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.
However, USCDI goes a step further and makes these data calls from FHIR APIs far more straightforward, increasing ease of use and accuracy of information.
Gaining an advantage from USCDI compliance
For organizations relying on data access, such as medical specialty society (MSS) registries, the introduction of USCDI and FHIR APIs is a critical asset. MSSs require access to various health systems to evaluate performance metrics and data quality to provide feedback on how healthcare organizations are matching up to national averages and report these findings to CMS.
CMS and ONC are working closely on the USCDI+ initiative to advance CMS’s use of interoperable datasets for quality measurement and other areas. The USCDI+ initiative aims to establish, harmonize, and advance the use of interoperable datasets that extend beyond the core data in the USCDI. The goal is to continue to improve data exchange across the health care ecosystem, including public health systems, for better coordination of care, enhanced clinical decision making, and a higher quality of care for patients.
Freeing up resources will enable healthcare organizations to focus on improving healthcare outcomes for patients. However, to gain an advantage from compliance, choosing the right technology partner is crucial.
Additionally, CMS-regulated payers are required to exchange the USCDI version 1 data set at the patient’s request, allowing the creation of a cumulative patient health record. Having a patient’s health information in one place will facilitate informed decision-making and efficient care, which can ultimately lead to better health outcomes.
How to identify the right technology partner
Choosing the right technology vendor to meet data quality requirements is no small task, but there are several key capabilities that should be prioritized. To meet USCDI requirements and ensure standardized information formatting, a vendor that is FHIR-native, not just FHIR-compatible, is key to long-term scalability. Another key requirement is stringent data security and encryption tools to manage user credentials and support data visualization and exploration across different health systems. Other technology features may include supporting universal data ingestion, direct integration of EHR and PRO data, patient-generated data collection, master data management (MDM) capabilities, and integration of deep health data.
However, for an external vendor to become a true partner, there are critical questions to ask: Who owns the data being managed? What happens to the data if the relationship ends? Are there licensing terms or submission costs? What happens if you want to move some features in-house?
The answers to these questions will help manage the expectations for growth, sustainability, interoperability, and adaptability, of registry technology and evolving compliance requirements. The data collected within a registry can make or break organizations depending on the partnerships made, so critical consideration is needed for success.
What was once thought to be an abstract dream, streamlined access to high-quality data in a digestible format is attainable with the advent of modern technology that is more affordable than ever before. As data becomes more robust through interoperability, the USCDI will continue to provide new opportunities for the healthcare industry. The goal is to reduce physician burnout, allow MSS registries to get access to data faster, and increase access to high-quality healthcare for patients who desperately need it.