This page is part of the Womens Health Technology Coordinated Registry Network FHIR IG (v0.2.0: STU 1 Ballot 2) based on FHIR R4. . For a full list of available versions, see the Directory of published versions 
CapabilityStatements for the IG
- CRN Instrument and Metadata Repository Conformance Requirements
- External CRN Data Collection System Conformance Requirements
- Women’s Health Registry
- EHR or Other Health IT System Conformance Requirements
- GUDID Database Conformance Requirements
- Terminology System Conformance Requirements
This section outlines conformance requirements for each of the CRN actors which includes the specific profiles, operations, security mechanisms and search parameters that need to be supported.
CRN Instrument and Metadata Repository Conformance Requirements
The following are the conformance requirements for the CRN Instrument and Metadata Repository.
Behavior and Formats
The CRN Instrument and Metadata Repository SHALL:
- Implement the RESTful behavior according to the FHIR HTTP Specification.
- Support json resource formats for all CRN interactions.
- Declare a CapabilityStatement identifying the list of profiles, operations and search parameters supported.
Implementation Note The FHIR HTTP specification outlines specific requirements on how to deal with successful operations, invalid parameters, unauthorized request, insufficient scopes, unknown resources etc.
Profiles and Interactions
The CRN Instrument and Metadata Repository needs to implement the profile specific interactions as specified in the table below.
Implementation Note The way to read the table (e.g. the first row) is as follows
The CRN Instrument and Metadata Repository SHALL support the CREATE, READ, SEARCH operations, SHOULD support the vREAD and HISTORY operations for the SDC Questionnaire profile.
| Profile Name | create | read | search (type level) | vread | history (instance level) |
|---|---|---|---|---|---|
| SDC Questionnaire | SHALL | SHALL | SHALL | SHOULD | SHOULD |
| SDC Populatable Questionnaire | SHALL | SHALL | SHALL | SHOULD | SHOULD |
| SDC Extractable Questionnaire | SHALL | SHALL | SHALL | SHOULD | SHOULD |
| SDC Adaptive Questionnaire | SHALL | SHALL | SHALL | SHOULD | SHOULD |
Search and Other Parameters
The CRN Instrument and Metadata Repository needs to implement the search parameters as specified in the table below.
Implementation Note The way to read the table (e.g. the first row) is as follows
The CRN Instrument and Metadata Repository SHALL support _id, identifier, combination of identifier & version search parameters and _summary search result parameters for the SDC Questionnaire profile.
| Profile Name | SEARCH and Search Result parameters and combinations |
|---|---|
| All SDC Questionnaire profiles | _id (SHALL) |
| identifier (SHALL) | |
| identifier & version (SHALL) | |
| _summary (SHALL) |
Security Requirements
The CRN Instrument and Metadata Repository SHALL support the Communication security mechanisms outlined in FHIR Security Specification
The CRN Instrument and Metadata Repository SHALL support the Authenitication security mechanisms outlined in FHIR Security Specification
The CRN Instrument and Metadata Repository SHOULD support other security recommendations outlined in FHIR Security as appropriate.
External CRN Data Collection System Conformance Requirements
The following are the conformance requirements for the External CRN Data Collection System.
Behavior and Formats
The External CRN Data Collection System SHALL:
- Implement the RESTful behavior according to the FHIR HTTP Specification.
- Support json resource formats for all CRN interactions.
- Declare a CapabilityStatement identifying the list of profiles, operations and search parameters supported.
Implementation Note The FHIR HTTP specification outlines specific requirements on how to deal with successful operations, invalid parameters, unauthorized request, insufficient scopes, unknown resources etc.
Profiles and Interactions
The External CRN Data Collection System needs to implement the profile specific interactions as specified in the table below.
