4/28/2025 3:34:19 PM Legal implications of agentic AI in healthcare: safeguarding patient privacy (part 3 of 3) By Vinita Kailasanath Philipp Roos Follow these links to read part 1 and part 2. *** Safeguarding patient privacy Safeguarding patient privacy is paramount when integrating...
4/21/2025 4:24:49 PM Legal implications of agentic AI in healthcare: potential for inaccurate or biased data (part 2 of 3) By Vinita Kailasanath Philipp Roos Follow these links to read part 1 and part 3. *** Potential for inaccurate or biased data Inaccuracy and bias in datasets used to build...
4/14/2025 7:14:52 PM Legal implications of agentic AI in healthcare: regulatory compliance (part 1 of 3) By Vinita Kailasanath Philipp Roos Follow these links to read part 2 and part 3. *** Introduction The agentic capabilities of large language models (LLMs) offer...
1/28/2025 8:13:39 PM 10 Key MedTech Themes for 2025 By Vinita Kailasanath Shannon O'Hara Note: this article originally ran in MedCity News The MedTech industry is accelerating at an unprecedented pace. As AI reshapes the...
9/25/2024 4:24:53 PM New era for European compulsory licensing on the horizon? By Victor Garcia Lopez Corin Gittinger On 26 June 2024, just days before the end of the Belgian presidency, the Council of the EU adopted its position on a proposed regulation...
6/19/2024 12:14:53 PM UK MHRA sets out its strategy on AI and the regulation of medical products By Harriet Hanks Sanjana Canumalla Sofia Schaffgotsch Tobias Messervy-Whiting +1 more... Show less The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its AI Strategy (the Strategy) in ‘Impact of AI on the...
6/11/2024 1:40:08 PM UK Government’s MedTech strategy: One year on and new innovation classification framework By Harriet Hanks Emily Bloxsome One year after publication of the UK’s inaugural MedTech strategy in February 2023, the UK Department for Health and Social Care (DHSC)...
4/18/2024 2:48:40 PM UK Government responds to Whitehead Review’s findings of systemic bias in UK medical devices By Harriet Hanks Sanjana Canumalla Matt Allison In March, the independent review into equity in medical devices chaired by Professor Dame Margaret Whitehead published its long-awaited...
3/21/2024 2:04:31 PM The first of its kind: exploring the European Health Data Space By Gernot Fritz Estella Dannhausen Carolina Costa Ludwig Hartenau +1 more... Show less We are going through what is known as the third major global economic wave at an unprecedented pace. This wave is driven by the growth...
1/19/2024 8:46:55 PM 10 Key MedTech Themes for 2024 By Vinita Kailasanath Sora Park Note: this article originally ran in MedCity News Increasing innovation in, and consumer demand for, healthcare technology continue to...
8/15/2023 9:34:58 AM EU EMA proposes risk-based approach to AI in pharma lifecycle By Harriet Hanks Beatrice Carrier Victor Garcia Lopez Sora Park Andrew Austin +2 more... Show less The European Medicines Agency (EMA) has published a draft Reflection Paper on the use of AI and machine learning (ML) in the medicinal...
8/11/2023 2:29:06 PM New regulation on access and use of research and health data in Germany By Christoph Werkmeister Tino Haupt There are vast amounts of sensitive health data that are being collected, but due to the stringent regulation on the use of such data not...