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...
BLOG POST: DR. AMAZON: SHINING A LIGHT ON HIPAA INADEQUACIES THROUGH AMAZON’S EXPANSION INTO THE HEALTHCARE INDUSTRY*
*This writing is a blog post. It is not a published IPTF Journal Article. Alexa Dawid Technology giants are spending billions to enter the healthcare space.[1] Offerings like Apple’s health monitoring functions on the iPhone, Microsoft’s cloud computing services for healthcare companies, and Meta’s fitness applications through its virtual reality goggles have transformed traditional notions of doctor’s offices and paper records into convenient digital systems.[2] Amazon has been one of the most ambitious within the space, debuting six HIPAA-compliant skills for Alexa in April 2019.[3] These skills mark the first time Alexa has surpassed HIPAA requirements in utilizing HIPAA-compliant...
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...
Antitrust Implications of the Banning Surveillance Advertising Act
Alisha Parker-Martell The Banning Surveillance Advertising Act, proposed in the 117th Congress of the House of Representatives by Congresswoman Eshoo, would improve consumer data protection but would also have negative consequences on market competition in sectors that utilize user data. This Act is indicative of a growing conflict between antitrust policy and consumer data privacy. This essay argues that future federal consumer data privacy legislation should attempt to balance the competing interests of market health and consumer privacy rights by prohibiting exploitative uses of consumer data and mandating consumer data sharing and a period of exclusive use of collected data....
Mind over Data: A Case for Increased Privacy Protections in Mobile Mental Health Apps
Marian Lemont As mobile mental health apps gain popularity as an emotional support alternative, privacy concerns regarding how consumers’ sensitive health data is handled are at an all-time high. Current federal privacy provisions provide insufficient consumer protection and thus render consumers’ sensitive information vulnerable to unwanted third-party sharing practices. The recently passed California Privacy Rights Act of 2020 (CPRA) includes new provisions governing businesses’ handling and deletion of sensitive user data. This article discusses how these new CPRA provisions provide a helpful framework to begin addressing this regulatory gap and identifies ways future privacy legislation can continue to strengthen mobile...
The Liquidation of Data Privacy: How an Outdated Bankruptcy Code Threatens Consumer Information
Michael R. Akselrad In the modern world, billions of people share personal information online every day, ranging from consumer preferences to biometric and genetic identifiers, leading to the commoditization of user data, the value of which may dwarf the other assets of even large, multinational corporations. In the ordinary course of business, this user data may be kept confidential through such measures as privacy policies, statutory protections, and the reputational backlash facing a company that acts too brazenly with users’ sensitive information. In bankruptcy, however, some of these safeguards are eliminated in the interest of maximizing the value of the...
The Case for Prohibiting the Sale of Individual Genetic Testing Data to Third Parties
Nathaniel Jaffe Genetic technology is getting cheaper, and millions of individuals are using direct-to-consumer genetic testing (DTC-GT) services. At the same time, the scientific understanding of genetics is improving, making sequencing information more valuable for predictive medicine, research, forensics, and many other fields. In turn, genetic information has become more valuable for third parties like insurers, researchers, and pharmaceutical companies. DTC-GT providers are in a position to provide increasingly low-cost services to a growing consumer base, while stockpiling data of increasing commercial value. The sale of genetic data threatens the privacy of the individuals who provided it and opens them...
Curbing Widespread Discrimination by Artificial Intelligence Hiring Tools: An Ex Ante Solution
Bradfield E. A. Biggers Artificial intelligence (AI) acolytes insist AI will pave the way for idealistic workplace hiring. Their idea is that AI can circumvent common human frailties, such as prejudices and narrow-mindedness, to achieve social and economic equality. Yet inherent biases permeating into AI algorithms stifle society’s goal of promoting equality in the workplace. Despite a growing awareness of AI’s potential for prejudice, politicians are slow to support substantial legislation regulating AI. Nevertheless, the judiciary will inevitably be tasked with addressing discrimination by AI technologies through an unprecedented construction of Title VII of the Civil Rights Act of 1964....
Interoperability’s Role in Striving for Precision Medicine
Martha Koroshetz President Obama announced the Precision Medicine Initiative in his 2015 State of the Union address, a research effort to find treatments that are tailored to specific genetic profiles and characteristics. This personalized and context-specific treatment approach will require big data analysis of patient outcomes and their genetic sequence, which must then be accessible and comprehensible to caregivers. The initiative must therefore be able to reconcile genetic data, demographic information, and health information, in the electronic health record. To achieve data interoperability, the organizations engaged in the initiative must confront questions of data privacy, standardize data exchange, and incentivize...