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- 2023
- Article
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices...
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- January 2023 (Revised March 2023)
- Case
OhmConnect: Energizing the Future
By: Jeffrey F. Rayport, Jennifer Fonstad and Nicole Tempest Keller
Founded in 2013, OhmConnect was a free consumer web app that alerted customers about peak hours of electricity demand, and paid them to lower their energy use at home during these periods. The company sold the aggregated reductions generated by thousands of households...
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Keywords:
App Development;
Renewable Energy;
Electricity Usage;
Regulations;
VC;
Technology;
Customer Acquisition Cost (CAC);
Scalability;
Applications and Software;
Growth and Development Strategy;
Governing Rules, Regulations, and Reforms;
Business Model;
Venture Capital;
Energy Industry;
United States;
California;
Texas;
Europe
- 2022
- Working Paper
Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data
By: Alexander O. Everhart and Ariel D. Stern
Medical devices increasingly include software components, which facilitate remote patient monitoring. The introduction of software into previously analog medical devices as well as innovation in software-driven devices may introduce new safety concerns—all the more so...
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- 2022
- Working Paper
Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to...
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- December 2022
- Article
Shaping Nascent Industries: Innovation Strategy and Regulatory Uncertainty in Personal Genomics
By: Cheng Gao and Rory McDonald
In nascent industries—whose new technologies are often poorly understood
by regulators—contending with regulatory uncertainty can be crucial to organizational survival and growth. Prior research on nonmarket strategy has largely
focused on established firms in mature...
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- November 2022
- Case
The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales
By: Regina E. Herzlinger and Tiffany Farrell
Can an online pharmacy both improve the quality and speed of care for patients who need branded drugs and stabilize profits for pharmaceutical manufacturers? UpScript, after years spent achieving legal and regulatory compliance and simultaneous technological innovation...
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- 2022
- White Paper
The Options Multiplier: Decoding the CareerWise Youth Apprentice Journey
By: Joseph B. Fuller, Rachel Lipson, Farah Mallah, Girish Pendse and Rachel Snyder
As more Americans question the appeal of costly
higher education programs, earn-and-learn models,
like apprenticeship, are attracting increasing
attention from policymakers and employers alike. While apprenticeship is widespread in many
parts of Europe,...
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- September 2022 (Revised December 2022)
- Case
Navya: Steering Toward a Driverless Future
By: Julian De Freitas, Elie Ofek, Shaun Ingledew and Tonia Labruyere
In 2022, Sophie Desormière arrived at French roboshuttle producer Navya, tasked with charting a new course in a challenging sector. The company, which had recently listed on the Paris Stock Exchange, was burning through cash reserves and needed to transform the promise...
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- 2022
- Article
Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response
By: Alexander MacKay and Samuel N. 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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Keywords:
Competition Policy;
Regulation;
Algorithmic Pricing;
Dynamic Pricing;
Economics;
Law And Economics;
Law And Regulation;
Consumer Protection;
Antitrust Law;
Industrial Organization;
Antitrust Issues And Policies;
Technological Change: Choices And Consequences;
Competition;
Policy;
Price;
Governing Rules, Regulations, and Reforms;
Microeconomics;
Duopoly and Oligopoly;
Law
- September 2022
- Article
Regulatory Spillover and Workplace Racial Inequality
By: Letian Zhang
This paper suggests that affirmative action bans in the U.S. public sector may influence racial inequality in the private sector. Since the 1990s, nine states have banned affirmative action practice in public universities and state governments. Though these bans have...
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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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- 2022
- Chapter
Measuring Compliance Risk and the Emergence of Analytics
By: Eugene F. Soltes
Corporate compliance manages a diverse set of regulatory and reputational concerns ranging from fraud to privacy to discrimination. However, effectively managing such risks has often been hampered by a lack of adequate information about when, where, and why misconduct...
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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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