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As an introduction to the Healthcare Information Technology Standards Panel (HITSP) Immunizations and Response Management Interoperability Specification, this section provides a high level overview of the information sharing scenario enabled by following this specification, provides a document map of the construct relationships for the Interoperability Specification, acknowledges the copyright protections that pertain, and provides a list of key reference documents and background material.
This section provides a high level definition of this Interoperability Specification and background information about the underlying Use Case that it is based upon.
The HITSP Immunizations and Response Management Interoperability Specification is created to be architecture neutral. It is intended to support current interoperability approaches installed between Electronic Health Records (EHRs) and Immunization Information Systems while allowing for a migration toward emerging interoperability implementations and document sharing environments where Personal Health Records (PHRs) are able to be included in the information flow. The Interoperability Specification also allows for basic electronic information exchanges to enable requirement communications and alerting mechanisms and to lay the foundation for future clinical support capabilities. These requirements and alerts are largely unstructured at this time pending further standardization efforts.
NOTE: All of the Immunizations and Response Management Use Case requirements have not been resolved at this time. The reader is referred to this specification, Section 3.1 Scope of Design for scoping details.
Each HITSPInteroperability Specification (IS)is comprised of a suite of constructs that, taken as a whole, define how to integrate and constrain existing standards and specifications to satisfy the requirementsimposed by a given Use Case. TheIS groups specific actions and actors to describe the relevant context(s) for the use ofHITSP constructs that further identify and constrain standards where necessary. In addition to ISs, there are three other types of HITSP constructs called Transaction Packages (TP), Transactions (T), andComponents (C). The document map in Figure 1-1depicts how this IS integrates and constrains HITSP constructs to support the information exchange, within the defined context of the Use Case. Implementers should read the documents that describe the constructs depicted in the diagram for their details and specific uses. Note that the baseline Security and Privacy constructs are not shown in the diagram, however, they are described in Table 1-1.
Figure 1-1 Interoperability Specification Document Map
The following table lists and describes the HITSP constructs that are used by the Interoperability Specification. All references to HITSP specifications are to the current, and Panel approved Released for Implementation versions of the specifications retrieved from www.hitsp.org.
Where HITSP has adopted HL7 V3.0 CDA/CCD for conveying information between Electronic Health Record (EHR) and Personal Health Record (PHR) applications and in other healthcare scenarios, it has consolidated common constraints applied against the Content Modules in HITSP/C83CDA Content Modules.Likewise,HITSP/C80 Clinical Document and Message Terminology maintains commonly applied terminology constraints. Readers should refer to HITSP/TN901 Technical Note for Clinical Documents to better understand how HITSP/C83 and HITSP/C80 are used by other constructs that are based upon HL7 V3.0 CDA/CCD (e.g., HITSP/C32Summary Documents Using HL7 Continuity of Care Document (CCD), HITSP/C48Encounter Document Using IHE Medical Summary (XDS-MS) and HITSP/C84 Consult and History & Physical Note).
