Difference between revisions of "PCC TF-1/XPHR"

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==XPHR Integration Profile==
 
==XPHR Integration Profile==
 
The '''Exchange of Personal Health Record Content (XPHR)''' integration profile describes the content and format of summary information extracted from a PHR system used by a patient for import into healthcare provider information systems, and visa versa.  The purpose of this profile is to support interoperability between PHR systems used by patients and the information systems used by healthcare providers.
 
The '''Exchange of Personal Health Record Content (XPHR)''' integration profile describes the content and format of summary information extracted from a PHR system used by a patient for import into healthcare provider information systems, and visa versa.  The purpose of this profile is to support interoperability between PHR systems used by patients and the information systems used by healthcare providers.
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Content Consumer actors should verify the Digital Signature of the submission set before use of the information it contains.
 
Content Consumer actors should verify the Digital Signature of the submission set before use of the information it contains.
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== Folder Content Modules ==
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This section contains modules that describe the content requirements of XDS Folders.  At present, the IHE PCC Technical Framework has not defined any Folder Modules.
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== CDA Release 2.0 Content Modules ==
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This section contains content modules based upon the HL7 CDA Release 2.0 Standard, and related standards and/or implementation guides.
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Revision as of 11:28, 14 May 2007

HIMSS and RSNA
Integrating the Healthcare Enterprise

IHEBandW.png

IHE Patient Care Coordination

Technical Framework
Cross-Enterprise Sharing of Medical Summaries (XDS-MS) Integration Profile

Revision 2.0
2006-2007

Draft


Volume 1

HIMSS and RSNA
Integrating the Healthcare Enterprise

IHEBandW.png

IHE Patient Care Coordination

Technical Framework
Volume I

Revision 3.0
2008-2009

Public Comment



XPHR Integration Profile

The Exchange of Personal Health Record Content (XPHR) integration profile describes the content and format of summary information extracted from a PHR system used by a patient for import into healthcare provider information systems, and visa versa. The purpose of this profile is to support interoperability between PHR systems used by patients and the information systems used by healthcare providers. This profile does not address all the data exchange requirements of PHR systems. A PHR system may leverage other IHE Integration and Content Profiles for interoperability in addition to the XPHR Content Profile. For example, a PHR Systems may implement XDS-MS to import medical summaries produced by EHR systems, XDS-I to import imaging information, XDS-Lab to import laboratory reports, et cetera.

Exchange of Personal Health Record Content (XPHR)

Upon seeing a healthcare provider for the first time, patients are requested to provide a great deal of information, including, their address, telephone numbers, birth date, sex, marital status, emergency contacts, insurance information, a medical and family history, and current medications and allergies. This information is also reviewed and updated on subsequent visits. This information is usually obtained by having the patient fill out one or more forms, whose contents are then manually transferred in to the information systems used by the healthcare provider. Automating this process will reduce transcription errors during the transfer of information, speed up the registration and check-in processes for patients, and also makes it possible for patients to have more participation in the management of their health information.

Providers also need to participate in helping patients to manage their healthcare information, however, providers should not be solely responsible for updating the patient's health record, since they often are only participating in a portion of the patient's overall health activities.

While PHR systems will allow patients to manage their healthcare information, and EHR and other information systems allow healthcare providers to manage the electronic records they maintain for their patients, but these two systems, operating separately, are not sufficient to allow patients and providers to collaborate in the care of the patient. What is needed is a way to integrate the activities of patients using a PHR system and healthcare providers using an EHR or other information system to provide for collaborative care between the patient and their provider.

The XPHR profile is intended to provide a mechanism for patients to supply the information most often requested by their healthcare providers, and to allow those same providers to assist patients in keeping their personal healthcare information up to date. It achieves this by allowing patients to provide a summary of their PHR information to providers, and gives providers a mechanism to suggest updates to the patient's PHR upon completion of a healthcare encounter.

Actors/Transaction

There are two actors in the XPHR profile, the Content Creator and the Content Consumer. Content is created by a Content Creator and is to be consumed by a Content Consumer. The sharing or transmission of content from one actor to the other is addressed by the appropriate use of IHE profiles described below, and is out of scope of this profile. A Document Source or a Portable Media Creator may embody the Content Creator Actor. A Document Consumer, a Document Recipient or a Portable Media Importer may embody the Content Consumer Actor. The sharing or transmission of content or updates from one actor to the other is addressed by the use of appropriate IHE profiles described in the section on Content Bindings with XDS, XDM and XDR.

XPHR Actor Diagram


Options

Actor Option
XPHR Options
Content Consumer View Option (1)
Document Import Option (1)
Section Import Option (1)
Discrete Data Import Option (1)
Content Creator Update Option
Note 1: The Actor shall support at least one of these options.

Content Consumer Options

View Option

This option defines the processing requirements placed on Content Consumers for providing access, rendering and management of the medical document. See the View Option in PCC TF-2 for more details on this option.

A Content Creator Actor should provide access to a style sheet that ensures consistent rendering of the medical document content as was displayed by the Content Consumer Actor.

The Content Consumer Actor shall be able to present a view of the document using this style sheet if present.

Document Import Option

This option defines the processing requirements placed on Content Consumers for providing access, and importing the entire medical document and managing it as part of the patient record. See the Document Import Option in PCC TF-2 for more details on this option.

Section Import Option

This option defines the processing requirements placed on Content Consumers for providing access to, and importing the selected section of the medical document and managing them as part of the patient record. See the Section Import Option in PCC TF-2 for more details on this option.

Discrete Data Import Option

This option defines the processing requirements placed on Content Consumers for providing access, and importing discrete data from selected sections of the medical document and managing them as part of the patient record. See the Discrete Data Import Option in PCC TF-2 for more details on this option.


Content Creator Options

Update Option

XD* Binding

It is expected that exchanges of PHR content will occur in an environment where the physician offices and hospitals have a coordinated infrastructure that serves the information sharing needs of this community of care. Several mechanisms are supported by IHE profiles:

  • A registry/repository-based infrastructure is defined by the IHE Cross-Enterprise Document Sharing (XDS) and other IHE Integration Profiles such as patient identification (PIX & PDQ), and notification of availability of documents (NAV).
  • A media-based infrastructure is defined by the IHE Cross-Enterprise Document Media Interchange (XDM) profile.
  • A reliable messaging-based infrastructure is defined by the IHE Cross-Enterprise Document Reliable Interchange (XDR) profile.
  • All of these infrastructures support Security and privacy through the use of the Consistent Time (CT) and Audit Trail and Node Authentication (ATNA) profiles.

For more details on these profiles, see the IHE IT Infrastructure Technical Framework, found here: http://www.ihe.net/Technical_Framework/.

Thus, implementors of the Content Consumer and Content Creator Actors must also implement either the ITI XDS, XDM or XDR Profiles to exchange content, using the bindings listed below.

XPHR Transactions and Content
Content Binding Actor Optionality
PHR Extract Module
PCC TF-2: 5.4.1.5
 Medical Document Binding to XD*
PCC TF-2: 4.1 		Content Creator R
Content Consumer R
PHR Update Module
PCC TF-2: 5.4.1.6 		Medical Document Binding to XD*
PCC TF-2: 4.1 		Content Creator O
Content Consumer R

XPHR Content Modules

PHR Extract Module

The content exchanged shall be structured and coded as required by the PHR Extract Module Content specified in PCC TF-2: 5.4.1.5. The Content Creator Actor creates a PHR Extract and shares it with the Content Consumer.

PHR Update Module

The content exchanged shall be structured and coded as required by the PHR Update Module Content specified in PCC TF-2: 5.4.1.6. The Content Creator Actor creates a PHR Update document as an addendum to a previously exchanged PHR Extract document. This Update is an addendum to the prior document, and reflects changes to that document that are suggested by the Content Creator Actor. A Content Consumer actor shall support viewing of an Update document, and may support import of the Update (see section 4.5.1 PHR Manager Options below) to reflect those changes to the PHR. The purpose of this content module is to provide a mechanism whereby healthcare providers, using applications that implement the Content Creator Actor, can suggest updates to a PHR for a patient.

XPHR Integration Profile Process Flow

One key use scenarios has been identified as an example. This use case originated in the Cross-Enterprise Document point-to-point Interchange (XDP) profile, and is reproduced here.

Personal Health Record (PHR) to ED/Primary Care EHR

Precondition: A patient is using a Personal Health Record application system at home for the record keeping of patient-originated medical information (e.g. social history, family history), snapshots of clinical information that may have been provided from previous care encounters (e.g. medication list, immunization records, etc), and current observations from home care medical devices (e.g. blood pressure, blood sugar level, etc).

Events: The patient requests their provider give them initial information to initialize their new PHR system. Later the patient does an extract of his PHR onto a portable media (USB key, CD) to bring to the care facility as a current set of medical data for the clinician. The patient experiences a medical condition requiring that he needs to present at the ED or his PCP for care. The ED physician or primary care physician receives the portable media from the patient and loads it an office PC to display and/or import, as desired, the information provided on the portable media. Following the encounter, the provider does an extract of appropriate data elements from the office EMR to yield a snapshot of the patient's medical record. This snapshot is then transferred to an interchange media for the patient to bring home and update his private PHR. The patient imports this document and uses the information in it to update the content of their PHR: e.g., by applying the changes recorded in the PHR Update appropriately .

Postcondition: The patient's PHR is up to date.

Basic Process Flow in XPHR Profile

Grouping with Other Actors

Cross Enterprise Document Sharing, Media Interchange and Reliable Messaging

The Content Creator and Content Consumer Actors shall be grouped with appropriate actors from the XDS, XDM or XDR integration profiles to support sharing of PHR Extracts and PHR Updates.

Document Digital Signature (DSG)

Content Creator actors should digitally sign all documents using the Digital Signature (DSG) Content Profile.

Content Consumer actors should verify the Digital Signature of the submission set before use of the information it contains.


Appendix A - Actor Descriptions

Actors are information systems or components of information systems that produce, manage, or act on information associated with operational activities in the enterprise.

Content Creator
The Content Creator Actor is responsible for the creation of content and transmission to a Content Consumer.
Content Consumer
A Content Consumer Actor is responsible for viewing, import, or other processing of content created by a Content Creator Actor.
Clinical Data Consumer
A clinical data consumer makes use of clinical patient data.
Clinical Data Source
A Clinical Data Sources maintains patient information about vital signs, problem and allergies, results from diagnostic tests (e.g., Lab, Imaging, or other test results), medications, immunizations or historical or planned visits and procedures.

