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Healthcare IT is a dynamic environment, and the push for digitization is especially strong in the US, where the ONC Cures Act Final Rule has triggered a steady stream of criteria and deadlines. There are two key US governmental agencies that enforce the provisions of the ONC Cures Act Final Rule, The Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS). These agencies have worked together to formulate a set of rules primarily focused on matters related to Fast Healthcare Interoperability Resources (FHIR), with a specific emphasis on addressing information-blocking and enhancing interoperability.
ONC Cures Act Final Rule
ONC, being the certifying authority for Electronic Health Records, garners significant attention with the ONC Cures Act Final Rule.The ONC Cures Act Final Rule gives patients and authorized healthcare providers secure access to electronic health information (EHI), with key provisions around Information Blocking, Interoperability, API functionality, and Certification. The most far-reaching compliance criteria are §170.315(g)(10) – Standardized API for patient and population services, and §170.315(b)(10) – Electronic Health Information export.
Meanwhile, the CMS Interoperability and Patient Access Final Rule mandates that health information must be available to patients and their clinicians via APIs, improving prior authorization and care co-ordination, reducing costs, and putting individuals at the center of their own healthcare.
Much of the regulation is focused on a core data set that care providers must be able to share. This core data set is defined by the ONC as the United States Core Data for Interoperability (USCDI) and is part of the ONC Cures Act Final Rule to set a baseline of required data elements for interoperability.
United States Core Data for Interoperability (USCDI)
USCDI represents the most basic building blocks of healthcare interoperability: a standardized – and evolving – set of data elements required for sharing information between health IT systems. These data elements cover a wide range of health information, such as patient demographics, clinical notes, medications, allergies, problems, procedures, laboratory results, and imaging reports.
USCDI V1 laid the foundation for interoperability throughout the ONC Cures Act Final Rule, so that FHIR and other interfaces can communicate with each other.
US Core and how it relates to USCDI
The US Core Implementation Guides provide detailed technical specifications and implementation guidance to support the adoption of the USCDI. They focus on a subset of FHIR resources and data elements that are considered essential for interoperability and support common use cases. These specify the content, structure, and format of the data to be exchanged to achieve interoperability and align systems and implementations.
There can be different implementation guides for various purposes or contexts, such as patient demographics, clinical notes, medications, and more. These guides help ensure that data is consistently structured and can be exchanged meaningfully across different health IT systems.
USCDI facilitates data exchange, US Core identifies how to achieve it. As you can see from the versions table, they are closely related. The USCDI establishes standardized data representation using a common code set. The US Core Implementation Guide incorporates profiles aligned with US Core, reflecting updates in USCDI with each new release. This integration links the standardized USCDI datasets to their representations in FHIR.
How about USCDI+?
USCDI+ takes things one step further by facilitating domain or program-specific data element lists as extensions to USCDI. ONC is advancing this initiative in the Public Health and in the Quality Measurement domain categories, and as a service to federal and industry partners.
Broaden your knowledge on US healthcare regulations
As one of the initiators of FHIR, Firely keeps a close eye on all FHIR-related compliance requirements, and we believe our insights have value for the wider healthcare IT community.
Our new eBook gives you a practical overview of all the relevant rules, implementation guides, and technologies. It’s a must-read that will help you understand their scope, decide what affects your use case, and help you make decisions.
As ONC and CMS continue to converge regulations and policy towards FHIR, Firely provides the software, training, and expertise that bring the standard to life. We’ve been involved since the beginning, with 100% FHIR-based solutions that enable compliance and innovation in one go. Who better to help you navigate the regulations, meet the deadlines, and make your HealthTech future-proof?