cdaefa:EFA Projectathon 2016

Dieses Material ist Teil des Leitfadens CDA für die elektronische Fallakte. Direkt im Wiki geändert werden sollten Schreibfehler, ergänzende Hinweise. Offene Fragen, die der Diskussionen bedürfen, sollten auf der Diskussionsseite aufgenommen werden. Liste der Seiten dieses Leitfadens: hier, Liste der Seiten, in denen dieses Material verwendet (transkludiert) siehe hier .

About Elektronische FallAkte (EFA)

The electronic Case Record (Elektronische FallAkte, EFA) is an initiative launched by German hospitals in 2006. Electronic case records provide a structured and integrated viewpoint of medical data that can be associated with an individual case. A case begins with an initial diagnosis and integrates as many in-stances of billing or treatment as required. A physician oversees the eCR, with the various attending physicians being responsible for the case records contents and completeness.

The decentralized handling and maintenance of case records is based on the metaphor of a supply network as a community of interest composed of autonomous actors working on a specific task. Since it is generally preferred that the actual place at which medical data and administrative information (e.g. user accounts) remains constant, the case record may be implemented quickly and efficiently in existing networks, and may furthermore facilitate the initiation of co-operation at a regional level as well as at a national scope.

The further development of the EFA technical specifications is sponsored by German hospitals, private hospital chains, and regional care networks who are organized within the EFA Verein (EFA Association). The recent release version 2.0 of EFA is fully compliant to IHE profiles and has been developed as a joint effort between EFA Verein, German IT vendors and Fraunhofer FOKUS. The IHE white paper "Access Control" was highly influenced by the EFA security architecture and the initiative that resulted in the forthcoming IHE profile supplement on digital patient consent was originally fueled by respective EFA requirements.

All EFA technical specification are open and available to the public at http://wiki.hl7.de/index.php?title=cdaefa:EFA_Spezifikation_v2.0.

EFA Projectathon: General Information

EFA Constraints and Extensions

IHE ITI-19 (Node Authentication)

EFA builds upon the same actors as the IHE ITI XDS, ATNA and XUA integration profiles. All actors will share messages using mutually authenticated TLS communication channels as defined in IHE ITI-19. For the EFA Projectathon the actors already tested with the IHE Connectathon tests will be used. Therefore there will be no additional requirements for vendors realated to ITI-19.

IHE ITI-20 (Record Audit Event)

All EFA actors record audit events to an Audit Repository actor. All EFA actors shall be able to issue IHE ITI-20 messages for all EFA transactions. These messages are fully compliant to the audit trail specifications of the underlying IHE transactions but contain an additional eventTypeCode element that signals the logical EFA transaction. For details see EFA Audit Trail Binding.

IHE XUA Get X-User Assertion

Regarding user authentication, two options will be offered for the EFA Projectathon:

1. EFA Clients may perform a local authentication which is asserted through an IHE XUA compliant X-User Assertion. EFA constraints the IHE XUA specification by requiring the provisioning of the Subject ID and Subject Organization ID attributes within this assertion.
2. EFA Clients may authenticate the user with an external WS Trust Identity Provider which will be set up by Fraunhofer FOKUS for the EFA Projectathon. Authentication will be performed by user ID and password. For obtaining the X-User Assertion WS Trust v1.2 RST/RSTR messages will be supported by the Identity Provider. A test server will be set up in advance to the Projectathon. (to be discussed: Version 1.2 of WS Trust acceptable for the vendors?)

For the Projectathon only SAML Bearer Subject Confirmation Method will be tested.

Test user definitions will be provided by Fraunhofer FOKUS (open issue: re-use of IHE Connectathon User profiles?)

IHE ITI-40 (Provide X-User Assertion)

Each EFA transaction shall by piggybacked with an X-User Assertion. The assertion shall comply to the constraints described above. The integration of the assertion into SOAP messages and the validation of the assertion are to be inmplemented as defined for IHE ITI-20.

IHE ITI-41 (Provide and Register Document Set-b)

EFA utilizes IHE ITI-41 for setting up a new EFA instance and for providing documents to an existing EFA.

