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- 2024
- Working Paper
Product Liability Litigation and Innovation: Evidence from Medical Devices
By: Alberto Galasso and Hong Luo
We examine the relationship between product liability litigation and innovation by systematically
combining data on product liability lawsuits with data on new product introductions in a panel dataset of
leading medical device firms. We first document a decline in...
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Keywords:
Lawsuits and Litigation;
Product Development;
Technological Innovation;
Safety;
Governing Rules, Regulations, and Reforms;
Medical Devices and Supplies Industry
Galasso, Alberto, and Hong Luo. "Product Liability Litigation and Innovation: Evidence from Medical Devices." Harvard Business School Working Paper, No. 24-063, March 2024.
- March 2024
- Case
Governing OpenAI
By: Lynn S. Paine, Suraj Srinivasan and Will Hurwitz
In late November 2023, OpenAI’s new board of directors took stock of the situation. The company, which sought to develop artificial general intelligence (AGI)—computer systems with capabilities exceeding human abilities—was looking to regain its footing after a chaotic...
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Keywords:
Artificial Intelligence;
Board Of Directors;
Board Decisions;
Board Dynamics;
Business Ethics;
Corporate Boards;
Governance Changes;
Governance Structure;
Leadership Change;
Legal Aspects Of Business;
Nonprofit;
Nonprofit Governance;
Open Source;
Partnerships;
Regulation;
Strategy And Execution;
Technological Change;
AI and Machine Learning;
Corporate Governance;
Leadership;
Management;
Mission and Purpose;
Technological Innovation;
Technology Industry;
San Francisco;
United States
- 2024
- Article
Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway
By: Mateo Aboy, Cristina Crespo and Ariel Stern
Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Technology Adoption;
Technological Innovation;
Safety;
Medical Devices and Supplies Industry;
United States
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway." Art. 29. npj Digital Medicine 7 (2024).
- 2024
- Working Paper
Private Regulation, Institutional Entrepreneurship and Climate Change: A Business History Perspective
By: Ann-Kristin Bergquist and Geoffrey Jones
Private regulatory systems, including voluntary efforts by firms to restrain their own behavior are the primary form of global climate change governance. However, when environmental challenges first rose up on the scientific and political agendas during the 1970s, the...
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Keywords:
Certification;
Climate Change;
Environmental Regulation;
Business History;
Governing Rules, Regulations, and Reforms;
Policy
Bergquist, Ann-Kristin, and Geoffrey Jones. "Private Regulation, Institutional Entrepreneurship and Climate Change: A Business History Perspective." Harvard Business School Working Paper, No. 24-041, January 2024.
- 2024
- Working Paper
Antitrust Platform Regulation and Entrepreneurship: Evidence from China
By: Ke Rong, D. Daniel Sokol, Di Zhou and Feng Zhu
Many jurisdictions have launched antitrust enforcement and brought in regulation of large tech platforms. The swift and strict implementation of China’s Anti-Monopoly Guidelines for the Platform Economy (Platform Guidelines) provides a quasi-natural experiment...
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Keywords:
Governing Rules, Regulations, and Reforms;
Competition;
Venture Capital;
Market Entry and Exit;
Supply and Industry;
China
Rong, Ke, D. Daniel Sokol, Di Zhou, and Feng Zhu. "Antitrust Platform Regulation and Entrepreneurship: Evidence from China." Harvard Business School Working Paper, No. 24-039, January 2024.
- January 11, 2024
- Article
Understanding the Tradeoffs of the Amazon Antitrust Case
By: Chiara Farronato, Andrey Fradkin, Andrei Hagiu and Dionne Lomax
Regulators in the United States and Europe have been taking on Big Tech, challenging what they say are the companies’ anti-competitive and predatory strategies that harm consumers and third-party users of their platforms. This article examines the FTC’s case against...
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Keywords:
Monopoly;
Governing Rules, Regulations, and Reforms;
Market Design;
Lawsuits and Litigation
Farronato, Chiara, Andrey Fradkin, Andrei Hagiu, and Dionne Lomax. "Understanding the Tradeoffs of the Amazon Antitrust Case." Harvard Business Review Digital Articles (January 11, 2024).
- 2024
- Case
Christiana Figueres and the Paris Climate Negotiations (A)
By: James K. Sebenius, Laurence A. Green, Hannah Riley-Bowles, Lara SanPietro and Mina Subramanian
This three-part, stop action case study, structured for classroom discussion, centers on Harvard’s Program on Negotiation 2022 Great Negotiator, Christiana Figueres, and her efforts as Executive Secretary of the United Nations Framework Convention on Climate Change...
