The moments we’ve all been waiting for since 2016 are fast approaching: the 21st Century Cures Act infrastructure is coming into place in 2022! The Cures Act laid out a vision for a rich health IT ecosystem of standards-based APIs and nationwide health information networks to securely open up electronically accessible information to patients themselves and to health care professionals supporting their care. As we’ve discussed in previous blogs, progress on nationwide network integration via TEFCA continues apace, and starting on October 6, all actors covered by the information blocking provisions of the Cures Act will be required to make available the full scope of electronic health information to other authorized parties. In this blog, we’re going to focus on the upcoming deadlines for availability of standards-based FHIR APIs.
There has been tremendous industry adoption of FHIR, so it may be surprising to many that this growth has occurred despite the fact that regulatory requirements for certified technology developers to deploy standard FHIR APIs have still not fully gone into effect. That changes this year, however, because the ONC Cures Act Final Rule requires that certified health IT developers update and provide their customers with FHIR-based application programming interfaces, also known as certified API technology, by December 31, 2022.
We’ve been closely monitoring certified health IT developers’ progress in updating their technology to be certified to the Cures Update criteria, specifically, §170.315(g)(10) Standardized API for patient and population services. As of August 1, roughly five percent of certified health IT developers have updated their technology to certified API technology. However, those five percent support roughly 66 percent and 77 percent of the in-patient and ambulatory users with their Health IT Modules nationwide, respectively.
Figure 1 Data Source: Certified Health IT Product List (CHPL). Percentages represent the certified health IT modules (i.e., product versions) compliant to a 2015 Edition Cures Update criterion to date as a proportion of the overall number of modules required to be compliant to that criterion (n) by December 31, 2022. Note the CHPL data is based on currently active certified health IT modules required to update.
Figure 2 Data Source: Certified Health IT Product List (CHPL); Medicare Promoting Interoperability Program. Percentages represent the proportion of the hospital and clinician user base with a certified API product whose API developer has a certified API product compliant to the (g)(10) criterion. Note the CHPL data is based on currently active certified health IT modules required to update, and the Medicare data reflects 2019 program reporting.
While many certified health IT developers have yet to certify their API technology to the new FHIR criteria, those with large user-bases already have, so it’s likely that those users will be provided with updated technology well before the December 31, 2022 deadline. Further, the 2022 Standards Version Advancement Process (SVAP) now includes the HL7® FHIR® US Core Implementation Guides 4.0.0 and 5.0.1, which some health IT developers were waiting for, and we anticipate that many health IT developers will now move forward to support these newer implementation specifications to certify to the FHIR-based API criterion.
In addition to technical specifications, Certification Program requirements also include “Conditions and Maintenance of Certification” for APIs, which set requirements for certified health IT developers in areas such as transparency, fees, and market competition. This means that as a clinician or health care provider you will have:
- Flexibility to connect apps to your existing certified health IT with defined timelines for certified health IT developers to register apps;
- Access to standardized electronic health information through the USCDI v1 and, if your certified health IT developer chose to adopt it, USCDI v2;
- Better transparency into your certified health IT developer’s business and technical practices, such as fees, to deploy apps in production environments.
A nationwide ecosystem of standard FHIR APIs will enable more innovation and solutions developed by industry and reduce one-off interfaces, resulting in lower interoperability costs in the future. Eligible hospitals and Critical Access Hospitals participating in the Medicare Promoting Interoperability program, and eligible clinicians participating in the Promoting Interoperability performance category of the Merit-Based Incentive program, will be required to use certified technology updated with the 2015 Cures Update (including FHIR APIs) for performance periods starting in 2023, as noted in the recently released Physician Fee Schedule proposed rule. To further support the diffusion of API capabilities, TEFCA has a FHIR Roadmap explicitly timed to follow fast on the heels of the FHIR API deadline in early 2023 to catalyze nationwide scalability of FHIR-based capabilities.
As noted earlier, certified health IT developers are required to update and make available to their customers standard FHIR APIs by the end of 2022. If you use a certified EHR and do not yet have a standard FHIR API available, we encourage you to contact your vendor to learn more about their plans to provide you with a certified API by the end of 2022 and enable you to fully participate in our 21st century digital healthcare future.
For additional information and resources on the benefits of the 2015 Edition Cures Update, check out a recently published Cures Update fact sheet. We encourage all stakeholders to familiarize themselves with the details provided in this fact sheet, and we welcome questions through the ONC Health IT Feedback and Inquiry Portal.