🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BSI PD CEN ISO/TS 82304-2:2021

BSI PD CEN ISO/TS 82304-2:2021

$215.11

Health software – Health and wellness apps. Quality and reliability

Published By Publication Date Number of Pages
BSI 2021 88
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Category:

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

This document provides quality requirements for health apps and defines a health app quality label in order to visualize the quality and reliability of health apps.

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.

PDF Catalog

PDF Pages PDF Title
2 undefined
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
3.1 General terms
13 3.2 Terms relating to apps
15 3.3 Terms relating to risk management
16 4 Health app assessment process
4.1 Quality assessment
4.2 Quality requirements
17 4.3 Health app quality report
4.4 Health app quality evidence pack
4.5 Health app quality label
5 Quality requirements
5.1 Product information
5.1.1 Product
18 5.1.2 App manufacturer
19 5.2 Healthy and safe
5.2.1 Health requirements
22 5.2.2 Health risks
25 5.2.3 Ethics
26 5.2.4 Health benefit
31 5.2.5 Societal benefit
32 5.3 Easy to use
5.3.1 Accessibility
34 5.3.2 Usability
38 5.4 Secure data
5.4.1 Privacy
44 5.4.2 Security
50 5.5 Robust build
5.5.1 Technical robustness
53 5.5.2 Interoperability
55 Annex A (normative) Health app quality label
62 Annex B (normative) Health app quality score calculation method
66 Annex C (informative) Rationale
67 Annex D (informative) Product safety and lifecycle process recommendations
75 Annex E (informative) Application profile – Contact tracing apps
78 Annex F (informative) Ethical considerations in health apps
81 Annex G (informative) Potential uses of this document
83 Bibliography

Related products

BSI PD CEN ISO/TS 82304-2:2021
$215.11