EFA XDS/XDR Resource Manager Binding

	Dieses Dokument gibt wieder: Implementierungsleitfaden EFA XDS/XDR Resource Manager Binding (0.9). Die Teilmaterialien gehören der Kategorie cdaefa an.

Implementierungsleitfaden

vorgelegt von:
February 2013
Jörg Caumanns, Raik Kuhlisch

Draft

Version:	0.9
Datum:	March 2013
Status:	xxx
Verfahren:	{{{Verfahren}}}
Realm:	Deutschland

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Hinweise zum Kommentierungsverfahren einschließlich aller Formulare und Kontaktadressen finden Sie auf der Seite "Kommentierung EFAv2.0".

EFA Resource Manager XDR/XDS Binding

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Within EFA the actors and transactions of the IHE XDS integration profile are mapped onto EFA Resource Manager actors and operations as follows:

Role	EFA Resource Manager Service	IHE XDS	Binding
Actor	EFA Client	Document Source (for createECR, createPartition, closeECR, registerConsent) Document Consumer (for listPartitions)	-
Actor	EFA Resource Manager	Document Repository (for createECR, createPartition, closeECR, registerConsent) Document Registry (for listPartitions)	-
Transaction	createECR	Provide and Register Document Set ITI-41	createECR
Transaction	createPartition	Provide and Register Document Set ITI-41	createPartition
Transaction	closeECR	Provide and Register Document Set ITI-41	closeECR
Transaction	listPartitions	Registry Stored Query ITI-18	listPartitions
Transaction	registerConsent	Provide and Register Document Set ITI-41	registerConsent

EFA XDS/XDR Binding: createECR

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The initialization of a new ECR is performed by creating a new XDS folder for the patient. The folder is classified by the ECR purpose codes and as such implicitly linked to all other folders (ECR: partitions) which are assigned to the same purpose.

This EFA binding introduces the following extensions and restrictions on the IHE XDR actor and transaction definitions in order to properly cover the EFA createECR operation and to align with the EFA security framework:

A new folder shall be created and purpose codes shall be provided for the newly created folder as codeList.
A consent information document containing the list of authorized subjects shall be provided through BPPC. A scanned consent document may be additionaly provided.
Additional error messages are defined that cover specific failure conditions of the EFA use cases
The availability of data fields is aligned to EFA privacy requirements
Documents cannot be copied by reference (Permissions are assigned to folders and therefore there is no easy way for an ECR Provider to verify the legitimacy for linking a document with another case record)
The application of security measures and the contents of the SOAP security header are specified normatively

Constraints on the Request Message

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The createECR request message implements the IHE Provide And Register DocumentSet transaction (ITI-41) request message as profiled in [IHE ITI TF-2b]

The following table shows how the createECR SFM is mapped onto the ITI-41 transaction:

createECR	ITI-41	Constraints
context	SAML Identity Assertion within the SOAP Security Header	see IHE Cookbook
patientID	XDS Folder Attribute: patientID XDS Document Attribute: patientID	The same patient identifier SHALL be used throughout all metadata
purpose	XDS Folder Attribute: codeList	see EFA XDS Folder Metadata Binding for details
ecrInfo	XDS Folder Attribute: title XDS Folder Attribute: uniqueID	Further elements of the ecrInfo structure MAY be set by the ECR provider.
consentInfo	XDS Document
consentDoc (optional)	XDS Document	Scaned documents SHALL be provided acc. to the XDS SD Integration Profile.

Following this, implementations SHALL consider the following constraints:

All provided documents SHALL be associated with a newly created XDS folder. Folder metadata SHALL be used as specified in the EFA XDS Folder Metadata Binding.
The request carries one or more documents. One of these documents SHALL be a consent information document.
All document metadata SHALL be provided as specified in the EFA XDS Document Metadata Binding.
The requestor (EFA Client) SHOULD provide documents embraced by a single IHE XDS submission set acc. to [IHE ITI TF-2a].
The EFA provider SHOULD ignore the submission set grouping and MUST ignore all associations between documents and submission sets.
All metadata of the submission set MUST NOT have EFA semantics. The EFA provider MUST solely rely on the document metadata and contents.
The EFA provider MUST NOT register documents that are provided by reference.

Expected Actions

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The XDS Document Repository provider SHALL respond to an ProvideAndRegisterDocument request message with the ProvideAndRegisterDocument response message containing a success indicator.

The provider of the XDS Document Repository provider MUST verify that the requesting service user has sufficient rights to setup a new ECR at this ECR Provider. This includes that the service user is registered with the provider and familiar with using ECRs. Additionaly the ECR provider SHALL verify the completeness and consistency of the provided consentInfo document. It SHALL verify that all named ECR participants are either registered with the provider or identifiable through a shared healthcare provider directory.

The ECR provider SHALL check if an ECR for the given patient and purpose already has been registered with this provider.

If no ECR with the given purpose exists for the given patient, the ECR Provider SHALL

setup a folder as specified in the request message
translate the provided consentInfo document into an access control policy which can be automatically enforced for each request to the newly setup ECR
store the provided documents within the XDS Document Repository
forward the metadata of the received documents to the XDS Document Registry for registration

If an ECR with the given purpose already exists for the given patient, the ECR Provider SHALL

assess the access control policy of that ECR with the "modify consent" operation. If this access is denied an error status SHALL be returned.
setup a folder as specified in the request message
extract the identified ECR participants from the provided consentInfo document and add them as authorized users to the existing access control policy.
store the provided documents within the XDS Document Repository
forward the metadata of the received documents to the XDS Document Registry for registration

In case of an error that relates to the transmission of the request or the processing of the EFA security token, the EFA Resource Manager Service provider MUST respond with the respective error status.

