# SCRIMED Boundary Release Approval Matrix Status: boundary-release-approval-matrix-active-fail-closed Boundary: 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. Release authority: not-authorized-boundary-release Release candidates: 9 Released boundaries: 0 Blocked boundaries: 9 Approval steps documented: true ## Operator Rule 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. ## Approval Paths ### Live PHI / ePHI processing - Boundary: No live PHI, patient identifiers, source medical records, production credentials, or raw connector payloads. - Decision: blocked-fail-closed - Can relieve boundary now: false - Current safe mode: synthetic, metadata-only, no-PHI, human-reviewed readiness material with fail-closed production behavior - Unlocks only after: HIPAA security risk analysis, BAA coverage, tenant isolation, privacy/security review, customer authorization, and incident-response evidence are complete. - Release hash: 5366e6d20895bfa5782fbdde388db50c9f90c80a94dfade17d0be123ffdbf021 - Steps: 1. PHI data inventory and classification - prepared; evidence satisfied: true; blocker: No live data until all PHI stores and flows are documented. 2. HIPAA security risk analysis - external_required; evidence satisfied: false; blocker: No PHI authority until qualified security/privacy review signs the risk analysis. 3. BAA and subprocessor coverage - external_required; evidence satisfied: false; blocker: No live PHI until signed agreements exist and are retained outside public code. 4. Tenant isolation, audit, and incident response - blocked_pending_evidence; evidence satisfied: false; blocker: No PHI workflow until protected runtime controls are tested with customer-specific approval. - Required signoffs: - privacy: pending_external; evidence: Privacy officer approval and live-data processing basis. - security: pending_external; evidence: Security risk acceptance and remediation closure. - legal: pending_external; evidence: BAA/DPA and subprocessor agreement approval. - customer: pending_customer; evidence: Customer tenant authorization for live PHI scope. - engineering: pending_internal; evidence: Protected runtime, RLS, audit, and incident evidence. - Safe workaround: Use synthetic fixtures, de-identified metadata planning, and no-PHI Health Records Safety Exchange reviews. ### Clinical decision support - Boundary: No final diagnosis, treatment recommendation, triage replacement, clinical validation claim, or autonomous clinical authority. - Decision: blocked-fail-closed - Can relieve boundary now: false - Current safe mode: synthetic clinical readiness scoring, evidence cards, uncertainty display, and human-review-only clinical workflow support - Unlocks only after: Intended use, FDA/CDS analysis, clinical safety case, validation protocol, evidence visibility, and clinician governance are approved. - Release hash: e10f6630fc430147932988e1195108e19a657bbc508473c0f621fc386a2c0c64 - Steps: 1. Intended-use and user-control definition - prepared; evidence satisfied: true; blocker: No CDS expansion until intended use and claim boundaries are explicit. 2. FDA/CDS/SaMD classification review - external_required; evidence satisfied: false; blocker: No public clinical authority claim until regulatory classification is complete. 3. Clinical validation and safety protocol - external_required; evidence satisfied: false; blocker: No clinical validation claim until protocol results are reviewed and approved. 4. Clinician final authority workflow - tracked; evidence satisfied: false; blocker: High-risk clinical outputs remain blocked unless reviewed. - Required signoffs: - clinical: pending_external; evidence: Medical director and specialty reviewer signoff. - regulatory: pending_external; evidence: FDA/CDS/SaMD classification approval. - legal: pending_external; evidence: External-use claim language approval. - security: pending_internal; evidence: No-PHI/PHI runtime boundary validation. - customer: pending_customer; evidence: Customer clinical governance approval for exact workflow. - Safe workaround: Offer synthetic Clinical Robustness Lab reviews, evidence summaries, and clinician-reviewed draft support only. ### Autonomous diagnosis, treatment, prescribing, or imaging interpretation - Boundary: No autonomous