Free ISO/TS 82304-2 health app assessment

It’s full title is CEN ISO/TS 82304-2:2021 - Health Software - Part 2: Health and wellness apps – Quality and reliability.

CEN means the standard was produced by the Comité Européen de Normalisation. ISO is the International Organization for Standardization. TS means Technical Specification. 82304-2 is the five digit number given to the standard, and it is the second part of ISO 82304. It was first published in 2021.

CEN ISO/TS 82304-2 was developed under CEN lead by ISO/TC 215 'Health informatics', in collaboration with IEC/TC 62 'Electrical equipment in medical practice', and adopted by CEN/TC 251 ‘Health informatics’, whose Secretariat is held by NEN, the Dutch national standardization committee.

ISO/TS 82304-2 provides quality requirements for health apps and defines a health app quality label in order to visualize the quality and reliability of health apps. It aims to provide consumers, patients, carers, health care professionals and their organisations, health authorities, health insurers and the wider public with a simple to understand mobile health app ‘quality label’.

It is important to note that a Technical Specification Standard is not a full international standard, and is therefore not binding or mandatory. A Technical Specification addresses work still under technical development, or where it is believed that there will be a future, but not immediate, possibility of agreement on an International Standard.

While ISO/TS 82304-2 also covers Software as a Medical Device (SaMD) apps, it does not supersede the need for such products to achieve regulatory approval under the EU MDR to earn the CE mark, which is a legal requirement in the EU.

ISO/TS 82304-2 self-assessment can be used voluntarily by developers of mobile health and wellness apps, including apps that are regulated as Software as a Medical Device (SaMD), as a useful checklist of compliance against the various key indicators of app quality within the Technical Specification.

In the future, if the TS standard is transitioned to an international standard, there may be an accreditation process by which developers can receive an official accreditation and quality label for their health app. However, currently there is no formal accreditation scheme in existence.

Included with this ISO/TS 82304-2 self-assessment are:

1. Fully automated self-assessment questionnaire covering all aspects of ISO/TS 82304-2
2. Your app’s scores and quality ratings for each section, and an overall quality rating
3. An illustrative example of your quality rating chart
4. Actionable recommendations to help you improve your overall quality rating
5. A detailed PDF report containing your scores, ratings and recommendations, emailed to you for your records

Not included: an official accreditation or official quality label, since there is no official accreditation scheme in place yet.

This self-assessment tool should be used to find out how you are doing against the technical specification. It is not an official accreditation, certification or audit. No certification scheme currently exists.

The results are based on your answers to a self-completed questionnaire, which automatically calculates your scores and ratings. No formal assessment is performed.

You will be able to see your quality ratings in an illustrative example ratings chart, but it is not an official quality label. You will also receive actionable recommendations on how you can improve your ratings, allowing you to work further on your app’s quality.

Unaccredited ‘app assessment organisations’ want to charge you thousands of pounds to assess against the ISO/TS 82304-2 technical specification standard. While it can be a useful indicator of compliance factors and health app quality, it is not a legislative standard, there is no formal accreditation scheme, and assessment is currently not mandatory.

We’re offering unlimited usage of our ISO/TS 82304-2 self-assessment tool completely free of charge simply to help health and wellness app developers better understand their compliance needs.

There’s no catch!

While it is not mandatory in order to use this self-assessment tool, we highly recommend you purchase a copy of ISO/TS 82304-2, as it gives further guidance and insight into how to demonstrate app quality as per the technical specification.

Copies must be purchased from an official ISO supplier.