Response Message (Full Success Scenario)

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If the EFA Document Registry Service provider is able to decode the received message and to properly initialize the new eCR and its initial partition it responds with an ebXML Registry Response with its status set to "urn:oasis:names:tc:ebxml-regrep:ResponseStatusType:Success"

If the service provider wants to respond with further information on the processing of the transmitted data or with a non-critical warning it SHOULD include an additional <RegistryErrorList> element. The severity MUST be set to “urn:oasis:names:tc:ebxml-regrep:ErrorSeverityType:Warning”:

  <rs:RegistryResponse
           status="urn:oasis:names:tc:ebxml-regrep:ResponseStatusType:Success">
     <rs:RegistryErrorList>
       <rs:RegistryError 
           severity=”urn:oasis:names:tc:ebxml-regrep:ErrorSeverityType:Warning” 
           errorCode=”....”
           codeContext=”Partition linked with existing ECR” 
           location="" />
     </rs:RegistryErrorList> 
   </rs:RegistryResponse>

The following warning messages and codes are defined:

Condition and Severity	Message	Code	Action to be taken
Request was received but not processed; e.g. because a manual intervention by the ECR provider is required to initalize a new ECR	Processing deferred	2201	None
An ECR with the given purpose already exists for the patient. Instead of initalizing a new ECR a partition has been added to the existing ECR.	Partition linked with existing ECR	2202	None

Response Message (Failure or Partial Failure Scenario)

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If the XDS Document Repository is able to decode the received message but the processing of the request failed, it responds with an ebXML Registry Response that contains a respective status indicator (see below).The response MUST contain a RegistryErrorList element that indicates the failure condition.

The instantiation of an ECR is an All-or-Nothing operation. Therefore in any case of failure the response status MUST be set to “urn:oasis:names:tc:ebxml-regrep:ResponseStatusType:Failure”.

The severity of each registry error message MUST be set to ”urn:oasis:names:tc:ebxml-regrep:ErrorSeverityType:Error”. Multiple registry error messages MAY be included within a single <rs:RegistryErrorList> element. Apart from the XDS-b error messages defined in Table 4.1-11 of [IHE ITI TF-3] the following error codes are defined for EFA:

Condition and Severity	Location	Message	Code	Action to be taken
The EFA provider requests a higher authentication trust level than assigned to the HP (e.g. password-based login is not accepted for the requested operation). (ERROR)	-	Weak Authentication	4702	If possible, the HP SHOULD log in again with a stronger mechansims (e.g. smartcard) and re-issue the request with the respective identity assertion.
The ECR provider only accepts consentInfo documents if they are digitally signed by an HP. (ERROR)	OID of the consentInfo document	No Signature	4704	If possible, the EFA Client SHOULD re-issue the request with the data signed by an HP.
The requestor has not sufficient permission to perform the requested operation (ERROR)	-	Policy Violation	4109	The request MUST NOT be processed by the service provider. The HP MAY request the patient to exted the consent.
An ECR of the given purpose already exists for the patient. The requestor does not have sufficient permissions to create a new partiton and to register new participants (ERROR)	-	Policy Violation	4109	The request MUST NOT be processed by the service provider. The HP MAY request the patient to exted the consent for the existing ECR.
The ECR provider is unable to identify one or more of the participants that are listed in the consentInfo document (ERROR)	OID of the participant that cannot be identified	Unknown HP Identity	4110	The request MUST NOT be processed by the service provider. The requestor SHOULD first resolve the participants' identities into identifiers which are resolvable to the ECR provider.

Security Considerations

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Message Protection

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The ECR requester MUST apply means to achieve message authenticity, message integrity and message confidentiality. The ECR provider MUST approve at least one of the following mechanisms.

Transport Layer Security with SAML Issued Endorsing Token

The request message and the response message are sent on an ECR-provider authenticated TLS-channel. In the Security Header the requester provides an ECR Identity Assertion and a wsu:timestamp element that is signed with the Subject-Confirmation-Key.

WS-Security-Policy Example

<wsp:Policy wsu:Id="ServicePortBindingPolicy">
    <sp:TransportBinding>
        <wsp:Policy>
            <sp:TransportToken>
                <wsp:Policy>
                    <sp:HttpsToken RequireClientCertificate="false" />
                </wsp:Policy>
            </sp:TransportToken>
            <sp:AlgorithmSuite>
                <wsp:Policy>
                    <sp:Basic256Sha256 />
                </wsp:Policy>
            </sp:AlgorithmSuite>
            <sp:IncludeTimestamp />
            <sp:Layout>
                <wsp:Policy>
                    <sp:Strict />
                </wsp:Policy>
            </sp:Layout>
        </wsp:Policy>
    </sp:TransportBinding>
    <sp:Wss11>
        <wsp:Policy />
    </sp:Wss11>
    <wsam:Addressing />
</wsp:Policy>
<wsp:Policy wsu:Id="Input_Policy">
    <sp:EndorsingSupportingTokens>
        <wsp:Policy>
            <sp:IssuedToken
                sp:IncludeToken="http://schemas.xmlsoap.org/ws/2005/07/securitypolicy/IncludeTokenAlwaysToRecipient">
                <sp:RequestSecurityTokenTemplate>
                    <wst:TokenType>http://docs.oasis-open.org/wss/oasis-wss-saml-token-profile-1.1#SAMLV2.0</wst:TokenType>
                    <wst:KeySize>2048</wst:KeySize>
                </sp:RequestSecurityTokenTemplate>
                <wsp:Policy></wsp:Policy>
            </sp:IssuedToken>
        </wsp:Policy>
    </sp:EndorsingSupportingTokens>
</wsp:Policy>

Asymmetric Message Protection

The request message and the response message are signed and encrypted. The ECR requester uses the key material corresponding with the Subject-Confirmation-Key provided with the issued ECR Identity Assertion. The ECR provider uses its service certificate and key. The wsu:timestamp element, all WS-Addressing elements and the SOAP-Body element MUST be signed. The SOAP-Body element MUST be encrypted.

