ISO/DTS 27790

ISO/TC 215/WG 2
Secretariat: ANSI
Date: 2025-0810-06
Health informatics — Document registry framework
Informatique de santé — Cadre d'enregistrement de document

ISO #####-#:####(X/DTS 27790:(en)
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ii
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Document registry framework . 4
4.1 Overview . 4
4.2 General structure of the framework based on IHE XDS . 4
4.3 General structure of the framework based on IHE MHD or IHE MHDS . 8
4.4 Document content profiles . 12
Bibliography . 14

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ISO #####-#:####(X/DTS 27790:(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
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in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO documentdocuments should be noted. This document was drafted in accordance with the editorial rules
of the ISO/IEC Directives, Part 2 (see www.iso.org/directiveswww.iso.org/directives).).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
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www.iso.org/iso/foreword.htmlwww.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, .
This second edition cancels and replaces the first edition (ISO/TC TS 27790:2009), which has been technically
revised.
The main changes are as follows:
— — Annex A was removed as only one country, the Republic of Korea, was included in it originally;
— — Updatedupdated to reflect the latest changes in the IHE document sharing profiles, such as the addition
of Mobile Health Document (MHD), addition of IHE Integration Profile, Mobile Health Document Sharing
(MHDS) IHE Integration Profile, and corrections to Cross-Enterprise Document Sharing (XDS.b) IHE
Integration Profile which facilitates. These profiles facilitate the registration, distribution and access
across health enterprises of patient electronic health records.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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Introduction
Development and implementation of electronic health records (EHR) are rapidly progressing around the
world. An appropriate deployment of EHR will enhance various aspects of healthcare delivery in the future.
EHR are thought to enable the provision of essential care information to providers at point-of-care through
information and telecommunications technologies. This includes a broad spectrum of capabilities including
acquisition, storage, presentation, and management of patient information (represented in different digital
forms such as video, audio or data) and communication of this information between care facilities with the
use of communications links.
Recent development of health information exchange where the patients’ EHR are accessed securely whenever
necessary (sharing EHR information at point-of-care and by the consumer citizen) requires that electronic
health records of an individual, although they originate from various health-related subjects distributed over
space and time, remain accessible irrespective of their centralized or distributed storage. The use of
centralized registry systems pointing to such records can greatly facilitate the discovery of their locations to
allow effective access to the appropriate and secured EHR.
Many organizations with operational large-scale deployments implement this foundational approach in
sharing health data among existing systems as a simple and effective service. However, these initial projects
identified several issues or gaps in document sharing that limited their deployment (e.g. lack of
standardization, fragmentation of health data, difficulty in locating distributed records, inconsistencies in
abilities to search records produced across many care delivery organization). The proposed framework
addresses such issues by offering consistent search data among data stored with various degrees of
granularity. There have been enough operational deployments across more than 20 countries with hundreds
of different health information systems and several millions of clinical documents shared to confirm the
robustness and efficiency of such a standards-based document sharing framework.
This document is targeted at policy makers, architects of national ehealth infrastructure, health IT product
managers and designers. It describes the principles and specification of interoperability needed to support a
registry system for locating and accessing records grouped into shared documents. The supported documents
may contain any type of person-centric health information, whether structured (e.g. coded patient summary,
numeric lab results) or unstructured (e.g. scanned images, free-text documents), depending on the source
standard for their content. The clinical document architecture (CDA), the Fast Healthcare Interoperability
Resources (FHIR), Digital Imaging and Communications in Medicine (DICOM) are standards that are likely
companions to this document. This document does not address the security and privacy considerations in
detail but refers to related interoperability standards and profiles designed to be used in conjunction. The
document is not intended to be prescriptive either from a methodological or a technological perspective but
rather to provide a coherent inclusive description of principles and practices that couldcan facilitate the
formulation of policies and governance practices locally or nationally.
The web services-based registry framework includes a document registry and associated repository to allow
the sharing of any form of health documents including HL7 CDA, FHIR documents, and DICOM objects.
