SHR Reference Model

Standard Health Record (SHR) Reference Model Specification

Welcome to the SHR Reference Model Documentation
Element Description

The end, remission or resolution.


Indicates the finding in question is either known absent (ruled out), not suspected, or unknown.


The route used to access the site of a procedure. It is used to distinguish open, closed, and percutaneous procedures.


Identifier assigned by the lab


Point in time when data was accessed.


The ontological status of the intervention, e.g., performed/not performed, requested/not requested.


Abstract class representing non-performance of any type of action.


Abstract class representing performance of any type of action.


Abstract class representing a request to not perform any type of action.


Abstract class representing a request for any type of action.


The action taken as a result of the adverse reaction. May include changing or discontinuing medication, reducing dose, etc.


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.


If the ActiveFlag is false, it indicates the record or item is no longer to be used and should generally be hidden for the user in the UI.


If the ActiveFlag is false, it indicates the record or item is no longer to be used and should generally be hidden for the user in the UI.


True if the group is an actual group (as opposed to definitional).


Supplemental instructions - e.g. 'with meals'.


Additive associated with container.


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).


Part of an address that contains the house number, apartment number, street name, street direction, P.O. Box number, delivery hints, and similar address information. (Source: HL7 FHIR).


The anatomic site at which medical intervention is applied.


Technique for administering medication.


A gender classification used for administrative purposes. Administrative gender is not necessarily the same as a biological description or a gender identity. This attribute does not include terms related to clinical gender.


A possible cause of an observed adverse event, known or theorized. There can be more than one possible cause.


A coded value specifying the level of injury suffered by the subject for whom the event is reported, using the CTCAE coding system.


The context for an adverse event that is known, suspected, or possibly occurred.


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.


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.


An instance of a negative response to the allergy or intolerance.


Context for adverse sensitivities that are known or suspected to exist.


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.


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.


Membership, association, or connection to an organization.


How long something has existed in time.


The age, age range, or age group when the cessation of life happens.


Subgroups of populations based on age.


A quantitative range of ages. One of the two ages must be specified.


A substance that causes an allergic reaction or irritation.


Height above sea level or above the earth's surface. Measured with with WGS84 datum.


The quantity of specimen collected


Anatomical location or specimen further detailing directionality.


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


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


Flag indicating if personally identifiable information has been withheld or disguised.


The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.


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.


The extent of a 2-dimensional surface enclosed within a boundary.


Indicates the pre-condition under which the drug or intervention should be used.


The parent class of contexts that can associate with AssertionTopic and its subclasses.


The base topic for conditions, allergies, adverse events, etc. These are things that are asserted to exist or not. The Value is interpreted in the context of the class; for an AdverseSensitivityToSubstance, the value is the substance, for a Condition, the Value represents the type of condition found.


The related clinical trial or other formal study.


At risk indicates the finding should be interpreted as a future possibility or expectation.


A file that contains audio, video, image, or similar content.


Information ascribing the record to a particular contributor or responsible person.


The person or organization who created the entry and is responsible for (and may certify) the content.


Average number CEP17 signals per cell (dual probe only)


Average number of HER2 signals per cell


The degree or magnitude of staining (nuclear positivity) across cells in the specimen.


The data itself.


Administrative sex assigned at birth and recorded on birth certificate.


The position or physical attitude of the body.


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.


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.


Presence (or absence) of a distinct anatomical or pathological morphological feature or organizational pattern, acquired or innate. Examples include tissue types, tumors, and wounds.


If the product is branded, and if so, the brand name of a product.


The marketing name for a brand name product


The presence of distant metastases, based on criteria defined by the staging system being used.


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.


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.


The size and extent of the primary tumor, based on criteria defined by the staging system being used.


The presence of metastases in regional lymph nodes, based on criteria defined by the staging system being used.


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


A body site specific to the breast structure.


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


Container volume or size.


A class or division of people or things having particular shared characteristics


Whether the adverse event is attributed to a treatment, course of the disease, unrelated to either, or unknown.


The degree of confidence in a conclusion or assertion.


The length of such a boundary line of a figure, area, or object.


The name of a municipality, city, town, village or other community or delivery center. (Source: HL7 FHIR).


