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- August 2022
- Article
Regulatory Considerations to Keep Pace with Innovation in Digital Health Products
By: John Torous, Ariel Dora Stern and Florence T. Bourgeois
Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a...
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- 2022
- Article
Regulatory Treatment of Changes in Fair Value and the Composition of Banks' Investment Portfolios
By: Michael Iselin, Jung Koo Kang and Joshua Madsen
In their implementation of Basel III, U.S. bank regulators are again including changes in the fair value of available-for-sale (AFS) debt securities in Tier 1 capital, but only for the largest U.S. banks. This paper investigates a potential impact of expanding this...
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- 2021
- Working Paper
Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response
By: Alexander J. MacKay and Samuel Weinstein
Pricing algorithms are rapidly transforming markets, from ride-sharing apps, to air travel, to online retail. Regulators and scholars have watched this development with a wary eye. Their focus so far has been on the potential for pricing algorithms to facilitate...
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- 2021
- Working Paper
Capitalism, Slavery, and the Legacy of Cesare Beccaria
The Milanese Marquis Cesare Beccaria (1738-1794) dedicated his life first to theorizing a more just and equal society grounded in individual rights, anchored in secular political economy rather than in religious dogma, then to realizing this bold vision...
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- October 2021
- Article
Can Self-Regulation Save Digital Platforms?
By: Michael A. Cusumano, Annabelle Gawer and David B. Yoffie
This article explores some of the critical challenges facing self-regulation and the regulatory environment for digital platforms. We examine several historical examples of firms and industries that attempted self-regulation before the Internet. All dealt with similar...
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- Article
The Harmonization of Lending Standards within Banks through Mandated Loan-Level Transparency
By: Jung Koo Kang, Maria Loumioti and Regina Wittenberg-Moerman
We explore whether the introduction of transparent reporting rules increases credit standard harmonization within a bank. We exploit the new loan-level reporting rules imposed on banks that borrow from the European Central Bank using repurchase agreements...
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- Article
Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring
By: Jan Benedikt Brönneke, Jennifer Müller, Konstantinos Mouratis, Julia Hagen and Ariel Dora Stern
In the area of cardiac monitoring, the use of digitally driven technologies is on the rise. While the development of medical products is advancing rapidly, allowing for new use-cases in cardiac monitoring and other areas, regulatory and legal requirements that govern...
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- Article
The Covid-19 Pandemic Should Not Delay Actions to Prevent Anticompetitive Consolidation in U.S. Health Care Markets
By: Leemore S. Dafny
This article describes potential regulatory and legislative reforms to assist antitrust enforcement agencies in halting anticompetitive acquisitions and practices, and preserving and promoting competition in health care markets.
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- 2021
- Working Paper
Regulatory Approval and Expanded Market Size
By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality...
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- 2021
- Article
To Thine Own Self Be True? Incentive Problems in Personalized Law
By: Jordan M. Barry, John William Hatfield and Scott Duke Kominers
Recent years have seen an explosion of scholarship on “personalized law.” Commentators foresee a world in which regulators armed with big data and machine learning techniques determine the optimal legal rule for every regulated party, then instantaneously disseminate...
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Keywords:
Personalized Law;
Regulation;
Regulatory Avoidance;
Regulatory Arbitrage;
Law And Economics;
Law And Technology;
Law And Artificial Intelligence;
Futurism;
Moral Hazard;
Elicitation;
Signaling;
Privacy;
Law;
Governing Rules, Regulations, and Reforms;
Information Technology;
AI and Machine Learning
- Article
Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials
By: Caroline Marra, William J. Gordon and Ariel Dora Stern
Objectives: In an effort to mitigate COVID-19 related challenges for clinical research, the U.S. Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of...
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- Article
Ten Year Sunset Rule for Healthcare Regulation Is a Nonstarter and Discouragement to Post-COVID-19 Investment
By: Regina E. Herzlinger and Eugene Schneller
U.S. healthcare delivery has not benefitted from the same productivity growth as many other service industries, such as bricks and mortar retailing, a loss that has gravely diminished cost control and access. Regulatory capture, which creates barriers to venture...
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- March 2021 (Revised December 2021)
- Supplement
Ant Financial (D)
By: Feng Zhu, Krishna G. Palepu, Kerry Herman and Susie Ma
The (D) case updates the case series from the time of Ant’s planned IPO, and the Chinese government’s regulatory shifts.
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- March 2021
- Article
The Effectiveness of White-Collar Crime Enforcement: Evidence from the War on Terror
By: Trung Nguyen
This paper analyzes the impact of changes in regulatory priorities and resource allocation on criminal enforcement of white‐collar criminal activities. Using the 9/11 terrorist attacks as a shock to the FBI's priorities and allocation of investigative resources, as...
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- November 2020 (Revised January 2021)
- Case
Zipline: The World's Largest Drone Delivery Network
By: Tarun Khanna and George Gonzalez
Zipline established the world's largest logistics network in Rwanda and Ghana by delivering medical supplies to hospitals via automated drones. The company is now looking to expand in the U.S. and partnered with Walmart to expand into home delivery. Zipline must...
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- September 2020
- Article
Regulatory Sandboxes: A Cure for mHealth Pilotitis?
By: Abhishek Bhatia, Rahul Matthan, Tarun Khanna and Satchit Balsari
Mobile health (mHealth) and related digital health interventions in the past decade have not always scaled globally as anticipated earlier despite large investments by governments and philanthropic foundations. The implementation of digital health tools has suffered...
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- 2020
- Working Paper
How Should U.S. Bank Regulators Respond to the COVID-19 Crisis?
Drawing on lessons from the 2007–2009 Global Financial Crisis (GFC) and a simple conceptual framework, we examine the response of U.S. bank regulators to the COVID-19 pandemic. We argue that the current regulatory strategy of “watchful waiting”—the same strategy that...
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- April 2020
- Article
Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning
By: Ariel Dora Stern and W. Nicholson Price, II
In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging...
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- 2020
- Working Paper
Capital Regulation and Product Market Outcomes
By: Ishita Sen and David Humphry
We present evidence of product market adjustments and asset reorganizations from the largest ever shift in risk regulation in a developed insurance market. Using proprietary data on insurance risk exposures from the Bank of England, we develop a measure of regulatory...
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- 2020
- Working Paper
Internal Models, Make Believe Prices, and Bond Market Cornering
By: Ishita Sen and Varun Sharma
Exploiting position-level heterogeneity in regulatory incentives to misreport and novel data on regulators, we document that U.S. life insurers inflate the values of corporate bonds using internal models. We estimate an additional $9-$18 billion decline in regulatory...
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