Register 09 · Compliance controls

CMS.

CMS can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting decisions. A team can use Planisphere's self-serve API to gate actions and retain a measurement record for internal or external compliance review; Planisphere does not certify compliance, perform the HIPAA risk analysis, or replace the safeguard system of record.

register 09 · Compliance controls· Healthcare regulation

Reviewed 2026-07-08

01 ·

Promise. compliance

The contract this mark binds — derived, not asserted.

CMS can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting decisions. A team can use Planisphere's self-serve API to gate actions and retain a measurement record for internal or external compliance review; Planisphere does not certify compliance, perform the HIPAA risk analysis, or replace the safeguard system of record.

Answers: What evidence can Planisphere prepare for CMS review?

02 ·

What this is.

Seventy-two regulatory cite-anchors, organized for evidence lookup and review

Use. Medicare/Medicaid coverage · algorithm cannot be the sole basis to deny care.

Register. 09 · Compliance controls — one of the 17 registers of the PLANiSPHERE corpus library.

03 ·

See it work.

Evidence record you can check — not code you have to trust.

Planisphere measures your tool deployment against CMS and seals the result into a signed, Merkle-rooted evidence record. The grade recomputes on your own hardware; the model state never crosses the boundary.

05 ·

The board that carries this.

Related marks, and the surface this one funnels to.

CMS (Medicare/Medicaid coverage · algorithm cannot be the sole basis to deny care) asks for an evidence record: CMS can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting decisions. Read the related clinical AI workflow product context at /medicine.

DSI Source Attributes reg 09 · the 31 predictive-DSI source attributes as an evidence checklist FDA PCCP reg 09 · Predetermined Change Control Plan · drift-bounded model updates FDA PCCP / SaMD reg 09 · Predetermined Change Control · medical AI FDA SaMD 510(k)/De Novo reg 09 · clearance pathway for AI/ML device software functions
06 ·

Routes here from.

Where this mark is referenced in the Planisphere surface.

Any internal link in the Planisphere site that names "CMS" canonicalises here.

See the record CMS asks for.

The console shows the evidence; the docs show the endpoints; the briefing shows what the product does and does not claim.

API ·

When CMS asks for proof, hand over records — not assurances.

record the duty · seal the receipt · verify offline

Planisphere records each duty event — an output marked, a disclosure shown, a review made — and seals it into a receipt that verifies offline against our published keys. You send hashes, never content. A record is evidence a third party can check; it is not a certification and not a legal determination.

See how a record is checked