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Publication and Discovery XDS and DSUB IT Infrastructure Planning Committee Ilia Fortunov - Microsoft XDS Cross-Enterprise Document Sharing What is XDS ? The Cross-Enterprise Document Sharing (XDS) IHE Integration Profile facilitates the registration, distribution and access across health enterprises of patient electronic health records It provides a standards-based specification for managing the sharing of documents between any healthcare enterprise 3 XDS Affinity Domains Group of healthcare enterprises that have agreed to work together using a common set of policies and XDS-based infrastructures for sharing patient clinical documents. Some examples are: • Regional community of care • Nationwide EHR • Specialized or disease-oriented (cardio, diabetes, oncology) • Government-sponsored or federation of enterprises • Insurance provider supported communities XDS profile is designed to accommodate a wide range of policies on: • Patient identification and consent • Controlling access to information • Format, content, structure, and representation of clinical information 4 Use Cases • Patient Care Summary (e.g. within a region) – Publishing of Care Summaries by providers – Access to patient’s Care Summary in an emergency • eReferral between primary and secondary care providers • Sharing of radiology reports and images between facilities • Sharing of laboratory reports by clinical laboratories with ordering physicians and other care providers • ePharmacy between community pharmacy and ambulatory physicians 5 Main Systems and Responsibilities • A document Repository is responsible for storing documents in a transparent, secure, reliable and persistent manner and responding to document retrieval requests. • A document Registry is responsible for storing information or metadata about those documents so that the documents of interest for the care of a patient may be easily found, selected and retrieved irrespective of the repository where they are actually stored. • Any IT system (e.g. point of care) may act as a Document Sources or Document Consumers submitting documents for registration, or querying/retrieving relevant documents. Notes: • Analogous to a library (book repository) and catalog/index • The Registry does not have access to the documents – an important separation from security and privacy perspective • Multiple Repositories can be linked to one Registry 6 XDS Flow and Interactions XDS Document (Metadata): Registry 3. Consumers search Consumer Class for documents with Patient Id specific information Author Facility Date of Service … 2. Repository registers the documents metadata and pointer with the Registry 4. Consumers retrieve selected documents from Repository (-ies) 1. Sources post document packages Source of to the Repository Documents Repository 7 XDS Transaction Diagram Patient Identity Source Patient Identity Feed [ITI-8] Patient Identity Feed HL7v3 [ITI-44] Registry Stored Query [ITI-18] Document Document Registry Consumer Register Document Set-b [ITI-42] Retrieve Document Set [ITI-43] Document Document Source Provide&Register Repository Document Set-b [ITI-41] Integrated Document Source/Repository 8 XDS Actors • Document Source – producer and publisher of documents, responsible for sending documents and their metadata to a Document Repository actor • Document Repository is responsible for both the persistent storage of these documents as well as for their registration with the appropriate Document Registry • Document Registry maintains metadata about each registered document and a link to the Document in the Repository where it is stored. Responds to queries from Document Consumer actors about documents meeting specific criteria. • Document Consumer queries a Document Registry for documents meeting certain criteria, and retrieves selected documents from one or more Document Repository actors • Patient Identity Source provides unique identifier for each patient and maintaining a collection of identity traits. This facilitates the validation of patient identifiers by the Registry Actor in its interactions with other actors • Integrated Document Source/Repository combines the functionality of the Document Source and Document Repository actors into a single actor that does not expose the Provide and Register Document Set transaction 9 XDS Transactions (1) • Provide and Register Document Set – For each document in the submitted set, the Document Source Actor provides both the documents as an opaque octet stream and the corresponding metadata to the Document Repository. The Document Repository is responsible to persistently store these documents, and to register them in the Document Registry using the Register Documents transaction. • Register Document Set allows a Document Repository Actor to register one or more documents with a Document Registry, by supplying metadata about each document to be registered. This document metadata will be used to create an XDS Document Entry in the registry. 