Allergies and Intolerances

Emory Healthcare comments on Criticality

EHC strongly supports the proposed addition of Allergy Intolerance Criticality as a data element within the United States Core Data for Interoperability (USCDI). However, we also recommend further differentiation within the 'Allergy and Intolerance' section, which currently aggregates allergic reactions, non-allergic adverse drug reactions, side effects, and intolerances. We recommend segmenting drug reactions from the following classifications: 

Drug Allergies: We see a clear and significant use case for criticality in specific scenarios, particularly with drug allergies where cross-reactivity and severe systemic reactions are well-documented. A standardized criticality here is invaluable for immediate patient safety.

Foods and Other Agents: For food allergies, environmental allergies, or other agents that may have less significant cross-reactivity or direct disease-food interactions, the utility of a "criticality" classification can be less pronounced. The clinical impact often varies widely, and a blanket application might not always be beneficial.

We also note that Provenance of these data is vital, as what patients might perceive as severe discomfort or significant impact on their quality of life might not necessarily equate to a high-risk medical event. This inherent subjectivity makes it difficult to consistently apply a standardized criticality. Despite these challenges, we strongly agree with the need for a national standard to classify criticality. A simplified, standardized approach, such as classifying criticality into low, high, and unable to assess risk, would greatly simplify the classification process and improve consistency across systems. This approach could provide actionable information while acknowledging the complexities of certain reactions and data input. We recommend that the ONC continue to emphasize and potentially further define the requirements for capturing and exchanging Allergy and Intolerance Criticality, while also providing clear guidance on its appropriate application and the need for a simplified, nationally standardized classification system (e.g., low, high, unable to assess risk). 

2026 Emory Healthcare USCDI_v7 Comment Letter.pdf

CMS-CCSQ Applauds this data element’s inclusion in USCDIv7

CMS CCSQ supports the inclusion of Allergy Intolerance Criticality in USCDI v7.

Allergy Criticality Note for Implementation Challenges

The proposed Criticality data element has the following note for implementation challenges: “Educational awareness for clinicians will be necessary since this field has replaced severity in clinical practice.”  We request that this statement be rephrased, as this element has not replaced severity in clinical practice. Severity is the clinical assessment of a specific allergic reaction when it occurs (e.g., mild, moderate, severe). Criticality is an estimate of the potential clinical harm, or seriousness, of a reaction to an identified substance (e.g., low, high, unknown). Clinicians use both severity and criticality in practice to diagnose and treat allergies and intolerances. In some systems, criticality may be derived, in part, by the severity of a previous reaction. We propose changing the Criticality data element note to the following: “Educational awareness for clinicians may be necessary since this field can be derived from severity or has replaced severity in some clinical systems.” Also, there is a Level 2 USCDI element Reaction Severity that we support being added to future versions of the USCDI data standard. 

AAAAI supports Allergy

The American Academy of Allergy, Asthma & Immunology (AAAAI) strongly supports the proposed addition of Allergy Intolerance Criticality as a data element within the United States Core Data for Interoperability (USCDI). The AAAAI represents thousands of allergist-immunologists dedicated to improving the diagnosis, treatment and documentation of allergic and immunologic diseases. We believe this proposed change directly advances patient safety, enables better clinical decisions, and lays critical groundwork for the broader modernization of allergy documentation in electronic health records (EHRs).

Why the AAAAI Supports This Change

The current allergy module in most EHRs fails to adequately communicate the clinical criticality of documented reactions. At present, a patient with a history of anaphylaxis to penicillin and a patient with a mild gastrointestinal intolerance to the same drug often carry identical allergy labels, an ambiguity that impairs clinical decision-making and contributes to unnecessary drug avoidance. The proposed Allergy intolerance Criticality data element, offering standardized coded values of Low Criticality, High Criticality, and Unable to Assess, addresses this gap directly. Its addition is crucial to improve patient safety and will result in better outcomes by not avoiding drugs with low risk in favor of treating a disease with high risk of morbidity. By enabling clinicians to distinguish potentially life-threatening reactions from less severe  ones, this element supports more actionable, proportionate clinical responses across care settings. 

However, although the Standards Bulletin announcing version 7 of USCDI shows the Criticality data element is included, it does not have a bold S next to it. This means that it is suggested as “should support”. We strongly recommend that this important data element should be designated as Must Support.  