Table 1-1 List of Constructs
|
Construct |
Description |
|
HITSP/C19 - Entity Identity Assertion |
The Entity Identity Assertion Component provides the mechanisms to ensure that an entity is the person or application that claims the identity provided. An example of this Component is the validation and assertion of a consumer logging on to a Personal Health Record (PHR) system |
|
HITSP/C26 - Nonrepudiation of Origin |
The Nonrepudiation of Origin Component provides the mechanisms to support Nonrepudiation of Origin, which refers to both the proof of the integrity and origin of documents in a high-assurance manner, which can be verified by any party. This Component does not provide Nonrepudiation of Receipt |
|
HITSP/C62 - Unstructured Document |
The Unstructured Document Component is provided for the capture and storage of patient identifiable, unstructured document content, such as text, PDF, and images rendered in PDF. It is based on the Cross-Enterprise Sharing of Scanned Documents (XDS-SD) profile from the Integrating the Healthcare Enterprise (IHE) IT Infrastructure Technical Framework (ITI-TF) |
|
HITSP/C70 - Immunization Query and Response |
The Immunization Query and Response Component is used for a message based exchange of immunization information. It specifies the use of HL7 Version 2.3.1 Query for Vaccination Record (VXQ), to send a query from the message sender (clinician system, schools, IIS) to the message receiver (immunization registry) |
|
HITSP/C72 - Immunization Message |
The Immunization Message Component provides the capability to communicate an update to a patient's vaccination record. It is based upon the Centers for Disease Control and Prevention Implementation Guide for Immunizations Data Transaction using Version 2.3.1 of the Health Level Seven (HL7) Standard Protocol Implementation Guide Version 2.2 June 2006 |
|
HITSP/C78 - Immunization Document |
The Immunization Document Component defines the immunization data content to be exchanged between healthcare entities such as immunization information systems, electronic medical records systems, personal healthcare record systems and other stakeholders. It is based upon the IHE Patient Care Coordination (PCC) Technical Framework Supplement 2008-2009, Immunization Content (IC), Trial Implementation Version 1.0 |
|
HITSP/C80 - Clinical Document and Message Terminology |
The Clinical Document and Message Terminology Component defines the vocabularies and terminologies utilized by HITSP specifications for Clinical Documents and Messages used to support the interoperable transmission of information |
|
HITSP/C82 - Emergency Common Alerting Protocol |
The Emergency Common Alerting Protocol Component selects the OASIS Common Alerting Protocol (CAP) v1.1 standard, and is used as a multicast notification message sent to an identified channel. The intended recipients are populations such as all emergency departments in XXX county, within a geographic area, etc |
|
HITSP/C83 - CDA Content Modules |
The CDA Content Modules Component defines the content modules for document based HITSP constructs utilizing clinical information. These Content Modules are based on IHE PCC Technical Framework Volume II, Release 4. These technical frameworks contain specifications for document sections that are consistent with all implementation guides for clinical documents currently selected for HITSP constructs |
|
HITSP/C88 - Anonymize Immunizations and Response Management Data |
The Anonymize Immunizations and Response Management Data Component provides the ability to anonymize patient identifiable information for Immunization and Response Management. It provides specific instruction for anonymizing data that was created as part of routine clinical care delivery in preparation for repurposing the data. Anonymization, according to the International Organization for Standardization (ISO), is the process that removes the association between the identifying data set and the data subject |
|
HITSP/T15 - Collect and Communicate Security Audit Trail |
The Collect and Communicate Security Audit Trail Transaction is a means to provide assurance that security policies are being followed or enforced and that risks are being mitigated. This document describes the mechanisms to define and identify security relevant events and the data to be collected and communicated as determined by policy, regulation or risk analysis. It also provides the mechanism to determine the record format to support analytical reports that are needed |
|
HITSP/T16 - Consistent Time |
The Consistent Time Transaction provides a mechanism to ensure that all of the entities that are communicating within the network have synchronized system clocks |
|
HITSP/T17 - Secured Communication Channel |
The Secured Communication Channel Transaction provides the mechanisms to ensure the authenticity, integrity, and confidentiality of transmissions, and the mutual trust between communicating parties. Its objectives include providing: Mutual node authentication to assure each node of the others identity; Transmission integrity to guard against improper information modification or destruction while in transit; and Transmission confidentiality to ensure that information in transit is not disclosed to unauthorized individuals, entities, or processes |
|
HITSP/T23 - Patient Demographics Query |
