While digital innovation has already transformed many industries profoundly, the healthcare and life sciences sector came later into the focus of disruptive developments. In this highly regulated field, market entry barriers seemed quite high for new players. However, with Apple’s latest announcement that its Apple Watch Series 4 will feature an electrical heart rate sensor, and a new ECG app able to provide users with electro diagrams, it is obvious that the health and fitness market with its enormous market potential will be a new playing field for game changers. This panel will explore the regulatory landscape applicable to eHealth devices and apps, including the protection of health related data, data ownership, artificial intelligence in predictive analytics, software as medical device under the new MDR and special health related advertising law.