Appendix B - Transaction Descriptions

Transactions are interactions between actors that transfer the required information through standards-based messages. The PCC Technical Framework does not define any specific transactions, as these are assumed to be carried out through the use of transactions defined in other IHE Profiles.

Query Existing Data
Request information about recent patient information, used to obtain vital signs measurements, problems and allergies, diagnostic results, medications, immunizations, or procedures or visits relevant for a patient. The query may request information about some or all of the above topics, or may request information on a specific topic, or one entered for a specific encounter or date range.


Appendix C - How to Prepare an IHE Integration Statement

IHE Integration Statements are documents prepared and published by vendors to describe the conformance of their products with the IHE Technical Framework. They identify the specific IHE capabilities a given product supports in terms of IHE actors and integration profiles described in the technical frameworks of each domain.

Users familiar with these concepts can use Integration Statements to determine what level of integration a vendor asserts a product supports with complementary systems and what clinical and operational benefits such integration might provide. Integration Statements are intended to be used in conjunction with statements of conformance to specific standards (e.g., HL7, IETF, DICOM, W3C, etc.).

IHE provides a process for vendors to test their implementations of IHE actors and integration profiles. The IHE testing process, culminating in a multi-party interactive testing event called the Connectathon, provides vendors with valuable feedback and provides a baseline indication of the conformance of their implementations. The process is not intended to independently evaluate, or ensure, product compliance. In publishing the results of the Connectathon and facilitating access to vendors' IHE Integration Statements, IHE and its sponsoring organizations are in no way attesting to the accuracy or validity of any vendor's IHE Integration Statements or any other claims by vendors regarding their products.

IMPORTANT -- PLEASE NOTE: Vendors have sole responsibility for the accuracy and validity of their IHE Integration Statements. Vendors' Integration Statements are made available through IHE simply for consideration by parties seeking information about the integration capabilities of particular products. IHE and its sponsoring organizations have not evaluated or approved any IHE Integration Statement or any related product, and IHE and its sponsoring organizations shall have no liability or responsibility to any party for any claims or damages, whether direct, indirect, incidental or consequential, including but not limited to business interruption and loss of revenue, arising from any use of, or reliance upon, any IHE Integration Statement.


Structure and Content of an IHE Integration Statement

An IHE Integration Statement for a product shall include:

  1. The Vendor Name
  2. The Product Name (as used in the commercial context) to which the IHE Integration Statement applies.
  3. The Product Version to which the IHE Integration Statement applies.
  4. A publication date and optionally a revision designation for the IHE Integration Statement.
  5. The following statement: "This product implements all transactions required in the IHE Technical Framework to support the IHE Integration Profiles, Actors and Options listed below:"
  6. A list of IHE Integration Profiles supported by the product and, for each Integration Profile, a list of IHE Actors supported. For each integration profile/actor combination, one or more of the options defined in the IHE Technical Framework may also be stated. Profiles, Actors and Options shall use the names defined by the IHE Technical Framework Volume I. (Note: The vendor may also elect to indicate the version number of the Technical Framework referenced for each Integration Profile.)

Note that implementation of the integration profile implies implementation of all required transactions for an actor as well as selected options.

The statement shall also include references and/or internet links to the following information:

  1. Specific internet address (or universal resource locator [URL]) where the vendor's Integration Statements are posted
  2. URL where the vendor's standards conformance statements (e.g., HL7, DICOM, etc.) relevant to the IHE transactions implemented by the product are posted.
  3. URL of the IHE Initiative's web page for general IHE information www.himss.org/ihe.

An IHE Integration Statement is not intended to promote or advertise aspects of a product not directly related to its implementation of IHE capabilities.

Format of an IHE Integration Statement

Each Integration Statement shall follow the format shown below. Vendors may add a cover page and any necessary additional information in accordance with their product documentation policies.

IHE Integration Statement Date 12 Oct 2005
Vendor Product Name Version
Any Medical Systems Co. IntegrateRecord V2.3
This product implements all transactions required in the IHE Technical Framework to support the IHE Integration Profiles, Actors and Options listed below:
Integration Profiles Implemented Actors Implemented Options Implemented
Cross-Enterprise Sharing of Medical Summaries Document Consumer View Option
Audit Trail and Node Authentication Secure Node none
Patient Identity Cross-referencing Patient Identifier Cross-reference Consumer PIX Update Notification
Internet address for vendor's IHE information:www.anymedicalsystemsco.com/ihe
Links to Standards Conformance Statements for the Implementation
HL7 www.anymedicalsystemsco.com/hl7
Links to general information on IHE
In North America: www.ihe.het In Europe: www.ihe-europe.org In Japan: www.jira-net.or.jp/ihe-j

IHE Integration Statement template

An IHE Integration Statement template (MS Word version) is available here.

The IHE Product Registry

The assumption of an integration statement is that all actors listed are functionally grouped and conform to any profile specifications for such groupings. In case of exceptions the vendor must explicitly describe the functional groupings.

IHE has developed a new Web-based database of Integration Statements. The IHE Product Registry enables developers to create, manage and publish Integration Statements for their commercial and open source healthcare IT systems. It allows users to browse for these systems based on their conformance with specific IHE Actors and Profiles. The system is open for use by developers and users now!

Appendix D - Braden Scale for Predicting Pressure Sore Risk

See File:Braden.pdf

Glossary

The following terms are used in various places within this technical framework, and are defined below. The complete IHE Glossary is available on the IHE Wiki at http://wiki.ihe.net/index.php/IHE_Glossary .

Actor
An entity within a use case diagram that can perform an action within a use case diagram. Possible actions are creation or consumption of a message
Acuity Assessment

Also known as triage category, this is the acuity of the patient assigned during the process of ED triage. A number of evidenced based triage scales exist, including the Emergency Severity Index (ESI), Canadian Triage and Acuity Scale (CTAS), the Australasian Triage Scale (ATS), and the Manchester Triage System. In many emergency departments, patients may simply be classified as emergent, urgent or non-urgent.

ADT
Admit, Discharge & Transfer.
Affinity Domain Policy
Affinity Domain Policy that clearly defines the appropriate uses of the XDS Affinity Domain. Within this policy is a defined set of acceptable use Privacy Consent Policies that are published and understood.
ASTM
Formerly the American Society of Testing and Materials, now ASTM International. An SDO that develops a number of standards across a wide variety of industries, including healthcare.
ATNA
Audit Trail and Node Authentication. An IHE ITI profile.
Care Context
The participations surrounding the care provision act, and the attributes of that act. Everything in the document header. Data history, links to clinical reasoning.
Continuity of Care Document(CCD)
An HL7 Clinical Document Architecture (CDA) implementation alternative to ASTM ADJE2369 for institutions or organizations committed to HL7 standards. This specification was developed as a collaborative effort between ASTM and HL7. More information is available from http://www.hl7.org.
Continuity of Care Record (CCR)
A core data set of the most relevant administrative, demographic, and clinical information facts about a patient’s healthcare, covering one or more encounters. The CCR is Designation E2369-05 of the ASTM (American Society for Testing and Materials, International). More information is available from http://www.astm.org.
Clinical Document Architecture (CDA)
An HL7 standard for the exchange for clinical documents. It specifies the structure and semantics of clinical documents. More information is available from http://www.hl7.org.
Content Binding
A content binding describes how the payload used in an IHE transaction is related to and/or constrained by the data elements contained within the content sent or received in those transactions.
CRS
Care Record Summary. An implementation guide that constrains CDA Release 2 for Care Record Summary documents.
CT
Consistent Time Integration Profile.
DICOM
Digital Imaging and Communication in Medicine
DSG
Digital Signatures. An IHE ITI Profile.
EDIS
An Emergency Department Information System (EDIS) is an extended EHR system used to manage data in support of Emergency Department patient care and operations. The functions of an EDIS may be provided by a single application or multiple applications.
eMPI
Enterprise Master Patient Index.
EMR
Electronic Medical Record, an Electronic Health Record system used within an enterprise to deliver care (also called EHR-CR by IHE-XDS).
Estimated Time of Arrival
the time the patient being referred can be expected to arrive in the emergency department.
EUA
Enterprise User Authentication Integration Profile.
Expected Actions
Actions which should occur as the result of a trigger event.
HIMSS
Healthcare Information and Management Systems Society.
HL7
Health Level Seven
HIS
Hospital Information System.
IHE
Integrating the Healthcare Enterprise.
Interaction Diagram
A diagram that depicts data flow and sequencing of events.
IT
Information Technology.
Logical Observation Identifiers Names and Codes (LOINC®)
A vocabulary developed by the Regenstrief Institute aimed at standardizing laboratory and clinical codes for use in clinical care, outcomes management, and research. Additional information found at http://www.regenstrief.org/medinformatics/loinc/.
Mode of Arrival
The method of transportation used to transport the patient to the Emergency Department.
MPI
Master Patient Index.
MRN
Medical Record Number.
NAV
Notification of Document Availability
OID
Object Identifier. (See also 'Globally Unique Identifier').
Patient Identifier Cross-reference Domain
Consists of a set of Patient Identifier Domains known and managed by a Patient Identifier Cross-reference Manager Actor. The Patient Identifier Cross-reference Manager Actor is responsible for providing lists of "alias" identifiers from different Patient Identifier Domains.
Patient Identifier Domain
A single system or a set of interconnected systems that all share a common identification scheme for patients. Such a scheme includes: (1) a single identifier-issuing authority, (2) an assignment process of an identifier to a patient, (3) a permanent record of issued patient identifiers with associated traits, and (4) a maintenance process over time. The goal of Patient Identification is to reduce errors.
PDF
Portable Document Format.
PIX
Patient Identifier Cross Referencing. An IHE ITI Profile.
PDQ
Patient Demographics Query. An IHE ITI Profile.
PHR
Personal Health Record
Procedure
In the context of a "Pre-procedure History and Physical," the "procedure" is a surgery or an invasive examination of a patient that is required by quality review organizations to be preceded by a pre-procedure assessment of procedure risk and anesthesia risk. This assessment is typically referred to as a "Pre-operative" or "Pre-procedure History and Physical."
Process Flow Diagram
A graphical illustration of the flow of processes and interactions among the actors involved in a particular example.
Proposed disposition
the intended disposition (i.e. admission to ICU, discharge to home, transfer to psychiatric hospital), if known, that the referring provider expects the patient will end up after the emergency department intervention.
Referral Source
An individual, group, or agency that determined the patient should seek care at the ED. Referral source may be used to determine appropriate discharge referrals and services, or to provide surveillance data for program and service planning, or to examine referral patterns.
Role
The actions of an actor in a use case.
RSNA
Radiological Society of North America.
sig.
A Latin abbreviation for signetur used to represent the instruction following the medication name.
Scope
A brief description of the transaction.

