Global Regulatory Approach Towards M-Health

Abstract

The past decade has witnessed rapid advancement in telecommunication and computer technologies. The smart phone is one result of that technological development and has been adopted by hundreds of millions of people worldwide. Innovators in the medical device industry quickly recognized the potential to use smartphones to expand the capabilities of healthcare professionals via mobile medical applications (apps) resident on these devices. These apps raise unique challenges for regulation by the drug regulatory authorities worldwide including the Food and Drug Administration (FDA), European Medical Association (EMA) etc. The focus of this article is to shed light on the current trends and future aspects of the regulatory framework implied on the Mobile Health (mHealth).