Cures Act Final Rule: Key Deadlines for Interoperability Compliance
The 21st Century Cures Act Final Rule—issued by the Office of the National Coordinator for Health Information Technology (ONC)—mandates the interoperability of healthcare information systems by 2024.
Providers need to be aware of upcoming regulatory dates and compliance requirements to stay on track.
Let’s take a look at the key milestones ahead in 2022 and 2023 that will move organizations down the path to interoperability.
21st Century Cures Act Interoperability Summary
The goal of the 21st Century Cures Act of 2016 was to increase choice and access for patients and providers. To achieve interoperability, electronic health records (EHR) vendors must be able to provide single patient data exports and full system data exports at any time.
As of January 1, 2024, patients, providers, communities, and researchers are expected to have a fully interoperable health IT infrastructure that allows participants to securely share electronic health information (EHI).
Key Deadlines for 21st Century Cures Act Requirements
Here are the compliance dates to end information blocking and move toward interoperability according to ONC’s Final Rule:
- April 1, 2022
- October 6, 2022
- December 31, 2022
- March 15, 2023
- December 31, 2023
The following sections will explain the tasks that must be done according to each date.
🗓 April 1, 2022: First Attestation to Conditions of Certification (CoC) Required
On April 1, 2022, a 30-day window opens for developers to start submitting attestations of compliance. These submissions will take place twice a year.
Attestations will be submitted to ONC-Authorized Certification Bodies (ONC-ACBs). ONC will then make the documents available to the public through the Certified Health IT Product List (CHPL). These certification requirements apply to all health IT developers of certified health IT.
🗓 October 6, 2022: EHI Definition No Longer Limited to EHI Identified by Data Elements in the United States Core Data for Interoperability (USCDI)
On October 6, 2022, all EHI must be made sharable. This now includes billing records and claims details.
The ONC defines eight sharing exceptions that aren't classified as information blocking:
- Preventing Harm
- Privacy
- Security
- Infeasibility
- Health IT Performance
- Content and Manner
- Fees
- Licensing
The first five exceptions involve not fulfilling requests to access, exchange, or use EHI. The last three exceptions involve procedures for fulfilling requests to access, exchange, or use EHI.
🗓 December 31, 2022: New HL7® FHIR® API Capability and Other Cures Update Criteria Must Be Made Available
On December 31, 2022, providers must comply with Health Level Seven/Fast Healthcare Interoperability Resources (HL7®/FHIR®). FHIR® is an application programming interface (API) that enables communication among multiple sources. The combination of FHIR® and web services will provide a similar type of integration that exists in social media feeds.
🗓 March 15, 2023: Submission of Initial Real World Testing Results
On March 15, 2023, developers must submit real-world testing results from 2022. Though developers aren’t required to test their certified health IT in every type of clinical setting, they’re expected to address each setting type in which their health IT product is marketed.
🗓 December 31, 2023: EHI Export Capability Must Be Made Available
On December 31, 2023, EHI export capability must be activated. Two comprehensive export features will be required: single patient and full system. The export file must be computable and include documentation to allow for interpretation and use of EHI.
At the start of 2024, digital health data should be easily exchanged among providers, and patients will have more control and better access when it comes to their records.
Are You Ready for 21st Century Cures Act Interoperability?
The ONC encourages organizations that are facing interoperability compliance challenges to build upon existing health IT infrastructure.
There are steps providers can take right now with tools they may already have to begin a secure and seamless transition to interoperability.
Learn more about zPaper’s solutions for healthcare providers to manage the entire healthcare document journey within a HITRUST (Health Information Trust Alliance) certified and HIPAA (Health Insurance Portability and Accountability Act) compliant platform.
