Intellectual Property

PatentNext Takeaway: This post highlights the FDA’s increasing regulatory efforts for artificial intelligence (AI) and machine learning (ML)-enabled medical devices (MLMDs), with a focus on managing device AI/ML updates through Predetermined Change Control Plans (PCCPs). The FDA emphasizes five guiding principles for PCCPs to ensure safety, risk management, and transparency for MLMDs throughout their lifecycle.

On 5 September  2024, the EU, UK and US joined seven other states[1] in signing the Council of Europe Framework Convention on Artificial Intelligence and Human Rights, Democracy and the Rule of Law (“Treaty”) – the first international treaty governing the safe use of artificial intelligence (‘‘AI’’).[2] The Treaty remains subject to ratification,

Artificial Intelligence (AI) is commonly thought of as the capacity of computer systems to execute tasks that usually need human intelligence, such as learning, reasoning, and making decisions.[1]  It covers a range of specialised fields, each focusing on different functions.  For example, machine learning allows computers to learn from data, computer vision enables them to