Adverse Event

$10 / year

Adverse Event is an event resource from a Fast Healthcare Interoperability Resources (FHIR) workflow perspective and applies to events that occur during the course of medical care or medical research which may impact an individual as the recipient of care or the participant in a research study. Health care organizations monitor and report both adverse events as well as events that had the potential to cause patient harm. Data are often aggregated for reporting purposes.

Complexity

An event within a care setting, might or might not impact an individual but had the potential to cause an adverse event. An adverse event is the result of an intervention that caused unintentional harm to a specific subject or group of subjects. Examples of adverse events include the administration of an incorrect drug or an incorrect dose of a drug causing an adverse reaction, the use of an implanted device that causes an infection, or a biologic used during a research study that causes unanticipated renal failure. These events are characterized by the need to capture cause and effect (although they might not be known at the time of the event), severity, and outcome.

The context of an adverse event is also important. A subject may have conditions or current treatments (medications, diet, devices) that impact their response to a newly introduced medication, device or procedure. Knowledge of these variables is essential in establishing a cause and effect relationship for an adverse event.

A potential adverse event may also be called a near miss or an error. These are also events but because they were detected but did not cause harm to a subject. Examples of potential adverse events include a product problem such as a faulty pacemaker that is detected prior implantation, a doctor working simultaneously on two electronic health records realizing the order for a drug was entered on the incorrect patient and then canceling the order, or a patient with a peanut allergy notices that his hospital dinner tray includes peanuts, and he does not eat the peanuts.

The Adverse Event resource is designed to represent events that have a harmful impact on a subject or had the potential to cause harm to a subject but were avoided. In the course of medical care, there are many actions that may impact how a subject responds to a particular treatment impacting patient safety. Therefore, the Adverse Event resource may reference multiple other resources to represent the context or details of an adverse event including but not limited to Observation, Condition, Medication Adminsitration, Immunization, Procedure, or Research Study.

A Detected Issue reference is also related to the context of an Adverse Event to the extent that a known risk for a potential issue such as a drug-drug interaction is documented. If in the context of a known issue, and adverse event occurs, citing this relationship is important for preventing such an occurrence in the future.

The Adverse Event resource should not be used when a more specific resource exists. The Adverse Event resource is not intended to be used to capture potential subject risk in a prospective manner. A more appropriate resource for this purpose would be Risk Assessment which captures predicted outcomes for a patient or population on the basis of source information. Examples include a prognosis statement for a particular condition, risk of health outcome (heart attack, particular type of cancer) on the basis of lifestyle factors and/or family history or list of potential health risks based on a patient’s genetic analysis.

Fast Healthcare Interoperability Resources (FHIR) is a draft standard describing data formats and elements (known as “resources”) and an application programming interface (API) for exchanging electronic health records. The standard was created by the Health Level Seven International (HL7) health-care standards organization.

Its goal is to facilitate interoperation between legacy healthcare systems, to make it easy to provide healthcare information to healthcare providers and individuals on a wide variety of devices from computers to tablets to cell phones, and to allow third-party application developers to provide medical applications which can be easily integrated into existing systems.

FHIR provides an alternative to document-centric approaches by directly exposing discrete data elements as services. For example, basic elements of healthcare like patients, admissions, diagnostic reports and medications can each be retrieved and manipulated via their own resource URLs (Uniform Resource Locators). FHIR was supported at an American Medical Informatics Association meeting by many EHR (Electronic Health Record) vendors which value its open and extensible nature.

Date Created

2018-09-20

Last Modified

2019-11-01

Version

4.0.1

Update Frequency

Annual

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs; Health Level Seven International;

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

FHIR, HL7, Medical Terminology, Processes Data, Processes Information, Processes Documentation, Health Information Exchange, Electronic Health Records, FHIR Smart, Smart on FHIR

Other Titles

FHIR Adverse Event Resource, Electronic Health Records Exchange Through FHIR

NameDescriptionTypeConstraints
Concept_NameName of the concept in the FHIR structurestringrequired : 1
Computer_Ready_NameA Computer-ready name (e.g. a token) that identifies the structure - suitable for code generation. Note that this name (and other names relevant for code generation, including element & slice names, codes etc) may collide with reserved words in the relevant target language, and code generators will need to handle this.string-
TypeThe type the structure describes.string-
Dollar_RefThe Dollar_Ref ($ref) string value contains a Uniform Resource Identifier (URI) which identifies the location of the JSON (JavaScript Object Notation) value being referenced.string-
DescriptionA free text natural language description of the structure and its usestring-
ItemsThe value of the keyword should be an object or an array of objects. If the keyword value is an object, then for the data array to be valid each item of the array should be valid according to the schema in this value.string-
EnumThe enum is used to restrict a value to a fixed set of values. It must be an array with at least one element, where each element is unique.string-
RequiredThe value of the keyword should be an array of unique strings. The data object to be valid should contain all properties with names equal to the elements in the keyword value.string-
ConstThe value of this keyword can be anything. The data is valid if it is deeply equal to the value of the keyword.string-
Concept NameComputer Ready NameTypeDollar RefDescriptionItemsEnumRequiredConst
AdverseEventresourceTypeThis is a AdverseEvent resourceAdverseEvent
AdverseEventid#/definitions/idThe logical id of the resource as used in the URL for the resource. Once assigned this value never changes.
AdverseEventmeta#/definitions/MetaThe metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
AdverseEventimplicitRules#/definitions/uriA reference to a set of rules that were followed when the resource was constructed and which must be understood when processing the content. Often this is a reference to an implementation guide that defines the special rules along with other profiles etc.
AdverseEvent_implicitRules#/definitions/ElementExtensions for implicitRules
AdverseEventlanguage#/definitions/codeThe base language in which the resource is written.
AdverseEvent_language#/definitions/ElementExtensions for language
AdverseEventtext#/definitions/NarrativeA human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
AdverseEventcontainedarrayThese resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently and nor can they have their own independent transaction scope.{'$ref': '#/definitions/ResourceList'}
AdverseEventextensionarrayMay be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension there is a set of requirements that SHALL be met as part of the definition of the extension.{'$ref': '#/definitions/Extension'}
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