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      • Faculty Publications  (113)

      Regulatory Reforms Remove Regulatory Reforms →

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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...  View Details
      Keywords: Recalls; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry
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      Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
      • 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...  View Details
      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
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      Rayport, Jeffrey F., Jennifer Fonstad, and Nicole Tempest Keller. "OhmConnect: Energizing the Future." Harvard Business School Case 823-065, January 2023. (Revised March 2023.)
      • 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...  View Details
      Keywords: Technological Innovation; Safety; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Medical Devices and Supplies Industry
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      Everhart, Alexander O., and Ariel D. Stern. "Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data." Harvard Business School Working Paper, No. 23-035, November 2022.
      • 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...  View Details
      Keywords: Research and Development; Governing Rules, Regulations, and Reforms; Product Development
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      Chandra, Amitabh, Jennifer Kao, Kathleen Miller, and Ariel D. Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." NBER Working Paper Series, No. 30712, December 2022.
      • 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...  View Details
      Keywords: Technological Change; Innovation; Qualitative Methods; New Categories; Entrepreneurship; Technological Innovation; Governing Rules, Regulations, and Reforms; Risk and Uncertainty; Strategy
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      Gao, Cheng, and Rory McDonald. "Shaping Nascent Industries: Innovation Strategy and Regulatory Uncertainty in Personal Genomics." Administrative Science Quarterly 67, no. 4 (December 2022): 915–967.
      • 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...  View Details
      Keywords: DTC; Internet and the Web; Marketing Channels; Customer Value and Value Chain; Governing Rules, Regulations, and Reforms; Competitive Strategy; Service Delivery; Growth and Development Strategy; Pharmaceutical Industry; Health Industry; Retail Industry
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      Herzlinger, Regina E., and Tiffany Farrell. "The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales." Harvard Business School Case 323-031, November 2022.
      • 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,...  View Details
      Keywords: Apprenticeship; Higher Education; Training; Personal Development and Career; Cost vs Benefits; Success; Governing Rules, Regulations, and Reforms
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      Fuller, Joseph B., Rachel Lipson, Farah Mallah, Girish Pendse, and Rachel Snyder. "The Options Multiplier: Decoding the CareerWise Youth Apprentice Journey." White Paper, Project on Workforce at Harvard, November 2022.
      • 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...  View Details
      Keywords: Autonomous Vehicles; Market Entry and Exit; Opportunities; Governing Rules, Regulations, and Reforms; Consumer Behavior; Business Model; Auto Industry; Transportation Industry; France; United States
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      De Freitas, Julian, Elie Ofek, Shaun Ingledew, and Tonia Labruyere. "Navya: Steering Toward a Driverless Future." Harvard Business School Case 523-046, September 2022. (Revised December 2022.)
      • 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...  View Details
      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
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      MacKay, Alexander, and Samuel N. Weinstein. "Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response." Washington University Law Review 100, no. 1 (2022): 111–174. (Direct download.)
      • 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...  View Details
      Keywords: Inequality; Regulation; Law; Organizational Norm; CEO; Affirmative Action; Organizations; Private Sector; Equality and Inequality; Diversity; Race; Governing Rules, Regulations, and Reforms
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      Zhang, Letian. "Regulatory Spillover and Workplace Racial Inequality." Administrative Science Quarterly 67, no. 3 (September 2022): 595–629.
      • 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...  View Details
      Keywords: Emerging Technologies; Governing Rules, Regulations, and Reforms; Innovation and Invention; Medical Devices and Supplies Industry
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      Torous, John, Ariel Dora Stern, and Florence T. Bourgeois. "Regulatory Considerations to Keep Pace with Innovation in Digital Health Products." npj Digital Medicine 5, no. 121 (August 2022).
      • 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...  View Details
      Keywords: Fair Value Accounting; SFAS 115; Basel III; Governing Rules, Regulations, and Reforms; Banks and Banking; Debt Securities; Credit; Risk and Uncertainty; Investment Portfolio; Decision Making; Banking Industry; United States
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      Iselin, Michael, Jung Koo Kang, and Joshua Madsen. "Regulatory Treatment of Changes in Fair Value and the Composition of Banks' Investment Portfolios." Journal of Financial Reporting 7, no. 1 (2022): 123–143.
      • 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...  View Details
      Keywords: Compliance; Risk; Analytics; Governance Compliance; Governing Rules, Regulations, and Reforms; Risk Management; Analytics and Data Science
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      Soltes, Eugene F. "Measuring Compliance Risk and the Emergence of Analytics." Chap. 8 in Measuring Compliance: Assessing Corporate Crime and Misconduct Prevention, edited by Melissa Rorie and Benjamin van Rooij, 137–152. Cambridge University Press, 2022.
      • 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...  View Details
      Keywords: Competition Policy; Regulation; Algorithmic Pricing; Dynamic Pricing; Law And Economics; Law And Regulation; Consumer Protection; Competition; Policy; Price; Governing Rules, Regulations, and Reforms; Economics
      Citation
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      MacKay, Alexander J., and Samuel Weinstein. "Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response." Harvard Business School Working Paper, No. 22-050, January 2022. (Direct download.)
      • 2021
      • Working Paper

      Capitalism, Slavery, and the Legacy of Cesare Beccaria

      By: Sophus A. Reinert
      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...  View Details
      Keywords: Slavery; Racism; Capitalism; History; Society
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      Reinert, Sophus A. "Capitalism, Slavery, and the Legacy of Cesare Beccaria." Harvard Business School Working Paper, No. 22-034, December 2021. (Revised January 2022.)
      • 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...  View Details
      Keywords: Self-regulation; Government Regulation; Digital Platforms; Governing Rules, Regulations, and Reforms
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      Cusumano, Michael A., Annabelle Gawer, and David B. Yoffie. "Can Self-Regulation Save Digital Platforms?" Industrial and Corporate Change 30, no. 5 (October 2021): 1259–1285.
      • 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...  View Details
      Keywords: Transparency; External And Internal Reporting; Credit Term Harmonization; Regulatory Scrutiny; Banks and Banking; Credit; Financial Reporting; Governing Rules, Regulations, and Reforms; Learning
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      Kang, Jung Koo, Maria Loumioti, and Regina Wittenberg-Moerman. "The Harmonization of Lending Standards within Banks through Mandated Loan-Level Transparency." Journal of Accounting & Economics 72, no. 1 (August 2021): 101386.
      • 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...  View Details
      Keywords: Wearables; Regulatory Changes; Medical Technology; Medical Devices; Market Access; Market Entry and Exit; Information Technology; Health Care and Treatment; Governing Rules, Regulations, and Reforms; United States; Germany; Belgium
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      Brönneke, Jan Benedikt, Jennifer Müller, Konstantinos Mouratis, Julia Hagen, and Ariel Dora Stern. "Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring." Art. 4937. Sensors 21, no. 14 (July 2021).
      • 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.  View Details
      Keywords: Health Care and Treatment; Markets; Competition; Governing Rules, Regulations, and Reforms
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      Dafny, Leemore S. "The Covid-19 Pandemic Should Not Delay Actions to Prevent Anticompetitive Consolidation in U.S. Health Care Markets." Promarket (June 10, 2021).
      • 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...  View Details
      Keywords: New Medicines; Regulatory Approval; Health Care and Treatment; Research and Development; Governing Rules, Regulations, and Reforms; Markets; Expansion; Pharmaceutical Industry
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      Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
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