SSCRIMED
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Approvals Readiness

Global Approval and Certification Readiness

SCRIMED prepares for domestic and global approvals without claiming them early.

This control plane translates current U.S., EU, UK, Australian, and global assurance expectations into SCRIMED-owned tracks, evidence gates, regional buyer packs, proof routes, and blocked claims before production healthcare operation.

Download Certification BriefInspect APIApprovals LadderGlobal ReachDeployment Profiles
Statusglobal-approval-certification-readiness-control-plane-active
Sources10
Tracks6
Gates5
Regions5
Roadmap4
Blocked claims24
Evidence artifacts30

Operating boundary

Prepare evidence now; claim approval only after qualified external review.

SCRIMED Global Approval and Certification Readiness organizes domestic and international privacy, security, AI governance, medical-device, clinical-safety, interoperability, and procurement evidence needed before production healthcare operation. It is readiness planning only. It does not grant legal advice, regulatory approval, HIPAA compliance certification, SOC 2/HITRUST/ISO certification, FDA clearance, ONC certification, EU AI Act conformity, GDPR compliance assurance, NHS approval, MHRA approval, Australian cyber certification, PHI processing authority, public-sector procurement approval, reimbursement assurance, production connector approval, or live clinical care authority.

01Turn approval requirements into SCRIMED-owned evidence packages.
02Stand up audit-ready security, privacy, and AI governance foundations.
03Prepare regulated healthcare AI productization only where strategically chosen.
04Scale global deployments through localized assurance packs.

Tracks

Each future approval family has a route, owner, evidence packet, and blocked-claim list.

United States

U.S. HIPAA, BAA, and PHI Readiness

Prepare SCRIMED for healthcare buyer diligence and future PHI/ePHI scope while keeping current public and pilot flows synthetic-only.

Stand up a metadata-only HIPAA evidence room and assign risk-analysis, BAA, breach, access-review, and subprocessor owners.
  • Status: evidence-build-required
  • Evidence: HIPAA security risk analysis, Administrative, physical, and technical safeguard matrix, BAA/DPA template and non-PHI determination workflow, Breach notification and incident response runbook, Vendor, subprocessor, access-review, and audit-log registers
  • Proof: /approvals-readiness, /trust-center, /trust-safety-operations, /pilot-workspace/access
  • Blocked: HIPAA certified, PHI approved, BAA executed, production ePHI processing
United States

U.S. FDA CDS and SaMD Classification

Prevent clinical-intelligence features from becoming unauthorized device claims while preserving a route to regulated clinical productization if deliberately chosen.

Produce a module-by-module intended-use and CDS/SaMD classification memo before adding any patient-specific clinical claim.
  • Status: external-review-required
  • Evidence: Intended-use memo per module, CDS non-device criteria analysis, SaMD risk classification and pathway memo, Clinical evidence and validation plan, Human factors, transparency, model-change, and post-market monitoring plan
  • Proof: /clinical-authority-readiness, /clinical-care-activation, /qa-claim-guard, /trust-os
  • Blocked: FDA cleared, diagnostic device, autonomous clinical decision, medical device approved
Global

SOC 2, HITRUST, ISO 27001, and ISO 42001 Sequencing

Move from internal control readiness to independent security, privacy, and AI governance assurance without claiming certification early.

Create a certification sequencing board: SOC 2 readiness first, ISO 42001 AI management in parallel, HITRUST/ISO 27001 after buyer-driven scope.
  • Status: evidence-build-required
  • Evidence: Control inventory and ownership map, Risk register and audit evidence cadence, Change management, incident response, access control, vendor risk, and backup evidence, AI inventory, model evaluation, TrustOS decisions, and AI risk treatment plan, External auditor selection and readiness assessment
  • Proof: /trust-center, /service-reliability, /release-continuity, /qa-evidence
  • Blocked: SOC 2 certified, HITRUST certified, ISO certified, security certified
European Union

EU AI Act, GDPR, and European Health Data Readiness

Prepare SCRIMED for EU deployment conversations with high-risk AI triage, personal-data governance, cross-border transfer controls, and deployer documentation.

Add EU-specific deployment-profile gates for AI Act high-risk triage, GDPR DPIA, SCC/DPA, hosting, and post-market monitoring.
  • Status: external-review-required
  • Evidence: EU AI Act high-risk classification memo, Technical documentation and logging plan, Data governance, quality, bias, and representative-dataset controls, Human oversight, robustness, cybersecurity, and accuracy evidence, GDPR DPIA, lawful basis, DPA/SCC, retention, data-subject rights, and transfer mechanism
  • Proof: /global-reach, /deployment-profiles, /strategic-intelligence, /trust-center
  • Blocked: GDPR compliant, EU AI Act conformant, CE marked, EU production approved
United Kingdom

UK NHS DTAC and MHRA Software/AI Readiness

Prepare SCRIMED for UK NHS and private-provider review with DTAC evidence, clinical-safety controls, MHRA intended-purpose classification, and medical-device escalation gates.

