Submission of Clinical Research Data Contained in EHRs and Other Systems for General Purpose or Preserving Specific FDA Requirements


Pharmacy HIT Collaborative's Comments on ONC's Proposed 2018 ISA

The Pharmacy HIT Collaborative supports the use of IHE-RFD (Retrieve Form for Data Capture), HL7 Clinical Document Architecture (CDA), Release 2.0, Final Edition, and CDISC Pharmacogeneomics/genetics (PGx) Implementation Guide.

On behalf of Wayne Kubick,…

On behalf of Wayne Kubick, CTO of Hl7: "I don’t understand why this section is here at all.  It’s not addressing all FDA requirements, and I don’t believe these are currently in use for actual integration.  I don’t even understand what the title means.  It’s misleading at best and hardly of practical use.  The last row on pharmacogenomics was approved, but I don’t see how it’s applicable for this activity, since there’s no use case involving EHRs or systems.  It’s a conversion to CDISC structures and terminologies."