Digital Health & Technology

Expert Analysis

• AI Regulatory Gaps May Fuel FCA Enforcement Action

  

  The intersection of artificial intelligence and False Claims Act enforcement presents legal risk for government contractors across several industries, particularly in the absence of a federal regulatory framework explicitly governing its development and use, say attorneys at O’Melveny.

• Health Cos. Must Act Quickly To Secure Digital Front Doors

  

  A fast-approaching deadline will require health providers to implement digital accessibility standards to their websites, necessitating important compliance steps that will help to ensure equal access to online health services, say attorneys at Holland & Knight.

• Congress Should Ax Privacy Bill For Not Shielding Consumers

  

  The SECURE Data Act should be rejected because, despite Congress' claims, it would not meaningfully rein in data practices, but instead would weaken enforcement, eliminate stronger protections and prioritize data extraction over consumer protection and accountability, say attorneys at DiCello Levitt.

• DOJ Delay Of ADA Web Rule Undermines Equal Access

  

  The U.S. Department of Justice's recent decision to delay compliance dates for regulations ensuring accessible government services online benefits no one, as it is long overdue for disabled Americans and doesn't lessen covered entities' legal obligations or litigation risk, say Mark Riccobono at the National Federation of the Blind and Eve Hill at Brown Goldstein.

• Insurer Lessons From 1st Wave Of GenAI Coverage Rulings

  

  Several pending cases target the issue of whether generative AI may appropriately replace human professional decision-making, and though each case is still in discovery, the decisions thus far provide insurers with guidance on how courts may view these claims, say attorneys at Simpson Thacher.

• A Check-Up On HHS' Push To Implement AI Infrastructure

  

  The U.S. Department of Health and Human Services has made some headway in its efforts to implement artificial intelligence across its agencies, but will have to overcome a number of near-term tests in order to be successful, says Theodore Thompson at Stinson.

• 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.