- In a meeting of ONC’s Precision Medicine Task Force, healthcare leaders proposed the agency create more robust health IT standards in the wake of huge stores of health data needed in the Precision Medicine Initiative (PMI).
The Task Force, which met last week, explained how PMI will require more data than just fits in a patient’s EHR. The initiative utilizes patient-generated health data (PGHD), genomic data stores, and data collected from industry focus groups, like the Patient-Centered Outcomes Research Network (PCORnet).
“The volumes of data inherent in these queries and these exchanges would be well beyond what is currently encountered in our newborn but growing EHR ecosystem,” said the Task Force’s co-chair Andy Wiesenthal. “There’s going to be lots of data sources that we are not currently including, especially data directly from patients.”
Because of these varying data sources, as well as the massive volume of data they will bring with them, it is necessary that ONC develop better interoperability standards. This initiative relies on searchable, query-based health technology in order to better utilize the data available through seamless information exchange.
Perhaps the most groundbreaking portion of the meeting, the Task Force called for ONC to incorporate standards pertaining to PMI into the agency’s Interoperability Roadmap. Incorporating such an addendum would help guide healthcare professionals in understanding the data flows and standards used in PMI.
Likewise, the Task Force recommended ONC identify minimum data sets and standards for PGHD, PMI, and phenotypic data, as well as the support network to continuously inform patients of their personally contributed health data.
PMI should also emphasize the use of advanced programming interfaces (APIs) such as FHIR to store interoperable health data, including medication information, lab information, and claims data, all of which markedly affect the data repositories for PMI.
The Initiative should make this data available to not just healthcare professionals, but to the patients as well. Giving patients access to their the data which they are contributing, the Task Force explained, will increase their engagement and make them more likely to continue contributing data to the Initiative.
“Also, we felt that the participants’ access to their aggregated information will promote participation and retention,” said the Task Force’s other co-chair, Leslie Kelly Hall. “So data return should offer dynamic and compelling visualizations to promote its use. And patients should have access to computable, raw genetic testing and sequencing data.”
Such availability can be supported by policy measures, like NIH-sponsored patient education measures. These policies should also encompass data access standards for both healthcare professionals and patients.
To enable this vast amount of data exchange, the Task Force asserted that providers and other healthcare professionals will need to anticipate a moderate amount of work to obtain and translate the data, making it more useable for their research efforts.
However, PMI participants should also be using standard data formats for exchange, particularly APIs. Different API formats, like Argonaut, PCORnet, and others, as well as a plethora of FHIR apps like SMART, should particularly be utilized.
Interoperability is indeed the core of the Precision Medicine Initiative, and other federal agencies have been doing their part to support it. Just last month, the Food and Drug Administration issued a statement urging healthcare professionals to prioritize the seamless transfer of health information.
“A defining characteristic of such a network is the ability to leverage all available data for different tasks as needed, allowing the network to integrate complex relationships between data input and output,” said FDA’s Rachel E. Sherman, MD, MPH, and Robert M. Califf, MD, in a blog post. “Coupled with interoperable standards, a national system for evidence generation based on these principles will be capable of generating very large quantities of data and enabling those data to flow among system components.”