SNOMED-CT® A comprehensive clinical terminology, originally created by the College of American Pathologists (CAP) and, as of April 2007, owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a non-for-profit association in Denmark. The CAP continues to support SNOMED CT operations under contract to the IHTSDO and provides SNOMED-related products and services as a licensee of the terminology. More information available from http://www.ihtsdo.org/ or the United States National Library of Medicine at http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html

Transport Mode
the method the patient employs, or is provided to get to the emergency department.
Trigger Event
An event such as the reception of a message or completion of a process, which causes another action to occur.
UID
Unique Identifier (See also Globally Unique Identifier).
Universal ID
Unique identifier over time within the UID type. Each UID must belong to one of specifically enumerated species. Universal ID must follow syntactic rules of its scheme.
Use Case
A graphical depiction of the actors and operation of a system.
XUA
Cross Enterprise User Authentication
XDS
Cross Enterprise Document Sharing

Volume 2

HIMSS and RSNA
Integrating the Healthcare Enterprise

IHEBandW.png

IHE Patient Care Coordination

Technical Framework
Volume II

Revision 3.0
2008-2009

Public Comment


IHE Transactions

This section defines each IHE transaction in detail, specifying the standards used, and the information transferred.

Cross Enterprise Document Content Transactions

At present, all transactions used by the PCC Content Profiles appear in ITI TF-2. General Options defined in content profiles for a Content Consumer are described below.

View Option

A Content Consumer that supports the View Option shall be able to:

  1. Use the appropriate XD* transactions to obtain the document along with associated necessary metadata.
  2. Render the document for viewing. This rendering shall meet the requirements defined for CDA Release 2 content presentation semantics (See Section 1.2.4 of the CDA Specification: Human readability and rendering CDA Documents). CDA Header information providing context critical information shall also be rendered in a human readable manner. This includes at a minimum the ability to render the document with the stylesheet specifications provided by the document source, if the document source provides a stylesheet. Content Consumers may optionally view the document with their own stylesheet, but must provide a mechanism to view using the source stylesheet.
  3. Support traversal of links for documents that contain links to other documents managed within the sharing framework.
  4. Print the document to paper.
Document Import Option

This Option requires that the View Option be supported. In addition, the Content Consumer that supports the Document Import Option shall be able to support the storage of the entire document (as provided by the sharing framework, along with sufficient metadata to ensure its later viewing) both for discharge summary or referral documents. This Option requires the proper tracking of the document origin. Once a document has been imported, the Content Consumer shall offer a means to view the document without the need to retrieve it again from the sharing framework. When viewed after it was imported, a Content Consumer may chose to access the sharing framework to find out if the related Document viewed has been deprecated, replaced or addended.


Note: For example, when using XDS, a Content Consumer may choose to query the Document Registry about a document previously imported in order to find out if this previously imported document may have been replaced or has received an addendum. This capability is offered to Content Consumers by this Integration Profile, but not required, as the events that may justify such a query are extremely implementation specific.


Section Import Option

This Option requires that the View Option be supported. In addition, the Content Consumer that supports the Section Import Option shall be able to support the import of one or more sections of the document (along with sufficient metadata to link the data to its source) both for discharge summary or referral. This Option requires the proper tracking of the document section origin. Once sections have been selected, a Content Consumer shall offer a means to copy the imported section(s) into local data structures as free text. This is to support the display of section level information for comparison or editing in workflows such as medication reconciliation while discrete data import is not possible. When viewed again after it is imported, a Content Consumer may chose to access the sharing framework to find out if the related information has been updated.


Note: For example, when using XDS, a Content Consumer may choose to query the Document Registry about a document whose sections were previously imported in order to find out if this previously imported document may have been replaced or has received an addendum. This capability is offered to Content Consumers by this Integration Profile, but not required, as the events that may justify such a query are extremely implementation specific.


This Option does not require, but does not exclude the Content Consumer from offering a means to select and import specific subsets of the narrative text of a section.

Discrete Data Import Option

This Option does not require that the View, Import Document or Section Import Options be supported. The Content Consumer that supports the Discrete Data Import Option shall be able to support the storage of the structured content of one or more sections of the document. This Option requires that the user be offered the possibility to select among the specific sections that include structured content a set of clinically relevant record entries (e.g. a problem or an allergy in a list) for import as part of the local patient record with the proper tracking of its origin.


Note: The Discrete Data Import Option does not require the support of the View, Import Document or Import Sections Options so that it could be used alone to support implementations of Content Consumers such as Public Health Data or Clinical Research systems that might aggregate and anonymize specific population healthcare information data as Document Consumer Actors, but one where no care provider actually views the medical summaries.


When discrete data is accessed after it was imported, a Content Consumer may choose to check if the document related to the discrete data viewed has been deprecated, replaced or addended.

A Content Consumer Actor grouped with the XDS Document Source Actor may query the Document Registry about a document from which discrete data was previously imported in order to find out if this previously imported document may have been replaced or has received an addendum. This capability is offered to Content Consumers by this Integration Profile, but not required, as the events that may justify such a query are extremely implementation specific.

IHE Patient Care Coordination Bindings

This section describes how the payload used in a transaction of an IHE profile is related to and/or constrains the data elements sent or received in those transactions. This section is where any specific dependencies between the content and transaction are defined.

A content integration profile can define multiple bindings. Each binding should identify the transactions and content to which it applies.

The source for all required and optional attributes have been defined in the bindings below. Three tables describe the three main XDS object types: XDSDocumentEntry, XDSSubmissionSet, and XDSFolder. XDSSubmissionSet and XDSDocumentEntry are required. Use of XDSFolder is optional. These concepts are universal to XDS, XDR and XDM.

The columns of the following tables are:

  • <XXX> attribute – name of an XDS attribute, followed by any discussion of the binding detail.
  • Optional? - Indicates the required status of the XDS attribute, and is one of R, R2, or O (optional). This column is filled with the values specified in the XDS Profile as a convenience.
  • Source Type – Will contain one of the following values:
Source Type Description
SA Source document Attribute – value is copied directly from source document. The Source/Value column identifies where in the source document this attribute comes from. Specify the location in XPath when possible.
SAT Source document Attribute with Transformation – value is copied from source document and transformed. The Source/Value column identifies where in the source document this attribute comes from. Specify the location in XPath when possible. Extended Discussion column must not be empty and the transform must be defined in the extended discussion
FM Fixed (constant) by Mapping - for all source documents. Source/Value column contains the value to be used in all documents.
FAD Fixed by Affinity Domain – value configured into Affinity Domain, all documents will use this value.
CAD Coded in Affinity Domain – a list of acceptable codes are to be configured into Affinity Domain. The value for this attribute shall be taken from this list.
CADT Coded in Affinity Domain with Transform - a list of acceptable codes are to be configured into Affinity Domain. The value for this attribute shall be taken from this list.
n/a Not Applicable – may be used with an optionality R2 or O attribute to indicate it is not to be used.
DS Document Source – value comes from the Document Source actor. Use Source/Value column or Extended Discussion to give details.
O Other – Extended Discussion must be 'yes' and details given in an Extended Discussion.
  • Source/Value – This column indicates the source or the value used.

The following tables are intended to be summaries of the mapping and transforms. The accompanying sections labeled 'Extended Discussion' are to contain the details as necessary.

Medical Document Binding to XDS, XDM and XDR

This binding defines a transformation that generates metadata for the XDSDocumentEntry element of appropriate transactions from the XDS, XDM and XDR profiles given a medical document and information from other sources. The medical document refers to the document being stored in a repository that will be referenced in the registry. The other sources of information include the configuration of the Document Source actor, the Affinity Domain, the site or facility, local agreements, other documents in the registry/repository, and this Content Profile.

In many cases, the CDA document is created for the purposes of sharing within an affinity domain. In these cases the context of the CDA and the context of the affinity domain are the same, in which case the following mappings shall apply.

In other cases, the CDA document may have been created for internal use, and are subsequentyly being shared. In these cases the context of the CDA document would not neccessarily coincide with that of the affinity domain, and the mappings below would not necessarily apply.

Please note the specifics given in the table below.

XDSDocumentEntry Metadata

XDSDocumentEntry Attribute Optional? Source Type Source/ Value
availabilityStatus R DS  
authorInstitution R2 SAT

$inst <= /ClinicalDocument/author
/assignedAuthor
/representedOrganization

The authorInstitution can be formated
using the following XPath expression, where $inst in the expression below represents the representedOrganization.
concat($inst/name)

authorPerson R2 SAT

$person <= /ClinicalDocument/author

The author can be formatted using the following XPath expression, where $person in the expression below represents the author.
concat(
$person/id/@extension,"^",
$person/assignedPerson/name/family,"^",
$person/assignedPerson/name/given[1],"^",
$person/assignedPerson/name/given[2],"^",
$person/assignedPerson/name/suffix,"^",
$person/assignedPerson/name/prefix,"^",
"^^^&", $person/id/@root,"&ISO")

authorRole R2 SAT This metadata element should be based on a mapping of the participation function defined in the CDA document to the set of author roles configured for the affinity domain. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate:
/ClincicalDocument/author/
participationFunction
authorSpecialty R2 SAT This metadata element should be based on a mapping of the code associated with the assignedAuthor to detailed defined classification system for healthcare providers such configured in the affinitity domain. Possible classifications include those found in SNOMED-CT, or the HIPAA Healthcare Provider Taxonomy. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate:
/ClinicalDocument/author/
assignedAuthor/code
classCode R CADT Derived from a mapping of /ClinicalDocument/code/@code to an Affinity Domain specified coded value to use and coding system. Affinity Domains are encouraged to use the appropriate value for Type of Service, based on the LOINC Type of Service (see Page 53 of the LOINC User's Manual). Must be consistent with /ClinicalDocument/code/@code
classCodeDisplayName R CADT DisplayName of the classCode derived. Derived from a mapping of /ClinicalDocument/code/@code to the appropriate Display Name based on the Type of Service. Must be Consitent with /ClinicalDocument/code/@code
confidentialityCode R CADT Derived from a mapping of /ClinicalDocument/confidentialityCode/@code to an Affinity Domain specified coded value and coding system. When using the BPPC profile, the confidentialyCode may also be obtained from the <authorization> element.


