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

Overview

EN ISO 20737:2026, Health informatics - Interoperability of personal health decision support services sets out key interoperability requirements for personal health decision support (PHDS) services in healthcare IT environments. Published by CEN, this standard ensures that PHDS services, data providers, and PHDS clients can reliably exchange, validate, and process personal health data to enable accurate and timely self-care decision-making. Central to the standard are strict privacy and security controls, robust error handling, and semantic data alignment. While providing comprehensive interoperability guidance, this standard does not address specific implementation or development methods for PHDS solutions, allowing flexibility for diverse healthcare IT ecosystems.

Key Topics

• Interoperability Framework: EN ISO 20737:2026 identifies PHDS services, data providers, and PHDS clients as key actors. It specifies how these roles interact to acquire, process, and deliver decision support, based on explicit user consent.
• Data Exchange Requirements: Data must be exchanged using standardized APIs and formats, with mechanisms for validation, mapping, and transformation to support semantic interoperability.
• Consent and Authorization: All data flows must be authorized by the data owner. An authorization server manages identity verification, consent management, and access control.
• Privacy and Security: The standard mandates end-to-end encryption, access control (including role-based access control), audit logging, incident response protocols, and mechanisms for managing consent and supporting secure data deletion upon user request.
• Robust Error Handling: PHDS services must provide acknowledgements, error responses, and communication failure handling to ensure reliability.
• Metadata and Provenance: Data providers are required to transmit metadata, timestamps, and provenance information to ensure traceability, accuracy, and compliance.

Applications

EN ISO 20737:2026 has wide applicability in health informatics, supporting secure, interoperable personal health decision support at multiple levels:

• Self-care Facilitation: Enables individuals to make informed choices regarding treatment, disease management, understanding health risks, and adherence to care plans-based on trusted, up-to-date personal health data.
• Healthcare Provider Support: Assists healthcare professionals by integrating PHDS output into care workflows, ensuring that patient-reported and device-generated health data are accurately processed for decision support.
• Mobile Health Applications: Devices and apps (such as fitness trackers and digital health platforms) can leverage standardized PHDS interoperability for seamless and secure data sharing with external PHDS services.
• Patient Portals and EHR Integration: Supports integration of PHDS with electronic health records (EHR) and personal health records (PHR), promoting data portability and interoperability in line with standards like HL7 FHIR and HL7 CDA.
• Chronic Disease Management: Real-time data transfer and actionable feedback for patients dealing with long-term health conditions, enabling better self-management and communication with care teams.

Related Standards

EN ISO 20737:2026 aligns with broader health informatics and interoperability efforts, including:

• ISO 13606 (Electronic health record communication): Semantics and structure for EHR data exchange.
• ISO 22857 (Health informatics - Guidelines on protection of health information): Principles for personal health data privacy.
• HL7 FHIR and HL7 CDA: Standard data formats and APIs for health data exchange.
• ISO/IEC 24791-1 (Role-based access control in healthcare): Standards for secure, authorized data access.
• SNOMED CT, LOINC: Clinical terminologies to ensure semantic data interoperability.

By applying EN ISO 20737:2026, organizations across the health sector can foster patient empowerment, streamline data-driven decision support, and comply with recognized best practices for interoperability, security, and privacy in personal health informatics.

SLOVENSKI STANDARD
oSIST prEN ISO 20737:2025
01-november-2025
Health informatics - Medsebojna povezljivost storitev za podporo pri odločanju o
osebnem zdravju (ISO/DIS 20737:2025)
Health informatics - Interoperability of personal health decision support services
(ISO/DIS 20737:2025)
Medizinische Informatik - Interoperabilität von Diensten zur Unterstützung persönlicher
Gesundheitsentscheidungen (ISO/DIS 20737:2025)
Informatique de santé - Interopérabilité des services d'aide à la décision en matière de
santé personnelle (ISO/DIS 20737:2025)
Ta slovenski standard je istoveten z: prEN ISO 20737
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 20737:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 20737:2025
oSIST prEN ISO 20737:2025
DRAFT
International
Standard
ISO/DIS 20737
ISO/TC 215
Health informatics —
Secretariat: ANSI
Interoperability of personal health
Voting begins on:
decision support services
2025-08-27
ICS: 35.240.80
Voting terminates on:
2025-11-19
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 20737:2025(en)
oSIST prEN ISO 20737:2025
DRAFT
ISO/DIS 20737:2025(en)
International
Standard
ISO/DIS 20737
ISO/TC 215
Health informatics —
Secretariat: ANSI
Interoperability of personal health
Voting begins on:
decision support services
ICS: 35.240.80
Voting terminates on:
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
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POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
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NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 20737:2025(en)
ii
oSIST prEN ISO 20737:2025
ISO/DIS 20737:2025(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 Deciding on a course of treatment . .6
5.4.2 Managing a chronic disease.6
5.4.3 Understanding health risks .6
5.4.4 Adhering to a treatment plan .7
5.4.5 Choosing a healthcare provider .7
6 Interoperability requirements for personal health decision support . 7
6.1 PHDS service.7
6.1.1 Support for health data exchange .7
6.1.2 Acquisition via standardized APIs .7
6.1.3 Integration with PHDS clients .7
6.1.4 Validation of incoming health data .7
6.1.5 Automatic data synchronization .7
6.1.6 Semantic data mapping and transformation .7
6.1.7 Acknowledgement and error response generation .7
6.1.8 Robust error-handling mechanisms .8
6.1.9 Audit logging of data transactions .8
6.1.10 Transformation into decision-support-ready formats .8
6.1.11 Data visualization and reporting tools .8
6.2 Data provider .8
6.2.1 Use of standard data formats and terminologies .8
6.2.2 Secure transmission of health data .8
6.2.3 Support for updates and corrections .8
6.2.4 Metadata and provenance information . .8
6.2.5 Real-time or near real-time data transmission .8
6.2.6 Consent-based data sharing .8
6.2.7 Multi-endpoint transmission support .9
6.2.8 Data compression .9
6.3 PHDS client .9
6.3.1 Result reception .9
6.3.2 Acknowledgement to PHDS service .9
6.3.3 Secure communication channel .9
6.3.4 User authentication and authorization .9
6.3.5 User-friendly result Presentation .9
6.3.6 Customizable result Display.9
6.4 Privacy and security considerations .9
6.4.1 Data encryption.9
6.4.2 Access control .10
6.4.3 Data retention .10
6.4.4 Incident response .10

iii
oSIST prEN ISO 20737:2025
ISO/DIS 20737:2025(en)
6.4.5 Consent management .10
6.4.6 User-initiated data deletion .10
6.4.7 Security notifications .10
Bibliography .11

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oSIST prEN ISO 20737:2025
ISO/DIS 20737:2025(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 established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
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For an explanation on 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 the following URL: 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 atwww.iso.org/members.html.

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ISO/DIS 20737:2025(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 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 intervention is a tool or strategy 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 standard defines interoperability 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
oSIST prEN ISO 20737:2025
DRAFT International Standard ISO/DIS 20737:2025(en)
Health informatics — Interoperability of personal health
decision support services
1 Scope
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 considered to be within
the scope.
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.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
data owner
person or organization having responsibility and authority for the data
[SOURCE: ISO/TR 14292:2012, 2.10, modified]
3.2
data provider
entity that is a source of data
[SOURCE: ISO/IEC/IEEE 15939:2017, 3.5, modified]
3.3
electronic health record
health record where all information is stored on electronic media
[SOURCE: ISO 13606:2019, 3.3.13]
3.4
health risk
combination of the likelihood of occurrence of harm to health and the severit
...