WS-Security-Policy Example

<wsp:Policy wsu:Id="ServicePortBindingPolicy">
    <sp:AsymmetricBinding>
        <wsp:Policy>
            <sp:InitiatorToken>
                <wsp:Policy>
                    <sp:IssuedToken sp:IncludeToken="http://schemas.xmlsoap.org/ws/2005/07/securitypolicy/IncludeToken/AlwaysToRecipient">
                        <sp:RequestSecurityTokenTemplate>
                            <wst:TokenType>http://docs.oasis-open.org/wss/oasis-wss-saml-token-profile-1.1#SAMLV2.0</wst:TokenType>
                            <wst:KeySize>2048</wst:KeySize>
                        </sp:RequestSecurityTokenTemplate>
                        <wsp:Policy></wsp:Policy>
                    </sp:IssuedToken>
                </wsp:Policy>
            </sp:InitiatorToken>
            <sp:RecipientToken>
                <wsp:Policy>
                    <sp:X509Token sp:IncludeToken="http://schemas.xmlsoap.org/ws/2005/07/securitypolicy/IncludeToken/AlwaysToInitiator">
                        <wsp:Policy><sp:WssX509V3Token10 /></wsp:Policy>
                    </sp:X509Token>
                </wsp:Policy>
            </sp:RecipientToken>
            <sp:AlgorithmSuite><wsp:Policy><sp:Basic256 /></wsp:Policy></sp:AlgorithmSuite>
            <sp:Layout><wsp:Policy><sp:Strict /></wsp:Policy></sp:Layout>
            <sp:IncludeTimestamp />
            <sp:OnlySignEntireHeadersAndBody />
        </wsp:Policy>
    </sp:AsymmetricBinding>
    <sp:Wss11><wsp:Policy></wsp:Policy></sp:Wss11>
    <sp:Trust10>
        <wsp:Policy><sp:MustSupportIssuedTokens /></wsp:Policy>
    </sp:Trust10>
    <wsap10:UsingAddressing />
</wsp:Policy>

WS-SecureConversation bootstrapped with SAML Issued Token

The request message and the response message are signed and encrypted. Both the ECR requester and the ECR provider use a symmetric Secure-Conversation-Token key. The Secure-Conversation-Token MUST reference the issued ECR Identity Assertion. The wsu:timestamp element, all WS-Addressing elements and the SOAP-Body element MUST be signed. The SOAP-Body element MUST be encrypted.

Audit Trail

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The EFA Provider MUST write an audit trail entry according to the EFA v1.2 Audit Trail specification. The following table defines which categories MUST be filled (R), which MAY be filled (O) and which categories MUST NOT be used (X).

category	Opt.	Description
Event	R	Audited event
Requesting Point of Care	R	Health professional organization that issued the original request.
Human Requestor	R	HP that triggered the request
Source Gateway	R	EFA Client node address at the point of Care
Target Gateway	R	EFA provider node address
Audit Source	R	Legal entity that ensures the uniqueness of the identifiers that are used to identify active participants
Patient	R	Patient
Event Target	R	Reference to the newly instantiated partition (see below)
Error Message	O	Only used in case that the request handling was not completed successfully

For the Event Target Category the following fields MUST be provided:

Field Name	Opt.	Value Constraints
ParticipantObjectTypeCode	R	MUST be “2” (System Object)
ParticipantObjectTypeCodeRole	R	MUST be “4” (Resource)
ParticipantObjectIDTypeCode	R	MUST be “12” (URI)
ParticipantObjectID	R	MUST be string-encoded URNs of the newly instantiated partition and all provided documents

EFA XDS/XDR Binding: createPartition

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The linkage of a new partition to an existing ECR is performed by creating a new XDS folder for the patient. The folder is classified by the ECR purpose codes of the existing ECR and as such implicitly linked to all other folders (ECR: partitions) which are already assigned to the same ECR.

This EFA binding introduces the following extensions and restrictions on the IHE XDR actor and transaction definitions in order to properly cover the EFA createPartition operation and to align with the EFA security framework:

A new folder shall be created and purpose codes shall be provided for the newly created folder as codeList
Additional error messages are defined that cover specific failure conditions of the EFA use cases
The availability of data fields is aligned to EFA privacy requirements
Documents cannot be copied by reference (Permissions are assigned to folders and therefore there is no easy way for an ECR Provider to verify the legitimacy for linking a document with another case record)
The application of security measures and the contents of the SOAP security header are specified normatively

Constraints on the Request Message

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The createPartition request message implements the IHE Provide And Register DocumentSet transaction (ITI-41) request message as profiled in [IHE ITI TF-2b]

The following table shows how the createPartition SFM is mapped onto the ITI-41 transaction:

createECR	ITI-41	Constraints
context	SAML Identity Assertion within the SOAP Security Header	see IHE Cookbook
ecrRef	XDS Folder Attribute: patientID XDS Folder Attribute: codeList	The codeList shall contain all purpose codes as assigned to the existing ECR the new partition is to be linked with
partitionInfo	XDS Folder Attribute: title XDS Folder Attribute: uniqueID	Further elements of the partitionInfo structure MAY be set by the ECR provider.
initialDoc	XDS Document	At least a single document shall be provided when a new partition is initialized.

