The tension between "shipping fast" and "staying compliant" reaches a peak when healthcare teams integrate AI features into certified legacy platforms, resulting in a modern compliance collision under evolving frameworks like the EU AI Act, FDA PCCP, and GMLP. This burden is compounded by years of "legacy compliance debt" layered onto ambiguous AI obligations. The session demonstrates how an AI-powered gap analysis can quickly ingest the legacy codebase and new AI modules to surface every regulatory shortfall—such as missing explainability evidence or bias documentation—in a fraction of the time required by manual consultancy. The presentation shows how these gaps are transformed into a prioritized, framework-tagged remediation plan for the development team. Ultimately, the session explores how to navigate this new category of compliance debt, ensuring innovation is not sacrificed for regulatory necessity.
LANGUAGE
English
LEVEL
Advanced
FORMAT
Talk
