Healthcare — FDA Escalates GLP-1 Crackdown as Moderna Settles $2.25B Patent Case; Malpractice Insurance Adapts to AI Era

Healthcare · 2026-03-05

Today's developments reveal intensifying regulatory scrutiny in the digital health space alongside major financial implications in the vaccine market. The FDA's expanded warnings to telehealth companies about compounded GLP-1s signal a broader crackdown on unauthorized weight loss drug variants, while Moderna's $2.25 billion settlement with Roivant sets a significant precedent for mRNA patent…

OPENING As artificial intelligence reshapes healthcare delivery, the most pressing conversation isn't about the technology—it's about who bears responsibility when things go wrong. This week's developments around medical malpractice insurance in the AI era signal a fundamental shift that could dramatically impact how quickly and broadly these tools are adopted in clinical settings.

The collision of AI implementation and medical liability is creating unprecedented complexity in healthcare delivery. Traditional malpractice frameworks were designed for human decision-making, not algorithmic interventions. As healthcare providers increasingly rely on AI tools for everything from diagnosis to treatment planning, the lines of responsibility become increasingly blurred. Are physicians liable for following AI recommendations that prove incorrect? Are developers responsible when their algorithms miss critical patterns? These questions aren't just academic—they're actively shaping how cautiously or aggressively healthcare organizations deploy AI solutions.

This challenge comes at a particularly complex moment, as we're seeing increased regulatory scrutiny across healthcare technology. The FDA's expanded warnings to telehealth companies about compounded GLP-1s highlight the growing tension between innovation and oversight. Meanwhile, the ASTP/ONC's renewed focus on interoperability in 2026 adds another layer of complexity—AI systems are only as good as the data they can access, and fragmented health records remain a significant barrier to reliable AI implementation.

The ripple effects extend beyond clinical care into the business of healthcare. This week's massive settlement between Moderna and Roivant over COVID-19 vaccine patents serves as a stark reminder that innovation in healthcare always comes with liability considerations. As AI becomes more deeply embedded in healthcare delivery, we're likely to see similar high-stakes battles over responsibility and compensation when outcomes don't meet expectations.

The healthcare industry's approach to managing AI liability will likely determine the technology's adoption rate more than the capabilities of the technology itself. Conservative interpretations of liability could create a chilling effect on innovation, while overly permissive frameworks might expose patients to unacceptable risks. Finding the right balance will require unprecedented cooperation between healthcare providers, insurers, technology companies, and regulators.

WHAT TO WATCH Keep a close eye on how malpractice insurers adjust their policies and premiums in response to AI adoption. Their risk calculations will serve as a leading indicator of how quickly healthcare organizations can practically implement AI solutions, regardless of the technology's promise. The next few months will likely see the emergence of new insurance products specifically designed for AI-assisted healthcare delivery, potentially creating a new paradigm for how we think about medical liability in the digital age.