# SCRIMED Clinical Production Readiness Task Ledger

Status: clinical-production-readiness-task-ledger-active
Clinical production ready: no
Readiness score: 37
Required task count: 22
Incomplete task count: 22
Critical open task count: 15
External-review task count: 7
Blocked task count: 2
Current operating mode: synthetic-no-phi-demo-pilot-diligence-and-readiness-services

## Boundary
SCRIMED Clinical Production Readiness is a source-controlled task ledger and operating tracker for the work required before live clinical production, PHI/ePHI scope, production EHR or payer connectivity, patient-impacting AI, regulated clinical claims, customer go-live, and global clinical deployment. It does not grant legal advice, medical advice, regulatory approval, HIPAA compliance, SOC 2/HITRUST/ISO certification, FDA clearance, ONC certification, EU AI Act conformity, GDPR compliance assurance, PHI processing authority, production connector approval, customer permission, launch approval, reimbursement assurance, contractual SLA, revenue guarantee, profit guarantee, securities material, investment advice, valuation assurance, or live clinical care authority.

This brief is not legal advice, medical advice, regulatory approval, HIPAA compliance assurance, security certification, FDA clearance, ONC certification, EU AI Act conformity, GDPR compliance assurance, PHI authority, connector approval, customer permission, launch approval, reimbursement assurance, revenue guarantee, profit guarantee, securities material, investment advice, valuation assurance, or live clinical care authorization.

## Required Clinical Production Tasks
- cpr-001 Approve intended use and clinical claim boundaries per product module. (critical, external-review-required, complete: no). Owner: Product, clinical governance, regulatory counsel, and Claim Guard. Required for: Any patient-specific clinical recommendation, care workflow, triage, or regulated clinical claim.. Missing: Qualified regulatory counsel review; Named licensed clinical owner; Approved intended-use register; Customer-specific clinical sponsor approval. Current use while pending: Keep product language to synthetic workflow intelligence, no-PHI planning, and clinician-reviewed draft support.. Boundary: No diagnosis, treatment, triage, prescribing, patient outreach, or autonomous clinical decision authority.
- cpr-002 Stand up licensed clinical governance, safety case, hazard log, and escalation policy. (critical, evidence-build-required, complete: no). Owner: Clinical governance, TrustOS, product, and customer clinical sponsor. Required for: Live clinical workflows, patient-safety posture, and customer go-live review.. Missing: Licensed governance appointment; Customer care-setting scope; Clinical safety signoff; Post-launch safety monitoring cadence. Current use while pending: Use safety case templates and synthetic scenarios in demos to show discipline without affecting patients.. Boundary: No live care impact or patient instruction until clinical signoff and customer go-live approval.
- cpr-003 Complete HIPAA risk analysis and administrative, physical, and technical safeguard map. (critical, evidence-build-required, complete: no). Owner: Privacy, security, legal, and operations. Required for: Any PHI/ePHI scope, BAA-backed operation, or healthcare vendor-risk approval.. Missing: Qualified privacy/security review; Documented risk treatment; BAA/DPA templates; Subprocessor and access-review register. Current use while pending: Sell no-PHI evidence rooms, security-readiness posture, and synthetic pilot reviews without claiming HIPAA compliance.. Boundary: No PHI or ePHI processing approval and no HIPAA certification claim.
- cpr-004 Finalize BAA/DPA, non-PHI determination, data classification, retention, deletion, and legal-hold workflow. (critical, external-review-required, complete: no). Owner: Legal, privacy, security, customer compliance, and operations. Required for: Customer data intake, PHI/ePHI, source records, signed artifacts, and enterprise contracting.. Missing: Counsel-approved templates; Customer contract execution; Data residency and cross-border review where applicable; Signed customer data authority. Current use while pending: Keep pilots synthetic, metadata-only, or buyer-provided non-PHI with written boundary language.. Boundary: No customer permission, data processing authority, or PHI processing authorization.
- cpr-005 Complete security assurance path for SOC 2, HITRUST, ISO 27001, penetration-test, and procurement evidence. (critical, evidence-build-required, complete: no). Owner: Security, compliance, procurement, and qualified assessors. Required for: Enterprise vendor-risk acceptance and regulated healthcare procurement.. Missing: Independent assessor selection; Evidence collection cadence; Customer procurement acceptance; Issued certification or explicit no-certification boundary. Current use while pending: Provide security-readiness packets and no-sensitive-artifact evidence links without certification claims.. Boundary: No SOC 2, HITRUST, ISO, penetration-test approval, or customer vendor-risk approval claim.
