ABSTRACT
BACKGROUND: The lack of an international standard for assessing and communicating health app quality and the lack of consensus about what makes a high-quality health app negatively affect the uptake of such apps. At the request of the European Commission, the international Standard Development Organizations (SDOs), European Committee for Standardization, International Organization for Standardization, and International Electrotechnical Commission have joined forces to develop a technical specification (TS) for assessing the quality and reliability of health and wellness apps. OBJECTIVE: This study aimed to create a useful, globally applicable, trustworthy, and usable framework to assess health app quality. METHODS: A 2-round Delphi technique with 83 experts from 6 continents (predominantly Europe) participating in one (n=42, 51%) or both (n=41, 49%) rounds was used to achieve consensus on a framework for assessing health app quality. Aims included identifying the maximum 100 requirement questions for the uptake of apps that do or do not qualify as medical devices. The draft assessment framework was built on 26 existing frameworks, the principles of stringent legislation, and input from 20 core experts. A follow-up survey with 28 respondents informed a scoring mechanism for the questions. After subsequent alignment with related standards, the quality assessment framework was tested and fine-tuned with manufacturers of 11 COVID-19 symptom apps. National mirror committees from the 52 countries that participated in the SDO technical committees were invited to comment on 4 working drafts and subsequently vote on the TS. RESULTS: The final quality assessment framework includes 81 questions, 67 (83%) of which impact the scores of 4 overarching quality aspects. After testing with people with low health literacy, these aspects were phrased as "Healthy and safe," "Easy to use," "Secure data," and "Robust build." The scoring mechanism enables communication of the quality assessment results in a health app quality score and label, alongside a detailed report. Unstructured interviews with stakeholders revealed that evidence and third-party assessment are needed for health app uptake. The manufacturers considered the time needed to complete the assessment and gather evidence (2-4 days) acceptable. Publication of CEN-ISO/TS 82304-2:2021 Health software - Part 2: Health and wellness apps - Quality and reliability was approved in May 2021 in a nearly unanimous vote by 34 national SDOs, including 6 of the 10 most populous countries worldwide. CONCLUSIONS: A useful and usable international standard for health app quality assessment was developed. Its quality, approval rate, and early use provide proof of its potential to become the trusted, commonly used global framework. The framework will help manufacturers enhance and efficiently demonstrate the quality of health apps, consumers, and health care professionals to make informed decisions on health apps. It will also help insurers to make reimbursement decisions on health apps.
ABSTRACT
OBJECTIVE: Health checks may empower individuals to take better care of their health, but they may incorporate risks of incorrect test results, overdiagnosis and overtreatment as well. Some health checks are strictly regulated, such as in many of the national screening programs, but the ones offered outside such programs and in the commercial domain, are not. We developed a European consensus agreement for quality criteria. METHOD: Quality criteria were developed with the contribution of 43 experts from 16 European countries and 8 European organizations. A working group drafted a proposal, which was revised in several rounds of internal and external review by a multidisciplinary group of experts. RESULT: The quality criteria address the provision of information, communication and informed consent, predictive ability and utility of the test, and quality assurance. CONCLUSION: The consensus agreement on the quality of health checks aim to enhance informed decision making in clients and protects the affordability of the health care system. The criteria can be developed further into a formal standard and regulation if such authority is warranted.
