This post discusses the current regulation of AI/ML enabled medical devices in the UK and compares potential policy changes with the US. The emergence of Artificial Intelligence (AI) and Machine Learning (ML) systems in medical devices has been linked to improved healthcare – for example, by providing earlier and more accurate diagnoses to patients, automating … Continue reading “AI/ML-enabled Medical Devices: Regulatory Discussion in the UK and the US”
Author: Everyday Cyborgs
The Changing Face of Medical Devices Regulation? A Consultation & Expected New Regulations
This piece was originally posted as a Birmingham Law School Research Blog Post This post reflects on the potential reforms indicated by the recent MHRA consultation on the future of medical devices regulation In September 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation seeking views on potential amendments to medical devices … Continue reading “The Changing Face of Medical Devices Regulation? A Consultation & Expected New Regulations”
The Commissioner for Patient Safety: A Missed Opportunity?
In this blogpost Dr Victoria Moore explores the role of the Patient Safety Commissioner, arguing that it may not be sufficient to ensure patient safety I am nearly a couple of months late for New Year predictions, but nevertheless, here is mine for 2022. I predict that the new Patient Safety Commissioner (PSC) role – … Continue reading “The Commissioner for Patient Safety: A Missed Opportunity?”
Filling up the timeline: have I missed anything?
This post offers a short update on the historical work our project is pursuing; particularly concerning a timeline resource which some of you may be kind enough to help with. Briefly though I would like to flag that our project is still recruiting those living with attached or implanted devices and prosthetics, to participate in … Continue reading “Filling up the timeline: have I missed anything?”
Embodiment and the Everyday Cyborg: Philosophical and Sociological Approaches
In this post we consider how to study the embodiment of everyday cyborgs using phenomenological and sociological methods Although we often identify the locus of the self in the mind, what our body is like can have important effects on who we are. Our body is the means through which we perceive the world and … Continue reading “Embodiment and the Everyday Cyborg: Philosophical and Sociological Approaches”
A Ghost Map of Medical Device Companies in the UK and Ireland (c.1970-2021)
Continuing our occasional series looking at medical devices from a historical perspective, we here provide a foundational resource for those looking into medical device business history. Building on our earlier preliminary historical research concerning the publics of medical devices, we are here sharing a way to visualise some of the most important businesses for the … Continue reading “A Ghost Map of Medical Device Companies in the UK and Ireland (c.1970-2021)”
Medical Devices as Boundary Technologies: Economics, Medicine, and the State in Ireland
Continuing our occasional series of posts looking at medical devices from a historical perspective, Kevin Matthew Jones surveys newspaper coverage from the early 2000s, finding devices linked with national identity, culture, finance and fame. In the first of my blog posts, I outlined the research I have conducted with the Everyday Cyborgs 2.0 project on … Continue reading “Medical Devices as Boundary Technologies: Economics, Medicine, and the State in Ireland”
Making Meaning in Medical Devices – A Historical View
This post is the second in an occasional series, building up a historical picture of the everyday cyborg. During my time with the Everyday Cyborgs project, I have catalogued historical newspaper articles that have used the term ‘medical device’, in order to chart its development in British popular media since 1945. Here are a few reflections on what I … Continue reading “Making Meaning in Medical Devices – A Historical View”
Software as a Medical Device: A Bad Regulatory Fit?
This post introduces some of the gaps and uncertainties we are exploring in relation to software as a medical device Advances in information technology have resulted in increasingly complex or “smart” medical devices that are capable of running software, lending these devices ever more complex functionalities. Often the relevant software comes as part and parcel … Continue reading “Software as a Medical Device: A Bad Regulatory Fit?”
The Medicines and Medical Devices Act 2021 & Uncertain Regulatory Futures
This piece was originally posted as a University of Birmingham Research Perspective “The final legislation, much like the Bill as originally introduced, does little to address the current unwieldy nature of the existing system of medicines and medical devices regulation.” The Act has the potential to significantly impact the regulation of medicines, veterinary medicines, and medical … Continue reading “The Medicines and Medical Devices Act 2021 & Uncertain Regulatory Futures”