CertiScan Device Registry Implementation Guide (FHIR R4B)
0.1.0 - ci-build
CertiScan Device Registry Implementation Guide (FHIR R4B) - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Official URL: https://fhir.certiscan.cloud/device-registry/0.1.0/ImplementationGuide/certiscan.device-registry | Version: 0.1.0 | |||
| Draft as of 2025-06-05 | Computable Name: CertiScanDeviceRegistryIG | |||
The CertiScan Device Registry provides a standardized way to share and consume data about CertiScan hardware. Integrated systems can use these resources to identify the specific device used, monitor its use count and current status, and determine when a dose was removed — with details about which dose was removed and the temperature at the time.
Here is a good place to start: Resource Profile: CertiScan Device Registry Bundle.
Serial Number (Tag-Prefix): Assigned at manufacturing/QA. It never changes and serves as the permanent identifier for that tag.
Tag ID: A unique identifier in the format <serial-number><constant><use-count>.
Use Count: Starts at 0. The write operation of starting (or restarting the package) increments this value by 1, up to the defined Max Use. In the cloud, each new use count is treated as a separate tag-id. Incrementing the use count clears the current dose on the device and prepares it for a new run — typically corresponding to a medication refill.
Max Use: The maximum number of times the device can be started or restarted. Once Use Count > Max Use, no further starts are allowed.
Package ID: A project- or site-specific and must be globally unique. If not set explicitly, it defaults to the current Tag ID.
Kit ID: A globally unique identifier for a collection of packages or Tag IDs used for a study or similar purpose. If not part of a kit, it is null.
Label: A project-specific identifier indicating the package’s intent or contents (e.g., study arm name or medication code). Downstream systems can use this label to filter or display devices based on their assigned role or contents. It is typically not unique.
Dose Events: Each time medication is removed, a dose event is recorded with a timestamp. If the package is a Med-ic blister pack, the event also includes a dose-line value to indicate which dose was removed. This allows precise adherence tracking.
For each "run" (defined by a given Use Count), multiple dose events can be tracked. Each dose event includes a timestamp (effectiveDateTime) indicating when medication was removed.
Temperature: If the device includes environmental sensors, it can optionally report the latest, minimum, and maximum temperature readings. This data helps monitor storage and handling conditions.
Status Reason: Reflects whether the device is:
Not started (Use Count = 0)Recording in progress (active run)Recording completed (stopped/run finished)Scan events push the device’s latest data (use count, temperature, status, etc.) to the cloud via either CertiScan Express / CertiScan Connect.
{
"resourceType": "Bundle",
"type": "collection",
"meta": {
"profile": [
"https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-registry-bundle"
]
},
"entry": [
{
"fullUrl": "certiscan://anonymous/patient",
"resource": {
"resourceType": "Patient",
"id": "anon-pt",
"name": [
{
"use": "official",
"family": "Anonymous",
"given": [
"Patient"
]
}
],
"text": {
"status": "generated",
"div": "<div xmlns='http://www.w3.org/1999/xhtml'>Anonymous Patient</div>"
}
}
},
{
"fullUrl": "certiscan://anonymous/provider",
"resource": {
