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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Blog
Steps Healthcare Organizations Can Take to Prepare for Cures Act Interoperability Standards
Approaches to ease into the 21st Century Cures Act regulatory requirements
Aug 27, 2020
Since the final 21st Century Cures Act (Cures Act) rules were released in March 2020, the nation has been facing a global pandemic, which coincidentally underscores the need for greater healthcare data interoperability.
Now is the time when healthcare organizations must begin preparing to comply with the Cures Act. They should begin assessing their health information exchange capabilities, and the changes or additions that are needed to comply with the Trusted Exchange Framework and Common Agreement (TEFCA).
While healthcare technology vendors are designing changes to capture the additional data elements that will be required under the Cures Act, others are developing new applications to facilitate the use and management of health data by patients.
Data identification
A first step toward compliance with the Cures Act requirements is identifying tools, systems and applications that hold data elements needed to support interoperability. Once you have identified the data source, gaps in data collection can then documented and remediated. This is a good time to start, or in some instances, accelerate the principles of data management.
Understanding the qualified data is essential when preparing for interoperability, because every business process captures and maintains data differently. Some leverage structured data elements in an exact model, while others maintain data in unstructured, free form fields. Within a healthcare organization, multiple systems are often encountered with the only consistency being the inconsistencies in identifying, capturing, and storing data.
In addition, data quality is critical to producing easily integrated data. Healthcare organizations should start a baseline for their data quality metrics to help focus efforts on those areas that will need improvement to support data collection and transmission.
Data mapping
After identifying all relevant data sources, the process of mapping data fields to the Health Level 7 (HL7) transaction sets, and the U.S. Core Data for Interoperability (USCDI) standards, can begin.
Since designating HL7 FHIR (Release 4) as the standard for Healthcare Information Exchange, mapping your data sources, formats, and fields to the standard formats is necessary for exchanging data. This also necessitates discussion about how your organization will accept external data and incorporate the health data into the patients’ record without adding complexity or clutter to the record set.
Compliance strategy and implementation plan
Once you have assessed your healthcare organization’s existing processes and systems, a strategy and implementation plan are documented. A compliance strategy needs to account for the outcomes from all assessments and outline the steps, technologies, skills/people, and funding required to adhere to the new information exchange standards.
Healthcare organizations must prepare by assessing the efforts needed to update their technology systems, defining a path forward and getting certified to exchange healthcare information.
IQVIA can help your healthcare organization in addressing 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.
Cures Act: Getting Ready for the Implementation of TEFCA and Healthcare Interoperability Standards
In this white paper, IQVIA experts walk through the 21st Century Cures Act and the set of final rules mandating regulatory compliance for healthcare information exchange.