Standard Health Record

Primary profiles defined as part of this Implementation Guide

Name Based On Definition
AdverseEventPresenceStatement AdverseEvent

The topic (independent of context) for any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. EXAMPLE(S): back pain, headache, pulmonary embolism, death. An AdverseEvent may also document a causal relationship to an intervention is at least a reasonable possibility i.e., the relationship cannot be ruled out.

AdverseSensitivityToSubstance AllergyIntolerance

A finding related to the presence or absence of an individual’s risk or sensitivity to a substance or class of substances. A finding can be taken as tantamount to a representation of an allergic condition, allowing it to be tracked over time.

BodyStructureAbsenceStatement Basic

Presence of a distinct anatomical or pathological morphological feature or organizational pattern, acquired or innate. Examples include tissue types, tumors, and wounds. Body structures are continuants that allow observations of the same body structure to be related to be tracked over time.

BodyStructurePresenceStatement Condition

Presence of a distinct anatomical or pathological morphological feature or organizational pattern, acquired or innate. Examples include tissue types, tumors, and wounds. Body structures are continuants that allow observations of the same body structure to be related to be tracked over time.

BreastCancerHistologicGrade Observation

The Elston Grade/Nottingham Score, representative of the aggressive potential of the tumor. Well differentiated cells (Grade 1) look similar to normal cells and are usually slow growing, while poorly differentiated cells (Grade 3) look very different than normal and are fast-growing.

BreastCancerPresenceStatement Condition

Diagnosis of cancer originating in the tissues of the breast, and potentially spread to other organs of the body.

The BreastCancerPresenceStatement is a subclass of ConditionPresenceStatement, which is a departure from CIMI. In CIMI, this would be a archetype of ClinicalStatement combining a BreastCancerConditionTopic with the ConditionPresenceContext. This would require definition of BreastCancerConditionTopic in the reference model, follwed by introduction of constraints on Value, Category, Stage, and MorphologyBehavior in the corresponding archetype.

BreastCancerStage Observation

The stage of a breast cancer. Different staging systems use different staging groups, so there are currently no terminology bindings associated with this class.

BreastSite BodySite

A body site specific to the breast structure.

BreastSpecimen Specimen

Specimen resulting from biopsy or excision of breast and surrounding tissue.

ClinicalNote Basic

An entry concerning a patient where the result is a narrative text. Can be related to a specific Focus, such as a condition; and evidence and interpretation from FindingTopic.

ConditionAbsenceStatement Basic

A finding that a condition is or was not present in the subject at a certain time, not necessarily the time the information is gathered.

ConditionPresenceStatement Condition

A condition that is or may be present in a subject. ‘Condition’ is interpreted broadly and could be a disorder, abnormality, problem, injury, complaint, functionality, illness, disease, ailment, sickness, affliction, upset, difficulty, disorder, symptom, worry, or trouble.

In CIMI terms, it is an archetype of ClinicalStatement that combines a ConditionTopic with the ConditionPresenceContext context. The core attributes of ClinicalStatement are not included here because of mapping difficulties to FHIR DomainResource.

Coverage Coverage

Health insurance coverage available (even if not used for payment for a given encounter).

DCISNuclearGrade Observation

An evaluation of the size and shape of the nucleus in tumor cells and the percentage of tumor cells that are in the process of dividing or growing. Cancers with low nuclear grade grow and spread less quickly than cancers with high nuclear grade.

DiseaseProgression Observation

A finding related to the current trend of a particular existing disease. This concept is most often used for chronic and incurable diseases where the status and trendline of the disease is an important determinant of therapy and prognosis. The specific disorder being evaluated must be cited in the Focus_Reference or Focus_CodeableConcept as a reference to a Condition.

EstrogenReceptorStatus Observation

Estrogen receptor alpha is the predominant estrogen receptor expressed in breast tissue and is overexpressed in around 50% of breast carcinomas. ER status (positive=present or overexpressed; negative=absent) is a factor in determining prognosis and treatment options.