"resourceType": "Practitioner",
"id": "anon-prov",
"name": [
{
"use": "official",
"family": "Anonymous",
"given": [
"Provider"
]
}
],
"text": {
"status": "generated",
"div": "<div xmlns='http://www.w3.org/1999/xhtml'>Anonymous Provider</div>"
}
}
},
{
"fullUrl": "urn:uuid:2aa1a6b9-1de8-5aa2-869f-2e0ca8ebe841",
"resource": {
"resourceType": "Device",
"meta": {
"profile": [
"https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device"
]
},
"id": "2aa1a6b9-1de8-5aa2-869f-2e0ca8ebe841",
"type": {
"coding": [
{
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-type-cs",
"code": "ecap",
"display": "eCap Smart Bottle Cap"
}
]
},
"identifier": [
{
"use": "secondary",
"type": {
"coding": [
{
"code": "tag-id",
"display": "Tag ID",
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-identifier-cs"
}
]
},
"value": "5000-BR1"
}
],
"deviceName": [
{
"name": "eCap Smart Bottle Cap",
"type": "manufacturer-name"
}
],
"manufacturer": "Information Mediary Corporation",
"serialNumber": "5000",
"expirationDate": "2028-04-30",
"version": [
{
"type": {
"coding": [
{
"code": "hardware",
"display": "Hardware Version",
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-version-cs"
}
]
},
"value": "2.1.0"
},
{
"type": {
"coding": [
{
"code": "firmware",
"display": "Firmware Version",
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-version-cs"
}
]
},
"value": "1.1.1"
}
],
"status": "active",
"statusReason": [
{
"coding": [
{
"code": "recording-in-progress",
"display": "Recording in progress",
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-status-reason-rec-cs"
}
],
"text": "Recording in progress since 2025-05-01T17:00:23+00:00"
},
{
"coding": [
{
"code": "fully_opperational",
"display": "Fully Operational",
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-status-reason-diagnostic-cs"
}
],
"text": "Fully Operational"
}
],
"extension": [
{
"url": "https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-use-count",
"valueInteger": 1
},
{
"url": "https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-max-use",
"valueInteger": 4096
},
{
"url": "https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-label",
"valueString": "epc009|38mm Argus-loc eCAP<eCAP Dose>"
}
],
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Ecap 5000-BR1 Fully Operational (recording)</div>"
}
}
},
{
"fullUrl": "urn:uuid:3aa6a467-f3ce-519d-89be-828cd331e160",
"resource": {
"resourceType": "Observation",
"meta": {
"profile": [
"https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-express-scan"
],
"lastUpdated": "2025-06-05T19:29:44+00:00"
},
"id": "3aa6a467-f3ce-519d-89be-828cd331e160",
"category": [
{
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/observation-category",
"code": "procedure",
"display": "Procedure"
}
]
}
],
"code": {
"coding": [
{
"code": "express",
"display": "CertiScan Express Scan",
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-scan-type-cs"
}
]
},
"subject": {
"reference": "certiscan://anonymous/patient",
"display": "Anonymous Patient"
},
"device": {
"reference": "urn:uuid:2aa1a6b9-1de8-5aa2-869f-2e0ca8ebe841",
"type": "Device",
"display": "Ecap 5000-BR1"
},
"performer": [
{
"reference": "certiscan://anonymous/provider",
"display": "Anonymous Provider"
}
],
"status": "final",
"effectiveDateTime": "2025-06-05T19:29:43+00:00",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Tag 5000-BR1 scanned at 2025-06-05T19:29:43+00:00</div>"
},
"extension": [
{
"url": "https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-scan-ip",
