Law and AI

8 important questions on Law and AI

Name some examples of law that are applicable to AI? But not made for AI (5)

  • GDPR (EU) => general data protection regulation
  • Medical devices regulation (EU)
  • Clinical trial regulation (EU)
  • Human rights
  • Product liability directive

Which new law is now available for AI? What is the problem with this law?

EU Artificial Intelligence Act = law
Problem = not specific for medical AI.

Proposals
AI liability directives EU
European Health data space
Global AI laws

What is the approach of the EU AI act?

  1. Risk-based approach. The higher the risks the stricter the approach, with 4 categories.
  2. Horizontal approach = non sector specific


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What kind of research is alway high risk?

Medical devices = good

What are the obligations of the physician?

  • This is vague => because of the non specific guidelines.

=> this is a high  priority to make these guidelines

AI needs big data. What are the consequences? And what are the privacy and data governances?

  • How to deal with privacy => right to privacy
  • How to maintain good quality of data => if you let biased data in your model. The outcome will be biased too.

What is the European Health Data Space?

A proposal by the EU to make a platform for:
• Research, innovation and including training and testing of algorithms
• Talk about options about opt-out

One of the ethical requirements of AI is human oversight. What does this mean? And why is this a problem for doctors?

The tool must be effectively overseen by natural persons. =>
  • understand the relevant capacities and limitations of the high-risk AI system
  • monitor the system
  • to remain aware of the possible tendency of automatically relying or over-relying


PROBLEM because => doctors are not fully able to understand (knowledge and skills) and don't have time to investigate in this. Tendency to over-accept algorithmic output. Doctors are not willing.

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