Understanding who develops and maintains healthcare standards is essential for implementing them correctly. Here are the key organizations you’ll encounter.
ANSI (American National Standards Institute)
Role: Accreditor of standards in the United States Website: https://www.ansi.org/
ANSI doesn’t develop standards itself but accredits standards developed by other organizations. It coordinates the U.S. voluntary standardization system.
Key Functions:
- Accredits standards developing organizations (SDOs)
- Approves standards as American National Standards
- Represents U.S. interests in international standardization
Example: HL7 is an ANSI-accredited standards developing organization.
ISO (International Organization for Standardization)
Role: Coordinates development of global healthcare information standards Relevant Committee: ISO Technical Committee 215 (Health Informatics)
Key Standards from ISO TC 215:
- ISO 13606: Electronic health record communication
- ISO 27799: Health informatics security management
- ISO 13485: Medical devices quality management
- ISO/IEEE 11073: Personal health devices communication
HL7 International (Health Level Seven)
Role: Develops clinical and administrative data standards Focus: Healthcare information exchange and integration
Major Standards:
- HL7 V2: Messaging standard (most widely implemented)
- HL7 V3: XML-based messaging and models
- FHIR (Fast Healthcare Interoperability Resources): Modern API-based standard
IHE (Integrating the Healthcare Enterprise)
Role: Develops integration profiles using existing standards Focus: Practical implementation guides
IHE doesn’t create new standards but defines how to use existing standards together to solve specific clinical problems.
NEMA (National Electrical Manufacturers Association)
Role: Maintains DICOM standard Focus: Medical imaging communication
SNOMED International
Role: Maintains SNOMED CT Focus: Clinical terminology
Regenstrief Institute
Role: Maintains LOINC Focus: Laboratory and clinical observations terminology
ONC (Office of the National Coordinator for Health IT)
Role: U.S. government agency coordinating health IT adoption Key Functions:
- Coordinates adoption of healthcare IT standards
- Promotes interoperability
- Administers certification programs for health IT products
- Promotes meaningful use of certified EHR technology
CMS (Centers for Medicare & Medicaid Services)
Role: U.S. federal agency administering Medicare and Medicaid Standards Impact:
- Mandates use of specific standards through regulations
- Requires standards for electronic transactions
- Drives adoption through reimbursement incentives