Greater quality and reliability: the Label2Enable project promotes the adoption of international standards for apps for health care use

The Tic Salut Social Foundation is collaborating with the Label2Enable project financed by the European Commission’s HORIZON-HLTH-2021 programme.


In 2021 the European Committee for Standardization (CEN), in collaboration with the International Organization for Standardization) published international standards to ensure the quality and reliability of health care applications according to the Health Informatics – Part 2 standard: Health and Wellness Apps – Quality and Reliability (CEN-ISO/TS 82304-2) .

This standard has great potential for impact on citizens because prior to its publication there were no quality standard models for health apps.

Label2Enable promotes the adoption of CEN-ISO/TS 82304-2 in Europe to create a standard and trusted certificate that promotes and protects patients, health care workers and health care systems in the European market. Thus a global, reliable, legislative structure will be shared that offers ethical guarantees to the potential users of these products.

In turn, developers will have to prove compliance with various quality criteria to evaluate organisations accredited for this purpose.

Evaluation system

CEN-ISO/TS 82304-2 provides a form with 87 questions on various topics: accessibility, ethics, technical quality and interoperability. 67 of these questions are essential to achieve the ISO.

The questions are divided into 5 groups to establish the product’s quality level and obtain a score based on their level of relevance on a quality scale from A to E:

  1. Basic product information
  2. Patient health and safety criterion
  3. Usability criterion
  4. Data security criterion
  5. Robust build criterion

CEN-ISO/TS 82304-2 certification label


One of the main goals of the CEN-ISO/TS 82304-2 standard is for developers to be able to offer users tools with the maximum effectiveness. The table below classifies the uses that can be given to it by interested parties:






Patients, caregivers, citizens Easily detect the most secure, reliable and effective apps on the market.


App developers


Follow the guidelines required to produce quality applications with greater viability.
App evaluators


Follow a standardised model for evaluation.
Health care providers and professionals


Recommend safe and quality apps to your patients.
Health systems and authorities


Make better decisions on which applications to acquire or finance in accordance with global criteria.
App stores (Google Play, AppStore, etc.)


Advise your customers on the best apps they can download.


  • This rule has a great potential for impact on citizens because before its publication there were no standard quality models for Health Apps.