The issues of quality and safety are two important things that should be addressed with all health-related apps as it is set to become a significant source of health information and guidance. Apps that fall under the medical device category are bound by regulations and policies within the European Union such as the Conformité Européenne or widely known as the CE marking and acts, directives as well as policies for regulating medical devices. On the other hand, there are health apps that fall under the non-medical device category, like apps for health promotion that are commonly used to supplement the education of children on health behaviors and risk preventions or apps that promote mindfulness, relaxations or simply offer health information. Non-medical device apps are those that are not used in any way to diagnose, prevent, monitor, treat nor alleviate a disease, injury or handicap as defined by the European Commission (2017).
If we look at some literature, some say it’s like the “Wild West” for health apps under the non-medical device category. Imagine the cowboys, outlaws and who knows what else were out there way back then in a desert-ish town, where everyone just do what they want as they please. Speaking of metaphors, let’s update it in another way and make it somehow closer to our digital age – it’s a runaway train! Although, we have regulations on data protection and privacy for everything digital when it comes to use of personal information, regardless of whether it’s a medical or non-medical device app, it is not just enough when we are talking about a person’s health and well-being. Big things came from small things so a wise man once said, imagine what a little misinformation or misuse that apparently does not have an immediate or direct effect to our human physiology can lead to in the long run. Uncontrolled, unregulated and unchecked health apps like a runaway train, poses as a looming predicament.
The Qvalidi Tool project led by the Qvalidi Consortium and the University of Turku’s Department of Nursing Science recognize the need to address the degree of quality and validity of health and well-being apps under the non-medical device category. To recognize these shortcomings is definitely a good start to devise solutions to bridge the gap. The project developed a comprehensive checklist in 2019 based on research and up-to-date guidelines to support the development, evaluation and reporting of health and well-being apps. Currently, the on-going study designed a practical and easy-to-use evaluation scale and will be tested to establish its psychometric properties.
MHSc, MSN, RN, Doctoral Candidate (DPNurs)
Department of Nursing Science, University of Turku
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