AI Risk Assessments: Future-Proofing Your Innovation When Rules Can Change Mid-Game
In this Expert Focus podcast, DLA Piper partner Danny Tobey is joined by Aviva Wein, an assistant general counsel at Johnson & Johnson, to discuss how medical device and pharmaceutical companies are future-proofing their innovations in artificial intelligence as new regulations and risks arise.
Danny Tobey
Aviva Wein
How AI will transform healthcare
AI will be used in more widely in drug development and is already being used in robot-assisted surgery; even in in commercial activities, in supply chains and in healthcare chatbots.
It is important that this new world is approached with principles in mind: fairness, privacy, responsibility, security and transparency.
The role of risk assessment in developing new products: how is AI different, if at all?
When thinking about AI/software/robotics in the context of liability and risk, you have to make the case as to why this is different and why a different approach is needed.
Risk assessment is a key part of all product development and clearance. AI is no different in that regard, but it is less static.
Products that integrate AI carry different kinds of risks, such as failure to update software, faulty assumptions included in the AI or use of poor quality data. These can result in negative clinical outcomes.
Decision-making machines
The person versus tool dichotomy is harder to manage. Who oversees whom? When does the human operator override the machine and when is it better for them to not?
This issue is even more complex in the healthcare space. How should people be trained to use these new machines? Where does the liability lie?
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