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Selected attribute definitions

Attribute name	Datatype	Definition
Adverse reaction
severity	Coded	Assessment of the severity of the reaction
didNotOccurFlag	Boolean	Indicates a reaction did not occur at contact with substance
OccurrenceDate	DateTime	Time stamp for manifestation of the reaction
Health condition
status	Coded	Current status of the concern
Adverse sensitivity to substance
criticality	Coded	Clinical judgement regarding potential seriousness of a future reaction.
sensitivityType	Coded	Allergy; intolerance
createdDate	Date Time	Date time the entry was created
Substance
identifier	Coded	Coded reference to the substance involved in the reaction
name	String	Name of the substance
Exposure
exposureDate	Date Time	Date time when the exposure occurred; may be approximated
exposureType	Coded	How the exposure occurred, eg vaccination, prescription, administration, accidental
Manifestation
severity	Coded	Severity of the manifestation of the reaction
reactionType	Coded	Clinical finding characterizing the reaction, eg code for rash or hives
Sensitivity test
identifier	Identifier	Identifier pointing to results of the sensitivity test
name	String	Name of the test

1.1.3 Fast Healthcare Interoperability Resources (FHIR®; HL7®)

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Table 1 shows the definition of the main AllergyIntolerance resource elements along with details about their terminology bindings.

Path/Element	Definition	Values	Binding Strength	Binding
AllergyIntolerance .clinicalStatus	The clinical status of the allergy or intolerance.	- active - inactive - resolved	Required	AllergyIntoleranceClinicalStatusCodes
AllergyIntolerance .verificationStatus	Assertion about certainty associated with a propensity, or potential risk, of a reaction to the identified substance.	- unconfirmed - confirmed - refuted - entered-in-error	Required	AllergyIntoleranceVerificationStatusCodes
AllergyIntolerance.type	Identification of the underlying physiological mechanism for the reaction risk, if known.	- allergy - intolerance	Required	AllergyIntoleranceType
AllergyIntolerance .category	Category of an identified substance associated with allergies or intolerances.	- food - medication - environment - biologic	Required	AllergyIntoleranceCategory
AllergyIntolerance .criticality	Estimate of the potential clinical harm, or seriousness, of a reaction to an identified substance.	- low - high - unable-to-assess	Required	AllergyIntoleranceCriticality
AllergyIntolerance.code	Code for an allergy or intolerance statement (either a positive or a negated/excluded statement). This may be a code for a substance or pharmaceutical product that is considered to be responsible for the adverse reaction risk (e.g., "Latex"), an allergy or intolerance condition (e.g., "Latex allergy"), or a negated/excluded code for a specific substance or class (e.g., "No latex allergy") or a general or categorical negated statement (e.g., "No known allergy", "No known drug allergies").		Example	AllergyIntoleranceSubstance/Product,ConditionAndNegationCodes
AllergyIntolerance .reaction.substance	Identification of the specific substance (or pharmaceutical product) considered to be responsible for the Adverse Reaction manifestation. It can differ from the AllergyIntolerance.code in some circumstances (ex: reaction to a product containing the substance responsible).		Example	SubstanceCode
AllergyIntolerance .reaction.manifestation	Clinical symptoms and/or signs that are observed or associated with an Adverse Reaction Event.		Example	SNOMEDCTClinicalFindings
AllergyIntolerance .reaction.severity	Clinical assessment of the severity of a reaction event as a whole, potentially considering multiple different manifestations.	- mild - moderate - severe	Required	AllergyIntoleranceSeverity
AllergyIntolerance .reaction.exposureRoute	A coded concept describing the route or physiological path by which the subject was exposed to the substance.		Example	SNOMEDCTRouteCodes

It is important to note that

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Table 2 shows the definition of the main Observation resource elements along with details about their terminology bindings.