"valueString": "127.0.0.1"
},
{
"url": "https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-scan-user-agent",
"valueString": "IntelliJ HTTP Client/PyCharm 2025.1.1.1"
},
{
"url": "https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-scan-payload",
"extension": [
{
"url": "source",
"valueCodeableConcept": {
"coding": [
{
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-scan-payload-source-cs",
"code": "express",
"display": "Certiscan Express Payload"
}
],
"text": "Certiscan Express Payload of 504 bytes"
}
},
{
"url": "format",
"valueCoding": {
"system": "http://www.iana.org/assignments/media-types",
"code": "application/octet-stream",
"display": "Binary data"
}
},
{
"url": "data",
"valueString": "gAQ=AAAAABOIAQEBAQECAQAABACABAADAADmAAAAABOIvnMAADUAAAAAAAAAALEAAABqAAAARwAAAAAAAAAAiIsOaxKSIbcAxXIFAWQACAAABQDgsQAAAAAAABwAAAAAAgAgAAAAAAAAACwAACwAAAAAAAAAAAAABKsNVgWZAAAAAMUAAQAiGggYEBAAIAAC2h5PAgB_IJEAAAIKv_8PBAAAAAAAAAAlAAAmBn8E6AAAAAAAAAAAAAAAKQAAEAAAB____wAAAABB1nq71ss4qQAAAAAAAAAAAAAAAAAAAACpaBOopwAABQAAAAAAAAAGfwToAAAAAAAAAAAAAAAA7Xs3gA4S7QAAvHYH4H7wTEPuWRJ7I80DE2tJJSUspGesHyUAZXBjMDA5fDM4bW0gQXJndXMtbG9jIGVDQVA8ZUNBUCBEb3NlPv8B05h6JgDBAQAAAB9VBGRldGFpbC1leHByZXNzLmRldi5jZzJjLnJvY2tzL0WV3lo~"
}
]
}
]
}
},
{
"fullUrl": "urn:uuid:cfb92f49-454c-527e-bc11-7b40d292b717",
"resource": {
"resourceType": "Observation",
"meta": {
"profile": [
"https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-temperature-last"
],
"lastUpdated": "2025-06-05T19:29:44+00:00"
},
"id": "cfb92f49-454c-527e-bc11-7b40d292b717",
"category": [
{
"coding": [
{
"code": "social-history",
"display": "Social History",
"system": "http://terminology.hl7.org/CodeSystem/observation-category"
}
]
}
],
"code": {
"coding": [
{
"code": "last",
"display": "Last Temperature Reading",
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-temperature-cs"
}
]
},
"performer": [
{
"reference": "certiscan://anonymous/provider",
"display": "Anonymous Provider"
}
],
"subject": {
"reference": "certiscan://anonymous/patient",
"display": "Anonymous Patient"
},
"derivedFrom": [
{
"reference": "urn:uuid:3aa6a467-f3ce-519d-89be-828cd331e160",
"type": "Observation"
}
],
"device": {
"reference": "urn:uuid:2aa1a6b9-1de8-5aa2-869f-2e0ca8ebe841",
"type": "Device",
"display": "Ecap 5000-BR1"
},
"status": "final",
"effectiveDateTime": "2025-06-05T19:29:43+00:00",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Last Temperature Reading (23.15 \u00b0C) at 2025-06-05T19:29:43+00:00</div>"
},
"valueQuantity": {
"value": 23.15,
"unit": "\u00b0C",
"system": "http://unitsofmeasure.org",
"code": "Cel"
}
}
},
{
"fullUrl": "urn:uuid:b0768b18-7270-5f06-9cc8-4e0de0117b92",
"resource": {
"resourceType": "Observation",
"meta": {
"profile": [
"https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-temperature-high"
],
"lastUpdated": "2025-06-05T19:29:44+00:00"
},
"id": "b0768b18-7270-5f06-9cc8-4e0de0117b92",
"category": [
{
"coding": [
{
"code": "social-history",
"display": "Social History",
"system": "http://terminology.hl7.org/CodeSystem/observation-category"
}
]
}
],
"code": {
"coding": [
{
"code": "high",
"display": "High Temperature Reading",
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-temperature-cs"
}
]
},
"performer": [
{
"reference": "certiscan://anonymous/provider",
"display": "Anonymous Provider"
}
],
"subject": {
"reference": "certiscan://anonymous/patient",
"display": "Anonymous Patient"
},
"derivedFrom": [
{
"reference": "urn:uuid:3aa6a467-f3ce-519d-89be-828cd331e160",
"type": "Observation"
