[
  {"std_id": "ISO 15197:2026", "organization": "ISO/TC 212", "published_date": "2026-02-10", "title": "In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus", "scope": "BGMS accuracy criteria revision; tightening of accuracy to 95% within ±10 mg/dL or ±10%", "impact": "BGM/SMBG 정확도 기준 강화; KFDA·FDA 인허가에 직접 영향", "relevance": ["CGM", "BGMS"], "kor_market_note": "한국 시판 SMBG 재시험 필요 가능; 식약처 정합화 예상"},
  {"std_id": "ISO 14971:2026/AMD 1", "organization": "ISO/IEC", "published_date": "2026-03-22", "title": "Medical devices - Application of risk management to medical devices - Amendment 1: AI/ML considerations", "scope": "Risk management for adaptive AI systems; pre-determined change control plan (PCCP) alignment with FDA", "impact": "모든 AI SaMD 인허가에 영향, PCCP 의무화 흐름", "relevance": ["SaMD", "DTx", "AI/ML"], "kor_market_note": "KFDA AI 의료기기 가이드라인 2025-개정 정합"},
  {"std_id": "IEC 62366-1:2026", "organization": "IEC/SC 62A", "published_date": "2026-01-18", "title": "Medical devices - Part 1: Application of usability engineering to medical devices", "scope": "Usability for diabetes self-care devices; pediatric and elderly considerations expanded", "impact": "CGM/AID/pen 사용성 평가 요구사항 강화", "relevance": ["CGM", "AID", "PEN", "DTx"], "kor_market_note": "한국인 사용자 그룹 별도 평가 권장"},
  {"std_id": "IEC 62304:2026/AMD 2", "organization": "IEC/SC 62A", "published_date": "2026-04-05", "title": "Medical device software - Software life cycle processes - Amendment 2: Continuous learning AI", "scope": "Lifecycle for continuously-learning AI; mandatory model versioning + post-market surveillance hooks", "impact": "AI SaMD 모델 업데이트 절차 표준화", "relevance": ["SaMD", "AI/ML", "DTx"], "kor_market_note": "KFDA Pre-Cert 시범사업과 align"},
  {"std_id": "ISO 13485:2016/AMD 2:2026", "organization": "ISO/TC 210", "published_date": "2026-02-28", "title": "Medical devices - Quality management systems - Requirements for regulatory purposes", "scope": "EU MDR + FDA QMSR harmonization clarifications", "impact": "QMS 운영 전 분야 영향, FDA QMSR(2026 시행) 정합", "relevance": ["ALL"], "kor_market_note": "한국 GMP와 정합화 진행 중"},
  {"std_id": "AAMI TIR45:2026", "organization": "AAMI", "published_date": "2026-03-14", "title": "Guidance on the use of agile practices in the development of medical device software", "scope": "Agile + DevOps for SaMD; CI/CD pipeline documentation", "impact": "DTx·SaMD 개발 프로세스 가이드", "relevance": ["SaMD", "DTx"], "kor_market_note": "닥터앤서 3.0 같은 컨소시엄 개발에 직접 적용 가능"},
  {"std_id": "UL 2900-2-1:2026", "organization": "UL Standards & Engagement", "published_date": "2026-01-25", "title": "Standard for Software Cybersecurity for Network-Connectable Products - Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems", "scope": "Cybersecurity for CGM/AID/pump connectivity; SBOM mandatory", "impact": "FDA cyber 가이던스(2023)와 align, KFDA 사이버보안 가이드라인", "relevance": ["CGM", "AID", "PEN", "SaMD"], "kor_market_note": "KFDA 사이버보안 가이드라인 2025 개정 정합"},
  {"std_id": "IEC 60601-2-24:2026", "organization": "IEC", "published_date": "2026-02-05", "title": "Medical electrical equipment - Particular requirements for the basic safety and essential performance of infusion pumps and controllers", "scope": "Insulin pump safety; AID-specific clauses added", "impact": "AID/펌프 인허가 핵심 기준", "relevance": ["AID"], "kor_market_note": "KFDA 인슐린펌프 가이드라인 개정 예정"},
  {"std_id": "IEC 82304-2:2026", "organization": "IEC", "published_date": "2026-03-30", "title": "Health software - Part 2: Health and wellness apps - Quality and reliability", "scope": "Quality label for health & wellness apps; CE/UKCA referenced", "impact": "DTx 외 wellness 영역 표준", "relevance": ["DTx", "WEARABLE"], "kor_market_note": "K-DTx 비의료기기 wellness 구분에 활용"},
  {"std_id": "ISO/TR 24971:2026", "organization": "ISO", "published_date": "2026-04-15", "title": "Medical devices - Guidance on the application of ISO 14971", "scope": "Updated guidance for ML/AI risk; aligned with 14971 AMD 1", "impact": "AI SaMD 위험관리 실무 가이드", "relevance": ["SaMD", "AI/ML"], "kor_market_note": "KFDA 위험관리 가이드라인 정합"},
  {"std_id": "AAMI SW96:2026", "organization": "AAMI", "published_date": "2026-04-22", "title": "Standard for medical device security - Security risk management for device manufacturers", "scope": "Security risk per device lifecycle; aligns with FDA premarket cyber", "impact": "AID/CGM/SaMD 사이버보안 인허가 필수", "relevance": ["CGM", "AID", "SaMD", "DTx"], "kor_market_note": "KFDA 시판전 사이버보안 자료 정합"},
  {"std_id": "ISO 20916:2026/AMD 1", "organization": "ISO/TC 212", "published_date": "2026-05-02", "title": "In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice", "scope": "Clinical performance design for SMBG/CGM studies", "impact": "CGM 임상시험 설계 기준 강화", "relevance": ["CGM", "BGMS"], "kor_market_note": "한국 CGM 다국가 임상에 영향"},
  {"std_id": "NICE Evidence Standards Framework for Digital Health Technologies v3", "organization": "NICE (UK)", "published_date": "2026-03-08", "title": "ESF v3 - DHT evidence tiers for NHS adoption", "scope": "Tier C high-evidence DTx for diabetes; cost-effectiveness threshold added", "impact": "UK DTx 채택 게이트 강화", "relevance": ["DTx", "SaMD"], "kor_market_note": "한국 신의료기술평가 디지털 트랙 벤치마크"},
  {"std_id": "FDA PCCP Guidance Final 2026", "organization": "FDA CDRH", "published_date": "2026-02-26", "title": "Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions", "scope": "PCCP final guidance; post-market modification protocols", "impact": "모든 AI SaMD 인허가 표준화", "relevance": ["SaMD", "AI/ML", "DTx"], "kor_market_note": "KFDA AI 의료기기 모델 변경 가이드라인 도입 예상"},
  {"std_id": "KFDA 디지털치료기기 인증제도 v2.0", "organization": "식품의약품안전처", "published_date": "2026-04-30", "title": "디지털치료기기 허가·심사 가이드라인 개정(안)", "scope": "DTx 임상시험 설계·실사용데이터 기준 구체화, 만성질환(당뇨/MASLD) 트랙 추가", "impact": "K-DTx 인허가 절차 명확화, 보험급여 연계", "relevance": ["DTx"], "kor_market_note": "WELT-DM 같은 국내 DTx에 직접 영향, 닥터앤서 3.0 align"}
]