Patient Generated Health Data (PGHD) Working Group

[SCYou (Seng Chan You)]

@dave16884
I’m not familiar with CDISC SDTM model, but this thread might be helpful for you.

@mitrarocca

The goal of this project is to enable querying any of the 4 CDMs (Sentinel, PCORnet, OMOP and i2b2/ACT) leveraging an intermediary/über model and generate HL7 FHIR or CDISC standards (SDTM) as the output. This is a FDA-led initiative in collaboration with 3 Institutes at NIH as well as HHS/ONC and is one of the projects within the portfolio of the HHS/Assistant Secretary for Planning and Evaluation (ASPE) Patient-Centered Outcomes Research Trust Fund (PCORTF) program:https://aspe.hhs.gov/os-pcortf-funded-projectsBRIDG is a Domain Analysis Model (DAM) developed by FDA, NCI and is an ISO, HL7 and CDISC standard. BRIDG is implemented by a few biopharmaceutical companies, academia, FDA and NCI as the underlying model for Metadata Registry (MDR), rare disease registries, by a large CRO as the basis for a central canonical data model (CDM) to increase semantic consistency and quality across a diverse portfolio of products and services. For more information about BRIDG, it would be best to visit HL7’s Web site:HL7 Standards Product Brief - HL7 Version 3 Domain Analysis Model: Biomedical Research Integrated Domain Group (BRIDG), Release 5 | HL7 International