HIMSS News

HIMSS Comments on ONC Interoperability Regulation Focus on Capitalizing on Innovation and Patient Access

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On Monday, June 3, HIMSS submitted its public comment letter on the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program (RIN: 0955-AA01). HIMSS offered feedback that focused on leveraging ideas from the 21st Century Cures Act that seek to put our health system and stakeholders on a path to transform healthcare. We fully support the efforts from across the Department of Health and Human Services (HHS) to provide patients with secure access to actionable information and sets a course for a healthcare paradigm that takes full advantage of the promise of standards-based application programming interface (API) technology.

HIMSS voiced support, at a high level, for the Information Blocking Exceptions in the proposed regulation, as they identify the appropriate categories that will help inform the community as well as define sharing boundaries and expectations that will lead to greater information exchange. Themes from the Information Blocking Exceptions all bolster ONC’s approach: implemented in a consistent and non-discriminatory manner; reasonably related and uniformly applied; and, based on objective and verifiable criteria.

We also asked for supplementary information to accompany the exceptions that would include a list of best practices for broadly sharing more information, consistent with the exceptions. Such a list could serve to reinforce the positive behaviors expected of the regulated actors, establishing “safe lanes” for specific use cases and reducing compliance costs and risks. These best practices could also help communicate more detailed information around the intended roles and expectations for each of the regulated actors, developers, providers, or networks/exchanges.

In addition, HIMSS wants ONC to rollback the “Electronic Health Information (EHI)” definition to focus on using the US Core Data for Interoperability (USCDI) data classes as the current requirement in the near-term. In the future, HIMSS would like to see USCDI expanded to include additional data classes that encompass more information streams, including: social determinants of health data, patient-generated health data, wearables data, genomics data, and healthcare cost and price information.

Moreover, HIMSS wants ONC to adopt Health Level 7 (HL7®) Fast Healthcare Interoperability Resources (FHIR®) Release 4 (R4) in the final rule for reference, requiring health IT developers seeking certification to build, test, and certify systems solely to FHIR R4 and its associated implementation specifications.

In terms of APIs, HIMSS supports the idea that health IT developers publish APIs and allow health information from such technology “to be accessed, exchanged, and used without special effort.” We applaud the proposed regulation’s prohibition on any fees, except those expressly permitted, and support the idea that Technology Suppliers should not engage in pricing practices that create barriers to entry and competition for apps that health care providers seek to use.

For the Conditions and Maintenance of Certification Requirements, HIMSS strongly supports the Real World Testing requirement as well as the Standards Version Advancement Process as appropriate tools to test conformance in healthcare settings.

HIMSS also expresses support for the underlying concept and goals of the Trusted Exchange Framework and Common Agreement (TEFCA) as forward-looking, but we need to see the final guidance document before rendering a judgement on its usefulness toward the community’s efforts to more broadly share information.

HIMSS also pledged to continue working across the entire stakeholder community to emphasize the importance of increased funding levels for ONC, given the increased workload at the agency that accompanies the new responsibilities inherent in this regulation.

View the full letter