Implementation Note The way to read the table (e.g. the first row) is as follows
The External CRN Data Collection System SHALL support the CREATE, READ, SEARCH operations, SHOULD support the vREAD and HISTORY operations for the SDC Questionnaire profile.
| Profile/Resource Name | create | read | search (type level) | vread | history (instance level) |
|---|---|---|---|---|---|
| SDC Questionnaire | SHALL | SHALL | SHALL | SHOULD | SHOULD |
| SDC QuestionnaireResponse | SHALL | SHALL | SHALL | SHOULD | SHOULD |
| SDC Populatable Questionnaire - Note2 | SHOULD | SHOULD | SHOULD | SHOULD | SHOULD |
| SDC Extractable Questionnaire - Note2 | SHOULD | SHOULD | SHOULD | SHOULD | SHOULD |
| SDC Adaptive Questionnaire - Note2 | SHOULD | SHOULD | SHOULD | SHOULD | SHOULD |
| US Core Profiles - Note1 | MAY | MAY | MAY | MAY | MAY |
Note1: US Core Profiles are optional and only needs to be supported if the External CRN Data Collection System intends to auto populate the Questionnaire or extract data from QuestionnaireResponse.
Note2: The different variations of Questionnaire profiles are optional and only needed if the External CRN Data Collection System intends to autopopulate, transform collected data to FHIR Resources or administer adaptive questionnaires.
Search and Other Parameters
The External CRN Data Collection System needs to implement the search parameters as specified in the table below.
Implementation Note The way to read the table (e.g. the first row) is as follows
The External CRN Data Collection System SHALL support _id, identifier, combination of identifier & version search parameters and _summary search result parameters for the SDC Questionnaire profile.
| Profile Name | SEARCH and Search Result parameters and combinations |
|---|---|
| All SDC Questionnaire profiles | _id (SHALL) |
| identifier (SHALL) | |
| identifier & version (SHALL) | |
| _summary (SHALL) | |
| SDC QuestionnaireResponse | _id (SHALL) |
| identifier (SHALL) | |
| patient (SHALL) | |
| questionnaire (SHALL) | |
| author (SHALL) | |
| authored (SHALL) | |
| US Core profiles | SHOULD support Search parameters as specified by US Core |
Auto population options
External CRN Data Collection System SHOULD support the auto population of CRN instrument using the Questionnaire Populate operation leveraging the following techniques
- Use FHIRPath to determine auto population questions and resources. This is described further in SDC Populate Page.
- Using SMART on FHIR EHR launch sequence to obtain essential context data
- Query EHR using US Core profile APIs to extract the data necessary to populate the instrument
Transforming QuestionnaireResponse to FHIR Resources
Many systems deal with granular FHIR Resources such as Observations, Conditions, AllergyIntolerance, MedicationStatement etc and capturing information using these FHIR Resources will make the data available for many use cases. On the other hand when instruments are used to capture data in the form of QuestionnaireResponse and stored as QuestionnaireResponse, the data is not widely available for several use cases. In order to reuse the data for different use cases and make it available via appropriate FHIR Resources, the QuestionnaireResponse can be translated into FHIR Resources using the techniques outlined at SDC Extract Operations.
External CRN Data Collection System SHOULD support the SDC Extract Operations to transform data from QuestionnaireResponse to FHIR Resources.
Administering Adaptive Questionnaires and PRO Measures
External CRN Data Collection System SHOULD use the PRO FHIR IG capabilities to administer Adaptive Questionnaires and PRO Measures.
Security Requirements
The External CRN Data Collection System SHALL support the Communication security mechanisms outlined in FHIR Security Specification
The External CRN Data Collection System SHALL support the Authentication security mechanisms outlined in FHIR Security Specification
The External CRN Data Collection System SHOULD support other security recommendations outlined in FHIR Security as appropriate.
SMART on FHIR App Interactions
For External CRN Data Collection System interacting with EHRs to receive patient and other clinical context data from the EHR the following requirements apply:
The External CRN Data Collection System SHALL support the EHR Launch Sequence from the SMART on FHIR App Authorization guide as a client.
The External CRN Data Collection System SHALL request information from EHR during EHR Launch Sequence using tokens and parameters for US Core profiles as a client.
In order to store collected CRN data in the EHR, The External CRN Data Collection System SHALL use create interaction for the SDC QuestionnnaireResponse profile with the EHR as the target system. (i.e. the External App will do a POST to the EHR FHIR endpoint to store the QuestionnaireResponse data).
Women’s Health Registry
The following are the conformance requirements for the Womens Health Registry actor.