- cpr-006 Enforce production identity, RBAC, SSO, AAL2, access review, least privilege, and credential lifecycle. (critical, foundation-active, complete: no). Owner: Security, tenant governance, platform, and customer IT. Required for: Customer SSO, production tenant access, protected proof release, and PHI/ePHI workflows.. Missing: Customer IdP configuration; Production role map; Break-glass approval; Attestation evidence and audit export. Current use while pending: Use AAL2 protected synthetic workspaces and no-secret operator packets for demos and diligence.. Boundary: No customer SSO or production invitation authority until customer and security approval.
- cpr-007 Validate immutable audit logging, evidence retention, release decisions, reviewer signoffs, and access-log reconciliation. (critical, foundation-active, complete: no). Owner: TrustOS, release engineering, security, and customer operations. Required for: Clinical accountability, buyer proof release, incident review, and enterprise auditability.. Missing: Customer-specific audit export acceptance; Legal hold policy; Evidence integrity review; Production incident linkage. Current use while pending: Use buyer proof packets and protected demos to show audit discipline without live clinical action.. Boundary: Audit evidence does not authorize PHI, release, customer proof, or clinical production.
- cpr-008 Complete customer-specific FHIR, HL7 v2, C-CDA, DICOM, X12, payer, and EHR sandbox acceptance tests. (critical, evidence-build-required, complete: no). Owner: Interoperability, health-record safety, security, and customer integration. Required for: Any production health-record, payer, or EHR integration.. Missing: Customer sandbox credentials; Conformance run evidence; Integration monitoring plan; Customer platform approval. Current use while pending: Sell no-PHI interoperability mapping, fixture validation, and sandbox-readiness assessments.. Boundary: No live connector, live record retrieval, payer submission, or EHR writeback authority.
- cpr-009 Approve EHR writeback, record mutation, payer submission, patient outreach, and production connector execution separately. (critical, blocked-before-approval, complete: no). Owner: Customer executive sponsor, clinical governance, interoperability, legal, privacy, and security. Required for: Any patient-impacting external-system action.. Missing: Signed customer production connector authority; Clinical safety signoff; Integration acceptance evidence; Support escalation and rollback test. Current use while pending: Demonstrate draft-only reviewer packets and no-write synthetic simulations.. Boundary: No writeback, mutation, outreach, payer submission, or production connector execution.
- cpr-010 Complete FDA CDS/SaMD classification, QMS escalation, and premarket pathway decision where required. (critical, external-review-required, complete: no). Owner: Regulatory counsel, product, clinical governance, AI platform, and quality. Required for: Clinical AI functions that could be regulated as medical device software.. Missing: Qualified FDA digital-health counsel review; Q-Submission or premarket plan if needed; Clinical evidence plan; Design-control and risk-management artifacts. Current use while pending: Position clinical AI as synthetic, planning, operational, or draft support with human review.. Boundary: No FDA-cleared, diagnostic, treatment, or autonomous clinical-device claim.
- cpr-011 Decide ONC health IT certification, information-blocking, USCDI, SMART/FHIR, and EHR marketplace claim scope. (high, external-review-required, complete: no). Owner: Interoperability, legal, health IT certification counsel, and platform partnerships. Required for: Certified health IT claims, EHR marketplace positioning, and formal interoperability claims.. Missing: ONC/certification counsel review; Marketplace partner requirements; Certification-body or EHR partner evidence where required. Current use while pending: Describe standards-readiness and synthetic conformance without certified health IT claims.. Boundary: No ONC certification, EHR marketplace approval, or certified connector claim.
- cpr-012 Complete AI model inventory, evaluation, red-team, bias, drift, hallucination, source-attribution, and monitoring controls. (critical, evidence-build-required, complete: no). Owner: AI platform, TrustOS, QA, clinical governance, security, and product. Required for: Any clinical, operational, payer, or documentation AI workflow with customer reliance.. Missing: Customer-specific eval acceptance; Clinical reviewer rubric; Model-change policy; Live monitoring and rollback integration. Current use while pending: Use AI evals, Trust Cards, and source-attributed synthetic demonstrations in buyer diligence.. Boundary: No live autonomous AI, production model-routing approval, or error-free accuracy guarantee.
