It covers issues associated with the planning, development, design, maintenance and operation of telecommunications equipment for persons with a wide range of sensory, physical and cognitive abilities, including older persons and persons with permanent or temporary disabilities (hereafter referred to as older persons and persons with disabilities).

NOTE 1 This Standard also provides general guidelines for distributing, acquiring and evaluating telecommunications equipment for persons with a wide range of sensory, physical and cognitive abilities, including older persons and persons with disabilities.

NOTE 2 Products and product groups designed with new concepts that are outside the categories of conventional products, such as complex products, should also comply with this Standard.

Where standards specific to such product groups are established, however, those standards should be applied.

This document is applicable to health apps, which are a special form of health software. It covers the entire life cycle of health apps.

This document is intended for use by app manufacturers as well as app assessment organizations in order to communicate the quality and reliability of a health app. Consumers, patients, carers, health care professionals and their organizations, health authorities, health insurers and the wider public can use the health app quality label and report when recommending or selecting a health app for use, or for adoption in care guidelines, care pathways and care contracts.

NOTE 1   Health apps can be subject to national legislation, such as for medical devices.

NOTE 2   See Annex C for additional details on the scope.

Outside the scope of this document are guidelines to comply to the medical device regulation.

This document is not applicable to Western medicine and Japanese Kampo medicine. It is not applicable to the design and management of artificial intelligence diagnosis and treatment.

ISO/TS 27790:2009 also references a number of companion standards-based specifications that offer optional extensions to enhance the basic capabilities offered by IHE XDS. It references the support of the following.

1. An XDS extension supporting the fragmentation of the content of the documents into two parts: a header fragment and a body fragment. This separation scheme enhances confidentiality because the gathering both of header and body and their relational information involves cracking into multiple repository servers. This has been developed as an IHE Korean Extension on the IHE XDS Profile.
2. A series of security- and privacy-related IHE profiles, such as Patient Identification Cross-Referencing (PIX), Patient Demographics Query (PDQ), Basic Patient Privacy Consent (BPPC), Cross-Enterprise User Assertion (XUA).

ISO/TS 27527:2010 can be applied to all providers of services, individuals and organizations. It details both data and processes for collection and application of identifying information for providers. It defines demographic and other identifying data elements suited to capture and use for the identification of providers in health care settings and provides guidance on their application.

ISO/TS 27527:2010 provides:

• definitions of data elements to support the identification of individual providers and organizational providers for purposes such as electronic health record authentication and authorization, communications, role definitions, delegation of authority, and the management of certification of individuals where more than one discipline is concerned;
• guidance on the development, population, governance and ongoing management of provider identifiers from multiple potential sources. This includes identification of processes to support national, multinational and provincial/state or local level identification. Unique identifier structures may differ for different purposes, or with different originating organizations. For this reason, a generic approach to the structure of these identifiers is given in ISO/TS 27527:2010 to support multiple unique identifiers and the ability to link these to the relevant provider.
• Annex A provides information to support the process of identification and implementation of provider identification in health care information systems.

ISO/TS 27527:2010 is primarily concerned with provider identification data for clinical and administrative purposes. ISO/TS 27527:2010 is intended for use by health and health-related establishments that create, use or maintain records on providers. Establishments are intended to use ISO/TS 27527:2010, where appropriate, for collecting data when registering providers.

ISO/TS 27527:2010 does not include the process for development of unique identifiers. Standards for the development of identifiers are provided in ISO/TS 22220.

Data required to meet identification purposes is highly dependent upon the place and purpose of identification. ISO/TS 27527:2010 identifies a range of data that support the identification of an individual or organization used in different health care environments.

ISO/TS 27527:2010 does not attempt to identify all the use cases for which the items included are relevant; however, the data elements are provided to allow their consistent representation where they are found appropriate to support identification activities of the organization or jurisdiction.