“We do not intend to make a lot of changes for software and AI in legislation, because that isn’t the proper way to regulate [this technology]. It moves too fast and [legislation] is not flexible enough,” Johan Ordish, head of software and AI at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), has said.
Instead, Ordish explained during a presentation at the Association of British HealthTech Industries (ABHI) regulatory conference in London, the MHRA will be utilizing guidance documents, standards, and collaborative projects to...