This chapter focuses on m-Health, i.e. technologies offered through mobile devices with particular regard to those having a specific health purpose. The contribution highlights that the mass use of these technologies is raising many challenges to national and European legislators, who are now facing a twofold task: assuring safety and reliance of the data generated by these products and protecting patients/consumers’ privacy and confidentiality. From the first perspective, such software may sometimes be classified as medical devices, although this classification is not always easy since there could be “border-line products”. If a software is classified as a medical device, then its safety and efficacy are guaranteed by the applicability of relevant regulations, which dictate specific prerequisites, obligations and responsibilities for manufacturers as well as distributors. From a data protection perspective, the mass use of these technologies allows the collection of huge amounts of personal data, both sensitive data (as relating to health conditions) and data that can nonetheless contribute to the creation of detailed user profiles.