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.


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.


A flag indicating whether the condition is active or inactive, recurring, in remission, or resolved (as of the last update of the Condition).


A direction indicated by an angle relative to 12 o'clock.


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


An evaluation component whose value is a code (concept).


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


A formal terminology system.


The version of the vocabulary being used, if applicable.


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.


The time period between the chilling of a tissue or tissue sample and the time it is warmed.

CIMI Alignment: In CIMI Version 0.0.4, specimen processing is represented as a 'SpecimenProcessingPerformed' clinical statement, mapped to FHIR Procedure. However, specimen processing should actually map to Specimen.processing, part of the Specimen resource. It would be a difficult mapping exercise (beyond the scope of this IG) to express the mapping rule that any CIMI SpecimenProcessingPerformed clinical statement needs to mapped to FHIR by (1) finding the corresponding Specimen entity, and (2) mapping the content of (possibly multiple) SpecimenProcessingPerformed into the FHIR Specimen resource. To avoid this complexity, the breast cancer model expresses the cold ischemia time as an attribute of the BreastSpecimen rather than a separate procedure.


How the specimen was obtained.


The body site where specimen was collected


When the sample was obtained, as a specific time or time period.


A time period of combat zone duty. The time period does not necessarily correspond to the time period of a job; for example, a soldier may be deployed into a combat zone for 1 year out of 4 years of service.


This is the method the provider used to communicate. Examples include: Written, Telephoned, Verbal, Electronically Entered, Policy, Service Correction, Duplicate, etc. 'Code indicating the origin of the prescription.' - NCPDP Telecommunication (Field 419-DJ, Data Dictionary 201104). Possible values include: Written; Telephone; Electronic; Facsimile; Pharmacy; Not Known.


Percentage of cells with uniform intense complete membrane staining.


The actual value of the component finding.


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.


The context for a condition that is known, suspected, or possibly present.


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.


A condition, independent of context. 'Condition' is interpreted broadly to include disorder, abnormality, problem, injury, complaint, functionality, concern, illness, disease, ailment, sickness, affliction, upset, difficulty, disorder, symptom, worry, or trouble, independent of context. CIMI deviation: AnatomicalLocation is included here, rather than being a property of FindingSiteAssertionTopic, since it is a common property of conditions. Severity, diseasePhase, periodicity, and other properites of an actual observed condition belong in ConditionPresenceContext.


Describes an individual and how to reach them.


An electronic means of contacting an organization or individual.


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.


Mime type of the content, with charset etc.


A code representing the ontological status of the statement, e.g., whether it exists, does not exist, is planned, etc. Attribute aligns with the SNOMED CT Situation with Explicit Context (SWEC) Concept Model context attributes: 'Finding context (attribute)' (SCTID: 408729009) and 'Procedure context (attribute)' (SCTID: 408730004). The range allowed for this attribute shall be consistent with the SNOMED CT concept model specification for SWEC.


A correction factor that is applied to the sampled data points before they are added to the origin.


Provenance information specific to the cosigning of the clinical statement.


The number of items (0 or more), as an integer.


How many times the event should take place during one recurrence interval, for example, to specify 3-4 times per day, the CountPerInterval should be 3 to 4.


Country - a nation as commonly understood or generally accepted, expressed in ISO 3166 Alpha-2 (2-letter) codes.


A country acting as an assuing authority for a document.


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


The point in time when the information was recorded in the system of record.


The potential clinical harm associated with a condition. When the worst case result is assessed to have a life-threatening or organ system threatening potential, it is considered to be of high criticality.


A person’s current economic relationship to a job, for example, employed (currently working for compensation), unemployed (i.e., searching for work for compensation), or not in the labor force (e.g., student, homemaker, not seeking work). Employment status is not the same as classification of work. The relevant time is when the status was effective (not when the information was gathered). For example, if the status is 'retired' then the relevant time is the retirement date.


A quotidian landmark, such as rising, mealtime, or bedtime, when an event should take place.


Serves as a common ancestor of all CIMI types which represent the core granularity of the model.


A date of birth or approximate year or period (year or date range), if estimated.


The calendar date of subject's death.


A day of the week that the pattern should take place.


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.


