| Medical Wearables in Clinical Decision-making Technology Assessment |
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"Background: Wearable medical devices (""wearables""), such as continuous glucose monitors, are devices that are worn externally on the human body or clothing, that monitor or collect health-related data. Because these devices may facilitate more timely and personalized patient care, some researchers, policymakers, and others have proposed increasing the use of wearables in clinical decision-making. However, laws, data infrastructure, and clinical practices do not yet allow for widespread implementation of wearables for diagnosis or prescribing treatment. For example, the diagnostic accuracy of many wearables in clinical use has not been fully tested, and fewer than 10 types of devices have been approved by the U.S. Food and Drug Administration. Additionally, artificial intelligence (AI) is being used to augment the clinical capabilities of some wearables but may face potential algorithmic bias and data privacy issues. Therefore, multiple actions may be required to fully realize potential benefits of wearables in clinical decision-making.
Key Questions: (1) What are potential benefits and challenges of using wearables in clinical decision-making? (2) What are potential benefits and challenges of using AI to augment the clinical decision-making capabilities of such wearables? (3) What policy options, if any, might help address challenges and enhance benefits associated with the use of wearables in clinical decision-making?"
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