FDA steps up AI governance and auditing

Anthony Habayeb
November 16, 2021

Thank you, FDA Digital Health Center, led by Bakul Patel and most recently, your partnership with Canada and the UK to further your thought leadership around regulating machine learning and AI in a consequential environment like health care.

With GMLP, Good Machine Learning Practices, which is something you introduced several years ago and are furthering in this updated guidance, you are really communicating that in order to create assurances in confidence in AI systems, there needs to be  a lifecycle of governance. It is not just a technical problem. It is a multidisciplinary and cross-functional problem.

Multidisciplinary approach to AI governance

With GMLP, a company using machine learning can evidence their responsible practices from inception through deployment. Where they can confirm that live data happening in the wild is consistent with model training data and clinical data. Where humans are empowered to perform evaluations and tests of systems versus simply expecting some model-unique explainability.

This is a complex problem. I really commend what the FDA has done in terms of providing a workable framework that lets companies invest in machine learning and create positive impacts on our lives, but also allows regulators to perform their role to help protect us and keep us safe from systems or technologies that might not be ready to be used on patients.

AI can create a positive change in healthcare

I founded this company because I fundamentally believe in the positive potential of machine learning. In no industry do I believe in our potential more than in healthcare and medical devices. We don't have enough doctors. We don't have enough clinicians or technologies to provide the level of care that I think people deserve. Thanks to machine learning and leveraging big data, I believe we can improve the health care system across the world.

By having regulatory frameworks like GMLP, I believe we can strike a balance between necessary regulation and accelerated innovation to ultimately improve our lives. So, thank you to the FDA and its partners for continuing to lead on a really complex topic with your principles.

Movember is here

For those of you that have men in your life that you care about in the month of November, some of us would like to raise awareness through Movember. For those men in your lives that maybe don't love to go to the doctor and don't like to get checkups, I encourage you to talk to them about doing so this month because you'd like to have them around.

Thank you all for listening. Have a great day.

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