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Keywords:
Climate Change;
Negotiation;
Environmental Regulation;
International Relations;
Leadership
Sebenius, James K., Laurence A. Green, Hannah Riley-Bowles, Lara SanPietro, and Mina Subramanian. "Christiana Figueres and the Paris Climate Negotiations (A)." Program on Negotiation at Harvard Law School Case, 2024.
- 2024
- Case
Christiana Figueres and the Paris Climate Negotiations (B)
By: James K. Sebenius, Laurence A. Green, Hannah Riley-Bowles, Lara SanPietro and Mina Subramanian
This three-part, stop action case study, structured for classroom discussion, centers on Harvard’s Program on Negotiation 2022 Great Negotiator, Christiana Figueres, and her efforts as Executive Secretary of the United Nations Framework Convention on Climate Change...
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Keywords:
Climate Change;
Negotiation;
Environmental Regulation;
International Relations;
Leadership
Sebenius, James K., Laurence A. Green, Hannah Riley-Bowles, Lara SanPietro, and Mina Subramanian. "Christiana Figueres and the Paris Climate Negotiations (B)." Program on Negotiation at Harvard Law School Case, 2024.
- December 2023
- Case
The American Bully XL
By: Robin Greenwood, Richard S. Ruback, Johnathan Sun and Robert Ialenti
The American Bully XL, first introduced to the United Kingdom around 2014, had been held responsible for a disproportionate share of both dog-related attacks and deaths. The case discusses the announcement, in October 2023, that the dog breed would be added to a list...
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- November 2023 (Revised March 2024)
- Technical Note
Customer Data Privacy
By: Eva Ascarza and Ta-Wei Huang
This note provides an overview of the evolving landscape of customer data privacy in 2023. It highlights two pivotal aspects that make privacy a central concern for businesses: building and maintaining customer trust and navigating the intricate regulatory...
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Keywords:
Customer Relationship Management;
Governance Compliance;
Governing Rules, Regulations, and Reforms;
Risk and Uncertainty;
Reputation;
Trust;
Information Management;
Retail Industry;
Technology Industry;
Financial Services Industry;
Telecommunications Industry;
Europe;
United States
Ascarza, Eva, and Ta-Wei Huang. "Customer Data Privacy." Harvard Business School Technical Note 524-005, November 2023. (Revised March 2024.)
- November 2023
- Case
Will Fintechs and Central Banks Play in Emtech’s Sandbox?
By: Daniel Isenberg and William R. Kerr
In February 2023, Emtech’s founder Carmelle Cadet is facing a dilemma. Rapidly running out of cash, Cadet has a term sheet from a leading VC but has a choice of how to structure the investment. The decision will have significant implications for Cadet’s own stake, as...
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Keywords:
Cryptocurrency
Isenberg, Daniel, and William R. Kerr. "Will Fintechs and Central Banks Play in Emtech’s Sandbox?" Harvard Business School Case 824-096, November 2023.
- 2023
- Working Paper
The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina
By: Sebastian Calónico, Rafael Di Tella and Juan Cruz Lopez Del Valle
We document the diffusion of nebulized ibuprofen in Argentina as a treatment for COVID-19. As the pandemic spread, this clinically unsupported drug reached thousands of patients, even some seriously ill, despite warnings by the regulator and medical societies. Detailed...
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Keywords:
COVID-19;
Health Care and Treatment;
Health Pandemics;
Adoption;
Behavior;
Governing Rules, Regulations, and Reforms;
Learning
Calónico, Sebastian, Rafael Di Tella, and Juan Cruz Lopez Del Valle. "The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina." NBER Working Paper Series, No. 31781, October 2023.
- October 2023 (Revised January 2024)
- Case
McDonald's Board of Directors (A)
By: Lynn S. Paine and Will Hurwitz
In October 2019, the McDonald’s Corporation board of directors, chaired by Enrique Hernandez, Jr., gathered to learn the results of their outside counsel’s investigation into the conduct of the CEO. On the surface, the iconic fast-food chain was thriving as growing...
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Keywords:
Board Of Directors;
Board Chair;
Board Decisions;
Business Ethics;
Corporate Boards;
Fast Food;
Franchising;
Legal Aspects Of Business;
Legal Battle;
Legal Settlement;
Misconduct;
Regulation;
Reorganization;
Restaurant Industry;
Sexual Harassment;
Shareholders;
Stakeholder Management;
Strategy And Execution;
Turnaround;
Corporate Accountability;
Corporate Governance;
Culture;
Executive Compensation;
Leadership;
Management;
Ethics;
Governing and Advisory Boards;
Business and Stakeholder Relations;
Food and Beverage Industry;
Illinois;
United States
Paine, Lynn S., and Will Hurwitz. "McDonald's Board of Directors (A)." Harvard Business School Case 324-044, October 2023. (Revised January 2024.)
