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- Faculty Publications (214)
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- All HBS Web (365)
- Faculty Publications (214)
- May 2024
- Article
Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms
By: Caroline Marra and Ariel D. Stern
Digital health technologies (DHTs) can enable more patient-centric therapeutic development by generating evidence that captures how patients feel and function, enabling decentralized trial designs that increase participant inclusivity and convenience, and collecting... View Details
Keywords: Health Care and Treatment; Technological Innovation; Product Development; Health Testing and Trials; Governing Rules, Regulations, and Reforms
Marra, Caroline, and Ariel D. Stern. "Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms." Clinical Pharmacology & Therapeutics 115, no. 5 (May 2024): 988–992.
- July 2010 (Revised June 2012)
- Background Note
Note: Regulation of Hedge Fund Managers in the U.K. Before and After the Global Financial Crisis
By: Robert C. Pozen and Melissa Anne Hammerle
This note will examine the regulatory framework for hedge funds in the United Kingdom (UK) before and after the financial crisis of 2008. First, it will discuss European Union (EU)-level regulation that applies to the UK as an EU member state. Second, it will discuss... View Details
Keywords: Financial Crisis; Investment Funds; Governing Rules, Regulations, and Reforms; Laws and Statutes; Business and Government Relations; Financial Services Industry; European Union; United Kingdom
Pozen, Robert C., and Melissa Anne Hammerle. "Note: Regulation of Hedge Fund Managers in the U.K. Before and After the Global Financial Crisis." Harvard Business School Background Note 311-014, July 2010. (Revised June 2012.)
- August 1991 (Revised March 1993)
- Case
Champion International Corp.: Timber, Trade, and the Northern Spotted Owl
Champion's forest products division owns timberlands, sawmills, and plywood mills in the Pacific Northwest. The listing of the northern spotted owl as an endangered species, and restrictions on exports of logs from state-owned lands, have disrupted the stumpage, log... View Details
Keywords: Science-Based Business; Natural Environment; Product Marketing; Governing Rules, Regulations, and Reforms; Government and Politics; Environmental Sustainability; Corporate Strategy; Trade; Decisions; Management Teams; Forest Products Industry; North and Central America
Reinhardt, Forest L. "Champion International Corp.: Timber, Trade, and the Northern Spotted Owl." Harvard Business School Case 792-017, August 1991. (Revised March 1993.)
- February 26, 2024
- Article
Making Workplaces Safer Through Machine Learning
By: Matthew S. Johnson, David I. Levine and Michael W. Toffel
Machine learning algorithms can dramatically improve regulatory effectiveness. This short article describes the authors' scholarly work that shows how the U.S. Occupational Safety and Health Administration (OSHA) could have reduced nearly twice as many occupational... View Details
Keywords: Government Experimentation; Auditing; Inspection; Evaluation; Process Improvement; Government Administration; AI and Machine Learning; Safety; Governing Rules, Regulations, and Reforms
Johnson, Matthew S., David I. Levine, and Michael W. Toffel. "Making Workplaces Safer Through Machine Learning." Regulatory Review (February 26, 2024).
- 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
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).
- 2023
- Working Paper
When Insurers Exit: Climate Losses, Fragile Insurers, and Mortgage Markets
By: Pari Sastry, Ishita Sen and Ana-Maria Tenekedjieva
This paper studies how homeowners insurance markets respond to growing climate losses and how this impacts mortgage market dynamics. Using Florida as a case study, we show that traditional insurers are exiting high risk areas, and new lower quality insurers are... View Details
Keywords: Insurance; Natural Disasters; Governing Rules, Regulations, and Reforms; Insurance Industry; Florida
Sastry, Pari, Ishita Sen, and Ana-Maria Tenekedjieva. "When Insurers Exit: Climate Losses, Fragile Insurers, and Mortgage Markets." Harvard Business School Working Paper, No. 24-051, February 2024. (SSRN Working Paper Series, No. 4674279, December 2023.)
- Article
Red Light States: Who Buys Online Adult Entertainment?
By: Benjamin Edelman
This paper studies the adult online entertainment industry, particularly the consumption side of the market. In particular, it focuses on the demographics and consumption patterns of those who subscribe to adult entertainment websites. On the surface, this business... View Details
Keywords: Online Technology; Segmentation; Film Entertainment; Demographics; Web Sites; Competition; Governing Rules, Regulations, and Reforms; Demand and Consumers; Legal Liability; Culture; Religion; Entertainment and Recreation Industry; United States
Edelman, Benjamin. "Red Light States: Who Buys Online Adult Entertainment?" Journal of Economic Perspectives 23, no. 1 (Winter 2009): 209–220.
- Article
Is It Time for Auditor Independence Yet?