10 XDS Transactions (2) • Patient Identity Feed conveys the patient identifier and corroborating demographic data, in order to populate the Document Registry with patient identifiers that have been registered for the XDS Affinity Domain. (At least one of the options [ITI-8] or [ITI-44] must be supported.) • Registry Stored Query is issued by the Document Consumer Actor to a Document Registry. It will return registry metadata containing a list of document entries found to meet the specified criteria including the locations and identifier of each corresponding document in one or more Document Repositories. • Retrieve Document Set – initiated by a Document Consumer. The Document Repository shall return the document set that was specified by the Document Consumer. 11 XDS Document Content Types XDS profile is content agnostic – it can be used with a variety of document types, including: • XDS-SD: Scanned document, plain text or PDF/A, in HL7 CDA R2 format • XDS-MS: Medical summary in HL7 CDA format • XDS-I: Radiology report in plain text of PDF format, or reference to a collection of DICOM SOP Instances in a manifest document in the DICOM Key Object Selection format Also supported are many other document content profiles specified by the IHE Patient Care Coordination, Laboratory, Cardiology, Pharmacy Technical Frameworks 12 XDS – Actors and Options Actors Options Reference Document Replacement ITI TF-1: 10.2.1 Document Addendum ITI TF-1: 10.2.2 Document Source Document Transformation ITI TF-1: 10.2.3 Folder Management ITI TF-1: 10.2.4 Basic Patient Privacy Enforcement ITI TF-2b:22.214.171.124.3.1 Document Repository Document Registry Patient Identity Feed ITI TF-2a: 3.8 Patient Identity Source Patient Identity Feed HL7v3 ITI TF-2b: 3.44 ITI TF-2a: 126.96.36.199.3.5 Basic Patient Privacy Enforcement Document Consumer ITI TF-2b: 188.8.131.52.3.1 Basic Patient Privacy Proof ITI TF-2a: 184.108.40.206.3.6 13 Standards Used • ebRIM OASIS/ebXML Registry Information Model v3.0 • ebRS OASIS/ebXML Registry Services Specifications v3.0 • ITI TF-2x: Appendix V – WS-I Profiles BP 1.1, BSP 1.0 – WS-* Specifications (SOAP 1.2, MTOM/XOP) 14 Security and Privacy Considerations • All actors be grouped with a ATNA Secure Node Actor or Secure Application Actor resulting in each node (systems supporting XDS actors) of the XDS Affinity Domain should have audit and security mechanisms in place • Transactions between different secure nodes that use ATNA are encrypted • Each XDS Transaction will result in an audit event record sent to an ATNA Audit Record Repository Actor from each XDS actor • Timestamp consistency is provided by Consistent Time (CT) profile 15 XDS Workflow Health Information Exchange Network PIX or PDQ PIX or PDQ Query Patient Demographics Supplier Query Patient Identity XRef Mgr A87631 M8354673993 PMS M8354673993 14355 L-716 14355 L-716 A87631 ED Application Physician Office Document Document Registry Repository PACS Document Repository EHR System Query Document Register Document Provide & (using Patient ID) (using Patient ID) Register PACS Retrieve Document Maintain Lab Info. Record Audit Time System Event Maintain Time Teaching Hospital Maintain Community Clinic Time Audit record repository Time server ATNA CT Record Audit Event XDS Affinity Domain 16 Health Document Exchange Options Flexible Infrastructure XDS XDS INFRASTRUCTURE M8354673993 Publish L-716 A87631 14355 Query/Retrieve XDR Existing Reliable Send to Messaging System Send to Interchange Media XDM Read Write Including Email XCA XCA INFRASTRUCTURE M8354673993 L-716 A87631 14355 Query/Retrieve 17 IHE XDS adopted in National & Regional be updated and refined Projects (sample) Lower further by Charles P. NETHERLANDS Friesland Austria Italy Conto Corrente Natn’l Mamography Venetto - Friuli France Suisse VITL-Vermont Quebec, Toronto, Wales DMP St Gallen Alberta, British Columbia Imaging Austria Lausane Canada Infoway France Imaging Boston Medical IDF Center - MA For more complete list see: tinyurl.com/wwXDS Philadelphia HIE Belgium Flemish-Leuven KeyHIE Pennsylvania CareSpark – TN & VA SHARP CA South Africa THINC- New York Providence NCHICA – N. Carolina CHINA-Shanghai CHINA-MoH JAPAN-Nagoya Health System - Imaging Info Sharing Lab results sharing Imaging Info Sharing, OR 18 Nationwide PDI guideline 1 Who Is Using XDS? To be refined further • Stable specification since 2009 (See IHE ITI Technical Framework) • First implementation in clinical use in region of Genoa - Italy) since early 2006. • Several since: Lower Austria region, State of Vermont, Nagoya city, South Africa region, Dutch regions, etc. • Adopted by several national programs world-wide: France, Canada, Switzerland, USA, Slovenia, China, etc. • Numerous product implementations world-wide: Close to 100 EMR/Clinical Systems products shipping More than 20 Infrastructure products shipping 19 Open Source Implementations o be refined further Numerous open source implementations tested at Connectathon are available for XDS, ATNA and CT: – NIST under Source Forge http://sourceforge.net/projects/iheos/ – HIE-OS under Source Forge http://sourceforge.net/projects/hieos/ – Microsoft under codeplex http://ihe.codeplex.com/ – OHT – IHE Profiles Charter https://iheprofiles.projects.openhealthtools.org – OHT – Open Exchange Forge https://openexchange.projects.openhealthtools.org – OHT – Model Driven Health Tools-Charter https://mdht.projects.openhealthtools.org 2020 XDS References • Primary – ITI TF-1 Section 10 Cross-Enterprise Document Sharing (XDS.b) • Underlying Technical