Behavior and Formats
The Women’s Health Registry SHALL:
- Implement the RESTful behavior according to the FHIR HTTP Specification.
- Support json resource formats for all CRN interactions.
- Declare a CapabilityStatement identifying the list of profiles, operations and search parameters supported.
Implementation Note The FHIR HTTP specification outlines specific requirements on how to deal with successful operations, invalid parameters, unauthorized request, insufficient scopes, unknown resources etc.
Profiles and Interactions
The Women’s Health Registry needs to implement the profile specific interactions as specified in the table below.
Implementation Note The way to read the table (e.g. the first row) is as follows
The Women’s Health Registry SHALL support the CREATE, READ, SEARCH operations, SHOULD support the vREAD and HISTORY operations for the SDC Questionnaire profile.
| Profile/Resource Name | create | read | search (type level) | vread | history (instance level) |
|---|---|---|---|---|---|
| SDC Questionnaire | SHALL | SHALL | SHALL | SHOULD | SHOULD |
| SDC QuestionnaireResponse | SHALL | SHALL | SHALL | SHOULD | SHOULD |
| US Core Profiles - Note1 | SHOULD | SHOULD | SHOULD | SHOULD | SHOULD |
Note1: US Core Profiles are optional and only needs to be supported if the Women’s Health Registry receives data in the form of US Core profiles or if it transforms the QuestionnaireResponse to other FHIR Resources.
Search and Other Parameters
The Women’s Health Registry needs to implement the search parameters as specified in the table below.
Implementation Note The way to read the table (e.g. the first row) is as follows
The Women’s Health Registry SHALL support _id, identifier, combination of identifier & version search parameters and _summary search result parameters for the SDC Questionnaire profile.
| Profile Name | SEARCH and Search Result parameters and combinations |
|---|---|
| All SDC Questionnaire profiles | _id (SHALL) |
| identifier (SHALL) | |
| identifier & version (SHALL) | |
| _summary (SHALL) | |
| SDC QuestionnaireResponse | _id (SHALL) |
| identifier (SHALL) | |
| patient (SHALL) | |
| questionnaire (SHALL) | |
| author (SHALL) | |
| authored (SHALL) | |
| US Core profiles | SHOULD support Search parameters as specified by US Core |
Transforming QuestionnaireResponse to FHIR Resources
Many systems deal with granular FHIR Resources such as Observations, Conditions, AllergyIntolerance, MedicationStatement etc and capturing information using these FHIR Resources will make the data available for many use cases. On the other hand when instruments are used to capture data in the form of QuestionnaireResponse and stored as QuestionnaireResponse, the data is not widely available for several use cases. In order to reuse the data for different use cases and make it available via appropriate FHIR Resources, the QuestionnaireResponse can be translated into FHIR Resources using the techniques outlined at SDC Extract Operations.
Womens Health Registry SHOULD support the SDC Extract Operations to transform data from QuestionnaireResponse to FHIR Resources in cases where the sender does not create the necessary FHIR Resources.
Security Requirements
The Women’s Health Registry SHALL support the Communication security mechanisms outlined in FHIR Security Specification
The Women’s Health Registry SHALL support the Authentication security mechanisms outlined in FHIR Security Specification
The Women’s Health Registry SHOULD support other security recommendations outlined in FHIR Security as appropriate.
Feedback Required Should we require the use of SMART on FHIR Backend Services specification for interactions between the External CRN Data Collection System and the Womens Health Registry or leave it open ended until we get more experience using implementations ?
EHR or Other Health IT System Conformance Requirements
The following are the conformance requirements for the EHR or Other Health IT System.
Behavior and Formats
The EHR or Other Health IT System SHALL:
- Implement the RESTful behavior according to the FHIR HTTP Specification.
- Support json resource formats for all CRN interactions.
- Declare a CapabilityStatement identifying the list of profiles, operations and search parameters supported.
Implementation Note: The FHIR HTTP specification outlines specific requirements on how to deal with successful operations, invalid parameters, unauthorized request, insufficient scopes, unknown resources etc.
Profiles and Interactions
The EHR or Other Health IT System needs to implement the profile specific interactions as specified in the table below.
