This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act (FDCA), as well as regulatory issues unique to non-US companies. ...more
In Part I, we provided a high-level overview of Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its provisions. In Part II, we discuss how HIPAA is applied to mobile health (mHealth) application...more
Digital health technologies are revolutionizing the global health environment by advancing healthcare services, Big Data analytics and medical device development and innovation, expanding the reach, accessibility and...more