- cpr-013 Stand up AI management-system evidence for ISO/IEC 42001 alignment and EU high-risk AI readiness. (high, evidence-build-required, complete: no). Owner: AI governance, legal, privacy, security, quality, and regional counsel. Required for: Global AI assurance, EU high-risk AI planning, and enterprise buyer governance.. Missing: Qualified EU AI Act review; ISO 42001 certification decision; Regional technical documentation pack; Serious incident routing and reporting process. Current use while pending: Use AI governance mapping as a high-value diligence offer without conformity or certification claims.. Boundary: No EU AI Act conformity, ISO 42001 certification, or high-risk AI approval claim.
- cpr-014 Prove 24/7 support, incident response, breach response, uptime monitoring, escalation, and shutdown authority. (critical, evidence-build-required, complete: no). Owner: Service reliability, TrustOps, security, customer operations, and release steward. Required for: Production customer support and clinical go-live.. Missing: Named on-call owners; Customer escalation contacts; Incident tabletop results; Support-tier contract language. Current use while pending: Package incident-readiness and 24/7 review architecture as trust evidence for buyers and investors.. Boundary: No contractual SLA, managed SOC/MDR, production support guarantee, or clinical emergency response claim.
- cpr-015 Validate disaster recovery, backup, recovery time objectives, rollback, regional failover, and business continuity. (high, evidence-build-required, complete: no). Owner: Platform, service reliability, security, customer operations, and finance. Required for: Enterprise production resilience and procurement acceptance.. Missing: Production environment architecture; Customer resilience requirement; Restore test evidence; Runbook acceptance. Current use while pending: Use scale and reliability readiness as a structural differentiator in enterprise diligence.. Boundary: No uptime, failover, SLA, managed-service, or disaster-recovery guarantee.
- cpr-016 Formalize change management, release control, rollback, post-release review, and production access controls. (critical, foundation-active, complete: no). Owner: Release steward, platform, QA, TrustOS, and security. Required for: Any production deployment, clinical feature promotion, or customer-specific proof release.. Missing: Production change calendar; Customer release window process; High-risk feature approval board; Post-release clinical monitoring. Current use while pending: Keep release discipline visible to investors and buyers through public smoke, briefs, and protected proof packets.. Boundary: No release approval, customer proof release, or clinical go-live without signed authority.
- cpr-017 Execute customer MSA/SOW/BAA/DPA, service boundaries, billing, insurance, liability, and revenue-recognition review. (critical, external-review-required, complete: no). Owner: Legal, finance, accounting, tax, insurance, revenue operations, and deal desk. Required for: Paid clinical production, enterprise buyer commitments, and risk allocation.. Missing: Qualified counsel review; Qualified accounting/tax review; Insurance confirmation; Customer contract execution. Current use while pending: Sell scoped no-PHI paid pilots and readiness services through margin-safe work orders and deal-desk controls.. Boundary: No legal, accounting, tax, revenue, reimbursement, profit-margin, insurance, or contract authority.
- cpr-018 Complete reimbursement, coding, payer policy, prior-authorization, and claims-submission authority review. (high, external-review-required, complete: no). Owner: Revenue cycle, finance, legal, clinical governance, and customer operations. Required for: Payer workflow execution, coverage determinations, coding, submissions, or reimbursement claims.. Missing: Customer revenue-cycle approval; Payer-policy-specific review; Compliance signoff; Submission authority. Current use while pending: Offer denial-risk, prior-authorization packet drafting, and revenue-leakage analysis as human-reviewed draft support.. Boundary: No reimbursement, coverage, coding, payer submission, or financial outcome guarantee.
- cpr-019 Complete GDPR, EU AI Act, data residency, DPIA, transfer mechanism, and regional clinical/legal review before global production. (high, external-review-required, complete: no). Owner: Regional counsel, privacy, AI governance, security, and global partnerships. Required for: EU or global clinical deployment, personal-data processing, and regional buyer claims.. Missing: Region-specific legal review; DPIA and transfer decisions; Local clinical/procurement authority; Conformity assessment path where applicable. Current use while pending: Run global partner qualification, localization, and synthetic executive evaluations without personal data.. Boundary: No GDPR compliance assurance, EU AI Act conformity, regional approval, or global clinical-production claim.
- cpr-020 Decide ISO 13485/QMS, design controls, risk management, human factors, usability, and post-market surveillance scope. (high, evidence-build-required, complete: no). Owner: Quality, regulatory counsel, product, clinical governance, and design. Required for: Deliberate medical-device/SaMD productization and clinical production claims.. Missing: Quality owner assignment; Regulatory counsel review; Clinical evidence plan; Post-market process and complaint handling. Current use while pending: Frame QMS readiness as a future production path while selling synthetic validation and quality-readiness planning.. Boundary: No ISO 13485, medical-device QMS, or post-market surveillance approval claim.
