Appendix J: Content and Format of XDS Documents
The XDS Integration Profile purposely leaves a number of policies up to the XDS Affinity Domain to decide, including the structure and format of the content of XDS Documents to be shared, the mapping of content metadata into the XDS Document Registry, the coding of XDS Document metadata, the events that trigger an XDS Submission Request, and the policies concerning the use of XDS Folders to facilitate sharing.
It is important to recognize that until sufficient experience has been gained in cross-enterprise document sharing, it is not possible to establish common or even best practices in the use of the XDS Integration Profile. IHE has therefore chosen to abstain to make recommendations in these topics at this time.
IHE also recognizes that there will be a need for content-oriented integration profiles to be used in cooperation with this Integration Profile. It is expected that in the future the various IHE Domains (Patient Care Coordination, Cardiology, Laboratory, Radiology, IT Infrastructure, etc.) will produce IHE Integration Profiles refining the use of XDS within the domain. These various content-oriented integration profiles may rely on XDS, but would further constrain the forms of documents to be shared, or the uses of XDS features such as Folders and Submission Sets, et cetera.
XDS is content neutral. It neither prescribes nor prohibits the format, content, structure or representation of documents that can be retrieved from an XDS Document Repository. For the XDS Integration Profile to have immediate value to an XDS Affinity Domain, it must be able to adapt to the documents that are present and available from its members. Thus, prohibitions on content would only serve to limit the utility and adoption of the XDS Integration Profile. Similarly, XDS Affinity Domains must be able to adapt to emerging standards, which cannot be enumerated in any list of prescribed content formats.
IHE strongly recommends that XDS Affinity Domains adopt rules that require documents to comply with widely accepted standards where possible (e.g., HL7 CDA, CEN ENV 13606, ASTM CCR, and DICOM Composite Object).
Document Headers and Metadata
Because XDS is content neutral, XDS cannot validate metadata contained within the body of an XDS document against the metadata supplied to the XDS Document Registry. XDS Affinity shall therefore select content where IHE has defined Integration Profiles, or until that point, the XDS Affinity Domains shall carefully define how the attributes in the XDS Document Registry are filled.
Metadata and the Patient Record
Although metadata in the document header may be duplicated in the XDS Document Registry, the XDS Document Registry metadata has a particular role in term of being part of the legal medical record stored. It is definitively not part of the clinical record as managed by the XDS Document Repositories where documents reside. Furthermore, XDS does not provide for transactions to “sign” or legally authenticate the content of an XDS Submission Set (see the Document Digital Signature Profile (DSG), although it offers the ability to track its author, if the XDS Affinity Domain so desires to enforce it. The contents of XDS Folders are tracked, through the Submission Sets that contributed to placing document references in folders. However, the existence of document metadata in the registry and the potential medical acts involved in creating an XDS Submission Set or XDS Folder may make the contents of the XDS Document Registry part of the patient’s legal medical record. It will be up to individual XDS Affinity Domains to decide how to address the issues involved with these clinical acts and to resolve them in accord with common sense, acceptable medical practices, and local regulations.