R6 Ballot (1st Draft)
Clinical SummaryThis page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions 
| Clinical Decision Support Work Group | Maturity Level: 2 | Trial Use | Security Category: Patient | Compartments: Device, Patient, Practitioner |
Indicates an actual or potential clinical issue with or between one or more active or proposed clinical actions for a patient; e.g. Drug-drug interaction, Ineffective treatment frequency, Procedure-condition conflict, gaps in care, etc.
This resource is an event resource from a FHIR workflow perspective - see Workflow, specifically Event.
This resource applies to various circumstances where there is a concern about an existing or proposed set of clinical activity. The issue could relate to single, proposed, or multiple actions. It does not apply to technical issues (e.g. lack of user permissions) but could relate to violation of patient consent limitations. Examples include:
This resource represents a specific instance of a potential issue for a particular patient. It is not intended to represent general patient-independent knowledge, the ClinicalUseDefinition resource is defined for that purpose. This resource is also not intended to be used in defining general prohibitions on actions such as "No NSAIDs", "No solid oral dose forms" or "No MRIs - metallic tattoos". These guidelines can be captured using the AllergyIntolerance, AdverseEvent and/or Flag resources. Similarly, this resource is not to be used to capture clinical facts that may imply contraindications such as pregnancy, breast feeding, patient preferences, past procedures, etc. These would be represented using Condition, Procedure or other resources.
This resource only applies to documenting a risk associated with a specific planned or ongoing action, or the lack of an action which should be planned - not a general propensity to risk. The latter would be handled using AllergyIntolerance for substance-specific issues or Flag for other types of issues. In addition, the resource represents patient-specific and time-bound risk manifestations, not generic knowledge statements about risks that can exist.
This resource is limited to clinical issues associated with a proposed or ongoing action. It does not cover technical issues such as lack of permission, duplicate identifiers, insufficient data, and other business rule violations. Technical issues are conveyed using the OperationOutcome resource.
It is possible to have both OperationOutcome and DetectedIssue together, where the OperationOutcome might
indicate that a requested action was rejected due to a clinical issue and the DetectedIssue provides the details of the issue.
Detected issues are typically identified by decision support systems. However, they may also be captured directly by clinicians. The latter typically happens for one of two reasons:
Decision-support generated issues can result from calling a decision-support engine directly (e.g. via a custom OperationDefinition) or as part of an attempt to perform some other function (creating an order, submitting an insurance claim, capturing a medication list). When the issues are generated as a by-product of performing some other sort of action, they may be included in the "response" to the requested action in the same manner as an OperationOutcome. In fact, both may be present - the OperationOutcome indicating that there was a warning or error associated with the request and a DetectedIssue providing the clinical details. (The OperationOutcome could point to the DetectedIssue via an extension.)
In those circumstances where requested operations are rejected as a result of a detected issue, the workflow may support allowing the operation to be re-tried, provided that the identified issue is included as part of the submission (possibly also including a mitigation). In doing so, the sender acknowledges the issue and takes responsibility for it, thus allowing the requested operation to proceed. See Linking to Detected Issues for guidance on how a DetectedIssue instance might be included as part of another operation.
Systems that require such workflows should document expected behavior as part of their CapabilityStatement declarations.
