Healthcare AI Diligence for Investors
The Ethotechnics framework applies burden mapping, decision records, trust signal design, and escalation architecture to evaluate clinical AI safety risk for healthcare deals. Written memo. One debrief call. $15-25K per engagement.
Built on 15 years of healthcare product and venture experience.
Why clinical AI safety diligence matters
Healthcare AI companies touch patients, enter clinical workflows, and face FDA scrutiny — but most investor diligence processes lack clinical safety assessment. A thorough diligence review examines 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 delivered within 5 business days — structured, citable, board-ready
- Debrief call (15 min): Present findings and answer questions
Fee
$15,000–25,000 per deal. Volume available for fund-level retainers.