SCRIMED now has a tracked task ledger for the work required before clinical production.

cpr-001: Approve intended use and clinical claim boundaries per product module.

• Owner: Product, clinical governance, regulatory counsel, and Claim Guard
• Missing: Qualified regulatory counsel review, Named licensed clinical owner, Approved intended-use register, Customer-specific clinical sponsor approval
• Criteria: Module-by-module intended-use memo, Approved public and buyer claim register, Human-review and transparency language, Regulated pathway decision for each clinical feature
• Current use: Keep product language to synthetic workflow intelligence, no-PHI planning, and clinician-reviewed draft support.
• Proof: /clinical-authority-readiness, /clinical-care-activation, /qa-claim-guard, /approvals-readiness
• 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.

• Owner: Clinical governance, TrustOS, product, and customer clinical sponsor
• Missing: Licensed governance appointment, Customer care-setting scope, Clinical safety signoff, Post-launch safety monitoring cadence
• Criteria: Named licensed medical director or governance board, Clinical safety case, Hazard log and severity taxonomy, Escalation, override, and shutdown policy, Prospective pilot protocol and reviewer rubric
• Current use: Use safety case templates and synthetic scenarios in demos to show discipline without affecting patients.
• Proof: /clinical-authority-readiness, /clinical-care-activation, /trust-os, /health-records
• 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.

• Owner: Privacy, security, legal, and operations
• Missing: Qualified privacy/security review, Documented risk treatment, BAA/DPA templates, Subprocessor and access-review register
• Criteria: HIPAA risk analysis, Safeguard matrix, Access-control and audit-control evidence, Encryption, backup, recovery, deletion, and breach workflows, Workforce and vendor risk controls
• Current use: Sell no-PHI evidence rooms, security-readiness posture, and synthetic pilot reviews without claiming HIPAA compliance.
• Proof: /trust-center, /trust-safety-operations, /global-certification-readiness, /pilot-workspace/access
• 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.

• Owner: Legal, privacy, security, customer compliance, and operations
• Missing: Counsel-approved templates, Customer contract execution, Data residency and cross-border review where applicable, Signed customer data authority
• Criteria: BAA and DPA templates reviewed by counsel, Non-PHI determination workflow, Data classification matrix, Retention, deletion, legal hold, and backup policy, Customer-specific data-flow appendix
• Current use: Keep pilots synthetic, metadata-only, or buyer-provided non-PHI with written boundary language.
• Proof: /approvals-readiness, /pilot-workspace/access, /boundary-resolution, /public-market-readiness
• 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.

• Owner: Security, compliance, procurement, and qualified assessors
• Missing: Independent assessor selection, Evidence collection cadence, Customer procurement acceptance, Issued certification or explicit no-certification boundary
• Criteria: Control inventory and owners, Security policy set, Independent assessment or certification plan, Penetration-test and remediation evidence when requested, Vendor-risk questionnaire library
• Current use: Provide security-readiness packets and no-sensitive-artifact evidence links without certification claims.
• Proof: /trust-safety-operations, /global-certification-readiness, /service-reliability, /pilot-workspace/access
• 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.

• Owner: Security, tenant governance, platform, and customer IT
• Missing: Customer IdP configuration, Production role map, Break-glass approval, Attestation evidence and audit export
• Criteria: Customer SSO acceptance, Role and purpose-of-use matrix, AAL2 operator policy, Access review cadence, Credential rotation, revocation, and emergency access policy
• Current use: Use AAL2 protected synthetic workspaces and no-secret operator packets for demos and diligence.
• Proof: /pilot-workspace/access, /release-continuity, /qa-launch-kit, /qa-buyer-proof-release
• 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.

• Owner: TrustOS, release engineering, security, and customer operations
• Missing: Customer-specific audit export acceptance, Legal hold policy, Evidence integrity review, Production incident linkage
• Criteria: Append-only audit policy, Reviewer signoff workflow, Release decision register, Access-log reconciliation, Evidence retention and export runbooks
• Current use: Use buyer proof packets and protected demos to show audit discipline without live clinical action.
• Proof: /qa-buyer-proof-release, /buyer-release-control-run, /pilot-workspace/access, /release-continuity
• 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.

• Owner: Interoperability, health-record safety, security, and customer integration
• Missing: Customer sandbox credentials, Conformance run evidence, Integration monitoring plan, Customer platform approval
• Criteria: Standards map and profile assumptions, Synthetic and sandbox test fixtures, CapabilityStatement/interface profile review, ACK/NACK, reconciliation, provenance, and dead-letter controls, Customer sandbox signoff
• Current use: Sell no-PHI interoperability mapping, fixture validation, and sandbox-readiness assessments.
• Proof: /health-records, /api/health-records/extract, /interoperability, /integrations/fixture-validation
• 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.

