The following is a guest article by Lauren Riplinger, Vice President of Policy and Government Affairs at the American Health Information Management Association (AHIMA).
As actors work to comply with the Cures Act Final Rule, it’s become clear that greater consensus is needed regarding the interpretation of the definition of electronic health information (EHI) and the designated record set (DRS). As many readers know, the Cures Act Final Rule includes interoperability requirements related to information blocking and health IT certification. Both rely on the definition of EHI, which is grounded in the definition of the DRS, as defined by HIPAA.
I’m proud my organization AHIMA has been able to collaborate with the American Medical Informatics Association (AMIA) and the Electronic Health Record Association (EHRA) on a taskforce to examine the relationship between specific aspects of the Cures Act Final Rule and the definitions of DRS and EHI.
Why is this topic so critical? Because covered entities today generally interpret for themselves which records may be included in the DRS for compliance purposes. As a result, there is variation (and often discrepancy) in how healthcare organizations decide which types of records are included in the DRS. This has led to longstanding inconsistencies and confusion for covered entities and business associates about how to comply with federal regulations.
But nothing spurs action like a hard deadline. Beginning October 6, 2022, actors will be expected to adhere to the full scope of EHI for purposes of information blocking compliance. Certification to the EHI export is expected by December 31, 2023. The time for action is now.
Developing Recommendations
Our taskforce quickly determined we could make a positive impact by developing recommendations for a consensus-based approach to operationalizing the definition of EHI. We believe our recommendations will give stakeholders a roadmap to help think through how to operationalize important regulatory concepts in an electronic environment.
Our work began with analyzing different data classes – such as those covered in the US Core for Data Interoperability (USCDI) version 1 that are commonly contained and exchanged in health IT (including data classes found in the DRS) – to determine whether these data classes may be considered EHI. Whether a particular data class could be used for decision making, consistent with the definition of the DRS, is central to whether it may be considered EHI.
That said, there is an inherent challenge in being able to track programmatically in a health IT system whether a data class could be used in decision-making. This may lead actors to cast a wide net over what they consider EHI or cause them to rely on manual identification. The taskforce members realized that, in some circumstances, specific data classes may not be considered EHI depending on certain conditions. For example, data that is in draft form such as a clinical note or reports that are in the process of being written or edited but not signed by the clinician may not be considered EHI.
Our Preliminary Report
Whether a particular data class is considered EHI will evolve over time as additional data classes are relied on for decision-making. For that reason, the data classes examined in our preliminary report released in September are a “floor” for what might be considered EHI rather than a “ceiling.” Actors will need to keep this in mind that as they undertake their own discovery process for what might be considered part of their DRS and in turn EHI, should a patient or caregiver request a data element not included in this report but still relied on for decision-making; such information is likely required to be producible under the Cures Act Final Rule and HIPAA.
Next up for our taskforce is gathering feedback from stakeholders on our initial findings. Our goal is to refine a consensus understanding of what data classes are considered EHI to help clinicians and developers further operationalize the definition.
This report is a call to action, and I’m heartened there is a real desire across the industry to have important conversations and make progress on this critical issue. If you have any feedback on the report, please email us at Advocacy@AHIMA.org.
