What is ISO/TS 82304-2 about?

ISO/TS 82304-2 is the second part of the multiple series that provides quality requirements for health apps and defines a health app quality label in order to visualize the quality and reliability of health apps.

ISO/TS 82304-2 is applicable to health apps, which are a special form of health software. It covers the entire life cycle of health apps.

Note:

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

See Annex C for additional details on the scope.

Outside the scope of ISO/TS 82304-2 are guidelines to comply with the medical device regulation.

ISO/TS 82304-2 makes no attempt to determine whether a health app is or should be regulated.

Who is ISO/TS 82304-2 for?

ISO/TS 82304-2 on health and wellness apps is useful for:

Health software operator
App manufacturers
App assessment organizations
Consumers
Health care professionals and their organizations
Healthcare authorities
Healthcare insurers
Health app users

Why should you use ISO/TS 82304-2?

Health and wellness apps are a fast-growing market, and there are now hundreds of thousands, with the most popular of these having many millions of downloads each.

These apps often collect sensitive personal information yet do not have appropriate privacy controls, and provide advice on topics such as fertility, diet or activity that are not supported by any evidence. There are widespread concerns about the risks involved. At the same time, health apps that have proven to be effective and add to quality of life and even length of life, are not necessarily adopted at scale and reimbursed.

The working practice within app development is to deliver a focused piece of functionality, building on an existing platform - often with a small team doing the work who can be unfamiliar with health software development. ISO/TS 82304-2 includes Annex D to provide guidance specific to this community. .ISO/TS 82304-2 provides quality requirements and health app quality labels which help you communicate the quality and reliability of health apps.

ISO/TS 82304-2 defines a set of questions and supporting evidence which you can ensure the quality and reliability of a health app. A health app quality label as defined in ISO/TS 82304-2 enables you to summarize this information in a visually appealing way. However, you can use the health app quality label and report for adoption in care guidelines, care pathways and care contracts.

ISO/TS 82304-2 provides requirements for the specification for the health app quality label and a calculation method. This will help you to generate the quality score information that is displayed on the label of the document.

A vibrant transparent market for health apps will benefit individuals and programs across the world that are addressing issues such as aging population, unhealthy lifestyles, chronic diseases, affordability of or constrained budgets for health and care, unequal quality and access to health services, and shortages in health professionals.

PD CEN ISO/TS 82304-2:2021

Health software - Health and wellness apps. Quality and reliability

Current, Under Review

Published:

31 Aug 2021