The Collaborative Community on Ophthalmic Innovation’s Post

*FDA Issues Paper on the Responsible Use of Artificial Intelligence in Medical Research* There are 4 areas of focus in the paper, including fostering collaboration to safeguard public health; advancing the development of regulatory approaches to support innovations; promoting the development of standards, guidelines, best practices, and tools for the medical product life cycle; and supporting research that is related to the evaluation and monitoring of AI performance. https://lnkd.in/dsQ92BsT

Transparency! A critical aspect of AI development and use, but somewhat tricky to define! Lucky for us, yesterday, FDA - along with Health Canada | Santé Canada and the United Kingdom's Medicines and Healthcare products Regulatory Agency - jointly released guiding principles for transparency for machine learning-enabled medical devices (MLMDs). The principles focus on the who, what, when, where, why, and how behind transparency of MLMDs and advocate for a "holistic understanding of users, environments and workflows" that may be addressed "by applying human-centred design principles." What's more? They summarized these principles in a handy chart. Learn more at the link below! (15/52) #artificialintelligence #ai #aitransparency #machinelearning

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 focus on state-level regulations in the US offers insight into the evolving domestic regulatory landscape, which is important given the potential for varied requirements across different jurisdictions. The inclusion of the FDA's strategy for AI in medical products shows the specific challenges and considerations for AI in healthcare. This sector-specific approach means addressing the unique opportunities in medical applications of AI. #AIinHealthcare #MedTechRegulation #PharmaCompliance

The FDA’s recent focus on AI within medical products highlights a dynamic approach towards safety, innovation, and bias mitigation in healthcare. Key takeaways include a risk-based regulatory framework, forthcoming AI guidance documents, and a commitment to ensuring equity. For those in the healthcare and veteran communities, these developments promise to make significant impacts on patient care and medical product development. #HealthcareInnovation #FDA #ArtificialIntelligence #VeteransHealth

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

FDA’s recently published, "Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together," provides a summary of recurrent themes in bringing product to market. The agency describes its collaborative efforts to safeguard public health in the development and use of AI within its existing framework using:   ✅ A risk-based approach to innovation.    ✅ Providing efforts to support regulatory predictability with guidance to industry supporting predetermined change control and lifecycle management considerations.    ✅ Continue FDA efforts for standards development and promote best practices for safety and performance monitoring of AI enabled medical devices. ✅ Monitoring AI performance as part of the medical product lifecycle, with an emphasis on bias, as well as promote health equity and monitoring of AI tools in medical product development.   👉 Read more: https://lnkd.in/eQ27sNw5   Contact Enhanced Compliance Inc. to discuss how our regulatory consultants can help ensure your regulatory strategy conforms to current requirements and guidance. #ECI #Regulatory #AI #MedicalProducts

The FDA has published the paper: Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together. https://lnkd.in/dPFRbcqB Artificial intelligence (AI) is rapidly transforming our world, and healthcare is no exception. From medical diagnosis to drug discovery, AI is holding immense potential to revolutionize how we approach health and medicine. Governments and regulatory bodies are rightly concerned about ensuring AI in healthcare is trustworthy. This means avoiding bias and discrimination in the algorithms and datasets used to train these intelligent systems. The European Commission has taken a significant step by approving a legal framework for regulating AI alongside with the innovation package and coordinated plan on AI. Meanwhile, the US Food and Drug Administration (FDA) has published a white paper on AI in healthcare. This paper emphasizes the importance of responsible innovation, health equity, patient-centricity, and safeguarding public health. These efforts by regulatory bodies highlight the importance of foundational principles for developing AI technologies that are used in clinical trials and throughout the life cycle of medicinal products: non discrimination, no bias, transparency and data privacy and security. By focusing on these principles, we can ensure that AI becomes a powerful tool for improving clinical research, patient lives and public health, safeguarding patient safety and trust.

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