SSCRIMED
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Product Console

SCRIMED Clinical Care Activation

Clinical-care execution is a regulated activation path, not a switch.

SCRIMED can prepare enterprise buyers for governed clinical deployment through readiness gates, Trust Cards, human-review controls, evidence packets, and staged pilot planning. Live clinical care remains blocked until customer, legal, privacy, security, regulatory, clinician-governance, connector, monitoring, and go-live approvals are complete.

Download Readiness BriefInspect Activation APIAuthority ReadinessOpen Pilot Deal RoomProtected DossierApproval WorkflowReview TrustOS
Statusclinical-care-activation-gated
Care authoritynot-authorized-live-care
Readiness score19%
Hard gates16
Foundation ready3
External review4
Customer specific4
Blocked5

Hard boundary

SCRIMED is not authorized for live clinical care from the current product boundary.

SCRIMED Clinical Care Activation Readiness prepares regulated clinical deployment, but it does not authorize live clinical care, PHI processing, diagnosis, treatment, order entry, patient outreach, emergency triage, medical-device use, payer submission, record mutation, or autonomous clinical execution. Production clinical care requires signed customer scope, BAA/DPA where applicable, privacy/security/legal review, regulatory classification, licensed clinical governance, validated human-review workflow, approved connectors, monitoring, incident response, rollback, and explicit customer go-live approval.

01live diagnosis
02live treatment recommendation
03emergency triage or emergency advice
04order entry
05prescribing or medication changes
06EHR writeback or production record mutation
07patient outreach or patient instruction
08patient-specific risk prediction
09autonomous clinical decision support
10payer submission, claim submission, or coverage determination
11imaging interpretation for care
12medical-device functionality
13PHI or ePHI processing

Capability boundary

Current capabilities support readiness, not unsupervised patient-impacting execution.

authorized-current-boundary

Synthetic clinical workflow simulation

Uses synthetic scenarios and fixtures only; does not process live PHI or patient-specific data.

Inspect proof route
authorized-current-boundary

Enterprise clinical-care readiness planning

Supports buyer diligence, gate tracking, governance planning, and pilot design without delivering care.

Inspect proof route
authorized-current-boundary

Human-reviewed operational intelligence pilots

May be sold as governed synthetic or approved de-identified evaluation work; patient-impacting action remains blocked.

Inspect proof route
blocked-before-clinical-go-live

Live diagnosis, treatment, order entry, record mutation, and patient outreach

Requires the full activation gate set, signed customer scope, licensed clinical governance, PHI/security approval, connector validation, monitoring, and explicit go-live approval.

Inspect proof route

Clinical hard gates

Every live-care capability stays gated until evidence, owners, and approvals are complete.

Foundation-ready means SCRIMED has useful product evidence today. It does not mean the gate is fully cleared for production clinical care.

regulatory / external-review-required

Intended-use and regulatory classification review

FDA CDS/SaMD boundary review, intended-use statement, public claim review, labeling scope, and product-risk memo.

Any clinical decision-support, diagnostic, treatment, or medical-device-like deployment claim.
  • Owner: Regulatory counsel and clinical governance
  • Safe workaround: Keep outputs framed as operational intelligence, synthetic evaluation, draft support, or clinician-reviewed planning until classification is approved.
  • Blocked: clinical decision support claims, diagnosis support, treatment recommendations
clinical-governance / blocked

Licensed clinical governance board and accountable medical director

Named licensed reviewers, approval charter, escalation policy, scope-specific protocols, and sign-off records.

Any care-team workflow that influences patient-specific clinical decisions.
  • Owner: Clinical governance
  • Safe workaround: Run buyer demos and synthetic workflow reviews with clear non-clinical boundary language.
  • Blocked: live patient triage, care-plan recommendation, clinical safety scoring
clinical-governance / external-review-required

Clinical safety case, hazard analysis, and escalation model

Hazard log, unsafe-output taxonomy, clinician escalation policy, emergency boundary, safety acceptance criteria, and rollback plan.

Prospective clinical pilots, patient-specific risk prompts, or human-reviewed clinical workflows.
  • Owner: Clinical safety, legal, privacy, security, and product leadership
  • Safe workaround: Use TrustOS blocked-action traces and synthetic risk examples without patient-specific execution.
  • Blocked: patient-specific risk horizon prompts, emergency guidance, clinical escalation automation
legal-commercial / customer-specific

Signed customer clinical scope and care-setting authorization

Executed statement of work, care-setting scope, allowed users, excluded workflows, pilot objectives, and go-live approvers.

Any customer-environment clinical pilot or production workflow.
  • Owner: Enterprise sales, legal, customer sponsor, and clinical operations
  • Safe workaround: Sell and deliver synthetic pilot evaluation, readiness assessment, governance audit, and implementation blueprint packages.
  • Blocked: customer production pilot, site-specific workflow execution, customer go-live
privacy-security / customer-specific

BAA/DPA path, privacy notices, retention, residency, and processing register

BAA or non-PHI determination, DPA where applicable, privacy notice review, retention schedule, data residency map, and processor register.