We are seeking feedback if it is better to put the positive/negative status in Value or Interpretation. The current approach is that positive/negative designation is a value, even though that value is (in fact) an interpretation of evidence (NuclearPositivity and AverageStainingIntensity).

Facility Location

Services and space and equipment provided for a particular purpose; a building or place that provides a particular service or is used for a particular industry. Could be a clinical site, community site, or a mobile facility.

Group Group

A set of entities (personnel, material, or places) to be considered together. May be a pool of like-type resources, a team, or combination of personnel, material and places.

HER2ReceptorStatus Observation

HER2 receptor status. HER2 is a member of the human epidermal growth factor receptor family of proteins and is encoded by the ERBB2 oncogene. HER2 is overexpressed in 20-30% of breast tumors, and is associated with an aggressive clinical course and poor prognosis. HER2 status (positive=present or overexpressed; negative=absent) is a factor in determining prognosis and treatment options.

We are seeking feedback if it is better to put the positive/negative status in Value or Interpretation. The current approach is that positive/negative designation is a value, even though that value is (in fact) an interpretation of evidence from HER2 by IHC and/or HER2 by ISH tests, not a direct observation.

HER2byIHC Observation

HER2 receptor status as determined by Immunohistochemistry (IHC).

HER2byISH Observation

HER2 receptor status as determined by In Situ Hybridization (ISH).

ImagingProcedurePerformedStatement Procedure

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ImagingProcedureRequestedStatement ProcedureRequest

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LaboratoryProcedurePerformedStatement Procedure

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LaboratoryProcedureRequestedStatement ProcedureRequest

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MammaprintRecurrenceScore Observation

Breast cancer genomic signature assay for 10-year risk of distant recurrence score calculated by Mammaprint.

In the United States, MammaPrint can only be used on cancers that are stage I or stage II, invasive, smaller than 5 centimeters, and estrogen-receptor-positive or -negative. Scores range from -1.0 to +1.0, with scores less than 0 indicating high risk, and scores greater than 0 indicating low risk.

The is currently no LOINC code for Mammaprint test.

MedicationAdherenceStatement Observation

The degree (frequency) that the stated treatment plan, prescription, or protocol was followed. A statement of the ability and cooperation of the patient in taking medicine or supplement as recommended or prescribed. This includes correct timing, dosage, and frequency.

MedicationChangeStatement Basic

Description of a modification or change of a medication or dosage.

MedicationDispenseRequestedStatement MedicationRequest

An order for a medication to be dispensed and instructions for use.

MedicationDispenseTopic Basic

The action of ordering and deliving a medication to the party responsible for administering the medication.

MedicationNotPrescribedStatement Basic

A record of a medication NOT being prescribed. Recorded only when deviating from the normal expectation, care plan, or standard of care.

MedicationNotUsedStatement MedicationStatement

A record of a medication NOT used. Although usually not required, a medication not used is sometimes reported when deviating from normal expectation or care plan.

Medication Medication

A type of prescription drug or over-the-counter drug that is used to prevent, treat, or relieve symptoms of a disease or abnormal condition, but excluding vaccines.

MedicationUsedStatement MedicationStatement

A record of the use of a medication.

MilitaryServiceHistory Observation

History of service in the US military.

NoAdverseEventStatement Basic

Documentation of a situation where no adverse event has been detected or is known.

NoAdverseSensitivityToSubstance AllergyIntolerance

Used to record that a particular substance or class of substances does not pose a known elevated risk to the subject.

NoKnownAllergy AllergyIntolerance

Express no known allergies or hypersensitivity to any food, drug, biologic, or environmental substance.

NoKnownDrugAllergy AllergyIntolerance

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NoKnownFoodAllergy AllergyIntolerance

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OccupationalDataSummaryPanel Observation

Current and past activities for profit, wages, salary, or as a service to others.