An indication that the person is no longer living, given by a date, time of death, or a boolean value which, when true, indicates the person is deceased.


Indicator of significant change (delta) from the last or previous measurement.


The divisor of a fraction.


The extent downward or inward; the perpendicular measurement from the surface downward to determine deepness.


Indicates the source of information in the case the Entry has been created by logical extension or modification of one or more source entries.


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.


An text note containing additional details, explanation, description, comment, or summarization. Details can discuss, support, explain changes to, or dispute information.


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.


Unique Device Identifier (UDI) Barcode string number for a device, assigned by the organization using the device.


A diagnosis, which is a disease or injury determined to be present through evaluation of patient history, examination, and/or review of laboratory data.


A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.


The number of sample points at each time point. If this value is greater than one, then the dimensions will be interlaced - all the sample points for a point in time will be recorded at once.


The site where the procedure is performed.


The site where the procedure is performed.


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 FocusReference or FocusCodeableConcept as a reference to a Condition.


A string meant for reading by a person, for example, accompanying a code.


The measure of space separating two objects or points.


Distance between the feature of interest (e.g., the tumor) and the nipple.


The name of the administrative area at a level below that of a state but above that of a city or town. In the US, a county. Outside the US, a district or the equivalent. (Source: HL7 FHIR).


The dosage of the medication, prescribed or taken.


The amount of medication taken per dose, as a quantity or range.


The form in which active and/or inert ingredient(s) are physically presented.


The directions (signetur) on the drug prescription or dispensing record.


Identifying information from a drivers license.


The length of time that something continues.


A range of durations.


The date when something is to take effect.


The date and time span for which something is active, valid, or in force.


Abstract class defining the common metadata of all types of encapsulated data, such as images.


A person or organization that hires the services of another.


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.


Concepts representing classification of patient encounter such as ambulatory (outpatient), inpatient, emergency, home health or others due to local variations.


Specific type of encounter (e.g. e-mail consultation, surgical day-care, skilled nursing, rehabilitation).


Description of the group or groups enrolled or qualified to be enrolled in the study.


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


Parent class entity and role.


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.


A persistent, permanent identifier for an entry in a health record, unique within the scope of the health record.


SHR data element identifier, as a URI.


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).


Indicator of Hispanic or Latino origin.


Additional description of ethnicity.


A simplified, non-separable evaluation consisting of a finding code (represented by the Concept), value (or exception value), reference range, and interpretation. The subject of the evaluation component is the same as in the parent evaluation.


The technique used to create the finding, for example, the specific imaging technical, lab test code, or assessment vehicle.


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.


Context for recording an evaluation result, used to indicate an evaluation has been made.


The base class, independent of context for evaluations (measurements, tests, or questions). 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.


The length of the recurring event.


Reason that a value associated with a test or other finding is missing.


If true, exclude the subjects that match the criterion.


A context indicating the finding is an expectation, prognosis, or likely outcome.


The method that should be used to carry out the action.


When an action should be done. If the action is a series or recurs (e.g. daily blood sugar testing in the morning) then a Timing can be used to describe the periodicity.


Who should carry out the tests. For example, the patient or caregiver.


What type of party should carry out the testing.


When the item (medication, device, etc.) will expire.


A health record other than the current health record; may have been used to help populate the current record.


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.


The DBA (doing business as) or most commonly-used name for a facility.


The portion of a person's name that reflects the genealogy of the person. In western cultures, this is the 'last' name. In eastern cultures, the family name appears before the person's given name(s). In some cultures (e.g. Eritrea) the family name of a son is the first name of his father. (Source: HL7 V3).


The name of the father as it was or likely to have been recorded on the birth certificate of the subject; most likely the name of the father at the time of birth of the subject.


Constraints participants to classes that are accepted by FHIR as actors in procedures.


Flag indicating if this record represents a fictional (synthetic, not real) person.


The base class for representing the ontological status of a finding, e.g., present, absent, goal, risk, expectation, etc. This class aligns with the SNOMED Situation with Explicit Context.


The technique used to create the finding; for example, the specific imaging technique, lab test code, or assessment vehicle.

CIMI Alignment: In CIMI V0.0.4, this attribute was called 'method'. The value set binding reflects CIMI's preference for LOINC codes.


