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MASK‐air® is CE1‐registered but was not considered by the Ethical Committee of the Cologne Hospital (2017) as a medical device, given that it does not provide any recommendations concerning treatment or diagnosis. MASK‐air® follows GDPR regulations. An independent review board approval was not required for this specific study, as all data had been anonymized prior to the study (including geolocation‐related data) using k‐anonymity, and users agreed to have their data analyzed in the terms of use (translated into all languages and first customized according to the legislation of each country, allowing the use of the results for research purposes).13, 14
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