12 January 2018
As the fundamental basis of all computerised tasks, the use of algorithms in the diagnosis and treatment of patients is advancing across the delivery of healthcare services. What regulation governs their use? Is this regulation adequate in light of advances in machine learning for health? Does this regulatory framework strike a fair balance between the need for medical innovation and patient safety?
Healthcare technology is changing. The use of algorithms for increasingly important tasks is spreading across the healthcare sector. On the horizon are a new generation of machine learning algorithms that promise to inform diagnosis and assist in treatment.
Is our system of law and regulation ready for the challenge this technological shift presents?
As the use of algorithms becomes embedded in medicine and AI is introduced into routine clinical practice, there is an urgent need to revisit how algorithms are regulated in healthcare. Why? First, concern over the quality and safety of some health apps and algorithms being released onto the direct to consumer market. Second, with the introduction of the EU Medical Devices Regulation and EU In Vitro Diagnostic Devices Regulation, software developers could be caught out by new forms of regulation. Third, while there is much talk about ‘regulation of software in health’ or ‘regulation of AI’, little actual work has been done to provide a holistic understanding of the regulation that covers these tools.
With this project, we seek to address these concerns.
Johan Ordish talking about the project
This work on regulating algorithms in healthcare aims to clarify
Regulating algorithms in healthcare considers how algorithms in healthcare are regulated, from the data that is used to train an algorithm to the question of who is liable if something goes wrong. We consider the following general spheres of regulation:
Early 2019 - reports released
Workshop 2: Intellectual property and liability - Agenda
Briefing note Legal liability for machine learning in healthcare
Workshop 1: The GDPR and IVDR in practice - Agenda
Briefing note What is the GDPR?
Briefing noteWhat is the IVDR?
Working with the Centre for Law, Medicine and Life Sciences at the University of Cambridge, we’ve convened two workshops bringing together academics, legal practitioners, regulators, developers, and clinicians.
In early 2019, reports detailing our findings on each sphere of regulation will be released, following which a dissemination event is planned to provide more detail of the findings to invited stakeholders.
Algorithms as data
Algorithms as medical devices
The following briefing notes were released to inform the debate:
Co-organised with the Centre for Advanced Studies in Biomedical Innovation Law at the University of Copenhagen and the Centre for Law, Medicine and Life Sciences at the University of Cambridge, this workshop covered the following topics.
Algorithms as intellectual property
Algorithms as liability
The following briefing note was released to inform the debate:
This blog provides more details about the day.
(Page updated 15 November 2018)