Any clinical statement representing a finding.


Indicates whether the finding is preliminary, amended, final, etc.


Base class - independent of context - for all kinds of determinations: questions/answers, conditions, observations, allergies, and other findings.

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.

CIMI Alignment: In CIMI V0.0.4, FindingTopic has four attributes: result, description, multimedia, and intepretation. The model assumes the result of the finding, and interpretationof that result, are not part of the topic (the question), but part of the result (the answer), and therefore appears in the context (RecordedContext and PresenceContext).


The aspect or attribute of the subject of information that the finding relates to, other than an anatomical location. For example, the finding could deal with a condition, a behavior, a wound, or tumor. These are entities that are implied by clinical statements (see cimi.entity.MaterializedAssertion)


The system of formal syntax or interpretation associated with parsable content.


How many occurrences of an event per unit of time.


The countries of the world and major geopolitical subregions, such as US states.


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


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.


A named gestational time period, or a gestational age.


A time relative to a pregnancy or childbirth event.


The person's given name - e.g., John


A hypothetical or future finding that represents an objective or goal.


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.


An inclusion or exclusion criterion as part of defining a cohort. If the criterion is an unary, then TopicCode must be SCT#385432009 (not applicable)


A code describing the characteristic present, absent, or having a value in this group.


Cautions on the handling of this specimen.


A hash code of the data (sha-1, base64ed)


A photograph showing a person's face.


HER2 receptor status as determined by Immunohistochemistry (IHC).


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


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.


HER2 to CEP17 Ratio (dual probe only)


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


A unique string that identifies a specific person or thing.


Experimental class for an imaging procedure. This class is still incomplete at this time.


Substance used for this imaging procedure such as a contrast agent.


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


Conditions or situations where the procedure is recommended. In the Performed context, the actual indication should be reported.


An indirect device used for this procedure.


An indirect device used for this procedure.


The indirect site for this procedure.


The indirect site for this procedure.


A particular form or branch of economic or commercial activity.


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.


Specifies an material component in a non-medication substance.


The amount of an ingredient in a mixture, as a ratio. For example, 250 mg per tablet is expressed as a ratio where the numerator is 250mg and the denominator is 1 tablet.


Patient findings expected for the performance of the specified procedure. For instance, an x-ray of a fracture prior to a surgical procedure for a bone fracture.


Patient identifier at a healthcare provider, insurer, or other related organization.


A Quantity that is an integer.


A clinical interpretation of a finding.


True if the ingredient is an active ingredient in the medication.


An organization who issues a qualification, identifier, or license.


The classification of a person's job (one job) as defined by compensation and sector (e.g. paid, unpaid, self-employed, government, etc.). This is different from employment status: a person who is a volunteer (work classification) may have chosen not to be in the labor force (employment status).


A regular action performed at a single job.


The country, state or other region taking legal responsibility for the conduct of the study.


A procedure performed on a collected specimen such as a blood panel or a biopsy.


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


A human language, spoken or written.


Additional information about a person's use of language.


Language used for communication by a human, either the subject of record, parent, or other involved person.


The most recent date the entry was changed.


Anatomical location or specimen further detailing the side(s) of interest.


The angular distance north or south between an imaginary line around a heavenly body parallel to its equator and the equator itself. Measured with with WGS84 datum.


The measurement or linear extent of something from end to end; the greatest dimensions of a body.


A time in minutes before or after a given life event, for example, 30 minutes before a meal. Whether this means before or after is carried by the life event code.


A measure of the expectation of the occurrence of a particular event, as a percentage.


Abstract top level class in the CIMI hierarchy. The Locatable class reflects CIMI's implementation using Archetype Description Language (ADL). Its attributes (archetypenodeid, 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.


A position, site, or point in space where something can be found.


An imaginary great circle on the surface of a heavenly body passing through the poles at right angles to the equator. Measured with with WGS84 datum.


A distinctive alpha-numeric identification code assigned by the manufacturer or distributor to a specific quantity of manufactured material or product within a batch.


The lower limit on a range


The lower limit of detection of the measured points. This is needed if any of the data points have the value 'L' (lower than detection limit).


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.


