United States
ONC (Office of the National Coordinator for Health IT)
- Coordinates national health IT efforts
- Establishes standards through rulemaking
- Administers EHR certification program
- Promotes interoperability
ONC Certification Program:
- 2015 Edition: Previous certification criteria
- Cures Act Update: Current criteria including:
- Standardized API (FHIR)
- United States Core Data for Interoperability (USCDI)
- Patient access requirements
- Information blocking prohibition
CMS (Centers for Medicare & Medicaid Services)
- Promoting Interoperability Programs (formerly Meaningful Use)
- Quality Payment Program (QPP)
- MIPS (Merit-based Incentive Payment System)
- Advanced Alternative Payment Models (APMs)
- Interoperability and Patient Access Final Rule
21st Century Cures Act
- Information Blocking: Prohibits practices that interfere with access, exchange, or use of EHI
- Patient Access: Requires patient access to EHI via API
- Provider Directory: Requires provider directory via API
- Payer-to-Payer: Requires data exchange between payers
FDA (Food and Drug Administration)
- Regulates medical devices (including software)
- Risk-based approach to medical software
- Oversight of clinical decision support
- Cybersecurity guidance
European Union
Medical Device Regulation (MDR 2017/745)
- Replaced Medical Device Directive (MDD)
- More stringent requirements
- Software classification rules
- Clinical evaluation requirements
- Post-market surveillance
In Vitro Diagnostic Regulation (IVDR 2017/746)
- Regulates diagnostic software
- Risk-based classification
- Performance evaluation
- Quality management systems
CE Marking
- Indicates conformity with EU regulations
- Required to market medical devices in EU
- Involves conformity assessment by Notified Body
GDPR (General Data Protection Regulation)
- Applies to all personal data (including health)
- See Privacy and Security Standards section for details
United Kingdom (Post-Brexit)
MHRA (Medicines and Healthcare products Regulatory Agency)
- UK regulator for medical devices
- UKCA marking (replacing CE for UK market)
- Similar requirements to EU MDR
NHS Digital
- Sets standards for NHS IT systems
- DCB standards (Data Coordination Board)
- Publishes implementation guides
Canada
Health Canada
- Regulates medical devices
- SaMD guidance similar to FDA
- Class I-IV classification
- Pre-market review requirements
Canada Health Infoway
- Accelerates adoption of health IT
- Develops standards-based solutions
- Supports provinces and territories
Australia
TGA (Therapeutic Goods Administration)
- Regulates medical devices
- Risk-based classification
- Conformity assessment procedures
- Post-market monitoring
My Health Record
- National digital health record system
- FHIR-based
- Opt-out model
International Harmonization
IMDRF (International Medical Device Regulators Forum)
- Harmonizes medical device regulation
- Develops SaMD guidance adopted globally
- Working groups on various topics
Global Harmonization Task Force (GHTF)
- Predecessor to IMDRF
- Established foundation for harmonization