A shift to an international approach to safety and performance?
Regulators across the globe know, only to well, the challenges posed by software as a medical devices and specifically artificial intelligence (AI) and machine learning (ML). This is an area of great potential and fast pace innovation.
AI and ML open up a new world of possibilities to improve health care, the options are, in theory, ‘endless’. However, with such a fast pace sector there are challenges in ensuring safety and performance. Regulations, guiding principles and standards must evolve.
Three key voices – FDA, Health Canada and the MHRA have worked in collaboration to develop guiding principles in Good Machine Learning Practice for medical devices.
10 GUIDING PRINCIPLES :
This are areas where there can be advancements in GMLP, through work of the International Medical Device Regulators Forum (IMDRF), international standards organizations, and other collaborative bodies and regulators.
The team behind the document hope these principles will drive the sector to:
- Adopt good practices that have been proven in other sectors
- Tailor practices from other sectors so they are applicable to medical technology and the health care sector
- Create new practices specific for medical technology and the health care sector
International partnerships offer strength and opportunity in improving safety and performance in this space. There is no ‘quick answer’ but industry and patients will benefit from clear and consistent approaches to these products.
This document offers a starting point to how supporting the development, can allow for these products to offer safe and effective solutions that will improve, strengthen and reimagine healthcare solutions.