Healthcare data exchange compliance and regulatory-ready software development

• Health IT developers and vendors building EHR and related software.
• Healthcare providers using custom EHR solutions.
• Third-party integrators of healthcare data systems if build middleware or APIs that interact with certified systems (telehealth platforms, analytics tools).

• ONC Health IT Certification is required for EHR vendors and health IT developers whose products handle Electronic Health Information (EHI) in the U.S.

• Implement and expose FHIR API endpoints compatible with USCDI standards.
• Support SMART on FHIR for secure authentication and authorization.
• Data transformation and mapping capabilities for HL7 FHIR compliance.
• Publish FHIR API Service Base URLs quarterly, as required by HTI-1.

• Medicaid and CHIP managed care plans, state Medicaid and CHIP fee-for-service programs, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges are required to provide data access via APIs and implement prior authorization automation.
• Providers are not directly regulated by the rule but are key participants, integrating with payer APIs.

• No direct certification for payers, but health IT vendors offering revenue cycle and claim software handling EHI must be ONC-certified.

• Support secure, FHIR-based APIs aligned with CMS requirements:
  • API for patient access to claims and encounter data.
  • API for provider retrieval of patient data from payers.
  • Payer-to-Payer API for transferring patient data between health plans.
• Enable automated prior authorization workflows to reduce manual tasks.
• Integrate the following Da Vinci Burden Reduction components seamlessly into existing healthcare IT systems:
  • PAS (Prior Authorization Support) APIs for automated prior authorization.
  • PDex (Patient Data Exchange) for standardized patient data sharing.
  • CRD (Coverage Requirements Discovery) for querying coverage criteria.
  • DTR (Documentation Templates and Rules) for prior authorization documentation.

• Hospitals and clinics using KIS (Krankenhausinformationssystem) and KAS (Klinisches Arbeitsplatzsystem).
• Outpatient care centers and service providers required to integrate with TI.
• Health IT vendors building TI-compliant solutions.

• Gematik Certification is mandatory for all primary systems (e.g., KIS, KAS) to confirm ISiK and ISiP compliance before deployment in the TI.
• Certification involves automated testing using Gematik’s official test and simulation environment (Titus), validating conformance to all technical interface requirements.

• Implement FHIR APIs based on ISiK and ISiP specifications, including German core profiles and required resource types.
• Enable structured clinical and administrative data exchange using standardized RESTful workflows.
• Integrate with the Telematik Infrastructure (TI) components, including secure messaging and identity services.

• Healthcare providers involved in cross-border or international patient care.
• Health IT vendors developing electronic health record (EHR) systems with international interoperability capabilities.
• Public health authorities aiming to standardize patient data exchange across regions.

There is no specific certification for IPS. However, adherence to IPS standards can demonstrate a commitment to international interoperability and may be recognized within broader health IT certification programs.

• Support the generation and sharing of IPS documents as FHIR Bundles structured around the composition resource.
• Use standardized clinical profiles (Patient, Conditions, Medications, Allergies) based on the HL7 IPS Implementation Guide.
• Apply international terminologies like SNOMED CT, LOINC, and ATC/RxNorm for semantic consistency.
• Enable secure export and import of IPS documents to support cross-border and unplanned care scenarios.