• Owner: Customer executive sponsor, clinical governance, interoperability, legal, privacy, and security
• Missing: Signed customer production connector authority, Clinical safety signoff, Integration acceptance evidence, Support escalation and rollback test
• Criteria: Explicit action-by-action customer approval, Least-privilege token scope, Human reviewer workflow, Rollback and reconciliation plan, Audit log and shutdown authority
• Current use: Demonstrate draft-only reviewer packets and no-write synthetic simulations.
• Proof: /health-records, /clinical-authority-readiness, /pilot-workspace/access, /boundary-resolution
• 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.

• Owner: Regulatory counsel, product, clinical governance, AI platform, and quality
• Missing: Qualified FDA digital-health counsel review, Q-Submission or premarket plan if needed, Clinical evidence plan, Design-control and risk-management artifacts
• Criteria: CDS non-device criteria analysis, SaMD risk classification memo, FDA pathway decision, QMS and design-control escalation plan, Model-change and post-market monitoring policy
• Current use: Position clinical AI as synthetic, planning, operational, or draft support with human review.
• Proof: /global-certification-readiness, /clinical-authority-readiness, /platform-power, /evaluation
• 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.

• Owner: Interoperability, legal, health IT certification counsel, and platform partnerships
• Missing: ONC/certification counsel review, Marketplace partner requirements, Certification-body or EHR partner evidence where required
• Criteria: Claim scope memo, USCDI and FHIR API mapping, SMART launch and authorization review, Marketplace and partner approval path, Blocked ONC/certified-health-IT language
• Current use: Describe standards-readiness and synthetic conformance without certified health IT claims.
• Proof: /global-certification-readiness, /interoperability, /health-records, /integrations/fixture-validation
• 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.

• Owner: AI platform, TrustOS, QA, clinical governance, security, and product
• Missing: Customer-specific eval acceptance, Clinical reviewer rubric, Model-change policy, Live monitoring and rollback integration
• Criteria: Model and tool inventory, Evaluation datasets and acceptance thresholds, Red-team and adversarial review, Bias and drift monitoring, Source attribution and hallucination controls, Human override and incident learning
• Current use: Use AI evals, Trust Cards, and source-attributed synthetic demonstrations in buyer diligence.
• Proof: /platform-power, /evaluation, /trust-os, /continuous-review-audit
• 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.

• Owner: AI governance, legal, privacy, security, quality, and regional counsel
• Missing: Qualified EU AI Act review, ISO 42001 certification decision, Regional technical documentation pack, Serious incident routing and reporting process
• Criteria: AI policy and objectives, Risk treatment register, Technical documentation, Data governance and logging plan, Human oversight and post-market monitoring process
• Current use: Use AI governance mapping as a high-value diligence offer without conformity or certification claims.
• Proof: /global-certification-readiness, /continuous-review-audit, /platform-power, /trust-os
• 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.

• Owner: Service reliability, TrustOps, security, customer operations, and release steward
• Missing: Named on-call owners, Customer escalation contacts, Incident tabletop results, Support-tier contract language
• Criteria: On-call schedule, Incident and breach runbooks, Severity and escalation matrix, Status communication template, Shutdown authority, Tabletop exercise evidence
• Current use: Package incident-readiness and 24/7 review architecture as trust evidence for buyers and investors.
• Proof: /service-reliability, /trust-safety-operations, /continuous-review-audit, /launch-readiness
• 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.

• Owner: Platform, service reliability, security, customer operations, and finance
• Missing: Production environment architecture, Customer resilience requirement, Restore test evidence, Runbook acceptance
• Criteria: Backup and restore test, Recovery objectives, Rollback procedure, Regional failover review, Business continuity plan, Cost and capacity assumptions
• Current use: Use scale and reliability readiness as a structural differentiator in enterprise diligence.
• Proof: /enterprise-scalability, /service-reliability, /launch-readiness, /release-continuity
• 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.

• Owner: Release steward, platform, QA, TrustOS, and security
• Missing: Production change calendar, Customer release window process, High-risk feature approval board, Post-release clinical monitoring
• Criteria: Release checklist, Change-risk classification, QA and smoke evidence, Approval signoff, Rollback plan, Post-release review
• Current use: Keep release discipline visible to investors and buyers through public smoke, briefs, and protected proof packets.
• Proof: /release-continuity, /qa-evidence, /buyer-release-control-run, /operational-efficiency
• 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.

• Owner: Legal, finance, accounting, tax, insurance, revenue operations, and deal desk
• Missing: Qualified counsel review, Qualified accounting/tax review, Insurance confirmation, Customer contract execution
• Criteria: Executed contract stack, Service boundary exhibit, Insurance and liability review, Billing and payment readiness, Revenue-recognition and tax review, Change-order and scope creep controls
• Current use: Sell scoped no-PHI paid pilots and readiness services through margin-safe work orders and deal-desk controls.
• Proof: /enterprise-business-ops, /service-delivery, /offerings, /capital-vitality
• 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.

