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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Type Standard / Implementation Specification Standards Process Maturity Implementation Maturity Adoption Level Federally required Cost Test Tool Availability
Standard
Final
Production
Rating 4
No
Free
N/A
Standard
Final
Production
Rating 2
No
Free
N/A
Standard
Final
Production
Rating 3
No
Free
N/A
Standard
Final
Production
Rating 5
No
Free
N/A
Standard
Final
Production
Rating 1
No
Free
Yes
Standard
Final
Production
Rating 1
No
Free
N/A
Implementation Specification
Balloted Draft
Production
Rating 2
No
Free
N/A
Implementation Specification
Balloted Draft
Production
Rating 2
No
Free
N/A
Standard
Final
Feedback requested
Feedback Requested
No
Free
No
Implementation Specification
Final
Feedback requested
Feedback Requested
No
Free
No
Implementation Specification
Final
Feedback requested
Feedback Requested
No
Free
No
Emerging Standard
Balloted Draft
Feedback requested
Feedback Requested
No
Free
No
Limitations, Dependencies, and Preconditions for Consideration Applicable Value Set(s) and Starter Set(s)
  • Stakeholders should review 21CFR11 for more details.
  • See IHE projects in the Interoperability Proving Ground.
  • Feedback requested

Comment

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."