ISO/TS 6201:2025

Technical
Specification
ISO/TS 6201
First edition
Health informatics — Personalized
2025-02
digital health framework
Informatique de santé — Cadre de santé numérique personnalisé
Reference number
© ISO 2025
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Person-led health and personalized digital health record . 2
4.1 General .2
4.2 Personalized digital health record (PDHR) .2
4.3 Interoperability issues .3
5 Personalized digital health framework . 4
5.1 General .4
5.2 Personalized digital health framework (PDHF) description .5
6 Dynamic consent . 6
7 Personalized digital health patient journey . 8
Annex A (informative) Implementation use cases of personalized digital health framework .10
Annex B (informative) Implementing dynamic consent .13
Bibliography .15

iii
Foreword
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iv
Introduction
Developments in information and communication technology (ICT) have enabled data to be collected from
individuals in a variety of ways. Various health-related data not only facilitate finding effective treatment
strategies but also establishing personalized healthcare services, as Figure 1 depicts. Therefore, the concept
of digital healthcare has emerged. Digital healthcare can be defined as comprehensive medical services that
utilize an individual’s health-related data, including personal health data that may be collected from devices,
platforms and applications.
Figure 1 — Evolution in personalized digital health
Tremendous amounts of information can be produced by individuals, such as eating habits, exercise, hours
of sleep, and also health records. This information is considered along with physical, social, and mental
characteristics of individuals and can result in different treatment options and prescriptions. Accordingly,
personalized digital health (PDH) refers to electronic services that support the health of individuals when
they can add to and handle their own health information.
Existing medical care procedures focus on suggesting medical solutions when a disease occurs. Digital
health goes beyond that scope and supports an individual’s decision-making process by providing the most
appropriate advice based on their continuously generated health-related data. Personalized digital health
aims to go one step further, enabling an individual to identify and eliminate the potential causes of disease
before they occur.
Another goal of digital healthcare is to effectively monitor and manage personal health by using platforms
and applications that can provide personalized healthcare services. The personalized services are based on
an individual’s health information, including biometric information and family medical history, which are
stored in large databases.
Personalized digital services based on a combination of medical knowledge and IT solutions can improve
healthcare. If personalized digital health becomes the norm, a PDH service could utilize a patient’s genomic
information to help find the most appropriate drugs and treatment methods. This can be significantly enabled
by collecting, categorizing or “tagging”, and storing patients’ biometric information, medical documentation,
genetic analysis, smart or wearable device information, family history, and clinical examination information.
Medical data, previously managed by hospitals and institutions, are now being transformed and integrated
into PDH platforms, a concept that empowers individuals to be the decision-makers of their own health
information and data use. Therefore, PDH data comprises both health records from hospitals and health
professionals, and personal health data generated by smart devices.
When individuals are given the right to decide how their health data is handled or managed, a consent system
for their personal information is necessary. A consent system is a system in which individuals can actively
manage their consent at any time. Many people have given permission to use their personal information to
medical care institutions and other organizations. Traditionally, a paper-based agreement was widely used.
Nowadays, the number of medical institutions using digital contracts is rising because of the wide usage
of smartphones and PCs. However, since these methods are conducted on a one-off basis, it is difficult to
modify or withdraw the consent once it is given.

v
Dynamic consent is a form of consent that allows people to decide whether to provide specific information
via interactive digital interfaces. This agreement method was first implemented in biomedical and genomic
studies that required continuous contact with participants. Dynamic consent gives individuals more
autonomy by giving them the power to control their own data. A customized interface that enables two-
way communication between healthcare providers and users is important for dynamic consent to work
effectively.
Various stakeholders, such as researchers, healthcare providers, institutions and governments, can access
individuals’ health data through an efficient and dynamic consent system. To reach the full potential of
PDH services, quickly establishing standards for systems, infrastructure, platforms and frameworks
is imperative. Supporting personalized knowledge representation and related ontologies is mandatory
when seeking to transform how individuals manage their healthcare, and it can only be realized with PDH
technology. Otherwise, data integration is almost impossible, and failure of data management can hold back
the development of a successful digital health system.

vi
Technical Specification ISO/TS 6201:2025(en)
Health informatics — Personalized digital health framework
1 Scope
This document specifies a framework for the interoperability of services and information tailored towards
personalized digital health informatics. It establishes a common set of requirements and data specifications
necessary for multi-level interoperability, as well as for dynamic consent and knowledge sharing.
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
consent
freely given agreements based on adequate information obtained prior to the collection/use of participant data
[SOURCE: ISO 20252:2019, 3.20]
3.2
dynamic consent
consent (3.1) that enables communication between owners of the data and their consumers via digital
interfaces during the process of utilizing health data
3.3
interoperability
ability of two or more systems or components to exchange information and to use the information that has
been exchanged
[10]
[SOURCE: IEEE ]
3.4
personalized digital health
PDH
electronic services that support health of individuals when they can add and handle their health information
3.5
personalized digital health framework
PDHF
framework for the interoperability of services and information, tailored towards personalized digital health
(3.4) informatics, that establishes a common set of requirements and data specifications necessary for multi-
level interoperability, as well as for dynamic consent and knowledge sharing

4 Person-led health and personalized digital health record
4.1 General
Because of the increasing need for person centred care, there are several possible approaches to provide
the required healthcare, facilitating patient independence and self-care. Person-led health supports self-
care using data such as health records, lab results, medication, care plan, and person generated health
data (PGHD). On the other hand, several interoperability levels can be identified, such as business process,
syntactic and semantic ones, which apply to the person-led health data, as depicted in Figure 2.
Figure 2 — Interoperability levels and person-led health data
The personalized digital health framework (PDHF) specified in this document provides a solution to person
centred care. This PDHF achieves several objectives:
— facilitating interoperability between different healthcare institutions’ information systems;
...