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🔄 Rename HAISVS to HAARF in regulatory framework mappings
- Update all 9 regulatory framework mapping JSON files - Replace all 'haaisvs' references with 'haarf' for consistent branding - Maintain framework alignment across FDA, EU AI Act, Health Canada, NIST, OWASP, ISO, UK MHRA, WHO, and IMDRF mappings - No functional changes to mapping logic or coverage statistics - Ensures unified HAARF v1.0 terminology throughout project
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‎HAARF/1.0/mappings/eu-ai-act-mapping.json‎

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{
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"mapping_info": {
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"haaisvs_version": "1.0",
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"haarf_version": "1.0",
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"target_framework": "EU Artificial Intelligence Act",
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"target_version": "2024 Implementation",
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"mapping_date": "2025-01-10",
@@ -10,72 +10,72 @@
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},
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"mappings": [
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{
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"haaisvs_requirement": "1.1.1",
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"haaisvs_description": "Three-factor risk assessment (clinical function, autonomy, data sensitivity)",
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"haarf_requirement": "1.1.1",
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"haarf_description": "Three-factor risk assessment (clinical function, autonomy, data sensitivity)",
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"target_requirements": ["Article 6 - High-Risk AI Systems", "Annex III - Healthcare Applications"],
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"alignment_type": "direct",
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"notes": "EU AI Act requires risk classification - HAARF three-factor approach directly supports high-risk determination",
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"compliance_evidence": "Risk classification documentation demonstrating healthcare AI agent meets high-risk criteria under Annex III"
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},
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{
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"haaisvs_requirement": "1.3.1",
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"haaisvs_description": "Continuous clinical performance monitoring",
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"haarf_requirement": "1.3.1",
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"haarf_description": "Continuous clinical performance monitoring",
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"target_requirements": ["Article 61 - Post-market monitoring", "Article 72 - Reporting obligations"],
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"alignment_type": "direct",
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"notes": "Direct implementation of EU AI Act post-market monitoring requirements for healthcare AI",
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"compliance_evidence": "Post-market monitoring system, incident reporting procedures, and performance tracking documentation"
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},
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{
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"haaisvs_requirement": "2.1.1",
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"haaisvs_description": "Complete data lineage and provenance tracking",
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"haarf_requirement": "2.1.1",
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"haarf_description": "Complete data lineage and provenance tracking",
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"target_requirements": ["Article 10 - Data and data governance", "Article 15 - Accuracy requirements"],
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"alignment_type": "direct",
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"notes": "EU AI Act data governance requirements fully addressed by HAARF data lineage tracking",
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"compliance_evidence": "Data governance documentation, training data quality assurance, and bias monitoring systems"
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},
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{
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"haaisvs_requirement": "2.3.1",
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"haaisvs_description": "Explainable AI with clinically meaningful insights",
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"haarf_requirement": "2.3.1",
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"haarf_description": "Explainable AI with clinically meaningful insights",
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"target_requirements": ["Article 13 - Transparency obligations", "Article 86 - AI literacy"],
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"alignment_type": "direct",
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"notes": "EU transparency requirements for high-risk AI systems directly supported by HAARF XAI",
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"compliance_evidence": "AI system transparency documentation, user information provisions, and explainability validation"
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},
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{
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"haaisvs_requirement": "3.1.1",
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"haaisvs_description": "Healthcare-specific adversarial robustness testing",
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"haarf_requirement": "3.1.1",
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"haarf_description": "Healthcare-specific adversarial robustness testing",
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"target_requirements": ["Article 15 - Accuracy, robustness and cybersecurity", "Article 43 - Conformity assessment"],
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"alignment_type": "direct",
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"notes": "EU robustness requirements enhanced by HAARF healthcare-specific adversarial testing",
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"compliance_evidence": "Robustness testing protocols, adversarial attack resistance validation, cybersecurity assessment"
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},
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{
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"haaisvs_requirement": "4.1.1",
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"haaisvs_description": "Clinical accountability frameworks for healthcare professionals",
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"haarf_requirement": "4.1.1",
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"haarf_description": "Clinical accountability frameworks for healthcare professionals",
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"target_requirements": ["Article 14 - Human oversight", "Article 26 - User obligations"],
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"alignment_type": "direct",
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"notes": "EU human oversight requirements directly implemented through HAARF clinical accountability",
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"compliance_evidence": "Human oversight procedures, clinical professional competency requirements, override capabilities"
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},
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{
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"haaisvs_requirement": "7.1.1",
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"haaisvs_description": "Training data representativeness and demographic parity",
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"haarf_requirement": "7.1.1",
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"haarf_description": "Training data representativeness and demographic parity",
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"target_requirements": ["Article 10 - Data governance", "Article 7 - Amendments to Annex III"],
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"alignment_type": "direct",