The Patient Demographics Query Transaction is intended to provide a list patients and their demographics query/patient(s) and their demographics identified response message pair (QBP^Q22, RSP^K22) for use wherever such needs exist. This Transaction document extracts the Health Level Seven (HL7) version 2.5 Query and Response data mapping. The underlying basis for this extraction can be found in the Integrating the Healthcare Enterprise IT Infrastructure Technical Framework, Patient Demographics Query integration profile |
|
HITSP/T24- Pseudonymize |
The Pseudonymize Transaction is to describe a framework for including Pseudonymization Services where the use of dummy or pseudo references to specific patients or providers is required. Pseudo-identifiers are intended to allow accessibility to clinical information, while safeguarding any information that may compromise the privacy of the individual patient or provider. Using pseudo-identifiers can assist in compliance with HIPAA regulations regarding suppression of patient identification information |
|
HITSP/T29 - Notification of Document Availability |
The Notification of Document Availability Transaction is based on the Integrating the Healthcare Enterprise (IHE) IT Infrastructure Technical Framework (TF) Supplement - Notification of Document Availability (NAV). The Notification of Document Availability Transaction defines a mechanism for a healthcare stakeholder (e.g., provider, public health, etc) to notify providers or the patient about information that is available for retrieval pertaining to an identified patient. This Transaction defines the format, content, encoding and transmission of notification messages and acknowledgements between IHE NAV Actors and a known recipient (either a person or system) that participate in the same XDS Affinity Domain |
|
HITSP/T31 - Document Reliable Interchange |
The Document Reliable Interchange Transaction provides a standards-based mechanism for conveying a set of medical documents in a point-to-point network-based communication. This Transaction uses the IHE Cross-Enterprise Document Reliable Interchange (XDR) Integration Profile, a companion to the IHE Cross-Enterprise Document Sharing (XDS) Integration Profile. Cross-Enterprise Document Reliable Interchange (XDR) uses the XDS defined metadata formats in a simpler environment in which the communicating parties have agreed to a point-to-point interchange rather than communicating via document sharing |
|
HITSP/T33 - Transfer of Documents on Media |
The Transfer of Documents on Media Transaction describes both the type of media (CD-ROM, USB Memory, and e-Mail) that may be used to write the documents and provides a directory structure that must be followed in order for the contents to be successfully accessed and processed by systems. An example might be to transport data from one healthcare provider to another healthcare provider, or a healthcare consumer may wish to move the contents of a Personal Health Record (PHR) using physical media or e-mail. This Transaction uses the IHE Cross-Enterprise Document Media Interchange Integration Profile developed by Integrating the Healthcare Enterprise (IHE), a companion to the IHE Cross-Enterprise Document Sharing (XDS) Integration Profile |
|
HITSP/T63 - Emergency Message Distribution Element |
The Emergency Message Distribution Element Transaction selects the Emergency Data Exchange Language (EDXL) Distribution Element (DE) v1.0 standard, and is a multicast notification message sent to an identified population (it is assumed this is not to the general public, but to specifically identified populations, such as emergency departments) |
|
HITSP/T64 - Identify Communication Recipients |
The Identify Communication Recipients Transaction is intended to serve the purpose of identification of communication recipients and the subsequent purpose of delivery of alerts and bi-directional communications (e.g., public health agencies notifying a specific group of service providers about an event.) The method and criteria by which individuals are added to a directory is a policy decision, which is out of scope for this construct. It uses the Integrating the Healthcare Enterprise (IHE) Personnel White Pages profile which provides access to basic directory information for identifying one or more recipients |
|
HITSP/T66 - Retrieve Value Set |
The Retrieve Value Set Transaction is used to transform human or computer vocabularies. For example, it can be used to convert the initial capture of a human-readable concept into a computer vocabulary captured in a document or message that will be communicated. It may also be used in the reverse, to take computer vocabulary and convert to human-readable form |
|
HITSP/T81 - Retrieval of Medical Knowledge |
The Retrieval of Medical Knowledge Transaction enables the request and receipt of additional knowledge about a medical concept based on specific context parameters. This Transaction does not prescribe the knowledge content of the message returned but provides the specifications for the query for and receipt of additional knowledge. It uses the Health Level 7 (HL7) Context-Aware Information Retrieval (Infobutton) Specification: URL Implementation Guide as the base standard for implementation |
|
HITSP/TP13 - Manage Sharing of Documents |