Following this, implementations SHALL consider the following constraints:

All provided documents SHALL be associated with a newly created XDS folder. Folder metadata SHALL be used as specified in the EFA XDS Folder Metadata Binding.
The request shall provide one or more documents to the newly created folder.
All document metadata SHALL be provided as specified in the EFA XDS Document Metadata Binding.
The requestor (EFA Client) SHOULD embrace the provided documents as a single IHE XDS submission set acc. to [IHE ITI TF-2a].
The EFA provider SHOULD ignore the submission set grouping and MUST ignore all associations between documents and submission sets.
The EFA provider MUST NOT process any metadata assigned to the submission set, it MUST solely rely on the document metadata and contents.
The EFA provider MUST NOT register documents that are only provided through associations.

The Resource Manager SFM allows for initializing empty partitions while XDS requires at least a single document to be provided whenever a new folder is created.

Expected Actions

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The XDS Document Repository provider SHALL respond to an ProvideAndRegisterDocument request message with the ProvideAndRegisterDocument response message containing a success indicator.

The provider of the XDS Document Repository provider MUST verify that the requesting service user has sufficient rights to setup a new partition at this ECR Provider ant to link this partiton with an existing ECR.

In processing of this request the ECR Provider SHALL

assess the access control policy of the ECR with the "create partition" operation
setup a folder as specified in the request message
store the provided documents within the XDR Document Repository
forward the metadata of the received documents to the XDS Document Registry for registration

In case of an error that relates to the transmission of the request or the processing of the EFA security token, the XDS Document Repository MUST respond with the respective error status.

Response Message (Full Success Scenario)

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If the EFA Document Registry Service provider is able to decode the received message and to properly initialize the new partition it responds with an ebXML Registry Response with its status set to "urn:oasis:names:tc:ebxml-regrep:ResponseStatusType:Success"

Response Message (Failure or Partial Failure Scenario)

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If the XDS Document Repository is able to decode the received message but the processing of the request failed, it responds with an ebXML Registry Response that contains a respective status indicator (see below).The response MUST contain a RegistryErrorList element that indicates the failure condition.

If the partiton could not be created or if none of the provided documents was processed succesfully, the response status MUST be set to “urn:oasis:names:tc:ebxml-regrep:ResponseStatusType:Failure”. If the partition was successfully initialized and at least one document was processed successfully, the response status MUST be set to “urn:ihe:iti:2007:ResponseStatusType:PartialSuccess”. A failure location MUST be provided if the error does not apply to all provided documents. It MUST NOT be given if the error applies to all provided documents.

The severity of each registry error message MUST be set to ”urn:oasis:names:tc:ebxml-regrep:ErrorSeverityType:Error”. Multiple registry error messages MAY be included within a single <rs:RegistryErrorList> element. Apart from the XDS-b error messages defined in Table 4.1-11 of [IHE ITI TF-3] the following error codes are defined for EFA:

Condition and Severity	Location	Message	Code	Action to be taken
The EFA provider requests a higher authentication trust level than assigned to the HP (e.g. password-based login is not accepted for the requested operation). (ERROR)	-	Weak Authentication	4702	If possible, the HP SHOULD log in again with a stronger mechansims (e.g. smartcard) and re-issue the request with the respective identity assertion.
An ECR of the given purpose does not exist for the patient (ERROR)	-	Policy Violation	4109	The request MUST NOT be processed by the service provider.
The ECR provider only accepts medical documents if they are digitally signed by an HP. (ERROR)	OID of the consentInfo document	No Signature	4704	If possible, the EFA Client SHOULD re-issue the request with the data signed by an HP.
The requestor has not sufficient permission to perform the requested operation (ERROR)	-	Policy Violation	4109	The request MUST NOT be processed by the service provider. The HP MAY request the patient to exted the consent.
For data of the given kind the EFA provider only accepts PDF coded documents (ERROR)	OID of the document	PDF required	4107	The provided document MUST NOT be processed by the EFA provider. The EFA Client MUST re-transmit the document in PDF format.
A document of the provided kind does not comply with the EFA policy or the patient consent (ERROR)	OID of the document	Policy Violation	4109	The provided document MUST NOT be processed by the service provider. The HP MAY request the patient to exted the consent.
A document is provided by-reference. The ECR provider is unable to assess the legitamicity of this action or cannot copy the document into the given destination (ERROR)	OID of the document	Unresolvable Reference	4110	The provided reference MUST NOT be processed by the service provider. The HP MUST first obtain the document from its current source and then copy it into the destination folder.

Security Considerations

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Message Protection

See Message Protection topic in createECR section.

Audit Trail

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The EFA Provider MUST write an audit trail entry according to the EFA v1.2 Audit Trail specification. The following table defines which categories MUST be filled (R), which MAY be filled (O) and which categories MUST NOT be used (X).

category	Opt.	Description
Event	R	Audited event
Requesting Point of Care	R	Health professional organization that issued the original request.
Human Requestor	R	HP that triggered the request
Source Gateway	R	EFA Client node address at the point of Care
Target Gateway	R	EFA provider node address
Audit Source	R	Legal entity that ensures the uniqueness of the identifiers that are used to identify active participants
Patient	R	Patient
Event Target	R	Reference to the newly instantiated partition (see below)
Error Message	O	Only used in case that the request handling was not completed successfully

For the Event Target Category the following fields MUST be provided:

Field Name	Opt.	Value Constraints
ParticipantObjectTypeCode	R	MUST be “2” (System Object)
ParticipantObjectTypeCodeRole	R	MUST be “4” (Resource)
ParticipantObjectIDTypeCode	R	MUST be “12” (URI)
ParticipantObjectID	R	MUST be string-encoded URNs of the newly instantiated partition and all provided documents

EFA XDS/XDR Binding: closeECR

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The explicit shutdown of an ECR is performed by placing a consentInfo document that invalidates all previously given permissions into one of the ECR's partitions (folders). This may either be a newly created folder of an existing folder that is classified by the ECR purpose codes and as such implicitly represents the ECR that is to be closed.

