Policy letter to ONC for HIT on ONC’s Proposed Regulations To Implement 21st Century Cures Act’s Provisions

ONC’s proposed regulations take a giant leap forward for interoperability and health care by requiring standardized application programming interfaces (APIs) for patient and population services.  We applaud and wholeheartedly support this requirement as an essential prerequisite for moving digital health forward and establishing a national digital health ecosystem.  Based on our experience, we recommend that ONC adopt FHIR Release 4 as the API standard.  We urge ONC to require API access to “all data elements of a patient’s electronic health record” as the Cures Act requires, not “API access to a limited set of data elements” as ONC proposes.  This would effectively place a significant cap on data available for nationwide interoperability, and we propose two solutions for ONC’s consideration.  We also urge ONC to include “write” access now as well as “read” access for bi-directional or multi-directional interoperability.

We also provide comments on ONC’s careful, balanced regulatory structure to address the breadth and depth of documented information blocking and stop the damage; their application to health IT developers generally, not just health IT developers of certified health IT; and the U.S. Core Data for Interoperability and expansion of the Common Clinical Data Set.