1.0 INTRODUCTION

1.1 Overview

The HITSP Remote Monitoring Observation Document Component describes the document content to convey medical information collected by remote healthcare monitoring devices for the purpose of information exchange. The content may include administrative (e.g., registration, demographics, insurance, etc.) and clinical (results, vital signs, etc.) information. This specification defines content in order to promote interoperability between participating systems. Such systems may include Personal Health Record (PHRs) systems, Electronic Health Record (EHRs) systems, Practice Management Applications and other persons and systems as identified and permitted. Any given system creating or consuming the document may contain much more information than conveyed by this specification. Thus any specific use of this Component by another HITSP specification may constrain the content further based upon the requirements and context of the document exchange.

Remote Monitoring Observation Documents are essentially a subset of the healthcare data that has been developed for specific business Use Cases. This subset contains the minimum critical or pertinent medical information of sections and data elements as specified by the business cases. A Remote Monitoring Observation Document must be a representative extract of the creating system. The information in the Remote Monitoring Observation Document and the creating system must be consistent. Furthermore there should be no data elsewhere in the creating system that would contradict the meaning of any data in the construct. The expectation is that consuming systems will be able use this construct as a source of information to input and/or update information in their instantiation of the patient record. This specification does not define the policies applicable to the import of this information.

1.2 Copyright Permissions

2009 ANSI. This material may be copied without permission from ANSI only if and to the extent that the text is not altered in any fashion and ANSIs copyright is clearly noted.

Certain materials contained in this Interoperability Specification are reproduced from Health Level Seven (HL7) Implementation Guide for CDA Release 2.0 Personal Health Monitoring Report (PHMR) DSTU Release 1 with permission of Health Level Seven, Inc. No part of the material may be copied or reproduced in any form outside of the Interoperability Specification documents, including an electronic retrieval system, or made available on the Internet without the prior written permission of Health Level Seven, Inc. Copies of standards included in this Interoperability Specification may be purchased from the Health Level Seven, Inc. Material drawn from these standards is credited where used.

1.3 Reference Documents

This section provides a list of key reference documents and background material.

A list of key reference documents and background material is provided in the table below. These documents can be retrieved from www.hitsp.org.

Table 1-1 Reference Documents

Reference Document	Document Description
HITSP Acronyms List	Lists and defines the acronyms used in this document
HITSP Glossary	Provides definitions for relevant terms used by HITSP documents
TN901 - Clinical Documents	TN901 is a reference document to provide the overall context for use of the HITSP Care Management and Health Records constructs

1.4 Conformance

This section describes the conformance criteria, which are objective statements of requirements that can be used to determine if a specific behavior, function, interface, or code set has been implemented correctly.

1.4.1 Conformance Criteria

In order to claim conformance to this construct specification, an implementation must satisfy all the requirements and mandatory statements listed in this specification, the associated HITSP Interoperability Specification, its associated construct specifications, as well as conformance criteria from the selected base and composite standards. A conformant system must also implement all of the required interfaces within the scope, subset or implementation option that is selected from the associated Interoperability Specification.

Claims of conformance may only be made for the overall HITSP Interoperability Specification or Capability with which this construct is associated.

1.4.2 Conformance Scoping, Subsetting and Options

A HITSP Interoperability Specification must be implemented in its entirety for an implementation to claim conformance to the specification. HITSP may define the permissibility for interface scoping, subsetting or implementation options by which the specification may be implemented in a limited manner. Such scoping, subsetting and options may extend to associated constructs, such as this construct. This construct must implement all requirements within the selected scope, subset or options as defined in the associated Interoperability Specification to claim conformance.

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