Shaalan Beg MD MBA FASCO’s Post

Practical, consensus guidance on how to get the best out of technology in healthcare is always welcome. User buy-in is critical for all devices, no matter how sophisticated, to be accepted and scaled to where they can help the most patients.

In today’s blog, Matt Walker discusses the guiding principles released by the U.S. FDA, UK MHRA, and Health Canada regarding transparency in machine learning-enabled medical devices (MLMDs). Click here for background on the guiding principles and how they are likely to inform international standards for Good Machine Learning Practice (GMLP) Principles https://bit.ly/3zBCgNh

MHRA, FDA, and Health Canada have collaborated to set guiding principles on transparency for machine-learning medical devices. These principles, in alignment with previous guidelines, provide essential transparency practices for all medical devices. Stay informed on these crucial standards: Published: 13 June 2024 #MHRA #FDA #HealthCanada #MedicalDevices #Medtech #AI #machinelearning

FDA and Digital Medicine Society (DiMe) are having a public workshop on "Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle." #medtech #digitalhealth #medicaldevice #medicaldevices

It's #TransparencyTuesday, with a great set of guiding principles for #AITransparency. The FDA teamed up with Health Canada and the United Kingdom's Medicines and Healthcare products Regulatory Agency to provide definitions and fundamentals for #ML transparency. Even if your #AI tool has nothing to do with a medical device, they offer a great framework focused on the basics: who, why, what, where, when, and how. Reach out if you need help putting these into practice. #ExplainableAI #ResponsibleAI

FDA, Health Canada, and UK’s MHRA have issued today new guiding principles for transparency in the deployment of machine learning in medical devices. See the link: https://lnkd.in/gm8-8G7M . These transparency guiding principles build on the June 2021 guiding principles issued by the same regulators for Good Machine Learning Practice for medical device development. The new guiding principles document seeks to ensure that appropriate information about medical devices employing machine learning is clearly communicated to relevant parties, so they have a useful understanding how the device makes decisions or takes action, and is organized to address the standard questions: who, why, what, where, when, and how. How are you incorporating these two guiding principles documents into your software development practices? Your labeling?

Artificial Intelligence as a Medical Device AIaMD software manufacturers are you ready for the Medicines and Healthcare products Regulatory Agency AIRLOCK! https://lnkd.in/enZvfKJ6 We’ve acknowledged for sometime that the current conformity assessment processes associated with software as medical devices does not necessarily best-fit into the ‘physical’ engineered medical device framework therefore the MHRA and other collaborators such as Team AB (U.K. approved conformity assessment bodies) have established a pilot for a digital ‘airlock’ so that software developers can submit their products into a non-clinical environment and be soak tested to see for example of the algorithm ‘drifts’ as well as look for other hazards and hazardous situations. There is a webinar on the 6th June hosted by the MHRA on this topic here https://lnkd.in/esU-hhGp Bravo MHRA for dusting off that medical device safety leadership!!!!

In 2021, Health Canada, the U.S. Food and Drug Administration (FDA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly identified 10 guiding principles for good machine learning practice (GMLP) that supported the development of safe, effective and high-quality artificial intelligence/machine learning technologies that can learn from real-world use and, in some cases, improve device performance. Health Canada, FDA and MHRA have further identified guiding principles for transparency for machine learning-enabled medical devices (MLMDs). The use of “transparency” is explained to describe the degree to which appropriate information about a MLMD (including its intended use, development, performance and, when available, logic) is clearly communicated to relevant audiences. The guiding principles for transparent MLMDs are: relevant audiences; motivation; relevant information; placement of information; timing; and methods used to support transparency. #lifesciences #SaMD #MLMDs #blg #productslaw #ai

News Update FDA, Health Canada, and MHRA Unveil New Transparency Guidelines for AI-Powered Medical Devices In a significant step towards enhancing patient safety and trust in AI-powered healthcare technologies, the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have introduced new guidelines to promote transparency in machine learning-enabled medical devices (MLMDs). Building on their 2021 collaboration, which established 10 guiding principles for good machine learning practice (GMLP), these regulatory bodies are now focusing on ensuring clear communication and transparency in the development and use of these advanced technologies. #ai #healthcare #news https://lnkd.in/ddhhyqNR

MHRA launches regulatory sandbox for AI medical devices - Digital Health #MHRA Regulatory Sandbox for AI Medical Devices The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a regulatory sandbox for AI medical devices to streamline the approval process and ensure patient safety. #MHRARegulatorySandbox #AI Airlock for Medical Devices The regulatory sandbox, known as the AI Airlock, will provide a safe space for developers to test and validate their AI medical devices before seeking regulatory approval. #AIAirlock #Benefits of the Regulatory Sandbox By participating in the regulatory sandbox, developers can receive guidance from the MHRA on regulatory requirements, expedite the approval process, and ultimately bring their AI medical devices to market faster. #BenefitsOfSandbox #How to Apply Developers ai.mediformatica.com #mhra #health #devices #themhra #healthcare #medical #medicaldevice #medicaldevices #regulatorysandbox #alamd #digital #aiasamedicaldevice #digitalhealth #healthit #healthtech #healthcaretechnology @MediFormatica (https://buff.ly/3K7ismV)