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- All HBS Web
(229)
- News (33)
- Research (163)
- Multimedia (4)
- Faculty Publications (61)
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- 16 May 2016
- HBS Case
Food Safety Economics: The Cost of a Sick Customer
product, it can affect the entire supply for that brand. China implemented stricter food safety laws in April 2015, but the country may not have enough qualified enforcement staff. And inspectors don’t always enforce View Details
- May–June 2013
- Article
Can Global Brands Create Just Supply Chains? Response: Promoting Political Mobilization
By: Jodi L. Short and Michael W. Toffel
Codes of conduct indicate that working conditions are improving overall at the factories being monitored by multinational corporations, and that these codes of conduct also create possibilities for political mobilization that can improve labor conditions more broadly. View Details
Keywords: Regulation; Auditing; Labor Relations; Occupational Safety; Environmental Operations; Environmental Regulation; Employees; Labor; Labor and Management Relations; Governing Rules, Regulations, and Reforms; Manufacturing Industry; China; Bangladesh; India; Honduras; Nicaragua; Pakistan; Guatemala; Malaysia; Viet Nam
Short, Jodi L., and Michael W. Toffel. "Can Global Brands Create Just Supply Chains? Response: Promoting Political Mobilization." Boston Review 38, no. 3 (May–June 2013).
- 03 Dec 2015
- Op-Ed
How "New Nuclear" Power Could Save the Planet—If Regulators Would Allow It
Leaders from some 150 nations have convened in Paris this week for the COP21 conference with a singular goal: to fight the global threat of climate change. Each of them have brought to Paris their own national plan for reducing greenhouse gas emissions that drive... View Details
- November 2017
- Case
The 'Wonder Drug' That Killed Babies
By: Joshua Lev Krieger, Tom Nicholas and Matthew Preble
In the early 1960s, a popular drug taken by patients worldwide for a range of maladies was found to cause severe birth defects and other health problems in babies born to mothers who had taken it during a certain stage of fetal development. As many as 10,000 children... View Details
Keywords: Regulation; Business and Government Relations; Business and Community Relations; Business and Stakeholder Relations; Product Marketing; Corporate Social Responsibility and Impact; Business History; Health; Government Legislation; Corporate Accountability; Ethics; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; Public Administration Industry; United States; United Kingdom; Australia; Germany; Europe
Krieger, Joshua Lev, Tom Nicholas, and Matthew Preble. "The 'Wonder Drug' That Killed Babies." Harvard Business School Case 818-044, November 2017.
- 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... View Details
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).
- Forthcoming
- Article
Sending a Message: An Empirical Assessment of Responses to Punitive and Non-punitive Compliance Messaging Strategies
By: Jodi L. Short, Michael W. Toffel, Elizabeth A. Keenan and Melissa Ouellet
Regulators operate in an increasingly hostile political environment. The U.S. Supreme Court is ramping up efforts to curtail the authority of administrative agencies. The second election of Donald Trump to the presidency has unleashed a torrent of anti-regulatory... View Details
Keywords: Field Experiment; Compliance; Compliance Programs; Compliance Policies; Regulatory Enforcement; Environmental Regulation; Environmental Policy; Government Experimentation; Governance Compliance; Government Administration; Governing Rules, Regulations, and Reforms; Business and Government Relations; Construction Industry; Public Administration Industry; California; United States
Short, Jodi L., Michael W. Toffel, Elizabeth A. Keenan, and Melissa Ouellet. "Sending a Message: An Empirical Assessment of Responses to Punitive and Non-punitive Compliance Messaging Strategies." Ecology Law Quarterly (forthcoming).
- August 2019 (Revised February 2020)
- Teaching Note
Sidewalk Labs: Privacy in a City Built from the Internet Up
By: Leslie John and Mitch Weiss
Email mking@hbs.edu for a courtesy copy.
The case serves as a microcosm of issues of digital privacy: the availability of data – personal data in particular – has tremendous potential to improve people’s lives... View Details
The case serves as a microcosm of issues of digital privacy: the availability of data – personal data in particular – has tremendous potential to improve people’s lives... View Details
Keywords: Privacy; Privacy By Design; Privacy Regulation; Platforms; Data; Data Security; Behavioral Science; Analytics and Data Science; Safety; Entrepreneurship; Business and Government Relations; Consumer Behavior; Digital Platforms
John, Leslie, and Mitch Weiss. "Sidewalk Labs: Privacy in a City Built from the Internet Up." Harvard Business School Teaching Note 820-023, August 2019. (Revised February 2020.) (Email mking@hbs.edu for a courtesy copy.)
- Fall 2016
- Article
The Integrity of Private Third-party Compliance Monitoring
By: Jodi L. Short and Michael W. Toffel
Government agencies are increasingly turning to private, third-party monitors to inspect and assess regulated entities’ compliance with law. The integrity of these regulatory regimes rests on the validity of the information third-party monitors provide to regulators.... View Details
Keywords: Regulation; Compliance; Compliance Policies; Conflict Of Interest; Independent Third Party; Inspection; Audit Quality; Auditor; Audit; Environment; Safety; Conflict of Interests; Working Conditions; Labor; Corporate Social Responsibility and Impact; Governance Compliance; Accounting Audits
Short, Jodi L., and Michael W. Toffel. "The Integrity of Private Third-party Compliance Monitoring." Administrative & Regulatory Law News 42, no. 1 (Fall 2016): 22–25.
