EFA XDS/XDR ProvideAndRegisterDocument Binding

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EFA XDS/XDR ProvideAndRegisterDocument Binding

Within EFA the actors and transactions of the IHE XDR integration profile is mapped onto EFA services and messages as follows:

IHE XDR EFA Document Registry Service
Actor: Document Source EFA Client
Actor: Document Recipient EFA Provider
Transaction: Provide and Register Document Set ITI-41 ProvideAndRegisterDocument

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

  • 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

The ProvideAndRegisterDocument request message is issued by an EFA client at the point of care for providing and registering a medical document to an existing EFA instance. Each transmission carries one or more documents. All provided documents will be registered with the same folder within the same logical EFA The request message implements the IHE Provide And Register DocumentSet transaction (ITI-41) request message as profiled in [IHE ITI TF-2b] considering the following constraints:

  • 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 this 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

The EFA Document Registry Service provider SHALL respond to an ProvideAndRegisterDocument request message with the ProvideAndRegisterDocument response message containing a success indicator. It SHALL forward the received documents to the EFA Document Repository Service using any internal mechanism.

The EFA Document Registry Service provider MUST verify that the requesting service user has sufficient rights to submit the given kind of documents for the identified patient and into the identified folder.

In case of an error that relates to the transmission of the request or the processing of the EFA security token, the EFA Document Registry Service provider MUST respond with a fault message according to section xx.

Response Message (Full Success Scenario)

If the EFA Document Registry Service provider is able to decode the received message and to properly process/forward all transmitted documents 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”:

           codeContext=”Processing deferred” 
           location="" />

The following warning messages and codes are defined:

Condition and Severity Message Code Action to be taken
Documents were received but not processed Processing deferred 2201 None

Response Message (Failure or Partial Failure Scenario)

If the EFA Document Registry Service provider is able to decode the received message but the processing/forwarding of one or more documents 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 none of the documents was processed succesfully, the response status MUST be set to “urn:oasis:names:tc:ebxml-regrep:ResponseStatusType:Failure”. If 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.
The EFA Document Registry service provider only accepts data of the given kind if it is digitally signed by an HCP. (ERROR) OID of the document that caused the error. No Signature 4704 If possible, the EFA Client SHOULD re-issue the request with the data signed by an HP.
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 Audit Considerations

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 provided documents (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 UUIDs of the provided documents