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Health IT Regulation: Report of an Implementation ChallengeFunding None.
Over the past 14 years, Health Information Technology (Health IT) regulation has been successful in transitioning health care providers in the United States from paper-based to electronic health records. This success was largely a result of the Health Information Technology for Economic and Clinical Health Act, which offered incentive payments for Medicare and Medicaid providers who made Meaningful Use of Certified Health IT. During this period, the Office of the National Coordinator (ONC) has periodically updated the certification criteria to include various capabilities, including computerized provider order entry, electronic prescribing, transitions of care, clinical decision support, and patient education. However, even the best considered policies can lead to challenges in implementation. Here we cite an example of a successful public/private partnership to identify and reconcile one such challenge.
A significant update to the certification criteria occurred in 2020, when ONC added a new Application Programming Interface criterion that required support for Fast Healthcare Interoperability Resources R4. However, in the same 2020 update, ONC also required that certified Health IT support the Consolidated-Clinical Document Architecture (C-CDA) for transitions of care, clinical information reconciliation, care plans, and transmission of data to third parties and public health agencies. ONC gave Health IT developers until December 31, 2022, to be in compliance with the C-CDA requirements.
Although ONC required adoption of the latest version of C-CDA, many of the templates in the latest version were originally developed a decade ago. In particular, the Substance or Device Allergy—Intolerance Observation (v2) was included in the Health Level Seven International (HL7) Draft Standard for Trial Use ballot in September 2013. Buried on page 603 of 930 in that document, Table 491 required that to represent a code for an allergy to a substance, the C-CDA “SHALL” contain a code from the value set 2.16.840.1.1137184.108.40.2060.1 (Substance-Reactant for Intolerance). This grouping value set included a specific value set to represent drug classes called Medication drug class for allergen intolerance with Object Identifier 2.16.840.1.1137220.127.116.114.14. This value set contained SNOMED CT codes for drug classes as required by United States Core Data for Interoperability (USCDI) v1.
Fast forwarding to 2022, Health IT developers were using an ONC testing tool to test their compliance with the C-CDA requirement. For the concept of an allergy code noted above, the testing tool validated that the code was contained in the required value set. Unfortunately, several common drug classes were missing from the required value set. Using Medi-Span as a data source (Wolters Kluwer Health, Indianapolis, IN), we found 48 SNOMED CT codes that were missing from this value set, including common drug class concepts such as low-molecular weight heparin (87233003), β-2 adrenergic receptor agonists (320073005), selective serotonin reuptake inhibitors (349854005), and loop diuretics (830118008).
As a result of the omission of these concepts from the value set, it became difficult for Health IT developers to comply fully with the ONC regulation, since there was no way to represent many actual patient allergies to medication classes using the required value set. The C-CDA documents that these developers were submitting to the ONC testing tool were failing the validation test. If instead of the verb “SHALL,” the C-CDA template for allergies had used the verb “SHOULD” in the HL7 ballot 10 years ago, then compliance would have been possible by including codes that were outside of the value set, but admittedly with reduced consistency for the additional concepts.
For step 1, we worked with HL7 in the Fall of 2022 to update the value set. For step 2, we worked with ONC in January and February of 2023 to update the testing tool to use the new version of the value set. We would note that both HL7 and ONC were helpful and cooperative with the necessary updates.
We believe this report can serve as a model for ongoing collaboration between regulatory bodies and the implementation community to address any implementation challenges that will inevitably arise. While draft regulations are already subject to a public comment period prior to being finalized, it may be difficult for implementers to understand the full implications of these regulations until they are tested with real world data. Therefore, a process for addressing implementation challenges postregulation also needs to be in place. This process for postregulation surveillance could be modeled after the process used for postmarketing surveillance in the pharmaceutical industry. Reports of implementation challenges could be submitted to ONC for review, which in some cases may lead to ONC issuing clarification notices or regulatory updates. By working together, regulators and implementers can continue to improve our health care system for the patients whom we serve.
Protection of Human and Animal Subjects
This project did not include any human or animal subjects.
Received: 09 October 2023
Accepted: 19 December 2023
Article published online:
07 February 2024
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- 1 Office of the National Coordinator for Health Information Technology. Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. Published 2009. Accessed April 24, 2023 at: https://www.healthit.gov/sites/default/files/hitech_act_excerpt_from_arra_with_index.pdf
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