Medrio’s Post

🚨 FDA Commissioner Calls for Stronger #AI Regulation in Healthcare 🚨 The FDA Commissioner is urging #health systems to step up their efforts in regulating AI technologies. The focus is on AI assurance labs and the need for real-world effectiveness studies. Read more in STAT ⬇ https://lnkd.in/gFDSX9qu Also, check out the NEJM AI article co-authored by JCHI's Christopher Longhurst and Karandeep Singh for insights on establishing centers to assess AI’s clinical impact. ⬇ https://lnkd.in/g4yrDQP3 ⚡ The future of AI in healthcare depends on our commitment to ensuring its responsible implementation. ⚡ #FDA #ClinicalEffectiveness #Innovation

The new EU AI Act, which officially went into effect in February 2024, aims to regulate the development and use of artificial intelligence within the European Union. Here are some of its key points: Risk-based approach: The act takes a risk-based approach, classifying AI systems into different categories based on their potential to cause harm. This means stricter rules apply to "high-risk" systems, such as those used in healthcare, finance, or critical infrastructure. Banned AI practices: Certain AI practices are completely banned, including: Cognitive manipulation: Systems designed to manipulate people's behavior, especially targeting vulnerable groups. Social scoring: Classifying people based on their behavior or characteristics. Biometric categorization: Using sensitive biometric data like fingerprints or facial recognition to categorize people. Untargeted scraping of personal data: Mass collection of personal data from the internet without explicit consent. Emotion recognition in certain contexts: Using AI to assess emotions in the workplace or educational settings.

The roadmap to a trustworthy #AI implementation can be developed only through strong collaboration between the medical industry, regulators, professional societies, policy makers, and patients.   Richard Stephens from the #ESCPatientForum shares how #ArtificialIntelligence tools that are reliable and evidence-based, can contribute to improved #PatientOutcomes and care. #ESCardioCRT #patientsfirst World Heart Federation

AI is a novel regulatory challenge for healthcare. It can learn and evolve over time, which means it can perform differently in the real world than it did in its pre-market testing — so how can regulators tackle this challenge? Fortunately, AI has been around long enough for there to be a database of 950 FDA-approved AI devices , which set a valuable precedent — and offers valuable insights to where AI might be useful & why. #AI #technology #healthcare

📣 The European Union has taken a significant step in regulating Artificial Intelligence (AI) in healthcare. The EU AI Act, Regulation (EU) 2024/1689, has been published and will have a direct impact on all software regulated as medical products in Europe that incorporate AI. The countdown to compliance has begun with the AI Act coming into force on 2 August 2024. The roadmap for compliance includes discontinuing prohibited AI practices by 2 February 2025, implementing codes of practice by 2 May 2025, and conforming to General Purpose AI models and establishing the AI Governance structure by 2 August 2025. This comprehensive legislative framework will apply to all AI-inclusive software regulated as Medical Devices in Europe. Stay informed and prepare for the changes ahead! #AIRegulation #HealthcareTech

AI in healthcare offers immense potential, but several barriers stand in the way. This blog post breaks down four critical challenges: 1) complex regulations, 2) algorithmic biases, 3) the importance of human oversight, and 4) seamless integration with current systems. Each challenge demands a unique approach to ensure AI remains safe, fair, and effective. This piece offers practical solutions and a roadmap to overcome these barriers for responsible AI use in healthcare. #genai #healthcare #regulations #biases https://zuehlke.smh.re/36q

As artificial intelligence reshapes how researchers, drugmakers, health care providers and others in the field operate, learn how the healthcare sector is on the verge of big changes. Delve into the next installment of The AI Impact now. https://lnkd.in/eyQ5J4Bp

Trust is essential for clinicians to embrace AI https://ift.tt/5RtkBCS

The New England Journal of Medicine just published an insightful article on the emerging regulatory landscape for AI in clinical settings. As we navigate the complexities of integrating AI into healthcare, understanding these regulations is crucial for ensuring safety, efficacy, and ethical standards. Check out the full article for a deeper dive into how these regulations are shaping the future of healthcare innovation: https://lnkd.in/eDeY5gi6 #AI #HealthcareInnovation #ClinicalAI #Regulations #NEJM

The integration of Artificial Intelligence (AI) in healthcare is rapidly transforming the industry, offering improved diagnostics, personalized treatments, and advanced predictive analytics. AI's ability to process large datasets enhances diagnostic accuracy, aiding in early disease detection and tailored treatment strategies. However, the implementation of AI in healthcare presents challenges such as data privacy concerns, ethical issues, and the need for seamless integration with existing infrastructure. Despite these challenges, AI's potential in healthcare is vast. Don't you think? #Healthcare #DigitalHealth #ArtificialIntelligence https://lnkd.in/ebR9_EJ6