• Owner: Revenue cycle, finance, legal, clinical governance, and customer operations
• Missing: Customer revenue-cycle approval, Payer-policy-specific review, Compliance signoff, Submission authority
• Criteria: CMS/payer policy review, Coding and billing compliance review, Human reviewer assignment, No-guarantee reimbursement language, Measurement methodology accepted by customer
• Current use: Offer denial-risk, prior-authorization packet drafting, and revenue-leakage analysis as human-reviewed draft support.
• Proof: /public-market-readiness, /pilot-deal-room, /health-records, /enterprise-business-ops
• 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.

• Owner: Regional counsel, privacy, AI governance, security, and global partnerships
• Missing: Region-specific legal review, DPIA and transfer decisions, Local clinical/procurement authority, Conformity assessment path where applicable
• Criteria: Controller/processor role map, Lawful basis and DPIA review, DPA/SCC transfer workflow, EU AI Act high-risk triage, Data residency and regional clinical review, Local buyer language approval
• Current use: Run global partner qualification, localization, and synthetic executive evaluations without personal data.
• Proof: /global-certification-readiness, /global-reach, /deployment-profiles, /investor-audience-readiness
• 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.

• Owner: Quality, regulatory counsel, product, clinical governance, and design
• Missing: Quality owner assignment, Regulatory counsel review, Clinical evidence plan, Post-market process and complaint handling
• Criteria: QMS applicability memo, Design-control procedure, Risk-management file, Human factors and usability plan, Post-market surveillance and complaint process
• Current use: Frame QMS readiness as a future production path while selling synthetic validation and quality-readiness planning.
• Proof: /global-certification-readiness, /clinical-authority-readiness, /platform-power, /continuous-review-audit
• 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.

• Owner: Customer executive sponsor, SCRIMED release steward, security, clinical governance, support, and legal
• Missing: Customer go-live approval, Clinical/legal/security/privacy signoffs, Support roster, Production environment validation
• Criteria: Signed production readiness checklist, Customer SSO and RBAC accepted, Monitoring and incident contacts active, Rollback and shutdown tested, Post-launch review cadence approved
• Current use: Use production-readiness packets inside sales operations to prepare without enabling production.
• Proof: /launch-readiness, /pilot-workspace/access, /sales-operations, /service-delivery
• 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.

• Owner: Executive Operating Council, TrustOS, legal, finance, clinical governance, and release steward
• Missing: Board/advisor review schedule, Risk acceptance template, Evidence expiration policy, Clinical production decision log
• Criteria: Standing review cadence, Owner matrix, Evidence aging report, Risk acceptance record, Blocked-claim review, Investor and buyer language refresh
• Current use: Use the ledger as a strategic management asset in investor and enterprise buyer conversations.
• Proof: /company-assessment, /clinical-production-readiness, /continuous-review-audit, /public-market-readiness
• Board review does not create clinical, legal, financial, regulatory, or customer authority.

Synthetic executive operating assessment

• 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.
• Proof: /company-assessment, /clinical-production-readiness, /offerings
• Blocked claims: clinical production ready, certified, PHI approved, revenue guaranteed

No-PHI health-record and interoperability readiness package

• 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.
• Proof: /health-records, /interoperability, /integrations/fixture-validation
• Blocked claims: live connector approved, EHR writeback ready, ONC certified, payer submission approved

AI governance and TrustOS diligence review

• 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.
• Proof: /platform-power, /trust-os, /evaluation, /continuous-review-audit
• Blocked claims: live autonomous AI, error-free AI, EU AI Act conformant, ISO 42001 certified

Buyer diligence and proof-release workbench

• 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.
• Proof: /qa-buyer-proof-release, /buyer-release-control-run, /pilot-workspace/access
• Blocked claims: customer permission, public distribution approved, PHI included, security certified

Service delivery workbench for no-PHI paid pilots

• 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.
• Proof: /offerings, /service-delivery, /enterprise-business-ops
• Blocked claims: SOW executed, SLA guaranteed, PHI authorized, profit guaranteed

Investor and clinic readiness packets

• 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.
• Proof: /investor-audience-readiness, /capital-vitality, /growth-engine, /public-market-readiness
• Blocked claims: securities offer, investment advice, valuation assurance, revenue guarantee

Enterprise operations and margin lock

• 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.
• Proof: /enterprise-business-ops, /service-delivery, /capital-vitality
• Blocked claims: audited financials, tax advice, profit margin guarantee, contract authority

24/7 review and innovation operating loop

• 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.
• Proof: /continuous-review-audit, /qa-evidence, /service-reliability, /operational-efficiency
• Blocked claims: managed SOC, autonomous remediation, public quantum claim, certification

Launch-safe public product and demo motion

• 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.
• Proof: /launch-readiness, /client-onboarding, /product, /demos
• Blocked claims: public launch approval, clinical production ready, customer result guaranteed, live PHI

Global certification and approval roadmap service

• 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.
• Proof: /global-certification-readiness, /global-reach, /deployment-profiles
• Blocked claims: global approval, GDPR compliant, EU AI Act conformant, regional clinical authorization