This EFA binding introduces the following extensions and restrictions on the IHE XDR actor and transaction definitions in order to properly cover the EFA closeECR operation and to align with the EFA security framework:

A new folder may be created. Purpose codes shall be provided for the newly created folder as codeList
A consent information document that invalidates all previously given permissions shall be provided through BPPC. A scanned consent revocation document may be additionaly provided.
Additional error messages are defined that cover specific failure conditions of the EFA use cases
The availability of data fields is aligned to EFA privacy requirements
The application of security measures and the contents of the SOAP security header are specified normatively

Constraints on the Request Message

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The closeECR request message implements the IHE Provide And Register DocumentSet transaction (ITI-41) request message as profiled in [IHE ITI TF-2b]

The following table shows how the closeECR SFM is mapped onto the ITI-41 transaction:

closeECR	ITI-41	Constraints
context	SAML Identity Assertion within the SOAP Security Header	see IHE Cookbook
ecrRef	XDS Folder Attribute: patientID XDS Folder Attribute: codeList	The codeList shall contain all purpose codes as assigned to the ECR that is to be closed
consentInfo	XDS Document
consentDoc (optional)	XDS Document	Scaned documents SHALL be provided acc. to the XDS SD Integration Profile.

Following this, implementations SHALL consider the following constraints:

All provided documents SHALL be associated with a newly created XDS folder or with a folder that is already part of the ECR. Folder metadata SHALL be used as specified in the EFA XDS Folder Metadata Binding.
The request carries one or more documents. One of these documents SHALL be a consent information document.
All document metadata SHALL be provided as specified in the EFA XDS Document Metadata Binding.
The requestor (EFA Client) SHOULD embrace the provided documents as a single IHE XDS submission set acc. to [IHE ITI TF-2a].
The EFA provider SHOULD ignore the submission set grouping and MUST ignore all associations between documents and submission sets.
The EFA provider MUST NOT process any metadata assigned to the submission set, it MUST solely rely on the document metadata and contents.
The EFA provider MUST NOT register documents that are only provided through associations.

The Resource Manager SFM allows for closing partitions without providing any arguments but the ECR identifer. This binding makes the consentInfo document mandatory because ITI-41 provides more comfortable means for closing an ECR as other transactions that may be considered instead.

Expected Actions

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The XDS Document Repository provider SHALL respond to an ProvideAndRegisterDocument request message with the ProvideAndRegisterDocument response message containing a success indicator.

The provider of the XDS Document Repository MUST verify that the requesting service user has sufficient rights to close an ECR at this ECR Provider. This includes that the service user is registered with the provider and familiar with using ECRs. Additionaly the ECR provider SHALL verify the completeness and consistency of the provided consentInfo document.

In processing this request the ECR Provider SHALL

assess the access control policy of that ECR with the "modify consent" operation. If this access is denied an error status SHALL be returned.
setup a folder as specified in the request message
store the provided documents within the XDR Document Repository
forward the metadata of the received documents to the XDS Document Registry for registration
change the status of the ECR and all its partitions (folders) to "grace"
Adapt all permissions to the new status of the ECR

In case of an error that relates to the transmission of the request or the processing of the EFA security token, the EFA Resource Manager Service provider MUST respond with the respective error status.

Response Message (Full Success Scenario)

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If the EFA Document Registry Service provider is able to decode the received message and to properly change the status of the ECR and its partitions it responds with an ebXML Registry Response with its status set to "urn:oasis:names:tc:ebxml-regrep:ResponseStatusType:Success"

If the service provider wants to respond with further information on the processing of the transmitted data or with a non-critical warning it SHOULD include an additional <RegistryErrorList> element. The severity MUST be set to “urn:oasis:names:tc:ebxml-regrep:ErrorSeverityType:Warning”.

The following warning messages and codes are defined:

Condition and Severity	Message	Code	Action to be taken
Request was received but not processed; e.g. because a manual intervention by the ECR provider is required to close an ECR	Processing deferred	2201	None

Response Message (Failure or Partial Failure Scenario)

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If the XDS Document Repository is able to decode the received message but the processing of the request failed, it responds with an ebXML Registry Response that contains a respective status indicator (see below).The response MUST contain a RegistryErrorList element that indicates the failure condition.

The shutdown of an ECR is an All-or-Nothing operation. Therefore in any case of failure the response status MUST be set to “urn:oasis:names:tc:ebxml-regrep:ResponseStatusType:Failure”.

The severity of each registry error message MUST be set to ”urn:oasis:names:tc:ebxml-regrep:ErrorSeverityType:Error”. Multiple registry error messages MAY be included within a single <rs:RegistryErrorList> element. Apart from the XDS-b error messages defined in Table 4.1-11 of [IHE ITI TF-3] the following error codes are defined for EFA:

Condition and Severity	Location	Message	Code	Action to be taken
The EFA provider requests a higher authentication trust level than assigned to the HP (e.g. password-based login is not accepted for the requested operation). (ERROR)	-	Weak Authentication	4702	If possible, the HP SHOULD log in again with a stronger mechansims (e.g. smartcard) and re-issue the request with the respective identity assertion.
The ECR provider only accepts consentInfo documents if they are digitally signed by an HP. (ERROR)	OID of the consentInfo document	No Signature	4704	If possible, the EFA Client SHOULD re-issue the request with the data signed by an HP.
The requestor has not sufficient permission to perform the requested operation (ERROR)	-	Policy Violation	4109	The request MUST NOT be processed by the service provider. The HP MAY request the patient to exted the consent.
An ECR of the given purpose does not exist for the patient (ERROR)	-	Policy Violation	4109	The request MUST NOT be processed by the service provider.

