ONC proposed rule would update criteria for CDS products, improve health data sharing

The Office of the National Coordinator for Health Information Technology (ONC) has published a proposed rule that creates new requirements for health information technology under the ONC Health IT Certification Program. The proposed rule is meant to ensure stakeholders are not unnecessarily prevented from accessing health IT, which has significant implications for clinical decision support (CDS) software products.

The proposed rule will officially be published 18 April and is mandated by the 21^st Century Cures Act passed in 2016. It is meant to improve sharing of medical information and proposes to update the Health IT Certification Program run by the ONC under the Department of Health and Human Services (HHS).

“In addition to fulfilling important statutory obligations of the 21st Century Cures Act, implementing these provisions is critical to advancing interoperability, promoting health equity, and supporting expansion of appropriate access, exchange, and use of electronic health information,” said Micky Tripathi, national coordinator for health information technology.

ONC says the proposed rule is also meant to establish a new baseline version of the United States Core Data for Interoperability (USCDI) which is a standardized set of health data classes and constituent data elements that allow interoperability of health information.

“Additionally, this proposed rule would provide enhancements to support information sharing under the information blocking regulations,” said ONC.

“The implementation of these provisions would advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information,” the agency added. “The proposed rule would also update the Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs.”

A key aspect of proposed rule is it would revise a number of certification criteria, including existing criteria for CDS software, patient demographics and observations, electronic case reporting and application programming interfaces for patient and population services.

CDS products are a growing sector of the medtech industry and have significant interest from the industry as well as regulators at the Food and Drug Administration (FDA), who want to ensure maximum transparency of how such products develop their recommendations when used in clinical settings. The updates to the criteria for CDS software are meant to keep pace with advances in the technology that ultimately should help healthcare providers in their use of the products according to the health IT agency.

“This [updated] criterion would reflect an array of contemporary functionalities, data elements, and software applications, including the use of predictive models or algorithms, that certified Health IT Module(s) enable or interface with to aid decision-making in healthcare,” said ONC.

“We propose to adopt a new definition for 'predictive decision support intervention,' ... and we propose that developers of certified health IT with Health IT Module(s) ... would be subject to requirements to provide transparency of predictive [decision support interventions (DSI)],” the agency added. “Specifically, we propose that Health IT Modules that enable or interface with predictive DSIs enable a user to review predictive DSI ‘source attribute’ information through the Health IT Module."

Besides updating the certification criterion for CDS software, the rule proposes to implement the Electronic Health Record Reporting Program as a new condition for developers under the ONC program, modify and expand exceptions in the information blocking regulations to support information sharing, adopt the latest finalized USCDI as a program standard and update other program standards.

Stakeholders are asked to comment on the proposed rule by 20 June.

HHS, proposed rule

ONC proposed rule would update criteria for CDS products, improve health data sharing

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