/ClinicalDocument/
confidentialityCode/@code
-AND/OR-
/ClinicalDocument/authorization/
consent[
templateId/@root=
'1.3.6.1.4.1.19376.1.5.3.1.2.5'
] /code/@code

comments O DS  
creationTime R SAT /ClinicalDocument/effectiveTime


Times specified in clinical documents may be specified with a precision in fractional sections, and may contain a time zone offset. In the XDS Metadata, it can be precise to the second, and is always given in UTC, so the timezone offset if present must be added to the current time to obtain the UTC time.

entryUUID R DS  
eventCodeList O CADT These values express a collection of keywords that may be relevant to the consumer of the documents in the registry. They may come from anywhere in the CDA document, according to its purpose.
eventCodeDisplayNameList R
(if event
Code is valued) 		CADT These are the display names for the collection of keywords described above.
formatCode R FM The format code for each PCC Document content profile is provided within the document specifications.
healthcareFacilityTypeCode R CAD A fixed value assigned to the Document Source and configured form a set of Affinity Domain defined values. Must be concistent with /clinicalDocument/code
healthcareFacility
TypeCodeDisplay
Name 		R CAD Must be concistent with /clinicalDocument/code
intendedRecipient (for XDR, XDM) O SAT

$person <= /ClinicalDocument/intendedRecipient
and/or
$inst <= /ClinicalDocument/intendedRecipient/receivedOrganization

The intendedRecipient can be formated
using the following XPath expression, where $inst in the expression below represents the receivedOrganization and where $person in the expression below represents the intendedRecipient.
concat(
$person/id/@extension,"^",
$person/informationRecipient/name/family,"^",
$person/informationRecipient/name/given[1],"^",
$person/informationRecipient/name/given[2],"^",
$person/informationRecipient/name/suffix,"^",
$person/informationRecipient/name/prefix,"^",
"^^^&", $person/id/@root,"&ISO",
"|"
$inst/name)

"^^^^^&",
$inst/id/@root, "&ISO", "^^^^", $inst/id/@extension)
-->

languageCode R SA /ClinicalDocument/languageCode
legalAuthenticator O SAT $person <= /ClinicalDocument/
legalAuthenticator


The legalAuthenticator can be formatted using the following XPath expression, where $person in the expression below represents the legalAuthenticator.
concat(
$person/id/@extension,"^",
$person/assignedPerson/name/family,"^",
$person/assignedPerson/name/given[1],"^",
$person/assignedPerson/name/given[2],"^",
$person/assignedPerson/name/suffix,"^",
$person/assignedPerson/name/prefix,"^",
"^^^&", $person/id/@root,"&ISO")

mimeType R FM text/xml
parentDocumentRelationship R
(when applicable) 		DS Local document versions need not always be published, and so no exact mapping can be determined from the content of the CDA document.
The parentDocumentRelationship may be determined in some configurations from the relatedDocument element present in the CDA dsocument. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate:
/ClinicalDocument/relatedDocument/@typeCode
parentDocumentId R
(when parent
Document
Relationship is present) 		DS Local document versions need not always be published, and so no exact mapping can be determined from the content of the CDA document.
The parentDocumentId may be determined in some configurations from the relatedDocument element present in the CDA dsocument. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate:
$docID <= /ClinicalDocument/
relatedDocument/parentDocument/id


The parentDocumentId can be formatted using the following XPath expression, where $docID in the expression below represents the identifier.
concat($docID/@root,"^", $docID/@extension)

patientId R DS The XDS Affinity Domain patient ID can be mapped from the patientRole/id element using transactions from the ITI PIX or PDQ profiles. See sourcePatientId below. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate:


$patID <= /ClinicalDocument/recordTarget/
patientRole/id

practiceSettingCode R CAD This elements should be based on a coarse classification system for the class of specialty practice. Recommend the use of the classification system for Practice Setting, such as that described by the Subject Matter Domain in LOINC.
practiceSettingCodeDisplayName R CAD This element shall contain the display names associated with the codes described above.
serviceStartTime R2 SAT /ClinicalDocument/documentationOf/
serviceEvent/effectiveTime/low/
@value


Times specified in clinical documents may be specified with a precision in fractional sections, and may contain a time zone offset. In the XDS Metadata, it can be precise to the second, and is always given in UTC, so the timezone offset if present must be added to the current time to obtain the UTC time.

serviceStopTime R2 SAT /ClinicalDocument/documentationOf/
serviceEvent/effectiveTime/high/
@value


Times specified in clinical documents may be specified with a precision in fractional sections, and may contain a time zone offset. In the XDS Metadata, it can be precise to the second, and is always given in UTC, so the timezone offset if present must be added to the current time to obtain the UTC time.

sourcePatientId R SAT $patID <= /ClinicalDocument/recordTarget/
patientRole/id


The patientId can be formatted using the following XPath expression, where $patID in the expression below represents the appropriate identifier.
concat($patID/@extension,"^^^&", $patID/@root, "&ISO")

sourcePatientInfo R SAT /ClinicalDocument/recordTarget/
patientRole


The sourcePatientInfo metadata element can be assembled from various components of the patientRole element in the clinical document.

title O SA /ClinicalDocument/title
typeCode R CADT /ClinicalDocument/code/@code


The typeCode should be mapped from the ClinicalDocument/code element to a set of document type codes configured in the affinity domain. One suggested coding system to use for typeCode is LOINC, in which case the mapping step can be omitted.

typeCodeDisplay
Name 		R CADT /ClinicalDocument/code/@displayName
uniqueId R SAT $docID <= /ClinicalDocument/id


The uniqueId can be formatted using the following XPath expression, where $docID in the expression below represents the identifier.
concat($docID/@root,"^", $docID/@extension)

XDSSubmissionSet Metadata

The submission set metadata is as defined for XDS, and is not necessarily affected by the content of the clinical document. Metadata values in an XDSSubmissionSet with names identical to those in the XDSDocumentEntry may be inherited from XDSDocumentEntry metadata, but this is left to affinity domain policy and/or application configuration.

Use of XDS Submission Set

This content format uses the XDS Submission Set to create a package of information to send from one provider to another. All documents referenced by the Medical Summary in this Package must be in the submission set.

Use of XDS Folders

No specific requirements identified.

Configuration

IHE Content Profiles using this binding require that Content Creators and Content Consumers be configurable with institution and other specific attributes or parameters. Implementers should be aware of these requirements to make such attributes easily configurable. There shall be a mechanism for the publishing and distribution of style sheets used to view clinical documents.

Extensions from other Domains

Scanned Documents (XDS-SD)

XDS-SD is a CDA R2 document and thus conforms to the XDS Metadata requirements in the PCC-TF, volume 2, Section 5 unless otherwise specified below.

XDSDocumentEntry

XDS-SD leverages the XDS DocumentEntry Metadata requirements in the PCC-TF, volume 2, Section 5.1.1.1.1 and in PCC_TF-2/Bindings unless otherwise specified below

XDSDocumentEntry.formatCode

The XDSDocumentEntry.formatCode shall be urn:ihe:iti:xds-sd:pdf:2008 when the document is scanned pdf and urn:ihe:iti:xds-sd:text:2008 when the document is scanned text. The formatCode codeSystem shall be 1.3.6.1.4.1.19376.1.2.3.

XDSDocumentEntry.uniqueId

This value shall be the ClinicalDocument/id in the HL7 CDA R2 header. The root attribute is required, and the extension attribute is optional. In accordance with the XDS.a profile, total length is limited to 128 characters; for XDS.b the limit is 256 characters. Additionally see PCC-TF, volume 2, Section 5.1.1.1.1 or PCC_TF-2/Bindings for further content specification.

Relating instances of XDS-SD documents

In general, most instances of XDS-SD will not have parent documents. It is possible, however, in some specific use cases that instances of XDS-SD documents are related. For example, for a particular document it may be the case that both the PDF scanned content and somewhat equivalent plaintext need to be wrapped and submitted. Each document would correspond to separate XDSDocumentEntries linked via an XFRM Association that indicates one document is a transform of the other. These can be submitted in a single submission set, or in separate ones. Other specific examples may exist and this profile does not preclude the notion of a parent document for these cases.

XDSSubmissionSet

No additional constraints. Particular to this profile, a legitimate use of submission sets would be to maintain a logical grouping of multiple XDS-SD documents. We encourage such usage. For more information, see PCC-TF-2 Section 5.1.1.1.2 or PCC_TF-2/Bindings.

XDSFolder

No additional requirements. For more information, see PCC-TF-2 Section 5.1.1.1.3 or PCC_TF-2/Bindings.

Basic Patient Privacy Consents (BPPC)

Laboratory Reports (XD-LAB)

XD-Lab is a CDA R2 document and thus conforms to the XDS Metadata requirements in the PCC-TF, volume 2, Section 5 unless otherwise specified below.

XDSDocumentEntry

XD-Lab leverages the XDS DocumentEntry Metadata requirements in the PCC-TF, volume 2, Section 5.1.1.1.1 and in PCC_TF-2/Bindings unless otherwise specified below

XDSDocumentEntry.eventCodeList

XD-Lab documents further constrain the the XDSDocumentEntry.eventCodeList to the following.

XDSDocumentEntry
Attribute Optional? Source Type Source/ Value
eventCodeList R2 SAT ClinicalDocument / component / structuredBody / component / section / entry / act / entryRelationship / organizer (templateId="1.3.6.1.4.1.19376.1.3.1.1")/ component / observation(templateId="1.3.6.1.4.1.19376.1.3.1.1.1")/code

AND

ClinicalDocument / component / structuredBody / component / section / entry / act / subject / code

If the document has Reportable Condition, then this code shall be among those listed in the eventCodeList. Additionally, if the document contains information about a Non-Human Subject, then the code that indicates what this subject is shall be among those listed in the eventCodeList. Thus, this attribute has been enhanced from the XDS profile from O to R2.

XDSDocumentEntry.formatCode

The XDSDocumentEntry.formatCode shall be urn:ihe:lab:xd-lab:2008 The formatCode codeSystem shall be 1.3.6.1.4.1.19376.1.2.3.

XDSSubmissionSet

No additional constraints. For more information, see PCC-TF-2 Section 5.1.1.1.2 or PCC_TF-2/Bindings.

XDSFolder

No additional requirements. For more information, see PCC-TF-2 Section 5.1.1.1.3 or PCC_TF-2/Bindings.

Namespaces and Vocabularies

This section lists the namespaces and identifiers defined or referenced by the IHE PCC Technical Framework, and the vocabularies defined or referenced herein.

The following vocabularies are referenced in this document. An extensive list of registered vocabularies can be found at http://www.hl7.org/oid/.

