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Course

3. Artificial intelligence in medical devices:
Regulatory framework and liability

  • CME-certified course
  • CME points: 2
  • Modules: 1
  • Learning time: 45 minutes
  • Speaker: Dr. Vera Rödel
  • On demand
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Overview
As we have seen, artificial intelligence (AI) has made rapid progress in recent years and is increasingly being used in various areas of medicine. These developments not only bring immense benefits but also raise numerous legal and regulatory issues. The following module provides an overview of the current status and future developments in the regulatory framework and liability requirements for AI-based medical devices.In particular, it focuses on liability regulations and the need for a clear regulatory framework to ensure the safety and efficacy of AI-based medical devices. This module provides a comprehensive overview of the current regulatory requirements relating to AI in medical devices, analyses the existing liability requirements and proposes a model framework for the responsible and legally compliant use of AI in the medical field.It also provides an outlook on future regulation under the Artificial Intelligence Act (AIA). Finally, the liability system for AI-based medical devices is explained, including the challenges of the current Product Liability Directive and possible future liability rules.

After completing this course

  • you will be able to understand the definition and classification of AI from a regulatory perspective.
  • you will be able to explain how software classified as a medical device is implemented in medical practice.
  • you will be familiar with the proposal for a modelling framework as a guideline for "AI governance for generative AI".
  • you will have an overview of the liability for AI training data.
  • you will know what is behind the Artificial Intelligence Act (AIA) and its risk categories and what impact it has on MDR medical devices. 
  • you will have gained an insight into the human oversight of high-risk AI systems.
Course contents

Course modules

The course speaker

Dr. Vera Rödel, MMHM

Biography
Dr. Vera Rödel holds a Doctor of Laws and a Master's in Health and Medical Management. With over 12 years of experience in the pharmaceutical industry, Dr. Rödel has specialised in pharmaceutical law, antitrust and risk governance roles. Her extensive legal expertise and deep understanding of health and medical management have been instrumental in developing Valmed A(I)cademy®.

Educational background
Doctor of Laws, Johannes Gutenberg University Mainz
Master in Health and Medical Management (MHMM), FAU Erlangen-Nürnberg
Transparency

Conflicts of interest

The conflicts of interest can be viewed by clicking here.

Sponsorships

The following company is a sponsor: Merck Healthcare Germany GmbH. The expenses of Merck Healthcare Germany GmbH for one training unit amount to approximately € 5,000.
One-off costs for the technical realisation amount to approximately € 44,000. 
CME points

CME-accredited

Our courses are CME-accredited by the Medical Association of Hessen. Our courses also offer European CME points (ECMEC®s).
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