- cpr-021 Complete customer production go-live checklist, SSO/RBAC acceptance, monitoring, rollback test, support handoff, and shutdown authority. (critical, blocked-before-approval, complete: no). Owner: Customer executive sponsor, SCRIMED release steward, security, clinical governance, support, and legal. Required for: Any live customer clinical production tenant.. Missing: Customer go-live approval; Clinical/legal/security/privacy signoffs; Support roster; Production environment validation. Current use while pending: Use production-readiness packets inside sales operations to prepare without enabling production.. Boundary: No customer production go-live, automated invitation, SSO activation, or clinical workflow launch.
- cpr-022 Create board-level clinical production readiness review cadence with owner, due date, evidence aging, risk acceptance, and blocked-claim review. (high, foundation-active, complete: no). Owner: Executive Operating Council, TrustOS, legal, finance, clinical governance, and release steward. Required for: Company-level accountability before regulated expansion.. Missing: Board/advisor review schedule; Risk acceptance template; Evidence expiration policy; Clinical production decision log. Current use while pending: Use the ledger as a strategic management asset in investor and enterprise buyer conversations.. Boundary: Board review does not create clinical, legal, financial, regulatory, or customer authority.

## Next Task Sequence
- cpr-009: Approve EHR writeback, record mutation, payer submission, patient outreach, and production connector execution separately. -> Signed customer production connector authority
- cpr-021: Complete customer production go-live checklist, SSO/RBAC acceptance, monitoring, rollback test, support handoff, and shutdown authority. -> Customer go-live approval
- cpr-001: Approve intended use and clinical claim boundaries per product module. -> Qualified regulatory counsel review
- cpr-004: Finalize BAA/DPA, non-PHI determination, data classification, retention, deletion, and legal-hold workflow. -> Counsel-approved templates
- cpr-010: Complete FDA CDS/SaMD classification, QMS escalation, and premarket pathway decision where required. -> Qualified FDA digital-health counsel review
- cpr-017: Execute customer MSA/SOW/BAA/DPA, service boundaries, billing, insurance, liability, and revenue-recognition review. -> Qualified counsel review
- cpr-002: Stand up licensed clinical governance, safety case, hazard log, and escalation policy. -> Licensed governance appointment
- cpr-003: Complete HIPAA risk analysis and administrative, physical, and technical safeguard map. -> Qualified privacy/security review

## Current Capability Maximization
- Synthetic executive operating assessment (activate-now) for Founders, health-system operators, faith-based clinics, investors, and transformation sponsors. Strategic: Lead with whole-company and buyer-operating clarity while retaining all clinical-production hard stops. Financial: Package as a paid discovery, readiness, or board-prep engagement before regulated deployment. Structural: Routes every conversation through company score, task ledger, proof routes, and retained boundaries. Next: Bundle Company Assessment plus Clinical Production Readiness into the first executive packet. Blocked claims: clinical production ready, certified, PHI approved, revenue guaranteed.
- No-PHI health-record and interoperability readiness package (activate-now) for Health-system integration teams, payers, clinics, and EHR reviewers. Strategic: Turn live-data blockers into standards maps, sandbox plans, source-attribution tests, and safety controls. Financial: Sell scoped no-PHI interoperability assessment or sandbox-prep services. Structural: Creates customer-specific evidence before requesting credentials or live connector access. Next: Offer a no-PHI FHIR/HL7/C-CDA/DICOM/X12 mapping workshop with deliverable acceptance criteria. Blocked claims: live connector approved, EHR writeback ready, ONC certified, payer submission approved.
- AI governance and TrustOS diligence review (package-now) for Compliance reviewers, AI governance committees, security teams, and investors. Strategic: Position SCRIMED as governance-first healthcare AI without claiming autonomous production authority. Financial: Package AI inventory, model-route, eval, red-team, and claims-guard review as a service line. Structural: Connects platform power, TrustOS, continuous review, and future certification evidence. Next: Create a buyer-facing AI governance review packet with model, agent, eval, and retained-gate tables. Blocked claims: live autonomous AI, error-free AI, EU AI Act conformant, ISO 42001 certified.
