Healthcare & Life Sciences

Keep PHI out of prompts, and prove every clinical AI decision.

Healthcare teams want the productivity of AI without putting protected health information at risk or losing the audit trail a regulator expects. DataStrict enforces minimum-necessary access on the data path and records every decision, so clinical and administrative AI stays inside HIPAA and emerging medical-AI rules.

The pressure

The risk isn't the model. It's what reaches it.

Generative AI raises the stakes on data that was already regulated. These are the pressures DataStrict was built to hold for you.

All industries

  • 01

    PHI flowing into LLMs, retrieval systems, and chat logs that were never scoped for it.

  • 02

    Clinical decision support that needs human oversight and a defensible record of how it behaved.

  • 03

    Business Associate obligations that have to hold across every model and vendor in the stack.

  • 04

    High-risk medical AI obligations arriving under the EU AI Act and software-as-a-medical-device rules.

What we enforce

Controls that run, evidence that holds.

01

PHI redacted on the data path

Entity detection identifies and masks protected health information before it reaches a model, with policy deciding redact versus block.

02

Human oversight where it counts

Ambiguous or high-risk responses escalate for review instead of passing silently - oversight becomes a control, not a hope.

03

An audit trail for OCR

Every access and decision is recorded in a tamper-evident Ledger, so you can show exactly how a clinical AI behaved.

Obligations

Mapped to the rules you answer to.

HIPAA

Privacy and Security Rules for protected health information - minimum necessary, access control, and audit.

EU AI Act

Many medical and diagnostic AI uses are high-risk, with human oversight and record-keeping duties.

FDA (SaMD / GMLP)

Software as a medical device and good machine learning practice expectations for clinical AI.

HITRUST CSF

A common certification framework that maps HIPAA and security controls for healthcare vendors.

External links are provided for reference and are not affiliated with DataStrict. See how obligations become enforced controls on the compliance page, and where the software runs on deployment.

Govern AI like infrastructure.

Talk to our team about deploying DataStrict across your enterprise stack.