Vocabularies Used
codeSystem codeSystemName Description
1.3.6.1.4.1.19376.1.5.3.1 IHE PCC Template Identifiers This is the root OID for all IHE PCC Templates. A list of PCC templates can be found below in CDA Release 2.0 Content Modules.
1.3.6.1.4.1.19376.1.5.3.2 IHEActCode See IHEActCode Vocabulary below
1.3.6.1.4.1.19376.1.5.3.3 IHE PCC RoleCode See IHERoleCode Vocabulary below
1.3.6.1.4.1.19376.1.5.3.4   Namespace OID used for IHE Extensions to CDA Release 2.0
2.16.840.1.113883.10.20.1 CCD Root OID Root OID used for by ASTM/HL7 Continuity of Care Document
2.16.840.1.113883.5.112 RouteOfAdministration See the HL7 RouteOfAdministration Vocabulary
2.16.840.1.113883.5.1063 SeverityObservation See the HL7 SeverityObservation Vocabulary
2.16.840.1.113883.5.7 ActPriority See the HL7 ActPriority Vocabulary
2.16.840.1.113883.6.1 LOINC Logical Observation Identifier Names and Codes
2.16.840.1.113883.6.96 SNOMED-CT SNOMED Controlled Terminology
2.16.840.1.113883.6.103 ICD-9CM (diagnosis codes) International Classification of Diseases, Clinical Modifiers, Version 9
2.16.840.1.113883.6.104 ICD-9CM (procedure codes) International Classification of Diseases, Clinical Modifiers, Version 9
2.16.840.1.113883.6.26 MEDCIN A classification system from MEDICOMP Systems.
2.16.840.1.113883.6.88 RxNorm RxNorm
2.16.840.1.113883.6.63 FDDC First DataBank Drug Codes
2.16.840.1.113883.6.12 C4 Current Procedure Terminology 4 (CPT-4) codes.
2.16.840.1.113883.6.257 Minimum Data Set for Long Term Care The root OID for Minimum Data Set Answer Lists
1.2.840.10008.2.16.4 DCM DICOM Controlled Terminology; PS 3.16 Content Mapping Resource, Annex D
2.16.840.1.113883.6.24 MDC ISO/IEEE 11073 Medical Device Nomenclature
2.16.840.1.113883.3.26.1.5 NDF-RT National Drug File Reference Terminology (NCI version)
2.16.840.1.113883.11.19465 nuccProviderCodes National Uniform Codes Council Healthcare Provider Terminology
2.16.840.1.113883.6.255.1336 X12DE1336 Insurance Type Code (ASC X12 Data Element 1336)
2.16.840.1.113883.6.256 RadLex RadLex (Radiological Society of North America)

The IHE FormatCode vocabulary is now managed in an Implementation Guide published using FHIR.

This FormatCode vocabulary represents:

  • Code System 1.3.6.1.4.1.19376.1.2.3
  • Value Set 1.3.6.1.4.1.19376.1.2.7.1

IHEActCode Vocabulary

CCD   ASTM/HL7 Continuity of Care Document
CCR   ASTM CCR Implementation Guide

The IHEActCode vocabulary is a small vocabulary of clinical acts that are not presently supported by the HL7 ActCode vocabulary. The root namespace (OID) for this vocabulary is 1.3.6.1.4.1.19376.1.5.3.2. These vocabulary terms are based on the vocabulary and concepts used in the CCR and CCD standards listed above.

Code Description
COMMENT This is the act of commenting on another act.
PINSTRUCT This is the act of providing instructions to a patient regarding the use of medication.
FINSTRUCT This is the act of providing instructions to the supplier regarding the fulfillment of the medication order.
IMMUNIZ The act of immunization of a patient using a particular substance or class of substances identified using a specified vocabulary. Use of this vocabulary term requires the use of either the SUBSTANCE or SUBSTCLASS qualifier described below, along with an identified substance or class of substances.
DRUG The act of treating a patient with a particular substance or class of substances identified using a specified vocabulary. Use of this vocabulary term requires the use of either the SUBSTANCE or SUBSTCLASS qualifier described below, along with an identified substance or class of substances.
INTOL An observation that a patient is somehow intollerant of (e.g., allergic to) a particular substance or class of substances using a specified vocabulary. Use of this vocabulary term requires the use of either the SUBSTANCE or SUBSTCLASS qualifier described below, along with an identified substance or class of substances.
SUBSTANCE A qualifier that identifies the substance used to treat a patient in an immunization or drug treatment act. The substance is expected to be identified using a vocabulary such as RxNORM, SNOMED CT or other similar vocabulary and should be specific enough to identify the ingredients of the substance used.
SUBSTCLASS A qualifier that identifies the class of substance used to treat a patient in an immunization or drug treatment act. The class of substances is expected to be identified using a vocabulary such as NDF-RT, SNOMED CT or other similar vocabulary, and should be broad enough to classify substances by mechanism of action (e.g., Beta Blocker), intended effect (Dieuretic, antibiotic) or ...


For Public Comment What else needs to appear above for SUBSTCLASS?


IHERoleCode Vocabulary

The IHERoleCode vocabulary is a small vocabulary of role codes that are not presently supported by the HL7 Role Code vocabulary. The root namespace (OID) for this vocabulary is 1.3.6.1.4.1.19376.1.5.3.3.

IHERoleCode Vocabulary
Code Description
EMPLOYER The employer of a person.
SCHOOL The school in which a person is enrolled.
AFFILIATED An organization with which a person is affiliated (e.g., a volunteer organization).
PHARMACY The pharmacy a person uses.

Folder Content Modules

This section contains modules that describe the content requirements of XDS Folders. At present, the IHE PCC Technical Framework has not defined any Folder Modules.

CDA Release 2.0 Content Modules

This section contains content modules based upon the HL7 CDA Release 2.0 Standard, and related standards and/or implementation guides.

CDA Document Content Modules

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Final.gif Medical Documents Specification 1.3.6.1.4.1.19376.1.5.3.1.1.1

This section defines the base set of constraints used by almost all medical document profiles described the PCC Technical Framework.



Standards
CDAR2 HL7 CDA Release 2.0
CDTHP CDA for Common Document Types History and Physical Notes (DSTU)
XMLXSL Associating Style Sheets with XML documents



Conformance

CDA Release 2.0 documents that conform to the requirements of this content module shall indicate their conformance by the inclusion of the appropriate <templateId> elements in the header of the document. This is shown in the sample document below.

Sample Medical Documents Document 
<ClinicalDocument xmlns='urn:hl7-org:v3'>
  <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>
  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.1'/>
  <id root=' ' extension=' '/>
  <code code=' ' displayName=' '
    codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
  <title>Medical Documents</title>
  <effectiveTime value='20240419012005'/>
  <confidentialityCode code='N' displayName='Normal' 
    codeSystem='2.16.840.1.113883.5.25' codeSystemName='Confidentiality' />
  <languageCode code='en-US'/>     
     :
  <component><structuredBody>
       
  </structuredBody></component>
</ClinicalDocument>

  

   <!-- Verify the document type code -->
   <assert test='cda:code[@code = "{{{LOINC}}}"]'>
     Error: The document type code of a Medical Documents must be {{{LOINC}}}
   </assert>
   <assert test='cda:code[@codeSystem = "2.16.840.1.113883.6.1"]'>
     Error: The document type code must come from the LOINC code 
     system (2.16.840.1.113883.6.1).
   </assert>
Specification

The constraints for encoding of the CDA Header (Level 1) can be found in the CDA for Common Document Types History and Physical Implementation Guide, in the section 2. CDA Header -- General Constraints.

  • IHE Medical Documents shall follow all constraints found in that section with the exception of the constraint on realmcode found in CONF-HP-15:.
  • IHE Medical Documents which are implemented for the US Realm shall follow ALL constraints found in that section, and shall use both the IHE Medical Document templateId (1.3.6.1.4.1.19376.1.5.3.1.1.1) and the HL7 General Header Constraints templateId (2.16.840.1.113883.10.20.3).}}
Realm Constraints Template IDs Required
Universal CONF-HP-1 through CONF-HP-14
CONF-HP-16 through CONF-HP-52		 1.3.6.1.4.1.19376.1.5.3.1.1.1
US CONF-HP-1 through CONF-HP-52 1.3.6.1.4.1.19376.1.5.3.1.1.1
2.16.840.1.113883.10.20.3
Style Sheets

Document sources should provide an XML style sheet to render the content of the Medical Summary document. The output of this style sheet shall be an XHTML Basic (see http://www.w3.org/TR/xhtml-basic/) document that renders the clinical content of a Medical Summary Document as closely as possible as the sending provider viewed the completed document. When a style sheet is provided, at least one processing instruction shall be included in the document that including a link to the URL for the XML style sheet. To ensure that the style sheet is available to all receivers, more than one stylesheet link may be included.

When a stylesheet is used within an XDS Affinity domain, the link to it shall be provided using an HTTPS or HTTP URL. 

<?xml-stylesheet href='https://foobar:8080/mystylesheet.xsl' type='text/xsl'?>


When using XDM or XDR to exchange documents, the stylesheet shall also be exchanged on the media. The link to the stylesheet shall be recorded as a relative URL. 

<?xml-stylesheet href='../../stylesheets/mystylesheet.xsl' type='text/xsl'?>


Style sheets should not rely on graphic or other media resources. If graphics other media resources are used, these shall be accessible in the same way as the stylesheet. The Content Creator need not be the provider of the resources (stylesheet or graphcs).

When a Content Creator provides a style sheet, Content Consumers must provide a mechanism to render the document with that style sheet. Content Consumers may view the document with their own style sheet.

To record the stylesheet within a CDA Document that might be used in both an XDS and XDM environment, more than one stylesheet processing instruction is required. In this case, all style sheet processing instructions included must include the alternate='yes' attribute. 

<?xml-stylesheet href='https://foobar:8080/mystylesheet.xsl' type='text/xsl' alternate='yes'?>
<?xml-stylesheet href='../../stylesheets/mystylesheet.xsl' type='text/xsl' alternate='yes'?>

A Content Consumer that is attempting to render a document using the document supplied stylesheet may use the first style sheet processing instruction for which it is able to obtain the style sheet content, and shall not report any errors if it is able to find at least one stylesheet to render with.

Distinctions of None

Information that is sent must clearly identify distinctions between

None
It is known with complete confidence that there are none. Used in the context of problem and medication lists, this indicates that the sender knows that there is no relevant information that can be sent.
None Known
None are known at this time, but it is not known with complete confidence than none exist. Used in the context of allergy lists, where essentially, it is impossible to prove the negative that no allergies exist, it is only possible to assert that none have been found to date.
None Known Did Ask
None are known at this time, and it is not known with complete confidence than none exist, but the information was requested. Also used in the context of allergy lists, where essentially, it is impossible to prove the negative that no allergies exist, it is only possible to assert that none have been found to date.
Unknown
The information is not known, or is otherwise unavailable.