Any PHI, ePHI, payer member data, live clinical record, or patient identifier enters SCRIMED systems.
  • Owner: Privacy, legal, security, and customer compliance
  • Safe workaround: Keep public and pilot routes synthetic-only and metadata-only until the customer-specific data path is signed.
  • Blocked: PHI processing, patient identifiers, payer member data, live clinical records
privacy-security / external-review-required

HIPAA Security Rule safeguard mapping

Administrative, physical, and technical safeguard mapping; risk analysis; access controls; audit controls; transmission security; and contingency plan.

Any ePHI processing or production healthcare customer security review.
  • Owner: Security, privacy, compliance, and qualified external reviewer
  • Safe workaround: Use current TrustOS, protected workspace, audit, rate-limit, passkey/AAL2, and no-PHI controls as readiness evidence, not compliance certification.
  • Blocked: ePHI workflows, clinical data storage, production tenant PHI processing
identity-access / foundation-ready

Production identity, RBAC, AAL2/SSO, and access review

Supabase Auth, passkey or magic-link sign-in, AAL2 gates for protected actions, tenant-admin checks, and access-review planning.

Customer users access protected clinical or operational workspaces.
  • Owner: Security engineering and customer identity administrator
  • Safe workaround: Continue protected synthetic pilots with tenant-admin AAL2 and explicit role boundaries while customer SSO remains gated.
  • Blocked: broad customer user onboarding, patient-context access, break-glass access
privacy-security / blocked

PHI-ready data architecture, encryption, deletion, legal hold, and regional controls

Data classification, encryption/key management, DLP, malware scanning, deletion workflow, legal hold, residency, backup, and restore testing.

Any live clinical data persistence, evidence vault upload, or production workspace memory.
  • Owner: Security architecture, privacy, platform engineering, and customer compliance
  • Safe workaround: Keep evidence vault readiness metadata-only and disable sensitive document upload until signed controls exist.
  • Blocked: clinical memory persistence, medical-record storage, evidence vault PHI upload
interoperability / blocked

FHIR, HL7, DICOM, X12, payer, and EHR connector validation

Conformance testing, customer sandbox acceptance, interface monitoring, reconciliation, mapping review, purpose-of-use policy, and partner sign-off.

Any production connector reads, writes, orders, referrals, payer transactions, imaging retrieval, or record mutation.
  • Owner: Interoperability engineering, customer integration team, and clinical operations
  • Safe workaround: Use deterministic synthetic conformance kits, integration fixtures, and connector contracts until a customer sandbox is approved.
  • Blocked: EHR writeback, order entry, referral submission, claim submission, imaging retrieval
clinical-governance / foundation-ready

Human authority model, reviewer workflow, and override logging

Human review required controls, reviewer status fields, blocked actions, Trust Cards, audit traces, and protected packet exports.

Any AI-assisted workflow that influences clinical, payer, or operational actions.
  • Owner: TrustOS, clinical operations, and customer workflow owner
  • Safe workaround: Keep every output draft-only, recommendation-like, evidence-backed, and review-required.
  • Blocked: autonomous clinical decisions, autonomous outreach, autonomous payer submission
safety-monitoring / blocked

Clinical validation protocol and licensed sign-off

Validation cohort, inclusion/exclusion criteria, source truth, reviewer rubric, acceptance thresholds, bias/equity review, and sign-off.

Any patient-specific output is used in care delivery or clinical operations.
  • Owner: Clinical validation lead, customer medical leadership, and quality team
  • Safe workaround: Measure workflow outcomes on synthetic or approved de-identified data while clinical correctness remains unvalidated.
  • Blocked: clinical correctness scoring in care, risk prediction, care-gap scoring
safety-monitoring / external-review-required

Clinical, privacy, security, and AI incident response playbooks

Severity model, notification matrix, breach analysis path, adverse-event escalation, containment actions, legal hold, and post-incident review.

Any production clinical, PHI, or customer-integrated workflow.
  • Owner: Trust safety operations, security, privacy, legal, and clinical governance
  • Safe workaround: Use current Trust Safety Operations incident workspaces for no-PHI synthetic issues and readiness rehearsal.
  • Blocked: 24/7 clinical operations, production PHI incident handling, adverse-event handling
safety-monitoring / foundation-ready

Continuous validation, monitoring, drift, and outcome learning

QA evidence ledger, manual run evidence capture, workflow outcome metrics, command snapshots, trust metrics, and escalation rates.

Scaled pilots, model-route changes, and production workflow expansion.
  • Owner: TrustOS, QA, product analytics, and customer operations
  • Safe workaround: Retain synthetic QA and buyer-demo evidence while production observability remains customer-specific.
  • Blocked: automated scale-up, model route auto-promotion, unmonitored workflow execution
legal-commercial / customer-specific

Reimbursement, claims, coding, and payer policy review

Payer policy sources, CMS/coverage review, coding compliance review, no-guarantee reimbursement language, and human approval.