}
],
"device": {
"reference": "urn:uuid:2aa1a6b9-1de8-5aa2-869f-2e0ca8ebe841",
"type": "Device",
"display": "Ecap 5000-BR1"
},
"status": "final",
"effectiveDateTime": "2025-06-05T19:29:43+00:00",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">High Temperature Reading (28.43 \u00b0C) at 2025-06-05T19:29:43+00:00</div>"
},
"valueQuantity": {
"value": 28.43,
"unit": "\u00b0C",
"system": "http://unitsofmeasure.org",
"code": "Cel"
}
}
},
{
"fullUrl": "urn:uuid:9fec4169-da74-5d8d-a801-ff1b24bf768c",
"resource": {
"resourceType": "Observation",
"meta": {
"profile": [
"https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-temperature-low"
],
"lastUpdated": "2025-06-05T19:29:44+00:00"
},
"id": "9fec4169-da74-5d8d-a801-ff1b24bf768c",
"category": [
{
"coding": [
{
"code": "social-history",
"display": "Social History",
"system": "http://terminology.hl7.org/CodeSystem/observation-category"
}
]
}
],
"code": {
"coding": [
{
"code": "low",
"display": "Low Temperature Reading",
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-temperature-cs"
}
]
},
"performer": [
{
"reference": "certiscan://anonymous/provider",
"display": "Anonymous Provider"
}
],
"subject": {
"reference": "certiscan://anonymous/patient",
"display": "Anonymous Patient"
},
"derivedFrom": [
{
"reference": "urn:uuid:3aa6a467-f3ce-519d-89be-828cd331e160",
"type": "Observation"
}
],
"device": {
"reference": "urn:uuid:2aa1a6b9-1de8-5aa2-869f-2e0ca8ebe841",
"type": "Device",
"display": "Ecap 5000-BR1"
},
"status": "final",
"effectiveDateTime": "2025-06-05T19:29:43+00:00",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Low Temperature Reading (16.92 \u00b0C) at 2025-06-05T19:29:43+00:00</div>"
},
"valueQuantity": {
"value": 16.92,
"unit": "\u00b0C",
"system": "http://unitsofmeasure.org",
"code": "Cel"
}
}
},
{
"fullUrl": "urn:uuid:58fb4129-b281-5a84-acb8-731f74edae51",
"resource": {
"resourceType": "Observation",
"meta": {
"profile": [
"https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-dose-panel"
],
"lastUpdated": "2025-06-05T19:29:44+00:00"
},
"id": "58fb4129-b281-5a84-acb8-731f74edae51",
"status": "preliminary",
"category": [
{
"coding": [
{
"code": "therapy",
"display": "Therapy",
"system": "http://terminology.hl7.org/CodeSystem/observation-category"
}
]
}
],
"code": {
"coding": [
{
"code": "dose-event-panel",
"display": "Dose Event Panel",
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-dose-panel-cs"
}
]
},
"performer": [
{
"reference": "certiscan://anonymous/provider",
"display": "Anonymous Provider"
}
],
"subject": {
"reference": "certiscan://anonymous/patient",
"display": "Anonymous Patient"
},
"derivedFrom": [
{
"reference": "urn:uuid:3aa6a467-f3ce-519d-89be-828cd331e160",
"type": "Observation"
}
],
"device": {
"reference": "urn:uuid:2aa1a6b9-1de8-5aa2-869f-2e0ca8ebe841",
"type": "Device",
"display": "Ecap 5000-BR1"
},
"effectiveDateTime": "2025-06-05T19:29:43+00:00",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Dose event panel for tag 5000-BR1 at 2025-06-05T19:29:43+00:00</div>"
},
"hasMember": [
{
"reference": "urn:uuid:9911b6fa-a52d-5106-a696-fd17e76ce769",
"type": "Observation"
},
{
"reference": "urn:uuid:772052cf-4f21-5259-bc4b-8bf4cc7739c7",
"type": "Observation"
},
{
"reference": "urn:uuid:0afd75a4-97e9-567f-b089-e865f05f06e2",
"type": "Observation"
},
{
"reference": "urn:uuid:4c7dbdb7-b67c-5503-88d0-355956447947",
"type": "Observation"
},
{
"reference": "urn:uuid:34b6524b-f0bb-5607-9fa7-5112da916251",
"type": "Observation"
},
{
