Business Talk

Artificial Intelligence: EMA promotes a risk-based approach to ensure patient safety and data integrity

This week, the EMA released a reflection paper on using artificial intelligence and machine learning throughout a medicine’s product life cycle. The paper recommends a risk-based approach that weighs patient safety and integrity of development data. The paper is scheduled for consultation through the end of the year.

Regulatory background

In April 2021, the E.U. released both a coordinated plan on artificial intelligence (AI) and a proposal for a regulation.

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