Any event which meets the three reporting criteria (MEDDEV 2.12/1 rev 8, 5.1.1) is considered an adverse incident and must be reported to the MHRA. For software as a medical device (SaMD), indirect harm is the most probable outcome of…
The consultation on this white paper and the associated AI regulation impact assessment closes on 21 June 2023. The links to the consultation surveys can be found here. In the National AI Strategy, the government committed to developing a pro-innovation…
The purpose of the AI Liability Directive proposal is to improve the functioning of the internal market by laying down uniform rules for certain aspects of non-contractual civil liability for damage caused with the involvement of AI systems. The proposal…
The workforce is also changing: millennials have new expectations and most people seek a good work-life balance through flexible careers. The NHS Long Term Plan identifies the need for more healthcare workers to respond to this increasing demand. Digital healthcare…
The Blueprint for an AI Bill of Rights is a guide for a society that protects all people from these threatsāand uses technologies in ways that reinforce our highest values. Responding to the experiences of the American public, and informed…
Professor Ben Goldacre was commissioned by the government in February 2021 to review how to improve safety and security in the use of health data for research and analysis. The report makes 185 recommendations that would benefit patients and the…
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