The battle between regulation and innovation in digital health applications which use artificial intelligence

Abstract

The use of AI in the digital health sector has been rising consistently over the past years and it is common for people to make use of digital health applications which use AI for various health and wellbeing reasons. Furthermore, innovation in relation to AI is high in the present times and also within the digital health sector. This thesis aims to analyse the existing regulatory environment which regulates these applications with the aim of understanding whether a balance is reached between innovation and protection of users. Regulation should not deter innovation, and neither should it fail to protect users from risks prevalent within AI in the digital health market. This is why ideally a balance should be reached. The research will be based on doctrinal analysis and an interdisciplinary literature review to explain the issues which arise from the use of AI within digital health applications. Regulation affects innovation in relation to technology in multiple ways and the regulator faces issues such as the pacing problem and difficulty to maintain regulatory connection within the fast-moving pace of technology. The research sets out the issues relating to the use of AI in digital health in relation to three topics: the classification of AI as a medical device, sourcing and processing of health data, and transparency and accountability in AI. Any existing or proposed EU legislation, namely the Artificial Intelligence Act, the Medical Devices Regulation, the General Data Protection Regulation and the European Health Data Space Regulation, which regulate digital health applications in relation to these issues were analysed in order to understand the extent of applicable provisions. These provisions were then analysed to understand their effects on innovation versus user protection and it was concluded that the current regulatory environment does not reach a balance. It favours innovation in some instances through legal certainty and deters both innovation and user protection in other instances.

Date of Award	29 Jun 2023
Original language	English
Awarding Institution	Universidade Católica Portuguesa
Supervisor	Giovanna Mifsud Bonnici (Supervisor)