In the context of CDA, sections that are required to be present but have no information should use one of the above phrases where appropriate.

An appropriate machine readable entry shall be present for problems, medications and allergies to indicate the reason that no information. Codes for recording unknown or no information are provided in the section on the Problem, Allergy and Medications Entry.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Trial.gif Medical Summary Specification 1.3.6.1.4.1.19376.1.5.3.1.1.2

A medical summary contains a snapshot of the patient's medical information, including at the very least, a list of the patients problems, medications and allergies. A Medical Summary is an abstract template that is expected to be further refined by additional document templates.


Parent Template

This document is an instance of the Medical Document template.

Standards
CDAR2 HL7 CDA Release 2.0


Specification
Data Element Name Opt Template ID
Problem Concern Entry R 1.3.6.1.4.1.19376.1.5.3.1.4.5.2
Allergy Concern Entry R 1.3.6.1.4.1.19376.1.5.3.1.4.5.3
Medications R 1.3.6.1.4.1.19376.1.5.3.1.4.7


Conformance

CDA Release 2.0 documents that conform to the requirements of this content module shall indicate their conformance by the inclusion of the appropriate <templateId> elements in the header of the document. This is shown in the sample document below. A CDA Document may conform to more than one template. This content module inherits from the Medical Document content module, and so must conform to the requirements of that template as well, thus all <templateId> elements shown in the example below shall be included.

Sample Medical Summary Document 
<ClinicalDocument xmlns='urn:hl7-org:v3'>
  <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>
  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.1'/>
  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.2'/>
  <id root=' ' extension=' '/>
  <code code=' ' displayName=' '
    codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
  <title>Medical Summary</title>
  <effectiveTime value='20240419012005'/>
  <confidentialityCode code='N' displayName='Normal' 
    codeSystem='2.16.840.1.113883.5.25' codeSystemName='Confidentiality' />
  <languageCode code='en-US'/>     
     :
  <component><structuredBody>
       
  </structuredBody></component>
</ClinicalDocument>
Schematron
<pattern name='Template_1.3.6.1.4.1.19376.1.5.3.1.1.2'>
 <rule context='*[cda:templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.1.2"]'>
   <!-- Verify that the template id is used on the appropriate type of object -->
   <assert test='../cda:ClinicalDocument'>
     Error: The Medical Summary can only be used on Clinical Documents.
   </assert> 
   <!-- Verify that the parent templateId is also present. -->
   <assert test='cda:templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.1.1"]'>
     Error: The parent template identifier for Medical Summary is not present.
   </assert> 
   <!-- Verify the document type code -->
   <assert test='cda:code[@code = "{{{LOINC}}}"]'>
     Error: The document type code of a Medical Summary must be {{{LOINC}}}
   </assert>
   <assert test='cda:code[@codeSystem = "2.16.840.1.113883.6.1"]'>
     Error: The document type code must come from the LOINC code 
     system (2.16.840.1.113883.6.1).
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.4.5.2"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Medical Summary Document must contain a(n) Problem Concern Entry Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.2
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.4.5.3"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Medical Summary Document must contain a(n) Allergy Concern Entry Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.2
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.4.7"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Medical Summary Document must contain a(n) Medications Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.2
   </assert> 
 </rule>
</pattern>
Document Specification

A medical summary is a type of medical document, and incorporates the constraints defined for Medical Documents, and requires the recording of Problems, Allergies and Medications.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Trial.gif PHR Extract Specification 1.3.6.1.4.1.19376.1.5.3.1.1.5

The PHR Extract module describes the document content that summarizes information contained within a Personal Health Record. While a PHR can contain a great deal more information (including clinical documents, lab reported, images, trend data, monitoring data) et cetera, this content module only deals with the format of the summary information from the PHR.

An PHR Extract Module is a type of medical summary, and incorporates the constraints defined for Medical Summaries. While mappings have been provided to various standards, this content module conforms to the ASTM/HL7 Continuity of Care Document as well as this guide.

The following table describes the data elements that may be present in a PHR Extract. The first column of this table is drawn from the Common Data Elements in the PHR found in Appendix B of the AHIMA Report: The Role of the Personal Health Record in the EHR. Indented items in this column of the table provide more detail for the item they appear underneath.

These data elements were then mapped to the ASTM CCR, HL7 CDA, CRS and CCD and the implicit data elements referenced by the HL7 PHR Conformance Criteria.

A further requirement of transfers of information between PHR and EHR systems is that authorship of the information stored within the PHR shall be tracable through the various import/export cycles. PHR Manager Actors must be secure nodes, which requires logging of any updates to or accesses of PHR information. The DSG profile should be used to ensure that information coming into, or exiting these systems is verifiably authored.


Format Code

The XDSDocumentEntry format code for this content is urn:ihe:pcc:xphr:2007

Parent Template

This document is an instance of the Medical Summary template.

LOINC Code

The LOINC code for this document is 34133-9 Summary of Episode Note

Standards
AHIMA-PHR AHIMA PHR Common Data Elements
CDAR2 HL7 CDA Release 2.0
CRS HL7 Care Record Summary
CCD ASTM/HL7 Continuity of Care Document
HL7-PHR HL7 PHR Functional Model (Draft)
LOINC Logical Observation Identifier Names and Codes
Data Element Index
AHIMA Common Data Elements ASTM Continuity of Care Record HL7 Clincial Document Architecture, Care Record Summary or Continuity of Care Document HL7 PHR Conformance Criteria
Personal Information Patient patientRole Demographic Information
Name Patient patient/name Demographic Information
Address Patient patientRole/addr Contact Information
Contact Information Patient patientRole/telecom Contact Information
Personal Identification Information Patient patientRole/id Demographic Information
Gender Patient patient/administrativeGenderCode Demographic Information
Date of Birth Patient patient/birthTime Demographic Information
Marital Status Patient patient/maritalStatusCode  
Race Patient patient/raceCode  
Ethnicity Patient patient/ethnicGroupCode Demographic Information
(Religious Affiliation[1]) Patient patient/religiousAffiliationCode Spiritual Affiliation / Considerations
Languages Spoken Patient patient/languageCommunication  
Employer and School Contacts Social History  
Hazardous Working Conditions Social History HISTORY OF OCCUPATIONAL EXPOSURE  
Emergency Contacts Support  
Healthcare Providers Practitioners serviceEvent/performer Healthcare Providers
Insurance Providers Insurance Health Insurance or Pharmacy Insurance
Pharamacy   performer
Legal Documents and Medical Directives Advance Directives ADVANCE DIRECTIVES Advance Directive
General Medical Information
Height, Weight		 Vital Signs VITAL SIGNS  
Blood Type Results RELEVANT DIAGNOSTIC TESTS AND/OR LABORATORY DATA  
Last Physical or Checkup Encounters HISTORY OF OUTPATIENT VISITS Clinical Encounters and Procedures List
Allergies and Drug Sensitivies Alerts HISTORY OF ALLERGIES Allergy and Reaction List
Conditions Problems HISTORY OF PAST ILLNESS
- or -
PROBLEM LIST		 Problem List
Surgeries Procedures HISTORY OF SURGICAL PROCEDURES Clinical Encounters and Procedures List
Medications – Prescription and Non-Prescription Medications HISTORY OF MEDICATION USE Medication List
Immunizations Immunizations HISTORY OF IMMUNIZATIONS Immunizations List
Doctor Visits Encounters HISTORY OF OUTPATIENT VISITS Clinical Encounters and Procedures List
Hospitalizations Encounters HISTORY OF HOSPITALIZATIONS Clinical Encounters and Procedures List
Other Healthcare Visits Encounters HISTORY OF OUTPATIENT VISITS Clinical Encounters and Procedures List
Clinical Tests Results RELEVANT DIAGNOSTIC TESTS AND/OR LABORATORY DATA Laboratory and Test Results
Pregnancies   HISTORY OF PREGNANCIES  
Medical Devices Medical Devices HISTORY OF MEDICAL DEVICE USE  
Family Member History Family History HISTORY OF FAMILY MEMBER DISEASES Family History
Foreign Travel   HISTORY OF TRAVEL  
Therapy Plan of Care TREATMENT PLAN Care Plans, Goals and Disease Management
Vital Signs Vital signs VITAL SIGNS  
(Functional Status[2]) Functional Status FUNCTIONAL STATUS  
Specification
Data Element Name Opt Template ID
Personal Information
 
Name
Address
Contact Information
Personal Identification
Gender
Date of Birth

Thes components are required of all Medical Documents

R 1.3.6.1.4.1.19376.1.5.3.1.1.1
Personal Information
 
Marital Status

This commponent is optional in Medical Documents, but required if known in this specification.

R2 1.3.6.1.4.1.19376.1.5.3.1.1.1
Personal Information
 
Race
Ethnicity
Religious Affiliation [2]

These components are optional in Medical Documents

O 1.3.6.1.4.1.19376.1.5.3.1.1.1
Languages Spoken R2 1.3.6.1.4.1.19376.1.5.3.1.2.1
Employer and School Contacts O 1.3.6.1.4.1.19376.1.5.3.1.2.2
Hazardous Working Conditions O 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.1
Patient Contacts R2 1.3.6.1.4.1.19376.1.5.3.1.2.4
Healthcare Providers R 1.3.6.1.4.1.19376.1.5.3.1.2.3
Insurance Providers R2 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.7
Pharamacy R2 1.3.6.1.4.1.19376.1.5.3.1.2.3
Legal Documents and Medical Directives R2 1.3.6.1.4.1.19376.1.5.3.1.3.34
Allergies and Drug Sensitivities R 1.3.6.1.4.1.19376.1.5.3.1.3.13
Conditions R 1.3.6.1.4.1.19376.1.5.3.1.3.8
Conditions (cont) R 1.3.6.1.4.1.19376.1.5.3.1.3.6
Surgeries R2 1.3.6.1.4.1.19376.1.5.3.1.3.12
Medications – Prescription and Non-Prescription R 1.3.6.1.4.1.19376.1.5.3.1.3.19
Immunizations R2 1.3.6.1.4.1.19376.1.5.3.1.3.23
Doctor Visits / Last Physical or Checkup O 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.3
Hospitalizations O 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.3
Other Healthcare Visits O 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.3
Clinical Tests / Blood Type O 1.3.6.1.4.1.19376.1.5.3.1.3.28
Pregnancies O 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.4
Medical Devices R2 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.5
Family Member History O 1.3.6.1.4.1.19376.1.5.3.1.3.15
Foreign Travel O 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.6
Plan of Care O 1.3.6.1.4.1.19376.1.5.3.1.3.31
Coded Vital signs O 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2
Functional Status O 1.3.6.1.4.1.19376.1.5.3.1.3.17


Conformance

CDA Release 2.0 documents that conform to the requirements of this content module shall indicate their conformance by the inclusion of the appropriate <templateId> elements in the header of the document. This is shown in the sample document below. A CDA Document may conform to more than one template. This content module inherits from the Medical Summary content module, and so must conform to the requirements of that template as well, thus all <templateId> elements shown in the example below shall be included.