The Manage Sharing of Documents Transaction Package supports the sharing of patient records in the form of source attested objects called documents. A healthcare document is a composite of structured and coded health information, both narrative and tabular, that describes acts, observations and services for the purpose of exchange. No assumption is made by this construct in terms of the format and structure of the content of documents shared |
|
HITSP/TP20 - Access Control |
The Access Control Transaction Package provides the mechanism for security authorizations which control the enforcement of security policies including: role-based access control; entity based access control; context based access control; and the execution of consent directives. An example of this is a functional role that has the permission to perform an act (e.g., consumer updating a Personal Health Record (PHR). In an emergency, this construct must support the capability to alter access privileges to the appropriate level (failsafe/emergency access), which may include override of non-emergency consents |
|
HITSP/TP21 - Query for Existing Data |
The Query for Existing Data Transaction Package is based on the IHE Query for Existing Data Integration Profile (QED) which supports dynamic queries for clinical data, including vital signs, problems, medications, immunizations, diagnostic results, procedures and visit history. A wide variety of systems often needs access to dynamic clinical information stored and maintained in an EMR system or other clinical data repository. The construct makes the information widely available to other systems within and across enterprises to support provision of better clinical care |
|
HITSP/TP22 - Patient ID Cross-Referencing |
The Patient ID Cross-Referencing Transaction Package is used for identifying and cross-referencing different attributes for the same patient. It contains a query for cross-reference and patient identity feed transactions. These transactions are used to identify patients from a list of potentials, and/or to communicate patient demographic data |
|
HITSP/TP30 - Manage Consent Directives |
The Manage Consent Directives Transaction Package describes the messages needed to capture, manage, and communicate rights granted or withheld by a consumer to one or more identified entities in a defined role to access, collect, use or disclose Individually Identifiable Health Information (IIHI), and also supports the delegation of the patients right to consent. The transactions described in this construct are intended to be carried out by HITSP/TP13 - Manage Sharing of Documents |
COPYRIGHT NOTICE
2008 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.
Materials reproduced from the Accredited Standards Committee (ASC) X12 Standards Release 004010 with permission of Washington Publishing Company (WPC). Copies of the Implementation Guide may be purchased from WPC at www.wpc-edi.com.
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 WPC. Material drawn from these standards is credited where used.
ASTM International materials used in this document have been extracted, with permission from E1762-95 (2003) Standard Guide for Electronic Authentication of Health Care Information, copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428. Copies of this standard are available through the ASTM Web Site at www.astm.org.
Excerpts from the Centers for Disease Control and Prevention Implementation Guide for Immunization Data Transactions using Version 2.3.1 of the Health Level Seven (HL7) Standard Protocol Version 2.2 are reproduced here with the assistance of the Centers for Disease Control and Prevention. This information is in the public domain and copies can be obtained at www.cdc.gov/vaccines .
DICOM materials used in this document have been extracted from relevant copyrighted materials with permission of the Digital Imaging and Communication Standards Committee. Copies of this standard may be retrieved from DICOM at medical.nema.org.
Certain materials contained in this Interoperability Specification are reproduced from Health Level Seven (HL7) Version 3.0 Context-Aware Information Retrieval Specification: URL Implementation Guide, HL7 Version 2.5, Chapter 2 Control, Chapter 3 Patient Administration, Chapter 5 Query, Health Level Seven (HL7) Clinical Document Architecture (CDA) Release 2.0, Health Level Seven (HL7) Common Terminology Services (CTS) Release 1, Health Level Seven (HL7) Implementation Guide for CDA Release 2: History and Physical Notes, Health Level Seven (HL7) Implementation Guide for CDA Release 2: Consultation Note, HL7 Implementation Guide: CDA Release 2 - Continuity of Care Document (CCD), HL7 Version 2.3.1, HL7 Role Based Access Control (RBAC) Healthcare Permissions Catalog, HL7 Version 2.3.1 Chapter 2 Control, Chapter 3 Patient Administration, HL7 Version 2.5, Chapter 2 Control, Chapter 3 Patient Administration, Chapter 5 Query, HL7 Version 2.5.1, HL7 Version 3.0, HL7 Version 3.0 Infrastructure Management - Query Infrastructure, Release 2 DSTU Ballot 1 - September 2008, HL7 Version 3.0 Privacy Consent related specifications and HL7 Version 3.0 Standard: Transport Specification - Web Services Profile, Release 2 Committee Ballot 1 - May 2008 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.
IHE materials used in this document have been extracted from relevant copyrighted materials with permission of Integrating the Healthcare Enterprise (IHE) International. Copies of this standard may be retrieved from the IHE Web Site at www.ihe.net.