"reference": "urn:uuid:7f789ec2-e7f2-51ac-83ac-30c054eb6c85",
"type": "Observation"
},
{
"reference": "urn:uuid:fdb9ac8a-ec92-5881-a1c4-71c863d065ed",
"type": "Observation"
}
]
}
},
{
"fullUrl": "urn:uuid:9911b6fa-a52d-5106-a696-fd17e76ce769",
"resource": {
"resourceType": "Observation",
"meta": {
"profile": [
"https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-ecap-dose"
],
"lastUpdated": "2025-06-05T19:29:44+00:00"
},
"id": "9911b6fa-a52d-5106-a696-fd17e76ce769",
"category": [
{
"coding": [
{
"code": "therapy",
"display": "Therapy",
"system": "http://terminology.hl7.org/CodeSystem/observation-category"
}
]
}
],
"code": {
"coding": [
{
"code": "ecap",
"display": "Ecap Dose",
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-dose-type-cs"
}
]
},
"performer": [
{
"reference": "certiscan://anonymous/provider",
"display": "Anonymous Provider"
}
],
"subject": {
"reference": "certiscan://anonymous/patient",
"display": "Anonymous Patient"
},
"derivedFrom": [
{
"reference": "urn:uuid:3aa6a467-f3ce-519d-89be-828cd331e160",
"type": "Observation"
}
],
"device": {
"reference": "urn:uuid:2aa1a6b9-1de8-5aa2-869f-2e0ca8ebe841",
"type": "Device",
"display": "Ecap 5000-BR1"
},
"status": "final",
"effectiveDateTime": "2025-05-01T17:04:00+00:00",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Dose event for tag 5000-BR1 at 2025-05-01T17:04:00+00:00</div>"
}
}
},
{
"fullUrl": "urn:uuid:772052cf-4f21-5259-bc4b-8bf4cc7739c7",
"resource": {
"resourceType": "Observation",
"meta": {
"profile": [
"https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-ecap-dose"
],
"lastUpdated": "2025-06-05T19:29:44+00:00"
},
"id": "772052cf-4f21-5259-bc4b-8bf4cc7739c7",
"category": [
{
"coding": [
{
"code": "therapy",
"display": "Therapy",
"system": "http://terminology.hl7.org/CodeSystem/observation-category"
}
]
}
],
"code": {
"coding": [
{
"code": "ecap",
"display": "Ecap Dose",
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-dose-type-cs"
}
]
},
"performer": [
{
"reference": "certiscan://anonymous/provider",
"display": "Anonymous Provider"
}
],
"subject": {
"reference": "certiscan://anonymous/patient",
"display": "Anonymous Patient"
},
"derivedFrom": [
{
"reference": "urn:uuid:3aa6a467-f3ce-519d-89be-828cd331e160",
"type": "Observation"
}
],
"device": {
"reference": "urn:uuid:2aa1a6b9-1de8-5aa2-869f-2e0ca8ebe841",
"type": "Device",
"display": "Ecap 5000-BR1"
},
"status": "final",
"effectiveDateTime": "2025-05-05T21:07:00+00:00",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Dose event for tag 5000-BR1 at 2025-05-05T21:07:00+00:00</div>"
}
}
},
{
"fullUrl": "urn:uuid:0afd75a4-97e9-567f-b089-e865f05f06e2",
"resource": {
"resourceType": "Observation",
"meta": {
"profile": [
"https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-ecap-dose"
],
"lastUpdated": "2025-06-05T19:29:44+00:00"
},
"id": "0afd75a4-97e9-567f-b089-e865f05f06e2",
"category": [
{
"coding": [
{
"code": "therapy",
"display": "Therapy",
"system": "http://terminology.hl7.org/CodeSystem/observation-category"
}
]
}
],
"code": {
"coding": [
{
"code": "ecap",
"display": "Ecap Dose",
"system": "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-dose-type-cs"
}
]
},
"performer": [
{
"reference": "certiscan://anonymous/provider",
"display": "Anonymous Provider"
}
],
"subject": {
"reference": "certiscan://anonymous/patient",
"display": "Anonymous Patient"
},
"derivedFrom": [
{
"reference": "urn:uuid:3aa6a467-f3ce-519d-89be-828cd331e160",
"type": "Observation"
}
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