Ch 7 Health Informatics Standards

• Standards ensure compatibility and efficiency via rules and definitions.
• Biomedical informatics relies on standards for data collection, manipulation, and transmission.
• The 21st Century Cures Act promotes biomedical research innovation, mandating EHR interoperability.

The Need for Health Informatics Standards

• Healthcare's fragmentation necessitates standards to improve communication among providers.
• Early standards focused on data exchange between clinical laboratories and hospital systems.
• Broader interoperability led to the development of HL7.
• Standards are necessary as the system shifts from fee-for-service to value-based care.

Early IT Standards in Healthcare

• Early healthcare IT systems focused on billing and accounting with limited clinical functionality.
• Departmental systems emerged in the 1970s and 1980s, increasing the need for interoperability.
• ASTM addressed laboratory data exchange, but interface maintenance costs led to HL7.

Transitioning to Modern Standards

• Newer healthcare models, like ACOs, require integrated data across institutions.
• Standardized identifiers for patients, providers, and payers are essential for interoperability.
• Patient identification poses challenges due to privacy concerns.

Areas Requiring Standards

• Standardization is needed in patient admissions, laboratory results, and medication management.
• Clinical knowledge must be encoded in standardized formats for sharing and reuse.
• HL7's FHIR is increasingly important for data exchange.

Standards Development and Organizations

• Standards development is collaborative and involves multiple stakeholders.
• Standards can be created through ad hoc agreements, de facto adoption, government mandates, or consensus.
• The process includes identifying a need, conceptualizing the standard, drafting, reviewing, and implementing it.
• Organizations like HL7, ASTM, and DICOM play key roles in developing healthcare standards.

The Standards Development Process

• Creating standards involves balancing competing interests and ensuring broad participation.
• Early standards often address immediate needs.
• "Gap standards" fill in missing pieces for comprehensive interoperability.
• The process includes drafting, reviewing, and refining standards, with conformance testing.

Key Standards Organizations

• ANSI: Coordinates U.S. standards development, also represents the country in international standardization efforts.
• HL7: Develops standards for clinical data exchange, including FHIR.
• DICOM: Focuses on medical imaging standards.
• CDISC: Creates standards for clinical research data.
• SNOMED International: Maintains the SNOMED-CT terminology.

Clinical Models and Terminologies

• Structured and coded data are essential for interoperability.
• Clinical models define the structure of data.
• Terminologies provide the codes.
• SNOMED-CT is for clinical terms.
• LOINC is for laboratory tests.
• RxNorm is for medications.
• These standards enable data sharing and reuse across systems.

Data Interchange Standards

• Data interchange standards facilitate the exchange of healthcare information.
• HL7's messaging standards and CDA are for clinical documents.
• FHIR simplifies data exchange using RESTful APIs.
• These standards are critical for integrating diverse healthcare systems and enabling data sharing.

Future Directions

• The future of healthcare standards lies in achieving true semantic interoperability.
• New standards are needed for emerging data types like genomic information.
• Standards are needed for technologies like mobile health devices.
• Standards for privacy, security, and patient identification will also be crucial.
• Standards enable the seamless exchange of information across systems and improve patient care.
• Ensuring standards meet the needs of a rapidly changing landscape is critical.