EN ISO 20737:2026

• Abstract:

  This document specifies interoperability requirements for personal health decision support (PHDS) services between actors in the PHDS environment, which include PHDS services, data providers, and PHDS clients. It includes requirements for data exchange, validation, and error handling among participants to support accurate and timely decision-making. It also describes the privacy and security considerations for PHDS. However, the specifics of how PHDS services are developed or implemented are not covered.

• Status: Published
• Publication Date: 01-Sep-2026
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 2 - Terminology and knowledge representation
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 02-Sep-2026
• Completion Date: 02-Sep-2026
• Ref Project: SIST EN ISO 20737:2026 - Health informatics - Interoperability of personal health decision support services (ISO 20737:2026)

• Referred By: EN ISO/ASTM 52933:2024 - Additive manufacturing - Environment, health and safety - Test method for the hazardous substances emitted from material extrusion type 3D printers in the non-industrial places (ISO/ASTM 52933:2024, Corrected version 2025-06)
• Effective Date: 28-Jan-2026
• Referred By: EN ISO 27548:2024 - Additive manufacturing of plastics - Environment, health, and safety - Test method for determination of particle and chemical emission rates from desktop material extrusion 3D printer (ISO 27548:2024)
• Effective Date: 28-Jan-2026
• Referred By: EN ISO 18562-3:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024)
• Effective Date: 28-Jan-2026
• Consolidated By: ISO 20737:2026 - Health informatics — Interoperability of personal health decision support services
• Effective Date: 12-Feb-2026

EN ISO 20737:2026 is a CEN European Standard for health informatics on the interoperability of personal health decision support (PHDS) services. It specifies how PHDS services, data providers, and PHDS clients exchange data, validate it, handle errors, and manage privacy and security so decision support can be delivered accurately and on time. It is intended for organizations that build, integrate, or procure PHDS-related systems.

What does EN ISO 20737:2026 specify?

EN ISO 20737:2026 sets interoperability requirements for PHDS services within the PHDS environment. It focuses on the exchange of personal health data between PHDS services, data providers, and PHDS clients, and it describes the privacy and security considerations that support trusted use.

The document is organized into these main parts: scope, normative references, terms and definitions, abbreviated terms, a PHDS concept and data-flow model, interoperability requirements, and a bibliography. Clause 5 explains how PHDS works in practice, and clause 6 states the interoperability requirements for each participant in the environment.

What are the key requirements of EN ISO 20737:2026?

EN ISO 20737:2026 puts the main responsibility for interoperability on the PHDS service, the data provider, and the PHDS client. It also defines a consent-driven data flow, so personal health data and decision-support results are exchanged only through authorized channels.

PHDS service behavior

Clause 6.1 requires a PHDS service to support health data exchange, use standardized APIs such as HL7® FHIR® APIs, integrate with PHDS clients, validate incoming health data, generate acknowledgements and error responses, handle communication failures, maintain audit logs, and transform acquired data into decision-support-ready formats. It may also provide data visualization and reporting tools.

In practice, this means the service needs a predictable interface for inbound data, a validation step before processing, and traceable transaction records. That helps teams check what came in, what failed, and what was delivered to the client.

Data acquisition and data meaning

Clause 6.1 also calls for semantic data mapping and transformation, and for automatic synchronization with data providers. The PHDS service should convert different data structures into standardized representations so the rule engine can use them consistently.

This matters when the service receives data from multiple systems with different formats or coding styles. Without mapping and synchronization, the same clinical fact can be interpreted differently or become stale.

Data provider obligations

Clause 6.2 requires data providers to produce data in recognized standard formats and use standardized clinical terminologies. It also requires secure transmission, support for updates and corrections, metadata and provenance information, consent-based sharing, and the ability to transmit to multiple endpoints when authorized.

In practical terms, a data provider must be able to say where data came from, when it was created or updated, and under what consent it is being shared. That is what makes the data usable and trustworthy for PHDS processing.

PHDS client duties

Clause 6.3 requires a PHDS client to receive decision-support results, acknowledge receipt, use a secure communication channel, authenticate and authorize users, and present results in a user-friendly, actionable format. It may also support customizable result display.

This means the client is not just a display layer. It has to protect the results, confirm delivery, and present them in a way the end user can act on.

Privacy and security across the environment

Clause 6.4 applies to all entities in the PHDS environment. It requires encryption for data at rest and in transit, role-based access control, retention policies, secure deletion when retention ends, a documented incident response plan, consent management, user-initiated data deletion, and security notifications from the PHDS client.

