Ensure Foundational Design and Performance for Bulk Data API
Recommendation:
Certified Health IT implementing FHIR Bulk Data APIs must be foundationally designed to operate efficiently at the population level, and their performance in exporting USCDI data must achieve parity with any proprietary bulk export mechanisms offered by the same system.
Rationale & Specifics:
To ensure the regulated Bulk FHIR API is a viable and primary mechanism for population data export, rather than a secondary, underperforming option:
- Performance Parity: The speed, efficiency, scalability, timeliness, and customization capabilities of the regulated FHIR Bulk Data export operation for USCDI data must be comparable to that of any non-FHIR, proprietary bulk export formats or methods (e.g., CSV exports from a data warehouse) offered by the same Health IT Module when exporting similar volumes of data for comparable patient cohorts. This is not directly certifiable in pre-market testing but should be an explicit expectation and potentially monitored through post-market surveillance or programs like the EHR Reporting Program.
- Designed for Population Scale: Health IT developers must attest that their FHIR Bulk Data API implementation is architected for efficient operation at population scale (e.g., leveraging appropriate database indexing, asynchronous processing, and scalable infrastructure), rather than being a simple iteration over single-patient APIs.
