Module 12 Presentations

07/02/2024

The Challenge of Artificial Intelligence Compliance

• Different Jurisdictions • UK, EU, USA, China all have different perspectives on how to regulate – for you to show compliance to different systems, you will need a lot more data than you think and be prepared to write the same information in a multitude of formats • Data Protection • You cannot look at AI from one perspective – AI’s interreact with data, healthcare systems etc, therefore, all DP rules from each jurisdiction come into play

The Organisation for Professionals in Regulatory Affairs

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The Challenge of Artificial Intelligence Compliance

• Quality Systems • AI’s and Quality Systems are not the best of friends. • ISO 9001 & ISO 13485 are the predominant Quality Standards in Healthcare, but are both built for physical products • ISO/IEC 42001 has been ‘designed’ for AI systems, but has conflicts both with 9001 / 13485 and within itself • There is no guidance on how 42001 interacts with existing systems • 42001 has also not been widely recognised as of yet

The Organisation for Professionals in Regulatory Affairs

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