- 2015
- Working Paper
The Integrity of Private Third-party Compliance Monitoring
By: Jodi L. Short and Michael W. Toffel
Government agencies are increasingly turning to private, third-party monitors to inspect and assess regulated entities’ compliance with law. The integrity of these regulatory regimes rests on the validity of the information third-party monitors provide to regulators.... View Details
Keywords: Regulation; Compliance; Compliance Policies; Conflict Of Interest; Independent Third Party; Inspection; Audit Quality; Auditor; Audit; Environment; Production; Supply Chain; Quality; Government Administration; Working Conditions; Safety; Labor; Governing Rules, Regulations, and Reforms; Governance Compliance; Manufacturing Industry; Public Administration Industry; Accounting Industry; Service Industry; United States
Short, Jodi L., and Michael W. Toffel. "The Integrity of Private Third-party Compliance Monitoring." Harvard Kennedy School Regulatory Policy Program Working Paper, No. RPP-2015-20, November 2015. (Revised December 2015.)
- 12 Dec 2012
- Research & Ideas
Power to the People: The Unexpected Influence of Small Coalitions
environmentalists, consumer activists, women's organizations, health-care advocates, and farmers—wield great influence in areas of regulation including trade, product safety, and labor. Read an excerpt from the book. "It's important to... View Details
Keywords: by Kim Girard
- July 2019
- Article
Challenges and Opportunities in Software-Driven Medical Devices
By: William J. Gordon and Ariel Dora Stern
The safety and security of medical devices driven by software, the software-development processes, and the need for data collection and privacy, all offer challenges and opportunities for device regulation and clinical care. View Details
Keywords: Medical Devices; Healthcare; Health Care; Health Care and Treatment; Applications and Software; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry
Gordon, William J., and Ariel Dora Stern. "Challenges and Opportunities in Software-Driven Medical Devices." Nature Biomedical Engineering 3, no. 7 (July 2019): 493–497.
- 21 May 2012
- Research & Ideas
OSHA Inspections: Protecting Employees or Killing Jobs?
killing jobs at a time when the United States can ill afford to lose them. Few regulatory agencies have a more direct effect on businesses than the Occupational Safety and Health Administration (OSHA), the federal agency responsible for... View Details
Keywords: by Michael Blanding
- 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
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.
- Forthcoming
- Article
Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
By: Amitabh Chandra, Jennifer Kao, Kathleen L. Miller and Ariel Dora Stern
Regulators of new products confront a tradeoff between speeding a product to market and collecting additional product quality information. The FDA's Breakthrough Therapy Designation (BTD) provides an opportunity to understand if regulators can use new policy to... View Details
Keywords: Innovation and Invention; Governing Rules, Regulations, and Reforms; Government Administration; Research and Development; Pharmaceutical Industry
Chandra, Amitabh, Jennifer Kao, Kathleen L. Miller, and Ariel Dora Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." Review of Economics and Statistics (forthcoming). (Pre-published online March 18, 2024.)
- October 2024
- Case
EU's Digital Services Act and Digital Markets Act
By: David B. Yoffie and Sarah von Bargen
Since the early 2020s, the EU began passing regulations on digital platforms and their marketplaces. One of the first was the Digital Services Act package, consisting of the Digital Services Act (DSA) and the Digital Markets Act (DMA). These regulations were focused on... View Details
Keywords: Digital Platforms; E-commerce; Governing Rules, Regulations, and Reforms; Cybersecurity; European Union
Yoffie, David B., and Sarah von Bargen. "EU's Digital Services Act and Digital Markets Act." Harvard Business School Case 725-372, October 2024.
- 2008
- Working Paper
Extending Producer Responsibility: An Evaluation Framework for Product Take-Back Policies
By: Michael W. Toffel, Antoinette Stein and Katharine Lee
Manufacturers are increasingly being required to adhere to product take-back regulations that require them to manage their products at the end of life. Such regulations seek to internalize products' entire life cycle costs into market prices, with the ultimate... View Details
Toffel, Michael W., Antoinette Stein, and Katharine Lee. "Extending Producer Responsibility: An Evaluation Framework for Product Take-Back Policies." Harvard Business School Working Paper, No. 09-026, July 2008. (September 2008.)
- 28 Mar 2023
- Research & Ideas
The FDA’s Speedy Drug Approvals Are Safe: A Win-Win for Patients and Pharma Innovation
Early in the COVID-19 pandemic, the US Food and Drug Administration faced the task of convincing a skeptical public of the safety of new vaccines when the agency began authorizing them for emergency use less than a year after the pandemic... View Details
- 2020
- Working Paper
Improving Regulatory Effectiveness Through Better Targeting: Evidence from OSHA
By: Matthew S. Johnson, David I. Levine and Michael W. Toffel
We study how a regulator can best target inspections. Our case study is a US Occupational Safety and Health Administration (OSHA) program that randomly allocated some inspections. On average, each inspection averted 2.4 serious injuries (9%) over the next five years.... View Details
Keywords: Government Administration; Working Conditions; Safety; Quality; Production; Analysis; Resource Allocation; Manufacturing Industry; United States
Johnson, Matthew S., David I. Levine, and Michael W. Toffel. "Improving Regulatory Effectiveness Through Better Targeting: Evidence from OSHA." Harvard Business School Working Paper, No. 20-019, August 2019. (Revised February 2020.)
- 10 Dec 2021
- Research & Ideas
Truth Be Told: Unpacking the Risks of Whistleblowing
complaint, but the class discussion turned to the motivations of the man who revealed the wrongdoing. Have you ever thought about blowing the whistle? Dey asked her students. Their response: We’ve thought about it, but it is so costly. At a time when View Details
Keywords: by April White
- 06 Nov 2008
- Working Paper Summaries