OncotypeDxDCISRecurrenceScore Observation

The Oncotype DX test for DCIS (Ductal Carcinoma in Situ) breast cancer. Risk scores range from 0 to 100 with the following interpretations: 0-38: Low-Risk, 39-54: Intermediate-Risk, 55+: High-Risk.

No LOINC code currently exists for this test. We are seeking feedback on the value of separating OncotypeDx scores for DCIS and invasive breast carcinomas. Does it make more sense to report the OncotypeDx as a single score, regardless of the type of cancer?

OncotypeDxInvasiveRecurrenceScore Observation

The Oncotype DX test for invasive breast cancer examines the activity of 21 genes in a patient’s breast tumor tissue to provide personalized information for tailoring treatment based on the biology of their individual disease. The value from 0 to 100 indicates the estimated risk of recurrence, with the highest risk indicated by a score greater than 31.

No LOINC code currently exists for this test. We are seeking feedback on the value of separating OncotypeDx scores for DCIS and invasive breast carcinomas. Does it make more sense to report the OncotypeDx as a single score, regardless of the type of cancer?

Organization Organization

A social or legal structure formed by human beings.

PastOrPresentJob Observation

A single job, past or present. The relevant time is the period the job was held.

Patient Patient

A person in the role of a patient, including extended demographic information about the subject of this health record.

Person Basic

A person relevant to the health or social situation of the subject (including the person of record him or herself).

Practitioner Practitioner

A person who practices a healing art.

ProcedureNotPerformedStatement Procedure

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ProcedurePerformedStatement Procedure

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ProcedureRequestedAgainstStatement ProcedureRequest

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ProcedureRequestedStatement ProcedureRequest

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ProgesteroneReceptorStatus Observation

Progesterone receptor status is a factor in determining prognosis and treatment options. The value is the percentage of cells that test (stain) positive for the presence of a receptor. The interpretation of positive or negative (found in the interpretation property) is based on the staining percentage, and may take into account the staining intensity.

Based on discussion with Cancer Interoperability Group subject matter experts, there was insufficient rationale to include the following components in the data model: StainingControl, PrimaryAntibody, Allred Score (both total and component scores). We are seeking feedback on whether or not those components should be included in this model.

We are seeking feedback if it is better to put the positive/negative status in Value or Interpretation. The current approach is that positive/negative designation is a value, even though that value is (in fact) an interpretation of evidence (NuclearPositivity and AverageStainingIntensity).

ProsignaRecurrenceScore Observation

Breast cancer genomic signature assay for 10-year risk of distant recurrence score calculated by Prosigna.

The Prosigna Score is reported on a 0 -100 scale (referred to as ROR Score or Risk of Recurrence Score in the literature), which is correlated with the probability of distant recurrence at ten years for post-menopausal women with hormone receptor positive, early stage breast cancer.

RelatedPerson RelatedPerson

A person in a role defined in relationship to a patient

RelationshipType Basic

The relationship of the subject to another person in the same extended family or extended family. May or may not be a blood relative.

ResearchSubject ResearchSubject

Record of a subject’s enrollment and participation in a research study.

SpecimenCollectionPerformedStatement Procedure

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SpecimenCollectionRequestedStatement ProcedureRequest

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SpecimenContainer Basic

Direct container of specimen (tube/slide, etc.)

SpecimenTreatment Basic

Treatment performed on the specimen.

Study ResearchStudy

A clinical trial or similar research study. Reference: list of FDA data elements describing a research study: prsinfo.clinicaltrials.gov/definitions.html

Substance Substance

Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.

SurgicalProcedureNotPerformedStatement Procedure

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SurgicalProcedurePerformedStatement Procedure

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SurgicalProcedureRequestedAgainstStatement ProcedureRequest

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SurgicalProcedureRequestedStatement ProcedureRequest

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ToxicReaction AdverseEvent

A grade 3 or 4 adverse reaction to medication, radiation treatment, or other therapy.

