On June 3, EHRA submitted feedback to ONC on its proposed rule, the  21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program. In this feedback, EHRA members drew on both their expertise as software developers and as contributors to standards work across the health IT industry. 

One theme of EHRA and other stakeholders’ feedback is that a focus on standards is critical. A particular standard proposed recently by ONC is the United States Core Data for Interoperability, or USCDI. USCDI “is a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange” and includes important health data classes. 

A wide array of stakeholders see the proposed USCDI as important to resolving concerns about ambiguity and scope with another definition proposed in ONC’s rule: the newly defined “Electronic Health Information” (EHI).

Some data classes of USCDI, such as medications, have been widely exchanged among clinicians and with patients for many years. Other data classes in USCDI, such as notes, would be a newer incorporation to interoperability certification requirements. USCDI already represents a significant portion of key clinical data for interoperable exchange, and the expectation is that the USCDI will continue to expand through a collaborative process over time to include additional prioritized data classes. Phase 2 of the HITAC’s NPRM USCDI Task Force is providing input on how this process should work.

A wide array of stakeholders see the proposed USCDI as important to resolving concerns about ambiguity and scope with another definition proposed in ONC’s rule: the newly defined “Electronic Health Information” (EHI). In our comments, EHRA supported adoption of USCDI as the next iteration beyond the Common Clinical Data Set as defined in the 2015 Certification Edition:

“In particular, because the USCDI data set is defined so precisely, along with mechanisms for exchanging it among cooperating entities (FHIR/ARCH), it creates a useful bright line to determine if key information has indeed been “blocked.” Generally, we suggest that Conditions of Certification and Information Blocking obligations be considered as met if the USCDI data set is available or exchanged, given the challenges with broader and less clearly specified definitions such as EHI.”

Similar recommendations were made in comments from individual EHR developers, as well as by other stakeholders. For example, organizations representing physicians contributed the following suggestions:

• American College of Surgeons: “… this proposed definition of EHI is too vague, subjective, and potentially expansive for purposes of information blocking enforcement … To limit confusion and regulatory burden, we recommend that the information blocking restrictions in this rule only apply to the data classes in the USCDI.” (HHS-ONC-2019-0002-1854)
• The American College of Obstetricians and Gynecologists: “ACOG recommends that ONC constrain its definition of EHI to just the data elements represented by the USCDI for specified actors.” (HHS-ONC-2019-0002-1349)
• Mayo Clinic: “We suggest clearer definitions, such as limiting “EHI” to electronically-maintained designated record sets or individually identifiable health information within the USCDI.” (HHS-ONC-2019-0002-1574)
• Johns Hopkins Medicine: “Narrow the definition of EHI subject to information blocking to a more limited and meaningful set of data by (i) aligning the definition of EHI with USCDI.” (HHS-ONC-2019-0002-1760)

Organizations representing hospitals also echoed the same theme:

• American Hospital Association: “We urge ONC to consider the technology at hand and how easily it can export or exchange data. For example, limiting the information blocking provisions to the USCDI would allow for technology to advance and information sharing to advance with it.” (HHS-ONC-2019-0002-1814)
• America’s Essential Hospitals: “ONC should limit the definition of EHI for information blocking purposes to the USCDI dataset because health IT products will be certified to the USCDI and, at a minimum, will contain this information.” (HHS-ONC-2019-0002-1628)
• Children’s Hospital Association: “We also urge the ONC to reformulate the definition of electronic health information (EHI) to meet congressional intent of the information blocking provisions of the Cures Act by limiting its scope to the proposed components of the USCDI.” (HHS-ONC-2019-0002-1819)
• Greater New York Hospital Association: “We urge ONC to streamline the definition of EHI to the USCDI and adopt future data elements and classes through the USCDI process.” (HHS-ONC-2019-0002-1846)

Industry groups, interoperability organizations, and standards organizations also supported a focus on USCDI:

• Workgroup for Electronic Data Interchange: “A logical, objective approach to promoting interoperability is necessary to reduce confusion. As such, ONC should limit EHI for the purposes of information blocking to the data content of the USCDI at this time.” (HHS-ONC-2019-0002-1187)
• Direct Trust: “The definition of EHI is quite broad, and the USCDI will offer a helpful, consistent framework for stakeholders to exchange EHI.” (HHS-ONC-2019-0002-1512)
• The Sequoia Project: “We suggest that enforcement focus most heavily on access to the USCDI (including API access), which will evolve over time to include more and more EHI. We pledge to work closely with the community and ONC to achieve this goal.” (HHS-ONC-2019-0002-0428)
• Indiana Health Information Exchange: “We encourage ONC to weigh the immediate benefit of applying the information blocking prohibitions and exceptions only to a more narrowly defined data class most valuable to actors and patients such as the USCDI, rather than EHI.” (HHS-ONC-2019-0002-1783)

Finally, Federal Trade Commission staff also identified the definition of EHI as important to narrow: 

• Federal Trade Commission staff: “Consider adjusting the definition of EHI, so that it applies more narrowly to the information that is the focus of the statute, such as the information needed for patient treatment and HIT interoperability.” (HHS-ONC-2019-0002-1923)

For similar comments from other organizations, click here.

New data classes can be added over time to the USCDI as the necessary standards to structure and value the relevant data are defined, adopted, and matured to a level supporting national deployment.  Without such standards, inclusion of data beyond the USCDI will yield ambiguity and data that is hard to use across stakeholders.

Now that the public comment window for this proposed rule has closed, ONC is digesting the input from a wide array of engaged stakeholders as they determine how to proceed toward their goal of furthering the interoperability and patient access goals of 21stCentury Cures. EHRA continues to work with its members and other stakeholders across the industry to contribute our unique expertise on how to best deliver on these same data sharing objectives.