Harmful or undesired physiological responses associated with exposure to a substance.

Data Element

Substance (Food)

Common food substances and allergens that can cause harmful or undesirable physioloical responses when exposed to the substance or the substance is consumed.


Persistent need to exchange data regarding food allergies

With full appreciation for IMO's comments from 1.5 years ago that the some of the value sets relevant to this data element were poorly curated at that time, I would like to weigh in as a provider to reassert the clinical importance of this element for safe comprehensive patient care. Today, clinicians must rely on the Problem List to document food allergies, which few do in a consistent manner.  Many attempt to enter this data within the Allergies/Intolerances section of EHRs, where they may be forced to select inappropriate medication-related data items from an Allergen code set, which leads to inaccurate data and potentially false positive and/or false negative decision support alerts. Adding this Level 2 data element to USCDI v5 would create the needed industry incentive to move us toward consistent capture and exchange of this important health information.

Level 2 Data Class: Allergies and Intolerances

Level 2 Data Element: Substance (Food)


While IMO agrees that documentation of non-medication allergies is important in clinical care, we do have concerns regarding maturity and use of the technical specifications cited to support the proposed Level 2 data element submissions in this data class.

The following technical specifications are cited to support the proposed level 2 data elements in the Allergies and Intolerances data class:

  • C-CDA Implementation Guidance Conformance (CONF:1098-16324), for Substance or Device Allergy - Intolerance Observation (V2)
  • FHIR US Core Allergy Intolerance Profile: (v1.0.0: STU based on FHIR R3).
  • FHIR US Core Resource Profile: USCore AllergyIntolerance (v5.0.0 Preview CI Build)

The C-CDA specification for Substance or Device Allergy is not widely implemented and therefore does not meet the requirement as a Level 2 data element. The value set referenced in the specification, Substance Reactant for Intolerance OID: 2.16.840.1.113762.1.4.1010.1 is poorly curated. This value set contains over 47,000 codes, includes active pharmaceutical ingredients (single and multiple ingredient drugs and mix of branded and non-proprietary names), drugs used in veterinary medicine to include Ivermectin (Heartgard Plus) and Chlorhexidine Gluconate (Vet One), as well as codes for non-medications.

Neither FHIR technical specification meets the critiera for a Level 1 or Level 2 data element as they have not been implemented in production environments. The FHIR R3 US Core Allergy Intolerance Profile references the value set, Substance Other Than Clinical Drug OID: 2.16.840.1.113762.1.4.1010.9. This value set is poorly curated, contains over 21,000 codes that include codes for antibodies, antigens and amino acids in addition to relevant content for non-medications.  It is also worth noting that the v5.0.0 FHIR AllergyIntolerance profile references an entirely different value set Common substances for allergy and intolerance documentation including refutations OID: 2.16.840.1.113762.1.4.1186.8 which includes substances, medications, and food.   

IMO does not support the inclusion of Level 2 data elements (Substance (Non-Medication), Substance (Food)) in the Allergies and Intolerances Data Class in USCDI V3 as currently proposed. 


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