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Privacy Aspects Of Direct-To-Consumer Artificial Intelligence/Machine Learning Health Apps, Sara Gerke, Delaram Rezaeikhonakdar
Privacy Aspects Of Direct-To-Consumer Artificial Intelligence/Machine Learning Health Apps, Sara Gerke, Delaram Rezaeikhonakdar
Faculty Scholarly Works
Direct-To-Consumer Artificial Intelligence/Machine Learning health apps (DTC AI/ML health apps) are increasingly being made available for download in app stores. However, such apps raise challenges, one of which is providing adequate protection of consumers' privacy. This article analyzes the privacy aspects of DTC AI/ML health apps and suggests how consumers' privacy could be better protected in the United States. In particular, it discusses the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Federal Trade Commission (FTC) Act, the FTC's Health Breach Notification Rule, the California Consumer Privacy Act of 2018, the California Privacy Rights Act of 2020, the …
Health Ai For Good Rather Than Evil? The Need For A New Regulatory Framework For Ai-Based Medical Devices, Sara Gerke
Health Ai For Good Rather Than Evil? The Need For A New Regulatory Framework For Ai-Based Medical Devices, Sara Gerke
Faculty Scholarly Works
Artificial intelligence (AI), especially its subset machine learning, has tremendous potential to improve health care. However, health AI also raises new regulatory challenges. In this Article, I argue that there is a need for a new regulatory framework for AI-based medical devices in the U.S. that ensures that such devices are reasonably safe and effective when placed on the market and will remain so throughout their life cycle. I advocate for U.S. Food and Drug Administration (FDA) and congressional actions. I focus on how the FDA could - with additional statutory authority - regulate AI-based medical devices. I show that …