CDMH FHIR IG Proposal

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 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.

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.

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

U.S

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.

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.

When IG Proposal Is Complete

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