Implementation Note The way to read the table (e.g. the first row) is as follows
The EHR or Other Health IT System SHALL support the READ, SEARCH operations,and MAY support the vREAD, CREATE and HISTORY operations for the US Core profiles.
| Profile/Resource Name | create | read | search (type level) | vread | history (instance level) |
|---|---|---|---|---|---|
| US Core Profiles - Note1 | MAY | SHALL | SHALL | MAY | MAY |
Note1: US Core profiles are required to be supported by the EHR in order to facilitate the auto population of the CRN instrument.
Search and Other Parameters
The EHR or Other Health IT System needs to implement the search parameters as specified in the table below.
| Profile Name | SEARCH and Search Result parameters and combinations |
|---|---|
| US Core profiles | SHOULD support Search parameters as specified by US Core |
Security Requirements
The EHR or Other Health IT System SHALL support the Communication security mechanisms outlined in FHIR Security Specification
The EHR or Other Health IT System SHALL support the Authentication security mechanisms outlined in FHIR Security Specification
The EHR or Other Health IT System SHOULD support other security recommendations outlined in FHIR Security as appropriate.
SMART on FHIR App Interactions
For EHR or Other Health IT Systems supporting the collection of PRO data using External PRO Administration System by passing patient context information the following requirements apply.
The EHR or Other Health IT System SHALL support the EHR Launch Sequence from the SMART on FHIR App Authorization guide applicable to the EHR.
The EHR or Other Health IT System SHALL support information retrieval during EHR Launch Sequence using tokens and parameters for US Core profiles
GUDID Database Conformance Requirements
The following are the conformance requirements for the GUDID database.
Behavior and Formats
The GUDID database SHALL:
- Implement the RESTful behavior according to the FHIR HTTP Specification.
- Support json resource formats for all CRN interactions.
- Declare a CapabilityStatement identifying the list of profiles, operations and search parameters supported.
Implementation Note: The FHIR HTTP specification outlines specific requirements on how to deal with successful operations, invalid parameters, unauthorized request, insufficient scopes, unknown resources etc.
Profiles and Interactions
The GUDID database needs to implement the profile specific interactions as specified in the table below.
Implementation Note The way to read the table (e.g. the first row) is as follows
The GUDID database SHALL support the READ, SEARCH operations,and MAY support the vREAD, CREATE and HISTORY operations for the device-crn profile.
| Profile/Resource Name | create | read | search (type level) | vread | history (instance level) |
|---|---|---|---|---|---|
| device-crn profile | MAY | SHALL | SHALL | MAY | MAY |
| devicedefinition-crn profile | MAY | SHALL | SHALL | MAY | MAY |
Search and Other Parameters
The GUDID database needs to implement the search parameters as specified in the table below.
| Profile Name | SEARCH and Search Result parameters and combinations |
|---|---|
| device-crn | udiCarrier (DI) - SHALL |
| devicedefinition-crn | udiCarrier (DI) - SHALL |
Security Requirements
The GUDID database SHALL support the Communication security mechanisms outlined in FHIR Security Specification
The GUDID database SHALL support the Authentication security mechanisms outlined in FHIR Security Specification
The GUDID database SHOULD support other security recommendations outlined in FHIR Security as appropriate.
Terminology System Conformance Requirements
The following are the conformance requirements for the Terminology System
Behavior and Formats
The Terminology System SHALL:
- Implement the RESTful behavior according to the FHIR HTTP Specification.
- Support json resource formats for all CRN interactions.
- Declare a CapabilityStatement identifying the list of profiles, operations and search parameters supported.
Implementation Note The FHIR HTTP specification outlines specific requirements on how to deal with successful operations, invalid parameters, unauthorized request, insufficient scopes, unknown resources etc.
Profiles and Interactions
The Terminology System *SHALL support the CodeSystems and ValueSets along with their FHIR operations required for the CRN IG. needs to implement the profile specific interactions as specified in the table below.
Security Requirements
The Terminology System SHALL support the Communication security mechanisms outlined in FHIR Security Specification
The Terminology System SHALL support the Authentication security mechanisms outlined in FHIR Security Specification
The Terminology System SHOULD support other security recommendations outlined in FHIR Security as appropriate.
