Jim Flynn and Alaap Shah Quoted in Healthcare IT News on Building AI Governance Before Deployment

For hospital boards, health system executives, and digital health companies deploying generative AI, governance choices made before a tool goes live determine whether the organization can defend its practices later.

In a recent article by Healthcare IT News, the publication examined how health systems should build AI governance that begins before deployment and extends through incident response. James (Jim) P. Flynn, Managing Director of Epstein Becker Green and counsel to health systems on health care litigation and regulatory compliance, and Alaap B. Shah, Member of the Firm at Epstein Becker Green and counsel to health care and digital health companies on AI governance and data privacy, outlined what that framework should include.

Flynn recommends an AI governance committee at the board or C-suite level, bringing together legal, compliance, clinical, IT, and patient-safety leaders to oversee vendor selection, validation, monitoring, and incident response. He frames the decision in governance terms rather than operational ones.

“AI adoption is not treated as a procurement decision,” Flynn said. “As I see it, it's a governance decision with clinical, legal and operational implications.”

Shah advises health systems to independently validate AI performance across diverse patient populations before deployment, rather than relying solely on vendor claims, and to negotiate contract terms covering audit rights, access to performance data, and notice of model updates. He also recommends periodic audits comparing AI-suggested documentation against the clinician-approved note.

“Do not wait for regulatory clarity because the regulatory landscape for AI in healthcare is a work in progress,” Shah said. “Build your governance framework now as if the most stringent requirements will apply.”

Get in Touch

To discuss how to structure AI governance committees, vendor contract terms, and retention architecture for AI tools used in patient care, contact Jim Flynn at jflynn@ebglaw.com or Alaap Shah at abshah@ebglaw.com.