Framework Content – ITI TF-1 • Appendix J Content and Format of XDS Documents • Appendix K XDS Concept Details • Appendix M Cross-Enterprise Document Sharing and IHE Roadmap – ITI TF-2a • Section 3.8 Patient Identity Feed • Section 3.18 Registry Stored query – ITI TF-2b • Section 3.41 Provide and Register Document Set-b • Section 3.42 Register Document Set-b • Section 3.43 Retrieve Document Set – ITI TF-2x • Appendix V “Web Services for IHE Transactions” – ITI TF-3 • Section 4.1 XDS Metadata Model 21 DSUB Document Metadata Subscription supplement DSUB Overview The Document Metadata Subscription (DSUB) supplement contains two related parts: • Publish/Subscribe Infrastructure: General framework for defining web-services based publish/subscribe interactions • Document Metadata Subscription (DSUB) Integration Profile: Use of subscriptions within an XDS Affinity Domain or across communities 23 Publish/Subscribe Infrastructure • Presents a framework for building event-driven information exchange patterns using a publish/subscribe data exchange model • Defines the transport of publish, subscribe and notify messages. • Supports IHE profiles which define the use case specific content to be carried in the publish, subscribe and notify messages Document Metadata Subscription (DSUB) first profile to use this framework. 24 Publish/Subscribe Infrastructure Actors and Transactions Publisher Publish 220.127.116.11 Notification Subscribe 18.104.22.168 Subscriber Broker Notify 22.214.171.124 Notification Recipient 25 Possible Combined Actors Publisher Publisher Notification Subscribe Subscriber Publish Broker Notify Notification Subscribe Broker Notification Publisher Recipient Notify Notification Subscribe Broker Notification Subscriber Recipient Notify Notification Subscriber Recipient 26 Document Metadata Subscription (DSUB) Integration Profile • Defines a subscription which allows for the matching of metadata during the publication of a new document for a given patient, and results in the delivery of a notification. • Enabled within an XDS Affinity Domain or XCA environment • Use Cases – Emergency Department: Notification of new document availability during treatment – Primary Care Management: PCP receives notification when new documents for patient are available 27 DSUB Actors and Transactions Document Metadata Document Metadata Publisher Subscriber Document Metadata Publish [ITI-54] Document Metadata Document Metadata Subscribe [ITI-52] Notification Broker Document Metadata Notify [ITI-53] Document Metadata Notification Recipient 28 Transactions • Document Metadata Subscribe : start a subscription for a particular topic and filtering within that topic. Supports full and minimal notifications and where to send the notification. • Document Metadata Notify : send a notification about the availability of a document or documents of interest, based on the subscribers' filters on selected topics • Document Metadata Publish : notify that an event occurred for which there may be a subscription. 29 DSUB Process Flow Notification Notification Publisher Subscriber Broker Recipient XDS Document XDS Document Source Subscribe Consumer XDS Document Registry Publish Notify Publish Notify Unsubscribe Publish 30 DSUB Subscription Topics and Standards • DSUB Topic Tree – ihe:FullDocumentEntry : subscribes to Document Entry registration events; the notification shall contain the full metadata describing each matching Document Entry – ihe:MinimalDocumentEntry : subscribes to Document Entry registration events; the notification shall contain a minimal set of data (identifiers only) describing each matching Document Entry • DSUB Standards – OASIS Web Services Notification Family of Standards • WS-BaseNotification 1.3 OASIS Standard • WS-BrokeredNotification 1.3 OASIS Standard • WS-Topics 1.3 OASIS Standard • ITI TF-2x: Appendix V – Filter expression • Registry Stored Query [ITI-18] 31 Security and Privacy • The risk assessment spreadsheet for DSUB profile is available from http://wiki.ihe.net/images/4/46/DSUB_risk_assesment.xls • For general IHE risks and threats see ITI TF-1: Appendix L • Many risks cannot be mitigated by the IHE profile and instead the responsibility for mitigation is transferred to the implementer: – A policy decision can be made during the Subscribe transaction, whether the subscription is an authorized subscription and whether a notification/type of notification is authorized. (This could be based on the XUA identity, the consumer address value, etc.) – This profile does not include the solution to changes of policy between the subscribe time and notify time (which can be substantial). The recommendation is that the policy is enforced conservatively (i.e. the length of subscription can be determined by the Document Metadata Notification Broker). • Specific security considerations are presented in the security section of each transaction in Volume 2b. 32 DSUB References • Primary – DSUB Supplement Rev 1.4 2010-08-10 • Underlying Technical Framework Content – ITI TF-2a • Section 3.18 Registry Stored query – ITI TF-2b • Section 126.96.36.199 Register Document Set-b Request • Section 188.8.131.52.2 Message Semantics – ITI TF-2x • Appendix V “Web Services for IHE Transactions” 33 34
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