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.
Author’s
Information:
Kaile Kubota
MHSc, MSN, RN, Doctoral Candidate (DPNurs)
Department of Nursing Science, University of Turku
kakubo(at)utu.fi
References:
Albrecht,
U., Von Jan, U., & Pramann, O. (2013). Standard reporting for medical apps.
Studies in Health Technology and Informatics, 190, 201–203.
https://doi.org/10.3233/978-1-61499-276-9-201
European
Commission. (2017). Regulation (EU) 2017/745 of the European Parliament and of
the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC,
Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing
Council Directives 90/385/EEC and93/42/EEC (Text with EEA relevance.)
https://eur-lex.europa.eu/legal-content/ EN/ALL/?uri=CELEX:32017R0745
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