For implementers, this turns privacy and security into shared operational requirements, not optional add-ons. It affects storage, transmission, user access, retention, and breach handling.

Authorization and consent flow

Clause 5.3 describes the data flow using an authorization server, access tokens, and explicit authorization from the data owner. The data provider and PHDS client are pre-registered as trusted entities, and the PHDS service validates the token before exchanging data or results.

That flow is important because it ties interoperability to consent and identity checks. It helps prevent unauthorized data exchange while keeping the process structured enough for automation.

Typical PHDS use cases

Clause 5.4 gives example uses such as deciding on a course of treatment, managing a chronic disease, understanding health risks, adhering to a treatment plan, and choosing a healthcare provider. These examples show the kind of output a PHDS service is expected to support.

For a buyer or integrator, this indicates that the standard is aimed at decision support for self-care and patient-facing guidance, not at the clinical development of the underlying rules.

What terms does EN ISO 20737:2026 define?

• Personal health decision support (PHDS) - A service approach that processes personal health data and delivers personalized guidance, alerts, or recommendations for self-care decisions.
• Data owner - The person or organization responsible for the data and authorized to approve its sharing.
• Data provider - The entity that sources and transmits data to the PHDS service.
• Personal health data - Personal data that is relevant to the health of an identified or identifiable natural person.
• Electronic health record (EHR) - A health record in which all information is stored on electronic media.
• Personal health record (PHR) - A health record, or part of one, for which the subject of care or a legal representative is the data controller.
• Application programming interface (API) - The standardized interface used for data acquisition and integration between systems.
• Fast healthcare interoperability resource (FHIR®) - A named standard family used here as an example of a standardized API and data format.

Who uses EN ISO 20737:2026?

EN ISO 20737:2026 is used by PHDS service developers, data provider organizations, and PHDS client developers who need a common way to exchange health data and decision-support results. It is also relevant to healthcare organizations, mobile health application vendors, web-based health application vendors, PHR repository operators, and makers of personal health devices and fitness trackers.

Quality managers, security teams, and buyers can use it to check whether a PHDS solution supports consent, authentication, encryption, audit logging, data correction, and interoperable interfaces. It is especially relevant where self-care guidance depends on data from multiple systems.

Which standards are used with EN ISO 20737:2026?

The terms section and bibliography link EN ISO 20737:2026 to several related documents that supply definitions or background concepts. These include ISO/TR 14292:2012 for personal health records context, ISO/IEC/IEEE 15939:2017 for the source of the data provider definition, ISO 13606-1:2019 for electronic health record modeling, ISO 22857:2013 for personal health data protection, ISO 18308:2011 for personal health record architecture, and ISO/IEC 24775-2:2021 and ISO/IEC 24791-1:2010 for privacy/security-related definitions.

What does the EN ISO 20737:2026 document contain?

The document contains a PHDS concept model, data-flow descriptions, and example use cases that show how the service, data provider, authorization server, and PHDS client interact. Figures illustrate the network setup, the concept model, and the authorization-driven data flow.

Clause 6 contains the main interoperability requirements for the PHDS service, data provider, PHDS client, and shared privacy/security controls. The bibliography adds background sources for the defined terms and the self-care context used in the introduction.

SLOVENSKI STANDARD
01-november-2026
Zdravstvena informatika - Medsebojna povezljivost storitev za podporo pri
odločanju o osebnem zdravju (ISO 20737:2026)
Health informatics - Interoperability of personal health decision support services (ISO
20737:2026)
Medizinische Informatik - Interoperabilität von Diensten zur Unterstützung persönlicher
Gesundheitsentscheidungen (ISO 20737:2026)
Informatique de santé - Interopérabilité des services d'aide à la décision en matière de
santé personnelle (ISO 20737:2026)
Ta slovenski standard je istoveten z: EN ISO 20737:2026
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 20737
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2026
EUROPÄISCHE NORM
ICS 35.240.80
English Version
Health informatics - Interoperability of personal health
decision support services (ISO 20737:2026)
Informatique de santé - Interopérabilité des services Medizinische Informatik - Interoperabilität von
d'aide à la décision en matière de santé personnelle Diensten zur Unterstützung persönlicher
(ISO 20737:2026) Gesundheitsentscheidungen (ISO 20737:2026)
This European Standard was approved by CEN on 20 December 2025.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20737:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 20737:2026) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2027, and conflicting national standards shall
be withdrawn at the latest by March 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 20737:2026 has been approved by CEN as EN ISO 20737:2026 without any modification.

