HealthTech Startup Due Diligence Checklist for Investors (2026)
This checklist covers 18 due diligence items for HealthTech startups. Each item has been validated against institutional investor practice. DDR automates the majority of these checks from a single pitch deck PDF upload.
18 checklist items · 4 red flags automatically detected · See a sample DDR report
HealthTech Sector
✓
FDA regulatory status confirmed (clearance, exempt, or pre-submission in process)
✓
HIPAA compliance program documented with BAA template
✓
Clinical evidence reviewed with methodology assessment
✓
Payor coverage or CPT code strategy documented
✓
Reference customer interviews completed
✓
Data security assessment and breach history reviewed
✓
Stark Law / Anti-Kickback compliance verified for any referral arrangements
Deep Dive
✓
Verify FDA clearance status and any 510(k) submission history
✓
Confirm HIPAA compliance framework: BAA templates, security officer, breach history
✓
Review clinical evidence: study design, sample size, statistical significance
✓
Assess payor coverage and reimbursement status
✓
Interview reference customers (physicians, administrators, patients)
Regulatory
✓
Verify: FDA 510(k) or PMA: medical device and diagnostic claims require pre-market review
✓
Verify: HIPAA: PHI handling requires BAAs, security officer, breach notification protocol
✓
Verify: Stark Law and Anti-Kickback Statute: referral and compensation arrangements in healthcare
OSINT Signals
✓
Check: FDA 510(k) database: verify clearance status and device classification
✓
Check: PubMed: search for published clinical studies mentioning the company
✓
Check: ClinicalTrials.gov: check for registered studies
DDR AUTOMATES THIS CHECKLIST
Upload a HealthTech startup pitch deck and DDR automatically completes 13+ of these 18 checklist items — sourcing data from 13 OSINT signals, benchmarking against 3 comparable companies, and detecting all 4 critical red flags.
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