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- 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
- 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.
- 2023
- Article
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices...
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Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
- January 2023 (Revised March 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
- 2022
- Working Paper
Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data
By: Alexander O. Everhart and Ariel D. Stern
Medical devices increasingly include software components, which facilitate remote patient monitoring. The introduction of software into previously analog medical devices as well as innovation in software-driven devices may introduce new safety concerns—all the more so...
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Keywords:
Technological Innovation;
Safety;
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Medical Devices and Supplies Industry
Everhart, Alexander O., and Ariel D. Stern. "Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data." Harvard Business School Working Paper, No. 23-035, November 2022.
- 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 December 2022)
- 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 December 2022.)
- 2022
- Article
Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response
By: Alexander MacKay and Samuel N. Weinstein
Pricing algorithms are rapidly transforming markets, from ride-sharing apps, to air travel, to online retail. Regulators and scholars have watched this development with a wary eye. Their focus so far has been on the potential for pricing algorithms to facilitate...
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Keywords:
Competition Policy;
Regulation;
Algorithmic Pricing;
Dynamic Pricing;
Economics;
Law And Economics;
Law And Regulation;
Consumer Protection;
Antitrust Law;
Industrial Organization;
Antitrust Issues And Policies;
Technological Change: Choices And Consequences;
Competition;
Policy;
Price;
Governing Rules, Regulations, and Reforms;
Microeconomics;
Duopoly and Oligopoly;
Law
MacKay, Alexander, and Samuel N. Weinstein. "Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response." Washington University Law Review 100, no. 1 (2022): 111–174. (Direct download.)
- September 2022
- Article
Regulatory Spillover and Workplace Racial Inequality
By: Letian Zhang
This paper suggests that affirmative action bans in the U.S. public sector may influence racial inequality in the private sector. Since the 1990s, nine states have banned affirmative action practice in public universities and state governments. Though these bans have...
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Keywords:
Inequality;
Regulation;
Law;
Organizational Norm;
CEO;
Affirmative Action;
Organizations;
Private Sector;
Equality and Inequality;
Diversity;
Race;
Governing Rules, Regulations, and Reforms
Zhang, Letian. "Regulatory Spillover and Workplace Racial Inequality." Administrative Science Quarterly 67, no. 3 (September 2022): 595–629.
- August 2022
- Article
Regulatory Considerations to Keep Pace with Innovation in Digital Health Products
By: John Torous, Ariel Dora Stern and Florence T. Bourgeois
Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a...
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Keywords:
Emerging Technologies;
Governing Rules, Regulations, and Reforms;
Innovation and Invention;
Medical Devices and Supplies Industry
Torous, John, Ariel Dora Stern, and Florence T. Bourgeois. "Regulatory Considerations to Keep Pace with Innovation in Digital Health Products." npj Digital Medicine 5, no. 121 (August 2022).
- 2022
- Article
Regulatory Treatment of Changes in Fair Value and the Composition of Banks' Investment Portfolios
By: Michael Iselin, Jung Koo Kang and Joshua Madsen
In their implementation of Basel III, U.S. bank regulators are again including changes in the fair value of available-for-sale (AFS) debt securities in Tier 1 capital, but only for the largest U.S. banks. This paper investigates a potential impact of expanding this...
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Keywords:
Fair Value Accounting;
SFAS 115;
Basel III;
Governing Rules, Regulations, and Reforms;
Banks and Banking;
Debt Securities;
Credit;
Risk and Uncertainty;
Investment Portfolio;
Decision Making;
Banking Industry;
United States
Iselin, Michael, Jung Koo Kang, and Joshua Madsen. "Regulatory Treatment of Changes in Fair Value and the Composition of Banks' Investment Portfolios." Journal of Financial Reporting 7, no. 1 (2022): 123–143.
- June 9, 2023
- Article
A Radical Treatment for Insulin Pricing
By: Leemore S. Dafny
In 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar for long-acting insulin, which many hoped would be substantially cheaper than the reference branded product. I explain why prices have barely changed, and argue that a...
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Keywords:
Biosimilars;
Rebates;
Pharmaceuticals;
Health Care and Treatment;
Price;
Governing Rules, Regulations, and Reforms;
Pharmaceutical Industry;
United States
Dafny, Leemore S. "A Radical Treatment for Insulin Pricing." New England Journal of Medicine 386, no. 23 (June 9, 2023): 2157–2159.
- 2022
- Chapter
Measuring Compliance Risk and the Emergence of Analytics
By: Eugene F. Soltes
Corporate compliance manages a diverse set of regulatory and reputational concerns ranging from fraud to privacy to discrimination. However, effectively managing such risks has often been hampered by a lack of adequate information about when, where, and why misconduct...
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Keywords:
Compliance;
Risk;
Analytics;
Governance Compliance;
Governing Rules, Regulations, and Reforms;
Risk Management;
Analytics and Data Science
Soltes, Eugene F. "Measuring Compliance Risk and the Emergence of Analytics." Chap. 8 in Measuring Compliance: Assessing Corporate Crime and Misconduct Prevention, edited by Melissa Rorie and Benjamin van Rooij, 137–152. Cambridge University Press, 2022.
- 2021
- Working Paper
Capitalism, Slavery, and the Legacy of Cesare Beccaria
The Milanese Marquis Cesare Beccaria (1738-1794) dedicated his life first to theorizing a more just and equal society grounded in individual rights, anchored in secular political economy rather than in religious dogma, then to realizing this bold vision...
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Reinert, Sophus A. "Capitalism, Slavery, and the Legacy of Cesare Beccaria." Harvard Business School Working Paper, No. 22-034, December 2021. (Revised January 2022.)
- October 2021
- Article
Can Self-Regulation Save Digital Platforms?
By: Michael A. Cusumano, Annabelle Gawer and David B. Yoffie
This article explores some of the critical challenges facing self-regulation and the regulatory environment for digital platforms. We examine several historical examples of firms and industries that attempted self-regulation before the Internet. All dealt with similar...
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Keywords:
Self-regulation;
Government Regulation;
Digital Platforms;
Governing Rules, Regulations, and Reforms
Cusumano, Michael A., Annabelle Gawer, and David B. Yoffie. "Can Self-Regulation Save Digital Platforms?" Industrial and Corporate Change 30, no. 5 (October 2021): 1259–1285.