Alaap B. Shah, Member of the Firm in the Health Care & Life Sciences practice, authored an article in the May 2026 edition of the TechREG Chronicle, titled "From Experimentation to Execution: Healthcare AI's Rapid Adoption Necessitates Robust Governance."
Following is an excerpt:
Artificial intelligence has rapidly transitioned from pilot programs to full-scale deployment across clinical and non-clinical healthcare settings, outpacing the legal and regulatory frameworks designed to govern it. This article examines key AI use case scenarios as a way to explore key applicable regulatory frameworks that may govern use AI uses such as the FDA's Software as a Medical Device framework, HIPAA, ONC's Information Blocking Rules, and emerging state AI legislation. Across each use case, the article identifies area of potential liability and enforcement risks stemming from the misalignment between rapid AI adoption and regulatory readiness. The article concludes that organizations and their AI vendors should move beyond reactive compliance and invest proactively in robust AI governance infrastructure to achieve sustainable success. Organizations that do so will not only mitigate legal exposure but will position themselves to scale AI capabilities with greater institutional confidence and competitive advantage.
