Hälso- och sjukvårdsinformatik

ISO 25237:2017 contains principles and requirements for privacy protection using pseudonymization services for the protection of personal health information. This document is applicable to organizations who wish to undertake pseudonymization processes for themselves or to organizations who make a claim of trustworthiness for operations engaged in pseudonymization services. ISO 25237:2017 - defines one basic concept for pseudonymization (see Clause 5), - defines one basic methodology for pseudonymization services including organizational, as well as technical aspects (see Clause 6), - specifies a policy framework and minimal requirements for controlled re-identification (see Clause 7), - gives an overview of different use cases for pseudonymization that can be both reversible and irreversible (see Annex A), - gives a guide to risk assessment for re-identification (see Annex B), - provides an example of a system that uses de-identification (see Annex C), - provides informative requirements to an interoperability to pseudonymization services (see Annex D), and - specifies a policy framework and minimal requirements for trustworthy practices for the operations of a pseudonymization service (see Annex E).

This document specifies a means for communicating part or all of the electronic health record (EHR) of one or more identified subjects of care between EHR systems, or between EHR systems and a centralised EHR data repository. It can also be used for EHR communication between an EHR system or repository and clinical applications or middleware components (such as decision support components), or personal health applications and devices, that need to access or provide EHR data, or as the representation of EHR data within a distributed (federated) record system. This document will predominantly be used to support the direct care given to identifiable individuals or self-care by individuals themselves, or to support population monitoring systems such as disease registries and public health surveillance. Uses of health records for other purposes such as teaching, clinical audit, administration and reporting, service management, research and epidemiology, which often require anonymization or aggregation of individual records, are not the focus of this document but such secondary uses might also find the document useful. This Part 1 of the multipart series is an Information Viewpoint specification as defined by the Open Distributed Processing ? Reference model: Overview (ISO/IEC 10746-1). This document is not intended to specify the internal architecture or database design of EHR systems.