Expert Analysis

• The Road Ahead For Drug Development In The US

  

  Against the backdrop of drug manufacturers potentially looking to move development efforts overseas, the U.S. Food and Drug Administration's latest guidance on new approach methodologies signals the FDA is likely to be receptive to industry innovation that makes U.S.-based drug development faster or less expensive, creating opportunities and compliance risks for tech companies, say attorneys at Morgan Lewis.

• Del. Blackbaud Ruling Signals A New Era For Cyberinsurance

  

  The recent Delaware Supreme Court ruling in Travelers v. Blackbaud shows that cyberinsurance is moving into a second maturity phase, in which insurers will increasingly attempt to recover their payments from vendors and insureds will face new pressure to justify cyber incident reimbursements, say Steven Teppler at Mandelbaum Barrett and Jade Davis at Shumaker.

• How To Engage With Gov't's Direct-To-Consumer Drug Policy

  

  The U.S. Department of Health and Human Services' recent request for industry input on manufacturers' direct-to-consumer drug sales reflects the government's caution in this arena, and allows stakeholders a rare opportunity to help shape policy, says Mary Kohler at Kohler Health Law.

• FDA's Biosimilarity Guidance Holds Uncertain Implications

  

  The U.S. Food and Drug Administration's new draft guidance aimed at simplifying the biosimilarity demonstration process may not be enough to overcome the barriers that have historically constrained biosimilar competition, and could affect biosimilar access in unexpected ways, say analysts at Analysis Group.

• Health Co.'s 'Success Story' Misstep Holds HIPAA Lessons

  

  Cadia Healthcare Facilities' fall settlement with the U.S. Department of Health and Human Services for improperly disclosing patients' protected health information in online success stories is an instructive example of Health Insurance Portability and Accountability Act risks that can arise from digital marketing efforts, say attorneys at Woods Rogers.

• Methods For Challenging State Civil Investigative Demands

  

  Ongoing challenges to enforcement actions underscore the uphill battle businesses face in arguing that a state investigation is prohibited by federal law, but when properly deployed, these arguments present a viable strategy to resist civil investigative demands issued by state attorneys general, say attorneys at Troutman Pepper.

• What FDA Guidance Means For Future Of Health Software

  

  Two significant final guidance documents released by the U.S. Food and Drug Administration last month reflect a targeted effort to ease innovation friction around specific areas, including singular clinical decision support recommendations and sensor-based wearables, while maintaining established regulatory boundaries, say attorneys at Covington.

• Federal Preemption In AI And Robotics Is Essential

  

  Federal preemption offers a unified front at a decisive moment that is essential for safeguarding America's economic edge in artificial intelligence and robotics against global rivals, harnessing trillions of dollars in potential, securing high-skilled jobs through human augmentation, and defending technological sovereignty, says Steven Weisburd at Shook Hardy.

• California's New Privacy Laws Demand Preparation From Cos.

  

  An increase in breach disclosures is coinciding with California's most comprehensive privacy and artificial intelligence legislation taking effect, illustrating the range of vulnerabilities organizations in the state face and highlighting that the key to successfully managing these requirements is investing in capabilities before they became urgent, says Camilo Artiga-Purcell at Kiteworks.

• AI Scientific Discovery Order Implications For Life Sciences

  

  President Donald Trump's November executive order establishing a government effort to use artificial intelligence to accelerate scientific discovery has the potential to leverage significant federal resources and data to support research, drug and device approvals, and AI model training in the life sciences sector, say attorneys at Hogan Lovells.

• Remote Patient Monitoring Is At Regulatory Inflection Point

  

  With remote patient monitoring at the center of new federal pilot programs and a recent report from the U.S. Department of Health and Human Services' Office of Inspector General examining Medicare billing for those services, it is clear that balancing innovation and risk will be a central challenge ahead for digital health stakeholders, say attorneys at Morgan Lewis.

• Texas AG Wields Consumer Protection Law Against Tech Cos.

  

  Texas Attorney General Ken Paxton has targeted technology companies using the Texas Deceptive Trade Practices Act, a broadly worded statute that gives the attorney general wide latitude to pursue claims beyond traditional consumer protection, creating unique litigation risks, say attorneys at Yetter Coleman.

• Utah's AI Prescription Renewal Pilot Could Inform Policy

  

  Utah recently became the first state to approve an artificial intelligence system for autonomously renewing certain prescription medicines, providing a test case for how regulators may be able to draw boundaries between administrative automation and medical judgment, say Jashaswi Ghosh at Holon Law Partners and Bryant Godfrey at Foley Hoag.