The registry framework specializes in health two different application programming interfaces (API);):
— The W3C Web Services Standards, ISO 15000 (ebXML registry standards) and OASIS ebXML Registry
Information Model 3.0 through the use of the IHE Cross-Enterprise Document Sharing (XDS) from the
Integrating the Healthcare Enterprise (IHE) Information Technology Infrastructure (ITI) technical
framework, quotingsummarizing from the Cross-Enterprise Document Sharing (XDS) Profile:
“The Cross-Enterprise Document Sharing IHE Integration Profile facilitates the registration, distribution
and access across health enterprises of patient and citizen electronic health records. Cross-Enterprise
Document Sharing (XDS) is focused on providing a standards-based specification for managing the
sharing of documents between all health enterprises, ranging from private physician offices to clinics to
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ISO #####-#:####(X/DTS 27790:(en)
acute care in--patient facilities to personal heath record systems. The XDS IHE Integration Profile assumes
that these enterprises belong to one or more affinity domains. An affinity domain is a group of healthcare
enterprises that have agreed to work together using a common set of policies and that share a common
registry infrastructure.”
— The HL7 FHIR Document Reference resources through the use of the IHE Mobile access to Health
Document (MHD) or the more extensive IHE Mobile Health Document Sharing (MHDS) from the
Integrating the Healthcare Enterprise (IHE) Information Technology Infrastructure (ITI) technical
framework, quotingsummarizing from the Mobile access to Health Document Sharing (MHDS) Profile:
[38 ]
“The Mobile access to Health Documents (MHD ) ) Profile defines a standardized API for mobile devices,
like smartphones and tablets, to share health documents. It simplifies the document sharing process
originally used in XDS and XCA, making it easier for mobile and simple systems to submit, query, and
retrieve health documents.
[39]
The MHDS Profile provides a framework for communities to exchange health information by using a
combination of other IHE profiles. It covers essential functions like patient identification, document
management and storage, and privacy and security, all to ensure a standardized and interoperable
approach to health information sharing.”
[9 ]
This document also references a number of companion standards-based specifications [9] that offer optional
extensions to enhance the basic capabilities offered by IHE XDSnamelyXDS, namely a series of security-related
[9 ]
and privacy-related IHE profiles, such as Patient Identification Cross-Referencing (PIX [9]), ), Patient
[9 ] [9 ]
Demographics Query (PDQ [9]), ), Basic Patient Privacy Consent (BPPC [9]), ), and Cross-Enterprise User
[9 ]
Assertion (XUA [9]). ).
NoteNOTE The use of IHE Audit trail and Node Authentication (ATNA) as well as Consistent Time (CT) is required as part
of IHE XDS. These Profiles are therefore not listed above.
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Health informatics — Document registry framework
1 Scope
This document specifies a general-purpose document registry framework for transmitting, storing and
utilizing documents in clinical and personalized health environments. It is quite broad in its applicability to
realise the goal of sharing health-related documents spanning a broad spectrum of health domains such as
healthcare specialities covering laboratory, cardiology, eye care, etc. and the many areas of personalized
health.
This document also supports shared document registration and retrieval via the federation of documents’
registries (see IHE Cross-Community Access) in terms of individual users to reduce health information
extrusion possibilities.
This document supports the sharing of documents of any standardized content in the context of healthcare
and well-being. It describes the means of locating and accessing shared documents among a diverse set of
health organizations. It is designed to leverage existing health informatics for structuring and semantically
rich health information, if so desired. It does not require the development of new health informatics standards.
2 Normative references
There are no normative references in the document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— — IEC Electropedia: available at http://www.electropedia.org/
3.1 3.1
actor
user of the system-of-interest interacting with the system in a particular usage context or role
3.2 3.2
architecture
set of design artefacts or descriptive representations that are relevant for describing an object such that it can
be produced to requirements (quality) as well as maintained over the period of its useful life (change)
3.3 3.3
authentication
act of verifying the claimed identity of an entity
[SOURCE: ISO/IEC 10181-2:1996, 3.3, modified — “provision of assurance” was changed to “act of verifying”.]
3.4 3.4
authorization
granting of rights, including the granting of access based on access rights
[SOURCE: ISO 7498--2:1989, 3.3.10]
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3.5 3.5
clinical document
defined and complete information object that can include text, images, sounds, and other multimedia content
EXAMPLES EXAMPLE Discharge, summary, progress note, procedure report, a medical image, etc.
Note 1 to entry: A clinical document has six characteristics: persistence, stewardship, potential for authentication,
context, wholeness and human readability.