Critically, standardizing this data element through USCDI will promote consistent implementation across EHR vendors, reduce reliance on free-text entries, and enable clinical decision support tools to better prioritize allergy alerts. This has the potential to meaningfully reduce  alert fatigue—a well-documented problem that leads clinicians to override warnings that may, in some cases, represent true safety hazards. 

Context: AAAAI’s Ongoing Work on EHR Allergy Documentation 

The AAAAI has been a leading voice in advocating for the modernization of allergy documentation within electronic health records. We are eager to collaborate with the ONC, EHR vendors, and other healthcare stakeholders to implement standardized frameworks that move beyond the limitations of current systems, such as over-reliance on free-text and inconsistent terminology. While the addition of Allergy Intolerance Criticality is a meaningful and necessary first step, we remain enthusiastic about sharing our broader vision for more precise, actionable documentation, including improved hierarchical categorization and enhanced clinical decision support, to ensure patient safety and reduce clinician alert fatigue across all care settings. 

The USCDI as Foundation for Future Progress

The AAAAI views the USCDI standards as foundational infrastructure upon which future progress in allergy documentation must be built. Standardized, coded data elements, exchanged interoperably across systems, are a prerequisite for the more advanced reforms our field envisions: improved allergy delabeling workflows, natural language processing–assisted reconciliation, genetic and pharmacogenomic risk integration, and cross-institutional alert exchange that does not depend solely on patient self-report. Without alignment at the USCDI level, locally implemented improvements will remain siloed and unable to achieve population-level safety gains. 

The AAAAI is committed to serving as a resource to ONC, EHR vendors, and other stakeholders as this work continues. We encourage ONC to finalize the inclusion of Allergy Intolerance Criticality in the USCDI, but to change its designation to Must Support. 

Respectfully submitted, 

Carla M. Davis, MD, FAAAAI

President, American Academy of Allergy, Asthma & Immunology

Recommendation for terminology standard designation

SNOMED International recommends that ONC designate SNOMED CT U.S. Edition as an applicable vocabulary standard for Allergy Intolerance Criticality. 

SNOMED CT includes validated clinical severity and risk concepts, such as 24484000 |Severe (severity modifier)|, 6736007 |Moderate (severity modifier)|, and 255604002 |Mild (qualifier value)|. This provides a clinically precise vocabulary for criticality assessment, enabling consistent risk stratification across EHR and clinical decision support systems. Designating SNOMED CT for this element ensures intra-class consistency: SNOMED CT is already required for Drug Class Allergy Intolerance, Non-Medication Allergy Intolerance, and Reaction within the same Allergies and Intolerances data class.

Allergy Intolerance Criticality is a patient safety data element with direct clinical decision support implications. Inconsistent coding of criticality severity across systems creates risk of medication errors and inappropriate care decisions, particularly in emergency and cross-organisational settings where allergy data must be reliably exchanged. SNOMED CT designation as the applicable standard for this element supports ONC's Clinical Decision Support (CDS) certification criteria, which reference SNOMED CT as a core clinical terminology for condition and severity coding, and aligns with the patient safety objectives of the 21st Century Cures Act's information blocking provisions.

Criticality evidence more useful than criticality judgment

Criticality evidence would be more useful than judgment

The criticality requirement envisions a scenario where the documenting provider has information about criticality that the receiving provider does not have. It would be good for the receiving provider to have this information.

But it's not clear that asking prior providers to assign criticality judgments will bring this about. Criticality judgments without evidence add burden to the recording provider, potentially degrading data quality, without a clear benefit to the receiver.

Criticality judgments can often be inferred based on known combinations of medication & symptom, such as 'penicillin + dyspnea' or 'morphine + nausea'. Adding such a judgment provides little value to the receiver.

A criticality judgment might provide value if it deviates from clinical norms, but without supporting evidence it might only create ambiguity. In a high-acuity setting, a 'High' criticality rating for a common, non-severe reaction (like nausea) without evidence why the provider determines that this case is different could lead to unnecessary care delays or diagnostic distraction.

Criticality evidence (optional) would be useful in such cases.

