Given that healthcare is an industry where decisions can literally be a matter of life and death, the importance of effective regulation can’t be overstated. Now this is one hell of a challenge even for the most seasoned professionals.

Artificial Intelligence (AI) and Machine Learning (ML) present novel regulatory challenges.

Unlike traditional medical devices, these technologies are capable of evolving and learning over time. This means that they could perform differently in the real world than they did during their pre-market testing.

While this could mean improved patient outcomes, it also could introduce new risks that need to be managed. Which is no easy task with a constantly changing algorithm.

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