- Buyer diligence and proof-release workbench (activate-now) for Enterprise buyers, procurement, vendor-risk teams, and board reviewers. Strategic: Make proof sharing auditable, recipient-controlled, claim-guarded, and no-PHI by design. Financial: Improves close confidence for paid pilots by giving buyers controlled evidence without over-disclosure. Structural: Forces AAL2, release decision, reviewer signoff, recipient control, and access-log reconciliation. Next: Use protected Buyer Proof Release as the default before any customer-specific evidence leaves SCRIMED. Blocked claims: customer permission, public distribution approved, PHI included, security certified.
- Service delivery workbench for no-PHI paid pilots (activate-now) for Clinics, health systems, payers, operational teams, and enterprise sponsors. Strategic: Convert broad interest into scoped work orders with acceptance criteria and hard boundaries. Financial: Protects gross margin through packaged scope, price floors, change control, and deliverable templates. Structural: Creates repeatable delivery lanes before clinical production dependencies are complete. Next: Route every paid pilot through Offerings, Service Delivery, Enterprise Business Ops, and Claim Guard. Blocked claims: SOW executed, SLA guaranteed, PHI authorized, profit guaranteed.
- Investor and clinic readiness packets (review-before-sale) for Angel investors, private investors, strategic partners, faith-based clinics, and public-sector sponsors. Strategic: Turn the current platform into a credible story of traction, gates, evidence, and disciplined upside. Financial: Supports fundraising and sponsorship conversations without securities, valuation, or revenue promises. Structural: Links audiences to the exact packet, proof route, blocked claims, and next action. Next: Use investor audience readiness and capital vitality before every capital, donor, or clinic packet. Blocked claims: securities offer, investment advice, valuation assurance, revenue guarantee.
- Enterprise operations and margin lock (activate-now) for Enterprise buyers, board, finance, and delivery leadership. Strategic: Make Scrimed look and behave like a serious enterprise vendor before production authority exists. Financial: Controls price floor, scope creep, billing readiness, revenue recognition triage, and tax review. Structural: Runs proposals through deal desk, qualified review, margin model, and blocked-claim checks. Next: Make Enterprise Business Ops mandatory before proposals, renewals, enterprise pilots, or investment packets. Blocked claims: audited financials, tax advice, profit margin guarantee, contract authority.
- 24/7 review and innovation operating loop (package-now) for Internal operators, investors, security reviewers, and innovation partners. Strategic: Shows that Scrimed improves accuracy, evidence freshness, claims control, security drift, and future research continuously. Financial: Supports premium pilot pricing through governance, monitoring, and continuous-improvement evidence. Structural: Keeps internal research, quantum exploration, agent loops, incident learning, and release quality inside review gates. Next: Create named queue owners for accuracy sampling, evidence aging, claims drift, security drift, QA regression, and internal research. Blocked claims: managed SOC, autonomous remediation, public quantum claim, certification.
- Launch-safe public product and demo motion (activate-now) for Prospects, demo attendees, pilots, advisors, and early investors. Strategic: Maximizes today's platform surface without crossing PHI, production, clinical, or certification boundaries. Financial: Enables demos, paid discovery, pilot intake, and evidence-driven follow-up now. Structural: Keeps branded-domain smoke, navigation, onboarding, and launch hard stops explicit. Next: Use Launch Readiness, Onboarding, and Product Console before external campaigns or demos. Blocked claims: public launch approval, clinical production ready, customer result guaranteed, live PHI.
- Global certification and approval roadmap service (review-before-sale) for Global partners, regional buyers, strategic investors, and health systems. Strategic: Turns global complexity into a visible roadmap rather than an unbounded promise. Financial: Can be sold as readiness assessment, localization prep, and diligence package support. Structural: Coordinates region, privacy, AI, cyber, clinical, procurement, and data-residency gates. Next: Offer regional readiness packs only with qualified local-review disclaimers. Blocked claims: global approval, GDPR compliant, EU AI Act conformant, regional clinical authorization.

## Production Gates
- Clinical authority and intended use: owner Clinical governance, product, and regulatory counsel; blocks diagnosis, treatment, triage, patient messaging, clinical recommendations; completion signal Approved intended-use statement, clinical governance owner, hazard analysis, human-review policy, and regulated-product pathway decision.
- PHI/ePHI and privacy authority: owner Privacy, security, legal, and customer compliance; blocks PHI ingestion, patient identifiers, source records, production credentials; completion signal Executed BAA/DPA or written non-PHI determination, HIPAA risk analysis, data classification, retention, deletion, and breach process.