The organization that manages the operation of an activity, facility, or service provision.


A sign or symptom of an underlying condition.


When the item (medication, device, etc.) was produced.


The organization producing the product or test.


The name of the company who produce the device.


The most recent marital status of a person.


The relative match of the mapped concept to the original (target) concept. Examples include broader (i.e., the mapped term is more general than the original), equivalent, narrower (e.g. mapped concept is 'atypical diabetes mellitus' and the original term is 'diabetes mellitus'), or unknown.


A thing whose existence is implied by an assertion of presence. For example, a wound presence assertion implies there is a physical wound that exists. Observation of a tumor implies there is a tumor that exists. Assertion of a condition in a patient implies there is one more countable instance (case) of that condition in the world. The MaterializedAssertion allows one to refer to the implied entity as an actual entity. In other words, MaterializedAssertion represents the reification of a clinical statement. CIMI Alignment: not part of CIMI.


Upper bound on a count.


The maximum amount of a medication to be taken in a given period of time (e.g., no more than x in any 24-hour period)


Whether the subject requires an interpreter to communicate with an English-speaking provider.


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.


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.


The medication taken, prior to the change.


The medication taken, prior to the change.


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


Indicates that a medication product has been dispensed for a named person/patient. This includes a description of the medication product (supply) provided and the instructions for administering the medication. The medication dispense is the result of a pharmacy system responding to a medication order.


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


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


Specifies an material component in a medication.


Reason that patient did not adhere to a medication regimen.


Indicates that a medication product has NOT been dispensed for a named person/patient. This may be a result of the timing out of an order or detection of pharmacist of duplicate prescription or other reason.


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


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.


Base class for actions involving medications, independent of context.


A record of the use of a medication.


A course or dose of medication for a patient, independent of context of being recommended, used, or not used. Medication use can be reported, directly observed, or inferred from clinical events associated with orders, prescriptions written, pharmacy dispensings, procedural administrations, and other patient-reported information.


A person or entity in a group.


The technique used to carry out an action, for example, the specific imaging technical or assessment vehicle.


The person's middle name.


The branch of the US military that the subject has served.


How the subject was formally discharged from the US Military.


The time period of US military service.


History of service in the US military.


The current connection to the US military.


The length of time between sampling times, measured in milliseconds.


Lower bound on a count.


How fast the tumor cells are growing and dividing, determined from the number of mitotic cells present. Scored 1 to 3, with 3 being the most mitotic cells. We are seeking feedback on the value of representing the mitotic rate as a value rather than coded ranges.


A facility that moves from place to place, such as Meals-On-Wheels.


Representation of an amount of currency or monetary value.


The kind of structure being represented. This can define both normal and abnormal morphologies.


A description of the morphology and behavioral characteristics of the cancer.


The time of the last or latest of a series of events.


The name of the mother as it was or likely to have been recorded on the birth certificate of the subject. This is most likely the name prior to marriage of the mother (aka the maiden name).


Indication if the person was part of a multiple birth event.


Order of birth of the person in multiple birth event (if part of multiple birth).


Abstract supertype for the name of an entity.


The name as plain unstructured or semi-structured text.


A human-readable narrative, potentially including images, that contains a summary of the resource, and may be used to represent the content of the resource to a human.


Additional information on how the narrative was generated, and the scope of information contained.


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


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


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


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


Parent for classes in CIMI that do not have enough context to stand alone. These reusable building blocks/data elements can be used to create classes by composition.


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


The point in time or span of time in which something did not happen.


A record that a clinical act was not performed at a certain time or during a stated period of time, particularly when there might be an expectation of performing such an act, for example, if a vaccination is not given because of parental objection. Do not use this context if the act was initiated or started but aborted or cancelled.


How large and varied the nuclei of the tumor cells are. Scored 1 to 3, with 3 being the most pleomorphism.


The percentage of cells that test (stain) positive for the presence of a receptor.

We are seeking feedback on whether nuclear positivity should be an exact percentage or a range of percentages. As currently defined, an exact nuclear positivity could be represented by a zero-width range, where the lower and upper bounds would be the same number.


