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DeviceObservation FHIR Resource Proposal

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Owning committee name

Health Care Devices (DEV) WG

Contributing or Reviewing Work Groups

FHIR Project Team

FHIR Resource Development Project Insight ID


Scope of coverage

This resource describes a set of observations made on a subject by a device, where the observations are entered directly into the patient's EHR. The scope includes observations made by devices on patients, other devices, and locations, and covers all disciplines, locales, and delivery environments. The device is intended particularly to be used for devices that are fixed to patients and provide data directly into a patient's EHR.

The scope of this resource does not include diagnostic reports, which although partially or entirely generated by machines, are subject to the diagnostic service process. There may be some lack of clarity which resource to use with regard to POC testing devices that are managed by a diagnostic service but affixed to the patient. For this reason, the actual observations that are made are the same between the two cases - the difference is one of attribution; a device observation is used when the attribution of the data is made against the device, not the diagnostic service, and also that the Device Observation is only to be used where there is no interpretation prior to entering the data in the EHR.

RIM scope

An observation that is either a battery or a cluster where attribution (performer) is a device

Resource appropriateness

  • Devices contribute observations to the EHR directly
  • the provenance (primarily kind, identity and status of the device) may be relevant to the interpretation of the data
  • resource is very focused - a container of a group of observations that provides information about how they are grouped and gathered

Expected implementations

  • devices or proxies/gateways that gather data and provide it to EHRS
  • repositories that record patient related observations and make it available for review

Content sources

  • ISO 11073-10101.
  • IHE device profiles
  • HL7 v2 profiles (IHE and others)
  • vital signs section of CCDA

Example Scenarios

  • vital signs
  • ECG device
  • wearable glucose monitor
  • wireless heartrate monitor

Resource Relationships

  • this resource could be referenced in any context where patient related observations may be used. Typically, these will be higher level resources (level3+ in Bo's stack)
  • this resource refers to the following other resources:
    • The standard subject cluster (Patient | Device | Location)
    • The source device
    • The Observation Resource for the actual observations in the set


This resource will be ready for DSTU ballot in Sept

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