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

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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 Health IT systems.  It’s a conversion to CDISC structures and terminologies."