Regulatory Insights in Digital Health

Abstract

Digital health is an all-encompassing term that includes a wide range of technologies ranging from general wellness products to medical devices, such as mobile health applications, wearable devices, telemedicine platforms, interoperable medical devices, and electronic health records (EHRs). Digital health has witnessed remarkable growth in recent years, leading to the development of various technologies with the potential to revolutionize healthcare. Regulatory affairs professionals play a crucial role in navigating the complexities of digital health regulations, enabling companies to comply with evolving requirements while fostering innovation. This chapter delves into key regulatory considerations for digital health products, including medical devices, software as a medical device (SaMD), cybersecurity, artificial intelligence (AI) and machine learning (ML)-based devices. It also highlights the importance of international collaboration in harmonizing regulatory standards and facilitating the global adoption of digital health technologies.