Medical AI is advancing gastrointestinal endoscopy – but what happens when it contributes to a medical error? Legal experts are pioneering efforts to develop guidelines on medical AI liability.
Generalist Medical Artificial Intelligence (GMAI) models pose a significant challenge to current regulatory frameworks. Experts discuss how regulation of these models could work in the future.
AI technology holds promise for personalised cancer therapies. However, rigid and slow approval requirements impede its introduction, say experts – and point out how this might be changed.
Digital pathology brings benefits for sample management and optimisation, lets pathologists work on samples remotely: The UK Government has now approved the use of the technique for cancer samples.
UK law changes threaten the security of messaging apps – and their use in the NHS. Doctors warn that patient care will suffer if they can no longer use apps such as WhatsApp to share information.
It's an important milestone for gene editing technology: a novel treatment for sickle cell disease utilizing CRISPR-Cas9, has now received FDA approval – a first for this type of therapy.
According to the European Dementia Monitor, there is still a clear East/West divide, with significant differences between countries in terms of availability, affordability, legal and human rights.
Sure, AI still has a long way go. But maybe one day in the not-so-distant future, AI will provide us with information about our current state of health, such as the number of red blood cells, cholesterol levels, fat percentage, and how many seconds last night's beer will shorten our life expectancy.
Under the impulse of the European Commission, the in vitro diagnostic industry is developing emerging technologies to implement sustainable practices in medical laboratories. As sustainability has been a growing priority of the European Union (EU) in the last decade, ‘the medical technology sector, particularly the IVD sector, must comply with European legislation in this field like all other…
LLM-based generative chat tools such as ChatGPT or Google’s MedPaLM have great medical potential, but there are inherent risks associated with their unregulated use in healthcare.
January 28 saw the celebration of the “Data Protection Day” as it is called in Europe, or respectively the “Privacy Day” as it is referred to outside of Europe. It marks the date on which the Council of Europe’s data protection convention, known as “Convention 108” was opened for signature back in 1981. According to the Council of Europe, it is the ‘only international,…
Current EU regulation does not adequately consider the environmental emissions of pharmaceuticals in global manufacturing supply chains, a recent study from Finland concludes.
New advanced therapies can alleviate or cure chronic diseases. But medical progress, such as the gene editing tool CRISPR, raises the question of how rights should be protected and balanced.
Medical imaging and healthcare IT company Esaote reports that it has completed the transition of its medical devices to comply with the new Medical Device Regulation (MDR).
New changes made to the timetable for the In vitro Diagnostic Medical Device Regulation (IVDR) across Europe could have a significant impact on manufacturers and users, an expert points out. While the extension of the transition period was a welcome step, other changes which were hoped for remain painfully absent.
The in vitro diagnostic regulation (IVDR) aims to make tests safer, more reliable, and sustainable. Unfortunately, it is also widely regarded a bureaucratic nightmare. At the ECCMID Day on Diagnostics, an expert proposed a more constructive approach.
Despite a five-year transition period for In-vitro Diagnostic Medical Device Regulation (IVDR), experts fear many actors in the field are still not prepared for the regulations coming into force.
In May 2022 a shortage of several lab tests may come as many manufacturers struggle to comply with EU regulation requirements covering in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746). Even modified tests and laboratory-developed tests will present a problem for hospitals and labs as explained by Dr Thomas Streichert.
With interoperability stalled, stakeholders are seeking new ways to create an interoperable ecosystem. IT specialist Jason Steen describes the state of interoperability in Australia and calls for more governmental commitment and international standards.
