Law and Health 4.0

Today, more and more products are based on advanced technical and technological solutions (e.g. nanotechnology) or are equipped with systems (software) referred to as artificial intelligence (AI). This is also the case in the healthcare/medical sector, where the focus is on people and their health. As a result, particularly significant regulatory challenges arise in this area due to the emergence of increasingly sophisticated health services and medical devices. As has been shown by the actions and behaviours of market participants to date, it is important to have both legal rules (hard law and soft law) and ethical standards. This chapter highlights selected issues and legislative challenges faced by lawmakers in relation to the development of technology and the use of solutions based on AI and nanotechnology in medicine. The regulations in this area must, on the one hand, take into consideration the good of the patient (protect his health, privacy, etc.), but on the other, they cannot hinder technological progress, as it is also in the patient's best interest. The potential of AI is recognized both by individual countries and international organisations embarking on regulation. Similar efforts are also pursued at the EU level, where a number of documents and acts relevant to healthcare have been issued. This chapter explains selected issues and legislative challenges faced by lawmakers in relation to the development of technology and the use of solutions based on Artificial Intelligence (AI) and nanotechnology in medicine. AI systems already exist, to mention only voice assistants, speech and face recognition systems, robotic devices, or autonomous cars. AI-based systems and solutions are by no means a recent creation; in fact, they have been present for several decades. It was only recently that the progress in the ability to create complex algorithms, the increase in computing power of the newly designed devices, and the existence of large amounts of data have resulted in a ‘new quality’ ‒ a new level of advancement. The judicature defines the term due diligence in this context as “the exercise of due care that can be normally expected from the perpetrator given his/her ordinary ability to anticipate the consequences of his/her actions”.