Security Considerations

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Message Protection

See Message Protection topic in createECR section.

Audit Trail

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The EFA Provider MUST write an audit trail entry according to the EFA v1.2 Audit Trail specification. The following table defines which categories MUST be filled (R), which MAY be filled (O) and which categories MUST NOT be used (X).

category	Opt.	Description
Event	R	Audited event
Requesting Point of Care	R	Health professional organization that issued the original request.
Human Requestor	R	HP that triggered the request
Source Gateway	R	EFA Client node address at the point of Care
Target Gateway	R	EFA provider node address
Audit Source	R	Legal entity that ensures the uniqueness of the identifiers that are used to identify active participants
Patient	R	Patient
Event Target	R	References to all partitions that are affected by this operation (see below)
Error Message	O	Only used in case that the request handling was not completed successfully

For the Event Target Category the following fields MUST be provided:

Field Name	Opt.	Value Constraints
ParticipantObjectTypeCode	R	MUST be “2” (System Object)
ParticipantObjectTypeCodeRole	R	MUST be “4” (Resource)
ParticipantObjectIDTypeCode	R	MUST be “12” (URI)
ParticipantObjectID	R	MUST be string-encoded URNs of all partitions that belong the the closed ECR

EFA XDS Binding: listPartitions

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ECR partitions are implemented as XDS folders. Therefore listing partitions corresponds to listing all accessible ECR-classified folders which are assigned to a given patient.

This EFA binding introduces the following extensions and restrictions on the IHE XDS actor and transaction definitions in order to properly cover the EFA listPartitions operation and to align with the EFA security framework:

The query is restricted to folder metadata and does not return any data contained within that folders.
Additional error messages are defined that cover specific failure conditions of the EFA use cases
The availability of data fields is aligned to EFA privacy requirements
The application of security measures and the contents of the SOAP security header are specified normatively

Constraints on the Request Message

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The listPartitions request message implements the FindFolder flavor of the IHE Registry Stored Query transaction (ITI-18) request message as defined in [IHE ITI TF-2b#3.18.4.1.2.3.7.3].

The following table shows how the listPartitions SFM is mapped onto the ITI-18 transaction's query arguments:

listPartitions	ITI-18	Constraints
context	SAML Identity Assertion within the SOAP Security Header	see IHE Cookbook
patientID	$XDSFolderPatientId	The patient ID used must be resolvable by the ECR Provider.
purpose	$XDSFolderCodeList	The codeList MUST contain the ECR-Folder classification code (see EFA XDS Folder Metadata Binding for the respective code). The codeList MUST contain a purpose code, which restricts the query to the partitons of a specific ECR.

In addition the following constrains must be considered:

The $XDSFolderLastUpdateTimeFrom and/or $XDSFolderLastUpdateTimeTo query arguments MAY be used. If given, they MUST be considered by the Document Registry.
The $XDSFolderStatus query arguent SHALL be set to "Approved".

Example

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<query:AdhocQueryRequest xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
   xsi:schemaLocation="urn:oasis:names:tc:ebxml-regrep:xsd:query:3.0 ../schemas/query.xsd"
   xmlns:query="urn:oasis:names:tc:ebxml-regrep:xsd:query:3.0"
   xmlns:rs="urn:oasis:names:tc:ebxml-regrep:xsd:rs:3.0"
   xmlns:rim="urn:oasis:names:tc:ebxml-regrep:xsd:rim:3.0">
   <query:ResponseOption returnComposedObjects="true" returnType="LeafClass"/>
   <rim:AdhocQuery id="urn:uuid:958f3006-baad-4929-a4de-ff1114824431">
      <rim:Slot name="$XDSFolderPatientId">
         <rim:ValueList>
            <rim:Value>'90378912821^^^&amp;amp1.3.6.1.4.1.21367.2005.3.7&amp;ampISO'</rim:Value>
         </rim:ValueList>
      </rim:Slot>
      <rim:Slot name="$XDSFolderStatus">
         <rim:ValueList>
            <rim:Value>'urn:oasis:names:tc:ebxml-regrep:StatusType:Approved'</rim:Value>
         </rim:ValueList>
      </rim:Slot>
      <rim:Slot name="$XDSFolderCodeList">
         <rim:ValueList>
            <rim:Value>'ECR^^^IHE-D-Cookbook-FolderClassCode'</rim:Value>
         </rim:ValueList>
      </rim:Slot>
   </rim:AdhocQuery>
</query:AdhocQueryRequest>

Expected Actions

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The XDS Document Registry provider SHALL respond to a Registry Stored Query request message with the Registry Stored Query response message containing a success indicator and listing XDS metadata of all folders that match the given query. The provider of the XDS Document Registry provider MUST verify that the requesting service user has sufficient rights to access the discovered XDS folders.

In processing of this request the ECR Provider SHALL

assess the access control policy of all folders assigned to the given patient
discover all folders that match the query and the policy
respond to the requestor with the metadata of the discovered folders. Metadata provided SHALL comply to the EFA XDS Folder Metadata Binding.

In case of an error that relates to the transmission of the request or the processing of the EFA security token, the XDS Document Registry MUST respond with the respective error status.

Response Message (Full Success Scenario)

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If the EFA Document Registry Service provider

is able to decode and process the received message and
at least one partition exists for the given patient that is accessible to the requestor

it responds with the registry metadata of the discovered partitions.

Response Message (Failure or Partial Failure Scenario)

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If the XDS Document Registry is unable to successfuly process the query request it MUST respond with a ListResponse message that only contains a <AdhocQueryResponse/RegistryResponse> element.