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"notes": "EU data quality and bias prevention requirements enhanced by HAARF population equity measures",
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"compliance_evidence": "Training data diversity analysis, demographic representation validation, bias mitigation strategies"
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},
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{
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"haaisvs_requirement": "8.1.1",
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"haaisvs_description": "Role-based tool access controls for healthcare AI agents",
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"haarf_requirement": "8.1.1",
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"haarf_description": "Role-based tool access controls for healthcare AI agents",
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"target_requirements": ["Article 16 - Risk management system", "Article 43 - Conformity assessment"],
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"alignment_type": "partial",
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"notes": "EU risk management covers general system risks - HAARF C8 adds specific tool integration controls",
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"compliance_evidence": "Tool access control matrix, integration risk assessment, clinical appropriateness validation"
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},
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{
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"haaisvs_requirement": "8.3.1",
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"haaisvs_description": "Medical device integration maintaining classification integrity",
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"haarf_requirement": "8.3.1",
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"haarf_description": "Medical device integration maintaining classification integrity",
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"target_requirements": ["Medical Device Regulation (MDR) 2017/745", "Article 43 - Conformity assessment"],
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"alignment_type": "direct",
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"notes": "Tool integration with EU MDR devices requires careful classification management under both AI Act and MDR",
@@ -100,7 +100,7 @@
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}
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},
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"coverage_analysis": {
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"total_haaisvs_requirements": 279,
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"total_haarf_requirements": 279,
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"mapped_to_eu_ai_act": 198,
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"direct_alignment": 156,
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"partial_alignment": 42,

‎HAARF/1.0/mappings/fda-mapping.json‎

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{
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"mapping_info": {
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"haaisvs_version": "1.0",
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"haarf_version": "1.0",
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"target_framework": "FDA Digital Health Guidance & Medical Device Regulations",
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"target_version": "2024 Updates",
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"mapping_date": "2025-01-10",
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},
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"mappings": [
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{
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"haaisvs_requirement": "1.1.1",
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"haaisvs_description": "Three-factor risk assessment (clinical function, autonomy, data sensitivity)",
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"haarf_requirement": "1.1.1",
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"haarf_description": "Three-factor risk assessment (clinical function, autonomy, data sensitivity)",
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"target_requirements": ["21 CFR 814.20(b)(1)", "Digital Health Guidance v1.0 Section 3.2"],
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"alignment_type": "direct",
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"notes": "FDA requires risk assessment for medical device classification - HAARF three-factor approach directly supports FDA Class determination",
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"compliance_evidence": "Risk assessment documentation showing clinical function analysis, autonomy level classification, and data sensitivity evaluation"
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},
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{
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"haaisvs_requirement": "1.2.1",
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"haaisvs_description": "FDA-style PCCP implementation for high-risk AI agents",
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"haarf_requirement": "1.2.1",
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"haarf_description": "FDA-style PCCP implementation for high-risk AI agents",
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"target_requirements": ["FDA PCCP Guidance 2023", "21 CFR 814.39"],
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"alignment_type": "direct",
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"notes": "Direct implementation of FDA PCCP requirements for AI/ML medical devices",
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"compliance_evidence": "PCCP documentation including modification types, validation protocols, performance criteria, and change control procedures"
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},
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{
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"haaisvs_requirement": "1.3.1",
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"haaisvs_description": "Continuous clinical performance monitoring",
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"haarf_requirement": "1.3.1",
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"haarf_description": "Continuous clinical performance monitoring",
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"target_requirements": ["FDA Real-World Performance Study Guidance", "21 CFR 814.82"],
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"alignment_type": "direct",
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"notes": "Supports FDA post-market surveillance and real-world performance monitoring requirements",
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"compliance_evidence": "Clinical performance monitoring plan, statistical analysis protocols, and performance degradation alert systems"
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},
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{
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"haaisvs_requirement": "2.1.2",
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"haaisvs_description": "Health Canada SGBA+ documentation and bias assessment",
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"haarf_requirement": "2.1.2",
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"haarf_description": "Health Canada SGBA+ documentation and bias assessment",
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"target_requirements": ["FDA Diversity Action Plans", "FDA Medical Device Cybersecurity Guidance"],
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"alignment_type": "partial",
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"notes": "FDA diversity requirements less comprehensive than Health Canada SGBA+ but HAARF addresses both",
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"compliance_evidence": "Demographic diversity analysis, bias assessment documentation, and mitigation strategies"
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},
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{
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"haaisvs_requirement": "2.3.1",
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"haaisvs_description": "Explainable AI with clinically meaningful insights",
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"haarf_requirement": "2.3.1",