For setting up a new EFA

The ITI-41 message shall

• create a new XDS folder. The folder shall be contained within the submission set. The folder metadata shall include a codeList element with two classification codes. The codes to be used will be provided by Fraunhofer FOKUS as part of the test case configuration.
• contain a digital consent consent document that complies to the EPPC-G specification. EFA Client actors who implement the EFA Digital Consent Option shall provide means to assemble such a document based on the Projectathon test case definition. For other clients Fraunhofer FOKUS will provide a pre-defined consent document together with XDS metadata that shall be integrated with the ITI-41 message as-is. In both scenarios the consent document shall be associated with the newly created XDS folder.

EFA Provider actors that implement the EFA Digital Consent Option shall validate the consent document and configure access permissions to the newly created EFA acordingly. Provider actors that do not implement this option will be provided by an XACML-coded access control configuration by Fraunhofer FOKUS. This configuration shall only be activated after a valid ITI-41 message containing a consent document within a newly created XDS folder (containing a defined classification code and patient ID) was received.

For placing documents into an existing EFA

the EFA Client actor shall be aware of the folder classification codes which were set when the EFA was set up (see above). In case the actor is not the one who created the EFA, the Client actor shall browse the EFA prior to providing new documents (see below).

The ITI-41 message for providing a document to an existing EFA shall

• contain a has-member association to an XDS folder which either
  • is contained within the submission set. In this case the folder shall contain the same classifications within the codeList element as the folder that was created when the EFA was set up.
  • already exists as part of the EFA.

contain one or more documents according to the IHE ITI-41 specification. The sourcePatientInfo metadata element shall not be used. The confidentialityCode shall be "N".

IHE ITI-18 (Registry Stored Query)

EFA Client and Provider actors shall implement the FindFolders and GetFolderAndContents queries of IHE ITI-18:

• for FindFolders the patient ID and the folder classification (codeList) shall be provided by the EFA Client.
• the EFA Provider shall enforce the permissions on the EFA as set within the patient's consent during EFA initialization.

Other queries shall not provide any documents that are part of an EFA. EFA providers may respond to such requests with an access permission error. Remark: The EFA specification demands for supporting GetAssociations queries. This will be obsolet with the next EFA release and will therefore not be tested at the EFA Projectathon.

IHE ITI-43 (Retrieve Document Set)

The only constraints EFA imposes on the ITI-43 transaction are

• EFA Provider actors shall enforce the permissions on the EFA the capsules the requested documents as set within the patient's consent during EFA initialization,
• all requested documents shall be associated with the same XDS folder.

EFA Projectathon Test Cases

Test Case 1: User Authentication

Only authenticated users are allowed to initialize a new EFA instance or to access an existing EFA. For creating a new EFA instance, the user must be registered with the EFA provider where the EFA is to be initialized. For accessing an existing EFA, the user must be granted respective permission through the affected patient's consent.

For the EFA Projectathon vendors shall be able to either obtain a valid EFA Identity Assertion from a given EFA Identity Provider or to self-issue a valid EFA Identity Assertion using a locally deployed trusted authority. The EFA Identity Assertion is a XUA User Assertion that shall follow the constraints as defined at http://wiki.hl7.de/index.php?title=cdaefa:EFA_Identity_Assertion_SAML2_Binding.

EFA Client actors shall piggyback each request with a valid EFA Identity Assertion by using the means of the IHE ITI-40 transactions. EFA Provider actors shall be able to validate the provided assertion and to match the contained attributes with the access control policy of the EFA instance that is to be accessed through the request.

• Implementation Guidelines: User Authentication at the EFA Client (coming soon)
• Implementation Guidelines: EFA Identity Assertion processing at the EFA Provider (coming soon)
• Example: EFA Identity Assertion (coming soon)
• Example: WS Trust RST Request for obtaining an EFA Identity Assertion (coming soon)
• Example: EFA Identity Assertion inside SOAP header (coming soon)
• Online Test Tool: EFA Identity Provider (coming soon)
• Online Test Tool: EFA Identity Assertion Validator (coming soon)

Test Case 2: EFA Initialization

A new EFA instance is set up by creating a respectively classified XDS folder at the EFA Provider and uploading a machine readable consent document into this folder.

