Experts discuss about the future of regulation in medical devices
Artificial Intelligence (AI) is a major trend in medicine as it can complement classical diagnostic and therapeutic methods. While AI methods are already being introduced e.g. in order to improve ECG analysis, questions on regulation are arising: How can AI be implemented in legal regulations on the quality assurance of measuring instruments in medicine? What is, in this area, the task of metrology, the science of accurate measurements? Questions like these can be discussed on the Medicine Event which takes place in the Physikalisch-Technische Bundesanstalt (PTB), Berlin institute, on 4 November (and also as an online event). Deadline is 1 November 2022.
Register here (Deadline: 1 November 2022)
The digital transformation of the healthcare sector has been an important driver for improving a broad range of outcomes, including innovative medical products. Artificial intelligence (AI), especially machine learning (ML), are opening up new frontiers in medicine but are also leading to unprecedented challenges associated with regulating their use. New regulatory approaches supporting the introduction of new technologies are needed: The parallel development of technology and regulation under real-world conditions, for example, takes a practical approach to realising policy goals.
Metrology can make a valuable contribution to regulation. Quality metrics and reference data developed by metrology for example can support an objective and impartial evaluation of algorithms and thus strengthen the social acceptance of the use of AI. This workshop will discuss the role of metrology in supporting modern approaches to regulation that are compatible with current software development processes. The focus will be on the requirements that Regulations (EU) 2017/745 on medical devices, (EU) 2017/746 on in vitro diagnostic medical devices, and the proposed European Regulation on establishing harmonised rules for artificial intelligence (Artificial Intelligence Act) are setting for medical devices with a high software content (especially AI).
Key questions on the role of metrology are:
- • How will emerging technologies be regulated in the future?
- • How can metrology contribute to clear guidelines and procedural instructions for medical devices with a high software content in order to check the quality of the data and the (AI) procedures?
- • How can metrology be efficiently integrated into agile regulation methods?
es/ptb
Contact:
Dr. David Auerbach, Coordinator of the Steering Group for Medicine, Phone: +49531 592-3102, E-mail: 
david.auerbach(at)ptb.de
PTB Medicine Event 2022: The Future of Regulation in Medical Devices
4. November 2022, PTB's Berlin Institute, Hermann von Helmholtz Lecture Hall
Programme
10:00 Welcome & Introduction
10:15 Stephen Gilbert, TU Dresden & Daniel Truhn, University Hospital Aachen
Artificial intelligence / machine learning based software as medical device:
• the challenges of regulating complex device systems
• Debiased synthetic image data, as a training, test and metrology platform
11:00 Steffen Buchholz, Federal Ministry of Health
Regulatory challenges of AI in medical devices the view of the German Federal Ministry of Health.
11:30 Christoph Hoeschen, Universität Magdeburg
Methods and applications of artificial intelligence in diagnostic radiology and radiotherapy possibilities, framework conditions and pitfalls.
12:00 Lunch Break
13:00 Dirk Schlesinger, TÜV Verband
Regulation of AI as a source of competitive advantage – some practical considerations.
13:30 Guillaume Avrin, GMED & LNE
Evaluation of artificial intelligence at LNE and feedback on medical devices.
14:00 Claudia Reinel, DIN e.V.
Improving legislation: How standardization supports and relieves federal rulemaking.
14:30 Coffee Break
15:00 Hans Rabus, PhysikalischTechniche Bundesanstalt
The ‘Quality Infrastructure Digital’ initiative: Introduction of the use case metrology for artificial intelligence in medicine (M4AIM).
15:30 Panel Discussion
16:00 End