INTERNATIONAL TELECOMMUNICATION UNION FG-AI4H-K-039 TELECOMMUNICATION STANDARDIZATION SECTOR ITU-T Focus Group on AI for Health STUDY PERIOD 2017-2020 Original: English WG(s): DAISAM E-meeting, 27-29 January 2021 DOCUMENT Source: Editors Title: Updated DEL2.2: Good practices for health applications of machine learning: Considerations for manufacturers and regulators Purpose: Discussion Contact: Luis Oala Email:
[email protected] HHI Fraunhofer Germany Contact: Christian Johner Email:
[email protected] Johner Institute for Healthcare IT Germany Contact: Pradeep Balachandran Email:
[email protected] Technical Consultant (Digital Health) India Abstract: This document contains the latest draft of the FG-AI4H deliverable DEL02.2 "Good practices for health applications of machine learning: Considerations for manufacturers and regulators". This deliverable defines a set of guidelines intended to serve the AI solution developers/manufacturers on how to do conduct a comprehensive requirements analysis and to streamline the conformity assessment procedures to ensure regulatory compliance for the AI based Medical Devices (AI/ML-MD). International Telecommunication Union ITU-T FG-AI4H Deliverable TELECOMMUNICATION STANDARDIZATION SECTOR OF ITU (draft 27-01-2021) DEL2.2 Good practices for health applications of machine learning: Considerations for manufacturers and regulators - i - FG-AI4H-K-039 Summary This technical paper recommends a set of good machine learning practice guidelines to the manufacturers and regulators