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The FDA is ramping up its regulatory efforts, particularly through the implementation of Predetermined Change Control Plans (PCCPs) to manage AI/ML updates. These plans are guided by five key principles aimed at ensuring safety, risk management, and transparency throughout a device's lifecycle. Notably, there has been a substantial increase in FDA submissions and patent filings for AI-based medical devices since 2016, reflecting the growing interest and innovation in this field. Read partner Ryan Phelan’s post about this here: https://bit.ly/3Xz0FeM

AI-based Medical Devices and the FDA’s Predetermined Change Control Plans (PCCPs) PatentNext Takeaway: This post highlights the FDA's increasing regulatory efforts for artificial intelligence (AI) and machine learning (ML)-enabled

The UK’s Patents Act excludes, from patent protection, “a program for a computer.” Yet, a decision by the High Court on November 21, 2023 evaluated a patent claim including an Artificial Neural Network (ANN), and held that the exclusion did not apply. In response to the High Court’s decision, the UKIPO temporarily suspended its guidance on patent applications relating to AI inventions, and issued interim guidance that Patent Examiners should not object to inventions involving ANNs under the “program for a computer” exclusion. Read more in Bill Samore's latest blog post at PatentNext.com: https://www.patentnext.com/2023/12/uks-high-court-opens-the-door-for-more-ai-inventions/

UK’s High Court Opens The Door For More AI Inventions The UK’s Patents Act 1977 § 1(2)(c) excludes, from patent protection, “a program for a computer.”  Under this exclusion, the UK Intellectual Property