Advances in software and its application in a medical device and as a medical device have opened the door for many new technological capabilities in healthcare. Around the globe, government agencies have begun to take a heightened interest in how these devices are regulated. Whether it is software embedded in a medical device, software as a medical device, mobile medical applications, or artificial intelligence/machine learning mechanisms, there are potential risks to both user and patient. Cybersecurity is the gateway for evaluating vulnerabilities and protecting devices and patients. In this article, we examine how the EU has introduced new regulations regarding software, cybersecurity, and the impact on the total product life cycle development and innovation of new technologies. Privacy rules in compliance with the EU General Data Protection Regulation may present innovators with challenges by limiting AI’s usage of patient data.