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Medical Device Data Sharing with Enterprise Health Systems

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Medical Device Data Sharing with Enterprise Health Systems Cross Paradigm Implementation Guide

This cross-paradigm implementation guide is intended to support implementers and enable the exchange of medical device reported data with HER systems capable of exchange standard based messages, documents, and resources HL7 Meaningful Use IGs (e.g. CDA R2 C-CDA 2.1 IG, Hl7 Version 2 LRI) and emerging IGs (e.g. FHIR Data Access Framework – DAF). This project both reuses and expands the contents of the HL7 Version 3 Domain Analysis Model (DAM): Detailed Clinical Models for Medical Devices (DCM4MD), Release 1 as the basis for requirements and additional constraints to CDA, HL7 Version, and FHIR Implementation guides applicable in the US to improve support medical device interoperability.

This project builds upon the previous, DCM4MD Release 1, DAM, Domain Analysis Model (DAM) work to describe the information exchanged by medical devices with information systems using reusable Detailed Clinical Models (DCM. The DCMs are providing full semantics and structural description of measurements, settings, and other events reported by devices using standard clinical terminology. The analysis process associated with DAMs is used here to identify the context and content of DCMs as units of information intended to enable interoperability across devices and systems. The DCMs and the associated DAM enable semantic interoperability for medical device measurements across devices and information system regardless of the information exchange standard used to move the information across (e.g. HL7 Version 2.x, HL7 CDA, etc.). The revised DAM is intended to improve consensus building regarding interoperability requirements and workflow automation between the business stakeholders, clinicians, vendors, and integrators (both IT and clinical engineering) by involving the involving the clinicians in the definition of information relevant to interoperability with medical devices.

Project Scope Statement

CrossParadigm_IG_Medical_Device_interoperability.v2.docx - this version was discussed/approved on 11/14/2016.

Approach and Links

Based on the DAM, the project team will harmonize existing specifications including Vital Signs profile definition ( to develop consistent guidance to implementers using HL7 standards to convey medical device observation to information systems and EHR systems.

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