International
Standard
ISO 20737
First edition
Health informatics —
2026-08
Interoperability of personal health
decision support services
Informatique de santé — Interopérabilité des services d'aide à la
décision en matière de santé personnelle
Reference number
ISO 20737:2026(en) © ISO 2026
ISO 20737:2026(en)
© ISO 2026
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.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 20737:2026(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 2
5 Personal health decision support . 3
5.1 General .3
5.2 Concept model .4
5.3 Data flows .4
5.3.1 General .4
5.3.2 Data flow between the PHDS service and data provider.5
5.3.3 Data flow between the PHDS service and PHDS client .6
5.4 Use cases .6
5.4.1 General .6
5.4.2 Deciding on a course of treatment . .6
5.4.3 Managing a chronic disease.6
5.4.4 Understanding health risks .6
5.4.5 Adhering to a treatment plan .7
5.4.6 Choosing a healthcare provider .7
6 Interoperability requirements for personal health decision support . 7
6.1 PHDS service.7
6.1.1 General .7
6.1.2 Support for health data exchange .7
6.1.3 Data acquisition via standardized APIs .7
6.1.4 Integration with PHDS clients .7
6.1.5 Validation of incoming health data .7
6.1.6 Automatic data synchronization .7
6.1.7 Semantic data mapping and transformation .7
6.1.8 Acknowledgement and error response generation .7
6.1.9 Robust error-handling mechanisms .8
6.1.10 Audit logging of data transactions .8
6.1.11 Transformation into decision-support-ready formats .8
6.1.12 Data visualization and reporting tools .8
6.2 Data provider .8
6.2.1 General .8
6.2.2 Use of standard data formats and terminologies .8
6.2.3 Secure transmission of health data .8
6.2.4 Support for updates and corrections .8
6.2.5 Metadata and provenance information . .8
6.2.6 Real-time or near real-time data transmission .8
6.2.7 Consent-based data sharing .8
6.2.8 Multi-endpoint transmission support .9
6.2.9 Data compression .9
6.3 PHDS client .9
6.3.1 General .9
6.3.2 Result reception .9
6.3.3 Acknowledgement to PHDS service .9
6.3.4 Secure communication channel .9
6.3.5 User authentication and authorization .9
6.3.6 User-friendly result presentation .9
6.3.7 Customizable result display .9
6.4 Privacy and security considerations .9

iii
ISO 20737:2026(en)
6.4.1 General .9
6.4.2 Data encryption.10
6.4.3 Access control .10
6.4.4 Data retention .10
6.4.5 Incident response .10
6.4.6 Consent management .10
6.4.7 User-initiated data deletion .10
6.4.8 Security notifications .10
Bibliography .11

iv
ISO 20737:2026(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
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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)
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This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration with
European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health informatics, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
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.

v
ISO 20737:2026(en)
Introduction
Personal health decision support (PHDS) enables personalized decision support for self-care decisions
by processing health data provided by or on behalf of an individual. It is designed to assist individuals in
making informed decisions about their health by delivering context-specific recommendations, alerts, or
guidance derived from personal health data. PHDS is implemented as a standalone service or as part of a
health platform (for example, an electronic health record system or a health application) and can support a
wide range of use cases.
Self-care is an activity in which individuals manage their own health, including health promotion, disease
[1]
prevention and control, self-medication, and rehabilitation. The World Health Organization (WHO)
defines self-care as “the ability of individuals, families, and communities to promote health, prevent disease,
[2]
maintain health, and cope with illness and disability with or without the support of a health worker”.
WHO also says: “on average, individuals spend less than one hour a year with a health worker versus over
[2]
8 700 hours a year in self-care”. Self-care interventions are tools or strategies that can promote health,
prevent disease, manage chronic conditions, and cope with illness or disability with or without the support
[1][2][3]
of healthcare professionals. Persons choose self-care interventions for various reasons, such as
[2][4]
convenience, confidentiality, and cost. The self-care interventions are evidence-based and provided to
[5]
individuals in ways that better support self-care.
This document defines interoperability for seamless interaction among stakeholders, including PHDS
services, data providers, and PHDS clients, to support the safe and effective use of PHDS. It highlights
the importance of standardized data exchange, validation, and communication while also addressing the
essential privacy and security considerations that ensure user trust.

vi
International Standard ISO 20737:2026(en)
Health informatics — Interoperability of personal health
decision support services
1 Scope
This document specifies interoperability requirements for personal health decision support (PHDS) services
betwe
...