diagnosis, treatment, prescribing, order placement, pharmacy action, or imaging interpretation. - Decision: blocked-fail-closed - Can relieve boundary now: false - Current safe mode: recommendation-free readiness analysis, safety linting, draft-only education, and clinician-governed review queues - Unlocks only after: A separate regulated clinical product pathway, malpractice coverage, medical governance, prescribing compliance, and production safety case are approved. - Release hash: ee48d433d3367a9b0838e713002aa118162e1b75e3b2c778807cb27361385cb3 - Steps: 1. Autonomous authority ban retained - prepared; evidence satisfied: true; blocker: Autonomous care remains blocked by design. 2. Regulated product pathway - external_required; evidence satisfied: false; blocker: No autonomous action until applicable regulator and clinical governance path is complete. 3. Prescribing, ordering, EHR, and pharmacy compliance - external_required; evidence satisfied: false; blocker: No prescribing or medication action without licensed clinician and required legal/compliance evidence. - Required signoffs: - clinical: pending_external; evidence: Medical director and specialty governance approval. - regulatory: pending_external; evidence: Applicable regulated product pathway approval. - legal: pending_external; evidence: Malpractice, prescribing, and product-liability review. - customer: pending_customer; evidence: Customer clinical governance and workflow approval. - Safe workaround: Use draft-only education, documentation support, and clinician-reviewed safety/evidence summaries. ### EHR writeback and production connector activation - Boundary: No EHR writeback, chart filing, record mutation, order entry, or production connector approval. - Decision: blocked-fail-closed - Can relieve boundary now: false - Current safe mode: readiness architecture, sandbox-only connector planning, synthetic FHIR validation, and human-reviewed writeback design - Unlocks only after: Customer authorization, EHR vendor app registration, scoped SMART/FHIR permissions, sandbox validation, rollback plan, and clinical signoff are complete. - Release hash: bffd1ce5c88e3ed7102a9ab55769f6e5552627f9971a1ede8c2a411771e0d4b0 - Steps: 1. Read-only sandbox validation - tracked; evidence satisfied: false; blocker: No writeback until read-only sandbox behavior is proven. 2. Write-scope and change-control approval - customer_required; evidence satisfied: false; blocker: No write scope without customer and EHR governance approval. 3. Production connector review - external_required; evidence satisfied: false; blocker: No production connector activation without external approval evidence. - Required signoffs: - customer: pending_customer; evidence: Customer IT, clinical informatics, and tenant admin approval. - security: pending_external; evidence: Vendor/customer security review approval. - clinical: pending_customer; evidence: Clinical workflow owner approval. - engineering: pending_internal; evidence: Sandbox, rollback, and audit evidence. - Safe workaround: Generate draft packets and human-readable summaries for manual review outside SCRIMED writeback paths. ### Payer submission, prior authorization, claims, and appeals - Boundary: No autonomous payer submission, claim filing, prior authorization submission, appeal filing, or reimbursement guarantee. - Decision: blocked-fail-closed - Can relieve boundary now: false - Current safe mode: synthetic payer workflow planning, draft packets, RCM intelligence, and human-reviewed payer readiness material - Unlocks only after: Trading partner agreement, payer/clearinghouse approval, X12/FHIR validation, provider attestation, and human submitter approval are complete. - Release hash: aeb45559072d24b60e97d5ab49462bd7e9041061fcc12c8a615bd58a9b13097a - Steps: 1. Payer workflow scope and provider attestation - prepared; evidence satisfied: true; blocker: No payer transmission until authorized submitter workflow is approved. 2. Trading partner and payer approval - external_required; evidence satisfied: false; blocker: No payer submission without payer/clearinghouse authorization. 