CDMH FHIR IG Proposal

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Approved 2018-08-08


PutProposedIGNameHere

Common Data Model Harmonization for Research FHIR Implementation Guide

Owning work group name

BR&R

Committee Approval Date:

2018-05-17

Contributing or Reviewing Work Groups

  • None

FHIR Development Project Insight ID

1424

Scope of coverage

The project is relevant to FDA Researchers who are trying to access data from multiple research networks using multiple data models. The project is sponsored by FDA and ONC to create the implementation guide. The pilot organizations from different networks including Sentinel, PCORnet are working with FDA to implement the approach and provide feedback.

The data that is being accessed by the FDA Researchers currently is limited to Clinical Data elements and includes the ONC 2015 Common Clinical Data Set, information about PROs, information about trial participation.

The project will specifically perform the following • Create and update FHIR profiles which can be used to represent the data that is being accessed by the researchers, The profiles will be based on US Core and CDM Mappings. • Update the DAF-Research IG which has already created some of these profiles.

IG Purpose

The current landscape for data access by researchers from multiple data marts is very cumbersome as mappings and translation tools are required to enable data access with each data mart as every data mart has a different representation of the data using a different model. This project aims to harmonize these data models to a single model in order to • Create Queries for identification of specific cohorts • Translating these queries to the 4 different models using mappings that are provided • Creating query results using the native formats • Translating the results into a common format and providing a FHIR output for researchers to develop further tools.


Content location

https://github.com/HL7/cdmh


Proposed IG realm and code

us/cdmh

Maintenance Plan

The current funding for the project expires in September 2019.

The plan is to use a model similar to US Core where the initial content is developed and adopted by various pilot organizations and networks and then transition the Implementation guide to the BR&R work group long term.

Short Description

The CDMH FHIR IG provides the guidance necessary to map the four common data models namely Sentinel, PCORnet CDM, i2b2 and OMOP to FHIR resources and profiles.

Long Description

The current landscape for data access by researchers from multiple data marts is very cumbersome as mappings and translation tools are required to enable data access with each data mart as every data mart has a different representation of the data using a different model. This project aims to harmonize these data models to a single model in order to • Create Queries for identification of specific cohorts • Translating these queries to the 4 different models using mappings that are provided • Creating query results using the native formats • Translating the results into a common format and providing a FHIR output for researchers to develop further tools.


Involved parties

FDA

ONC

Expected implementations

Multiple Hospital Organizations already participating in PCORnet.

Content sources

US Core

DAF-Research

Example Scenarios

  • FDA Researchers would like to create a query that can extract data about patients taking certain drugs for cancer from research networks which have different data models being used.

IG Relationships

Reusing US Core IG profiles where applicable.

Adding profiles of profiles based on US Core IG.

Reusing the DAF Research IG Capabilities C3 and C4 that have been already elaborated.

The DAF Research IG mappings to the various models and FHIR will be updated and republished.

Timelines

Ballot for Comment in September 2018 Cycle

STU Ballot in January 2019 Cycle

The project timelines are driven by pilots that are being conducted currently in a limited fashion.

After the current pilots are done, the feedback obtained from the pilots will be incorporated into the IG which will then be balloted for STU for a larger number of pilots across the FDA eco-system.

All of the above activities are driven by the end date of September 2019 before which a robust IG is expected to be published that can be leveraged by new PCOR projects as they get spun up.

When IG Proposal Is Complete

When you have completed your proposal, please send an email to FMGcontact@HL7.org

FMG Notes