AdvaMed Responds to Congressional RFI on AI in Health Care
WASHINGTON, D.C. – This week, AdvaMed, the Medtech Association, responded to a request for information from Congressman Ami Bera regarding the use of artificial intelligence (AI) in health care.
From the letter: “We recognize AI as a transformational tool with the potential to improve health outcomes, enhance efficiency of patient care, lower costs, and make advancements in healthcare… Our members develop AI-enabled tools that are integrated into medical devices or are regulated as medical devices themselves, as well as standalone AI tools to support patient care.
“We recognize that the pace of innovation is fast, but we believe the FDA’s existing regulatory authorities are robust and flexible to ensure the safe and effective use of AI/ML technology in medical devices. As state and federal legislators seek to ensure AI/ML-enabled technologies in all industries are used safely, FDA should continue to maintain regulatory oversight of medical devices, including the interoperability between devices and non-devices.
“AdvaMed member companies take seriously the level of trust placed in them by patients and have consistently taken action to self-identify best practices to balance innovation with patient protections. Measures to ensure access to safe and reliable AI healthcare services include:
- Improved policies for access to data sets necessary to develop effective AI algorithms and promote AI innovation.
- Expanding FDA’s authorization to permit use of electronic labeling (e-labeling) in lieu of paper labeling. E-labeling, particularly for software-based devices, is a more efficient and environmentally conscientious method to transfer information to the user. Further, e-labeling offers flexibilities in the presentation of information that can promote healthcare equity. For example, e-labeling font size can be adjusted for the visually impaired and can be provided in multiple languages and formats.
- Revising the current FDA guidance on Clinical Decision Support Software to ensure the recommendations better align with the 21st Century Cures Act (e.g., ensure AI-based CDS that produces a single output, such as a recommendation for a particular treatment option that is consistent with common treatment guidelines, wouldn’t de facto be regulated as a medical device).”
Read the full letter here.
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