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- 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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- 2022
- Working Paper
The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives
By: Ariel Dora Stern
For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with...
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- 2022
- Working Paper
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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- 2022
- Working Paper
Do Safety Management System Standards Indicate Safer Operations? Evidence from the OHSAS 18001 Occupational Health and Safety Standard
By: Kala Viswanathan, Matthew S. Johnson and Michael W. Toffel
Problem definition: In light of the enormous disruptions and costs associated with occupational injuries, companies and buyers are increasingly looking to voluntary occupational health and safety standards to improve worker safety. Yet because these standards...
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- Article
Internal Deadlines, Drug Approvals, and Safety Problems
By: Lauren Cohen, Umit Gurun and Danielle Li
Absent explicit quotas, incentives, reporting, or fiscal year-end motives, drug approvals around the world surge in December, at month-ends, and before respective major national holidays. Drugs approved before these informal deadlines are associated with significantly...
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- June 2020
- Article
How Scheduling Can Bias Quality Assessment: Evidence from Food Safety Inspections
By: Maria Ibanez and Michael W. Toffel
Accuracy and consistency are critical for inspections to be an effective, fair, and useful tool for assessing risks, quality, and suppliers—and for making decisions based on those assessments. We examine how inspector schedules could introduce bias that erodes...
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- 2020
- Discussion Paper
Acting Now While Preparing for Tomorrow: Competitiveness Upgrading Under the Shadow of COVID-19
By: Christian H.M. Ketels and Peter Clinch
This paper aims to provide policy makers, especially those focused on the longer-term growth potential
of their countries, with an initial framework to think about their action priorities in the context of the
overall COVID-19 response. Our focus is on the...
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- 2021
- Working Paper
Elusive Safety: The New Geography of Capital Flows and Risk
By: Laura Alfaro, Ester Faia, Ruth Judson and Tim Schmidt-Eisenlohr
A confidential dataset with industry-level disaggregation of U.S. cross-border claims and liabilities, shows U.S. securities to be increasingly intermediated by tax-haven-financial-centers (THFC) and less regulated funds. These securities are risky, in...
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- 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...
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- January 2020
- Case
Governing PG&E
By: Lynn S. Paine and Will Hurwitz
The five commissioners of the California Public Utilities Commission (CPUC) listened intently at a public forum in April 2019 as PG&E Corporation’s out-going chairman Richard Kelly described the company’s proposed new board. PG&E, which provided electricity and natural...
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Keywords:
Bankruptcy;
Board Of Directors;
Board Dynamics;
Business Ethics;
Business Model Innovation;
Corporate Boards;
Energy Efficiency;
Environmental And Social Sustainability;
Government And Business;
Hedge Funds;
Institutional Investors;
Legal Aspects Of Business;
Regulated Monopolies;
Regulation;
Shareholders;
Stakeholder Management;
Strategy And Execution;
Utilities;
Insolvency and Bankruptcy;
Governing and Advisory Boards;
Ethics;
Capital Structure;
Climate Change;
Corporate Accountability;
Corporate Governance;
Environmental Sustainability;
Executive Compensation;
Leadership;
Management;
Safety;
Business and Government Relations;
Energy Industry;
Utilities Industry;
California;
United States
- September 2019 (Revised May 2020)
- Case
Keroche (A): Fighting for Share in the Kenyan Alcoholic Drinks Market
By: Ramon Casadesus-Masanell and Pippa Tubman Armerding
This case discusses the challenges faced by Kenyan alcoholic drinks producer Keroche Industries Limited in 2003, when the Kenyan government accused the company of manufacturing and selling substandard alcoholic drinks, revoked its liquor licenses, and shut down its...
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Keywords:
Keroche;
Alcohol;
Wine;
Manufacturing;
Informal Market;
Regulation;
Illicit;
Illegal;
Shutdown;
Factory;
Low-income Consumers;
Multinational;
Local;
Government;
Allegations;
Accusations;
Negative Press;
EABL;
Tusker;
Beer;
SAB;
Chang'aa;
Naivasha;
Rift Valley;
East Africa;
Lawsuit;
Legal Battle;
Business Ventures;
Business Exit or Shutdown;
Business Growth and Maturation;
Business Startups;
Production;
Safety;
Quality;
Distribution;
Small Business;
Family Business;
Crime and Corruption;
Customer Focus and Relationships;
Decisions;
Income;
Demographics;
Geographic Scope;
Geographic Location;
Goods and Commodities;
Government Legislation;
Growth and Development;
Business History;
Lawsuits and Litigation;
Laws and Statutes;
Lawfulness;
Goals and Objectives;
Consumer Behavior;
Market Entry and Exit;
Problems and Challenges;
Social Issues;
Poverty;
Strategy;
Competition;
Entrepreneurship;
Manufacturing Industry;
Food and Beverage Industry;
Kenya;
Nairobi;
Africa
- September 2019
- Supplement
Keroche (B): Considering Entry into the Kenyan Beer Market
By: Ramon Casadesus-Masanell and Pippa Tubman Armerding
This case discusses the situation of the Kenyan alcoholic drinks producer Keroche in July 2004, when co-founder Tabitha Karanja was debating whether to enter the Kenyan beer market. Doing so would mean direct competition with the multinational EABL in an industry and...
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Keywords:
Keroche;
Alcohol;
Alcoholic Drinks;
Alcoholic Beverages;
Beverages;
Drinks;
Wine Industry;
Wine;
Fortified Wine;
Viena;
Beer;
Beer Market;
Manufacturing;
Production Capacity;
Capacity;
Growth;
Regulated;
Unregulated;
Informal;
Informal Market;
Regulation;
Illicit;
Illegal;
Substandard;
Dangerous;
Shutdown;
Factory;
Safe;
Affordable;
Low-income Consumers;
Business Growth and Maturation;
Business Startups;
Production;
Investment;
Safety;
Quality;
Small Business;
Family Business;
Crime and Corruption;
Customer Focus and Relationships;
Decisions;
Income;
Demographics;
Geographic Scope;
Geographic Location;
Goods and Commodities;
Government Legislation;
Growth and Development;
Business History;
Lawsuits and Litigation;
Laws and Statutes;
Lawfulness;
Goals and Objectives;
Consumer Behavior;
Market Entry and Exit;
Problems and Challenges;
Social Issues;
Poverty;
Strategy;
Competition;
Entrepreneurship;
Marketing;
Manufacturing Industry;
Food and Beverage Industry;
Kenya;
Nairobi;
Africa
- 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....
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- 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
- 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.
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- Article
Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries
By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer
Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... 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...
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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
- October 2017 (Revised April 2018)
- Case
Improving Worker Safety in the Era of Machine Learning (A)
By: Michael W. Toffel, Dan Levy, Jose Ramon Morales Arilla and Matthew S. Johnson
Managers make predictions all the time: How fast will my markets grow? How much inventory do I need? How intensively should I monitor my suppliers? Which potential customers will be most responsive to a particular marketing campaign? Which job candidates should I...
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- 2018
- Working Paper
How Scheduling Can Bias Quality Assessment: Evidence from Food Safety Inspections
By: Maria Ibanez and Michael W. Toffel
Many production processes are subject to inspection to ensure they meet quality, safety, and environmental standards imposed by companies and regulators. Inspection accuracy is critical to inspections being a useful input to assessing risks, allocating quality...
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- 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....
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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