Difference between revisions of "CRN FHIR IG Proposal"
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| − | This page documents a [[:category: | + | This page documents a [[:category:Approved FHIR IG Proposal|Approved]] [[:category:FHIR IG Proposal|FHIR IG Proposal]] |
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[[Category:FHIR IG Proposal]] | [[Category:FHIR IG Proposal]] | ||
| − | [[Category: | + | [[Category:Approved FHIR IG Proposal]] |
| + | Approved 2018-08-08 | ||
<!-- For additional guidance on considerations for resource creation, refer to [[FHIR IG Considerations]] --> | <!-- For additional guidance on considerations for resource creation, refer to [[FHIR IG Considerations]] --> | ||
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==FHIR Development Project Insight ID== | ==FHIR Development Project Insight ID== | ||
| − | + | 1426 | |
==Scope of coverage== | ==Scope of coverage== | ||
| + | |||
| + | The project is relevant to the following Women's Health Registries which include | ||
| + | |||
| + | * COMPARE-UF, | ||
| + | * PFDR, | ||
| + | * CREST !!! , | ||
| + | * AUGS, | ||
| + | * SUFU and other Sterilization Registries. | ||
| + | |||
| + | These registries will be monitoring Women's Health on the use of devices and implants and other procedures for conditions such as Uterine Fibroids, Pelvic Floor Disorders, Mesh treatments and other sterilization therapies related to Women's Health. | ||
The IG is going to use the following resources to enable CRN work | The IG is going to use the following resources to enable CRN work | ||
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* Device | * Device | ||
* US Core profiles | * US Core profiles | ||
| − | |||
==IG Purpose== | ==IG Purpose== | ||
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==Proposed IG realm and code== | ==Proposed IG realm and code== | ||
| − | + | us/womens-health-registries | |
==Maintenance Plan== | ==Maintenance Plan== | ||
<!-- What commitment does the WG have to maintaining this IG as the FHIR core specification continues to evolve - particularly if the initial project sponsors are no longer providing resources --> | <!-- What commitment does the WG have to maintaining this IG as the FHIR core specification continues to evolve - particularly if the initial project sponsors are no longer providing resources --> | ||
| + | |||
| + | The current funding for the project expires in September 2019. | ||
| + | |||
| + | The intention is to follow the US Core Model, where the IG is developed and piloted by the various registries and then working with BR&R and CCRF transfer the ownership of the IG to the relevant HL7 WG as it has long term implications and can be used by registries in general beyond Women's Health Registries. | ||
==Short Description== | ==Short Description== | ||
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FDA | FDA | ||
| + | |||
ONC | ONC | ||
==Expected implementations== | ==Expected implementations== | ||
| − | Registry Pilots expected. | + | Registry Pilots expected. |
| + | |||
| + | * AUGS, | ||
| + | * SUFU etc. | ||
==Content sources== | ==Content sources== | ||
| − | SDC FHIR IG | + | SDC FHIR IG profiles for Questionnaire and QuestionnaireResponse as needed. |
| − | + | ||
| + | US Core profiles for clinical data as applicable and needed. | ||
==Example Scenarios== | ==Example Scenarios== | ||
| Line 102: | Line 121: | ||
==IG Relationships== | ==IG Relationships== | ||
| − | + | Reuse the SDC FHIR IG profiles for Questionnaire and QuestionnaireResponse as needed. | |
| + | |||
| + | Reuse the PRO FHIR IG APIs for Administering an instrument and collecting data. | ||
| + | |||
| + | Reuse the US Core profiles for clinical data as applicable and needed. | ||
==Timelines== | ==Timelines== | ||
| − | + | Ballot for Comment in September 2018 Cycle | |
| − | STU Ballot for | + | |
| + | STU Ballot in January 2019 Cycle | ||
| + | |||
| + | The project timelines are driven by the registries planning to establish their infrastructure for data collection. Some of them have established infrastructure but are evaluating efficient mechanisms to use data collected during clinical care by EHRs. The IG will provide a target infrastructure for these registries that are getting setup from an interoperable technology stand point. Lack of an official IG impacts the infrastructure planning for pilots and downstream activities. | ||
| + | |||
| + | The pilots are expected to start in the later part of the year and provide feedback to be incorporated into the IG prior to September 2019 at which point a robust IG is expected to exist that is implemented by many of the registries. | ||
==When IG Proposal Is Complete== | ==When IG Proposal Is Complete== | ||
| Line 113: | Line 141: | ||
==FMG Notes== | ==FMG Notes== | ||
| + | * Would like the non-data element piece broken out into a separate implmentation guide in the future. This is consistent with proposed FDA direction | ||
Latest revision as of 04:51, 9 August 2018
This page documents a Approved FHIR IG Proposal
Approved 2018-08-08
Contents
- 1 PutProposedIGNameHere
- 1.1 Owning work group name
- 1.2 Committee Approval Date:
- 1.3 Contributing or Reviewing Work Groups
- 1.4 FHIR Development Project Insight ID
- 1.5 Scope of coverage
- 1.6 IG Purpose
- 1.7 Content location
- 1.8 Proposed IG realm and code
- 1.9 Maintenance Plan
- 1.10 Short Description
- 1.11 Long Description
- 1.12 Involved parties
- 1.13 Expected implementations
- 1.14 Content sources
- 1.15 Example Scenarios
- 1.16 IG Relationships
- 1.17 Timelines
- 1.18 When IG Proposal Is Complete
- 1.19 FMG Notes
PutProposedIGNameHere
Womens Health Technology Coordinated Registry Network
Owning work group name
Committee Approval Date:
2018-06-12
Contributing or Reviewing Work Groups
- O&O
- CIC
FHIR Development Project Insight ID
1426
Scope of coverage
The project is relevant to the following Women's Health Registries which include
- COMPARE-UF,
- PFDR,
- CREST !!! ,
- AUGS,
- SUFU and other Sterilization Registries.