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"haarf_description": "Explainable AI with clinically meaningful insights",
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"target_requirements": ["FDA Software Pre-Cert Guidance", "21 CFR 820.30"],
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"alignment_type": "direct",
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"notes": "FDA design controls require understanding of software function - XAI supports clinical validation requirements",
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"compliance_evidence": "XAI implementation documentation, clinical validation of explanations, healthcare professional usability testing"
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},
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{
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"haaisvs_requirement": "3.1.1",
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"haaisvs_description": "Healthcare-specific adversarial robustness testing",
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"haarf_requirement": "3.1.1",
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"haarf_description": "Healthcare-specific adversarial robustness testing",
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"target_requirements": ["FDA Medical Device Cybersecurity Guidance", "21 CFR 820.30(g)"],
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"alignment_type": "partial",
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"notes": "FDA cybersecurity guidance covers general threats - HAARF adds AI-specific adversarial testing",
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"compliance_evidence": "Adversarial testing protocols, robustness validation results, and threat model documentation"
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},
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{
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"haaisvs_requirement": "4.1.1",
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"haaisvs_description": "Clinical accountability frameworks for healthcare professionals",
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"haarf_requirement": "4.1.1",
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"haarf_description": "Clinical accountability frameworks for healthcare professionals",
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"target_requirements": ["FDA Human Factors Guidance", "21 CFR 820.30(h)"],
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"alignment_type": "direct",
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"notes": "FDA human factors requirements directly supported by HAARF clinical accountability frameworks",
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"compliance_evidence": "Clinical oversight procedures, healthcare professional competency requirements, and accountability documentation"
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},
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{
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"haaisvs_requirement": "8.1.1",
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"haaisvs_description": "Role-based tool access controls for healthcare AI agents",
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"haarf_requirement": "8.1.1",
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"haarf_description": "Role-based tool access controls for healthcare AI agents",
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"target_requirements": ["FDA Medical Device Interoperability Guidance", "21 CFR 820.30"],
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"alignment_type": "direct",
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"notes": "Critical FDA priority - tool access controls essential for medical device integration safety",
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"compliance_evidence": "Tool authorization matrix, clinical appropriateness validation, and access control audit trails"
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},
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{
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"haaisvs_requirement": "8.3.1",
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"haaisvs_description": "FDA-regulated medical device integration maintaining classification integrity",
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"haarf_requirement": "8.3.1",
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"haarf_description": "FDA-regulated medical device integration maintaining classification integrity",
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"target_requirements": ["FDA Medical Device Interoperability Guidance", "21 CFR 807"],
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"alignment_type": "direct",
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"notes": "Directly addresses FDA's highest priority concern - tool integration without altering device classification",
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"compliance_evidence": "Device classification impact analysis, interoperability validation, safety function verification"
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},
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{
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"haaisvs_requirement": "8.7.1",
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"haaisvs_description": "Regulatory classification analysis for tool combinations",
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"haarf_requirement": "8.7.1",
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"haarf_description": "Regulatory classification analysis for tool combinations",
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"target_requirements": ["FDA Device Classification", "510(k) Guidance", "Combination Product Guidance"],
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"alignment_type": "direct",
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"notes": "Essential for determining correct FDA submission pathway for tool-enabled agents",
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}
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},
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"coverage_analysis": {
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"total_haaisvs_requirements": 279,
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"total_haarf_requirements": 279,
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"mapped_to_fda": 234,
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"direct_alignment": 185,
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"partial_alignment": 49,

‎HAARF/1.0/mappings/health-canada-mapping.json‎

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{
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"mapping_info": {
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"haaisvs_version": "1.0",
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"haarf_version": "1.0",
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"target_framework": "Health Canada Sex- and Gender-Based Analysis Plus (SGBA+) & Medical Device Regulations",
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"target_version": "2024 AI/ML Guidance",
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"mapping_date": "2025-01-10",
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},
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"mappings": [
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{
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"haaisvs_requirement": "1.1.4",
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"haaisvs_description": "SaMD risk mapping with four-tier classification system",
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"haarf_requirement": "1.1.4",
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"haarf_description": "SaMD risk mapping with four-tier classification system",
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"target_requirements": ["Health Canada SaMD Guidance", "Medical Device Regulations (MDR)"],
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"alignment_type": "direct",
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"notes": "Health Canada SaMD classification directly supported by HAARF four-tier risk mapping",
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"compliance_evidence": "SaMD classification documentation, risk categorization evidence, Health Canada pathway determination"
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},
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{