Path/Element	Definition	Values	Binding Strength	Binding
Observation.status	The status of the result value.	- registered - preliminary - final - amended - corrected - cancelled - entered in error - unknown	Required	ObservationStatus
Observation.category	A code that classifies the general type of observation being made.		Preferred	Observation Category Codes
Observation.code	Type of observation (code / type). Describes what was observed. Sometimes this is called the observation "name".		Example	LOINC Codes
Observation.dataAbsentReason	Provides a reason why the expected value in the element Observation.value[x] is missing.		Extensible	DataAbsentReason
Observation.interpretation	A categorical assessment of an observation value. For example, high, low, normal.		Extensible	Observation InterpretationCodes
Observation.bodySite	Indicates the site on the subject's body where the observation was made (i.e. the target site). May include laterality.		Example	SNOMED CT Body Structures
Observation.method	Indicates the mechanism used to perform the observation.		Example	ObservationMethods
Observation.referenceRange.type	Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.		Preferred	Observation Reference Range MeaningCodes
Observation.referenceRange.appliesTo	Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race.		Example	Observation Reference Range AppliesToCodes
Observation.component.code	Type of component observation (code / type). Describes what was observed. Sometimes this is called the observation "code".		Example	LOINC Codes
Observation.component.dataAbsentreason	Provides a reason why the expected value in the element Observation.component.value[x] is missing.		Extensible	DataAbsentReason
Observation.component.interpretation	A categorical assessment of an observation value. For example, high, low, normal.		Extensible	Observation InterpretationCodes

1.1.3.3 Condition resource

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Table 3 shows the definition of the main Condition resource elements along with details about their terminology bindings.

Path/Element	Definition	Values	Binding Strength	Binding
Condition.clinicalStatus	The clinical status of the condition or diagnosis.	- active - recurrence - relapse - inactive - remission - resolved	Required	ConditionClinicalStatusCodes
Condition.verificationStatus	The verification status to support or decline the clinical status of the condition or diagnosis.	- unconfirmed - provisional - differential - confirmed - refuted - entered-in-error	Required	ConditionVerificationStatus
Condition.category	A category assigned to the condition.		Extensible	ConditionCategoryCodes
Condition.severity	A subjective assessment of the severity of the condition as evaluated by the clinician.		Preferred	Condition/DiagnosisSeverity
Condition.code	Identification of the condition or diagnosis.		Example	Condition/Problem/DiagnosisCodes
Condition.bodySite	Codes describing anatomical locations. May include laterality.		Example	SNOMEDCTBodyStructures
Condition.stage.summary	Codes describing condition stages (e.g. Cancer stages).		Example	ConditionStage
Condition.stage.type	Codes describing the kind of condition staging (e.g. clinical or pathological).		Example	ConditionStageType
Condition.evidence.code	Codes that describe the manifestation or symptoms of a condition.		Example	ManifestationAndSymptomCodes

1.1.3.4 Example of a typical Medication allergy resource from a clinical system (id = "medication") (JSON format):

Code Block

{

  "resourceType": "AllergyIntolerance",

  "id": "medication",

  "text": {

    "status": "generated",

    "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative with Details</b></p><p><b>id</b>: medication</p><p><b>clinicalStatus</b>: Active <span>(Details : {http://terminology.hl7.org/CodeSystem/allergyintolerance-clinical code 'active' = 'Active', given as 'Active'})</span></p><p><b>verificationStatus</b>: Unconfirmed <span>(Details : {http://terminology.hl7.org/CodeSystem/allergyintolerance-verification code 'unconfirmed' = 'Unconfirmed', given as 'Unconfirmed'})</span></p><p><b>category</b>: medication</p><p><b>criticality</b>: high</p><p><b>code</b>: Penicillin G <span>(Details : {RxNorm code '7980' = 'Penicillin G', given as 'Penicillin G'})</span></p><p><b>patient</b>: <a>Patient/example</a></p><p><b>recordedDate</b>: 01/03/2010</p><p><b>recorder</b>: <a>Practitioner/13</a></p><h3>Reactions</h3><table><tr><td>-</td><td><b>Manifestation</b></td></tr><tr><td>*</td><td>Hives <span>(Details : {SNOMED CT code '247472004' = 'Weal', given as 'Hives'})</span></td></tr></table></div>"

  },

  "clinicalStatus": {

    "coding": [

      {

        "system": "http://terminology.hl7.org/CodeSystem/allergyintolerance-clinical",

        "code": "active",

        "display": "Active"

      }

    ]

  },

  "verificationStatus": {

    "coding": [

      {

        "system": "http://terminology.hl7.org/CodeSystem/allergyintolerance-verification",

        "code": "unconfirmed",

        "display": "Unconfirmed"

      }

    ]

  },

  "category": [

    "medication"

