Role of Legal Issues in Education of Biomedical Informatics

摘要

The aim of the paper is to present the current state of legislation concerning software in healthcare, especially software that is a medical device according to the legislation. Furthermore, we will discuss how to incorporate this topic into the teaching of biomedical informatics. As of May 2021, the EU Regulation 2017/745 of the European Parliament and of the Council (MDR - Medical Device Regulation) came into force, which largely expands the definition of a medical device and changes the way of notification of a medical device compared to the previous legislation. In addition, the MDR also redefines the rules for software as a medical device and defines the classification of different types of software into risk classes, with software moving to higher risk classes in most cases.At the same time, the use of software in the healthcare sector continues to expand. So far, this issue has not received much attention in the teaching of computer science or biomedical informatics. However, we consider very important that students become familiar with the legislative environment that affects the development and use of software in the specific environment of healthcare on an ongoing basis during their studies. In addition to the MDR, this includes the law on cyber security, the law on the digitization of healthcare and other related regulations. In addition, there are a number of technical standards that are closely related to the aforementioned laws. Therefore, students need to learn to understand these standards in order to be able to apply them in their future jobs.In 2019, the Faculty of Biomedical Engineering of CTU received accreditation for the Master's degree program in Biomedical and Clinical Informatics. Already in the curriculum design, we have envisaged the inclusion of the above-mentioned topics in the curriculum. Thus, the courses of Legislation and Safety of Biomedical Software and Data and Biomedical Data Safety and Security were introduced to the curricula.