Law Commons^™

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 …

When Is A Change Significant? The Update Problem Of Apps In Medical And Behavioral Research, Carmel Shachar, Sara Gerke, Walker Morrell, Aaron Kirby, I. Glenn Cohen, Barbara E. Bierer

Faculty Scholarly Works

Digital applications (apps) are commonly used across the research ecosystem. While apps are frequently updated in the course of clinical and behavioral research, there is limited guidance as to when an app update should trigger action related to human research participant protections and who should be responsible for monitoring and reviewing these updates. We term this the “update problem” and argue that, while it is the principal investigator's duty to track all relevant updates, the level of involvement and re-review by the institutional review board (IRB) of an approved research protocol should vary depending on whether the update may be …

Blockchain And The Genesis Of Creative Justice To Disintermediate Creativity, Tonya M. Evans

Faculty Scholarly Works

Historically, the art market has been shrouded in opaqueness and exclusivity, permissioned access and asymmetry of information that rivals the systemic ills of legacy financial markets that led to the Great Recession. Moreover, legacy art market stakeholders have, through the centuries, been entrenched in elitist and inequitable notions of art that excluded Black artists. These legacy intermediaries have also consistently demonstrated a deep and enduring disdain for any art connected to the digital world. That is, until the age of COVID-19 and the dramatically increasing value and dominance of the non-fungible token (NFT) market.

This Essay explores why, and how, …

The Need For A System View To Regulate Artificial Intelligence/Machine Learning-Based Software As Medical Devices, Sara Gerke, Boris Babic, Theodoros Evgeniou, I. Glenn Cohen

Faculty Scholarly Works

Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized treatment plans. However, the emergence of AI/ML in medicine also creates challenges, which regulators must pay attention to. Which medical AI/ML-based products should be reviewed by regulators? What evidence should be required to permit marketing for AI/ML-based software as a medical device (SaMD)? How can we ensure the safety and effectiveness of AI/ML-based SaMD that may change over time as they are applied to new data? The U.S. Food and Drug …

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 …

Germany’S Digital Health Reforms In The Covid-19 Era: Lessons And Opportunities For Other Countries, Sara Gerke, Ariel D. Stern, Timo Minssen

Faculty Scholarly Works

Reimbursement is a key challenge for many new digital health solutions, whose importance and value have been highlighted and expanded by the current COVID-19 pandemic. Germany’s new Digital Healthcare Act (Digitale–Versorgung–Gesetz or DVG) entitles all individuals covered by statutory health insurance to reimbursement for certain digital health applications (i.e., insurers will pay for their use). Since Germany, like the United States (US), is a multi-payer health care system, the new Act provides a particularly interesting case study for US policymakers. We first provide an overview of the new German DVG and outline the landscape for reimbursement of digital health solutions …

The Role Of Satellites And Smart Devices: Data Surprises And Security, Privacy, And Regulatory Challenges, Anne T. Mckenna, Amy C. Gaudion, Jenni L. Evans

Faculty Scholarly Works

Strava, a popular social media platform and mobile app like Facebook but specifically designed for athletes, posts a “heatmap” with consensually-obtained details about users’ workouts and geolocation. Strava’s heatmap depicts aggregated data of user location and movement by synthesizing GPS satellite data points and movement data from users’ smart devices together with satellite imagery. In January of 2018, a 20-year-old student tweeted that Strava’s heatmap revealed U.S. forward operating bases. The tweet revealed a significant national security issue and flagged substantial privacy and civil liberty concerns.

Smart devices, software applications, and social media platforms aggregate consumer data from multiple data …

Ai & Ip Innovation & Creativity In An Age Of Accelerated Change, Daryl Lim

Faculty Scholarly Works

From a glimmer in the eye of a Victorian woman ahead of her time, AI has become a cornerstone of innovation that “will be the defining technology of our time.” Around 2016, the convergence of computing power, funding, data, and open-source platforms tipped us into an AIdriven 4IR. AI can make a difference in accelerating disruptive innovation by bringing a data-driven approach to invention and creation. To do so, the law must embrace change and innovation as an imperative in a journey towards an ever-shifting horizon. In the creative arts, the work for hire doctrine provides a pragmatic legal vehicle …

Self-Replicating Technologies And The Challenge For The Patent And Antitrust Laws, Daryl Lim

Faculty Scholarly Works

Few patented inventions challenge the traditional boundaries of the patent and antitrust laws like those that are capable of multiplying as they are used. These self-replicating technologies are embedded in our food, fortify our vaccines, and form the computer code upon which the information age is based. These inventions create an inherent conflict between patentees and their customers. The conflict arises because every customer could become competitors as the product replicates, potentially making every first sale the patentee's last. They also challenge how we think about fundamental issues of ownership as well as innovation and market competition, and make it …

Copyright Under Siege: An Economic Analysis Of The Essential Facilities Doctrine And The Compulsory Licensing Of Copyrighted Works, Daryl Lim

Faculty Scholarly Works

No abstract provided.