Integrate Healthcare and Clinical Research by Leveraging EHRs and other Health IT Systems while Preserving FDA’s 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 Security Patterns for Consideration
  • Stakeholders should review 21CFR11 for more details.
  • See IHE projects in the Interoperability Proving Ground.
  • Feedback requested