Artificial intelligence (AI) has the potential to revolutionize all aspects of the delivery and practice of health care, but regulations are needed to ensure AI is developed and used in safe and ethical ways. The U.S. Food and Drug Administration (FDA)—which regulates AI when it is incorporated into medical devices—has called for a coordinated and comprehensive response to regulating AIopens in new window that involves industries such as health care, the federal government, and global organizations dedicated to medical products. As supply chains become increasingly complex and AI tools are developed and distributed across the globe, it is more important than ever to have harmonized standards to ensure the safety and efficacy of these tools.
Adding to this momentum, the FDA and the Department of Veterans Affairs (VA) have announced the launch of the first joint intergovernmental health AI laboratoryopens in new window that will provide a testing ground for AI models. This represents a key partnership between the FDA and the VA, the largest health system in the United States. The AI lab will offer an opportunity for researchers and developers to test AI technologies using VA data in a closed safe system where the data will be protected. This new lab represents a crucial step in the evaluation process of these developing AI technologies.
In a similar vein, the proliferation of AI health care tools has led to uncertainty among the public and health care professionals about where to find and how best to evaluate which tools might be appropriate for one’s needs. To help provide clarity, the Digital Medicine Society (DiMeopens in new window) recently launched the DiMe Sealopens in new window to assist health care providers, health systems, payers, and the public in finding high-quality and trustworthy tools. The society evaluates digital health software products based on standards such as evidence, usability, privacy, security, and equity in its vetting process. Learn more about products that have earned the DiMe Sealopens in new window.
