Communities left out of the data
When the patients who will ultimately use a medicine are not meaningfully represented in the data that shaped its development, the medicine may not serve them as well.
Ethical and Responsible AI with every Patient in mind
Drug Development should reflect every patient it serves.
Pharmaceutical AI is accelerating drug development at unprecedented speed. But when the data behind that AI doesn't reflect all patients — Black patients, Latino patients, Indigenous patients, older women, people from communities long excluded from medical research — the medicines it shapes may not work as well for the people who need them most.
Every patient deserves medicine developed with their community in mind. Purposa Health exists to make sure the AI driving that development reflects that commitment.
- Years in pharma
- 30+
- Our focus
- Drug Dev for ALL
- Time to act
- Now
THE PROBLEM
AI can close the gaps medicine has carried for generations. But only if we build it that way.
"It gives us the unprecedented ability to develop medicine with every patient community in mind. That is the work."
AI that has not learned from everyone
Most AI tools in drug development were not designed with the full diversity of patients in mind. The gap between who the AI knows and who the medicine is meant to serve is where Purposa Health works.
Exclusion that compounds
Every AI tool built on incomplete representation passes that gap downstream — into trial design, patient selection, safety analysis, and the label that guides prescribing for years.
Our services
Three tiers. One firm that understands both the science and the compliance obligation.
Every engagement begins with a conversation. We meet you where your AI risk lives.
TIER 1 — DIAGNOSTIC
AI Bias Audit
End-to-end audit of every AI tool in your pipeline — mapped to FDA 2025 and EU AI Act requirements.
TIER 2 — ADVISORY
Remediation & Design Advisory
Embedded advisory to remediate identified gaps and align governance with Diversity Action Plans.
TIER 3 — RETAINED
AI Integrity Governance
Retained AI integrity partner — ongoing monitoring, reporting, and governance across the lifecycle.
Our approach
Advisory with a sense of purpose.
- 01
Discover your AI risk
A confidential 30-minute conversation to map your AI landscape, regulatory exposure, and most urgent compliance gaps. No commitment required.
- 02
Audit and validate
Our proprietary Purposa Health Audit Framework™ assesses every AI tool against training data demographics, subgroup performance, and FDA and EU regulatory standards across five structured phases.
- 03
Remediate and govern
We stay with you through remediation, regulatory submission, or ongoing AI integrity governance — as deep as your needs require and as long as the risk demands.
Who we serve
We work with leaders who are asking the hard questions.
Chief Digital Officers
Deploying AI tools fast and need independent validation before EU AI Act deadlines hit.
Chief Medical Officers
Patient advocacy partners are questioning whether your AI reflects the patients your drug is designed to treat.
Regulatory Affairs Leaders
An IND or NDA submission includes AI-assisted analysis. You need a defensible equity validation narrative before it goes to FDA.
The mandate
The regulatory landscape is taking shape. Now is the time to assess.
FDA 2025 AI Guidance
AI tools used in drug development must demonstrate subgroup performance across demographic populations. Sponsors are accountable for the tools they deploy — not just the data they generate.
EU AI Act — August 2026
High-risk AI systems including those used in clinical decision support require bias audits, transparency documentation, and ongoing performance monitoring. Full enforcement begins August 2026.
Diversity Action Plans
FDA Diversity Action Plan requirements for clinical trials create an explicit linkage to AI tools that drive enrollment, patient matching, and protocol design. Most sponsors have not closed this gap yet.