HHS Shares the Location and Availability of the International Da Vinci Project Report
HHS Shares the Location and Availability of the International Da Vinci Project (Da Vinci) Report
The Department of Health and Human Services (HHS) is making our stakeholders aware of the availability of the International Da Vinci Project (Da Vinci) Report. The notice provides the location and information which includes test results from the use of the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) standards approved for use under the HIPAA exceptions process at Title 45 Code of Federal Regulations (CFR) § 162.940. The exception permitted Da Vinci to use the HL7 FHIR Prior Authorization Support (PAS) Implementation Guide (IG) and the HL7 FHIR Coverage Requirements Discovery (CRD) IG instead of the HIPAA-adopted standards for referral certification and authorization (prior authorization) transactions (X12N 278 Version 5010) and eligibility for a health plan (eligibility) transactions (X12N 270/271 Version 5010).
Background/Context
In accordance with the Presidential memorandum of January 20, 2025, titled ‘‘Regulatory Freeze Pending Review,’’ the display date of January 17, 2025, of the notice titled ‘‘the Availability of the International Da Vinci Project (Da Vinci) Report" was withdrawn and reissued for publication on April 29, 2025.
The Da Vinci Project is a private sector initiative comprised of industry-leading providers, payers, and technology vendors who are working together to accelerate the adoption of HL7 FHIR as the standard to support and integrate value-based care (VBC) data exchange across communities. Under 45 CFR § 162.940, any organization that receives an exception must submit to the National Standards Group (NSG) a report of its results, and include a cost-benefit analysis, within 90 days after completing the test. On March 10, 2021, HL7 submitted a request for an exception from the requirements to use the X12 278 and X12 270/271 HIPAA standards for prior authorization and eligibility transactions. Specifically, HL7 requested that the exception apply to Da Vinci member organizations designated as payers and their trading partners to allow them to use the HL7 FHIR PAS IG in conjunction with the HL7 FHIR CRD IG and Documentation Templates and Rules (DTR) IG.
In evaluating the request for the exception, NSG considered the following criteria, which are specified at 45 CFR § 162.940(b): 1) whether the proposed modification represented a significant improvement to the current standard; 2) the extent and length of time of the exception; and 3) consultations with Designated Standards Maintenance Organizations (DSMOs).
NSG notified HL7 that its exception request was approved on April 20, 2021, and provided details on the conditions for the approved exception, as required under 45 CFR § 162.940(c)(1). The HIPAA exception allowed for Da Vinci member organizations designated as payers and their trading partners to use alternative HL7 FHIR standards to support prior authorization and eligibility transactions without enforcement actions until April 14, 2024.
To find more information about the Da Vinci Project and the approval letter for the exception request and the test results report, please visit the following:
