When Mobile Applications Can Be Considered as Medical Devices? The Case of Natural Cycles

Abstract

There is growing evidence that fast advancing technology can positively affect the healthcare industry which has resulted in an increasing number of sophisticated digital medical devices brought into the consumers market. Whilst there are legislations in place to regulate the determination and classification of digital medical devices, the effects of such certification on our health are not clear. This paper provides an analysis of the existing regulations that apply to software as a medical device and identifies technology trends reshaping the healthcare industry. Further, my survey and interview data reveal the effects medical device certification has on customers and businesses and suggests a set of guidelines for the medical device determination process.