3. X12/FHIR validation and human review - blocked_pending_evidence; evidence satisfied: false; blocker: No automated submission until conformance and human review evidence exist. - Required signoffs: - payer: pending_external; evidence: Payer or clearinghouse trading-partner approval. - customer: pending_customer; evidence: Customer RCM and provider submitter approval. - legal: pending_external; evidence: Submission authority and contract review. - engineering: pending_internal; evidence: X12/FHIR validation, audit, and fail-closed evidence. - Safe workaround: Create draft prior-auth and claims packets for human review without transmitting to payers. ### Clinical research, outcomes learning, and human-subject data - Boundary: No live patient research, outcomes learning from identifiable data, or human-subject research claims without protocol review. - Decision: blocked-fail-closed - Can relieve boundary now: false - Current safe mode: synthetic research workflows, literature synthesis planning, and no-PHI evaluation registries - Unlocks only after: IRB determination or approval, consent/waiver analysis, protocol, privacy review, and data-minimization controls are complete. - Release hash: f5b64feb70e6f3c77db138e09c9d95732cd4238fce85037eb9fa6606abf5973a - Steps: 1. Research purpose and protocol - tracked; evidence satisfied: false; blocker: No live outcomes learning until protocol classification is complete. 2. IRB, consent, and waiver review - external_required; evidence satisfied: false; blocker: No human-subject data use until IRB/consent path is resolved. 3. Outcome learning governance - blocked_pending_evidence; evidence satisfied: false; blocker: No continuous learning from live data until governance and monitoring are approved. - Required signoffs: - research: pending_external; evidence: IRB or research governance determination. - privacy: pending_external; evidence: Consent, waiver, DUA, and privacy review. - clinical: pending_external; evidence: Clinical governance approval for outcome endpoints. - engineering: pending_internal; evidence: Dataset lineage, drift monitoring, and rollback evidence. - Safe workaround: Use synthetic scenarios, public literature, and reviewer-created SME expectations without live patient data. ### SOC 2, HIPAA, HITRUST, ISO, FDA, ONC, and certification claims - Boundary: No certification, clearance, validation, compliance-completion, or audited-report claims unless independently verified. - Decision: blocked-fail-closed - Can relieve boundary now: false - Current safe mode: readiness mapping, evidence collection, control preparation, and claim-safe diligence material - Unlocks only after: Qualified auditor, assessor, regulator, or certification body evidence exists for the exact claim and scope. - Release hash: 283d92647b1535e778bc2bfbb029e203022e69d012680baf728188561b89edaa - Steps: 1. Claim inventory and prohibited language control - prepared; evidence satisfied: true; blocker: No external claim without claim guard evidence. 2. SOC 2 readiness and audit path - external_required; evidence satisfied: false; blocker: No SOC 2 claim until the independent report exists. 3. Regulatory and certification body review - external_required; evidence satisfied: false; blocker: No certification or clearance language until independent authority is retained. - Required signoffs: - legal: pending_external; evidence: Approved external-use claim language. - security: pending_external; evidence: Security auditor/assessor evidence. - regulatory: pending_external; evidence: Regulator or certification body evidence where applicable. - finance: pending_external; evidence: Auditor engagement and report handling where SOC/audit applies. - Safe workaround: Say SCRIMED is preparing for audit/readiness review; do not claim certification, clearance, or compliance completion. ### Global operation, data residency, GDPR, EHDS, and EU AI Act readiness - Boundary: No global launch, regional regulatory approval, data-residency approval, public-sector procurement approval, or EU AI Act compliance claim. - Decision: blocked-fail-closed - Can relieve boundary now: false - Current safe mode: regional readiness mapping, synthetic localization, data-residency planning, and qualified-review routing - 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: 795bee1378a5bd9b59d5901dd89d8b82b26fb575fcda25bd453cb9bc1b94eeaa - Steps: 1. Regional data map and lawful basis - tracked; evidence satisfied: false; blocker: No regional launch claim until the data map and lawful basis are reviewed. 