4 key steps in preparing for the 21st Century Cures Act interoperability standards

The 21st Century Cures Act is currently scheduled to enter the enforcement phase in July 2021. Its objective is to put patients in control of their own healthcare information, ultimately improving the quality and efficiency of patient care. The new exchange standards were developed to ensure that healthcare organizations increase  adoption and promotion of interoperability, exchange healthcare information without blocking access to data, and increase patient access to data.

The final interoperability rule, released in March 2020, outlines the timeliness and framework for healthcare organizations to share patient data.

One area where the Cures Act specifically supports consumers in accessing their data is the requirement that all healthcare organizations support application programming interface (API) access to real-time health data. The final rule states that all Medicare Advantage, Medicaid, CHIP, and Affordable Care Act plans provide a Patient Access API, accessible using third-party applications by July 2021.

The Office of National Coordinator for Health Information Technology (ONC) has said that patients will be able to choose apps to assemble and read their records, giving the patient more control over their data and a better understanding of their treatment options, including care outcomes and the cost of care.

Cures Act preparation

Healthcare organizations should begin preparing to comply with the Cures Act. They should begin by assessing their health information exchange capabilities, and assessing any changes or additions needed to comply with the Trusted Exchange Framework and Common Agreement (TEFCA). While healthcare technology vendors are designing changes to capture the additional required data elements, others are developing new applications to facilitate the use and management of health data by patients.

IQVIA suggests following these steps for creating an action plan.

1. Identify data

A first step toward Cures Act compliance is to identify the tools, systems, and applications that hold data elements needed to support interoperability. Once the data sources have been identified, gaps in data collection can be documented and remediated

“Cures Act compliance will require organizations to identify the tools, systems, and applications that hold data elements needed to support interoperability.”

Every business process in a healthcare organization captures and maintains data differently, so it’s important to understand what data is essential in preparing for interoperability. Some processes leverage structured data elements in a model format, while others maintain data in unstructured, free form fields.

Also, it’s important to understand that the better the quality of data, the more easily you can integrate the data. Healthcare organizations should start with a baseline for their data quality measures to help focus their efforts on those areas that will need improvement to support data collection and transmission.

2. Data mapping

After identifying all relevant data sources, the next step is to map data fields to the Health

Level 7 (HL7) transaction sets and the U.S. Core Data for Interoperability (USCDI) standards.

Since designating HL7 FHIR (Release 4) as the standard for exchanging health information, mapping the data sources, formats, and fields will help facilitate discussions about how your organization will accept external data and incorporate it into the patient’s record without adding complexity or clutter.

3. Assess strategy and develop implementation plan

Next, it is essential to develop a compliance strategy and implementation plan. The strategy should account for all assessment outcomes and define the processes, steps, technologies, skills/people, and funding necessary to comply with the new information exchange standards. Healthcare organizations must assess what’s needed to update their technology, define a path forward, and certify the exchange of healthcare information.

“…it is essential to develop a compliance strategy and implementation plan.”

4. Timeline

When the Cures Act and final rule were released in March 2020, ONC said interoperability changes must take effect within the next six-to-36 months. Due to the pandemic, the Department of Health and Human Services announced in April 2020, that ONC and CMS were exercising discretionary enforcement until July 2021. However, there are multiple components that have not been extended, such as payer-to-payer transactions needed in January 2022.


IQVIA, the industry leader in the use of healthcare data, can assist healthcare organizations facing the

challenges of assessing, defining, and implementing the technology needed to support interoperability. Together, we can embrace the vision of the 21st Century Cures Act and improve the care and quality all members and patients deserve.

For more information on the Cures Act and how you can prepare, download IQVIA’s Cures Act: Getting Ready for the Implementation of TEFCA and Healthcare Interoperability Standards whitepaper.

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