The maximum number of times the dispense can be repeated. For medication dispense, this integer does NOT include the original order dispense. This means that if an order indicates dispense 30 tablets plus 3 repeats, then the order can be dispensed a total of 4 times and the patient can receive a total of 120 tablets.


How many times the action should be repeated.


The dividend of a fraction.


A person's work or business


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


A hazard that is specific to a person's work or work environment for a single job and with which the person might come in contact. A hazard is a source of potential harm to an individual's physical or mental health (e.g., biological, chemical, physical, psychological, radiological).


The length of time in which something happens.


The point in time or span of time in which something happens.


The point in time in which something happens.


The point in time or span of time in which something happens.


The party represented by the actual participant.


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?


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?


The beginning or first appearance of a mental or physical disorder.


A social or legal structure formed by human beings.


A list of alternate names that the organization is known as, or was known as in the past.


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


The name of the organization.


The base quantity that a measured value of zero represents. In addition, this provides the units of the entire measurement series.


The result of performing an action or behavior, for example, an adverse reaction or new finding.


Patient findings documented during the performance of the procedure.


True if the medication is available to consumers without a prescription.


The kind of container the medication comes in.


PanelMember represent the elements of a group of a related but independent evaluations. Examples are the measurements that compose a complete blood count (CBC), or the elements of a pathology report. Each member is an independent evaluation, but the grouping reflects a composite lab order, shared specimen, or a single report author. Typically the Category and Reason are not given for individual findings that are part of the panel, but rather given at the level of the panel itself.


The base topic for collections of independent findings.


A string that follows a formal syntax and can be analyzed and broken into meaningful parts.


An entity (usually a Practitioner, Patient, or Organization but potentially a device or other entity) that participates in a healthcare task or activity.


The point in time or span of time the participant is involved.


The role played by the participant engaged in the action, for example, as the attending physician, surgical assistant, etc.


The larger entity that this is a portion of. For example, an organization might be part of a larger organization, or an encounter with a hospitalist might be part of a larger hospitalization encounter.


Credential indicating citizenship.


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


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


Information for the patient, such as, where to get the test, how to prepare for the test, etc.


A subject of information that is constrained to be either a patient or a group.


A choice of Patient or Practitioner. Needed for mapping to FHIR.


A choice of Patient, Practitioner and RelatedPerson. Needed for mapping to FHIR, for example, mapping AdverseEvent.Signed to FHIR AdverseEvent.


Needed for mapping to FHIR, for example, mapping to FHIR MedicationStatement.informationSource.


A percentage value where 100.0 represents 100%.


A range of percentage values.


ActionContext indicating actual performance or execution of a healthcare-related action, e.g., 3rd dose of Hepatitis B vaccine administered on Dec 4th 2012, appendectomy performed today.


Information for the performer of the test, if needed.


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


A name used by a human being, written as it would be typically expressed. May include a breakdown of the various elements of the name (family name, given name, etc.).


The person this entry belongs to.


The location of a birth event. There may be multiple entries, but a person has only one place of birth.


A text written in a human language.


Owner of the policy


A sequence of letters and digits used as part of a postal address, often designating a geographic region


A person who practices a healing art.


A choice of Practitioner and RelatedPerson. Needed for mapping to FHIR, for example, mapping EncounterPerformed.Participant to FHIR Encounter.participant.individual


A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.


If the problem or condition existed before the current episode of care.


Code indicating the preference associated with the use of this name.


Contains a set of honorific terms that typically appear before a person's name, for example Mr., Mrs., Dr., etc.


PresenceContext indicates that the finding in question exists or is present to some level of certainty.

For example, if the finding involves a myocardial infarction, the presence context implies that cardiac arrest has (or may have) taken place. Note that the name Presence is used rather than Present to prevent confusion with the temporal meaning of present.


Indicates the individual who has primary oversite of the execution of the study.


An indication of the importance of an action.


The not performed context with constraints applicable to procedures, namely, the request must be a procedure request.


The performed context with constraints applicable to procedures.


The requested context with additional constraints applicable to procedures.


Description of a healthcare procedure, independent of action context. This can be a physical intervention like an operation, or less invasive like counseling or hypnotherapy.


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).


The type of evidence considered in determining disease progression.


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.


Why the item is used.


A right to practice medicine obtained by training and certification.


