HIPAA violations. FDA audit failures. PHI breaches. In healthcare, compliance failures don’t just cost money — they cost operating licences and patient trust.
One sprint. Zero exposure.
StackWeaver compresses healthcare compliance into weeks with AI-driven gap analysis, HIPAA control automation, and surgical execution. HIPAA readiness in 6–10 weeks. Multi-framework attestation in 3–6 months.
Healthcare compliance isn’t optional — it’s the foundation of trust, partnerships, and growth.
HIPAA violations carry fines of up to $1.9M per violation category per year. OCR audits are increasing. A compliance gap discovered during investigation costs ten times more than a gap closed in preparation.
A single PHI breach triggers mandatory patient notification, OCR investigation, and reputational damage that no PR campaign recovers from. We close the gaps that cause breaches — before they happen.
Hospital systems, insurance networks, and large healthcare organisations require HIPAA Business Associate Agreements backed by demonstrable compliance controls — not policy documents. We build the controls.
FDA’s Software as a Medical Device framework and cybersecurity guidance for digital health create new compliance obligations that most health tech companies aren’t tracking. We are.
Full gap analysis against HIPAA Security Rule administrative, physical, and technical safeguards. Risk assessment, control design, evidence package, and BAA readiness.
End-to-end mapping of where PHI lives, moves, and is accessed in your environment. Identifies exposure points that manual review misses.
SOC 2 Type I and II with healthcare-specific trust criteria. Designed for health tech companies that serve enterprise clients requiring both HIPAA and SOC 2 attestation.
Assessment against FDA cybersecurity guidance for medical devices and digital health software. Pre-submission readiness and post-market surveillance compliance.
Most HIPAA consultants write policies. We build controls, automate evidence, and produce the workpaper package your auditor requires. Policies don’t pass audits. Evidence does.
Same senior expertise. A fraction of the cost. Weeks, not months.
Every engagement led by senior engineers with healthcare compliance execution experience — not graduates applying templates.
If you handle any Protected Health Information (PHI), HIPAA applies from day one. Pre-revenue is actually the best time to build compliance in.
HIPAA is the legal requirement. HITRUST is a comprehensive certification framework that demonstrates HIPAA compliance plus additional security controls.
Typically 3–8 weeks depending on system complexity. We offer expedited programs for urgent partnership deadlines.
Start with a Pre-Deal Intelligence Sprint. 48–96 hours. Board-ready gap analysis. $4,900 flat fee.
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