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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :HL7 Announces Industry’s First EHR-S Functional Requirements Standar.. 2009-11-09 06:28:30 
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Subject :HL7 Announces Industry’s First EHR-S Functional Requirements Standard for Clinical Research

Dear all,
 
Standards development organization Health Level Seven has published an electronic health record standard for clinical research.

The Electronic Health Record System Functional Requirements Standard for Clinical Research identifies functionality requirements for using EHR data in regulated clinical research and offers a roadmap for integrating information to support patient care and clinical research processes.

The American National Standards Institute has approved the standard.

The new standard could serve as a resource for the Certification Commission for Health IT as it develops new clinical research certification criteria for EHR systems. For details of press release click here
 
Best Regards,
 
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