Structure
See the Extensions for this resource
UML Diagram (Legend)
XML Template
<DetectedIssue xmlns="http://hl7.org/fhir"><!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier Unique id for the detected issue --></identifier> <status value="[code]"/><!-- 1..1 preliminary | final | entered-in-error | mitigated --> <category><!-- 0..* CodeableConcept Type of detected issue, e.g. drug-drug, duplicate therapy, etc --></category> <code><!-- 0..1 CodeableConcept Specific type of detected issue, e.g. drug-drug, duplicate therapy, etc --></code> <severity value="[code]"/><!-- 0..1 high | moderate | low --> <subject><!-- 0..1 Reference(BiologicallyDerivedProduct|Device|Group|Location| Medication|NutritionProduct|Organization|Patient|Practitioner|Procedure| Substance) Associated subject --></subject> <encounter><!-- 0..1 Reference(Encounter) Encounter detected issue is part of --></encounter> <identified[x]><!-- 0..1 dateTime|Period When identified --></identified[x]> <author><!-- 0..1 Reference(Device|Patient|Practitioner|PractitionerRole| RelatedPerson) The provider or device that identified the issue --></author> <implicated><!-- 0..* Reference(Any) Problem resource --></implicated> <evidence> <!-- 0..* Supporting evidence --> <code><!-- 0..* CodeableConcept Manifestation --></code> <detail><!-- 0..* Reference(Any) Supporting information --></detail> </evidence> <detail value="[markdown]"/><!-- 0..1 Description and context --> <reference value="[uri]"/><!-- 0..1 Authority for issue --> <mitigation> <!-- 0..* Step taken to address --> <action><!-- 1..1 CodeableConcept What mitigation? --></action> <date value="[dateTime]"/><!-- 0..1 Date committed --> <author><!-- 0..1 Reference(Practitioner|PractitionerRole) Who is committing? --></author> <note><!-- 0..* Annotation Additional notes about the mitigation --></note> </mitigation> </DetectedIssue>
JSON Template
{
"resourceType" : "DetectedIssue",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Unique id for the detected issue
"status" : "<code>", // R! preliminary | final | entered-in-error | mitigated
"category" : [{ CodeableConcept }], // Type of detected issue, e.g. drug-drug, duplicate therapy, etc
"code" : { CodeableConcept }, // Specific type of detected issue, e.g. drug-drug, duplicate therapy, etc
"severity" : "<code>", // high | moderate | low
"subject" : { Reference(BiologicallyDerivedProduct|Device|Group|Location|
Medication|NutritionProduct|Organization|Patient|Practitioner|Procedure|
Substance) }, // Associated subject
"encounter" : { Reference(Encounter) }, // Encounter detected issue is part of
// identified[x]: When identified. One of these 2:
"identifiedDateTime" : "<dateTime>",
"identifiedPeriod" : { Period },
"author" : { Reference(Device|Patient|Practitioner|PractitionerRole|
RelatedPerson) }, // The provider or device that identified the issue
"implicated" : [{ Reference(Any) }], // Problem resource
"evidence" : [{ // Supporting evidence
"code" : [{ CodeableConcept }], // Manifestation
"detail" : [{ Reference(Any) }] // Supporting information
}],
"detail" : "<markdown>", // Description and context
"reference" : "<uri>", // Authority for issue
"mitigation" : [{ // Step taken to address
"action" : { CodeableConcept }, // R! What mitigation?
"date" : "<dateTime>", // Date committed
"author" : { Reference(Practitioner|PractitionerRole) }, // Who is committing?
"note" : [{ Annotation }] // Additional notes about the mitigation
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Changes from both R4 and R4B
| DetectedIssue | |
| DetectedIssue.status |
|
| DetectedIssue.category |
|
| DetectedIssue.subject |
|
| DetectedIssue.encounter |
|
| DetectedIssue.author |
|
| DetectedIssue.detail |
|
| DetectedIssue.mitigation.note |
|
| DetectedIssue.patient |
|
See the Full Difference for further information
This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.
See R4 <--> R5 Conversion Maps (status = See Conversions Summary.)
Structure
See the Extensions for this resource
XML Template
<DetectedIssue xmlns="http://hl7.org/fhir">
JSON Template
{
"resourceType" : "DetectedIssue",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Unique id for the detected issue
"status" : "<code>", // R! preliminary | final | entered-in-error | mitigated
"category" : [{ CodeableConcept }], // Type of detected issue, e.g. drug-drug, duplicate therapy, etc
"code" : { CodeableConcept }, // Specific type of detected issue, e.g. drug-drug, duplicate therapy, etc
"severity" : "<code>", // high | moderate | low
"subject" : { Reference(BiologicallyDerivedProduct|Device|Group|Location|
Medication|NutritionProduct|Organization|Patient|Practitioner|Procedure|
Substance) }, // Associated subject
"encounter" : { Reference(Encounter) }, // Encounter detected issue is part of
// identified[x]: When identified. One of these 2:
"identifiedDateTime" : "<dateTime>",
"identifiedPeriod" : { Period },
"author" : { Reference(Device|Patient|Practitioner|PractitionerRole|
RelatedPerson) }, // The provider or device that identified the issue
"implicated" : [{ Reference(Any) }], // Problem resource
"evidence" : [{ // Supporting evidence
"code" : [{ CodeableConcept }], // Manifestation
"detail" : [{ Reference(Any) }] // Supporting information
}],
"detail" : "<markdown>", // Description and context
"reference" : "<uri>", // Authority for issue
"mitigation" : [{ // Step taken to address
"action" : { CodeableConcept }, // R! What mitigation?
