Healthcare: Healthcare AI Compliance & Risk
Healthcare AI that passes legal, security, and clinical review.
HIPAA compliant, SOC 2 Type II, on prem/VPC deployment, PHI de identification, and full provenance: so your AI clears compliance instead of dying in it.
The short answer
Is AI in healthcare HIPAA compliant, and what is PHI vs PII?
AI in healthcare can be HIPAA compliant: compliance is a property of how the system is built and operated, not of the model itself. PII (personally identifiable information) is any data that identifies a person; PHI (protected health information) is the subset of PII tied to health, treatment, or payment, and it's what HIPAA regulates. A compliant clinical AI keeps PHI inside covered infrastructure (VPC or on prem), runs under a Business Associate Agreement (BAA) with access controls, encryption, and audit logging, and de identifies data before any component that sits outside that boundary.
What we build
Healthcare AI Compliance & Risk, engineered on your data.
HIPAA & BAA
BAA covered components, property level access controls, encryption in transit and at rest, and full query audit logging.
SOC 2 Type II
Independently audited controls across security, availability, and confidentiality for the platform.
On prem & VPC LLMs
Open weight models (Llama, Mistral) deployed in your VPC or on prem GPUs so PHI never leaves your infrastructure.
PHI de identification
Safe Harbor and Expert Determination de identification so only de identified context is ever sent to any external component.
HITRUST & data residency
Architecture and evidence packs against the HITRUST CSF, with region locked or on prem deployment for data residency requirements.
Cures Act & FDA awareness
Designs aligned to 21st Century Cures Act information blocking rules and informed by FDA AI/ML (SaMD) guidance for clinical software.
FAQ
Healthcare AI Compliance & Risk: frequently asked questions.
What is a Business Associate Agreement (BAA)?
A BAA is the contract HIPAA requires between a covered entity (like a provider or payer) and any vendor that handles PHI on its behalf. It binds the vendor to safeguard PHI, limits how it can be used, and defines breach responsibilities. We sign BAAs for the components that touch PHI.
How do you keep an LLM HIPAA compliant?
The reliable path is to keep PHI inside your boundary: run open weight models in your VPC or on prem so prompts and data never leave, with access controls, encryption, and audit logging. When a public API is genuinely needed, we use zero retention agreements and send only de identified context through a PHI de identification layer.
What is PHI de identification (Safe Harbor vs Expert Determination)?
De identification removes the link between data and a person so HIPAA no longer applies. Safe Harbor removes 18 specified identifiers; Expert Determination uses a qualified statistician to certify re identification risk is very small, which can retain more analytic value. We apply whichever fits the use case before data crosses a trust boundary.
Does the FDA regulate healthcare AI?
It can. Software that diagnoses, treats, or drives clinical decisions may be regulated as Software as a Medical Device (SaMD), and the FDA has specific guidance for AI/ML based devices. Most grounded decision support and documentation tools are designed to keep a clinician in the loop; where a use case approaches SaMD, we design to the applicable guidance and scope the regulatory path explicitly.
Explore the healthcare stack
Related healthcare capabilities.
Clinical GraphRAG & Decision Support
Ground every LLM answer in your clinical knowledge graph and the patient's record, with fact level citations your compliance team can click. Guaranteed hallucination reduction, in writing.
Learn morePatient 360 & Record Linkage
Resolve the same patient across EHR, claims, lab, pharmacy, and device data into a canonical patient graph: the foundation for care coordination, risk stratification, and every downstream clinical AI.
Learn moreEHR Integration
Connect Epic, Cerner (Oracle Health), Athenahealth, and more through FHIR, SMART on FHIR, and HL7 v2: then unify EHR, claims, lab, and pharmacy data into one provenance tracked knowledge graph your AI can actually trust.
Learn moreReady to build healthcare ai compliance & risk on grounded, compliant AI?
A 6 week pilot with one use case, fixed scope, and outcomes guaranteed in writing: hit the target or the pilot is free.