If we wish to support less knowledgeable providers by (possibly automatically) assigning judgment based only on clinical norms, this assignment should also be explicit about the rationale for the assignment (e.g., "expected criticality for this substance & reaction pair; no additional information".

CDC's support for CMS comment for USCDI v7

CDC supports CMS recommendation for adding Criticality to final USCDI v7

CMS-CCSQ Supports Criticality for USCDI v7

Recommendation:  CMS CCSQ recommends the Criticality element be added to final USCDI v7.

Rationale:  CMS CCSQ supports Post-Acute Care Interoperability (PACIO)’s recommendation to include the Criticality data element in USCDI v7. Adding this data element to the Allergies and Intolerances data class is essential for improving patient safety and clinical decision-making. The Criticality data element complements existing USCDI elements by providing critical, clinically actionable information about the severity and potential impact of allergic reactions, enabling healthcare providers to better assess risks and prioritize care. Under the administration’s priorities, CMS CCSQ and PACIO share a commitment to improving national prevention of poor health through the avoidance of allergic reactions experienced under the care of health providers by enhancing data exchange and empowering providers to make informed, patient-centered decisions. 

PACIO Recommends Advancement to USCDI V7

• Recommendation: Advance Criticality data element from Level 2 to USCDI V7. 
• Rationale: The PACIO Project Community* supports the earlier comments from CMS regarding food allergy intolerance, including the recommendation to advance the Criticality data element from Level 2 to inclusion in the USCDI V7. The inclusion of the Criticality data element in the Allergies and Intolerances data class of USCDI V7 is crucial for enhancing patient safety and clinical decision-making. The Criticality data element is the necessary companion to the allergy or intolerance agent and the clinical manifestation, aka reaction, that have been included in the USCDI since V4. While the patient's allergy or intolerance agent and clinical manifestation (reaction) provide foundational information about what triggers a reaction and how it presents, the Criticality data element adds an essential layer by indicating the severity and potential impact of a future reaction. This provides clinically actionable data for healthcare providers to assess risks more accurately and prioritize interventions, ensuring that they can make informed decisions about prescribing medications, selecting alternative treatments, and avoiding agents that could trigger severe reactions. 
• Current standards: The PACIO Community* recommends including LOINC as an applicable standard, specifically the LOINC 82606-5 code “Allergy or intolerance criticality”, and the LOINC-based example answer list for criticality, LOINC LL4063-5. HL7 FHIR R4 Allergy Intolerance Criticality, Rx Norm, SNOMED-CT, the National Drug Code (NDC), and LOINC.
• Current Use: Criticality is currently captured, stored, and accessed in multiple production EHRs.
  • Epic Systems captures the FHIR R4 AllergyIntolerance resource which includes Critically as seen on Open Epic.
  • Oracle captures the FHIR R4 AllergyIntolerance resource which includes Critically as seen on the Help Center.
• References: 
  • Goss FR, Zhou L, Plasek JM, Broverman C, Robinson G, Middleton B, Rocha RA. Evaluating standard terminologies for encoding allergy information. J Am Med Inform Assoc. 2013 Sep-Oct;20(5):969-79. doi: 10.1136/amiajnl-2012-000816. Epub 2013 Feb 9. PMID: 23396542; PMCID: PMC3756252.; https://pmc.ncbi.nlm.nih.gov/articles/PMC3756252/ 
  • HL7 AllergyIntolerance – FHIR v4.0.1: https://hl7.org/fhir/R4/allergyintolerance.html
• * The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, that aims to advance interoperable health information exchange between post-acute care (PAC) providers, patients, and other key stakeholders across health care. 

CMS-CCSQ Supports Criticality for USCDI v6

Recommendation: CMS CCSQ recommends the Criticality element be added to final USCDI v6.

Rationale: CMS CCSQ supports Post-Acute Care Interoperability (PACIO)’s recommendation to include the Criticality data element in USCDI v6. Adding this data element to the Allergies and Intolerances data class is essential for improving patient safety and clinical decision-making. The Criticality data element complements existing USCDI elements by providing critical information about the severity and potential impact of allergic reactions, enabling healthcare providers to better assess risks and prioritize care. CMS CCSQ and PACIO share a commitment to enhancing data exchange and empowering providers to make informed, patient-centered decisions.