ISO/TS 16551:2025

Health informatics - Reference model for virtual reality (VR)-based clinical practice simulation

This document specifies a reference model for virtual reality (VR)-based clinical practice simulation. This model includes components, relations, data element and types, and roles of the users.

Titre manque

General Information

• Status: Published
• Publication Date: 21-May-2025
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215 - Health informatics
• Current Stage: 6060 - International Standard published
• Start Date: 22-May-2025
• Due Date: 14-Oct-2025
• Completion Date: 22-May-2025

Overview

ISO/TS 16551:2025 - Health informatics - Reference model for virtual reality (VR)-based clinical practice simulation - defines a structured reference model to support the design, development and interoperability of VR-based clinical simulators. The Technical Specification describes the architecture, components, data elements and data types, user roles, and relationships needed to build realistic, patient‑safe virtual clinical training environments. Its aim is to promote openness, interoperability and efficiency in developing VR clinical simulations and virtual patients.

Key Topics

• Scope & purpose: a reference model for VR-based clinical practice simulation covering components, relations, data elements/types, and user roles.
• Two main models:
  • Simulation practice model - organized around Goal, Scenario, Task, and Activity to structure learning objectives and stepwise clinical practice.
  • Simulation data model - defines data used to construct realistic simulations: information on subject of care, health summary record, and VR-related data (graphics, sound, text).
• Components & data types: explicit data type definitions for goal, scenario, task, activity, subject-of-care information, health summary records, VR assets, and roles.
• Terminology & architecture: clear definitions (e.g., virtual reality, subject of care, role, component, architecture) to ensure common understanding across implementers.
• Interoperability focus: standardized component interfaces and data models to enable reuse, integration with health IT, and consistent simulation behavior.
• Implementation guidance: structured model intended to reduce development time, protect patient privacy, and enable consistent learner assessment.

Applications

ISO/TS 16551:2025 is practical for:

• VR simulation developers creating clinical training products and virtual patients.
• Health informatics architects designing simulator integration with EHRs or learning management systems.
• Medical and nursing educators structuring curricula and scenario libraries based on standardized Goals and Scenarios.
• Clinical skills assessment and accreditation bodies seeking consistent scenario definitions and outcome tracking.
• Researchers evaluating simulation effectiveness and comparing interventions across platforms.

Typical use cases include developing interoperable VR scenarios (CPR, delivery, emergency care), exchanging standardized health-summary inputs for realistic virtual patients, and implementing role-based learning workflows.

Related Standards

This Technical Specification sits within ISO health informatics work (ISO/TC 215) and references established terminology and concepts found in related standards (for example, ISO/IEC definitions for VR and ISO standards for health summary records). Implementers should consider related health informatics standards when integrating simulators with clinical data and certification processes.

Keywords: ISO/TS 16551:2025, VR-based clinical practice simulation, health informatics, reference model, interoperability, virtual patients, simulation data model, simulation practice model.

Standards Content (Sample)

Technical
Specification
ISO/TS 16551
First edition
Health informatics — Reference
2025-05
model for virtual reality (VR)-based
clinical practice simulation
Reference number
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Reference model for VR-based clinical practice simulation . 3
4.1 General .3
4.2 Simulation practice model .5
4.2.1 Goal .5
4.2.2 Scenario .5
4.2.3 Task .6
4.2.4 Activity .6
4.3 Simulation data model .7
4.3.1 Information on subject of care .7
4.3.2 Health summary record . . .7
4.3.3 VR-related data .7
4.3.4 Role .8
5 Components and data types for reference model . 8
5.1 Components and data types for the simulation practice model .8
5.1.1 General .8
5.1.2 Goal data type .9
5.1.3 Scenario data type .9
5.1.4 Task data type . .9
5.1.5 Activity data type .9
5.2 Components and data types for the simulation data model .9
5.2.1 General .9
5.2.2 Information on subject of care data type .10
5.2.3 Health summary record data type .11
5.2.4 VR-related data type .11
5.2.5 Role data type .11
Bibliography .12

iii
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
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with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
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For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
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.

iv
Introduction
Various virtual reality (VR)-based clinical practice simulations have been developed and used around
the world and the market for these simulations has been steadily growing. A VR-based clinical practice
simulation provides more realistic, life-like clinical training compared to other training methods such as
books, models and images. Moreover, it is possible to create virtual patients customized for various scenarios
while ensuring that patient safety and privacy are protected.
However, there are few standards available in the market for VR-based clinical simulation, which results in
inefficiencies in developing virtual simulation.
A structured standard model for clinical practice simulator creates openness and interoperability, and it can
save developers’ time and resources.

