Healthcare technology is changing. The use of algorithms for increasingly important tasks is spreading across the healthcare sector. A new generation of machine learning algorithms that promise to inform diagnosis and assist in treatment are emerging. This presents potential challenges for regulators and for digital health developers.
This project examined how algorithms in healthcare are currently regulated, and makes recommendations for improvement to ensure a suitable balance between the need for medical innovation and patient safety. The Algorithms as medical devices report focuses on one specific area of regulation (medical devices) and was developed to meet concerns of experts over the lack of clarity in this area.
Working with the Centre for Law, Medicine and Life Sciences at the University of Cambridge, we convened two workshops to bring together academics, legal practitioners, regulators, developers, and clinicians to discuss different aspects of regulating algorithms in healthcare. The first considered the relevant EU Regulations, whilst the second (co-organised with the Centre for Advanced Studies in Biomedical Innovation Law at the University of Copenhagen) considered issues of liability and intellectual property.
If you would like to know more about this project, please contact Alison Hall