Purposa Health Insights
Perspectives on AI population science, regulatory compliance, and the future of equitable drug development.
AI Compliance — Featured Resource
A complete guide to FDA artificial intelligence guidelines for drug development — what the guidance requires, what it means for your organization, and how to position yourself for compliance.
AI Compliance — New
The FY2027 House Appropriations Report contains specific time-bound FDA directives on AI in drug development and clinical trial population representation. Here is what it says and why it matters for your documentation posture now.
AI Compliance
As autonomous AI systems take on greater roles in drug development, a critical question remains unanswered: who verifies these systems perform equitably across every patient population before they reach a regulatory submission?
Population Science
FDA guidance on AI in drug development is evolving rapidly. The organizations that treat population representation as a compliance requirement — not a values statement — will be positioned to lead.
Agentic AI
A new class of autonomous AI tools is executing clinical workflows, pulling trial data, and making real-time decisions across pharma and biotech. The governance infrastructure to make these systems safe and representative has not kept pace.
AI Compliance
What sponsors need to know about population representation, subgroup performance, and the documentation regulators now expect when AI is used in clinical research.
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