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Healhcare Information Technology Standards Panel

HealthCare Information Technology Standards Panel

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HITSP operates under contract to the U.S. Department of Health and Human Services (HHS).

Requirements Design and Standards Selection

RDSS 144 - HITSP Clinical Research Requirements, Design and Standards Selection

This Requirements, Design, Standards Selection document focuses on ways in which electronic health record (EHR) data can support global clinical research activities. Specifically, the exchange of a core set of patient-level clinical information between EHRs and clinical research (CR) systems. This HITSP work product was informed by the prior work of HL7, CDISC, and IHE; testing and demonstrations of EHR and clinical research cooperation at four IHE Connectathons and three HIMSS Interoperability Showcase demonstrations, two real world implementations, and the functional profile developed by the EHR-CR collaborative of PhRMA and eClinical Forum.

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Construct	Title / Version	Referenced by	Status	Document Access
RDSS 144	HITSP Clinical Research Requirements, Design and Standards Selection Version:1.0		Public Comment	DOWNLOAD

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Reference Documents

Acronyms
AHIC Use Cases
Conventions (naming and numbering)
Glossary
Harmonization Framework
Interoperability Specifications Overview