April 21, 2021 – Healthcare stakeholders must enhance and address health IT data, health IT infrastructure, EHR integration, and policy development to achieve precision medicine, the Office of the National Coordinator for Health IT (ONC) said in a new blog post.
Precision medicine aims to improve healthcare by customizing patient care to specific patient needs.
Advancing precision medicine requires establishing an evidence base through extensive research built on genomic data at a unique scale. But as precision medicine data becomes increasingly complex and available, health IT and EHRs must evolve to integrate, interpret, and deliver this data.
ONC outlined four critical health IT needs to advance precision medicine: determining data requirements, building robust health IT infrastructure, integrating precision medicine data into the EHR, and developing relevant policies.
Determining Data Requirements
Data standardization and specific data requirements are critical for precision medicine. ONC said it developed methodologies to improve data collection and exchange by leveraging standardized APIs.
While the ONC final interoperability rule sets out to end information blocking, it also invites medical providers and device developers to promote patient data access using third-party apps and APIs. Once APIs are more prevalent, their research utilization should expand.
“Standardizing data generally results in improved data quality and consistency, but the use of data standards does not always result in data standardization due to inconsistent implementation of current standards and the use of proprietary standards, creating a constant need for harmonization,” ONC explained.
ONC noted these projects prove the importance of data accuracy, data consistency, data completeness, and data usefulness.
Establishing a Robust Infrastructure
Health IT must evolve to integrate, interpret, and exchange precision medicine data, primarily through improved interoperability.
ONC said it created projects around accessing patient data from other health IT systems, capturing data from outside clinical care, and advancing interoperability through standardized functions.
“Projects revealed that testing and validation activities are important for successfully implementing new functionality, but these activities can often be resource-intensive,” wrote ONC.
“The projects also revealed other infrastructure considerations and challenges. For example, firewalls impeded access to data sources such as devices that resided outside the firewall, and some sites did not have access to adequate data storage and management resources.”
Progress in genomic testing technology has not only introduced clinical genomic data into medicine, but genomic testing has also become a vital tool to help enhance clinical decision making and, ultimately, precision medicine. Thus, EHR integration is critical to expanding genomic data utilization.
The ONC final rule calls on medical providers and health IT developers to promote patient data access using third-party apps and APIs.
Utilizing all aspects of the interoperability rule, along with the Health Level 7 (HL7) genomics model and Fast Healthcare Interoperability Resources (FHIR), could help bridge the gap between patient genomic data and interoperability.
Healthcare stakeholders need to develop and improve policies to protect individual patient data.
Policies will need to touch on data sharing, ethics, and privacy, and security. For example, if researchers gather and share identifiable patient data, it could form privacy risks.
“Even though projects used existing standards, authenticating users and devices across multiple settings remains a challenge,” explained ONC. “Aligning security and permissions across disparate systems often resulted in time-consuming connection problems.”
The agency also noted concerns about security standards and how current policies and legislations currently protect genomic data.
ONC said it would continue to work with stakeholders from the All of Us Research Program and the National Institutes for Health (NIH) to spread the use of FHIR.
“ONC is advancing high-priority health data standards and developing a better understanding of the current API and app ecosystem,” wrote the agency.
“ONC’s 21st Century Cures Act Final Rule requires the adoption of the United States Core Data for Interoperability (USCDI) standard, which will help improve standardized data sharing needed for precision medicine. Recent LEAP in Health IT awards will address research functionality through open, FHIR®-based health IT tools and platforms that will benefit precision medicine,” ONC concluded.