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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.
The Proposal:
We welcome your input to this group and the next steps.
Setup a community with a series of TC meetings during Q2 and Q3.
Bring the community together in a couple of locations over the next 6 months including Boston Oct 2019 and a European meeting.
Work Form a CoI and work with regulators in NA and Europe to begin the discussions
Have invited speakers at these meetings
This is now the AI Centre of Excellence Community.
Community of Interest:
First Name | Last Name | Organization |
|---|---|---|
Adam | Roose | AAIH |
Adrian | Lubinski | GSK |
Szczepan | Baran | Novartis |
Swen-Eric | Schelhorn | Merck |
Sujeegar | Jeevanandam | Zifo |
Loganathan | Kumarasamy | Zifo |
Simon | Thornber | GSK |
Stephen | Amato | Northeastern Univ |
Morrie | Ruffin | Adjuvant |
M | Remer | M. Remer Consulting |
Markus | Blank | Bayer |
Andrew | Conkie | Red Star Consulting |
Brandon | Allgood | Integral TX |
The first call for the CoI was on October 14, 2020
This proposal has a sister proposal at: Validation of AI/ML diagnostic in view of regulatory compliance