From counting calories to tracking COVID-19 infections, there are – literally – hundreds of thousands of apps focused on health and wellness. More applications are being added every day. Many of these digital applications have access to sensitive personal information and have a positive or negative impact on the health of the user. In order to assess the effectiveness and reliability of the application, the new standard has been published.
Standard helps elevate
By broadening the range of health applications, the European Commission, which requested the standard, wants to make personalized healthcare possible and enable residents to actively work on their health. In addition, these types of tools can help provide 24/7 access to quality care at scale and contribute to reducing health inequalities and care workforce shortages.
The standard was developed by a working group of CEN (European Standardization Committee). From National Electronic Healthy Life Laboratory (NeLL) Petra Hoogendoorn and Cynthia Hallensleben were in this group. The NEN Standards Institute has also contributed. Last March, the concept of the ISO standard was launched. Until May 14, everyone can view and comment on the concept of ISO 82304-2. The working group will process the comments before the final ISO 82304-2 standard is published.
More transparency
“Using this standard, we want to make the utility of app use transparent to the health of the user and society. In this way, effective apps can become a regular part of healthcare and self-care,” says Hoogendoorn.
A total of 90 experts from eight stakeholder groups from six continents, including through the Delphi Study, contributed to the formulation of a questionnaire with 67 questions on the basis of which accredited review organizations could evaluate the applications. Questions include effectiveness, patient safety, ethics, accessibility, ease of use, protection of personal data, technical quality, and interoperability. The answers to these questions determine a score in four subjects:
- healthy and safe.
- easy to use.
- Data insurance.
- Solid.
Differences in the required information
Test results are displayed in an easily readable label, inspired by labels such as the EU Energy Label and Nutri-Score Food Label. The overall score and quality report provides a summary and further details of the health application nomenclature, respectively. In this way, differences in information needs are met. In order to make the poster useful for everyone, the Pharos Center for Expertise in Health Inequality tested people with low health skills to see if they understood the information correctly.
The guide is intended to help developers create effective health apps, and users and healthcare professionals to make good choices from apps. For example, applications can play an important role in the self-management of chronic patients, modifying an unhealthy lifestyle and supporting older target groups.