Any prior authorization, claim, coding, denial appeal, reimbursement, or payer-submission workflow.
  • Owner: Revenue cycle expert, payer policy lead, legal, and customer operations
  • Safe workaround: Provide denial-risk review and prior-auth support as draft, evidence-backed, human-reviewed operational intelligence.
  • Blocked: coverage determination, claim submission, billing finalization, reimbursement guarantee
clinical-governance / blocked

Patient communication, consent, accessibility, and emergency-care boundary

Consent model, communication templates, accessibility review, language support, patient-safety disclaimers, and emergency escalation policy.

Any patient-facing outreach, education, triage, scheduling, or care-plan communication.
  • Owner: Clinical operations, legal, privacy, patient experience, and customer sponsor
  • Safe workaround: Keep patient-facing materials as internal draft templates for authorized human review.
  • Blocked: patient outreach, patient education delivery, triage messaging, emergency advice
operations / customer-specific

Production go-live approval, rollback plan, and post-launch controls

Go-live checklist, launch approval packet, rollback plan, monitoring dashboard, support coverage, and post-launch review cadence.

Any live clinical-care production launch.
  • Owner: SCRIMED operator, customer executive sponsor, clinical sponsor, security, privacy, and legal
  • Safe workaround: Use buyer diligence exports, command intelligence packets, and clinical activation readiness briefs to prepare for approval.
  • Blocked: production launch, expanded production rollout, customer-wide activation

Activation path

Move from synthetic evaluation to supervised care only through staged evidence.

foundation-ready

Current: governed synthetic evaluation

Use the sellable product, demos, proof stack, TrustOS, protected workspaces, and buyer diligence rooms without live patient data.

Buyer, legal, privacy, security, regulatory, and clinical leaders agree on a scoped activation plan.
  • Product Console proof stack
  • QA evidence ledger
  • Buyer Diligence Export
  • Clinical activation readiness brief
customer-specific

Shadow-mode clinical readiness

Run SCRIMED in a customer-approved environment against de-identified or contract-approved data without impacting care.

Outputs are measured against reviewer ground truth, error taxonomy, latency, safety, and workflow outcomes.
  • BAA/DPA or non-PHI determination
  • Customer data-flow approval
  • Clinician reviewer rubric
  • Connector sandbox acceptance
external-review-required

Clinician-supervised prospective pilot

Introduce human-reviewed, scope-limited workflow support where authorized clinicians remain responsible for all decisions.

No severe unresolved safety issues, acceptable override/escalation rates, and signed continuation approval.
  • Clinical safety case
  • Licensed sign-off
  • Patient communication policy where applicable
  • Incident response and rollback plan
blocked

Limited production go-live

Run only the approved workflow, tenant, user group, connector set, and care setting with active monitoring.

Customer approves expansion after post-launch review, quality evidence, and safety review.
  • Production go-live packet
  • Connector conformance
  • Monitoring dashboard
  • Support and rollback coverage

Trust Cards

Clinical activation outputs carry confidence, risk, evidence, reviewer state, and audit events.

medium

Readiness gate decision

Any move from synthetic evaluation to customer clinical environment.

  • Confidence: high-for-boundary
  • Reviewer: operator-review-required
  • Audit: clinical-care-activation-readiness-reviewed
  • Validated: 2026-06-19
critical

Clinical recommendation-like output

Always required before patient-specific use.

  • Confidence: not-clinically-validated
  • Reviewer: blocked-before-licensed-clinical-review
  • Audit: clinical-output-blocked-before-authorization
  • Validated: 2026-06-19

Source authorities

Activation planning is anchored to external authority and SCRIMED internal controls.

external-authority

FDA Clinical Decision Support Software Guidance

SCRIMED must classify intended use and clinical decision-support boundaries before any clinical deployment claim.

Source current as of 2026-01-29
external-authority

HHS HIPAA Security Rule Summary

SCRIMED must map administrative, physical, and technical safeguards before processing ePHI.

Source current as of 2026-06-19
internal-control

SCRIMED TrustOS, Product Console, and Protected Pilot Workspace

Current product evidence supports governed synthetic pilots, audit trails, human review, protected operator workflows, and proof packets.

Current as of 2026-06-19

Operator actions

Best next move: sell readiness and synthetic pilots while clinical activation gates mature.

This protects SCRIMED legally, clinically, and commercially while building toward real customer production deployments.

01Keep current demos and pilots synthetic or approved de-identified evaluation only.
02Package this readiness brief into buyer diligence before any clinical-care pilot discussion.
03Define one narrow intended use and care setting before legal, regulatory, privacy, and clinical review.
04Obtain licensed clinician governance and customer approval before any patient-specific workflow.
05Complete PHI, connector, monitoring, incident response, and rollback gates before go-live.