If no matching folder is discovered or an error occured during the processing of the request, the response status MUST be set to “urn:oasis:names:tc:ebxml-regrep:ResponseStatusType:Failure”. If partitons of the patient are discovered but may be incomplete (e.g. due to a not-responding peer in an ECR P2P network), the response status MUST be set to “urn:ihe:iti:2007:ResponseStatusType:PartialSuccess”.

The severity of each registry error message MUST be set to ”urn:oasis:names:tc:ebxml-regrep:ErrorSeverityType:Error”. Multiple registry error messages MAY be included within a single <rs:RegistryErrorList> element. Apart from the XDS-b error messages defined in Table 4.1-11 of [IHE ITI TF-3] the following error codes are defined for ECR:

Condition and Severity	Message	Code	Action to be taken
The EFA provider requests a higher authentication trust level than assigned to the HP (e.g. password-based login is not accepted for the requested operation). (ERROR)	Weak Authentication	4702	If possible, the HP SHOULD log in again with a stronger mechansims (e.g. smartcard) and re-issue the request with the respective identity assertion.
The ECR provider is unable to verify the identity and/or the authenticity of the requestor (ERROR)	Invalid Subject	4703	The request MUST NOT be processed by the service provider.
The patient is unknown to the ECR provider.	No Data	1102	-
No partitions are registered for the given patient.	No Data	1102	-
None of the patient's partitions is accessible to the requestor.	No Data	1102	-

Security Considerations

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Message Protection

See Message Protection topic in createECR section.

Audit Trail

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The EFA Provider MUST write an audit trail entry according to the EFA v1.2 Audit Trail specification. The following table defines which categories MUST be filled (R), which MAY be filled (O) and which categories MUST NOT be used (X).

category	Opt.	Description
Event	R	Audited event
Requesting Point of Care	R	Health professional organization that issued the original request.
Human Requestor	R	HP that triggered the request
Source Gateway	R	EFA Client node address at the point of Care
Target Gateway	R	EFA provider node address
Audit Source	R	Legal entity that ensures the uniqueness of the identifiers that are used to identify active participants
Patient	R	Patient
Event Target	R	References to the partitions that are disclosed to the requestor (see below)
Error Message	O	Only used in case that the request handling was not completed successfully

For the Event Target Category the following fields MUST be provided:

Field Name	Opt.	Value Constraints
ParticipantObjectTypeCode	R	MUST be “2” (System Object)
ParticipantObjectTypeCodeRole	R	MUST be “4” (Resource)
ParticipantObjectIDTypeCode	R	MUST be “12” (URI)
ParticipantObjectID	R	MUST be string-encoded URNs of the partitions that are referenced within the response message

EFA XDS/XDR Binding: registerConsent

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The registration and enforcement of a new patient consent to an existing ECR is performed by placing a consentInfo document that expresses the new consent into one of the ECR's partitions (folders). This may either be a newly created folder of an existing folder that is classified by the ECR purpose codes and as such implicitly represents the ECR that is to be aligned to a new treatment setup.

This EFA binding introduces the following extensions and restrictions on the IHE XDR actor and transaction definitions in order to properly cover the EFA registerConsent operation and to align with the EFA security framework:

A new folder may be created. Purpose codes shall be provided for the newly created folder as codeList
A consent information document that expresses the new permissions shall be provided through BPPC. A scanned consent revocation document may be additionaly provided.
Additional error messages are defined that cover specific failure conditions of the EFA use cases
The availability of data fields is aligned to EFA privacy requirements
The application of security measures and the contents of the SOAP security header are specified normatively

Constraints on the Request Message

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The registerConsent request message implements the IHE Provide And Register DocumentSet transaction (ITI-41) request message as profiled in [IHE ITI TF-2b]

The following table shows how the registerConsent SFM is mapped onto the ITI-41 transaction:

registerConsent	ITI-41	Constraints
context	SAML Identity Assertion within the SOAP Security Header	see IHE Cookbook
ecrRef	XDS Folder Attribute: patientID XDS Folder Attribute: codeList	The codeList shall contain all purpose codes as assigned to the ECR that is to be aligned
consentInfo	XDS Document
consentDoc (optional)	XDS Document	Scaned documents SHALL be provided acc. to the XDS SD Integration Profile.

Following this, implementations SHALL consider the following constraints:

All provided documents SHALL be associated with a newly created XDS folder or with a folder that is already part of the ECR. Folder metadata SHALL be used as specified in the EFA XDS Folder Metadata Binding.
The request carries one or more documents. One of these documents SHALL be a consent information document.
All document metadata SHALL be provided as specified in the EFA XDS Document Metadata Binding.
The requestor (EFA Client) SHOULD embrace the provided documents as a single IHE XDS submission set acc. to [IHE ITI TF-2a].
The EFA provider SHOULD ignore the submission set grouping and MUST ignore all associations between documents and submission sets.
The EFA provider MUST NOT process any metadata assigned to the submission set, it MUST solely rely on the document metadata and contents.
The EFA provider MUST NOT register documents that are only provided through associations.

Expected Actions

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The XDS Document Repository provider SHALL respond to an ProvideAndRegisterDocument request message with the ProvideAndRegisterDocument response message containing a success indicator.

The provider of the XDS Document Repository MUST verify that the requesting service user has sufficient rights to register a consent document at this ECR Provider. This includes that the service user is registered with the provider and familiar with using ECRs. Additionaly the ECR provider SHALL verify the completeness and consistency of the provided consentInfo document.

