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- May 2024
- Article
Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms
By: Caroline Marra and Ariel D. Stern
Digital health technologies (DHTs) can enable more patient-centric therapeutic development by generating evidence that captures how patients feel and function, enabling decentralized trial designs that increase participant inclusivity and convenience, and collecting...
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Keywords:
Health Care and Treatment;
Technological Innovation;
Product Development;
Health Testing and Trials;
Governing Rules, Regulations, and Reforms
Marra, Caroline, and Ariel D. Stern. "Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms." Clinical Pharmacology & Therapeutics 115, no. 5 (May 2024): 988–992.
- 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.
- February 2024
- Teaching Note
Fusion Industry Association: Igniting the Future of Clean Energy
Teaching Note for HBS Case No. 624-064. This Teaching Note explores the Fusion Industry Association's efforts to advance commercial fusion energy, highlighting challenges in innovation, regulation, market structure, and financing within the emerging technology sector...
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- February 26, 2024
- Article
Making Workplaces Safer Through Machine Learning
By: Matthew S. Johnson, David I. Levine and Michael W. Toffel
Machine learning algorithms can dramatically improve regulatory effectiveness. This short article describes the authors' scholarly work that shows how the U.S. Occupational Safety and Health Administration (OSHA) could have reduced nearly twice as many occupational...
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Keywords:
Government Experimentation;
Auditing;
Inspection;
Evaluation;
Process Improvement;
Government Administration;
AI and Machine Learning;
Safety;
Governing Rules, Regulations, and Reforms
Johnson, Matthew S., David I. Levine, and Michael W. Toffel. "Making Workplaces Safer Through Machine Learning." Regulatory Review (February 26, 2024).
- 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).
- 2023
- Working Paper
When Insurers Exit: Climate Losses, Fragile Insurers, and Mortgage Markets
By: Pari Sastry, Ishita Sen and Ana-Maria Tenekedjieva
This paper studies how homeowners insurance markets respond to growing climate losses and how this impacts mortgage market dynamics. Using Florida as a case study, we show that traditional insurers are exiting high risk areas, and new lower quality insurers are...
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Keywords:
Insurance;
Natural Disasters;
Governing Rules, Regulations, and Reforms;
Insurance Industry;
Florida
Sastry, Pari, Ishita Sen, and Ana-Maria Tenekedjieva. "When Insurers Exit: Climate Losses, Fragile Insurers, and Mortgage Markets." Harvard Business School Working Paper, No. 24-051, February 2024. (SSRN Working Paper Series, No. 4674279, December 2023.)
- January 2024
- Case
Post-Wirecard: BaFin under Mark Branson
By: Jonas Heese, Carlota Moniz and Daniela Beyersdorfer
In November 2023, Mark Branson, the head of Germany's Federal Financial Supervisory Authority (BaFin), reflected on the efficacy of the reforms initiated since the Wirecard scandal. BaFin had been discredited after Wirecard’s downfall in 2020. The press had derided it...
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Keywords:
Accounting;
Crime and Corruption;
Governing Rules, Regulations, and Reforms;
Government Administration;
Failure;
Trust;
Financial Services Industry;
Public Administration Industry;
Germany
Heese, Jonas, Carlota Moniz, and Daniela Beyersdorfer. "Post-Wirecard: BaFin under Mark Branson." Harvard Business School Case 124-078, January 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).
- 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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- December 2023 (Revised May 2024)
- Case
Building Resiliency in McDonald's Supply Chain
By: David E. Bell, Damien McLoughlin and David Lane
Considers McDonald’s efforts to build resilience into its global supply chain so that the company and its suppliers can better navigate the increasing pressures and pace of climate change and regulatory change, including a focus on supplying sustainable beef, while the...
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Keywords:
Climate Change;
Supply Chain Management;
Business and Stakeholder Relations;
Risk and Uncertainty;
Governing Rules, Regulations, and Reforms;
Growth Management;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
United States;
Europe;
South America
Bell, David E., Damien McLoughlin, and David Lane. "Building Resiliency in McDonald's Supply Chain." Harvard Business School Case 524-001, December 2023. (Revised May 2024.)
- December 2023
- Case
Monsters in the Machine? Tackling the Challenge of Responsible AI
By: Paul M. Healy and Debora L. Spar
In November of 2022, the small tech company OpenAI released ChatGPT, an artificial intelligence chatbot which quickly captured the public’s imagination—becoming the world’s fastest-growing consumer application within months of its release. Though observers from across...
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Keywords:
Technological Innovation;
AI and Machine Learning;
Ethics;
Governing Rules, Regulations, and Reforms;
Technology Adoption;
Corporate Social Responsibility and Impact;
Technology Industry;
United States;
European Union;
China
Healy, Paul M., and Debora L. Spar. "Monsters in the Machine? Tackling the Challenge of Responsible AI." Harvard Business School Case 324-062, December 2023.
- 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;
Business Startups;
Venture Capital;
Cash Flow;
Currency;
Governing Rules, Regulations, and Reforms;
Digital Platforms
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
- 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
- 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.
- 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.