We have finalised the latest installment of our Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during May 2023 from the United States, United Kingdom, and European Union.
For the EU and UK, this provides an update of the progress of the EU AI…
The UK’s Medicines and Healthcare products Regulatory Authority (MHRA), the US Food and Drug Administration (FDA) and Health Canada have recently published a joint statement identifying ten guiding principles to help inform the development of Good Machine Learning Practice (GMLP). The purpose of these principles is to “help promote safe, effective, and high quality medical devices that use artificial intelligence and machine learning (AI/ML)”.
The development and use of medical devices that use AI and ML has grown considerably over the last few years and will continue to do so. It has been recognised that such technologies have the potential to transform the way in which healthcare is deployed globally, through the analyse of vast amounts of real-world data from which software algorithms can learn and improve. However, as these technologies become more complex and nuanced in their application, this brings into question how they should be overseen and regulated. Crucially, it must be ensured that such devices are safe and beneficial to those who use them, whilst recognising associated risks and limitations.Continue Reading Ten International Guiding Principles on Good Machine Learning in Medical Devices
The use of artificial intelligence (AI) and machine learning is growing at a significant pace and spreading across many industry sectors, including healthcare. With the rapid development of AI technology which has the potential to revolutionise many aspects of our lives, including in providing and receiving healthcare services, the concept of “creations of the mind” is no longer limited to creations by a human being. These technological developments mean that the legal framework governing intellectual property (IP) rights such as patents and copyright, which protect “creations of the mind”, may need to be adjusted to address the changes and impacts brought about by the use of AI.
In line with the UK government’s ambition for the UK to be a leader in AI and to better understand the implications AI might have for IP policy, as well as the impact IP might have for AI in the short to medium term, the UK IPO conducted a public consultation at the end of 2020. The aim of the consultation was to seek responses on a range of questions relating to AI and IP rights. The UK IPO received 92 responses from a wide range of stakeholders, including IP rights holders, producers of AI technology and academia. The government’s response to the call for views on AI and IP was published in March 2021, under which reforms to patent and copyright law and policy were discussed.
In this blog, we summarise the UK government’s conclusions from the consultation before considering the potential impact to digital health applications and companies.Continue Reading AI and IP: Implications for digital health from possible reforms to UK IP law
Apologies that it has been a while since we’ve posted! We have lots in the pipeline, starting with this webinar.
Today’s medical technology industry is being transformed by data—clinical data, vigilance data, real world data and personal data. As such, there is…
