Professional associations are beginning to weigh in on a proposal from the Office of the National Coordinator for Health Information Technology on a new national policy for healthcare data.

The goal is to enable nationwide data exchange among clinicians using different exchange networks, access for individuals wanting to use their own health data, bulk record exchange for accountable care organizations, and support for open and accessible application programming interfaces.

“This will have an impact on a range of stakeholders,” says Jeff Smith, vice president of public policy at the American Medical Informatics Association.

The stakeholders include everyone in the industry, he adds—clinicians, health information networks, insurers, vendors and vendor consortia such as the Commonwell and Sequoia Project interoperability initiatives.

ONC is working on two interoperability pilots. The Trusted Exchange Framework and Common Agreement (TEFCA) has the goal of providing a single on-ramp to interoperability for all stakeholders that is scalable across the nation, offers a competitive market allowing all to compete on information services and can achieve long-term sustainability. TEFCA outlines legal obligations of stakeholders. ONC released a draft for TEFCA in January.

The second pilot is the US Core Data for Interoperability (USDCI). It provides the underlying data policy by identifying priority data classes and establishing a process and timeline to make available such data classes for exchange through the TEFCA, Smith explains.

In the USDCI pilot, ONC expects to identify a core set of initial data types that will need to be standardized and available for data exchange. However, AMIA in comments sent to the government recommends that at the present time, standardization of data should not be a prerequisite for data exchange.

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While AMIA members are fierce advocates for standardization of data, the association fears that ONC is getting ahead of policy.

“As an appendix to the TEFCA, we understand the need to constrain and prioritize specific data classes; however, this data policy begs a fundamental question: Is standardization necessary for exchange?” its comment letter notes.

AMIA has developed a set of health IT data standards and interoperability policy principles, the group tells ONC, and it believes that clinical, research and information technology systems should be able to exchange biomedical, clinical and health data consistently and reliably using computable formats while preserving the intended meaning and relationships. “However, we question the proposed approach of the USCDI, which does not make available numerous data classes for exchange until they are structured, several years in the future.”

Consequently, AMIA recommends ONC finalize the first version of USCDI with a policy that enables sharing of all data classes in computable and human readable formats with gradual structuring of data classes over time.

“A policy that encourages non-standard data class exchange ensures that important data does not remain behind closed systems, and it will help identify data classes that need to be prioritized for standardization.”

Rather, ONC should finalize the USCDI Version 1, “with a policy that enables the sharing of all data classes in computable and human readable formats that gradually structures data classes over time,” AMIA advises. “A share-first, structure-later policy would allow all data classes not yet ready for inclusion in the USCDI to be exchangeable, even if it is only exchangeable as free text.”

In its comments to ONC, the College of Healthcare Information Management Executives is asking ONC for more time for public comment before finalizing TEFCA.

“Given the implications of TEFCA and the number of outstanding policy questions we still have, we urge ONC to offer an additional comment period this year for the public prior to finalizing (it),” its comment letter says.

Other CHIME comments include:

  • ONC should work with the National Institute for Standards and Technology (NIST) to pilot test TEFCA as required by the 21st Century Cures Act.
  • The Recognized Coordinating Entity should be a broad-based neutral entity that is a not-for-profit with multi-stakeholder representation—to include the provider community—on its board.
  • The framework should be structured to prevent any entity from monetizing the information that’s aggregated.
  • The framework’s data matching provisions should be modified or expanded to reflect expert input.

For now, ONC has proposed a policy, not a regulation, Smith says. But over time, he expects the government will make collection and exchange via the Trusted Exchange Framework and Common Agreement and information in the US Core Data for Interoperability program to be compulsory.

AMIA’s full comments are available here. Information on the government’s Trusted Exchange Framework and Common Agreement is available here.

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