Innovate Fast.
Stay Compliant.
HIPAA, FDA, clinical trials, BAAs — healthcare companies face the heaviest regulatory burden of any industry. CrestlineAI maps the landscape so you know exactly what applies and what to do.
The Healthcare Compliance Burden
$100+
Per-record HIPAA violation penalty — a single breach involving 10,000 records can cost over $1M before litigation even starts
+40%
Increase in FDA warning letters since 2020 — enforcement is accelerating and the agency is watching digital health closely
$50K+
Average cost of a single compliance audit — and most healthcare startups need multiple audits before their Series A
Quarterly
Healthcare regulations change every quarter — what was compliant last year may not be compliant today
Built For You
Your Healthcare Compliance Toolkit
Six AI-powered tools built for the regulations, contracts, and compliance challenges that healthcare companies actually face.
Compliance Scanner
Map your HIPAA, HITECH, FDA, and state-level health privacy obligations in minutes. Get a prioritized list of requirements with specific action items for your product and stage.
Try itPrivacy Policy Generator
Generate BAA-compliant privacy policies, notices of privacy practices, and data handling disclosures — customized to your data flows, vendors, and patient-facing products.
Try itContract Analyzer
Upload any vendor agreement, BAA, or clinical partnership contract and get instant analysis of PHI handling provisions, indemnification, and regulatory compliance terms.
Try itDue Diligence
Run compliance due diligence on partners, vendors, and acquisition targets. Surface regulatory history, enforcement actions, and compliance gaps before you sign.
Try itDocument Drafter
Draft clinical trial agreements, research collaboration contracts, data use agreements, and IRB submission documents from professional healthcare-specific templates.
Try itEntity Structure Advisor
Structure your entity for FDA submissions, clinical trials, and healthcare licensing requirements — including state-by-state corporate practice of medicine considerations.
Try itHow Teams Use CrestlineAI
Map HIPAA, HITECH, and state health privacy requirements
Input your product, data flows, and operating states — get a comprehensive map of every regulation that applies, with specific compliance steps ranked by risk and enforcement priority.
Generate BAA-compliant privacy policies
Create privacy policies and notices of privacy practices that satisfy HIPAA requirements, state health privacy laws, and app store health data disclosure rules — in minutes, not weeks.
Review vendor agreements for PHI handling
Upload your cloud provider, analytics vendor, or EHR integration contracts and instantly see whether PHI handling, breach notification, and security provisions meet HIPAA standards.
Run compliance due diligence on partners
Before signing a BAA or data sharing agreement, run due diligence on a partner's regulatory history — surface OCR enforcement actions, FDA warning letters, and state-level violations.
Draft clinical trial agreements
Generate clinical trial agreements, site agreements, and CRO contracts with proper regulatory language, IP provisions, and data ownership terms built in from the start.
Structure your entity for FDA submissions
Get guidance on entity structure, state licensing, and corporate organization that positions your company for FDA pre-submission meetings, 510(k) clearance, or PMA approval.
“We were three weeks from our Series A due diligence when we ran our compliance stack through CrestlineAI. It identified 12 gaps — including a BAA we never executed with our cloud provider and missing state health privacy registrations. We fixed everything before the investors' lawyers even looked. That tool saved our round.”
Dr. Anish R.
CEO, Digital Health Startup
Move Fast. Break Nothing.
Stop letting regulatory complexity slow your innovation. Get instant compliance mapping built for the way healthcare companies actually build.
Professional plan at $499/month — less than one compliance consultant day