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Publications

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    • All HBS Web  (211)
      • Faculty Publications  (34)

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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...  View Details
      Keywords: Research and Development; Governing Rules, Regulations, and Reforms; Product Development
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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.
      • 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...  View Details
      Keywords: AI and Machine Learning; Health Care and Treatment; Governing Rules, Regulations, and Reforms; Technological Innovation; Medical Devices and Supplies Industry
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      Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." NBER Working Paper Series, No. 30639, December 2022.
      • 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....  View Details
      Keywords: Economics Of Science; Risk Perception; Safety Regulations; Safety; Working Conditions; Governing Rules, Regulations, and Reforms; Innovation and Invention
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      Galasso, Alberto, Hong Luo, and Brooklynn Zhu. "Laboratory Safety and Research Productivity." Harvard Business School Working Paper, No. 22-072, May 2022.
      • 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...  View Details
      Keywords: Occupational Health; Occupational Safety; Program Evaluation; Safety Performance; Injuries; OHSAS 18001; ISO 45001; Standards; Safety; Quality; Operations; Performance Evaluation; Manufacturing Industry; United States
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      Viswanathan, Kala, Matthew S. Johnson, and Michael W. Toffel. "Do Safety Management System Standards Indicate Safer Operations? Evidence from the OHSAS 18001 Occupational Health and Safety Standard." Harvard Business School Working Paper, No. 22-042, December 2021. (Revised November 2022.)
      • 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...  View Details
      Keywords: Health; Economics; Government and Politics; Innovation and Invention; Research; Science; Biotechnology Industry; Health Industry; Pharmaceutical Industry
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      Cohen, Lauren, Umit Gurun, and Danielle Li. "Internal Deadlines, Drug Approvals, and Safety Problems." American Economic Review: Insights 3, no. 1 (March 2021): 67–82.
      • 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...  View Details
      Keywords: Assessment; Bias; Inspection; Scheduling; Econometric Analysis; Empirical Research; Regulation; Health; Food; Safety; Quality; Performance Consistency; Governing Rules, Regulations, and Reforms
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      Ibanez, Maria, and Michael W. Toffel. "How Scheduling Can Bias Quality Assessment: Evidence from Food Safety Inspections." Management Science 66, no. 6 (June 2020): 2396–2416. (Revised February 2019. Featured in Harvard Business Review, Forbes, Food Safety Magazine, Food Safety News, and KelloggInsight. (2020 MSOM Responsible Research Finalist.))
      • 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...  View Details
      Keywords: Competitiveness; COVID-19 Pandemic; Competition; Government Administration; Health Pandemics; Economy; Supply Chain; Safety
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      Ketels, Christian H.M., and Peter Clinch. "Acting Now While Preparing for Tomorrow: Competitiveness Upgrading Under the Shadow of COVID-19." Discussion Paper, Institute for Strategy and Competitiveness, Boston, MA, US, 2020.
      • 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...  View Details
      Keywords: Tax Havens; Financial Centers; Geography Of Flows; Profit Shifting; Tax Avoidance; Risk; Safe Assets; Hetergeneous Firms; Endogenous Entry; Endogenous Monitoring; Regulatory Arbitrage; Assets; Safety; Risk and Uncertainty; Capital; Global Range
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      Alfaro, Laura, Ester Faia, Ruth Judson, and Tim Schmidt-Eisenlohr. "Elusive Safety: The New Geography of Capital Flows and Risk." Harvard Business School Working Paper, No. 20-099, March 2020. (Revised February 2021.)
      • 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...  View Details
      Keywords: Machine Learning; Causal Inference; Health Care and Treatment; Safety; Governing Rules, Regulations, and Reforms
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      Stern, Ariel Dora, and W. Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.
      • 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...  View Details
      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
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      Paine, Lynn S., and Will Hurwitz. "Governing PG&E." Harvard Business School Case 320-024, January 2020.
      • 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...  View Details
      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
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      Casadesus-Masanell, Ramon, and Pippa Tubman Armerding. "Keroche (A): Fighting for Share in the Kenyan Alcoholic Drinks Market." Harvard Business School Case 720-390, September 2019. (Revised May 2020.)
      • 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...  View Details
      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
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      Casadesus-Masanell, Ramon, and Pippa Tubman Armerding. "Keroche (B): Considering Entry into the Kenyan Beer Market." Harvard Business School Supplement 720-391, September 2019.
      • 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
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      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.)
      • 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
      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
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      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.)
      • 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
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      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.
      • 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
      Keywords: Digital; Medicine; FDA; Health Care and Treatment; Applications and Software; Safety; Cybersecurity; Medical Devices and Supplies Industry
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      Stern, Ariel Dora, William J. Gordon, Adam B. Landman, and Daniel B. Kramer. "Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries." BMJ Open 9, no. 6 (June 2019).
      • 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
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      Krieger, Joshua Lev, Tom Nicholas, and Matthew Preble. "The 'Wonder Drug' That Killed Babies." Harvard Business School Case 818-044, November 2017.
      • 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...  View Details
      Keywords: Machine Learning; Policy Implementation; Empirical Research; Inspection; Occupational Safety; Occupational Health; Regulation; Analysis; Forecasting and Prediction; Policy; Operations; Supply Chain Management; Safety; Manufacturing Industry; Construction Industry; United States
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      Toffel, Michael W., Dan Levy, Jose Ramon Morales Arilla, and Matthew S. Johnson. "Improving Worker Safety in the Era of Machine Learning (A)." Harvard Business School Case 618-019, October 2017. (Revised April 2018.)
      • 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...  View Details
      Keywords: Assessment; Bias; Inspection; Scheduling; Econometric Analysis; Empirical Research; Regulation; Health; Food; Safety; Quality; Performance Consistency; Performance Evaluation; Food and Beverage Industry; Service Industry
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      Ibanez, Maria, and Michael W. Toffel. "How Scheduling Can Bias Quality Assessment: Evidence from Food Safety Inspections." Harvard Business School Working Paper, No. 17-090, April 2017. (Revised October 2018. Formerly titled "Assessing the Quality of Quality Assessment: The Role of Scheduling". Featured in Forbes, Food Safety Magazine, and Food Safety News.)
      • 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
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      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.
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