These registries will be monitoring Women's Health on the use of devices and implants and other procedures for conditions such as Uterine Fibroids, Pelvic Floor Disorders, Mesh treatments and other sterilization therapies related to Women's Health.
The IG is going to use the following resources to enable CRN work
- Questionnaire
- QuestionnaireResponse
- Device
- US Core profiles
IG Purpose
A landscape analysis of women’s health related registries have identified the lack of standardization in the capturing and exchange of data elements that can be used for multiple outcome research related use cases. The ability to link and query multiple registries will increase the effectiveness of the registries when used by researchers. In order to make this feasible, an interoperable standards-based platform is essential so that one can administer instruments*, collect data and exchange data from EHRs and other Health IT systems with Registries. In order to achieve this the following specific needs have been identified: • Identify and define data elements in a common format that will be used for defining the instrument. • Identify and outline the mechanisms to create data collection instruments based on standards. • Identify and outline the mechanisms to administer the instrument and collect the data. • Identify and outline the mechanisms to store and exchange the captured data with Registries and other Researchers. • Identify and outline mechanisms that can be used to link registries to increase the efficiencies and effectiveness.
Content location
https://github.com/HL7/coordinated-registry-network
Proposed IG realm and code
us/womens-health-registries
Maintenance Plan
The current funding for the project expires in September 2019.
The intention is to follow the US Core Model, where the IG is developed and piloted by the various registries and then working with BR&R and CCRF transfer the ownership of the IG to the relevant HL7 WG as it has long term implications and can be used by registries in general beyond Women's Health Registries.
Short Description
The purpose of the IG to provide the necessary guidance to use FHIR to build registries specific to monitoring Womens Health.
Long Description
A landscape analysis of women’s health related registries have identified the lack of standardization in the capturing and exchange of data elements that can be used for multiple outcome research related use cases. The ability to link and query multiple registries will increase the effectiveness of the registries when used by researchers. In order to make this feasible, an interoperable standards-based platform is essential so that one can administer instruments*, collect data and exchange data from EHRs and other Health IT systems with Registries. In order to achieve this the following specific needs have been identified: • Identify and define data elements in a common format that will be used for defining the instrument. • Identify and outline the mechanisms to create data collection instruments based on standards. • Identify and outline the mechanisms to administer the instrument and collect the data. • Identify and outline the mechanisms to store and exchange the captured data with Registries and other Researchers. • Identify and outline mechanisms that can be used to link registries to increase the efficiencies and effectiveness.
Involved parties
FDA
ONC
Expected implementations
Registry Pilots expected.
- AUGS,
- SUFU etc.
Content sources
SDC FHIR IG profiles for Questionnaire and QuestionnaireResponse as needed.
US Core profiles for clinical data as applicable and needed.
Example Scenarios
- WHT Registries would like to collect various data elements related to Uterine Fibroids for women who have specific device implants over a period of time and use it for research purposes.
IG Relationships
Reuse the SDC FHIR IG profiles for Questionnaire and QuestionnaireResponse as needed.
Reuse the PRO FHIR IG APIs for Administering an instrument and collecting data.
Reuse the US Core profiles for clinical data as applicable and needed.
Timelines
Ballot for Comment in September 2018 Cycle
STU Ballot in January 2019 Cycle
The project timelines are driven by the registries planning to establish their infrastructure for data collection. Some of them have established infrastructure but are evaluating efficient mechanisms to use data collected during clinical care by EHRs. The IG will provide a target infrastructure for these registries that are getting setup from an interoperable technology stand point. Lack of an official IG impacts the infrastructure planning for pilots and downstream activities.
The pilots are expected to start in the later part of the year and provide feedback to be incorporated into the IG prior to September 2019 at which point a robust IG is expected to exist that is implemented by many of the registries.
When IG Proposal Is Complete
When you have completed your proposal, please send an email to FMGcontact@HL7.org
FMG Notes
- Would like the non-data element piece broken out into a separate implmentation guide in the future. This is consistent with proposed FDA direction
