Logical Model a device has a set of

Logical Model (a device has a set of capabilities, e. g. , observations or procedures it can perform, with some parameters around that. Certain capabilities are shared by device. What is exactly device specific vs. general is to be addressed within Device Capability) (a device operates with certain settings, which can change over time, that need to be captured as the device or device component is used. ) Device Settings Device Instance 1. . * 1. . 1 (at a given point in time, although could be attached to different devices over time) (at a given point in time. Some devices do not contain identifiable components, while others can be operational with multiple) 0. . 1 0. . * Device Component Instance 1. . 1 0. . * 1. . 1 (the device component 1. . 1 uses the device for the definition of its capabilities) (the device component uses the device for the definition of its capabilities) Observation /Procedure/ etc. The observation obtained or procedure performed (or…) links back to the device or device component used to perform or obtain the observation/procedure/etc. plus the settings of the device (component) at that time. Device Definition 0. . 1 0. . * 1. . * Device Capability 1. . 1 (to keep it simple so that, if configuration details of a component as part of a device vary, there is not an unexpected ripple effect) 0. . * (device components that could Device Component Definition be configured into the “main” device) Note that any use of terminology that overlaps with current FHIR resources does not imply any mapping or suggested mapping to those FHIR resources.

(a device operates with certain settings, which can change over time, that need to be captured as the device or device component is used. ) Device Settings 1. . * 1. . 1 0. . 1 Device Instance 1. . 1 0. . * The observation obtained or procedure performed (or…) links back to the device or device component used to perform or obtain the observation/procedure/etc. plus the settings of the device (component) at that time. Observation /Procedure/ etc. Device Definition 0. . * 1. . * Device Capability

Option One - Combine

Device Kind Device Instances

Option Two Device Kind Type Description of Type 0. . 1 or 1. . 1 Dev Instance. Ref 0. . * 0. . 1 or 1. . 1 Observation 1 definition Device Instance Many instances referencing the same definition.

Proposed solutions Device Instance. . . Device Instance R e f e r e R n e cf ee r e n c e R e f e r e n c e Device Definition Only need to specify/exchange the device definition once regardless of the number of instances and any updates or changes to the instances (e. g. settings) Device Definition/Instance. . . Device Definition/Instance Need to specify/exchange the device definition each time an instance is added or changed

Proposed Option Device Instance R e f e r e n c e Instance is composed of: Instance identifiers 1) serial number, 2) batch, 3) mfg. date, 4) exp date 5) ID for human tissue… Status Dates (first used, …) Settings (may be multiple depending on device) Device Definition / Kind is composed of: 1) device identifier 2) manufacturer information 3) model information 4) Capabilities 5) Dates (introduced 6) Default Settings

Logical Model (extended) Observation /Procedure/ etc. (a device operates with certain settings, which can change over time, that need to be captured as the device or device component is used. ) Device Settings 1. . * 1. . 1 (at a given point in time, although could be Device Instance attached to different devices over time) (a device or device component has a set of capabilities, e. g. , observations or procedures it can perform, with some parameters around that. Certain capabilities are shared by device. What is exactly device specific vs. general is to be addressed within Device Capability) 0. . * 0. . 1 Device Component Instance (at a given point in time. Some devices do not contain identifiable components, while others can be operational with multiple) The observation obtained or procedure performed (or…) links back to the device or device cused to perform or obtain the observation/procedure/etc. plus the settings of the device (component) at that time. Propose that it may reference either a device definition (instance information unknown) or a device instance 1. . 1 Device Definition 1. . 1 ( 0. . * 1. . * Device Capability Mfg settings if configuration details of a component as part of a device vary, there is not an unexpected ripple effect) 0. . * (device components that could (the device component has its definition of its capabilities) 1. . 1 Device Component Definition be configured into the “main” device) 1. . 1 Note that any use of terminology that overlaps with current FHIR resources does not imply any mapping or suggested mapping to those FHIR resources.

Logical Model (compressed) 0. . 1 (a device operates with certain settings, which can change over time, that need to be captured as the device or device component is used. ) Device Settings 1. . * 1. . 1 0. . * Device Instance (the device component uses the device for the definition of its capabilities) 1. . 1 0. . * Device Definition 0. . * 1. . * Device Capability 0. . * (a device has a set of capabilities, e. g. , observations or procedures it can perform, with some parameters around that. Certain capabilities are shared by device. What is exactly device specific vs. general is to be addressed within Device Capability) The observation obtained or procedure performed (or…) links back to the device or device cused to perform or obtain the observation/procedure/etc. plus the settings of the device (component) at that time. Propose that it may reference either a device definition (instance information unknown) or a device instance 1. . 1 Observation /Procedure/ etc. Note that any use of terminology that overlaps with current FHIR resources does not imply any mapping or suggested mapping to those FHIR resources.