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What Makes a Quality Health App-Developing a Global Research-Based Health App Quality Assessment Framework for
Petra Hoogendoorn1, Anke Versluis1, Sanne van Kampen1
1National eHealth Living Lab, Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.
JMIR Formative Research
|December 20, 2022
Summary
A new international standard (CEN-ISO/TS 82304-2:2021) provides a framework for assessing health app quality. This standard helps manufacturers, consumers, and healthcare professionals make informed decisions about health and wellness apps.
Area of Science:
- Digital Health
- Health Informatics
- Software Engineering
Background:
- Lack of a global standard for health app quality assessment hinders adoption.
- International Standard Development Organizations (SDOs) collaborated to create a technical specification for health and wellness apps.
- Existing quality assessment methods lacked consensus, impacting user trust and uptake.
Purpose of the Study:
- To develop a globally applicable, trustworthy, and usable framework for assessing health app quality.
- To establish a consensus-based standard for evaluating health and wellness applications.
- To create a framework that addresses both medical device and non-medical device health apps.
Main Methods:
- A two-round Delphi technique involving 83 international experts.
- Development of an 81-question framework based on 26 existing frameworks and expert input.
- Testing and refinement with COVID-19 symptom app manufacturers and feedback from national mirror committees.
Main Results:
- The final framework comprises 81 questions categorized into "Healthy and safe," "Easy to use," "Secure data," and "Robust build."
- A scoring mechanism generates a health app quality score and label.
- Stakeholder feedback indicated a need for evidence and third-party assessment for app adoption.
Conclusions:
- A practical and usable international standard for health app quality assessment has been established.
- The standard is poised to become a trusted global framework, aiding manufacturers in quality enhancement and demonstration.
- It empowers consumers and healthcare professionals to make informed decisions and assists insurers with reimbursement.
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