Regulatory Workflows and Interactions - pharma
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Regulatory Workflows and Interactions - pharma, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions

Subscription

Page standards status: Informative

Subscription

The Subscription resource delivers real-time notifications when regulatory events occur — task status changes, new assignments, and decisions.

For Business Readers

A Subscription is like a notification rule. You tell the FHIR server: "Notify me when this specific Task changes status" or "Notify me when the regulator creates a new Task assigned to my organization." The server automatically sends a webhook notification every time the condition is met — no polling required.

In RWI-pharma, the Subscription resource is the mechanism that delivers real‑time notifications when regulatory events occur. A Subscription becomes active when:

  1. The event matches the trigger defined in the SubscriptionTopic, and
  2. The resource involved satisfies the Subscription.filterBy constraints.

When both conditions are met, the server sends a notification bundle to the subscriber’s configured Subscription.endpoint.

RWI-pharma uses Subscriptions for two primary regulatory event types:

  • Task Status Change — filtered by Task.identifier
    Notifies the requester when the regulator updates the status of a Task (e.g., received → accepted, in‑progress → on‑hold, completed).

  • Task Creation — filtered by Task.owner
    Notifies an Organization when the regulator creates a new Task for them (e.g., questions, decision letters, follow‑up actions).

These two patterns allow RWI-pharma participants to receive immediate, event‑driven updates without polling.

Example Subscription

For more information on how this ties into Subscriptions see: Real-time Subscriptions

Key Elements of the RWI-pharma Subscription Resource

Element Cardinality (RWI-pharma) Value / Example Purpose / Notes
Subscription.filterBy 0..* • filterParameter = identifier or owner
• value = e.g. Organization/1001		 Defines the subset of events the subscriber is interested in (e.g., Tasks for a specific organization or Tasks with a specific identifier)
Subscription.topic 1..1 Canonical URL of the SubscriptionTopic
e.g. http://myfhir/fhir/SubscriptionTopic/TaskStatusChangeWithIdentifierFilter		 Must exactly match the SubscriptionTopic.url that governs the event type and trigger logic
Subscription.endpoint 1..1 REST‑hook endpoint URL
e.g. https://hapi.requestcatcher.com/		 Destination where event notifications are delivered
Subscription.reason 1..1 Human‑readable explanation
e.g. “Notify Organization when a new Task is assigned”		 Describes the business purpose for auditability and transparency
Subscription.managingEntity 0..1 Reference(Organization)
e.g. Organization/1001		 Identifies the organization responsible for maintaining the subscription