Zanca Federica, Brusasco Caterina, Pesapane Filippo, Kwade Zuzanna, Beckers Ruth, Avanzo Michele
Palindromo Consulting, Leuven, Belgium.
MedDevConsult, Bossiere, Belgium; R&D Department, Ion Beam Applications, Louvain la Neuve, Belgium.
Semin Radiat Oncol. 2022 Oct;32(4):432-441. doi: 10.1016/j.semradonc.2022.06.012.
The rapidly evolving scenario of Artificial intelligence (AI) in medicine comes with new regulatory challenges, including certification, ownership, and control of data sharing, privacy protection, and accountability. The Medical Physicists (MPs) are traditionally responsible for ensuring the safety and quality of technology implementation in diagnostic and therapeutic settings. As such, they are also expected to contribute to the introduction of AI medical devices in routine clinical practice. Specifically, the MPs will play a stakeholder role for AI tools procurement, acceptance testing, commissioning, and quality assurance to confirm the claimed performances in relation to the medical device's intended use. Moreover, MPs who act as co-creators of such AI tools, will play a pivotal role in product requirements definition, data collection and annotation, clinical evaluation, support for regulatory pathways and marketing through scientific congresses and scientific publications. As AI software differs from the traditional (hardware) medical device that the MP is used to introduce in clinical settings, there is a need to acquire new competencies in the field of AI and its regulatory aspects. The purpose of this paper is to provide MPs with practical guidelines on regulatory aspects of AI medical devices, in the European and in the US landscape.
人工智能（AI）在医学领域迅速发展的形势带来了新的监管挑战，包括认证、所有权、数据共享的控制、隐私保护和问责制。传统上，医学物理师（MPs）负责确保诊断和治疗环境中技术应用的安全性和质量。因此，人们也期望他们为将人工智能医疗设备引入常规临床实践做出贡献。具体而言，医学物理师将在人工智能工具的采购、验收测试、调试和质量保证中扮演利益相关者的角色，以确认与医疗设备预期用途相关的宣称性能。此外，作为此类人工智能工具共同创造者的医学物理师，将在产品需求定义、数据收集和标注、临床评估、支持监管途径以及通过科学大会和科学出版物进行营销方面发挥关键作用。由于人工智能软件不同于医学物理师习惯在临床环境中引入的传统（硬件）医疗设备，因此需要在人工智能领域及其监管方面获得新的能力。本文的目的是为医学物理师提供关于欧洲和美国环境下人工智能医疗设备监管方面的实用指南。