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"haaisvs_requirement": "2.1.2",
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"haaisvs_description": "Health Canada SGBA+ documentation and bias assessment",
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"haarf_requirement": "2.1.2",
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"haarf_description": "Health Canada SGBA+ documentation and bias assessment",
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"target_requirements": ["SGBA+ Framework", "Health Canada Guidance Document on AI/ML"],
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"alignment_type": "direct",
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"notes": "Direct implementation of Health Canada SGBA+ requirements with enhanced intersectional analysis",
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"compliance_evidence": "SGBA+ analysis documentation, demographic diversity assessment, intersectional bias evaluation"
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},
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{
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"haaisvs_requirement": "1.3.4",
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"haaisvs_description": "Clinical performance monitoring with Health Canada SGBA+ compliance",
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"haarf_requirement": "1.3.4",
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"haarf_description": "Clinical performance monitoring with Health Canada SGBA+ compliance",
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"target_requirements": ["Post-market surveillance requirements", "SGBA+ monitoring obligations"],
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"alignment_type": "direct",
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"notes": "Continuous SGBA+ compliance monitoring ensures maintained performance across diverse populations",
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"compliance_evidence": "Population-stratified performance monitoring, SGBA+ compliance tracking, demographic outcome analysis"
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},
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{
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"haaisvs_requirement": "7.1.1",
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"haaisvs_description": "Training data representativeness with comprehensive demographic coverage",
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"haarf_requirement": "7.1.1",
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"haarf_description": "Training data representativeness with comprehensive demographic coverage",
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"target_requirements": ["SGBA+ Data Requirements", "Health Canada Diversity Guidelines"],
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"alignment_type": "enhanced",
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"notes": "HAARF extends Health Canada SGBA+ with enhanced intersectional analysis and global health considerations",
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"compliance_evidence": "Enhanced demographic representation analysis, intersectional bias assessment, vulnerable population coverage"
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},
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{
45-
"haaisvs_requirement": "7.2.1",
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"haaisvs_description": "Algorithmic bias detection with multi-metric fairness assessment",
45+
"haarf_requirement": "7.2.1",
46+
"haarf_description": "Algorithmic bias detection with multi-metric fairness assessment",
4747
"target_requirements": ["SGBA+ Bias Detection", "Health Equity Framework"],
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"alignment_type": "enhanced",
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"notes": "HAARF multi-metric approach provides comprehensive bias detection beyond standard SGBA+ requirements",
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"compliance_evidence": "Multi-metric fairness evaluation, intersectional bias analysis, health equity impact assessment"
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},
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{
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"haaisvs_requirement": "7.4.1",
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"haaisvs_description": "Vulnerable population protection with enhanced clinical safeguards",
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"haarf_requirement": "7.4.1",
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"haarf_description": "Vulnerable population protection with enhanced clinical safeguards",
5555
"target_requirements": ["SGBA+ Vulnerable Population Guidelines", "Health Equity Standards"],
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"alignment_type": "direct",
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"notes": "Vulnerable population protection directly addresses Health Canada SGBA+ equity requirements",
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"compliance_evidence": "Vulnerable population risk assessment, enhanced safety protocols, equity outcome monitoring"
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},
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{
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"haaisvs_requirement": "7.5.1",
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"haaisvs_description": "Global health equity considerations for resource-limited settings",
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"haarf_requirement": "7.5.1",
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"haarf_description": "Global health equity considerations for resource-limited settings",
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"target_requirements": ["Health Canada Global Health Strategy", "International Development Guidelines"],
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"alignment_type": "enhanced",
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"notes": "HAARF extends beyond domestic SGBA+ to include global health equity considerations",
6666
"compliance_evidence": "Resource-limited setting analysis, global health equity assessment, international deployment considerations"
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},
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{
69-
"haaisvs_requirement": "4.6.1",
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"haaisvs_description": "Clinical workflow integration with change management",
69+
"haarf_requirement": "4.6.1",
70+
"haarf_description": "Clinical workflow integration with change management",
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"target_requirements": ["Health Canada Implementation Guidance", "Clinical Integration Standards"],
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"alignment_type": "direct",
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"notes": "Clinical workflow integration supports Health Canada requirements for healthcare system implementation",
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"compliance_evidence": "Clinical workflow analysis, change management procedures, healthcare professional training documentation"
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},
7676
{
77-
"haaisvs_requirement": "8.2.2",
78-
"haaisvs_description": "Tool selection safety validation for patient populations",
77+
"haarf_requirement": "8.2.2",
78+
"haarf_description": "Tool selection safety validation for patient populations",
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"target_requirements": ["Health Canada Safety Requirements", "Population-Specific Guidelines"],
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"alignment_type": "direct",
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"notes": "Tool selection validation ensures patient population safety aligned with Health Canada requirements",
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}
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},
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"coverage_analysis": {
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"total_haaisvs_requirements": 279,
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"total_haarf_requirements": 279,
124124
"mapped_to_health_canada": 187,
125125
"direct_alignment": 134,
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"enhanced_alignment": 53,

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