Tampere University has a vital role in developing a new quality standard for mobile health apps

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The number of health and well-being applications for mobile devices is growing rapidly, making it difficult for consumers to assess their quality and safety. A new European quality standard for mobile health applications is about to make this easier.

The standard is aimed at both manufacturers of health and well-being apps and organisations evaluating them. Applications will be assessed in four areas: medical validity, privacy protection, usability, and technical quality.

“The standard check-list helps manufacturers to reach a basic level of security for mobile applications and, if all the quality criteria have been taken into account, a product gets a good rating,” says Alpo Värri, Research Director at Tampere University.

Tampere University makes a strong contribution to the development of the standard. Värri chaired the European standardisation working group (CEN/TC251/WG II Health Informatics — Technology and Applications Application) in which the standard was developed.

He also drafted, among other things, the basic proposal for more detailed guidelines on COVID-19 exposure monitoring applications. Terhi Holappa from Usbimed Oy in Oulu also participated in the project by contributing to the usability part of the standard especially.

An application receives a quality label based on a review. The new quality label resembles the widely used energy label where each criterion is colour-coded and given a letter from A to E with a total score derived from both.

In Finland, there are no organisations that perform reviews yet. Until Finland has its own mobile application assessment body, app developers may use the services of, for example, the English ORCHA review and certification body. An international quality label helps manufacturers to get their apps on the lists of apps recommended by health professionals.

Given the diverse levels of applications, several European countries had already started quality assessments based on their own criteria. This made it very difficult for application manufacturers to meet the requirements of all countries, which is why the EU funded a project to create a single European standard for reviewing the applications.

The standard, originally intended to be European, has attracted great interest elsewhere and is used world-wide.

The technical specification “ISO/TS 82304-2:2021 Health software - Part 2: Health and wellness apps - Quality and reliability” was published in August 2021.

The standard may be purchased from the SFS online store.

About the standard at the EU Cencenelec website

Research Director Alpo Värri, alpo.varri [at]



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