed Tests Rule Enough?

  

  Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

• 8 Questions To Ask Before Final CISA Breach Reporting Rule

  

  The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.

• Considering CGL Defense For Social Media Addiction Claims

  

  A recent lawsuit filed in California state court against Meta seeks damages from technology companies for the costs of treating children allegedly suffering from social media addiction, but the prospects of defense coverage under commercial general liability insurance policies for a potential new wave of claims look promising, say Craig Hirsch and Tae Andrews at Pasich.