Health-tech compliance
PHI changes everything it touches.- A health system sent a 200-question security review and the deal is paused until it's answered.
- We signed a BAA to close the pilot — before anyone checked what we'd warranted.
- Patient data is in staging, in analytics, and probably in prompt logs; nobody has mapped it.
- Our last 'risk analysis' was a template PDF from 2024 and procurement noticed.
Frameworks in play: HIPAA · SOC 2 · HITRUST (roadmap) · GDPR
Health-tech compliance is asymmetric: the law arrives with the first byte of PHI, the paperwork arrives with the first health-system deal, and enforcement arrives after the first incident — each earlier than teams expect.
The program shape that works
HIPAA and SOC 2 as one control set: shared technical safeguards evidenced once, plus HIPAA’s legal machinery — the risk analysis, the BAA chain, breach clocks and retention. The failure patterns are well-mapped; avoiding them is mostly sequencing.
Where health-tech differs operationally
PHI sprawl is the modern breach shape — staging environments, analytics pipelines, LLM prompts. The ePHI inventory has to be real and re-run when architecture changes, which is why our engagements start there and why the platform’s evidence automation watches the systems the inventory names.
HIPAA Compliance Services
HIPAA compliance services for healthtech and covered entities: security risk analysis, safeguards implementation, BAA management, and breach-ready procedures.
HIPAA Risk Analysis
A done-for-you HIPAA Security Risk Analysis — PHI mapping, threat assessment, and the remediation plan — delivered as the artifact OCR and customers request.
SOC 2 Compliance Services
Hands-on SOC 2 compliance services: gap assessment, control implementation, evidence collection, and audit support — platform included, experts driving.
What do health systems actually require from vendors now?
The Security Risk Analysis by name, the BAA and sub-BAA chain, safeguard specifics — and increasingly a SOC 2 Type II report alongside. Larger systems sometimes ask about HITRUST; for most startups the HIPAA + SOC 2 pairing clears review.
Is HIPAA enough without SOC 2?
Legally yes, commercially decreasingly. HIPAA has no third-party report, so procurement teams lean on SOC 2 as the independent evidence your controls operate. The pairing costs little more than either alone when built on one control set.
How fast can a health-tech startup get defensible?
The HIPAA foundation — risk analysis, BAAs, core safeguards — in weeks. The SOC 2 report follows its own timeline (a quarter to audit-ready plus the observation window). We sequence both against whichever deal is driving the clock.