The new year is here, and the healthcare industry is ringing in the Fast Health Interoperability Resources (FHIR®) §170.315(g)(10) certification (FHIR certification) from the Office of the National Coordinator for Health Information Technology (ONC).
This certification has been in the works since the 21st Century Cures Act was enacted in 2016 and has several provisions to promote interoperability among EHI entities. It will put the US healthcare industry on the road to a nationwide health network that will be capable of sharing patient health information.
Below is a quick recap of the FHIR certification and what it means to developers, providers, and patients.
What is FHIR (g)(10) certification?
On January 1, 2023, the Application Programming Interface (API) certification criterion in § 170.315(g)(10) replaced the “Application access—data category request” certification criterion (§ 170.315(g)(8)).
Essentially, this certification standardizes patient data elements so all EHRs will be using the same format. The (g)(10) FHIR® API is considered the most rigorous 21st Century Cures Act certification to date. This new certification requires the use of Health Level 7 (HL7®) FHIR standards with several implementation specifications aimed toward patient and population health services.
The goal is for providers and patients to easily transmit electronic health information (EHI) via the certified API without excessive restrictions, supporting advancement toward interoperability.
According to a recent article by the Office of the National Coordinator for Health Information Technology (ONC), as of August 1, 2022, only five percent of certified health IT developers had achieved FHIR certification; it is recommended that providers confirm their EHR or patient engagement system is compliant.
What if my organization did not meet the FHIR certification deadline(s)?
EHR vendors that did not meet the certification deadline can partner with a platform that is FHIR (g)(10) certified to take advantage of the compliant API connection without having to take on the development burden themselves.
During the course of certification, some EHRs may have become subject to additional deadlines. In these cases, the ONC may have required corrections (errata) as part of the certification process and developers have 90 days to pass testing that is prompted by errata. If an organization is running into challenges overcoming errata, partnering a certified platform may be the best solution to achieve certification.
What are the consequences of not being FHIR certified?
If a certified health IT developer has not updated to the standardized API for patient and population services, the ONC may begin a Direct Review (§170.580(a)(2)(iii)) for non-compliance with the API Maintenance of Certification requirement. This action may or may not require the developer to create and execute a Corrective Action Plan (CAP) to ensure that requirements are met.
A further consequence of non-compliance is the impact on the platform’s end-users. Certain Department of Health and Human Services (HHS) programs rely on certified technology to participate in value-based care initiatives. For example, the Merit-based Incentive Payment System (MIPS) programs administered by the Centers for Medicare & Medicaid Services (CMS) and participation in various Alternative Payment Models (APMs) for 2023 rely on the standardized g10 API certification.
Available resources to help meet FHIR certification
The ONC has produced several resources to help developers understand certification requirements and possible outcomes of non-certification, such as:
- The Certification Companion Guide: Application Programming Interfaces
- The API Resource Guide
- ONC Health IT Certification Program Overview
- The Direct Review Fact Sheet
- Certification Program Enforcement Outcomes
It’s not too late to become § 170.315(g)(10) certified
InteliChart gained it’s §170.315(g)(10) certification in September 2022 and is committed to continually developing and delivering market-leading patient engagement technology to its EHR partners. Learn how InteliChart can work with your organization by visiting our website.