When AI is used in healthcare and life sciences many of the same regulatory issues arise as when other technologies are used in Healthcare. This means that the impact on the regulatory process will have big implications and needs to be considered now to maximise the value of the AI in the overall process.
These issues are wide ranging and include the availability and use of data, public trust, mitigating risks, security, algorithmic bias, accountability, transparency, reproducibility and explainability of AI algorithms. Various AI codes of conduct have been proposed and for instance European Commission & FDA have released draft AI ethics & regulatory guidelines in early 2019.
Regulators have asserted the need to regulate a category of artificial intelligence systems whose performance constantly changes based on exposure to new patients and data in clinical settings. These AI and machine-learning systems present a particularly problem for regulators, because of the changes that might be happening in a continuous sense compared to the fixed model of traditional regulatory submission.
The challenge as an industry is to collaborate as a group, understand the implications and with the regulators.
Form a CoI and work with regulators in NA and Europe to begin the discussions.
Community of Interest:
M. Remer Consulting
Red Star Consulting
The first call for the CoI was on October 14, 2020. The main action item from this call is to make contact with other organizations; in particular, Artificial Intelligence Medical Devices (AIMDs, http://www.imdrf.org/workitems/wi-aimd.asp), CONSORT Ai Working Group, and the AAIH. A representative of AAIH was invited to our meeting, but could not make the time, and I (VM) caught up with him afterwards. The grand objective is to invite government regulator reps to a web panel.