Build a UK DTAC/MHRA evidence checklist and attach it to the global buyer localization pack.
  • Status: external-review-required
  • Evidence: DTAC clinical safety, data protection, technical security, interoperability, usability, and accessibility evidence, DCB0129/DCB0160 clinical-risk-management routing where applicable, DSPT and pre-acquisition questionnaire alignment, MHRA SaMD/AIaMD intended-purpose and classification memo, Post-market surveillance, change-management, and cybersecurity plan
  • Proof: /global-reach, /clinical-authority-readiness, /interoperability, /trust-center
  • Blocked: NHS approved, DTAC passed, MHRA approved, UK medical device certified
Australia

Australia Essential Eight and Health Deployment Readiness

Prepare SCRIMED for Australian provider, public-sector, and partner diligence with cyber baseline evidence and local privacy/procurement review gates.

Add Australia to deployment-profile readiness with Essential Eight evidence labels and privacy/procurement hard stops.
  • Status: evidence-build-required
  • Evidence: Essential Eight maturity mapping, Patch, MFA, application control, macro hardening, privilege, backup, and logging evidence, Australian privacy and hosting review, Incident-reporting and buyer security questionnaire packet, Local partner authority and implementation support model
  • Proof: /global-reach, /service-reliability, /deployment-profiles, /trust-center
  • Blocked: Australian government approved, Essential Eight certified, public-sector approved, health deployment authorized

Gates

SCRIMED cannot cross these lines until evidence, owners, and authority are complete.

gate

Intended-use and claim classification

Decide whether each SCRIMED module is operations intelligence, non-device CDS candidate, SaMD review candidate, or blocked care-delivery scope.

Product + clinical governance + regulatory counsel
  • Required before: clinical claims, patient-specific workflows, FDA/MHRA/EU medical-device planning
  • Evidence: intended-use memo, claims register, module classification table
  • Blocked: diagnosis language, treatment language, autonomous triage, medical-device approval claims
gate

Privacy and data-boundary approval

Prove whether a workflow remains synthetic/no-PHI/no-personal-data or needs HIPAA, GDPR, DPA, SCC, hosting, consent, and retention controls.

Privacy + legal + security
  • Required before: PHI processing, EU personal-data processing, cross-border transfer, customer data ingestion
  • Evidence: risk analysis, DPIA, BAA/DPA, SCC decision, retention schedule
  • Blocked: production PHI, EU personal-data movement, customer upload, patient outreach
gate

Security assurance and audit evidence

Move internal controls toward audit-ready evidence for SOC 2, ISO 27001, HITRUST, ISO 42001, and buyer security reviews.

Security + engineering + operations
  • Required before: enterprise license, protected production pilot, security certification claims
  • Evidence: control owner map, audit trail, incident response, access reviews, vendor risk register
  • Blocked: SOC 2 certified, HITRUST certified, ISO certified, security approved
gate

Human oversight and post-market monitoring

Make AI oversight, model drift, incidents, serious malfunctions, and change control inspectable before regulated or global deployment.

TrustOS + quality + clinical governance
  • Required before: EU high-risk AI use, SaMD production scope, adaptive AI deployment
  • Evidence: human oversight plan, monitoring plan, incident taxonomy, change protocol, rollback plan
  • Blocked: autonomous operation, adaptive model release, high-risk AI conformity, post-market compliance claim
gate

Regional procurement and localization authority

Confirm local legal, privacy, procurement, hosting, language, accessibility, and partner authority before country-specific sales claims.

Global partnerships + regional counsel + sales
  • Required before: public-sector claims, country launch, sovereign deployment, local customer proof
  • Evidence: regional counsel memo, hosting decision, localized claim review, partner authority record
  • Blocked: government approved, country-wide deployment, sovereign-ready approved, local certification complete

Regional packs

Domestic and global motion stays localized before production, procurement, or data claims expand.

launch

United States

Sell governed synthetic evaluations and no-PHI workflow intelligence while HIPAA, FDA, and SOC 2 evidence matures.

HIPAA/BAA, SOC 2 readiness, FDA/CDS/SaMD classification, ONC/EHR connector review
  • Buyer packet: security questionnaire, BAA path, intended-use memo, SOC 2 readiness map
  • Hard stops: PHI authority, clinical authority, production connector approval, security assurance evidence
strategic

European Union

Use no-personal-data strategic evaluations and EU buyer localization packs before EU personal-data or high-risk AI commitments.

EU AI Act high-risk triage, GDPR DPIA/DPA/SCC, hosting and transfer review, CE/MDR review if medical-device scope
  • Buyer packet: AI Act technical-documentation outline, GDPR data map, human oversight plan, deployment profile
  • Hard stops: GDPR role/lawful-basis approval, high-risk AI conformity route, EU hosting decision, medical-device review
strategic

United Kingdom

Offer UK synthetic pilot proof with DTAC-style diligence packets while medical-device and NHS assurance remain gated.

