Pablo R. Carbonell’s Post

Excellent article on EU AI Act's impact on medical devices and life sciences and points on scope of inclusion/exclusion of symbolic fixed-algorithmic systems. Stay informed about the latest developments in the industry and how they may affect your work. #EUAIAct #medicaldevices #lifesciences

🧠💡 At 11 AM today, don’t miss our essential workshop: "Navigating AI Compliance in Medical Devices: Insights into AI Experts' Involvement in EU MDR 2017/745 Assessments" featuring Alberto Alvarez and Andrea Sanino from BSI Gain crucial insights into how AI experts are navigating compliance with the EU MDR 2017/745 regulations. Alberto Alvarez and Andrea Sanino will provide valuable perspectives on the challenges and solutions in assessing AI technologies for medical devices. #IH24 #SaveLivesWithAI #HealthcareAI #BSI

Lots of recent developments in EU medical device regulation alongside proposals for post-Brexit reforms in the UK. In this short article Michaela Herron and I take a closer look, with a particular focus on software and AI. 🩺🤖💊🤳🩹⌚💉👩💻 https://bit.ly/3Lftbfw #AI #MedicalDevices #LifeSciences #MHCLaw

This video is part of a series of guest expert interviews that we recorded for our new Yale Certificate Program on Medical Software and Medical AI: https://lnkd.in/eF65H-Rt. 🎙 Our guest is Mr. Eric Henry, the Senior Quality Systems & Compliance Advisor at the law firm King & Spalding. He joined King & Spalding in 2018 after 30 years managing global technical and regulatory compliance organizations in various industries and in medical devices in particular over the last 22 years. 💡 We discuss the current and evolving state of medical AI regulation both in the United States and beyond. In particular we talk about the overall state of uncertainty in this area. In the EU, this is caused by the new EU AI Act and how it will be implemented (and how it relates to the Medical Device Regulation.) In the United States, we have a new administration that may change the priorities at the various agencies. We conclude with a discussion on issues related to healthcare AI tool development inside healthcare systems and the regulatory challenges that may arise there. Watch now: https://lnkd.in/gN9z2EKi Xenophon Papademetris | Yale Online | Yale School of Medicine #medicalsoftware #medicalai #airegulation

How HHS aims to keep AI-enabled medical devices working as they should - Federal News Network: How HHS aims to keep AI-enabled medical devices working as they should  Federal News Network http://dlvr.it/TDLrmf #ai #artificialintelligence

Pretty interresting article showing some statistics on AI/ML medical device products approved by the FDA. TLDR: Figure 4 in the article gives a quite good overview of the current landscapoe for AI in medical devices. https://lnkd.in/dmZZGNvW

🚀 We are excited to share the latest industry report from the Medical Device Innovation Consortium (MDIC), dated September 2024: Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI) and Machine Learning (ML)-enabled Medical Devices. 🧠💡 This report outlines a proactive approach to managing iterative updates in AI/ML-enabled medical devices, ensuring they maintain safety and effectiveness post-market. With a structured PCCP, developers can now plan for software changes, communicate updates effectively, and ensure AI/ML systems continue learning while minimizing risks. This framework is crucial for advancing regulatory science, reducing product development costs, and bringing innovations to patients faster. A must-read for those in digital health, AI/ML and medical devices! #AI #MachineLearning #MedicalDevices #Innovation #Regulation #HealthcareTech #MDIC #PCCP https://lnkd.in/ebvTcXQP

With the roll out of the EU Artificial Intelligence Act, here are some impacts it will have on medical devices. Organizations that develop and use AI-enabled medical devices should take proactive steps to review their AI practices in light of the new requirements under the AI Act. https://ow.ly/8Je050UgP6y #AIAct #EULaw #HealthcareAI

#AI meets #medical devices AI is finding its way into more and more areas of our everyday lives. This also applies to medical devices. But what influence or requirements does the use of AI in connection with medical devices have? There are currently no #laws or #standards that specifically regulate the use of AI in medical devices. However, medical devices must still comply with existing regulatory requirements such as #MDR and #IVDR. Furthermore, the requirements of the #EU AI Act must be complied with. The AI4H guideline from the World Health Organization/International Telecommunication Union and the community of interests of the designated institutions (IG-NB) helps to keep track of best practices for dealing with AI in medical devices. This describes a catalog of questions that is specifically adapted to AI in medical devices and is an interesting read. I hope you enjoy reading it.

Leon Doorn helping us understand the logic (and potential gaps) in the categorisation of AI enabled medical devices under the EU AI Act, and walking us through a comparison of the requirements of the MDR/IVDR and the EU AI act. RAPS Europe