Healthcare IT Interoperability, EHR interoperability, Hospital Interoperability

Policy & Regulation News

Work Begins on Precision Medicine Healthcare Data Standards

"The data movement to support this initiative is going to happen through chaos or some sort of standards."

- Over the next four months, a Health IT Standards Committee task force will be developing and refining recommendations to support the Precision Medicine Initiative (PMI) under which providers, researchers and patients will work toward individualized disease treatments. The Precision Medicine Task Force met Feb. 12 to begin mapping out opportunities for the Office of the National Coordinator for Health IT (ONC) to address health IT interoperability challenges related to PMI.

The Precision Medicine Task Force has begun mapping out opportunities for ONC to address health It interoperability challenges.

ONC will collaborate with federal partners such as the National Cancer Institute (NCI), Food and Drug Administration (FDA), National Institutes of Health (NIH) and Department of Veterans Affairs (VA) as the PMI moves forward. In doing so, ONC is expected to pilot the use of standards to enable data donation and patient access to information through application programming interfaces (APIs).

Task force co-chair Leslie Kelly Hall, senior vice president for policy at health IT firm Healthwise, noted that the PMI anticipates having 80,000 people signed up to participate by the end of this year. “The data movement to support this initiative is going to happen through chaos or some sort of standards that can help facilitate the movement and reach scale. That’s our job,” she said while explaining the group’s charge.

The core problem to be solved is the lack of a data standard model for EHR systems to capture an influx of genomic and patient-generated data. As a starting point, the task force will identify opportunities for ONC to pilot the use of standards to enable data donation and patient access through APIs — areas in which emerging FHIR and OAuth standards will likely come into play. Supporting interoperability of structured/coded data types will be a priority, followed by additional data types in later pilot phases.

Hall described the process as a “crawl-walk-run approach,” identifying what ONC needs to do at a minimum and then accelerating progress.

The interoperability pathways essential to PMI flow in several directions:

  • From lab systems to EHRs
  • From patients to EHRs
  • From EHRs to the research community
  • From lab systems to patients

“Each use case might involve a different standard,” commented Hall. “This is a challenge because each one of these areas present very different vocabulary and data structure needs.”

Federal initiatives

During the Feb. 12 session, the task force heard from NCI and FDA representatives regarding status of current PMI intiatives.

Tanja Davidsen, PhD, explained the structure and requirements of NCI’s Cancer Genomics Cloud Pilots and Genomic Data Commons, two current activities essential to building a cancer knowledgebase known as The Cancer Genome Atlas. This work will focus on imaging and lab data types, as well as “molecular characterization methods,” which would include data from the areas of pathology, radiology, clinical labs, therapeutics, diagnostics and outcomes.

NCI’s work will have to address effective data exchange, said Davidsen, particularly data access. Additionally, some data may contain personally identifiable information, which would need to be appropriately controlled and protected. At the same time, NCI will strive to avoid putting up undue barriers to researchers.

The task force also heard from FDA officials about its activities in regulating genomics technology.

David Litwack, PhD, policy advisor in FDA’s Center for Devices and Radiological Health, pointed out that data produced by next-generation genomic tests is critical for precision medicine. However, it also poses challenges when developers of genomic tests try to validate them to make sure their tests give accurate, reliable and meaningful results.

“This is requiring not just new regulatory policies, but also new technical and scientific approaches that will make it easier to develop, regulate and use tests,” said Litwack.

In that regard, FDA has launched an early version of precisionFDA, a cloud-based platform for community testing, piloting and benchmarking of new approaches to validating next-generation genomic sequencing analysis pipelines.

Amid this flurry of agency activity, task force member Andrey Ostrovsky, MD, CEO of analytics-based care coordination platform Care at Hand, shared a broad concern about making data from federal programs truly open.

“As we’re moving forward with the precision medicine work, particularly around IT and interoperability, we need to place huge emphasis on design considerations for user experience, so that all of the work in aggregating the data is actually accessible, and folks who want to contribute in a meaningful way — including patients — can do so without having to hack the system, so to speak,” Ostrovsky explained. “That goes especially for patients or innovators who may be predisposed to disparities in access to resources in the first place.”

The task force will hear from ONC, NIH and VA during its next meeting on Feb. 26. The group’s final recommendations to ONC will be presented on June 3.



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