By Angela Kennedy, director of strategic operations, medical specialty societies, IQVIA.
In 2016, the 21st Century Cures Act (Cures Act) resulted in new regulations that fundamentally changed the way deidentified patient data is accessed and utilized. However, data quality and interoperability between the various healthcare stakeholders has been a major hurdle.
When it comes to implementing the Cures Act, the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) each must administer the law’s requirements. Therefore, each agency has released a final rule over their respective jurisdiction.
Information blocking is a primary focus of the ONC final rule, which also requires that developers certified by the ONC Health IT Certification Program must have standardized Application Programming Interfaces (APIs) and implement Fast Healthcare Interoperability Resources (FHIR) technology, enabling individuals to access structured electronic health information securely and easily.
These advancements will only make information sharing easier. The CMS Interoperability and Patient Access final rule also focuses on API interoperability, requiring federal payers to make provider directory information publicly available. Specifically, it encourages interoperability and patient access to health information.
In a major step to ensure open sharing of information, the ONC introduced the US Core Data for Interoperability (USCDI). Since ONC is the certifying body for EHRs, providers must be prepared to transition to a new “Cures Edition” version of its software before the end of 2022.
What is USCDI?
USCDI encompasses a standard for data creation, a set of defined data classes and elements that Electronic Health Record (EHR) vendors must be able to provide. This creates an expectation for open and free access to healthcare data by industry stakeholders, including physicians, insurers, labs, registries, and the patients themselves. CMS requires that payers share the USCDI data they maintain with patients via the Patient Access API and with other payers via the Payer-to-Payer Data Exchange.
While some organizations have used APIs to aid the exchange of data, experts in the healthcare industry have been aware that for a truly free and open data exchange to work, modern technology and standards need to be put in place. This is where FHIR comes in.
What is FHIR?
FHIR is based on a new iteration of Representational State Transfer (REST) designs, which uses HTTP to enable the exchange of information between applications. That means if two applications adhere to the standards outlined for REST technologies, it makes it easier for two applications to exchange and manage healthcare data regardless of how it is stored. Not only do these applications now speak the same language, but FHIR has also created categories for certain healthcare interactions to further refine the data exchange by making it easily identifiable within each system.