Sample PHR Extract Document 
<ClinicalDocument xmlns='urn:hl7-org:v3'>
  <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>
  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.2'/>
  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.5'/>
  <id root=' ' extension=' '/>
  <code code='34133-9' displayName='Summary of Episode Note'
    codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
  <title>PHR Extract</title>
  <effectiveTime value='20240419012005'/>
  <confidentialityCode code='N' displayName='Normal' 
    codeSystem='2.16.840.1.113883.5.25' codeSystemName='Confidentiality' />
  <languageCode code='en-US'/>     
     :
  <component><structuredBody>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.5.3.1'/>
        <!-- Optional Hazardous Working Conditions Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.34'/>
        <!-- Required if known Legal Documents and Medical Directives Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.13'/>
        <!-- Required Allergies and Drug Sensitivities Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.8'/>
        <!-- Required Conditions Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.6'/>
        <!-- Required Conditions (cont) Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.12'/>
        <!-- Required if known Surgeries Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.19'/>
        <!-- Required Medications – Prescription and Non-Prescription Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.23'/>
        <!-- Required if known Immunizations Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.5.3.3'/>
        <!-- Optional Doctor Visits / Last Physical or Checkup Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.5.3.3'/>
        <!-- Optional Hospitalizations Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.5.3.3'/>
        <!-- Optional Other Healthcare Visits Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.28'/>
        <!-- Optional Clinical Tests / Blood Type Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.5.3.4'/>
        <!-- Optional Pregnancies Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.5.3.5'/>
        <!-- Required if known Medical Devices Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.15'/>
        <!-- Optional Family Member History Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.5.3.6'/>
        <!-- Optional Foreign Travel Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.31'/>
        <!-- Optional Plan of Care Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2'/>
        <!-- Optional Coded Vital signs Section content -->
      </section>
    </component>

    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.17'/>
        <!-- Optional Functional Status Section content -->
      </section>
    </component>

       
  </structuredBody></component>
</ClinicalDocument>
Schematron
<pattern name='Template_1.3.6.1.4.1.19376.1.5.3.1.1.5'>
 <rule context='*[cda:templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.1.5"]'>
   <!-- Verify that the template id is used on the appropriate type of object -->
   <assert test='../cda:ClinicalDocument'>
     Error: The PHR Extract can only be used on Clinical Documents.
   </assert> 
   <!-- Verify that the parent templateId is also present. -->
   <assert test='cda:templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.1.2"]'>
     Error: The parent template identifier for PHR Extract is not present.
   </assert> 
   <!-- Verify the document type code -->
   <assert test='cda:code[@code = "34133-9"]'>
     Error: The document type code of a PHR Extract must be 34133-9
   </assert>
   <assert test='cda:code[@codeSystem = "2.16.840.1.113883.6.1"]'>
     Error: The document type code must come from the LOINC code 
     system (2.16.840.1.113883.6.1).
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.1.1"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The PHR Extract Document must contain a(n) Personal Information Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5 
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.1.1"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  PHR Extract Document should contain a(n) Personal Information Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5 
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.1.1"]'> 
     <!-- Note any missing optional elements -->
     Note: This PHR Extract Document does not contain a(n) Personal Information Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5 
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.2.1"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  PHR Extract Document should contain a(n) Languages Spoken Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.2.2"]'> 
     <!-- Note any missing optional elements -->
     Note: This PHR Extract Document does not contain a(n) Employer and School Contacts Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.1.5.3.1"]'> 
     <!-- Note any missing optional elements -->
     Note: This PHR Extract Document does not contain a(n) Hazardous Working Conditions Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.2.4"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  PHR Extract Document should contain a(n) Patient Contacts Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.2.3"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The PHR Extract Document must contain a(n) Healthcare Providers Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.1.5.3.7"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  PHR Extract Document should contain a(n) Insurance Providers Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.2.3"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  PHR Extract Document should contain a(n) Pharamacy Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.34"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  PHR Extract Document should contain a(n) Legal Documents and Medical Directives Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.13"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The PHR Extract Document must contain a(n) Allergies and Drug Sensitivities Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.8"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The PHR Extract Document must contain a(n) Conditions Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.6"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The PHR Extract Document must contain a(n) Conditions (cont) Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.12"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  PHR Extract Document should contain a(n) Surgeries Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.19"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The PHR Extract Document must contain a(n) Medications – Prescription and Non-Prescription Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.23"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  PHR Extract Document should contain a(n) Immunizations Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.1.5.3.3"]'> 
     <!-- Note any missing optional elements -->
     Note: This PHR Extract Document does not contain a(n) Doctor Visits / Last Physical or Checkup Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.1.5.3.3"]'> 
     <!-- Note any missing optional elements -->
     Note: This PHR Extract Document does not contain a(n) Hospitalizations Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.1.5.3.3"]'> 
     <!-- Note any missing optional elements -->
     Note: This PHR Extract Document does not contain a(n) Other Healthcare Visits Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.28"]'> 
     <!-- Note any missing optional elements -->
     Note: This PHR Extract Document does not contain a(n) Clinical Tests / Blood Type Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.1.5.3.4"]'> 
     <!-- Note any missing optional elements -->
     Note: This PHR Extract Document does not contain a(n) Pregnancies Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.1.5.3.5"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  PHR Extract Document should contain a(n) Medical Devices Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.15"]'> 
     <!-- Note any missing optional elements -->
     Note: This PHR Extract Document does not contain a(n) Family Member History Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.1.5.3.6"]'> 
     <!-- Note any missing optional elements -->
     Note: This PHR Extract Document does not contain a(n) Foreign Travel Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.31"]'> 
     <!-- Note any missing optional elements -->
     Note: This PHR Extract Document does not contain a(n) Plan of Care Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2"]'> 
     <!-- Note any missing optional elements -->
     Note: This PHR Extract Document does not contain a(n) Coded Vital signs Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.17"]'> 
     <!-- Note any missing optional elements -->
     Note: This PHR Extract Document does not contain a(n) Functional Status Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.5
   </assert> 
 </rule>
</pattern>
Additional Constraints

The assignedAuthoring device shall be populated with information about the EHR and/or PHR which assisted in creation of the document.

All sections and entries within the document shall contain an <id> element.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Trial.gif PHR Update Specification 1.3.6.1.4.1.19376.1.5.3.1.1.6

The PHR Update Content Module is similar to the PHR Extract content module, except that it has a number of different constraints. First of all, it is not required to contain all of the information that the PHR Extract content module does. The reason for this is because the purpose of this module is to reflect the changes that should be made to a PHR based on a previously existing PHR Extract content module. So, while it makes use of the same data element index, almost all of the data elements are optional. The purpose of this module is to make it easier for an EHR to create content that can be used to update a PHR.


Format Code

The XDSDocumentEntry format code for this content is urn:ihe:pcc:xphr:2007




Conformance

CDA Release 2.0 documents that conform to the requirements of this content module shall indicate their conformance by the inclusion of the appropriate <templateId> elements in the header of the document. This is shown in the sample document below.

Sample PHR Update Document 
<ClinicalDocument xmlns='urn:hl7-org:v3'>
  <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>
  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.6'/>
  <id root=' ' extension=' '/>
  <code code=' ' displayName=' '
    codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
  <title>PHR Update</title>
  <effectiveTime value='20240419012005'/>
  <confidentialityCode code='N' displayName='Normal' 
    codeSystem='2.16.840.1.113883.5.25' codeSystemName='Confidentiality' />
  <languageCode code='en-US'/>     
     :
  <component><structuredBody>
       
  </structuredBody></component>
</ClinicalDocument>

  

   <!-- Verify the document type code -->
   <assert test='cda:code[@code = "{{{LOINC}}}"]'>
     Error: The document type code of a PHR Update must be {{{LOINC}}}
   </assert>
   <assert test='cda:code[@codeSystem = "2.16.840.1.113883.6.1"]'>
     Error: The document type code must come from the LOINC code 
     system (2.16.840.1.113883.6.1).
   </assert>
Requirements

The requirements of this module are that it support recording updates to the original PHR Extract. The PHR Extract is made up of a header, and several sections, each of which may contain one or more entries. Suggestions to add, remove or update a section or entry are described in more detail below.

Adding a New Section or Appending to an Existing Section

A PHR Reviewer Actor may suggest additional material for an existing or new section by simply adding that section to the PHR Update document.

Replacing a Section

A PHR Reviewer Actor may suggest a revision to a section in the PHR Extract by replacing that section. To replace a section, the PHR Reviewer Actor creates a section in the PHR Update document that is of the same type as the section to be replaced in the PHR Extract document, and adds a <ppc:replacementOf> element to that section to indicate the section that it replaces.

The replacementOf element is an extension to the CDA Release 2.0 standard, and is further described below in Appendix C Extensions to CDA Release 2.0.

Adding an Entry

A PHR Reviewer Actor may suggest a new entry be added to a section by simply including that entry in a like section in the PHR Update document.

Replacing or Removing an Entry

The PHR Review Actor can replace an existing entry by adding an entry of the same type with new or modified information, and including in that entry a <reference> element that has an <externalAct> element. The <id> element of the <externalAct> shall be that of the act that is being replaced

Removing an Entry

The PHR Reviewer Actor can suggest that an entry be removed by replacing it with an act who <statusCode> element has been set to nullified.

Constraints

The LOINC document type code is the same as for the PHR Extract content module. The PHR Update Content module must record the PHR Extract which it is updating

Appendix A - Examples Using PCC Content Profiles

Example documents conforming to each profile can be found on the IHE wiki at the following URLs.

