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BSI PAS 277:2015

BSI PAS 277:2015

$43.84

Health and wellness apps. Quality criteria across the life cycle. Code of practice

Published By Publication Date Number of Pages
BSI 2015 36
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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.

PDF Catalog

PDF Pages PDF Title
3 Contents
4 Foreword
5 Innovate UK statement
6 Introduction
7 1 Scope
2 Normative references
8 3 Terms and definitions
10 4 Fitness for purpose
11 5 Quality criteria
12 6 App project life cycle
19 7 Risk management
21 8 App project governance
22 9 Configuration management
23 10 Support
24 Annex A (informative) Relationship between PAS 277 and BS EN 62304:2006
25 Annex B (informative) Relationship between PAS 277 and ISB 0129
26 Annex C (informative) Relationship between PAS 277 and Health on the Net (HoN) quality criteria
27 Annex D (informative) Relationship between PAS 277 and eEurope 2002
28 Annex E (informative) Example health and wellness apps
30 Annex F (informative) Example risk repository analysis
32 Bibliography

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BSI PAS 277:2015
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