What's the difference between HIPAA and FDA PCCP / SaMD?

HIPAA (health privacy · patient data confidentiality) and FDA PCCP / SaMD (Predetermined Change Control · medical AI) are distinct cite-anchors. Planisphere's evidence record maps both controls for evaluator review; sufficiency remains evaluator-specific.

Do I need both HIPAA and FDA PCCP / SaMD in my record?

If both apply to your tool deployment, yes — and the record maps both controls in one artifact at no extra cost.

Comparison · register 09

HIPAA vs FDA PCCP / SaMD.

Two regulatory anchors. Planisphere's evidence record maps both controls. This page is the comparison query's canonical destination.

Scope an AI workflow review HIPAA brief FDA PCCP / SaMD brief

01 ·

When to lead with HIPAA.

Use HIPAA as the primary anchor when the evaluator is shaped this way.

Audience. health privacy · patient data confidentiality.

Shape. privacy shield · brass medical cross.

Where it lives in the record. The HIPAA cite-anchor pins next to every artifact in ATTESTATION.json. See the HIPAA brief for the field-level mapping.

02 ·

When to lead with FDA PCCP / SaMD.

Use FDA PCCP / SaMD as the primary anchor when the evaluator is shaped this way.

Audience. Predetermined Change Control · medical AI.

Shape. envelope + brass clearance clock.

Where it lives in the record. The FDA PCCP / SaMD cite-anchor pins next to every artifact in ATTESTATION.json. See the FDA PCCP / SaMD brief for the field-level mapping.

03 ·

Both at once.

The evidence record maps both anchors for review — you don't have to pick.

Planisphere's evidence record is multi-control by construction. HIPAA and FDA PCCP / SaMD are both keys in the record's requirement list; the same SHA-pinned, Merkle-rooted artifact gives both evaluators a shared review record.

The requirement list is open — add any standard the regulator names. See the full compliance-control register.

Compare AI options for compliance