Page 12 - Shaping ethics, regulation and standardization in AI for health

Shaping ethics, regulation and standardization in AI for health

for Health (GI-AI4H) aims to build upon the momentum and the framework developed by the
FG-AI4H, and further leverage and expand the community it developed.

2 Structure

2�1 Working Groups

The following working groups drove the development of horizontal (cross-cutting) guidance:
– Clinical evaluation of AI for health (WG-CE)
Co-chairs: Naomi Lee (NICE, UK), Shubhanan Upadhyay (ADA Health, Germany), Eva
Weicken (Fraunhofer HHI, Germany)
– Collaborations and Outreach (WG-CO)
Chair: Andrew Farlow (University of Oxford, UK)
– Data and AI solution assessment methods (WG-DAISAM)
Chair: Pat Baird (Philips)
Vice-chair: Luis Oala (Dotphoton AG)
– Data and AI solution handling (WG-DASH)
Chair: Marc Lecoultre (MLlab.AI, CH)
Vice chair: Ferath Kherif (CHUV, CH)
– Ethical considerations on AI for health (WG-Ethics)
Chair: Andreas Reis (WHO)
– Operations (WG-O)
Co-chairs: Markus Wenzel & Eva Weicken (Fraunhofer HHI, Germany)
– Regulatory considerations on AI for health (WG-RC)
Chair: Naomi Lee (NICE, UK)
Vice-chairs:
o Paolo Alcini (European Medicines Agency, EU), observer role
o Michael Berensmann (Federal Institute for Drugs and Medical Devices, Germany)
o Robin Seidel (Federal Institute for Drugs and Medical Devices, Germany)
o Liang Hong (Center for Medical Device Evaluation, National Medical Products
Administration, China)
o Chandrashekar Ranga (CDSCO, India)

The terms of reference (ToRs) of the various working groups can be found at
https:// www .itu .int/ en/ ITU -T/ focusgroups/ ai4h/ Pages/ wg .aspx.

2�2 Open Code Initiative (OCI)

The Open Code Initiative worked to implement the building blocks of the FG-AI4H assessment
platform as a digital public good, which can be used to support the end-to-end assessment of
AI for health algorithms under consideration of regulatory guidelines and the needs of all AI
for health stakeholders.

– Team leader: Marc Lecoultre (MLlab.AI, Switzerland)
[Public page | Development site]

2