  ],

  "criticality": "high",

  "code": {

    "coding": [

      {

        "system": "http://www.nlm.nih.gov/research/umls/rxnorm",

        "code": "7980",

        "display": "Penicillin G"

      }

    ]

  },

  "patient": {

    "reference": "Patient/example"

  },

  "recordedDate": "2010-03-01",

  "recorder": {

    "reference": "Practitioner/13"

  },

  "reaction": [

    {

      "manifestation": [

        {

          "coding": [

            {

              "system": "http://snomed.info/sct",

              "code": "247472004",

              "display": "Hives"

            }

          ]

        }

      ]

    }

  ]

}

1.1.3.5 Using SNOMED CT concepts in FHIR® resources

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The IPS includes the following conformance attributes:

M	Mandatory	Shall always be present and - where applicable - shall be instantiated with valid values. No exceptions or empty/null values are allowed in this case.
R	Required	A required element shall always be present and - where applicable - should be instantiated with valid values. Exceptions or empty/null values are allowed in this case.
RK	Required if Known	If there is information available, the element must be present and - where applicable - instantiated with valid values. If there is no information available, the element may be omitted, may be left empty, or may be instantiated with exceptional or null values depending on the implementation.
C	Conditional	Depending on predicate conditions, the element may assume different conformance strengths (e.g. O, R, RK) or not being present.
O	Optional	This data element can be omitted from a derived model, including from implementations. Recipient may ignore optional elements.

The Allergies and Intolerance section of IPS data set includes:

Data Element	Conformance	Datatype	Data Element Description
Allergies/Intolerances content status	C	coded	As this IPS Section is mandatory for conformance, information about “known absence of allergies” or no information about allergies is required to be stated. Known Content will be accompanied by the conditional list of Allergies and intolerances.
Allergies and Intolerances	C	List	If present then they shall be listed else give explicit reasons for why none are recorded. An ordered list comprising the name, code, a description of the Allergy/intolerance and Agent details for each Allergy/intolerance.
1) Allergy/Intolerance	M	Label concept	If allergies present then they shall be listed else give explicit reasons for why none are recorded. An ordered list comprising the name, code, a description of the Allergy/intolerance and Agent details for each Allergy/intolerance.
a. Allergy/Intolerance description	R	Text	Textual description of the allergy or intolerance.
b. Clinical status	R	Coded	Provides the current status of the allergy or intolerance (e.g., active)
c. Onset date	RK	Datetime	It shall be provided with the highest known precision, at least to the year
d. End Date	C	Datetime	If Clinical Status is non-active then an exception can be raised to indicate inconsistency. It shall be provided with the highest known precision, at least to the year.
e. Criticality	O	Coded	Represents the gravity of the potential risk for future life-threatening adverse reactions when exposed to a substance known to cause an adverse reaction in that individual.
f. Certainty	O	Coded	Assertion about certainty associated with the propensity, or potential risk, of a reaction to the identified substance.
g. Type of propensity	RK	Coded	Type of allergy or intolerance. (e.g., allergy)
h. Diagnosis	O	Coded	A code indicating the type of reaction and the agent; an alternative option for describing an allergy to the agent. (e.g., lactose intolerant)
i. Reaction	RK	Label Concept	A Label Concept recognizing that other data concerning the reaction may be made available in later versions of this standard.
i) Manifestation of the reaction	RK	Coded	Description of the clinical manifestation of the allergic reaction. Example: anaphylactic shock
ii) Severity	RK	Coded	Coded element that describes the subjective assessment of the severity of the condition as evaluated by the clinician, in the case of an allergy it is used as attribute of a manifestation of a reaction.
j. Agent	R	Label Concept
iii) Agent code	R	Coded	A specific allergen or other agent/substance to which the patient has an adverse reaction propensity.
iv) Category	O	Coded	Allergy substance category (eg food)

Additional information about FHIR® implementation guide of the International Patient Summary can be found here: http://hl7.org/fhir/uv/ips/ .

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1.1.3 Fast Healthcare Interoperability Resources (FHIR®; HL7®)

1.1.3.3 Condition resource

1.1.3.4 Example of a typical Medication allergy resource from a clinical system (id = "medication") (JSON format):

1.1.3.5 Using SNOMED CT concepts in FHIR® resources