Law Commons^™

A Proportionality-Based Framework For Government Regulation Of Digital Tracing Apps In Times Of Emergency, Sharon Bassan

Dickinson Law Review (2017-Present)

Times of emergency present an inherent conflict between the public interest and the preservation of individual rights. Such times require granting emergency powers to the government on behalf of the public interest and relaxing safeguards against government actions that infringe rights. The lack of theoretical framework to assess governmental decisions in times of emergency leads to a polarized and politicized discourse about potential policies, and often, to public distrust and lack of compliance.

Such a discourse was evident regarding Digital Tracing Apps (“DTAs”), which are apps installed on cellular phones to alert users that they were exposed to people who …

The Writing’S On The Wall: Using Multimedia Presentation Principles From The Museum World To Improve Law School Pedagogy, Cecilia A. Silver

Dickinson Law Review (2017-Present)

Law school pedagogy is a relic. Nearly 150 years after Christopher Langdell pioneered the case method, the typical doctrinal course remains predominantly a verbal domain, featuring lectures, Socratic dialogue, and final exams. But the visual disconnect between legal education and legal practice does students a disservice. Under the proliferating influence of laptops, iPads, smartphones, and Zoom, students now read, work, and study electronically more than they ever have before. So instead of business as usual, it’s time to embrace “visualization”—using multimedia to enhance, or even supplant, the near-exclusive reliance on language—to build a more vibrant and inclusive learning environment.

Law …

Book Review: This Is How They Tell Me The World Ends: The Cyberweapons Arms Race (2020) By Nicole Perlroth, Amy C. Gaudion

Dickinson Law Review (2017-Present)

No abstract provided.

Digital Home Health During The Covid-19 Pandemic Challenges To Safety, Liability, And Informed Consent, And The Way To Move Forward, Sara Gerke

Faculty Contributions to Books

In this chapter, I will first give an overview of the promise of digital home health. I will then discuss the regulation of digital home health before and during COVID-19 in the context of the US Federal Food, Drug, and Cosmetic Act (FDCA). This will be followed by a discussion of three digital home health challenges during the pandemic: 1) safety, 2) liability, and 3) informed consent. In this context, I will also make suggestions on how to move forward.

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, …

Cyberterrorism And The Public Safety Exception To Miranda, Mitch Snyder

Dickinson Law Review (2017-Present)

Cyberattacks against U.S. targets are becoming increasingly common. To effectively combat these attacks, law enforcement officers need the tools to respond to and prevent cyberattacks before they can occur.

In recent years, hackers have launched cyberattacks against infrastructural targets such as power grids, oil and gas distribution computer systems, and telecommunications networks. Cyberattacks have also targeted U.S. government websites, including the U.S. Department of Transportation and the U.S. Department of Treasury. Recently, a cyberattack against SolarWinds, a Texas-based I.T. company, compromised the computer and network systems of federal, state, and local governments; critical infrastructure entities; and other private sector organizations. …

The Absence Or Misuse Of Statistics In Forensic Science As A Contributor To Wrongful Convictions: From Pattern Matching To Medical Opinions About Child Abuse, Keith A. Findley

Dickinson Law Review (2017-Present)

The new scrutiny that has been applied to the forensic sciences since the emergence of DNA profiling as the gold standard three decades ago has identified numerous concerns about the absence of a solid scientific footing for most disciplines. This article examines one of the lesser-considered problems that afflicts virtually all of the pattern-matching (or “individualization”) disciplines (largely apart from DNA), and even undermines the validity of other forensic disciplines like forensic pathology and medical determinations about child abuse, particularly Shaken Baby Syndrome/Abusive Head Trauma (SBS/AHT). That problem is the absence or misuse of statistics. This article begins by applying …

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 …

A False Sense Of Security: How Congress And The Sec Are Dropping The Ball On Cryptocurrency, Tessa E. Shurr

Dickinson Law Review (2017-Present)

Today, companies use blockchain technology and digital assets for a variety of purposes. This Comment analyzes the digital token. If the Securities and Exchange Commission (SEC) views a digital token as a security, then the issuer of the digital token must comply with the registration and extensive disclosure requirements of federal securities laws.

To determine whether a digital asset is a security, the SEC relies on the test that the Supreme Court established in SEC v. W.J. Howey Co. Rather than enforcing a statute or agency rule, the SEC enforces securities laws by applying the Howey test on a fact-intensive …

Poland’S Challenge To Eu Directive 2019/790: Standing Up To The Destruction Of European Freedom Of Expression, Michaela Cloutier

Dickinson Law Review (2017-Present)

In 2019, the European Parliament and Council passed Directive 2019/790. The Directive’s passage marked the end of a fouryear- long legislative attempt to impose more liability for copyright violations on Online Service Providers, an effort which was controversial from the start. Online Service Providers fear that the 2019 Directive, especially its Article 17, will completely change the structure of liability on the Internet, forcing providers to adopt expensive content filtering systems. Free speech advocates fear that ineffective filtering technology will infringe upon Internet users’ rights to express themselves, and legal scholars have pointed out the Directive’s inconsistency with prior European …

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 …

Coinsensus: The Need For Uniform National Virtual Currency Regulations, Anisha Reddy

Dickinson Law Review (2017-Present)

Google search volume for bitcoin and bitcoin-related keywords increased by as much as 1000 percent in 2017 from previous years. This increased interest comes hand-in-hand with increased regulatory and legislative scrutiny. Currently, there is disparate regulation for virtual currencies across national and state borders alike. States’ promulgation of various and incongruous virtual currency regulations have forced service providers to withdraw from different states within the country. However, transactions are not contained within state lines, and disparate state-by-state regulation is impracticable.

The Uniform Law Commission recognized the need for uniform guidance for those entering the North American market and drafted the …

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.