Note 2 to entry: Adapted from Reference [32[32].].
3.6 3.6
consumer
person requiring, scheduled to receive, receiving or having received a healthcare service
Note 1 to entry: Consent can be revoked at any time and may be context-specific, particularly relevant for
implementations involving patient portals and mobile applications.
3.7 3.7
document registry
function or system designed to store, index, and enable discovery of clinical documents based on metadata,
supporting queries and access policies
3.8 3.8
electronic health record
EHR
longitudinal collection of personal health information of a single individual, entered or accepted by healthcare
providers, and stored electronically
Note 1 to entry: The record may be made available at any time to providers, who have been authorized by the individual,
as a tool in the provision of health care services. The individual has access to the record and can request changes to its
contents. The transmission and storage of the record is under strict security.
Note 2 to entry: Patient-controlled EHR access via third-party applications, consistent with FHIR and global patient
empowerment trends may be supported.
[Note 3 to entry: Adapted from ISO/IEEE 11073-10103:2014, 3.1.14].2025.
3.9 3.9
encounter
patient contact
contact between a clinician and patient
3.10 3.10
event
change in device status that is communicated by a notification reporting service
3.11 3.11
framework
logical structure for classifying and organizing complex information
3.12 3.12
information model
structured specification of the information requirements of a project
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3.13 3.14
interoperability
ability of two or more systems or components to exchange information and to use the information that has
been exchanged
3.14 3.15
model
abstraction used to express the relevant concepts and interdependencies of a project
3.15 3.16
operation
function or transformation that may be applied to or by objects in a class
Note 1 to entry: Sometimes also called service.
[SOURCE: ISO/TS 24541:2020, 3.16]
3.16 3.17
participant
data exporter and data importer
3.17 3.18
patient
individual person who is a subject of care
Note 1 to entry: Patient are clinical care recipients
[SOURCE: ISO/TR 21835:2020, 3.12]
3.18 3.19
privacy
freedom from intrusion into the private life or affairs of an individual when that intrusion results from undue
or illegal gathering and use of data about that individual
Note 1 to entry: Privacy includes key privacy principles such as data minimization, purpose limitation, and informed
consent under modern regulatory frameworks.
3.19 3.20
record
collection of data
3.20 3.21
registry
collection of all the official records relating to something, or the place where they are kept
3.21 3.22
repository
place where something is safely kept
3.22 3.23
security
combination of confidentiality, integrity and availability
3.23 3.24
service
specific behaviour that a communication party in a specific role is responsible for exhibiting
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3.24 3.25
shared document
byte sequence managed by actors in Document Sharingdocument sharing profiles
Note 1 to entry: There is no concept of equivalent Documents. If the byte sequence is different, then the Documents are
different. A Shared document may include a variety of content such as textual representation, images or a composition of
clinical information that contains observations and services for the purpose of exchange with the following
characteristics: Persistence, Stewardship, Potential for Authentication, and Wholeness. Shared documents may be
exchanged by IHE profiles such as XDS or MHD.
[38 ]
Note 2 to entry: Adapted from IHE IT Infrastructure Framework – Mobile Health Documents (MHD ). ).
3.25 3.26
system
demarcated part of the perceivable universe, existing in time and space, that maycan be regarded as a set of
elements and relationships between these elements
Note 1 to entry: A system is composed of actors and is an entity that operates through messages between actors.
4 Document registry framework
4.1 Overview
This framework is built upon widely adopted standards such as the FHIR Document Reference resource MHD
1)
Document Reference Comprehensive ‒ Mobile access to Health Documents (MHD) v4.2.2 and the HL7 CDA
® 2)
header/body structure. HL7 Standards Product Brief ‒ CDA Release 2 ǀ HL7 International . They have
contributed to the design and function of the registry framework, especially in terms of metadata alignment,
document querying, and exchange mechanisms.
4.2 General structure of the framework based on IHE XDS
4.2.1 General
The document registry framework includes a number of specification components organized as shown in
Figure 1Figure 1. These are specified in 4.2.24.2.2 to 4.2.44.2.5 and 4.44.4. .

1) https://profiles.ihe.net/ITI/MHD/index.html
2) https://www.hl7.org/implement/standards/index.cfm?ref=nav.
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