UsualOccupation Observation

The type of work a person has held for the longest amount of time during his or her life, regardless of the occupation currently held and regardless of whether or not it has been held for a continuous time.

Supporting profiles defined as part of this Implementation Guide

Name Based On Definition
AccessionIdentifier Identifier

Identifier assigned by the lab

ActionTopic Basic

An entry related to an action or intervention, whether potential or actual, past or future. An intervention is an action addressing a undesired health state, behavior, risk, or goal.

Address Address

An address expressed using postal conventions (as opposed to GPS or other location definition formats). This data type may be used to convey addresses for use in delivering mail as well as for visiting locations and which might not be valid for mail delivery. There are a variety of postal address formats defined around the world. (Source: HL7 FHIR).

Age Age

How long something has existed in time.

AnatomicalLocation BodySite

A location or structure in the body, including tissues, regions, cavities, and spaces; for example, right elbow, or left ventricle of the heart.

Annotation Annotation

An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.

ClinicalStatement Basic

A special type of information entry consisting of a topic and a context. The ClinicalStatement class provides the core pattern for more specific clinical statement classes, such as a statement that a finding has been found in a patient or that a procedure has been proposed by a clinical decision support system. The ClinicalStatement pattern defines the core attributes common to most clinical statements and specifies a composition pattern that encourage model component reuse and better alignment with the SNOMED CT Concept Model. A clinical statement is composed of the StatementTopic class (grouping of attributes for capturing information about a procedure or a clinical finding) and the StatementContext class (grouping of attributes providing the context for the statement topic such as whether a procedure was performed, requested, not performed or whether a finding is suspected present or absent in the patient). At the archetype level, the topic and context components are coordinated to form the clinical statement. For instance, the composition of the ProcedureTopic with the NotPerformed context indicates that the given procedure was not performed.

CodeableConcept CodeableConcept

A set of codes drawn from different coding systems, representing the same concept.

CodedEvaluationResultRecorded Observation

Represents the result of evaluations (measurements, tests, or questions) that have been performed whose answer is expressed as a code.

Coding Coding

Coding of a concept, drawn from a controlled vocabulary. Includes the vocabulary and version, if applicable. May include a display text, and a descriptor expressing the intended interpretation of the code.

ContactDetail ContactDetail

Describes an individual and how to reach them.

ContactPoint ContactPoint

An electronic means of contacting an organization or individual.

Content Basic

Abstract ancestor of all concrete content types. A unit of content that makes up a composition - e.g., a clinical statement in a patient record, a simple or composite action is a knowledge document, a catalog entry in a catalog.

DetailedEncounter Encounter

A detailed description of an interaction between a patient and healthcare provider(s) for the purpose of providing healthcare service(s) or assessing the health status of a patient.

Device Device

A specific durable physical device used in diagnosis or treatment. The value is the coding for a type of device, for example, a CPAP machine. The same device might be used on multiple patients.

Distance Distance

The measure of space separating two objects or points.

Dosage Dosage

The dosage of the medication, prescribed or taken.

Duration Duration

The length of time that something continues.

Encounter Encounter

A description of an interaction between a patient and healthcare provider(s) for the purpose of providing healthcare service(s) or assessing the health status of a patient.

Entity Basic

Root class for entities such as people, organizations, and devices that have a separately identifiable existence.

Entry DomainResource

Metadata attributes that apply to any item represented in the standard health record. An Entry may not belong exclusively to a single person’s health record, but could represent an entity that surfaces in multiple records, such as organizations or practitioners. If the entry belongs to a single person’s record, then the identity of the person of record must be recorded.

EvaluationResultRecorded Observation

Represents the result of evaluations (measurements, tests, or questions) that have been performed. EvaluationResultRecorded has a value representing the result (answer), or an ExceptionValue indicating why the value is not present. The subject of a finding can be the entire patient, or an entity such as a location body structure, intervention, or condition. Things observed about the subject can include social and behavioral factors, subjective and objective observations, and assessments.

