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- Faculty Publications (125)
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All HBS Web
(346)
- Faculty Publications (125)
- 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.
- 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...
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Keywords:
Transparency;
External And Internal Reporting;
Credit Term Harmonization;
Regulatory Scrutiny;
Banks and Banking;
Credit;
Financial Reporting;
Governing Rules, Regulations, and Reforms;
Learning
Kang, Jung Koo, Maria Loumioti, and Regina Wittenberg-Moerman. "The Harmonization of Lending Standards within Banks through Mandated Loan-Level Transparency." Journal of Accounting & Economics 72, no. 1 (August 2021): 101386.
- Article
Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring
By: Jan Benedikt Brönneke, Jennifer Müller, Konstantinos Mouratis, Julia Hagen and Ariel Dora Stern
In the area of cardiac monitoring, the use of digitally driven technologies is on the rise. While the development of medical products is advancing rapidly, allowing for new use-cases in cardiac monitoring and other areas, regulatory and legal requirements that govern...
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Keywords:
Wearables;
Regulatory Changes;
Medical Technology;
Medical Devices;
Market Access;
Market Entry and Exit;
Information Technology;
Health Care and Treatment;
Governing Rules, Regulations, and Reforms;
United States;
Germany;
Belgium
Brönneke, Jan Benedikt, Jennifer Müller, Konstantinos Mouratis, Julia Hagen, and Ariel Dora Stern. "Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring." Art. 4937. Sensors 21, no. 14 (July 2021).
- 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.
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Keywords:
Health Care and Treatment;
Markets;
Competition;
Governing Rules, Regulations, and Reforms
Dafny, Leemore S. "The Covid-19 Pandemic Should Not Delay Actions to Prevent Anticompetitive Consolidation in U.S. Health Care Markets." Promarket (June 10, 2021).
- 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...
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Keywords:
New Medicines;
Regulatory Approval;
Health Care and Treatment;
Research and Development;
Governing Rules, Regulations, and Reforms;
Markets;
Expansion;
Pharmaceutical Industry
Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
- 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...
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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
Barry, Jordan M., John William Hatfield, and Scott Duke Kominers. "To Thine Own Self Be True? Incentive Problems in Personalized Law." Art. 2. William & Mary Law Review 62, no. 3 (2021).
- Article
Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials
By: Caroline Marra, William J. Gordon and Ariel Dora Stern
Objectives: In an effort to mitigate COVID-19 related challenges for clinical research, the U.S. Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of...
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Keywords:
Connected Digital Products;
Telehealth;
Remote Monitoring;
Health Testing and Trials;
Research;
Governing Rules, Regulations, and Reforms;
Information Technology
Marra, Caroline, William J. Gordon, and Ariel Dora Stern. "Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials." BMJ Open 11, no. 6 (2021).
- 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...
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Keywords:
Health Care;
COVID-19;
Regulation;
Health Care and Treatment;
Health Pandemics;
Governing Rules, Regulations, and Reforms;
Investment
Herzlinger, Regina E., and Eugene Schneller. "Ten Year Sunset Rule for Healthcare Regulation Is a Nonstarter and Discouragement to Post-COVID-19 Investment." Journal of Health Care Finance 47, no. 4 (Spring 2021). (Special Commentary.)
- 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.
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Keywords:
Finance;
Information Technology;
Governing Rules, Regulations, and Reforms;
Financial Services Industry;
Technology Industry;
China;
Beijing
Zhu, Feng, Krishna G. Palepu, Kerry Herman, and Susie Ma. "Ant Financial (D)." Harvard Business School Supplement 621-089, March 2021. (Revised December 2021.)
- March 2021
- Article
The Effectiveness of White-Collar Crime Enforcement: Evidence from the War on Terror
By: Trung Nguyen
This paper analyzes the impact of changes in regulatory priorities and resource allocation on criminal enforcement of white‐collar criminal activities. Using the 9/11 terrorist attacks as a shock to the FBI's priorities and allocation of investigative resources, as...
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Keywords:
White-collar Crime;
Government Regulation;
Financial Fraud;
Securities Fraud;
Insider Trading;
Crime and Corruption;
Finance;
Governing Rules, Regulations, and Reforms;
Law Enforcement
Nguyen, Trung. "The Effectiveness of White-Collar Crime Enforcement: Evidence from the War on Terror." Journal of Accounting Research 59, no. 1 (March 2021): 5–58.
- 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...
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Keywords:
Drones;
Business Startups;
Expansion;
Growth and Development Strategy;
Governing Rules, Regulations, and Reforms;
Medical Devices and Supplies Industry;
United States;
Africa
Khanna, Tarun, and George Gonzalez. "Zipline: The World's Largest Drone Delivery Network." Harvard Business School Case 721-366, November 2020. (Revised March 2023.)
- 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...
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Keywords:
COVID-19 Pandemic;
Health;
Health Pandemics;
Organizational Change and Adaptation;
Organizational Structure;
Safety;
Governing Rules, Regulations, and Reforms;
Working Conditions
Neeley, Tsedal. "Does Your Company Need a Chief Medical Officer?" Harvard Business Review (website) (October 1, 2020).
- 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...
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Keywords:
COVID-19;
mHealth;
Digital Health;
Design Thinking;
Regulation;
Intervention;
Regulatory Sandbox;
Health Care and Treatment;
Technological Innovation;
Design;
Governing Rules, Regulations, and Reforms;
India
Bhatia, Abhishek, Rahul Matthan, Tarun Khanna, and Satchit Balsari. "Regulatory Sandboxes: A Cure for mHealth Pilotitis?" Journal of Medical Internet Research 22, no. 9 (September 2020).
- 2020
- Working Paper
How Should U.S. Bank Regulators Respond to the COVID-19 Crisis?
Drawing on lessons from the 2007–2009 Global Financial Crisis (GFC) and a simple conceptual framework, we examine the response of U.S. bank regulators to the COVID-19 pandemic. We argue that the current regulatory strategy of “watchful waiting”—the same strategy that...
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Keywords:
COVID-19;
Bank Regulation;
Recapitalization;
Health Pandemics;
Banks and Banking;
Governing Rules, Regulations, and Reforms;
Strategy;
Risk Management;
United States
Blank, Michael, Samuel G. Hanson, Jeremy C. Stein, and Adi Sunderam. "How Should U.S. Bank Regulators Respond to the COVID-19 Crisis?" Hutchins Center Working Paper, No. 63, June 2020.
- 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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Keywords:
Machine Learning;
Causal Inference;
Health Care and Treatment;
Safety;
Governing Rules, Regulations, and Reforms
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.