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  • BSI
    PAS 277:2015 Health and wellness apps. Quality criteria across the life cycle. Code of practice
    Edition: 2015
    $135.12
    / user per year

Description of PAS 277:2015 2015

This PAS gives recommendations for developers of health and wellness apps, intending to meet the needs of health care professionals, patients, carers and the wider public. It includes a set of quality criteria and covers the app project life cycle, through the development, testing, releasing and updating of an app, including native, hybrid and web based apps, those apps associated with wearable, ambient and other health equipment and apps that are linked to other apps. It also addresses fitness for purpose and the monitoring of usage.

This PAS does not cover the processes or criteria that an app developer or publisher follow to establish whether a health and wellness app is subject to regulatory control (e.g. as a medical device, or related to information governance).

This PAS informs the development of health and wellness apps irrespective of whether they are placed in the market, and including free of charge.

NOTE 1

The development and placing on the market, including free of charge, of a health and wellness app may be covered by certain legislation, for example the Medical Devices Directive [1].

NOTE 2

The focus of this PAS is on commodity apps available through app repositories, but may also be relevant to specialized applications running on other platforms.

NOTE 3

This PAS is not intended to replace documentation provided by platform curators on requirements for apps made available on the platform, unless referenced by platform curators.

NOTE 4

It is not intended to cover apps for enforcement or legal advice purposes. For example, apps used to monitor alcohol levels for drivers are out of scope.



Standard NumberPAS 277:2015
TitleHealth and wellness apps. Quality criteria across the life cycle. Code of practice
StatusWithdrawn
Publication Date2015-04-30
Withdrawn Date2023-10-25
DescriptorsSafety measures, Hazards, Risk assessment, Life cycle, Design, Maintenance, Identification methods, Software engineering techniques, Electrical medical equipment, Computer technology, Electrical equipment, Quality management, Life (durability), Computer software, Equipment safety, Quality assurance systems, Medical equipment
ICS03.120.01 Quality in general, 35.080 Software, 35.240.80 IT applications in health care technology
CommitteeZZ/3
ISBN978 0 580 87164 1
PublisherBSI
Pages0

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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