ONC: Data Standards, Security Key to Precision Medicine Success

ONC is working to advance precision medicine research by supporting projects that improve health data standards, adopting policies that support data security and privacy, and promoting data sharing among researchers.

As part of the Precision Medicine Initiative (PMI), a federal effort to accelerate the next generation of health research, ONC and its collaborators are seeking to rethink data access, storage, aggregation, and analysis.

“The increasing availability of electronic health data in the 21st century has tremendous potential to ignite a new era of inquiry and discovery. With precision medicine, researchers will be able to make new discoveries about health and illness to bring a more personalized approach to patient care,” Teresa Zayas Caban, Kevin Chaney, MGS, Stephanie Garcia, MPH, Tracy Okubo, PMP and Robert Carroll, PhD wrote in a recent blog post.

In particular, ONC collaborates with NIH on the All of Us Research Program, a project that aims to collect data from a diverse group of one million or more US patients. The program is a long-term research effort to increase understanding of health and disease and focuses on gathering massive amounts of data from participants. All of Us provides genotyping and genome sequencing for many individuals, and researchers are also gathering data from wearable devices.

The program is coming close to reaching its goal. According to ONC, as of February 23, 2020, more than 335,000 participants have consented, and more than 75 percent have completed the initial steps of the program.

To ensure this wealth of patient information is accessible and useful for research, ONC noted that interoperability and data sharing standards will need to be top priority.

“Making electronic health information easy to transfer among individuals, providers, and researchers is fundamental to assembling a program as large as All of Us, returning results to participants, and analyzing the data to make new discoveries. However, these transfers are only possible if different data types are interoperable—that is, connected by data standards,” the blog authors wrote.

ONC is leading several efforts to improve interoperability in health research. Sync for Science, a pilot project with six health IT developers, aims to allow individuals to access their health data and share it with researchers through consumer applications. Additionally, ONC partnered with NIH to establish Sync for Genes, a project that seeks to standardize the sharing of genomic data and information among labs, providers, patients, and researchers.

A third ONC project, Advancing Standards for Precision Medicine, is an effort to standardize data types often found outside the care delivery system that are critical for precision medicine, such as social determinants of health data.

Common data standards, such as the HL7 Fast Healthcare Interoperability Resources (FHIR) standard and the Observational Medical Outcomes Partnership (OMOP) Common Data Model, are critical for promoting interoperability across the healthcare landscape, ONC said.

“All of Us is using FHIR to transmit survey and physical measurements data, OMOP to bring in vast quantities of EHR data from program enrollment sites, and Sync for Science, which leverages FHIR as a pilot mechanism to intake EHR data from a broader range of health systems through their direct volunteer pathway,” the authors said.

In addition to data standards and interoperability, privacy and security will play a critical role in the success of precision medicine research. Application programming interfaces (APIs) will be a key asset to privacy and security initiatives, ONC said.

“For several years, ONC has been examining privacy and security principles in precision medicine and the broader application programming interface (API) ecosystem. APIs can be instrumental in ensuring that health information moves in a secure, computable format between patients, health care providers, and research organizations,” the authors wrote.

ONC has developed resources designed to help maintain privacy and security as organizations share EHR data and implement APIs. The Sync for Science API Privacy & Security report highlights important privacy and security concerns for healthcare APIs, while the PMI Data Security Principles Implementation Guide helps organizations that use patient data for research.

With these projects and documents, ONC is aiming to accelerate novel discoveries in precision medicine research.

“PMI weaves together the best aspirations of medicine, science, and technology to propose a radical shift in the way we study and improve health. By learning from past success and leveraging the most recent innovations, PMI aims to empower researchers to answer challenging questions—and think of entirely new ones,” said Robert Carroll, PhD, an author of the blog.

“ONC’s projects are integral to bringing together diverse participants, smart data, powerful tools, and multidisciplinary researchers to make medicine more personal.”

The success of precision medicine, with its multitudes of data, will depend on the industry’s ability to share and protect information.

“As All of Us looks to integrate novel data types and sources, the development, adoption and use of data standards will make it easier for research participants to access and share their health data, stimulate innovative tools for research, and allow researchers to reveal new insights and discoveries. Ultimately, we can shift healthcare toward treatment and prevention strategies that are tailored to each person’s unique characteristics,” the authors concluded.