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

Local Index

CertiScan Device Registry

The CertiScan Device Registry serves as a standardized way to identify and track CertiScan hardware (such as smart eCaps, Med-ic blister packs, and connected medication readers) across applications and systems. By using a consistent set of resource definitions, implementers can:

  • Track devices with a unique Tag ID (assigned at manufacturing/QA, then finalized when the package is started) and record details such as Use Count, Max Use, serial number prefix (tag-prefix), when medication is removed, and environmental temperature (if applicable).
  • Manage device lifecycles, including firmware or hardware version updates and operational status (e.g., “recording in progress,” “not started,” “recording completed,” or “diagnostic check”).
  • Associate devices with other clinical data, such as scan events, dosage information, or temperature readings, to build comprehensive medication adherence and therapy records.

Key Concepts

Tag ID, Serial Prefix & Use Count

During manufacturing/QA (assembly), when medications are loaded into the package, each device is assigned a permanent serial prefix (tag-prefix) and an initial Use Count of 0. The initial Tag ID (prefix + constant + 0) exists but the device remains in a “Not started” state. Only when a provider intentionally performs a write operation to start or restart the package does Use Count increment (to 1, 2, etc.), and the Tag ID is updated to <serial-prefix> + <constant> + <use-count>.

  • Serial Prefix (Tag-Prefix): Assigned at the factory during assembly and never changes.
  • Use Count: Begins at 0. Each time the package is (re)started by an authorized write operation (e.g., refilling the bottle or beginning a new study run), the Use Count increments by 1 (up to Max Use). Use Count has nothing to do with individual dose removals—it simply defines a new “run” and clears any prior dose history for that run.
  • Max Use: Maximum number of restarts or refills permitted. After Use Count exceeds Max Use, no further restarts are allowed.
  • Tag ID: Exists even at Use Count = 0 (prefix + constant + 0) but indicates “Not started.” Each subsequent write updates it.
  • Package ID: If explicitly set by a project (e.g., pharmacy or CRO), that value is used; otherwise, Package ID defaults to the current Tag ID.
  • Kit ID: Identifies a collection of packages or Tag IDs for a specific study purpose. If not part of a kit, Kit ID is null.

How to Use the Registry

  1. Create or Lookup a Device
    When a new CertiScan device is assembled (medications loaded), it receives a permanent serial-prefix (tag-prefix) and Use Count = 0. The Tag ID (prefix + constant + 0) exists but remains “Not started.” When an authorized provider performs the first write to start or restart the package, Use Count increments to 1, and the Tag ID becomes <serial-prefix> + <constant> + 1.
    • Serial Prefix (Tag-Prefix) is assigned at QA and never changes.
    • Use Count has nothing to do with medication removal; it only increments on authorized restarts or new runs.
    • Max Use defines the maximum allowed restarts or refills; if Use Count > Max Use, the device cannot be used again.
    • Package ID is an optional project-specific label (e.g., a pharmacy’s internal tracking number). If not set, it defaults to the current Tag ID.
    • Kit ID identifies a collection of packages or Tag IDs for a study purpose; if not part of a kit, it is null.
    • Registering a device to a patient record requires access to clinical records; patient-facing apps are not required—device scans via a simple tap suffice for usage reporting.

  2. Track Usage
    When medication is removed, a write operation updates Use Count and the new Tag ID is reconstructed (prefix + constant + updated count). Each dose event is recorded with its timestamp as the effectiveDateTime. The NFC (express) scan itself only transmits device data—current Use Count, any recorded temperature, and statusReason—to the cloud; it does not perform a write or imply dose removal. Use Count increments only on restart, not on dose removal. Hundreds of dose events can be recorded under a single Use Count.

  3. Monitor Status
    • Devices remain in “Not started” until the first write operation (start) occurs—this preserves battery life if the package may not be used for months or years.
    • Once medication is removed (and Use Count increments), the device transitions to “Recording in progress.”
    • When the recording process completes (e.g., after finalizing data transfer or marking the session complete), the status becomes “Recording completed.”
    • Only authorized providers can perform write operations on statusReason (express/NFC read cannot change recording state).
    • Diagnostic status can be set if a generic fault or maintenance check is needed; patients cannot toggle the recording status themselves.
  4. Integrate with Clinical Workflows
    Once a Tag ID is formed (after the first write), it can be referenced from other systems (e.g., an EHR or medication management platform). Scans, dose events, and temperature readings each include a reference to the same Tag ID, creating a unified history of how that device (and its package) was used.
    • If the patient has an account, the first scan can associate the Tag ID with that patient. For anonymous or ad-hoc scenarios, additional workflow decisions may be required to link scan data back to a patient or study ID.
    • Patients do not need a separate app or account; a simple one-touch scan (NFC) reports data to the cloud, and project staff can later reconcile scans with project/patient records.

Common Use Cases

  • Hospital Pharmacy: Ship prefilled packages to sites, register them when received, then track remaining doses as medication is removed. Labels (e.g., arm/medication values) used for study or clinical workflows are separate and not the same as Kit ID.
  • Clinical Trials: Ensuring every device used in a study is uniquely identified, and its usage history is auditable for regulatory compliance. Espicially, that medication is taken on time as prescribed.
  • Home Healthcare: Use a single tap scan (no patient account) to transmit device readings—Use Count, status, temperature—to the cloud, ensuring minimal patient burden.

Coming Soon

• More patient, clinical, and project details
• FHIR audit logging
• Dose correction to adjust dose time or create virtual doses if a dose was mis-managed.

Stay tuned for these features, which will allow even tighter integration with pharma supply chains, research platforms, and hospital asset management.