Profile and Content URL
XDS-MS  
 Referral Summary XDSMS Example1
 Discharge Summary XDSMS Example1
XPHR  
 XPHR Content XPHR Example1
 XPHR Update XPHR Example2
(EDR) ED Referral EDR Example
(APS) Antepartum Summary APS Example
(EDES)  
 Triage Note EDES Example1
 ED Nursing Note EDES Example2
 Composite Triage and Nursing Note EDES Example3
 ED Physician Note EDES Example4
(FSA) Functional Status Section FSA Example

Appendix B - Validating CDA Documents using the Framework

Many of the constraints specified by the content modules defined in the PCC Technical Framework can be validated automatically by software. Automated validation is a very desirable capability, as it makes it easier for implementers to test the correctness of their implementations. With regard to validation of the content module, the PCC Technical Framework narrative is the authoritative specification, not any automated software tool. Having said that, it is still very easy to create a validation framework for the IHE PCC Technical Framework using a XML validation tool such as Schematron. Since each content module has a name (the template identifier), any XML instance that reports itself to be of that "class" can be validated by creating assertions that must be true for each constraint indicated for the content module. In the XML representation, the <templateId> element is a child of the element that is claiming conformance to the template named. Thus the general pattern of a Schematron that validates a specific template is shown below: 

<schema xmlns="http://www.ascc.net/xml/schematron" xmlns:cda="urn:hl7-org:v3">
  <ns prefix="cda" uri="urn:hl7-org:v3" />
  <pattern name='ReferralSummary'>
    <rule context='*[cda:templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.1.3]"'>
      <!-- one or more assertions made by the content module -->
    </rule>
  </pattern>
</schema>

Validating Documents

For document content modules, the pattern can be extended to support common document content module constraints as shown below: 

<schema xmlns="http://www.ascc.net/xml/schematron" xmlns:cda="urn:hl7-org:v3">
  <ns prefix="cda" uri="urn:hl7-org:v3" />
  <pattern name='ReferralSummary'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.1.3]"'>
      <!-- Verify that the template id is used on the appropriate type of object -->
      <assert test='../ClinicalDocument'>
        Error: The referral content module can only be used on Clinical Documents.
      </assert>
      <!-- Verify that the parent templateId is also present. -->
      <assert test='templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.1.2"]'>
        Error: The parent template identifier for medical summary is not present.
      </assert>
      <!-- Verify the document type code -->
      <assert test='code[@code = "34133-9"]'>
        Error: The document type code of a referral summary must be
        34133-9 SUMMARIZATION OF EPISODE NOTE.
      </assert>
      <assert test='code[@codeSystem = "2.16.840.1.113883.6.1"]'>
        Error: The document type code must come from the LOINC code 
        system (2.16.840.1.113883.6.1).
      </assert>
      <!-- Verify that all required data elements are present -->
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
        Error: A referral summary must contain a reason for referral.
      </assert>
      <!-- Alert on any missing required if known elements -->
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.8"]'>
        Warning: A referral summary should contain a list of history of past illnesses.
      </assert>
      <!-- Note any missing optional elements -->
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.18"]'>
        Note: This referral summary does not contain the pertinent review of systems.
      </assert>
    </rule>
  </pattern>
</schema>

Validating Sections

The same pattern can be also applied to sections with just a few minor alterations. 

<schema xmlns="http://www.ascc.net/xml/schematron" xmlns:cda="urn:hl7-org:v3">
  <ns prefix="cda" uri="urn:hl7-org:v3" />
  <pattern name='ReasonForReferralUncoded'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
      <!-- Verify that the template id is used on the appropriate type of object -->
      <assert test='section'>
        Error: The coded reason for referral module can only be used on a section.
      </assert>
      <assert test='false'>
        Manual: Manually verify that this section contains narrative providing the
        reason for referral.
      </assert>
      <!-- Verify that the parent templateId is also present. -->
      <assert test='templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
        Error: The parent template identifier for the reason for referral 
        module is not present.
      </assert>
      <!-- Verify the section type code -->
      <assert test='code[@code = "42349-1"]'>
        Error: The section type code of the reason for referral section must be 42349-1
        REASON FOR REFERRAL.
      </assert>
      <assert test='code[@codeSystem = "2.16.840.1.113883.6.1"]'>
        Error: The section type code must come from the LOINC code 
        system (2.16.840.1.113883.6.1).
      </assert>
  </pattern>
  <pattern name='ReasonForReferralCoded'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.2"]'>
      <!-- The parent template will have already verified the type of object -->
      <!-- Verify that the parent templateId is also present. -->
      <assert test='templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
        Error: The parent template identifier for the reason for referral 
        module is not present.
      </assert>
      <!-- Don't bother with the section type code, as the parent template caught it -->
      <!-- Verify that all required data elements are present -->
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.4.13"]'>
        Error: A coded reason for referral section must contain an simple observation.
      </assert>
      <!-- Alert on any missing required if known elements -->
      <!-- Note any missing optional elements -->
    </rule>
  </pattern>
</schema>

A similar pattern can also be followed for Entry and Header content modules, and these are left as an exercise for the reader.

Phases of Validation and Types of Errors

Note that each message in the Schematrons shown above start with a simple text string that indicates whether the message indicates one of the following conditions:

  • An error, e.g., the failure to transmit a required element,
  • A warning, e.g., the failure to transmit a required if known element,
  • A note, e.g., the failure to transmit an optional element.
  • A manual test, e.g., a reminder to manually verify some piece of content.

Schematron supports the capability to group sets of rules into phases by the pattern name, and to specify which phases of validation should be run during processing. To take advantage of this capability, one simply breaks each <pattern> element above up into separate patterns depending upon whether the assertion indicates an error, warning, note or manual test, and then associate each pattern with a different phase. This is shown in the figure below. 

<schema xmlns="http://www.ascc.net/xml/schematron" xmlns:cda="urn:hl7-org:v3">
  <ns prefix="cda" uri="urn:hl7-org:v3" />
  <phase id="errors">
    <active pattern="ReasonForReferralUncoded_Errors"/>
    <active pattern="ReasonForReferralCoded_Errors"/>
  </phase>
  <phase id="manual">
    <active pattern="ReasonForReferralUncoded_Manual"/>
  </phase>
  <pattern name='ReasonForReferralUncoded_Errors'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
      <assert test='section'>
        Error: The coded reason for referral module can only be used on a section.
      </assert>
      <assert test='code[@code = "42349-1"]'>
        Error: The section type code of the reason for referral section must be 42349-1
        REASON FOR REFERRAL.
      </assert>
      <assert test='code[@codeSystem = "2.16.840.1.113883.6.1"]'>
        Error: The section type code must come from the LOINC code 
        system (2.16.840.1.113883.6.1).
      </assert>
    </rule>
  </pattern>
  <pattern name='ReasonForReferralUncoded_Manual'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
      <assert test='false'>
        Manual: Manually verify that this section contains narrative providing the
        reason for referral.
      </assert>
  </pattern>
  <pattern name='ReasonForReferralCoded_Errors'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.2"]'>
      <assert test='templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
        Error: The parent template identifier for the reason for referral not present.
      </assert>
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.4.13"]'>
        Error: A coded reason for referral section must contain an simple observation.
      </assert>
    </rule>
  </pattern>
</schema>

Using these simple "templates" for template validation one can simply create a collection of Schematron patterns that can be used to validate the content modules in the PCC Technical Framework. Such Schematrons are expected to be made available as part of the MESA test tools that are provided to IHE Connectathon participants, and which will also be made available to the general public after connectathon.

Appendix C - Extensions to CDA Release 2.0

This section describes extensions to CDA Release 2.0 that are used by the IHE Patient Care Coordination Technical Framework.

IHE PCC Extensions

All Extensions to CDA Release 2.0 created by the IHE PCC Technical Committee are in the namespace urn:ihe:pcc:hl7v3.

The approach used to create extension elements created for the PCC Technical Framework is the same as was used for the HL7 Care Record Summary (see Appendix E) and the ASTM/HL7 Continuity of Care Document (see secion 7.2).

replacementOf

The <replacementOf> extension element is applied to a section appearing in a PHR Update Document to indicate that that section's content should replace that of a previously existing section. The identifier of the previously existing section is given so that the PHR Manager receiving the Update content will know which section to replace. The model for this extension is shown below.

Model for replacementOf

Use of this extension is shown below. The <replacementOf> element appears after all other elements within the <section> element. The <id> element appearing in the <externalDocumentSection> element shall provide the identifier of the section being replaced in the parent document.

Example use of the replacementOf extension 
<section>
 <id root=' ' extension=' '/>
 
 <title>Name of the Section</title>
 <text>Text of the section</text>
 <entry></entry>
 <component></component>
 <pcc:replacementOf xmlns:pcc='urn:ihe:pcc:hl7v3'>
   <pcc:externalDocumentSection>
     <pcc:id root='58FCBE50-D4F2-4bda-BC1C-2105B284BBE3'/>
   <pcc:externalDocumentSection/>
 </pcc:replacementOf>
</section>

Extensions Defined Elsewhere used by IHE PCC

Entity Identifiers

There is often a need to record an identifer for an entity so that it can be subsequently referenced. This extension provides a mechnism to store that identifier. The element appears after any <realm>, <typeId> or <templateId> elements, but before all others in the entity where it is used: 

<playingEntity classCode='ENT' determinerCode='INSTANCE'>
 <sdtc:id root='1.3.6.4.1.4.1.2835.2' extension='EntityID'/>
   :
   .
</playingEntity>

Patient Identifier

There is a need to record the identifer by which a patient is known to another healthcare provider. This extension provides a role link between the assigned, related or associated entity, and the patient role.

Use of this extension to record the identifier under which the patient is known to a provider is shown below.

Example use of the Patient Identifier Extension 
<assignedEntity>
 <id extension='1' root='1.3.6.4.1.4.1.2835.1'/>
 
 <addr>
   <streetAddressLine>21 North Ave</streetAddressLine>
   <city>Burlington</city>
   <state>MA</state>
   <postalCode>01803</postalCode>
   <country>USA</country>
 </addr>
 <telecom value='tel:(999)555-1212' use='WP'/>
 <assignedPerson>
   <name>
     <prefix>Dr.</prefix><given>Bernard</given><family>Wiseman</family><suffix>Sr.</suffix>
   </name>
 </assignedPerson>
 <sdtc:patient xmlns:sdtc='urn:hl7-org:sdtc' >
   <sdtc:id root='1.3.6.4.1.4.1.2835.2' extension='PatientMRN'/>
 </sdtc:patient>
</assignedEntity>

The <patient> element records the link between the related, assigned or associated entity and the patient. The <id> element provides the identifier for the patient. The root attribute of the <id> should be the namespace used for patient identifiers by the entity. The extension attribute of the <id> element shall be the patient's medical record number or other identifier used by the entity to identify the patient.

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