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- July 2024
- Article
The Home State Effect: How Subnational Governments Shape Climate Coalitions
By: Jonas Meckling and Samuel Trachtman
Organized business interests often seek to block public interest regulations. But whether firms oppose regulation depends on institutional context. We argue that, in federal systems, sub-national policies and politics can have a home state effect on firms' national...
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Meckling, Jonas, and Samuel Trachtman. "The Home State Effect: How Subnational Governments Shape Climate Coalitions." Governance 37, no. 3 (July 2024): 887–905.
- 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 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).
- 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.)
- 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.
- January 2024
- Case
Colbún and Chile's Energy Transition
By: Forest Reinhardt, Jenyfeer Martinez Buitrago and Mariana Cal
In May 2023, Colbún, Chile’s second-largest electricity generator, plans capacity expansions using renewable energy and storage. This strategy supports Chile’s commitment to carbon neutrality (also known as net zero emissions) by 2050. The case delves into the...
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Keywords:
Transition;
Energy Generation;
Renewable Energy;
Climate Change;
Investment;
Governing Rules, Regulations, and Reforms;
Infrastructure;
Organizational Change and Adaptation;
Expansion;
Business Strategy;
Energy Industry;
Utilities Industry;
Latin America;
South America;
Chile
Reinhardt, Forest, Jenyfeer Martinez Buitrago, and Mariana Cal. "Colbún and Chile's Energy Transition." Harvard Business School Case 724-026, January 2024.
- 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;
Food and Beverage 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.)
- 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
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.
- June 2023
- Teaching Note
Agricultural Revolution without a Land Revolution: The Megafarms of CP Group
By: William C. Kirby and Noah B. Truwit
Teaching Note for HBS Case No. 316-150. The case introduces students to an innovative new agricultural venture on the outskirts of Beijing. It can be used as a platform to discuss broader issues of agricultural policy reform and regional disparities in social and...
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- June 2023
- Case
Biogen and the Aduhelm Melee
By: Amitabh Chandra and Lauren Gunasti
Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.
This... View Details
This... View Details
- June 2023
- Article
Regulatory Limits to Risk Management
By: Ishita Sen
Variable annuities, the largest liability of U.S. life insurers, are investment products containing long-dated minimum return guarantees. I show that guarantees with similar economic risks are treated differently by regulation and these differences impact insurers’...
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Keywords:
Interest Rate Risk;
Variable Annuities;
Capital Regulation;
Reinsurance;
Derivatives;
Risk Management;
Interest Rates;
Governing Rules, Regulations, and Reforms
Sen, Ishita. "Regulatory Limits to Risk Management." Review of Financial Studies 36, no. 6 (June 2023): 2175–2223.
- January 2023 (Revised December 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
Rayport, Jeffrey F., Jennifer Fonstad, and Nicole Tempest Keller. "OhmConnect: Energizing the Future." Harvard Business School Case 823-065, January 2023. (Revised December 2023.)
- 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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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...
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Keywords:
Technological Change;
Innovation;
Qualitative Methods;
New Categories;
Entrepreneurship;
Technological Innovation;
Governing Rules, Regulations, and Reforms;
Risk and Uncertainty;
Strategy
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, direct-to-consumer 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...
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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
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,...
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Keywords:
Apprenticeship;
Higher Education;
Training;
Personal Development and Career;
Cost vs Benefits;
Success;
Governing Rules, Regulations, and Reforms
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 May 2024)
- 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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Keywords:
Autonomous Vehicles;
Market Entry and Exit;
Opportunities;
Governing Rules, Regulations, and Reforms;
Consumer Behavior;
Business Model;
Auto Industry;
Transportation Industry;
France;
United States
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 May 2024.)