Point-of-Care Device Implementation Guide, published by HL7 International / Devices. This guide is not an authorized publication; it is the continuous build for version 0.4.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-pocd/ and changes regularly. See the Directory of published versions

Profiles

Page standards status: Informative

This Implementation Guide specifies profiles on the FHIR Device, DeviceMetric, and Observation resources. Each profile defines constraints, extensions, and terminology requirements for an implementation that claims conformance to this guide.

A point-of-care device model is made of multiple resource instances and the relationships between them. The following diagram shows the FHIR resource profiles (blue) and references to other profiles or FHIR core resources (white).

Must Support

For the profiles listed below, mustSupport set to true on data elements (flagged with a S in table view) shall be interpreted as follows:

• Data sources shall be capable of populating the element in a resource instance if the data is available and permissions allow.
• Data consumers shall be capable of consuming the element from the resource instance if the data is relevant to their business case.

Device Profiles and Extensions

Profile/Extension	Description
MDS Device profile	StructureDefinition for Device resources that represent a Medical Device System (MDS). This is the top-level resource in the hierarchical model of a Point-of-Care device.
VMD Device profile	StructureDefinition for Device resources that represent Virtual Medical Devices (VMD). These are medical-related subsystems in the hierarchical model of a Point-of-Care device.
Channel Device profile	StructureDefinition for Device resources that represent Channels, which are used for grouping metrics together.
Device Instance extension	StructureDefinition that adds an instance number or label to Device or DeviceMetric.
Approved Jurisdictions extension	StructureDefinition that adds approved jurisdictions to a Device.
Operator extension	StructureDefinition that adds an operator to a Device.
Operating hours extension	StructureDefinition that adds operating hours to a Device.
Operating cycles extension	StructureDefinition that adds operating cycles to a Device.
Operating mode extension	StructureDefinition that adds an operating mode to a Device.

DeviceMetric Profiles and Extensions

Profile/Extension	Description
Numeric DeviceMetric profile	StructureDefinition for DeviceMetric resources that represent numerical measurements, calculations, or settings characteristics and capabilities.
Enumeration DeviceMetric profile	StructureDefinition for DeviceMetric resources that represent coded or text status, annotations, or settings characteristics and capabilities.
Sample Array DeviceMetric profile	StructureDefinition for DeviceMetric resources that represent real-time waveforms or wave snippets characteristics and capabilities.
Device Instance extension	StructureDefinition that adds an instance number or label to Device or DeviceMetric.
Relation extension	StructureDefinition that adds relations to a DeviceMetric.
Metric availability extension	StructureDefinition that adds metric availability to a DeviceMetric.
Technical range extension	StructureDefinition that adds technical range and accuracy to a DeviceMetric.
Resolution extension	StructureDefinition that adds resolution to a DeviceMetric.
Sweep Speed extension	StructureDefinition that adds default sweep speed to a DeviceMetric.
Visual Grid extension	StructureDefinition that adds grid line definitions to a DeviceMetric.

Observation Profiles and Extensions

Profile/Extension	Description
Numeric Observation profile	StructureDefinition for Observation resources that represent numerical measurements, calculations, or settings.
Compound Numeric Observation profile	StructureDefinition for Observation resources that represent numerical measurements, calculations, or settings with multiple components.
Enumeration Observation profile	StructureDefinition for Observation resources that represent coded or text status, annotations, or settings.
Sample Array Observation profile	StructureDefinition for Observation resources that represent real-time waveforms or wave snippets.

Profiles only used for mappings

The profiles listed here are not intended to be used in actual implementations, but are used for mapping purposes for ISO/IEEE 11073-10207 (i.e. IEEE SDC) in this implementation guide.

Profile	Description
Observation profile	StructureDefinition for measurements and simple assertions made about a patient, device or other subject.
Patient profile	StructureDefinition for Patient resources that represent demographics and other administrative information.
Practitioner profile	StructureDefinition for Practitioner resources that represent demographics and other administrative information.