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Smart Wearables: The Overlooked And Underrated Essential Worker, Rebekah Hill
Smart Wearables: The Overlooked And Underrated Essential Worker, Rebekah Hill
William & Mary Law Review
This Note argues that the FDA should revamp its criteria for regulating medical devices to unambiguously include smart wearables. Specifically, this Note calls for the FDA to amend its definition of “medical device” to focus on what a device is technologically capable of rather than its intended use.
Part I will examine the established legislation regarding medical devices; in particular, it will examine the relationship between FDA regulations and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and argue that when taken together, HIPAA creates a strong presumption that smart wearables should be regulated by the FDA. This …
Optimizing Cybersecurity Risk In Medical Cyber-Physical Devices, Christopher S. Yoo, Bethany C. Lee
Optimizing Cybersecurity Risk In Medical Cyber-Physical Devices, Christopher S. Yoo, Bethany C. Lee
William & Mary Law Review
Medical devices are increasingly connected, both to cyber networks and to sensors collecting data from physical stimuli. These cyber-physical systems pose a new host of deadly security risks that traditional notions of cybersecurity struggle to take into account. Previously, we could predict how algorithms would function as they drew on defined inputs. But cyber-physical systems draw on unbounded inputs from the real world. Moreover, with wide networks of cyber-physical medical devices, a single cybersecurity breach could pose lethal dangers to masses of patients.
The U.S. Food and Drug Administration (FDA) is tasked with regulating medical devices to ensure safety and …