2. DPIA, DPA/SCCs, and data residency review - external_required; evidence satisfied: false; blocker: No regional processing until privacy and residency evidence exists. 3. AI Act and regional AI classification - external_required; evidence satisfied: false; blocker: No EU AI Act or regional AI compliance claim until classification is approved. - Required signoffs: - privacy: pending_external; evidence: DPIA, DPA/SCCs, data-residency, and lawful-basis review. - legal: pending_external; evidence: Regional counsel approval. - regulatory: pending_external; evidence: AI Act/regional AI classification approval. - customer: pending_customer; evidence: Customer regional deployment authorization. - security: pending_external; evidence: Hosting and transfer-control evidence. - Safe workaround: Use synthetic regional readiness packs and keep production data inside the approved existing environment. ### Customer go-live and production release - Boundary: No customer go-live approval, production connector approval, production clinical workflow approval, or managed-service commitment. - Decision: blocked-fail-closed - Can relieve boundary now: false - Current safe mode: buyer diligence, synthetic pilots, protected AAL2 evidence, and human-reviewed release packets - Unlocks only after: Customer acceptance, security review, clinical/operational owner signoff, rollback plan, support plan, and release authority are complete. - Release hash: 139bc047a9250d60d3dd913aafb5d67734a9aa99655bc45b8803c3d45a6eb953 - Steps: 1. Pilot acceptance criteria and scope control - prepared; evidence satisfied: true; blocker: No go-live without signed pilot/customer scope. 2. Release readiness evidence - blocked_pending_evidence; evidence satisfied: false; blocker: No customer go-live until current evidence packet is complete and approved. 3. Formal go-live approval - customer_required; evidence satisfied: false; blocker: No go-live before named approvals are retained. - Required signoffs: - customer: pending_customer; evidence: Named customer go-live approval. - security: pending_external; evidence: Customer/security release review. - engineering: pending_internal; evidence: Smoke, rollback, observability, and support evidence. - operations: pending_internal; evidence: Support, incident, and communication runbook. - legal: pending_external; evidence: Contract and service-scope approval. - Safe workaround: Run synthetic demos, no-PHI pilots, and protected diligence rooms until customer go-live authority exists. ## Evidence Work Queue Status: metadata-only-evidence-work-queue-active Work items: 133 Accepts raw evidence: false - Live PHI / ePHI processing / risk analysis report (approval-step-evidence, critical, external-evidence-required): No PHI authority until qualified security/privacy review signs the risk analysis. Owner: Security officer and qualified HIPAA advisor. Hash: c4a4dbee69be23b5b093d4f9917a35148882a55b23fb990e23603b3717dbec0b. - Live PHI / ePHI processing / risk treatment plan (approval-step-evidence, critical, external-evidence-required): No PHI authority until qualified security/privacy review signs the risk analysis. Owner: Security officer and qualified HIPAA advisor. Hash: 0643e0def3f403cbc1927b359e4cc1eb920d0f361e15be2bdbc6a29adf73afcc. - Live PHI / ePHI processing / control evidence (approval-step-evidence, critical, external-evidence-required): No PHI authority until qualified security/privacy review signs the risk analysis. Owner: Security officer and qualified HIPAA advisor. Hash: 988f2b37f9b69dd16cba43ac3c686e4066d9a45f3b94de067d8de577dd5559df. - Live PHI / ePHI processing / executive acceptance record (approval-step-evidence, critical, external-evidence-required): No PHI authority until qualified security/privacy review signs the risk analysis. Owner: Security officer and qualified HIPAA advisor. Hash: 42c1db0abe994c075c7983b470283f37da2713ca0cb14f893bb58361a8d9926c. - Live PHI / ePHI processing / executed BAA (approval-step-evidence, critical, external-evidence-required): No live PHI until signed agreements exist and are retained outside public code. Owner: Legal, privacy, vendor