[Publication] Anastasiya Kiseleva's article 'AI as a Medical Device: Is it Enough to Ensure Performance Transparency and Accountability?' is now published in the European Pharmaceutical Law Review (EPLR), issue 1/2020.
The importance of data used to train, validate, and apply AI, constant changes of algorithms due to self-learning make a huge difference between AI-based applications and regular medical devices. Anastasiya analyzed the US and EU regulatory frameworks to see if they consider this difference (spoiler: not really!). She argues that to ensure transparency of AI, the rules of cooperation between healthcare providers and manufacturers of medical devices shall be revised. Doctors feed AI with data in a real-world environment. Thus, they are the main subjects who influence the AI’s outcome after its market approval. Additionally, doctors are responsible for informing patients about the consequences and risks of the use of AI applications in their treatment. But, how can informed consent be ensured where healthcare professionals might lack the required understanding of the functioning of the devices and the risks they entail? For all these reasons, they need to cooperate with manufacturers of AI applications. To what extent, how, and when? Check Anastasiya's suggestions in the article!
Repost from the HALL website.