ONC interop rules must include measures for success, experts say

A blog post published in Health Affairs outlines a framework for tracking the effectiveness of stakeholder behavior in response to ONC data-sharing rules.
By Kat Jercich
03:14 PM

On June 30, the U.S. Department of Health and Human Services' final rules regarding healthcare technology – comprising regulations put forth by the Office of the National Coordinator for Health Information Technology and the Centers for Medicare and Medicaid Services concerning data sharing among patients, providers and app developers – went into effect.

ONC and CMS called the rules, which fulfill the related provisions of the 21st Century Cures Act, "transformative" at the time of their finalization. 

But, critics point out, the rules lacked a measure for effectiveness.

Writing for the Health Affairs blog this week, three University of California, San Francisco, informatics and health policy experts proposed a framework for short- and long-term measurements of stakeholder behavior. 

"In concept, the regulations take a giant leap forward," wrote Mark Savage, Aaron Neinstein and Julia Adler-Milstein in the post. "In practice, they might fall short of the nation’s goals. How will we know? How can we spot gaps and make timely corrections?"

"We must be able to gauge whether focal actors – in particular, [electronic health record] vendors and providers – are engaging in the desired behaviors, and at what levels, to meet national imperatives Congress set out in the Cures Act," they asserted.


The authors made recommendations regarding three main domains: individual data access, bulk data access and information blocking.

Regarding the first category, their recommended measures included the percentage of patients with timely, longitudinal health-record access across their providers; the percentage of patients who have the ability to contribute to their records; the percentage of patients with dynamic care plans shared among providers, patients and non-clinical caregivers; and the percentage of providers and health systems using third-party apps with EHR APIs.

"But more is needed," continued the authors. "From thousands of possible EHR data elements, the ONC’s current US Core Data for Interoperability (USCDI) – a standardized set of data elements that should be included in nationwide, interoperable health information exchange – includes only 21, omitting at least 50 elements 'critical' for interoperability."

So success measures, they advised, should incorporate the inclusion of USCDI elements too.

Regarding bulk data, the authors recommended tracking the percentage of providers using a FHIR bulk transfer API for established purposes. 

"The ONC’s regulations adopt a FHIR bulk-data standard that all certified EHR technology must meet for API-enabled 'read' and export services but do not require particular uses of this capability," they observed.

Finally, when it comes to information blocking, the authors acknowledged that it's difficult to quantify: "Direct measures of information blocking are likely not feasible."

However, they said, reports of how often specific (potentially information-blocking) behaviors are observed by health IT professionals and others could function as a proxy.


The future of interoperability implementation has continued to pose lingering questions for health systems and IT professionals.

Given the massive societal shift triggered by the COVID-19 crisis, ONC and CMS announced in April that they would exercise enforcement discretion regarding some of the rules' compliance dates.

Meanwhile, the pandemic has shined a spotlight on the importance of interoperability, with researchers noting the key role it could play in stemming the spread of coronavirus. At the same time, stakeholders have warned that increased information sharing shouldn't come at the cost of patient privacy.


"We cannot evaluate and improve what we do not measure. The ONC’s new regulations take significant steps toward interoperability, but there are many ways in which long-term policy goals and desired behaviors might still not materialize," wrote Savage, Neinstein and Adler-Milstein in the Health Affairs post. 

"Beginning measurement now is critical to establish baselines, assess progress toward the new regulatory minimums, and highlight the gaps we must address to achieve broader national needs and goals," they continued.

Actionable Intelligence

This month, we look at lessons from the COVID-19 pandemic on how data is put to work informing patient care decisions and population health.

Kat Jercich is senior editor of Healthcare IT News.
Twitter: @kjercich
Healthcare IT News is a HIMSS Media publication.

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