v
Technical Specification ISO/TS 16551:2025(en)
Health informatics — Reference model for virtual reality
(VR)-based clinical practice simulation
1 Scope
This document specifies a reference model for virtual reality (VR)-based clinical practice simulation.
This model includes components, relations, data element and types, and roles of the users.
2 Normative references
There are no normative references in this 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 https:// www .electropedia .org/
3.1
reference model
model that describes the general principles of interconnections in a system and the architecture (3.5)
resulting from those principles
[SOURCE: ISO/IEC 14543-2-1:2006, 3.2.28, modified — “network architecture” was changed to
“architecture”.]
3.2
virtual reality
VR
set of artificial conditions created by computer and dedicated electronic devices that simulate visual images
and possibly other sensory information of a user’s surrounding with which the user is allowed to interact
[SOURCE: ISO/IEC 5927:2024, 3.1.11]
3.3
physician
health professional who has successfully completed the prescribed course of studies in medicine in a
recognised medical school and who has met the qualifications for licensure in the practice of medicine set by
the state or country in which they are practicing
[SOURCE: ISO/TR 12773-1:2009, 2.36]

3.4
nurse
specially trained individual who provides autonomous, collaborative and holistic healthcare for the subject
of care (3.11), carers and significant others in response to their health, behavioural, social and physical
situation at a point in time
Note 1 to entry: Nursing includes midwives and obstetric care and other specialist services provided in a nursing
context.
Note 2 to entry: Nurses provide support and comfort to subjects of care, carers and significant others in response to
health services received including treatment received.
[SOURCE: ISO 18104:2023, 3.1.13, modified — Note 1 to entry was removed.]
3.5
architecture
set of rules to define the structure of a system and the interrelationships between its parts
[SOURCE: ISO 23903:2021, 3.1]
3.6
interoperability
ability of two or more systems or components (3.7) to exchange information and to use the information that
has been exchanged
[SOURCE: ISO 27790:2009, 3.39]
3.7
component
collection of system resources that (a) forms a physical or logical part of the system, (b) has specified
functions and interfaces, and (c) is treated (e.g. by policies or specifications) as existing independently of
other parts of the system
[SOURCE: ISO 81001-1:2021, 3.3.5]
3.8
clinical procedure
practice of a health practitioner that involves a combination of special skills or abilities and can require
drugs, devices, or both
[SOURCE: Adapted from Reference [26]]
3.9
health record
data repository regarding the health and care of a subject of care (3.11)
Note 1 to entry: Adapted from ISO 13940:2015, 3.9.7.
3.10
health summary record
health record (3.9) extract comprising a standardized collection of clinical and contextual information
(retrospective, concurrent, prospective) that provides a snapshot in time of a subject of care’s (3.11) health
information and healthcare
[SOURCE: ISO 27269:2021, 3.8.1.1, modified — The preferred term “patient summary” was removed; Note 1
to entry was removed.]
3.11
subject of care
person who uses, or is a potential user of, a health care service
Note 1 to entry: Subjects of care include individuals of all ages, families, groups, and communities, whether sick or
well, in any healthcare setting in accordance with their scope of practice, and they may also be referred to as patients
or healthcare consumers.
[SOURCE: ISO/TS 22220:2011, 3.2, modified — the preferred term “subject of health care” was removed;
Note 1 to entry was changed.]
3.12
role
set of competencies or performances, or both, that are associated with a task
[SOURCE: ISO 21298:2017, 3.21]
4 Reference model for VR-based clinical practice simulation
4.1 General
Clinical practice simulations based on virtual reality (VR) are educational and training tools that use
virtual reality technology to mimic and reproduce clinical environments, situations, and procedures. The
purpose of the simulations is to enable medical professionals, students, or other healthcare experts to
experience and practice real clinical situations. Through VR technology, users can immerse themselves in
a virtual environment to experience various clinical scenarios and safely practice necessary clinical skills
and procedures. This facilitates the acquisition of skills and decision-making abilities by users (learners) by
providing experiences similar to the real world while maintaining patient safety.
Also, users (learners) can apply theoretical knowledge to practical situations, acquire necessary skills, and
deepen their understanding of clinical contexts. VR-based clinical practice simulations should include virtual
patients that users can interact with, various medical scenarios, and simulations of clinical procedures,
enabling users to effectively prepare for complex and challenging clinical situations they can encounter in
actual clinical environments.
The reference model describes various aspects of VR-based clinical practice simulations, including necessary
components, data elements and types, roles, and their relationships. This structured standard model
ensures interoperability between VR-based clinical practice simulators and can increase the efficiency
of the development process. Figure 1 illustrates a generic architecture for the VR-based clinical practice
simulation system.
...