- Production connector and EHR/payer authority: owner Interoperability, security, customer integration, and platform partner; blocks live FHIR reads, EHR writeback, HL7 feeds, payer submissions, record mutation; completion signal Customer sandbox acceptance, conformance evidence, least-privilege connector policy, monitoring, rollback, and platform/customer approval.
- Security assurance and vendor-risk acceptance: owner Security, compliance, procurement, and customer vendor-risk; blocks security certification claims, production vendor acceptance, enterprise go-live; completion signal Independent assessment path, control inventory, access reviews, incident response, backup/recovery evidence, subprocessor register, and customer acceptance.
- Customer production go-live authority: owner Customer executive sponsor, SCRIMED release steward, support, legal, security, and clinical governance; blocks production tenant activation, customer SSO, automated invites, live workflows; completion signal Signed go-live checklist, SOW/MSA/BAA/DPA alignment, SSO/RBAC acceptance, monitoring, 24/7 escalation, rollback, shutdown, and post-launch review cadence.

## Source References
- HHS HIPAA Security Rule (United States, official-government): https://www.hhs.gov/hipaa/for-professionals/security/index.html. Readiness use: Anchor HIPAA risk analysis, ePHI safeguard mapping, access controls, audit controls, incident response, BAA/DPA, and breach-process readiness.
- FDA Clinical Decision Support Software Guidance (United States, official-regulator): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software. Readiness use: Anchor intended-use, human-review transparency, non-device CDS criteria, and escalation to regulated device review where claims require it.
- FDA AI/ML Software as a Medical Device (United States, official-regulator): https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device. Readiness use: Anchor AI-enabled SaMD lifecycle controls, model-change governance, performance monitoring, transparency, clinical evidence, and quality-management escalation.
- ONC Health IT Certification and Interoperability (United States, official-government): https://www.healthit.gov/topic/certification-ehrs/about-onc-health-it-certification-program. Readiness use: Anchor ONC certification, API, interoperability, USCDI, and health-IT connector claim review before SCRIMED represents certified health IT capability.
- NIST Cybersecurity Framework 2.0 (United States, official-government): https://www.nist.gov/cyberframework. Readiness use: Anchor cyber governance, risk identification, protection, detection, response, recovery, and enterprise security operating evidence.
- NIST AI Risk Management Framework (United States, official-government): https://www.nist.gov/itl/ai-risk-management-framework. Readiness use: Anchor AI inventory, risk measurement, model evaluation, human oversight, incident learning, and TrustOS evidence language.
- EU Artificial Intelligence Act (European Union, official-regulator): https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai. Readiness use: Anchor EU high-risk AI triage, technical documentation, logs, data governance, human oversight, cybersecurity, robustness, accuracy, and post-market planning.
- European Commission GDPR Legal Framework (European Union, official-government): https://commission.europa.eu/law/law-topic/data-protection/legal-framework-eu-data-protection_en. Readiness use: Anchor controller/processor role mapping, lawful basis, DPIA, cross-border transfer, data-subject rights, retention, deletion, and DPA/SCC workflows.
- ISO 13485 Medical Devices Quality Management (Global, official-standard): https://www.iso.org/standard/59752.html. Readiness use: Anchor medical-device quality management escalation if SCRIMED enters regulated medical-device or SaMD territory.
- ISO/IEC 42001 AI Management System (Global, official-standard): https://www.iso.org/standard/42001. Readiness use: Anchor AI management-system policy, objectives, risk treatment, traceability, audit cadence, and continual improvement.

## Hard Stops
- No PHI/ePHI, source medical records, patient identifiers, production credentials, or live endpoints enter SCRIMED until BAA/DPA, privacy/security, customer, and release authority are complete.
- No live diagnosis, treatment, triage, prescribing, patient outreach, payer submission, EHR writeback, record mutation, or autonomous clinical action.
- No FDA, ONC, HIPAA, SOC 2, HITRUST, ISO, EU AI Act, GDPR, DTAC, MHRA, regional, or security certification claim without issued evidence and qualified review.
- No production customer go-live without signed contract stack, customer authority, clinical governance, privacy/security approval, support readiness, monitoring, rollback, and shutdown authority.
- No revenue, reimbursement, ROI, savings, uptime, attack-proof, error-free AI, public-market, valuation, investment, securities, profit-margin, or donor claim outside qualified review.

## Next Company Move
Keep selling no-PHI demos, paid readiness services, synthetic pilots, diligence packets, and governance assessments now while the clinical-production task ledger remains incomplete and externally reviewed.