management, and customer sponsor. Hash: ae8b69e8ad04053eda540e7f888287da55e0c40d6d0c914ab6a846298e59a33e. - Live PHI / ePHI processing / subprocessor BAA/DPA (approval-step-evidence, critical, external-evidence-required): No live PHI until signed agreements exist and are retained outside public code. Owner: Legal, privacy, vendor management, and customer sponsor. Hash: c237ddbc6c40ad64adc4980cb5048d34631ffab4cd93f1db9652dfe13ccc670e. - Live PHI / ePHI processing / vendor security review (approval-step-evidence, critical, external-evidence-required): No live PHI until signed agreements exist and are retained outside public code. Owner: Legal, privacy, vendor management, and customer sponsor. Hash: e6655e4d7784dcbd9d74f3e5c46bf3579ebe94679620a00a183d4e1abef7622c. - Live PHI / ePHI processing / contract owner approval (approval-step-evidence, critical, external-evidence-required): No live PHI until signed agreements exist and are retained outside public code. Owner: Legal, privacy, vendor management, and customer sponsor. Hash: a1eb612186d2c85418ac6edf249e5025fff354f852650479f350b60857d1a938. - Live PHI / ePHI processing / RLS/RBAC evidence (approval-step-evidence, critical, blocked-sensitive-storage): No PHI workflow until protected runtime controls are tested with customer-specific approval. Owner: Platform, security, privacy, and tenant admin. Hash: b09130aeef07e41701514653ab1cb1811566118831298a5725df86ef28e88ac2. - Live PHI / ePHI processing / audit-log packet (approval-step-evidence, critical, blocked-sensitive-storage): No PHI workflow until protected runtime controls are tested with customer-specific approval. Owner: Platform, security, privacy, and tenant admin. Hash: fc024d20e97ee9afbd2bbb7f1b309d542e073f778f6a93becc5c1a06c6302aa0. - Live PHI / ePHI processing / incident response tabletop (approval-step-evidence, critical, blocked-sensitive-storage): No PHI workflow until protected runtime controls are tested with customer-specific approval. Owner: Platform, security, privacy, and tenant admin. Hash: 5846d2cbc8ece4fb2e889a3259ca8c66dd07bd809818dc0ce6e98523f67a0388. - Live PHI / ePHI processing / access review evidence (approval-step-evidence, critical, blocked-sensitive-storage): No PHI workflow until protected runtime controls are tested with customer-specific approval. Owner: Platform, security, privacy, and tenant admin. Hash: 5f8208178c0d4a425fadd0d0a7dedfbc416890ca59a0e4ea1ebb4afef8115740. - Clinical decision support / regulatory memo (approval-step-evidence, high, external-evidence-required): No public clinical authority claim until regulatory classification is complete. Owner: Regulatory counsel, clinical safety, and executive approver. Hash: 9952613dddb499e22c50656b190b590c4b7b1269490ae3dd13344da15fea2f01. - Clinical decision support / SaMD/CDS assessment (approval-step-evidence, high, external-evidence-required): No public clinical authority claim until regulatory classification is complete. Owner: Regulatory counsel, clinical safety, and executive approver. Hash: 17d898ad8de9e2179b73c4746cf7085341c87a17ba77ac8ccbdd3de6e9bbfd4b. - Clinical decision support / excluded/regulated rationale (approval-step-evidence, high, external-evidence-required): No public clinical authority claim until regulatory classification is complete. Owner: Regulatory counsel, clinical safety, and executive approver. Hash: 522265f06734fa4f79b283257d731a65edd1d47dbea305e9f105ef698488d85f. - Clinical decision support / external counsel review (approval-step-evidence, high, external-evidence-required): No public clinical authority claim until regulatory classification is complete. Owner: Regulatory counsel, clinical safety, and executive approver. Hash: 8fe3403cc516fad6556e5e8945d1bb8a3adbfc864100ca15d1e0b06b4e377f0c. - Clinical decision support / validation protocol (approval-step-evidence, high, external-evidence-required): No clinical validation claim until protocol results are reviewed and approved. Owner: Clinical QA, specialty reviewer, data science, and safety officer. Hash: a6cd7d7e6c8cef3ec5cf592cde90dcb7b280a35dc97b2453347d4681b7a9da45. - Clinical decision support / synthetic and retrospective test plan (approval-step-evidence, high, external-evidence-required): No clinical validation claim until protocol results