2023 Interoperability Standards Advisory

The ONC has released the 2023 Interoperability Standards Advisory (ISA) Reference Edition, with new and updated sections that respond to the ever-changing interoperability needs in healthcare.

Changes were made as part of a planned implementation of the ONC 21st Century Cures Act Final Rule, and in response to over 150 comments received by the ONC from the public and federal agencies last year.

Changes in 2023

Standards Version Advancement Process (SVAP) Integration

SVAP gives Certified Health IT Developers involved with the ONC Certification Program to have flexibility in how they update their Health IT Modules. As long as certain requirements are met, Health IT Developers can now use updated approved standards that are not in regulation.

The flexibility responds to the “Real World Testing” Condition and Certification (§ 170.405) requirement outlined in the ONC 21st Century Cures Act.

This change is to help achieve the interoperability demands of the ONC 21st Century Cures Act Final Rule, which requires the free, timely, and secure exchange of health information between EHRs and between patients and their providers. Basis of the rule is that, “Patients should be able to access their electronic medical record at no additional cost,” according to the final rule.

Under the “open notes” provision in the rule, providers are prevented from “information blocking,” meaning that all notes will be visible to the patient including administrative notes like appointment reminder phone calls, for example.

Pharmacy Interoperability

Subsections previously titled “Electronic Prescribing” and “Drug Formulary” have been combined into a new subsection titled, “Pharmacy Interoperability.”

ONC also updated Pharmacy Interoperability pages based on comments received, and included the National Council for Prescription Drug Programs (NCPDP®) SCRIPT Standard Implementation Guide Version 20222011 to all relevant pages.

Human and Social Services

This new subsection creates an interoperability standard between Human and Social Service providers and healthcare providers, and allows healthcare provider referrals with Human and Social Services.

 Adverse Event Reporting

In partnership with the FDA’s Center for Biologics Evaluations and Research (CBER) Biologics Effectiveness and Safety (BEST) Initiative, the new Adverse Event Reporting subsection addresses interoperability needs in the public health sector and contains BEST guidelines for the reporting of adverse events of biologics.

Laboratory subsections

Laboratory subsections have been added to Vocabulary/Code Set/Terminology and to Content/Structure sections of the advisory to improve interoperability standards.

Infrastructure subsection

This new subsection of the Services/Exchanges section has additional standards and implementation guides that are the fruit of HL7® FHIR® accelerator FHIR at Scale Taskforce and Unified Data Access Profiles (UDAP™).