ISO materials used in this document have been extracted from relevant copyrighted materials with permission of the International Organization for Standardization (ISO). Copies of these standards are available from ISO at www.iso.org .
This material includes SNOMED Clinical Terms (SNOMED CT) which is used by permission of the International Health Terminology Standards Development Organisation (IHTSDO). All rights reserved. SNOMED CT was originally created by The College of American Pathologists.
"SNOMED" and "SNOMED CT" are registered trademarks of the IHTSDO.
OASIS materials used in this document have been extracted from relevant copyrighted materials with permission of the Organization for the Advancement of Structured Information Standards (OASIS). Copies of this standard are available from OASIS at www.oasis-open.org.
This section provides a list of key reference documents and background material. If you are already familiar with this information, proceed to Section 2.0.
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 1-2 Reference Documents
|
Construct |
Description |
|
HITSP Acronyms List |
Lists and defines the acronyms used in this document |
|
HITSP Conventions List |
Describes the conventions that are used to convey the full descriptions and usage of standards in the HITSP specifications |
|
HITSP Interoperability Specification Overview |
Provides background information about the HITSP and its role in the overall U.S. efforts to realize large scale interoperability of health information. The document also provides a description of the HITSP process for healthcare standards harmonization and explains how to use the Interoperability Specifications and other related documents to inform your health IT system development or refinement |
|
HITSP Glossary |
Provides definitions for relevant terms used by HITSP documents |
|
HITSP Harmonization Framework |
Describes the current framework within which the Interoperability Specifications are built |
|
Immunizations & Response Management, Detailed Use Case, March 21, 2008 |
AHIC Use Case that is the basis of this Interoperability Specification |
|
TN900 - Security and Privacy Technical Note |
Developed as a reference document to provide the overall context for use of the HITSP Security and Privacy constructs. It includes the following: The scope, reference policy background, and Security and Privacy principles used in the development of the constructs A detailed description and schematics of the conceptual relationship between the Security and Privacy constructs A mapping of existing standards and constructs to be used in meeting the stated requirements of the AHIC Use Cases A list of identified gaps and the recommended approaches to resolving those gaps A roadmap for how the Security and Privacy constructs will evolve and eventually align with other HITSP Interoperability Specifications A conceptual framework for Security and Privacy management, including reference information on privacy policies, risk assessment, and risk management A description of the application of the Security and Privacy constructs to the HITSP Interoperability Specifications for the three initial AHIC Use Cases Biosurveillance, Electronic Health Records - Laboratory Results Reporting, and Consumer Empowerment HITSP will periodically update this Technical Note as required by the introduction of new contexts for use. |
|
TN901 - Technical Note for Clinical Documents |
Developed as a reference document to provide the overall context for use of the HITSP Care Management and Health Records constructs.It includes the following: The scope, background, and principles for use in the development of the CMHR constructs A detailed description and schematics of the relationship between CMHR constructs A conceptual framework for the construction of clinical documents An overview of Clinical Document concepts An overview of Vocabulary concepts |
Specific to the Immunizations and Response Management Use Case, the following are referenced for source data requirements:
Standards:
Vaccine Management System (VACMAN)
Strategic National Stockpile Systems and Vendor Management Inventory Systems
American Immunization Registry Association (AIRA) Modeling of Immunization Registry Operations Workgroup (MIROW) Management of Moved or Gone Elsewhere (MOGE) Status and Other Patient Designations in Immunization Information Systems, December, 2005
American Immunization Registry Association (AIRA) Modeling of Immunization Registry Operations Workgroup (MIROW) Vaccination level deduplication in Immunization Information Systems, December, 2006
American Immunization Registry Association (AIRA) Modeling of Immunization Registry Operations Workgroup (MIROW). Data quality assurance in Immunization Information Systems: Incoming Data, February 2008
Documents:
Immunization Information Systems NVAC Progress Report, February 2007: www.hhs.gov
IIS Data Code Book:Error! Hyperlink reference not valid. www.immregistries.org prepared by The American Immunization Registry Association Data Definitions Working Group
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