AMIA suggested ONC establish a “share now, standardize as needed” policy in its interoperability and information blocking proposed rule.
In recent comments submitted in response to an ONC Notice of Proposed Rulemaking regarding the interoperability and information blocking rules, AMIA recommended ONC include policies that support the exchange of unstructured data.
While AMIA stated its support for ONC’s efforts to implement the aims of the 21st Century Cures Act by promoting interoperability and reducing information blocking, the association expressed concern the rule may “solidify a dynamic where health data must be standardized before it is available for patient care or research.”
In the proposed rule, ONC provides a technical foundation to facilitate the exchange and access of supported or standardized data but failed to include similar support for unstructured information.
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A “share now, standardize as needed” policy supported by the Unstructured Document template part of the US Core Data for Interoperability Clinical Notes data class would help to facilitate the exchange of a wider variety of data types.
Proposed Electronic Health Information Export for Patient Access and Database Export policies provide mechanisms to ensure unstructured data are available to providers. However, AMIA cautioned these criteria may not be sufficient to flip the current paradigm where patients, researchers, and clinicians must depend on health IT developers to access data.
“[T]his NPRM perpetuates an imbalance where patients, clinicians, and researchers are beholden to health IT developers for routine access, exchange, and use of health data,” wrote AMIA. “If finalized as proposed, this NPRM will solidify a dynamic where health data must be standardized before it is available for patient care or research.”
A “share now, standardize as needed” policy would establish a baseline expectation that all EHI is available to patients, clinicians, and researchers when authorized. The policy would also position patients, clinicians, and researchers to identify data types in need of standardization rather than health IT developers.
“This approach is consistent with the USCDI data policy articulated by ONC in 2018 because it would enable health IT to exchange not just USCDI “supported” data elements, but would also provide a means for health IT to share structured (but potentially non-standardized) “candidate” and “emerging” data elements, as well as the constantly-evolving class of data that is neither standard, nor structured as an unstructured document,” wrote AMIA.
AMIA also offered recommendations for portions of the proposed rule related to reducing information blocking.
“AMIA views with skepticism any presumption that impeded data flows are categorically deemed “information blocking,” stated the association.
“Information blocking is not simply the absence of interoperability; interoperability may not occur for myriad reasons,” AMIA continued. “In addition to being dependent on standards for syntax, semantics, and transport, interoperability within the healthcare context needs agreement on when and how data should be presented within workflows.”
Despite AMIA’s concern that the term ‘information blocking’ has been inappropriately used to describe any lack of data exchange, the association supports most of the information blocking exceptions.
However, AMIA recommended ONC finalize the policy so that all EHI is subject to the information blocking rule and institute a period of enforcement discretion to help stakeholders learn and avoid wasteful litigation.
AMIA also suggested ONC reduce the scope of the definitions for health information network and health information exchange by focusing on whether entities have decision-making authority for the governance of health data use, predominately handle EHI, and have substantial influence over a technology or service that enables interoperability.
The association also recommended ONC ensure claims of exception to information blocking regulations are well-documented, reviewed by OIG in a timely manner, and made publically available online.
“We continue to appreciate ONC’s work in this important area, and we are eager to bring the expertise of health informatics professionals to this national priority,” concluded AMIA.
Date: May 29, 2019
Source: EHR Intelligence