Creating an EFA-compliant XDS folder and uploading the coded consent document is performed through a constrained implementation of IHE ITI-41 transaction. The constraints to be implemented are defined at http://wiki.hl7.de/index.php?title=cdaefa:EFA_XDS_ResourceManager#EFA_XDS.2FXDR_Binding:_createECR

Further details about this test case will be provided as soon as the concrete test scenario is finalized.

Test Case 3: Writing a Document to an Existing EFA

EFA documents are always stored to EFA folders (which are in fact just classified XDS folders). A new document may either be stored to an already existing folder or into a newly created folder. For the EFA projectathon vendors must demonstrate both of these scnearios.

The eCR transaction for providing a document to an EFA isnatsnce is a constrained implementation of IHE ITI-41. The constraints to be implemented are defined at http://wiki.hl7.de/index.php?title=cdaefa:EFA_XDS_DocumentRepository#EFA_XDS_Binding:_provideData.

Further details about this test case will be provided as soon as the concrete test scenario is finalized.

Test Case 4: Loading an Existing EFA's Table of Content

Each EFA instance is made up from one or more folders that hold the documents that are shared for a patient's treatment. When opening a EFA a physician's IT system first loads the table of contents of an identified EFA by

1. discovering the folders that belong to the selected EFA instance (IHE ITI-18 FindFolder query) and then
2. loading the metadata for each document within each of the EFA folders (IHE ITI-18 GetFolderAndContents query on each folder).

The constraints to be implemented are defined at http://wiki.hl7.de/index.php?title=cdaefa:EFA_XDS_ResourceManager#EFA_XDS_Binding:_listPartitions and http://wiki.hl7.de/index.php?title=cdaefa:EFA_XDS_DocumentRegistry#EFA_XDS_Binding:_listPartitionContent.

Further details about this test case will be provided as soon as the concrete test scenario is finalized.

Test Case 5: Fetching a Document from an Existing EFA

Once the table of content is read, the physican may select a document and download it for display or for storing it to his local case documentation.

This is done through a constrained implementation of IHE ITI-43. The constraints to be implemented are defined at http://wiki.hl7.de/index.php?title=cdaefa:EFA_XDS_DocumentRepository#EFA_XDS_Binding:_retrieveData.

Further details about this test case will be provided as soon as the concrete test scenario is finalized.

Option: Digital Consent

While Release 1 of the EFAv2.0 specification did not make any assumptions on the structure and coding of EFA consents, the forthcoming Release 2 (January 2016) demands for a structed HL7v3 CDA coded consent that implements the HL7 Implementation Guide for CDA® Release 2: Privacy Consent Directives, Release 1. An EFA profile of this implementation guide has been workedout in 2015 by bvitg, EFA-Verein and Fraunhofer FOKUS. As this extension to the EFA specification was just recently published, its implementation is not mandatory for successfully passing the EFA Projectathon. Nevertheless vendors that already implement this feature may receive a respective conformance declaration by choosing the EFA Digital Consent option.

• Implementation Guidelines: Digital Consent Option for EFA Client Actors (coming soon)
• Implementation Guidelines: Digital Consent Option for EFA Provider Actors
• Example: EFA Digital Consent Document
• Example: EFA compliant IHE ITI-41 Transaction including EFA Digital Consent

Option: Peer-2-Peer Networking of EFA Providers

Further details about this option will be provided as soon as the concrete test scenario is finalized.

Links and Documents

EFA Projectathon

In preparation for the 2016 EFA Projectathon EFA Verein and Fraunhofer FOKUS prepared several documents on the overal procedures and the EFA specific test cases:

• Projectathon Concept Paper (PDF, German): This paper sets the overall framing for the EFA Projectathon by documenting all agreements that have been made among the affected parties (EFA Verein, IHE Europe, bvitg, Fraunhofer FOKUS)
• Sketch of the Storyboard (PDF, English): This document sketches the storyboard that will be used as a baseline for the EFA Projectathon tests. For each step of the stroyboard the relevant links to the EFAv2.0 specification are given.
• Actors and Transactions (PDF, English): This document was used by IHE Europe for registering the EFA actors and transactions into gazelle. It defines the certifiable actors and EFA transactions that have to be implemented by EFA-compliant solutions. For each EFA transaction the underlying IHE transactions and EFA constraintes on these transactions are referenced.

