Healthcare AI Diligence for Investors
Clinical AI safety diligence for healthcare deals: does the safety architecture hold, does the evidence support the claims, and what regulatory exposure comes with the product. Written memo, one debrief call, $15–25K per deal.
Fifteen years of healthcare product and venture experience: kanav.net.
Why clinical AI safety diligence matters
Healthcare AI companies touch patients, sit inside clinical workflows, and face FDA scrutiny, but most investor diligence never assesses clinical safety. This review asks whether the safety architecture holds: can the system be stopped, reversed, and governed under pressure?
What you get
- Clinical validity assessment: does the published evidence support the company’s claims? Is the trial design appropriate for the clinical use case? Are there red flags in how outcomes are measured?
- Safety architecture review: escalation paths, override authority, stoppability, human-in-the-loop design. Where does the system break? Who catches it?
- Regulatory risk analysis: FDA AI/ML SaMD framework applicability, EU AI Act exposure, state-level healthcare AI transparency laws, CMS prior authorization reform implications
- Competitive landscape: who else is solving this problem? What differentiates this approach?
- Investment recommendation: summary of what holds, what’s risky, and what due diligence should verify before the next round.
Process
- Deal intake (async): You share the pitch deck, data room materials, and clinical evidence
- Founding team call (60 min): Clinical safety, regulatory, and operational questions that most diligence misses
- Written memo within 5 business days, structured and citable
- Debrief call (15 minutes): findings and questions
Fee
$15,000–25,000 per deal. Fund-level retainers available.
An example
A venture firm asked us to review an oncology decision-support product before closing its round. We found model updates changing treatment recommendations with no version change, and no way for a clinician to override a plan without filing a support ticket. The firm closed with safety covenants in the term sheet. Read the case study.