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    • All HBS Web  (308)
      • Faculty Publications  (105)

      Regulatory Reforms Remove Regulatory Reforms →

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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...  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
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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: Digital Platforms; Self-regulation; Government Regulation; Market 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; 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." 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.
      • 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...  View Details
      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
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      Barry, Jordan M., John William Hatfield, and Scott Duke Kominers. "To Thine Own Self Be True? Incentive Problems in Personalized Law." Art. 2. William & Mary Law Review 62, no. 3 (2021).
      • 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...  View Details
      Keywords: Connected Digital Products; Telehealth; Remote Monitoring; Health Testing and Trials; Research; Governing Rules, Regulations, and Reforms; Technology
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      Marra, Caroline, William J. Gordon, and Ariel Dora Stern. "Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials." BMJ Open 11, no. 6 (2021).
      • 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...  View Details
      Keywords: Health Care; COVID-19; Regulation; Health Care and Treatment; Health Pandemics; Governing Rules, Regulations, and Reforms; Investment
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      Herzlinger, Regina E., and Eugene Schneller. "Ten Year Sunset Rule for Healthcare Regulation Is a Nonstarter and Discouragement to Post-COVID-19 Investment." Journal of Health Care Finance 47, no. 4 (Spring 2021). (Special Commentary.)
      • 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.  View Details
      Keywords: Finance; Information Technology; Governing Rules, Regulations, and Reforms; Financial Services Industry; Technology Industry; China; Beijing
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      Zhu, Feng, Krishna G. Palepu, Kerry Herman, and Susie Ma. "Ant Financial (D)." Harvard Business School Supplement 621-089, March 2021. (Revised December 2021.)
      • 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...  View Details
      Keywords: White-collar Crime; Government Regulation; Financial Fraud; Securities Fraud; Insider Trading; Crime and Corruption; Finance; Governing Rules, Regulations, and Reforms; Law Enforcement
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      Nguyen, Trung. "The Effectiveness of White-Collar Crime Enforcement: Evidence from the War on Terror." Journal of Accounting Research 59, no. 1 (March 2021): 5–58.
      • 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...  View Details
      Keywords: Drones; Business Startups; Expansion; Growth and Development Strategy; Governing Rules, Regulations, and Reforms; United States; Africa
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      Khanna, Tarun, and George Gonzalez. "Zipline: The World's Largest Drone Delivery Network." Harvard Business School Case 721-366, November 2020. (Revised January 2021.)
      • 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...  View Details
      Keywords: COVID-19; mHealth; Digital Health; Design Thinking; Regulation; Intervention; Regulatory Sandbox; Health Care and Treatment; Technological Innovation; Design; Governing Rules, Regulations, and Reforms; India
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      Bhatia, Abhishek, Rahul Matthan, Tarun Khanna, and Satchit Balsari. "Regulatory Sandboxes: A Cure for mHealth Pilotitis?" Journal of Medical Internet Research 22, no. 9 (September 2020).
      • 2020
      • Working Paper

      How Should U.S. Bank Regulators Respond to the COVID-19 Crisis?

      By: Michael Blank, Samuel G. Hanson, Jeremy C. Stein and Adi Sunderam
      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...  View Details
      Keywords: COVID-19; Bank Regulation; Recapitalization; Health Pandemics; Banks and Banking; Governing Rules, Regulations, and Reforms; Strategy; Risk Management; United States
      Citation
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      Blank, Michael, Samuel G. Hanson, Jeremy C. Stein, and Adi Sunderam. "How Should U.S. Bank Regulators Respond to the COVID-19 Crisis?" Hutchins Center Working Paper, No. 63, June 2020.
      • 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...  View Details
      Keywords: Machine Learning; Causal Inference; Health Care and Treatment; Safety; Governing Rules, Regulations, and Reforms
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      Stern, Ariel Dora, and W. Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.
      • 2022
      • Working Paper

      Shaping Nascent Industries: Innovation Strategy and Regulatory Uncertainty in Personal Genomics

      By: Cheng Gao and Rory McDonald
      For a new market category to materialize, someone must actively bring it into existence. Yet it remains a mystery how entrepreneurs, whose resources are stretched thin, can accomplish this task. Prior research emphasizes the importance of market-shaping...  View Details
      Keywords: Technological Change; Innovation; Qualitative Methods; New Categories; Entrepreneurship; Technological Innovation; Governing Rules, Regulations, and Reforms; Risk and Uncertainty; Strategy
      Citation
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      Gao, Cheng, and Rory McDonald. "Shaping Nascent Industries: Innovation Strategy and Regulatory Uncertainty in Personal Genomics." Harvard Business School Working Paper, No. 20-095, March 2020. (Revised January 2022. Accepted for publication at Administrative Science Quarterly.)
      • 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...  View Details
      Keywords: Non-traditional-non-insurance; Risk Regulation; Product Market Concentration; Small Vs. Large Insurers; Insurance Risk Exposure; Insurance; Risk and Uncertainty; Governing Rules, Regulations, and Reforms
      Citation
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      Sen, Ishita, and David Humphry. "Capital Regulation and Product Market Outcomes." Working Paper, January 2020.
      • 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...  View Details
      Keywords: Life Insurers; Capital Regulation; Internal Models; Corporate Bonds; Regulatory Supervision; Concentrated Ownership; Bonds; Capital; Governing Rules, Regulations, and Reforms; Insurance; Investment Portfolio
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      Sen, Ishita, and Varun Sharma. "Internal Models, Make Believe Prices, and Bond Market Cornering." Working Paper, June 2020.
      • June 2019
      • Case

      Fangda Partners: A Step Ahead

      By: Ashish Nanda and Lisa Rohrer
      Elite Chinese law firm Fangda Partners has steered Alibaba and other Chinese and international clients through the complex legal, corporate, and regulatory challenges associated with executing international transactions. “Fangda has traveled a long distance in a short...  View Details
      Keywords: Law Firm; Law Firms; Growth; Legal Industry; Regulation; Professional Services; Law; Leadership; Growth and Development; Strategy; Governing Rules, Regulations, and Reforms; Legal Services Industry; China
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      Nanda, Ashish, and Lisa Rohrer. "Fangda Partners: A Step Ahead." Harvard Business School Case 719-406, June 2019.
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