Transparency is a Misplaced Regulatory Focus for Holding Adaptive Software as Medical Devices (SaMDs) Accountable
Quy Mai Adaptive Software as Medical Devices (SaMDs) play an increasingly critical role within clinical settings, assisting physicians with illness detection, diagnosis, and analysis. Use of Artificial Intelligence/Machine Learning (AI/ML) techniques, such as deep machine learning and neural networks, lends adaptive SaMDs unparalleled analytical power, but not without risks. Adaptive SaMDs are typically “black-box,” meaning that they compute data such that no one can determine how it rendered outputs. “Transparency,” in the form of explainability, is frequently raised in policy discussions as a solution to track when the SaMD has erred in computing outputs. The FDA, in seeking to uphold...
The CCPA: A Bargain for Data Transparency
Sonia Brunstad The California Consumer Privacy Act (CCPA), amended by the California Privacy Rights Act (CPRA), aims to increase consumer transparency regarding businesses’ use of personal data. Within the bargained-for-exchange relationship between companies and consumers, consumers benefit from data-collecting platforms while unknowingly paying the “price” of sharing personal data. The CCPA assumes that equipping consumers with increased transparency regarding such data-for-service transactions will place consumers in a better bargaining position. In so doing, the CCPA adopts an individualist framework, providing consumers with primarily self-management mechanisms to protect personal data. This essay argues that legislation such as the CCPA may more...