- October 2023
- Article
Laboratory Safety and Research Productivity
By: Alberto Galasso, Hong Luo and Brooklynn Zhu
Are laboratory safety practices a tax on scientific productivity? We examine this question by exploiting the substantial increase in safety regulations at the University of California following the shocking accidental death of a research assistant in 2008....
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Keywords:
Economics Of Science;
Risk Perception;
Safety Regulations;
Governing Rules, Regulations, and Reforms;
Working Conditions;
Safety;
Performance Productivity
Galasso, Alberto, Hong Luo, and Brooklynn Zhu. "Laboratory Safety and Research Productivity." Art. 104827. Research Policy 52, no. 8 (October 2023).
- September 2023
- Supplement
CMA CGM: Reducing the Carbon Footprint of Container Shipping
By: Willy Shih
Marine transport is the most cost-effective way to move large volumes over long distances, and container shipping is the backbone of international trade in goods. Yet shipping contributed 3% of worldwide greenhouse gas emissions, and the deep-sea segment, which...
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- September 2023
- Case
The Rise and Fall of FTX
In November 2022, Sam Bankman-Fried's multi-billion-dollar crypto exchange, FTX, collapsed, wiping out investors and throwing the crypto industry into disarray. As FTX's founder and CEO, Bankman-Fried developed a reputation for his unerring business sense and...
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Keywords:
Cryptocurrency;
Crime and Corruption;
Financial Statements;
Misleading and Fraudulent Advertising;
Insolvency and Bankruptcy;
Corporate Governance;
Governing Rules, Regulations, and Reforms;
Failure;
Restructuring;
United States;
Hong Kong;
Bahamas
Dey, Aiyesha, Jonas Heese, Joseph Pacelli, and Max Hancock. "The Rise and Fall of FTX." Harvard Business School Case 124-014, September 2023.
- September 2023
- Supplement
CMA CGM: Reducing the Carbon Footprint of Container Shipping
By: Willy Shih
Marine transport is the most cost-effective way to move large volumes over long distances, and container shipping is the backbone of international trade in goods. Yet shipping contributed 3% of worldwide greenhouse gas emissions, and the deep-sea segment, which...
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- August 2023 (Revised September 2023)
- Case
T.G.S. Transportation: Battery Electric or Hydrogen?
By: Willy C. Shih
Peter Schneider, the President of T.G.S. Transportation, Inc., faced a choice. His company operated drayage trucks that moved containerized cargo between the Ports of Los Angeles, Long Beach, and Oakland to customers across the State of California, with a focus on the...
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Keywords:
Decarbonization;
Clean Technology;
Energy;
Energy Policy;
Renewable Energy;
Environmental Sustainability;
Truck Transportation;
Transportation Industry;
United States;
California
Shih, Willy C. "T.G.S. Transportation: Battery Electric or Hydrogen?" Harvard Business School Case 624-032, August 2023. (Revised September 2023.)
- 2023
- Working Paper
Much Ado About Nothing? Overreaction to Random Regulatory Audits
By: Samuel Antill and Joseph Kalmenovitz
Regulators often audit firms to detect non-compliance. Exploiting a natural experiment in the lobbying industry, we show that firms overreact to audits and this response distorts prices and reduces welfare. Each year, federal regulators audit a random sample of...
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Antill, Samuel, and Joseph Kalmenovitz. "Much Ado About Nothing? Overreaction to Random Regulatory Audits." Working Paper, August 2023.
- 2023
- Article
Towards Bridging the Gaps between the Right to Explanation and the Right to Be Forgotten
By: Himabindu Lakkaraju, Satyapriya Krishna and Jiaqi Ma
The Right to Explanation and the Right to be Forgotten are two important principles outlined to regulate algorithmic decision making and data usage in real-world applications. While the right to explanation allows individuals to request an actionable explanation for an...
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Keywords:
Analytics and Data Science;
AI and Machine Learning;
Decision Making;
Governing Rules, Regulations, and Reforms
Lakkaraju, Himabindu, Satyapriya Krishna, and Jiaqi Ma. "Towards Bridging the Gaps between the Right to Explanation and the Right to Be Forgotten." Proceedings of the International Conference on Machine Learning (ICML) 40th (2023): 17808–17826.