A point in time, described qualitatively.


The frequency of an event, described qualitatively.


A qualitative (subjective) likelihood.


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


The amount that is to be dispensed for one fill.


Subjective association of a person with a named category of humans sharing common history, traits, place of family origin, nationality, tribe, or other inherited background.


Additional description of race or heritage.


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.


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


The justification for an action or non-action, conclusion, opinion, etc.


Time the item was delivered to, or accepted by, the receiving facility or unit.


The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.


Context for recording a finding, usually a Panel, used to indicate an evaluation has been made.

For example, measurement of blood pressure that has been made simply exists (although the value can be present or absent, accurate or inaccurate). The RecordedContext indicates the information presented stands on its own as presented. It can also apply to clinical notes.


The time of the attribution action.


Concept indicating the state of this record, e.g., 'entered in error'.


The period of time after which the pattern repeats, for example, each day. To specify an event should take place every other Monday, the recurrence interval should be two weeks, and DayOfWeek should be Monday.


A set of rules that describe when a recurring event is scheduled.


The start and end of the overall recurrence pattern in terms of dates/times or in terms of number of repeats. Could also be an event, such as when all doses are taken.


The usual or acceptable range for a test result.


A person in a role defined in relationship to a patient


The proposal, order, or plan that is partly or wholly fulfilled by the performance of this act.


The relationship of the SubjectOfInformation to the subject of record.


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


The time or time period that the finding addresses.

The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).


Represents a recommendation or order from a practitioner or clinical decision support system to NOT perform an act.


An order for something to take place.


Indicates the level of authority/intentionality associated with the request and where the request fits into the workflow chain.


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


URI where data can be found.


Number of bytes of content in the resource (if url provided)


The finding itself, such as the blood pressure value recorded.


Capacity in which an actor is involved in an activity. For instance, 'attending physician'. Note that attributes of the actor (an entity) that remain constant regardless of the role the actor plays should be part of the entity and not the role. For instance, a person may be a practitioner and a patient. In both cases their date of birth will be the same and thus such information should not be part of the role.


The way a substance enters an organism after contact, particularly, the route of drug administration.


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.


A code that connects the entry to a security policy. Security labels can be updated when the resource changes, or whenever the security sub-system chooses to.


The duration of an event, described semi-quantitatively.


The frequency of an event, described semi-quantitatively.


The sequence number for this specimen in a collection of specimens.


Clinical significance of adverse event usually associated with events that pose a threat to a patient's life or functioning. Seriousness of adverse event serves as a primary guide for defining regulatory reporting obligations and changes in medicinal product development and usage.


Percentage disability resulting from US Military Service.


Description of the place or type of surroundings where something is positioned or where an event takes place.


Degree of harshness or extent of a symptom, disorder, or condition.


A unique, persistent, permanent identifier for the overall health record belonging to the PersonOfRecord.


The party signing.


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


Type of signature


Provenance information specific to the signing of the clinical statement.


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


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.


A US social security number (SSN).


The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.


Identifier for the source specimen from which this specimen was derived.


Information about the proper handling of the 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.


Base class for actions related to the collection of a specimen, independent of context.


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


Quantity of specimen within container.


State of the specimen, such as obtained, processed, used.


Treatment performed on the specimen.


Accuracy and fluency in spoken communication in a language.


The organization responsible for the execution of the study.


The relative advancement in the course of a disease. The value is the summary stage or stage group. StageDetail optionally contains the full staging information.


The full staging information


A suffix used in conjuction with certain breast cancer stages, based on criteria defined by the staging system being used.


Indicates when the staging was done, in terms of treatment landmarks.


Sub-unit of a country with limited sovereignty in a federally organized country. A code may be used if codes are in common use (i.e. US 2 letter state codes). (Source: HL7 FHIR).


Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.


Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement.

StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc…), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).


A state or country acting as an assuing authority for a document.


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


The type of statistic that is represented by the value.


The current standing or state.


A clinical trial or similar research study. Reference: list of FDA data elements describing a research study:


Arm refers to pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol.


The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.


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


Categorization of the risk substance as a food, drug, or environmental agent. For difficult-to-classify substances, one can leave this field empty or choose the most typical category.


