ISO/TR 21835:2020 PDF

Overview

ISO/TR 21835:2020 is a technical report in health informatics that provides an environmental scan of common personal health data elements generated daily by smartphones, mobile apps and remote monitoring devices. It describes how patient-generated health data (PGHD) can be combined with EHRs, patient portals and PHR systems to supplement clinical data, reduce information gaps and give a more comprehensive picture of ongoing patient care. The report highlights the need for data quality, semantic clarity and interoperability to make daily health data usable at the point of care.

Key Topics

• Use cases: patient‑reported outcomes (PRO/PROMs), social determinants of health (SDH), observations of daily living (ODLs), PGHD and combined patient/provider data.
• Data categorization: patient‑generated indirect vs direct data, patient/provider combination data, and coded vs un‑coded data.
• Common data elements: examples include blood pressure, blood sugar, cholesterol, step count, sleep, stress, breath capacity, medications, allergies, vaccinations and medical image reports.
• Interoperability & standards alignment: discussion of ISO/IEEE 11073, IHE‑PCD Rosetta, HL7 FHIR®, AAMI/UL 2800 and the Continua/Personal Connected Health Alliance guidelines as tools to reduce ambiguity and enable semantic interoperability.
• Quality and safety: emphasis on accuracy, trust, measurement quality and mitigation of risk for integration into diagnostic and therapeutic decision making.
• IoT and mobile health: relevance of IoT devices and mobile environments in generating health-related data and the need for cross‑SDO collaboration.

Applications

• For EHR and PHR vendors: guidance on integrating PGHD and structuring common data elements for clinical use.
• For medical device and mobile app developers: insight into the data types and coding needs to support interoperability and clinical reliability.
• For health informaticians and interoperability architects: a reference for mapping ODLs, PROs and SDH to standards (e.g., FHIR resources, ISO/IEEE device profiles).
• For clinicians and care managers: understanding how continuous daily data can supplement episodic clinical measurements for better care coordination.
• For policy makers and standards bodies: baseline landscape for harmonizing safety, privacy and data quality expectations across devices and platforms.

Related standards

• ISO/IEEE 11073 (personal health device communication)
• IHE‑PCD Rosetta (device-to-EHR data mapping)
• HL7 FHIR® (interoperability and exchange)
• AAMI/UL 2800 (MD interface safety and interoperability)
• Continua Design Guidelines / PCHAlliance (end‑to‑end PGHD interoperability)

ISO/TR 21835:2020 is a practical reference for anyone implementing or governing the flow of daily personal health data into clinical systems, helping bridge mobile health, IoT and traditional healthcare records.