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mHealth label published

The new technical specification on a quality label for health and wellness apps has been published by ISO, CEN and IEC. It brings together and builds on guidelines and requirements for apps, by many local and national health organizations around the world to ensure they are safe, reliable and effective.

From counting calories to tracing COVID-19, there are hundreds of thousands of health and wellness apps on the market, and the thirst for them is only growing. However, many have access to highly sensitive personal information whilst others may offer advice that is not always supported by scientific evidence. In order to evaluate the quality and reliability of such apps effectively, a new technical specification (TS) has been published.

There are several International Standards on health software related to product safety and lifecycle processes that are applicable to all health software, including health apps. The technical specification published provides quality requirements and health app quality labels as ways for app manufacturers and app assessment organizations to communicate the quality and reliability of health apps.

The guidance provides an internationally agreed set of specifications to assess the apps, with a scoring methodology that gives a “traffic light” themed label. The label enables apps to be easily compared by users and health professionals.

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.

The technical specification will help the industry for health apps realize its potential in managing chronic diseases, tackling unhealthy lifestyles and supporting ageing populations. It also provides a helpful tool to promote the use of good-quality health apps where healthcare budgets are stretched and there are disparities in quality and access to health services.

ISO/TS 82304-2Health software – Part 2: Health and wellness apps – Quality and reliability, brings together and builds on guidelines and requirements for apps by many local and national health organizations around the world to ensure they are safe, reliable and effective.

ISO/TS 82304-2 was developed by ISO technical committee ISO/TC 215Health informatics, in collaboration with IEC/TC 62, Electrical equipment in medical practice, of the International Electrotechnical Commission (IEC). The project was led by CEN, the European Committee for Standardization.

CEN is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at the European level.