IHE Connectathon

IHE Europe set up a Google Group for Connectathon participants. All webinar announcements and Connectathon-related news will be posted to this group by IHE Europe.

Additionally IHE provides vendors with various Connectathon Training Materials. For many IHE Profiles links to existing testing tools are given on that site which enable vendors to tests their solutions in advance to the Connectathon.

Schematrons

Schematron files for validating EFA request messages can be downloaded from the FOKUS git-Repository:

https://gitlab.fokus.fraunhofer.de/EFA-2.0/efa2-schematron

At this site you will also find sample messages (positive and negative test cases).

IHE Webinars

IHE is offering a series of webinars for Connectathon participants:

14. December 2015 (Connectathon registration and important dates)

• Presentation
• Audio-Recording

Action Items

What	Who	When	Status/Result
Resolve open issues related to Projectathon organization (see Tcon protocols)	FOKUS to contact IHE Europe	ongoing activity. News will be distributed via Google Group.
provide XDS-folder eventCodes that shall be used for the EFA Projectathon	FOKUS. Register eventCodes with NIST.	22. January 2016	delayed. Will be available mid February.
Setup of an EFA Provider actor for testing. Registered vendors shall be able to connect to the EFA Provider via internet.	FOKUS	1. February 2016	delayed. Schematrons will be registered with gazelle until mid February. Test Provider actor lacks access control features and will not be available before end of February.
Provisioning of sample policy data for vendors who do not implement the "digital consent" option	FOKUS	12. February 2016
Provisioning of Schematrons for all relevant EFA transactions.	FOKUS	12. February 2016
Provide a list of validation tests that EFA Provider vendors need to perform on EFA Identity Assertions.	FOKUS	29. January 2016	obsolete. EFA tests will not request for validations beyond the ones mandated for IHE XUA.
Setup of an EFA Identity Provider for obtainig EFA-compliant XUA assertions. Registered vendors shall be able to connect to the Identity Provider via an open WS Trust interface.	FOKUS	29. January 2016	obsolete. For EFA Projectathon the XUA Identity Provider integrated with gazelle will be used.
Register for EFA Actors within gazelle	Vendors	22. January 2016 (extended deadline)	done. Registration closed.
Setup a doodle for finding a time slot for the next tcon	FOKUS	15. January 2016	done
Setup a Google Group for EFA Projectathon participants	FOKUS	15. January 2016	done
Resolve accepted change proposals to the EFA specification	FOKUS	15. January 2016	done
Provide an overview on the gaps between IHE "standard" profiles and EFA extensions/constraints	FOKUS	7. January 2016	done (see EFA Constraints and Extensions)
Provide further information and sample document/policy for "Digital Consent" Option	FOKUS	29. December 2015	done. See Digital Consent
Distribution of contact data for all EFA Projectathon participants	FOKUS	29. December 2015	done (sent out by Mail)
List contact data of FOKUS technical support team on the Projectathon Wiki.	FOKUS	asap	done. See Contact section on this page.

EFA Projectathon TCons

• TCon - 15.12.15, 10.00 Uhr (protocol, German)
• TCon - 18.12.15, 10.00 Uhr (protocol, German)
• TCon - 11.01.16, 10.00 Uhr (protocol, German)
• TCon - 03.02.16, 13.00 Uhr (protocol, German)
• TCon - 10.03.16, 10.00 Uhr (protocol, German)
• TCon - 11.03.16, 14.00 Uhr (protocol, German)

Contact

For questions about EFA in general and the EFA Projectathon organization please contact joerg.caumanns@fokus.fraunhofer.de.

For questions related to EFA technical specifications, EFA Projectathon technical implementation, EFA transaction samples and pre-projectathon testing support please contact ben.kraufmann@fokus.fraunhofer.de or raik.kuhlisch@fokus.fraunhofer.de.

News, questions and hints that may be relevant to all EFA Projectathon participants should be discussed in the EFA Projectathon Google Group.

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