are reviewed and approved. Owner: Clinical QA, specialty reviewer, data science, and safety officer. Hash: 2c9db3db2bcc6210a914a1ab277d9aaf851df548a59bb823c189c56c5c095bf1. - Clinical decision support / bias analysis (approval-step-evidence, high, external-evidence-required): No clinical validation claim until protocol results are reviewed and approved. Owner: Clinical QA, specialty reviewer, data science, and safety officer. Hash: 8434cc99c86d15eae481e6c382adf4e65f919ec751cf6668aab43f7b0822102f. - Clinical decision support / clinical safety case (approval-step-evidence, high, external-evidence-required): No clinical validation claim until protocol results are reviewed and approved. Owner: Clinical QA, specialty reviewer, data science, and safety officer. Hash: bff32e64213e9da1d81e6e03ea8658afe9f9fa621841102b1ecae3dd6123bea6. - Clinical decision support / human-in-the-loop policy (approval-step-evidence, high, internal-evidence-required): High-risk clinical outputs remain blocked unless reviewed. Owner: Medical director, clinical governance, Trust Engine owner, and product owner. Hash: 2a00362a5243d0a330ccc483eb0321f48a81acf2500d3f8b12bc063e54507b15. - Clinical decision support / review queue evidence (approval-step-evidence, high, internal-evidence-required): High-risk clinical outputs remain blocked unless reviewed. Owner: Medical director, clinical governance, Trust Engine owner, and product owner. Hash: 585fda25ec9daca0d44f03c7be7612fd6ed73bb3c1603ffc736401c0a77be7b8. - Clinical decision support / escalation policy (approval-step-evidence, high, internal-evidence-required): High-risk clinical outputs remain blocked unless reviewed. Owner: Medical director, clinical governance, Trust Engine owner, and product owner. Hash: 253eedabeca9044d8e7b5bf30123e8d40fd7c3ea0ab766d7f94d01a174096525. - Clinical decision support / evidence card requirements (approval-step-evidence, high, internal-evidence-required): High-risk clinical outputs remain blocked unless reviewed. Owner: Medical director, clinical governance, Trust Engine owner, and product owner. Hash: ce67e2174fa857d53d482b40c302ca0054ef03d5eceb44b650e2891509abd925. - Autonomous diagnosis, treatment, prescribing, or imaging interpretation / regulatory strategy (approval-step-evidence, critical, external-evidence-required): No autonomous action until applicable regulator and clinical governance path is complete. Owner: Regulatory counsel, medical director, quality, and executive sponsor. Hash: c170ad673d44eeb931effbd54ab2bcb7d84aa873fc57be0a09d4214b5c96ea19. - Autonomous diagnosis, treatment, prescribing, or imaging interpretation / quality management plan (approval-step-evidence, critical, external-evidence-required): No autonomous action until applicable regulator and clinical governance path is complete. Owner: Regulatory counsel, medical director, quality, and executive sponsor. Hash: 8783e011d1989fa48ad51da92cb1f9c4df96d603d3e0adf1bca9603c19891757. - Autonomous diagnosis, treatment, prescribing, or imaging interpretation / clinical evaluation plan (approval-step-evidence, critical, external-evidence-required): No autonomous action until applicable regulator and clinical governance path is complete. Owner: Regulatory counsel, medical director, quality, and executive sponsor. Hash: e699f229452daf4d2691b81626af4fbaebd18c047398c5a048bc7cd3a27bae9c. - Autonomous diagnosis, treatment, prescribing, or imaging interpretation / post-market monitoring plan (approval-step-evidence, critical, external-evidence-required): No autonomous action until applicable regulator and clinical governance path is complete. Owner: Regulatory counsel, medical director, quality, and executive sponsor. Hash: 5f45f0f5c4dad6e049e170a26973b5335d170fea1f75efb6e11e8703b73d9c4e. - Autonomous diagnosis, treatment, prescribing, or imaging interpretation / EPCS/e-prescribing review (approval-step-evidence, critical, external-evidence-required): No prescribing or medication action without licensed clinician and required legal/compliance evidence. Owner: Medical director, legal, pharmacy compliance, and customer clinical lead. Hash: 45b290b2508dfa1224255b605e9826e21f2c3abeaeb832c47fa3dce8a820e4ff. - Autonomous diagnosis, treatment, prescribing, or imaging interpretation / order-entry