Overview
ISO/TS 6201:2025 - Health informatics: Personalized digital health framework (PDHF) is a technical specification published by ISO (first edition, 2025). It defines a framework for the interoperability of services and information tailored to personalized digital health. The document establishes common requirements and data specifications to support multi‑level interoperability, dynamic consent, knowledge sharing and the creation of a personalized digital health record (PDHR) that combines clinical data with person‑generated health data (PGHD).
Key topics and technical requirements
- Multi‑level interoperability
Addresses technical, syntactic and semantic interoperability as well as business‑process and organizational levels to ensure consistent interpretation of health data across systems, regions and countries.
- Personalized Digital Health Record (PDHR)
Specifies the concept of a PDHR that integrates institutional health records (labs, medication, clinical notes) with PGHD from wearables, smartphones and IoT devices.
- Data specifications and modelling
Calls for interoperable data models and harmonization of information structures so heterogeneous data can be combined, searched and reused.
- Terminology and semantic interoperability
Emphasizes standardized terminologies and ontologies (e.g., SNOMED CT, LOINC, IDMP referenced) to enable identical meaning across systems.
- Dynamic consent and consent management
Defines dynamic consent as a digital, interactive approach enabling individuals to manage and change consent over time and to control who can access their health data.
- Security, access control and identity
Requires protections for privacy and controlled access to PDHRs, including identity and provenance services.
- Knowledge sharing and decision support
Supports representation and sharing of personalized knowledge (ontologies) to enable advanced analytics and personalized recommendations.
Practical applications and users
Who benefits and uses ISO/TS 6201:
- Health IT vendors and platform developers building PDHRs, consent management systems, or integration middleware.
- Hospitals, clinics and primary care providers integrating PGHD with electronic health records.
- Wearable and medical device manufacturers that need to exchange device data interoperably.
- Researchers and public‑health organizations seeking standardized, consented access to de‑identified datasets.
- Regulators and policymakers designing cross‑border data exchange, privacy and consent frameworks.
Practical uses include PDHR implementation, cross‑institutional data sharing, clinical decision support using combined clinical + PGHD, and dynamic consent portals for participant control.
Related standards
ISO/TS 6201 complements and references established health informatics standards and initiatives such as HL7 FHIR, SNOMED CT, LOINC, IDMP and IHE profiles for technical and semantic interoperability.