Central Cancer Registry Reporting Content IG
0.1.0 - STU 1 Ballot

This page is part of the Making EHR Data MOre available for Research and Public Health (MedMorph) Central Cancer Registry Reporting Content IG (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

Detailed Specification

This section defines the specific requirements for systems wishing to conform to actors specified in this MedMorph Central Cancer Registry Reporting Content IG. The specification focuses on using the Backend Service App to report the cancer data to central cancer registries.

Context

Pre-reading

Before reading this formal specification, implementers should first be familiar with these sections of the specification:

  • The Use Cases page provides the business context and general process flow enabled by the formal specification.

Conventions

This implementation guide uses specific terminology to flag statements that have relevance for the evaluation of conformance with the guide:

  • SHALL indicates requirements that must be met to be conformant with the specification.

  • SHOULD indicates behaviors that are strongly recommended (and which may result in interoperability issues or sub-optimal behavior if not adhered to), but which do not, for this version of the specification, affect the determination of specification conformance.

  • MAY describes optional behaviors that are free to consider but where there is no recommendation for or against adoption.

Claiming Conformance

Actors and Systems asserting conformance to this implementation guide have to implement the requirements outlined in the corresponding capability statements. The following definition of MUST SUPPORT is to be used in the implementation of the requirements.

MUST SUPPORT Definition
  • Systems SHALL be capable of populating data elements as specified by the profiles and data elements are returned using the specified APIs in the capability statement.
  • Systems SHALL be capable of processing resource instances containing the MUST SUPPORT data elements without generating an error or causing the application to fail. In other words, Systems SHOULD be capable of displaying the data elements for human use or storing it for other purposes.
  • In situations where information on a particular data element is not present and the reason for absence is unknown, Systems SHALL NOT include the data elements in the resource instance returned from executing the API requests.
  • When accessing Central Cancer Registry Reporting data, Systems SHALL interpret missing data elements within resource instances returned from API requests as data not present.

Profiles and Other IGs Usage

This specification makes significant use of FHIR profiles, search parameter definitions, and terminology artifacts to describe the content to be shared as part of MedMorph Central Cancer Registry Reporting Content IG workflows. The implementation guide is based on FHIR R4 and profiles are listed for each interaction.

The full set of profiles defined in this implementation guide can be found by following the links on the FHIR Artifacts page.

MedMorph Reference Architecture (RA) IG Usage

This IG leverages the MedMorph RA IG defined by HL7 Public Health WG as the reference architecture for automating and implementing the central cancer registry reporting use case.

US Core Usage

This IG leverages the US Core set of profiles defined by HL7 for sharing non-veterinary EMR individual health data in the U.S. Where US Core profiles exist, this IG either leverages them directly or uses them as a base for any additional constraints needed to support the research use cases. If no constraints are needed, this IG does not define any profiles.

US Public Health (US PH) library profiles Usage

This IG leverages the US PH library profiles defined by HL7 Public Health WG for sharing public health reporting data which includes the following profiles:

* USPublicHealthEncounter
* USPublicHealthPatient
mCode FHIR IG Usage

This IG leverages the mCode FHIR IG for exchanging cancer specific information which includes the following profiles

* Primary Cancer Condition
* Secondary Cancer Condition
* Cancer Stage Group Information 
* Cancer Related MedicationRequests 
* Cancer Related MedicationAdministration
* TNM Observations 
* RadiotherapyCourseSummary

Implementers SHOULD use the mCode Disease characterization and mCode Treatment guidance when using the above profiles.

Occupational Data for Health (ODH) IG Usage

This IG leverages the ODH FHIR IG for exchanging occupational data for health which includes the following profile

* UsualWork
Subscriptions Backport IG Usage

This IG leverages the Subscriptions Backport IG defined by HL7 Infrastructure WG for automating reporting workflows using subscriptions.

Bulk Data Access IG Usage

This IG leverages the BulkData Access IG defined by HL7 Infrastructure WG for enabling authentication and authorization between various actors involved in the workflows.

Implementation Requirements

SMART on FHIR Backend Services Authorization Requirements

This section outlines how the SMART on FHIR Backend Services Authorization will be used by the Central Cancer Registry (CCR) Reporting Content implementation guide.

  • The system actors namely EHRs, Backend Service App, Trusted Third Party and the Central Cancer Registry are required to use the SMART on FHIR Backend Services Authorization mechanisms as outlined below for the following interactions

    • Backend Service App accessing data from the EHR
    • Backend Service App posting data to the Central Cancer Registry data store.

  • ​System actors acting as servers (EHRs, Trusted Third Parties and Central Cancer Registry) SHALL advertise conformance to SMART Backend Services by hosting a Well-Known Uniform Resource Identifiers (URIs) as defined in the Bulk Data Access IG Authorization Section specification.

  • ​System actors acting as servers SHALL include token_endpoint, scopes_supported, token_endpoint_auth_methods_supported and token_endpoint_auth_signing_alg_values_supported as defined in the Bulk Data Access IG Authorization Section specification.

  • ​When System actors act as clients (Backend Service App), they SHALL share their JSON Web Key Set (JWKS) with the server System actors (EHRs, Trusted Third Party and Central Cancer Registry) using Uniform Resource Locators (URLs) as defined in the Bulk Data Access IG Authorization Section specification.

