Publications
Publications
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- All HBS Web
(366)
- Faculty Publications (128)
- 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
- 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... View Details
- 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,... View Details
- 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... View Details
- 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... View Details
- August 2022
- Article
Availability of New Medicines in the U.S. and Germany From 2004 to 2018
By: Katharina Blankart, Huseyin Naci and Amitabh Chandra
Importance: Germany's unique approach to coverage determination and pricing has ensured that effective medicines remain on the market, often at prices reduced through negotiation. However, less is known about trade-offs of this approach with regard to initial... View Details
- 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... View Details
- 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... View Details
- 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... View Details
- 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... View Details
- 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... View Details
- Article
The Harmonization of Lending Standards within Banks through Mandated Loan-Level Transparency
By: Jung Koo Kang, Maria Loumioti and Regina Wittenberg-Moerman
We explore whether the introduction of transparent reporting rules increases credit standard harmonization within a bank. We exploit the new loan-level reporting rules imposed on banks that borrow from the European Central Bank using repurchase agreements... View Details
- Article
The Covid-19 Pandemic Should Not Delay Actions to Prevent Anticompetitive Consolidation in U.S. Health Care Markets
By: Leemore S. Dafny
This article describes potential regulatory and legislative reforms to assist antitrust enforcement agencies in halting anticompetitive acquisitions and practices, and preserving and promoting competition in health care markets. View Details
- 2021
- Working Paper
Regulatory Approval and Expanded Market Size
By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality... View Details
- 2021
- Article
To Thine Own Self Be True? Incentive Problems in Personalized Law
By: Jordan M. Barry, John William Hatfield and Scott Duke Kominers
Recent years have seen an explosion of scholarship on “personalized law.” Commentators foresee a world in which regulators armed with big data and machine learning techniques determine the optimal legal rule for every regulated party, then instantaneously disseminate... View Details
Keywords: Personalized Law; Regulation; Regulatory Avoidance; Regulatory Arbitrage; Law And Economics; Law And Technology; Law And Artificial Intelligence; Futurism; Moral Hazard; Elicitation; Signaling; Privacy; Law; Governing Rules, Regulations, and Reforms; Information Technology; AI and Machine Learning
- Article
Ten Year Sunset Rule for Healthcare Regulation Is a Nonstarter and Discouragement to Post-COVID-19 Investment
By: Regina E. Herzlinger and Eugene Schneller
U.S. healthcare delivery has not benefitted from the same productivity growth as many other service industries, such as bricks and mortar retailing, a loss that has gravely diminished cost control and access. Regulatory capture, which creates barriers to venture... View Details
- March 2021 (Revised December 2021)
- Supplement
Ant Financial (D)
By: Feng Zhu, Krishna G. Palepu, Kerry Herman and Susie Ma
The (D) case updates the case series from the time of Ant’s planned IPO, and the Chinese government’s regulatory shifts. View Details
- November 2020 (Revised March 2023)
- Case
Zipline: The World's Largest Drone Delivery Network
By: Tarun Khanna and George Gonzalez
Zipline established the world's largest logistics network in Rwanda and Ghana by delivering medical supplies to hospitals via automated drones. The company is now looking to expand in the U.S. and partnered with Walmart to expand into home delivery. Zipline must... View Details
- Article
Does Your Company Need a Chief Medical Officer?
By: Tsedal Neeley
With the Covid-19 pandemic still raging but businesses trying to remain operational, organizations now have a life or death role to play in protecting the health of employees, customers, and the public. That means they need a new executive in the C-suite: a chief... View Details
- September 2020
- Article
Regulatory Sandboxes: A Cure for mHealth Pilotitis?
By: Abhishek Bhatia, Rahul Matthan, Tarun Khanna and Satchit Balsari
Mobile health (mHealth) and related digital health interventions in the past decade have not always scaled globally as anticipated earlier despite large investments by governments and philanthropic foundations. The implementation of digital health tools has suffered... View Details