NHS DTAC, DSPT alignment, MHRA SaMD/AIaMD classification, UK GDPR/ICO review
  • Buyer packet: DTAC evidence checklist, clinical safety file outline, interoperability proof, UK intended-purpose memo
  • Hard stops: NHS assurance, clinical safety signoff, MHRA/medical-device route, ICO/privacy review
watch

Australia

Use cyber-aligned partner discovery and synthetic pilots while Essential Eight and local privacy evidence are prepared.

Essential Eight maturity, privacy and hosting review, health procurement review, regional partner qualification
  • Buyer packet: Essential Eight mapping, incident-response summary, deployment profile, privacy/hosting decision memo
  • Hard stops: buyer security acceptance, privacy counsel review, public-sector procurement, production data approval
strategic

Middle East strategic markets

Lead with executive synthetic evidence, deployment profiles, and qualified partner review before national-program or sovereign claims.

regional counsel, data residency, public-sector procurement, Arabic/English claims review, sovereign deployment profile
  • Buyer packet: sovereign deployment profile, regional privacy review, partner authority register, public-sector procurement questions
  • Hard stops: government authority, data residency approval, local hosting decision, qualified partner signoff

Source review

Official requirements are reduced to SCRIMED implications and retained evidence work.

United States

HHS HIPAA Security Rule

HHS frames the Security Rule around administrative, physical, and technical safeguards for electronic protected health information, with a January 2025 proposed cybersecurity update noted by HHS.

SCRIMED needs a HIPAA risk analysis, safeguard map, BAA/DPA pathway, breach process, access review, and subprocessor register before PHI or ePHI scope.
United States

FDA Clinical Decision Support Software Guidance

FDA's January 2026 final CDS guidance clarifies when certain decision-support software functions may be excluded from device definition and when device policies continue to apply.

SCRIMED must maintain intended-use analysis, human-review transparency, non-device CDS criteria review, and SaMD escalation gates before clinical recommendation claims.
United States

FDA Artificial Intelligence in Software as a Medical Device

FDA highlights lifecycle management, premarket pathways, modifications, good machine-learning practice, transparency, predetermined change control, and AI-enabled device guidance work.

If SCRIMED deliberately enters regulated SaMD territory, it needs QMS, clinical evidence, risk management, performance monitoring, change control, transparency, and regulatory counsel before launch.
United States

NIST AI Risk Management Framework

NIST AI RMF is voluntary and intended to improve incorporation of trustworthiness considerations into design, development, use, and evaluation of AI systems.

SCRIMED should map AI inventory, risk taxonomy, measurement routines, model evaluation, incident response, and TrustOS evidence to NIST AI RMF language.
European Union

EU Artificial Intelligence Act

The EU describes high-risk AI obligations including risk assessment, data quality, activity logging, documentation, deployer information, human oversight, robustness, cybersecurity, and accuracy; current implementation timelines include 2027 and 2028 high-risk transition dates.

SCRIMED needs EU high-risk triage, technical documentation, data governance, logs, human oversight, post-market monitoring, serious-incident routing, and conformity-assessment planning before EU production claims.
European Union

European Commission GDPR Legal Framework

The Commission identifies the GDPR as the EU data-protection framework, applying since 25 May 2018 and covering personal-data rights, controllers/processors, supervisory authorities, and cross-border mechanisms.

SCRIMED needs GDPR role mapping, lawful-basis review, DPIA, DPA/SCC workflows, data-subject rights process, retention schedule, transfer mechanism, and DPO escalation before EU personal-data scope.
Global

ISO/IEC 42001:2023

ISO describes ISO/IEC 42001 as an AI management system standard for establishing, implementing, maintaining, and continually improving responsible AI management.

SCRIMED should build an AI Management System with policy, objectives, risk treatment, traceability, transparency, audit cadence, and continuous improvement before pursuing ISO 42001 certification.
United Kingdom

NHS Digital Technology Assessment Criteria

NHS DTAC covers clinical safety, data protection, technical security, interoperability, usability, and accessibility; NHS notes it does not replace other required approvals.

SCRIMED needs a UK buyer pack for clinical safety, data protection, security, interoperability, usability, accessibility, DSPT alignment, and medical-device escalation.
United Kingdom

MHRA Software and AI as a Medical Device Change Programme

MHRA roadmap work covers SaMD qualification, intended purpose, classification, premarket requirements, clinical evidence, post-market surveillance, change management, cybersecurity, and AIaMD-specific issues.

SCRIMED needs UK intended-purpose classification, clinical evidence plan, post-market surveillance model, change-control process, cybersecurity evidence, and MHRA counsel before UK clinical claims.
Australia

Australian Cyber Security Centre Essential Eight

The ACSC describes Essential Eight as eight baseline mitigation strategies that make compromise harder, while noting no set of mitigations guarantees protection from every cyber threat.

SCRIMED should map Australian buyer security diligence to Essential Eight maturity evidence, incident reporting, access hardening, patching, backups, application controls, and logging.