  • ​System actors acting as clients SHALL obtain the access token as defined in the Bulk Data Access IG Authorization Section specification.

  • For the Central Cancer Registry Reporting use cases, EHRs SHALL support the system/*.read scopes.

  • The Central Cancer Registry SHALL support the system/.read and system/.write scopes.

  • The healthcare organization’s existing processes along with the EHRs authorization server SHALL verify consent and other policy requirements before allowing the Backend Service App to access the data to be included in the central cancer registry report.

Knowledge Artifact and Knowledge Artifact Repository Requirements

  • Central Cancer Registry SHALL create a Knowledge Artifact following the constraints identified by the MedMorph Provisioning requirements

  • Central Cancer Registry SHALL publish the value sets required to trigger a cancer report for a patient with an encounter diagnosis of cancer. This can be published in the Central Cancer Registry FHIR Server or a separate Knowledge Artifact Repository.

  • Central Cancer Registry SHALL republish the value sets when the list of concepts comprising the value sets change.

  • Central Cancer Registry SHALL create the Knowledge Artifact following the constraints identified in ccrr-plandefinition.

  • The Central Cancer Registry SHALL implement the Knowledge Artifact Repository requirements as outlined in the MedMorph RA Knowledge Artifact Repository Requirements.

EHR Requirements
Authorization requirements
Subscription requirements

  • EHRs SHALL support the creation of Subscriptions for the encounter-close Subscription Topic

  • EHRs SHALL support rest-hook Subscription channel to notify the Backend Service App.

  • EHRs SHALL support Notification Bundles with full resource payload as outlined in the Backport Subscriptions IG.

  • For the Central Cancer Registry Reporting Ig, EHRs SHALL include the Encounter resource which was closed as part of the Notification Bundle.

  • EHRs SHALL support operations and APIs for Subscription, Notification Bundle, Subscription status resources as outlined in the EHR Capability Statement.

Data API requirements
  • EHRs SHALL support the APIs as outlined in the EHR Capability Statement for the Backend Service App to access patient data.
BSA Requirements
Authorization requirements
Subscription requirements
Subscription Notification API
  • BSA SHALL support a POST API /receive-notification with a payload of the Subscription Notification Bundle to receive the notifications from the EHR.
Knowledge Artifact processing requirements

  • The BSA SHALL allow the healthcare organization to activate/deactivate a specific Knowledge Artifact. Activation indicates applying the Knowledge Artifact and deactivation indicates not applying the Knowledge Artifact for events occurring within the healthcare organization.

  • BSA SHALL process the MedMorph Central Cancer Registry Reporting Knowledge Artifact and create Subscription resources in the EHR for each trigger event.

  • For the Central Cancer Registry Reporting IG, the BSA SHALL create the Subscription for the encounter-close Subscription Topic trigger event.

  • Upon deactivation of a Knowledge Artifact, The BSA SHALL delete the Subscriptions previously created by the BSA for the Knowledge Artifact. (e.g delete the Subscription created for encounter-close trigger event)

  • The BSA SHALL implement FhirPath expression processing to process the Central Cancer Registry Reporting Knowledge Artifact actions.

  • The BSA SHALL use the default queries outlined by the Central Cancer Registry Reporting Knowledge Artifact unless overridden by the healthcare organization.

  • The BSA SHALL ensure no duplicate reports are submitted for the same patient and encounter occurring within a healthcare organization.

Data API requirements
  • The BSA acting as a client SHALL use the APIs as outlined in the EHR Capability Statement to access patient data from the EHR
Report generation requirements

  • The BSA SHALL create a central cancer registry report following the constraints identified in Central Cancer Registry Content Bundle.

  • The BSA SHALL package the central cancer registry report following the constraints identified in Central Cancer Registry Reporting Bundle.

  • The BSA SHALL submit the message containing the central cancer registry report to the endpoint identified in the MedMorph Central Cancer Registry Reporting Knowledge Artifact unless overridden by the healthcare organization.

MedMorph RA Requirements
Central Cancer Registry Requirements
Message Receiving and Processing requirements

  • The Central Cancer Registry Data Store SHALL implement the $process-message operation on the ROOT URL of the FHIR Server to receive reports from the Backend Service App using the POST operation.

  • Upon receipt of the message, the Central Cancer Registry Data Store SHALL validate the message before accepting the message.

  • When there are validation failures, the Central Cancer Registry Data Store SHALL return an Operation Outcome response with the details of the validations as part of the POST response.

  • The Central Cancer Registry SHALL implement the PHA requirements as outlined in the MedMorph PHA requirements.

Trusted Third Party Requirements
Message Receiving and Processing requirements

  • Trusted Third Parties SHALL implement the $process-message operation on the ROOT URL of the FHIR Server to receive reports from the Backend Service App using the POST operation.

  • Upon receipt of the message, the Trusted Third Parties MAY validate the message before accepting the message.

  • When the message is validated and there are validation failures, Trusted Third Parties SHALL return an Operation Outcome response with the details of the validations as part of the POST response.

  • Once a message is accepted by a Trusted Third Party without errors, the Trusted Third Party will have to route the message to the Central Cancer Registry.

  • The TTP SHALL implement the Trusted Third Party requirements as outlined in the MedMorph RA TTP requirements.