Frequency Ratio

How many occurrences of an event per unit of time.

Geoposition Location

The location on the surface of the Earth, described by a latitude and longitude (and optional altitude).

GestationalAge Age

The age of the embryo or fetus. This may be assessed by medical history, physical examination, early immunologic pregnancy tests, radiography, ultrasonography, and amniotic fluid analysis.

HumanName HumanName

The CIMI person name, constrained to map correctly to FHIR.

Identifier Identifier

A unique string that identifies a specific person or thing.

Independent Basic

Base class for classes in CIMI that include enough context to stand alone. Analogous to FHIR’s DomainResource.

InformationEntry Basic

An entry in a patient record or in a report, generally used for the documentation of clinical information about a subject of information such as a patient or a relative of the patient, asserted by a particular source, recorded, and potentially verified.

IntegerQuantity Count

A Quantity that is an integer.

LaboratoryTestResultRecorded Observation

Measurement resulting from a laboratory analysis. The category is fixed to ‘laboratory’ to align with US-Core.

Locatable Basic

Abstract top level class in the CIMI hierarchy. The Locatable class reflects CIMI’s implementation using Archetype Description Language (ADL). Its attributes (archetype_node_id, name, and archetype_details) are necessary to serialize CIMI definitions in ADL, but have no clinical relevance. To avoid complicating the profiles with irrelevant extensions, the attributes of Locatable have been omitted.

MedicationTopic Basic

Base class for actions involving medications, independent of context.

Money Money

Representation of an amount of currency or monetary value.

NationalProviderIdentifier Identifier

A unique 10 digit number to allow US healthcare providers to identify themselves in a standard way throughout the healthcare industry.

NonLabCodedEvaluationResultRecorded Observation

A coded finding not based on a sample or measurement device.

NonLabPanelRecorded Observation

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OrganizationIdentifier Identifier

An identifier of the organization. An NPI preferred, tax id is allowed, and a local id is allowed in addition to ‘authoritative’ identifier

PanelRecorded Observation

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Percentage Quantity

A percentage value where 100.0 represents 100%.

PercentageRange Range

A range of percentage values.

Quantity Quantity

A quantity with units, whose value may be bounded from above or below, as defined in FHIR

Range Range

An interval defined by a quantitative upper and/or lower bound. One of the two bounds must be specified, and the lower bound must be less than the upper bound. When Quantities are specified, the units of measure must be the same.

Ratio Ratio

A unit of measurement for the quotient of the amount of one entity to another.

SampledData SampledData

Data that comes from a series of measurements taken by a device, which may have upper and lower limits. The data type also supports more than one dimension in the data.

Signature Signature

A digital Signature - XML DigSig, JWT, Graphical image of signature, etc.

SimpleQuantity Quantity

A quantity where the comparator is not used, as defined in FHIR

SimplifiedLaboratoryTestResultRecorded Observation

The usual case for a test result from a pathology lab, based on a specimen taken from a patient. Note that the body site is not explicit here; it is part of the specimen resource associated with the lab result.

Specimen Specimen

A specimen is a substance, physical object, or collection of objects, that the laboratory considers a single discrete, uniquely identified unit that is the subject of one or more steps in the laboratory workflow. A specimen may include multiple physical pieces as long as they are considered a single unit within the laboratory workflow. A specimen results from one to many specimen collection procedures, and may be contained in multiple specimen containers. Specimen may have one or more processing activities.

Statistic Quantity

A quantity that represents a statistic, e.g. maximum, minimum, mean, median, etc.

Timing Timing

A timing schedule that specifies an event that may occur multiple times. Timing offers a choice of multiple OccurrenceTime (used is used to specify specific times), or recurrence patterns.

UnitedStatesAddress Address

An address for a place in the USA, conforming to US mail postal conventions. (Source: HL7 FHIR).