The use of machine learning (ML) in medicine is becoming increasingly fundamental to analyse complex problems by discovering associations among different types of information and to generate knowledge for medical decision support. Many regulatory and ethical issues should be considered. Some relevant EU provisions, such as the General Data Protection Regulation, are applicable. However, the regulatory framework for developing and marketing a new health technology implementing ML may be quite complex. Other issues include the legal liability and the attribution of negligence in case of errors. Some of the above-mentioned concerns could be, at least partially, resolved in case the ML software is classified as a ‘medical device’, a category covered by EU/national provisions. Concluding, the challenge is to understand how sustainable is the regulatory system in relation to the ML innovation and how legal procedures should be revised in order to adapt them to the current regulatory framework.

机器学习 (ML) 在医学中的使用正变得越来越重要，通过发现不同类型信息之间的关联来分析复杂问题，并为医学决策支持生成知识。应考虑许多监管和伦理问题。一些相关的欧盟规定，例如通用数据保护条例，适用。但是，用于开发和营销实施 ML 的新健康技术的监管框架可能非常复杂。其他问题包括法律责任和发生错误时的疏忽归属。如果 ML 软件被归类为“医疗设备”，即欧盟/国家规定涵盖的类别，则上述一些问题至少可以部分解决。总结，