Part of the name that is acquired as a title due to academic, legal, employment or nobility status, etc. and that appears at the end of the name.


The amount of supervisory or management responsibilities of a person at one job. For military jobs, pay grade is used as a proxy because it can be interpreted across branches of service. A change in supervisory level is considered a new job.


Identifies the period time over which the supplied product is expected to be used, or the length of time the dispense is expected to last.


The technique used to reach the site of the procedure. Approaches may be through the skin or mucous membrane, through an orifice or external.


A surgical action, independent of action context.


A code used to relate entries to categories or workflows. Applications are not required to consider the tags when interpreting the meaning of an entry.


A user name or other identifier on a telecommunication network, such as a telephone number (including country code and extension, if necessary), email address, or SkypeID.


A description and/or code explaining the premature termination of the study.


Represents an alternative (mapped) Concept associated with a source concept (i.e., CodedText.concept or the textual value of the CodedText when no equivalent concept has been defined), and the relative match of the mapped Concept with respect to the source Concept. Mappings may be used to add classification terms (e.g. adding ICD classifiers to SNOMED descriptive terms), for computational convenience, or to provide equivalents in other terminologies (e.g. across nursing vocabularies).


Time of day the event should take place on the designated day(s). TimeOfDay should only be specified if the RecurrenceInterval and/or DayOfWeek establishes the day when the event should take place.


A period of time defined by a start and end time, date, or year. If the start element is missing, the start of the period is not known. If the end element is missing, it means that the period is ongoing, or the start may be in the past, and the end date in the future, which means that period is expected/planned to end at the specified time. The end value includes any matching date/time. For example, the period 2011-05-23 to 2011-05-27 includes all the times from the start of the 23rd May through to the end of the 27th of May.


The time at which something is to end or did end. Boundary is considered inclusive.


The time at which something is to take effect, start, or did start. Boundary is considered inclusive.


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.


A code for the timing schedule. Some codes such as BID are ubiquitous, but many institutions define their own additional codes. If a code is provided, the code is understood to be a complete statement of whatever is specified in the structured timing data, and either the code or the data may be used to interpret the Timing, with the exception that .repeat.bounds still applies over the code (and is not contained in the code).


When doses of medication should be administered.


A distinguishing word or group of words naming an item.


The concept representing the finding or action that is the topic of the statement.

For action topics, the TopicCode represents the action being described. For findings, the TopicCode represents the 'question' or property being investigated. For evaluation result findings, the TopicCode contains a concept for an observable entity, such as systolic blood pressure. For assertion findings, the TopicCode contains a code representing the condition, allergy, or other item being asserted. In all cases, the TopicCode describes the topic independent of the context of the action or the finding.


The total time spent on an activity, inclusive of all time intervals, whether continuous or interrupted.


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


A comparison between structures formed by the tumor cells and those formed by normal cells. Scored 1 to 3 with 3 being the most abnormal.


The most specific code (lowest level term) describing the kind or sort of thing being represented.


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


A state or territory in the USA expressed by 2-letter US Postal code.


Code for the unit of measure of the quantity.


The upper limit on a quantitative value.


The upper limit of detection of the measured points. This is needed if any of the data points have the value 'U' (higher than detection limit).


A unique URL on which the device may be contacted directly.


The access device used to perform the procedure.


The access device used to perform the procedure.


The device used to perform the procedure.


The device used to perform the procedure.


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.


The model number of the device, assigned by the manufacturer or vendor.


Whether an assessment has been confirmed by testing or observation. CIMI Alignment: This attribute corresponds to FindingContext.status, but has been defined to align with FHIR. In AllergyIntolerance, the type is code.


Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)


A number or code associated with the product that identifies a particular release iteration.


The amount of three dimensional space occupied by an object or the capacity of a space or container.


The time at which a condition or condition was first identified in a healthcare context.


The measurement or extent of something from side to side.


The typical number of days worked in a week by a person at one job.


The number of hours worked in a day or shift at one job by a person. For those working a split shift (divided into two parts that are separated by an interval longer than a normal rest period), it is the total of both periods of time in a shift.


A person's typical arrangement of working hours for one job.


Accuracy and fluency of reading and writing in a language.

SHR Reference Model