Pablo R. Carbonell’s Post

The European Commission has published the finalized text of the Artificial Intelligence Act (AIA) which establishes a legal framework to promote the uptake of “human centric and trustworthy” AI for medical devices, in vitro diagnostic devices (IVDs) and other products. The text is unchanged from the AI Act adopted by the European Parliament on 13 March. The Act creates the framework for the risk stratification on the AI tech, and for many analysts a large portion of AI’s use in healthcare would be classified under "high-risk". The requirements for high-risk devices will go into effect on 2 August 2026, while the AIA was published in the Official Journal on 12 July and will go into effect on 2 August this year. #artificialintelligence #regulation #AIA #medicaldevices https://lnkd.in/e94YdjWY

This is the third in the series of Emergo by UL’s Regulatory Updates on the European Artificial Intelligence (AI) Act (AIA).   In this Regulatory Update we focus specifically on the AIA and penalties and timelines. We also include definitions which are salient to this and a Table (really more a visual representation) which outlines all the upcoming deadlines. Read the article (with our SME Sade Sobande, RAC) here: https://lnkd.in/gNGbzK9G. Article four is next. Stay tuned for a discussion on high risk medical device systems and the relationship of the European device regulations (Medical Devices Regulations/In Vitro Diagnostic Devices Regulations) and the AIA, as well as the opening of the EU AI office. Series on AIA:  *Regulatory Update 1: history, scope, classification, conformity assessment and operator’s obligations of AIA: https://lnkd.in/gKmePHMe . *Regulatory Update 2: AIA best practices, enforcement and oversight, and AI regulatory sandboxes and real-world testing: https://lnkd.in/g9r6q3_e . #medicaldevice #regulatory #regulatoryaffairs #regulatorycompliance #AIA #nlf #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory

https://buff.ly/4ayoqrE The UK has outlined its stance on regulating AI as a medical device, with the MHRA stating that AI designed for medical purposes is highly likely to fit the criteria of a medical device. Currently, many AI products are categorized as low-risk, allowing them to enter the market without undergoing assessment by a notified body. However, the MHRA anticipates that numerous AI products will be reclassified to higher-risk categories under the new post-Brexit medical device regulatory framework. #MedicalDevices #AIRegulation

Many have seen the growth in artificial intelligence and machine learning-based medical devices cleared by the FDA. But how can clinical trial data guide our future outlook? Attorney Bradley Merrill Thompson, RAC, explores the information on clinicaltrials.gov, highlighting AI/ML products under investigation for future clinical use. #ArtificialIntelligence #MachineLearning #MedicalDevices

While the FDA never approved a Medical Device powered by LLM, this is an active field of interest and development by the US Agency, with the goal of providing clarity on the path and expectations for manufacturers based on their own regulatory science work. Naturally, radiology, as a field where most AI solutions have been reaching the market, is the first focus of the FDA. If anyone says that they know how to approve a Medical Device using an LLM, they don't. Not even the Regulators know, but at Complear, we have been working on the best strategies and working with the ecosystem to overcome current technical limitations. https://lnkd.in/dRgnXKc2

Collaborating across FDA centers on responsible and ethical AI innovation🤝 In March, CDRH jointly published a groundbreaking paper titled "Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together." The purpose of this paper was to provide greater transparency regarding how they collaborate to safeguard public health while fostering responsible and ethical innovation. Download the paper here: https://lnkd.in/gPi8CcuX #AIInnovation #HealthcareEthics #FDA #MedicalInnovation #PublicHealth #EthicalAI

Artificial intelligence and machine learning are revolutionizing medical device development and are increasingly being leveraged in applications ranging from digital image analysis to in vitro diagnostics. Detailed Predetermined Change Control Plans (PCCPs), which were first presented in 2023 FDA draft guidance, offer an approach to planning and implementing iterative post-market improvements to #AI and #ML-enabled medical devices. Explore the PCCP approach in our new industry report: https://lnkd.in/ebvTcXQP #medicaldevice #patientsafety #IVD #artificialintelligence #medtech #healthtech #HealthcareAI #HealthAI #MedicalDeviceAI

AI is poised to transform healthcare by expediting the digitalisation of medical devices. Predictions say the use of AI in medical devices is anticipated to proliferate worldwide in the coming years, while regulatory-wise, the world's attention has also been focused on the EU's AI Act and the implications of these first comprehensive AI rules. In 2021, the European Commission proposed the AI Act, which has since been the subject of intense debate.  👉 This new Act regulates AI systems in general but creates specific challenges for medical device manufacturers, who must comply with the requirements under the AI Act and the Medical Device and IVD regulations. The implications of the AI Act are still uncertain, and its full impact will only be understood once the implementation tools are in place, a situation reminiscent of the MDR and the IVDR. The following elaborations offer a broad overview of the requirements introduced by the new Act and how these may impact the availability of AI-based medical innovative devices in the European market. 👉 Read the full article: https://lnkd.in/gsPZhzg2 #AIAct #MedicalDevices #Digitalisation #MedTech

Interesting article by The National Law Review on the inadequacies of medical device regulation for innovative AI/ML devices in the US. Collaboration between industry stakeholders, researchers, and regulatory bodies is essential to ensure effective oversight and adaptation to emerging AI/ML medical device technologies. #AI #medicaldevices #FDA

Incorporating AI in neurorehabilitation is indeed a journey filled with potential, yet it demands our careful navigation. The promise it holds for enhancing diagnostics and therapy must be balanced with a deep commitment to ethics, patient privacy, and the nuances of AI-human interaction. It’s a pivotal moment for us in this field, and as we embrace this technological revolution, let’s proceed with both optimism and vigilance. Ensuring AI serves as a valuable ally in neurorehabilitation requires us to address these challenges head-on, paving the way for a future where technology and healthcare seamlessly converge for the betterment of patient care.