"date" : "<dateTime>", // Date committed
"author" : { Reference(Practitioner|PractitionerRole) }, // Who is committing?
"note" : [{ Annotation }] // Additional notes about the mitigation
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Changes from both R4 and R4B
| DetectedIssue | |
| DetectedIssue.status |
|
| DetectedIssue.category |
|
| DetectedIssue.subject |
|
| DetectedIssue.encounter |
|
| DetectedIssue.author |
|
| DetectedIssue.detail |
|
| DetectedIssue.mitigation.note |
|
| DetectedIssue.patient |
|
See the Full Difference for further information
This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.
See R4 <--> R5 Conversion Maps (status = See Conversions Summary.)
Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis
| Path | ValueSet | Type | Documentation |
|---|---|---|---|
| DetectedIssue.status | DetectedIssueStatus | Required | Indicates the status of a detected issue |
| DetectedIssue.category | DetectedIssueCategory | Preferred | Kinds of issues or contraindications, such as 'drug-drug interaction', 'duplicate therapy', etc. |
| DetectedIssue.code | DetectedIssueCategory | Preferred | Kinds of issues or contraindications, such as 'drug-drug interaction', 'duplicate therapy', etc. |
| DetectedIssue.severity | DetectedIssueSeverity | Required | Indicates the potential degree of impact of the identified issue on the patient. |
| DetectedIssue.evidence.code | ManifestationAndSymptomCodes | Example | Example value set for Manifestation and Symptom codes. |
| DetectedIssue.mitigation.action | DetectedIssueMitigationAction | Preferred | Kinds of mitigating actions and observations that can be associated with a detected issue or contraindication, such as 'added concurrent therapy', 'prior therapy documented', etc. |
DetectedIssue follows the pattern of linking from the resource created "second". As DetectedIssue originates in response to one or more other existing records, it points to those records rather than being pointed to from them.
In some cases, a detected issue might be associated with a single record. When this occurs, it may be stored as a contained resource within the implicated resource provided that there is no expected need to search for the detected issue directly. However, with detected issues that implicate multiple records, containment is more problematic. In some workflows, a detected issue might be deemed to be "owned" by the record whose creation triggers the contraindication being created - i.e. the "second" or "last" record. However, where multiple actions are proposed as part of a single submission, there can be no single owner and containment will not be feasible.
If there is a strong need to point from an implicated resource to DetectedIssue and containment is not appropriate, an extension can be used.
DetectedIssue is a resource that is frequently associated with workflow challenges where frequent alerts that are not clinically relevant result in clinicians tuning out (or turning off) the content and thus missing relevant alerts. Give consideration to this issue before making heavy use of this resource.
Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.
| Name | Type | Description | Expression | In Common |
| author | reference | The provider or device that identified the issue | DetectedIssue.author (Practitioner, Device, Patient, PractitionerRole, RelatedPerson) | |
| category | token | Issue Category, e.g. drug-drug, duplicate therapy, etc. | DetectedIssue.category | |
| code | token | Issue Type, e.g. drug-drug, duplicate therapy, etc. | DetectedIssue.code | 22 Resources |
| identified | date | When identified | DetectedIssue.identified.ofType(dateTime) | DetectedIssue.identified.ofType(Period) | |
| identifier | token | Unique id for the detected issue | DetectedIssue.identifier | 65 Resources |
| implicated | reference | Problem resource | DetectedIssue.implicated (Any) | |
| patient | reference | Associated patient | DetectedIssue.subject.where(resolve() is Patient) (Patient) | 66 Resources |
| status | token | The status of the issue | DetectedIssue.status | |
| subject | reference | Associated subject | DetectedIssue.subject (Practitioner, Group, Organization, BiologicallyDerivedProduct, NutritionProduct, Device, Medication, Patient, Procedure, Substance, Location) |
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot1 generated on Mon, Dec 18, 2023 15:17+1100.
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