LML would like to congratulate our close collaborators at the PHG Foundation on the publication of two reports.
'Regulating algorithms in healthcare: The GDPR and IVDR in practice', details the findings from a 2018 multidisciplinary workshop (of the same name). Attended by Dr Kathy Liddell (LML Director), Dr Jeff Skopek (LML Deputy Director), Prof. Mateo Aboy, Dr Cristina Crespo, and Dr David Erdos; the workshop addressed wider aspects of algorithm regulation. A subsequent workshop, 'Regulating algorithms in healthcare: intellectual property and liability', was convened jointly by LML, the PHG Foundation, and CeBIL.
Prompted by the aforementioned workshops, 'Algorithms as medical devices' is a detailed analysis of the field. It addresses questions such as: when might a digital health tool qualify as a medical device, and how will machine learning systems be regulated as medical devices? It also explores a number of specific challenges that machine learning poses for regulation, including the difficulty of interpretation by humans, and the compliance of such dynamic devices with the change management processes contained by current medical device regulation.
LML has also made significant progress on research in this space, collaborating closely with our partners at CeBIL. 'How does emerging patent case law in the US and Europe affect precision medicine?', was published as a feature patent article in the October 2019 issue of Nature Biotechnology. Written by Prof. Mateo Aboy, Dr Cristina Crespo, Dr Kathy Liddell, Prof. Glenn Cohen, Dr John Liddicoat, Dr Sara Gerke, and Prof. Timo Minssen, the paper investigates how today’s patent law will affect tomorrow’s innovation in the areas of: biomarkers and nature-based products; diagnostics; and algorithms, big data and AI. A further LML paper on regulatory responses to medical machine learning has been accepted for publication.
It is very pleasing that the collaborations and content aired at the 'Regulating Algorithms' workshops have resulted in such high quality outputs. Undoubtedly there will be more to come, with Ms Jennifer Anderson recently being appointed as a Research Associate with LML. Jennifer will work closely with Dr Jeff Skopek on 'Liability for Harms Caused by the Use of AI in Healthcare', a research project funded by a Wellcome Trust Seed Award.