Gareth Hughes’ Post

The EU AI Act significantly impacts the medical device industry by enforcing stringent safety and accountability standards. While this enhances patient safety and fosters consumer trust, it also introduces regulatory challenges and increased compliance costs. Adapting to these changes is crucial for balancing innovation with rigorous safety standards. #AI #ITCompliance #AIA #MDM

Breaking News: The FDA is paving the way for greater clarity in the world of AI medical devices! 🚀? They've proposed a new, human-centered definition of transparency to ensure that everyone, from patients to healthcare providers, can understand how AI algorithms in healthcare work. The aim? To bring light to the complex workings of nearly 700 AI devices hitting the market. Here’s to clearer, smarter, and more trustworthy healthcare innovations! 🌟? #medicaldevices #artificialintelligence https://lnkd.in/gBsY2mHH

The FDA recently provided insights into the regulatory processes for medical devices utilizing artificial intelligence or machine learning, collaborating with Health Canada and the UK's Medicines and Healthcare products Regulatory Agency to establish key principles for effective machine learning practices in 2021. Emphasizing transparency, the agencies highlighted the importance of disclosing how AI models generate results to users. This strategic move aims to clarify the role of AI in medical equipment and enhance overall understanding and trust in AI-driven healthcare technologies. #AIinHealthcare #RegulatoryInsightshttps://buff.ly/3VuGsWg

🚨 Important news for healthcare AI developers in the UK 🇬🇧 🚀 The MHRA has launched the AI Airlock, the first “regulatory sandbox” designed to evaluate AI-based medical devices. 🔎 The AI Airlock will test innovative AI-based devices in a controlled environment and generate important insights for both developers and regulators. 💡 Developers can apply to participate in a pilot project in early June 2024. Those selected will benefit from collaboration and knowledge-sharing with regulatory experts, and the project will help inform future regulatory policy. 🗓️ To learn more, join the upcoming webinar on 5th June 2024. https://lnkd.in/dpwDdvPm #medicaldevices #ai #healthcare

The Medicines and Healthcare Products Regulatory Agency (MHRA) has introduced AI Airlock, a new regulatory sandbox designed for AI as a medical device (#AIaMD). This initiative aims to address the challenges of regulating standalone #AI #medicaldevices by supporting 4-6 virtual or real-world projects through simulation. These projects will help explore regulatory issues when these devices are used for direct clinical purposes within the NHS. This move also advances MHRA's strategic approach to AI, outlined in a 2023 government white paper. #nemecys_eu

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

Free webinar 23JUL2024, 5 - 6:30 AM EDT. "Developers and manufacturers of AI medical devices are invited to hear early details of the MHRA AI Airlock project, which has been launched to help enhance understanding and accelerate solutions for the novel challenges of regulating AI medical devices. "The webinar will include presentations on the following topics: * the challenges of regulating AI medical devices: context and overview * an introduction to the aims and objectives of the AI Airlock project * opportunities and timelines for developers and manufacturers to get involved. "There will also be a Question and Answer session specifically aimed at answering questions from developers and manufacturers who are considering getting involved." #UK #MHRA #AI #AIAirlock #AIaMD https://lnkd.in/ghGmytEh

AI could help the fact that the slow and inefficient approval process is a major pain point for the medical device industry. Danish Mairaj makes a fantastic point: "...the current process for obtaining regulatory approval for a medical device was long and arduous... the use of AI can decrease the time for gaining approval and improve the current 10% success rate." #AI #Healthcare #MedicalDevice

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

AI is already making a significant contribution to the way healthcare is delivered in the UK and hopes are pinned on the MedTech sector to provide solutions that will address the pressures on the NHS and enable patients to benefit from faster, innovative care. With its responsibility for the safety, efficacy and quality of medicines and medical devices, the MHRA has now set out its strategic approach for the regulation of AI as well as how it plans to deploy AI in the way it delivers its services. This article discusses that, along with the AI Airlock project, which is designed to help the MHRA identify and address the challenges involved in regulating AI as a medical device. #AI #medtech #AIairlock #MHRA #medicaldevices https://lnkd.in/eP7WKXhk