Original GlobalMD Global Physician Organization 2024-05-12 06:56 United States
Distinguish between "medical-grade" and "non-medical-grade" AI software or AI-powered devices to see if they have regulatory approval. AI companies and R&D institutions may demonstrate some evidence-based evidence and clinical validation, but ultimately regulatory approval is still required to enter the clinic. Most of the AI software or AI-driven devices currently used in hospitals are not "medical-grade". Stay tuned for details.
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The application of AI technology in the healthcare field has aroused widespread attention and heated discussions. AI has shown great advantages and potential in improving the accuracy of disease diagnosis, optimizing treatment options, and enhancing surgical precision.
However, according to the regulatory regulations and requirements of medical products in various countries, AI software and AI-powered devices are still subject to strict approval and approval for use in medical settings (hospitals or home beds).
Although AI tools are already being used in diagnosis and treatment practices, such as AI software to assist in the identification of skin lesions; Predicting heart disease or adjuvant minimally invasive surgery, etc. However, the accuracy and homogeneous performance of these AI tools in different environments are still problematic, especially in data-driven contexts, which can lead to errors or "hallucinations", that is, AI decisions or recommendations do not match reality.
In order to ensure that the use of AI tools in healthcare is safe and effective, it is particularly important to have a "medical-grade" assessment, including scientific validation and adaptability testing, to confirm that the AI tool works stably in different environments and does not "fail" due to changes in the environment.
AI companies need to pay attention to the rigor of scientific verification of their products, avoid the risk of bias, and ensure the breadth and depth of testing. At the same time, doctors should be trained on how to use AI tools to judge compliance with medical procedures and rules.
Globally, a consensus is emerging on AI regulation, such as the European Union's AI Act and the US FDA's relevant review standards, but the localization and customization of medical AI technology still need to be revalidated and debugged. It also highlights the challenges of AI technology, as well as the diversification of regulatory policies and ethical rules.
The purpose of the AI Medicine and Smart Hospital Study Program in the United States is to "go global" and deeply investigate and exchange the consensus and differences of AI technology in solving medical problems and reviewing regulatory rules. Click on the link to follow the details.