Boundary Release Approval Matrix

SCRIMED can track every required approval without prematurely unlocking any preserved boundary.

This matrix turns the approval path into owned steps, evidence requirements, signoff lanes, and release hashes. It documents what is prepared, what remains externally required, and why production authority stays fail-closed until named human approvals exist.

Download Approval Brief Inspect API Clinical Readiness Global Approvals

Statusboundary-release-approval-matrix-active-fail-closed

Release candidates9

Released0

Blocked9

Steps29

Prepared steps6

Pending signoffs40

Evidence queue133

Raw evidenceblocked

Step trackingcomplete

Release rule

Documented is not approved. SCRIMED still requires named release authority.

SCRIMED Boundary Release Approval Matrix documents the approval path for preserved NO-GO boundaries. It does not grant PHI authority, clinical authority, payer submission authority, EHR writeback authority, production connector approval, certification claims, or customer go-live approval.

The matrix can complete the approval path documentation, but it cannot relieve a boundary. A separate named human release decision must be created after all evidence and signoffs are approved.

01live PHI approved

02autonomous clinical care approved

03diagnosis approved

04treatment or prescribing approved

05imaging interpretation approved

06EHR writeback approved

07payer submission approved

08production connector approved

09certification claim approved

10customer go-live approved

Approval path

Each preserved boundary has an approval path, missing evidence, signoff lanes, and a safe workaround.

Attach each preserved boundary to its evidence packet, assign the missing signoff owners, and keep the runtime fail-closed until approved release decisions exist.

external-approval-required

Live PHI / ePHI processing

No live PHI, patient identifiers, source medical records, production credentials, or raw connector payloads.

Release decision: blocked-fail-closed

Can relieve now: false
Unlocks only after: HIPAA security risk analysis, BAA coverage, tenant isolation, privacy/security review, customer authorization, and incident-response evidence are complete.
Release hash: 5366e6d20895bfa5
Safe workaround: Use synthetic fixtures, de-identified metadata planning, and no-PHI Health Records Safety Exchange reviews.

external-approval-required

Clinical decision support

No final diagnosis, treatment recommendation, triage replacement, clinical validation claim, or autonomous clinical authority.

Release decision: blocked-fail-closed

Can relieve now: false
Unlocks only after: Intended use, FDA/CDS analysis, clinical safety case, validation protocol, evidence visibility, and clinician governance are approved.
Release hash: e10f6630fc430147
Safe workaround: Offer synthetic Clinical Robustness Lab reviews, evidence summaries, and clinician-reviewed draft support only.

blocked-fail-closed

Autonomous diagnosis, treatment, prescribing, or imaging interpretation

No autonomous diagnosis, treatment, prescribing, order placement, pharmacy action, or imaging interpretation.

Release decision: blocked-fail-closed

Can relieve now: false
Unlocks only after: A separate regulated clinical product pathway, malpractice coverage, medical governance, prescribing compliance, and production safety case are approved.
Release hash: ee48d433d3367a9b
Safe workaround: Use draft-only education, documentation support, and clinician-reviewed safety/evidence summaries.

external-approval-required

EHR writeback and production connector activation

No EHR writeback, chart filing, record mutation, order entry, or production connector approval.

Release decision: blocked-fail-closed

Can relieve now: false
Unlocks only after: Customer authorization, EHR vendor app registration, scoped SMART/FHIR permissions, sandbox validation, rollback plan, and clinical signoff are complete.
Release hash: bffd1ce5c88e3ed7
Safe workaround: Generate draft packets and human-readable summaries for manual review outside SCRIMED writeback paths.

external-approval-required

Payer submission, prior authorization, claims, and appeals

No autonomous payer submission, claim filing, prior authorization submission, appeal filing, or reimbursement guarantee.

Release decision: blocked-fail-closed

Can relieve now: false
Unlocks only after: Trading partner agreement, payer/clearinghouse approval, X12/FHIR validation, provider attestation, and human submitter approval are complete.
Release hash: aeb45559072d24b6
Safe workaround: Create draft prior-auth and claims packets for human review without transmitting to payers.

external-approval-required

Clinical research, outcomes learning, and human-subject data

No live patient research, outcomes learning from identifiable data, or human-subject research claims without protocol review.

Release decision: blocked-fail-closed

Can relieve now: false
Unlocks only after: IRB determination or approval, consent/waiver analysis, protocol, privacy review, and data-minimization controls are complete.
Release hash: f5b64feb70e6f3c7
Safe workaround: Use synthetic scenarios, public literature, and reviewer-created SME expectations without live patient data.

external-approval-required

SOC 2, HIPAA, HITRUST, ISO, FDA, ONC, and certification claims

No certification, clearance, validation, compliance-completion, or audited-report claims unless independently verified.

Release decision: blocked-fail-closed

Can relieve now: false
Unlocks only after: Qualified auditor, assessor, regulator, or certification body evidence exists for the exact claim and scope.
Release hash: 283d92647b1535e7
Safe workaround: Say SCRIMED is preparing for audit/readiness review; do not claim certification, clearance, or compliance completion.

external-approval-required

Global operation, data residency, GDPR, EHDS, and EU AI Act readiness

No global launch, regional regulatory approval, data-residency approval, public-sector procurement approval, or EU AI Act compliance claim.

Release decision: blocked-fail-closed

Can relieve now: false
Unlocks only after: Regional counsel, privacy review, DPA/SCCs where needed, DPIA, data-residency decision, AI Act classification, and customer approval are complete.
Release hash: 795bee1378a5bd9b
Safe workaround: Use synthetic regional readiness packs and keep production data inside the approved existing environment.

customer-required

Customer go-live and production release

No customer go-live approval, production connector approval, production clinical workflow approval, or managed-service commitment.

Release decision: blocked-fail-closed

Can relieve now: false
Unlocks only after: Customer acceptance, security review, clinical/operational owner signoff, rollback plan, support plan, and release authority are complete.
Release hash: 139bc047a9250d60
Safe workaround: Run synthetic demos, no-PHI pilots, and protected diligence rooms until customer go-live authority exists.

Evidence work queue

Pending approvals become metadata-only work items; raw evidence stays outside public SCRIMED surfaces.

metadata-only-evidence-work-queue-active. 133 work items are required before any boundary can move toward a named human release decision.

critical / external-evidence-required