13.12.2023

Landmark EU Regulation points to implications for AI in Pharmacovigilance!

Landmark EU Regulation points to implications for AI in Pharmacovigilance!
The European Union reached an important milestone on Saturday with its proposed regulation of Artificial Intelligence.

The EU AI Act comes after intense discussions with EU Member States and the European Parliament, with approval scheduled in Spring 2024 and the act coming into force in 2026. The importance of this comes from what is known as the ‘Brussels Effect’, where European changes may inspire global shifts in AI governance.

Key Highlights of the Regulation:
· Details on the do’s and don'ts of AI utilization, including facial recognition and emotion detection technologies based on biometric data.
· Certain uses, such as in workplaces, schools, or retail environments will be strictly prohibited, with exceptions for state counter terrorism or criminal investigation needs.
· A ban on 'social scoring' by companies – the practice of evaluating individuals based on collected data.
· Clearly labeling of AI-generated content to avoid the spread of misinformation.

Potential impacts on pharmacovigilance:

· The act follows a risk-based approach for the AI application using four categories: unacceptable, high, limited and minimal/none.
· The act will impact pharmacovigilance because even where activities "self-categorise" their risk by their nature, pharmacovigilance is expected to be at least in the "high" category.
· Pharma companies, as well as vendors and integrators, may have additional constraints like readiness certifications, pre- and post-implementation obligations like reporting AI usage, and more.
· More control should have a positive effect on AI adoption as it should increase trust and confidence in PV AI Solutions where up to now, compared to other regulated domains like finance, pharmacovigilance has been more conservative.

The EU AI Act is a monumental step towards balancing AI technology innovation with ethical considerations and the protection of societal values, and this can only be a good thing for an area like pharmacovigilance which relies on confidence and trust to maintain patient safety.

iVigee will monitor the EU AI act rollout as we do with all the latest developments in AI and incorporate this in our AI in PV Masterclass, a comprehensive blend of theoretical knowledge, practical application, and latest innovation, tailored to corporate teams.

And we are experts on Generative AI implementations too! We can build PV AI Co-Pilots, AI-first processes / products, or update your existing predictive ML-based stack with the power of Large Language Models in a controlled and compliant way.

Connect with us today at iVigee AI Services.

Or contact Kane Smith or Robert Scheiner directly to talk about any of our other products and services.

#pvtechnology #pharmacovigilance #generativeai #ai #pvai #euaiact

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