controls (approval-step-evidence, critical, external-evidence-required): No prescribing or medication action without licensed clinician and required legal/compliance evidence. Owner: Medical director, legal, pharmacy compliance, and customer clinical lead. Hash: 161de8e9ca745dd131c99a667304a1f491aaf657e907f0e1ea3da9394956d0b6. - Autonomous diagnosis, treatment, prescribing, or imaging interpretation / malpractice coverage (approval-step-evidence, critical, external-evidence-required): No prescribing or medication action without licensed clinician and required legal/compliance evidence. Owner: Medical director, legal, pharmacy compliance, and customer clinical lead. Hash: 7ead5cc7396d613d644b149df00dcd48c304d296fd8fe724358f6f610b020418. - Autonomous diagnosis, treatment, prescribing, or imaging interpretation / pharmacy workflow approval (approval-step-evidence, critical, external-evidence-required): No prescribing or medication action without licensed clinician and required legal/compliance evidence. Owner: Medical director, legal, pharmacy compliance, and customer clinical lead. Hash: 037243ee9c8da3b0999c81107adf87d3b14846c48556dcd7d301db40254b6770. - EHR writeback and production connector activation / sandbox app registration (approval-step-evidence, high, internal-evidence-required): No writeback until read-only sandbox behavior is proven. Owner: Interoperability, platform, and customer IT. Hash: 0a84a2bca859691b4c91f8ad204c362bbe30d563e7f08e6d924b4fc42988c8a6. - EHR writeback and production connector activation / read-only scope list (approval-step-evidence, high, internal-evidence-required): No writeback until read-only sandbox behavior is proven. Owner: Interoperability, platform, and customer IT. Hash: 1c7484e9d0ab558066c09e092933408e36b1842911fa73bf3e0d4831921f6ed4. - EHR writeback and production connector activation / FHIR conformance results (approval-step-evidence, high, internal-evidence-required): No writeback until read-only sandbox behavior is proven. Owner: Interoperability, platform, and customer IT. Hash: b4124097290b86fe65ce776760bf6a74dd0cc90977f1e0ea0a5ff63a0db4c30c. - EHR writeback and production connector activation / audit trace (approval-step-evidence, high, internal-evidence-required): No writeback until read-only sandbox behavior is proven. Owner: Interoperability, platform, and customer IT. Hash: f7bbb5147f4528a5845f9a48b2e02abcf511c84322b9a4355aa417074d860830. - EHR writeback and production connector activation / scope request (approval-step-evidence, high, customer-evidence-required): No write scope without customer and EHR governance approval. Owner: Customer IT, clinical informatics, security, and SCRIMED platform. Hash: 496d9a14187a7c156f2593271239316253ccb7351f72bcf5475a88e58ecfb051. - EHR writeback and production connector activation / change-control ticket (approval-step-evidence, high, customer-evidence-required): No write scope without customer and EHR governance approval. Owner: Customer IT, clinical informatics, security, and SCRIMED platform. Hash: 6404d9b53e4743de5bd00c9412d06daf6519b6bc0eb7c2e9b0d39bfa7dee6ca5. - EHR writeback and production connector activation / rollback plan (approval-step-evidence, high, customer-evidence-required): No write scope without customer and EHR governance approval. Owner: Customer IT, clinical informatics, security, and SCRIMED platform. Hash: b01ca37c03bc6c75a5eb45d0e00178eee43763b3946e657f1be488979c84e714. - EHR writeback and production connector activation / human signoff policy (approval-step-evidence, high, customer-evidence-required): No write scope without customer and EHR governance approval. Owner: Customer IT, clinical informatics, security, and SCRIMED platform. Hash: ef06c16d53295f39e840229b31ddfc6403b6faab09e1560e321ff5f473afcca4. ## NO-GO Claims Still Preserved - live PHI approved - autonomous clinical care approved - diagnosis approved - treatment or prescribing approved - imaging interpretation approved - EHR writeback approved - payer submission approved - production connector approved - certification claim approved - customer go-live approved ## Next Action Attach each preserved boundary to its evidence packet, assign the missing signoff owners, and keep the runtime fail-closed until approved release decisions exist.