In processing this request the ECR Provider SHALL

assess the access control policy of that ECR with the "modify consent" operation. If this access is denied an error status SHALL be returned.
setup a folder as specified in the request message
store the provided documents within the XDR Document Repository
forward the metadata of the received documents to the XDS Document Registry for registration
adapt all permissions that are assigned to the ecrRef to the care team setting as described in the newly provided consent. All previously set permissions must be invalidated.
if the validity date is changed by the consent: register the new validity with the access control system
if the purpose is aligned by the new consent: change the eventList codes of all containers that are assigned to the eCR to the new purpose

In case of an error that relates to the transmission of the request or the processing of the EFA security token, the EFA Resource Manager Service provider MUST respond with the respective error status.

Response Message (Full Success Scenario)

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If the EFA Document Registry Service provider is able to decode the received message and to properly change the settings of the ECR and its partitions it responds with an ebXML Registry Response with its status set to "urn:oasis:names:tc:ebxml-regrep:ResponseStatusType:Success"

If the service provider wants to respond with further information on the processing of the transmitted data or with a non-critical warning it SHOULD include an additional <RegistryErrorList> element. The severity MUST be set to “urn:oasis:names:tc:ebxml-regrep:ErrorSeverityType:Warning”.

The following warning messages and codes are defined:

Condition and Severity	Message	Code	Action to be taken
Request was received but not processed; e.g. because a manual intervention by the ECR provider is required to change the security settings of an ECR	Processing deferred	2201	None

Response Message (Failure or Partial Failure Scenario)

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If the XDS Document Repository is able to decode the received message but the processing of the request failed, it responds with an ebXML Registry Response that contains a respective status indicator (see below).The response MUST contain a RegistryErrorList element that indicates the failure condition.

The modification of an ECR's security settings is an All-or-Nothing operation. Therefore in any case of failure the response status MUST be set to “urn:oasis:names:tc:ebxml-regrep:ResponseStatusType:Failure”.

The severity of each registry error message MUST be set to ”urn:oasis:names:tc:ebxml-regrep:ErrorSeverityType:Error”. Multiple registry error messages MAY be included within a single <rs:RegistryErrorList> element. Apart from the XDS-b error messages defined in Table 4.1-11 of [IHE ITI TF-3] the following error codes are defined for EFA:

Condition and Severity	Location	Message	Code	Action to be taken
The EFA provider requests a higher authentication trust level than assigned to the HP (e.g. password-based login is not accepted for the requested operation). (ERROR)	-	Weak Authentication	4702	If possible, the HP SHOULD log in again with a stronger mechansims (e.g. smartcard) and re-issue the request with the respective identity assertion.
The ECR provider only accepts consentInfo documents if they are digitally signed by an HP. (ERROR)	OID of the consentInfo document	No Signature	4704	If possible, the EFA Client SHOULD re-issue the request with the data signed by an HP.
The requestor has not sufficient permission to perform the requested operation (ERROR)	-	Policy Violation	4109	The request MUST NOT be processed by the service provider. The HP MAY request the patient to exted the consent.
An ECR of the given purpose does not exist for the patient (ERROR)	-	Policy Violation	4109	The request MUST NOT be processed by the service provider.

Security Considerations

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Message Protection

See Message Protection topic in createECR section.

Audit Trail

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The EFA Provider MUST write an audit trail entry according to the EFA v1.2 Audit Trail specification. The following table defines which categories MUST be filled (R), which MAY be filled (O) and which categories MUST NOT be used (X).

category	Opt.	Description
Event	R	Audited event
Requesting Point of Care	R	Health professional organization that issued the original request.
Human Requestor	R	HP that triggered the request
Source Gateway	R	EFA Client node address at the point of Care
Target Gateway	R	EFA provider node address
Audit Source	R	Legal entity that ensures the uniqueness of the identifiers that are used to identify active participants
Patient	R	Patient
Event Target	R	References to all partitions that are affected by this operation (see below)
Error Message	O	Only used in case that the request handling was not completed successfully

For the Event Target Category the following fields MUST be provided:

Field Name	Opt.	Value Constraints
ParticipantObjectTypeCode	R	MUST be “2” (System Object)
ParticipantObjectTypeCodeRole	R	MUST be “4” (Resource)
ParticipantObjectIDTypeCode	R	MUST be “12” (URI)
ParticipantObjectID	R	MUST be string-encoded URNs of all partitions that belong the the ECR that was modified

Referenzen und Querverweise

EFA-2.0-Spezifikation

EFA XDS/XDR Resource Manager Binding

Inhaltsverzeichnis

EFA Resource Manager XDR/XDS Binding

EFA XDS/XDR Binding: createECR

Constraints on the Request Message

Expected Actions

Response Message (Full Success Scenario)

Response Message (Failure or Partial Failure Scenario)

Security Considerations

Message Protection

Transport Layer Security with SAML Issued Endorsing Token

WS-Security-Policy Example

Asymmetric Message Protection

WS-Security-Policy Example

WS-SecureConversation bootstrapped with SAML Issued Token

Audit Trail

EFA XDS/XDR Binding: createPartition

Constraints on the Request Message

Expected Actions

Response Message (Full Success Scenario)

Response Message (Failure or Partial Failure Scenario)

Security Considerations

Message Protection

Audit Trail

EFA XDS/XDR Binding: closeECR

Constraints on the Request Message

Expected Actions

Response Message (Full Success Scenario)

Response Message (Failure or Partial Failure Scenario)

Security Considerations

Message Protection

Audit Trail

EFA XDS Binding: listPartitions

Constraints on the Request Message

Example

Expected Actions

Response Message (Full Success Scenario)

Response Message (Failure or Partial Failure Scenario)

Security Considerations

Message Protection

Audit Trail

EFA XDS/XDR Binding: registerConsent

Constraints on the Request Message

Expected Actions

Response Message (Full Success Scenario)

Response Message (Failure or Partial Failure Scenario)

Security Considerations

Message Protection

Audit Trail

Referenzen und Querverweise

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