By: M. H. Bazerman and D. A. Moore
Well before the collapse of Enron and Arthur Andersen, we argued that the auditing system had been corrupted by the incentives auditors face to please their clients. We stated that even honest auditors were incapable of independence within the current regulatory... View Details
Keywords: Accounting Audits; Change; Crime and Corruption; Customer Satisfaction; Governing Rules, Regulations, and Reforms; Failure; Motivation and Incentives
Bazerman, M. H., and D. A. Moore. "Is It Time for Auditor Independence Yet?" Accounting, Organizations and Society 36, nos. 4-5 (May–July 2011): 310–312.
- January 2024 (Revised January 2025)
- Case
Huawei: Resilience amid Autarky and Adversity
By: William C. Kirby and Daniel Fu
In September 2023, Huawei made a dramatic return to the global smartphone space with the launch of its Mate 60 Pro smartphone, equipped with an indigenously designed, 7nm chip. This came despite a myriad of export controls and restrictions imposed against the company... View Details
Keywords: International Strategy; Semiconductors; Smartphone; Government And Politics; Government And Business; Digital Infrastructure; 5G; Political Risk; Business and Government Relations; Global Strategy; Multinational Firms and Management; Governing Rules, Regulations, and Reforms; AI and Machine Learning; Mobile and Wireless Technology; Leadership; Retirement; Corporate Strategy; Technology Industry; China; United States; Europe; Asia; Middle East
- August 2024
- Case
Zipline: Expanding the World's Largest Autonomous Drone Delivery Network
By: Tarun Khanna and George Gonzalez
Zipline initially established the world's largest logistics network in Rwanda and Ghana by delivering medical supplies to hospitals via automated drones from a centralized hub. The company is now looking to expand to the U.S. home delivery market and designed a... View Details
Keywords: Governing Rules, Regulations, and Reforms; Growth and Development Strategy; Logistics; Expansion; Air Transportation; Business Model; Rwanda; Ghana; United States
Khanna, Tarun, and George Gonzalez. "Zipline: Expanding the World's Largest Autonomous Drone Delivery Network." Harvard Business School Case 725-381, August 2024.
- 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
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.
- Article
Optimizing Organic Waste to Energy Operations
By: Baris Ata, Deishin Lee and Mustafa H. Tongarlak
A waste-to-energy firm that recycles organic waste with energy recovery performs two environmentally beneficial functions: it diverts waste from landfill and it produces renewable energy. At the same time, the waste-to-energy firm serves and collects revenue from two... View Details
Keywords: Business Ventures; Energy Generation; Renewable Energy; Revenue; Customers; Strategy; Corporate Governance; Wastes and Waste Processing; Environmental Sustainability; Governing Rules, Regulations, and Reforms; Cost Management; Urban Scope
Ata, Baris, Deishin Lee, and Mustafa H. Tongarlak. "Optimizing Organic Waste to Energy Operations." Manufacturing & Service Operations Management 14, no. 2 (Spring 2012): 231–244.
- 14 Mar 2011
- Research & Ideas
Keeping Credit Flowing to Consumers in Need
The credit crunch and subsequent collapse of the nonprime mortgage market claimed many victims, including hundreds of thousands of low- and moderate-income Americans who lost their homes and savings. Today, regulators and policymakers are debating ways to View Details
- February 2025
- Article
Disclosure, Humanizing, and Contextual Vulnerability of Generative AI Chatbots
By: Julian De Freitas and I. Glenn Cohen
In the wake of recent advancements in generative AI, regulatory bodies are trying to keep pace. One key decision is whether to require app makers to disclose the use of generative AI-powered chatbots in their products. We suggest that some generative AI-based chatbots... View Details
Keywords: AI and Machine Learning; Governing Rules, Regulations, and Reforms; Applications and Software; Well-being
De Freitas, Julian, and I. Glenn Cohen. "Disclosure, Humanizing, and Contextual Vulnerability of Generative AI Chatbots." New England Journal of Medicine AI 2, no. 2 (February 2025).
- September 1991 (Revised February 1993)
- Case
Burroughs Wellcome and AZT (A)
Burroughs Wellcome Co., developer of AZT, the first drug approved by the U.S. Food and Drug Administration for the treatment of Acquired Immune Deficiency Syndrome (AIDS), finds itself under siege in September 1989 by AIDS activists and various segments of the U.S.... View Details
Keywords: Governing Rules, Regulations, and Reforms; Ethics; Business and Government Relations; Communication Strategy; Health Care and Treatment; Monopoly; Intellectual Property; Research and Development; Price; Pharmaceutical Industry; London
Emmons, Willis M., III. "Burroughs Wellcome and AZT (A)." Harvard Business School Case 792-004, September 1991. (Revised February 1993.)
- June 2019
- Case
Fangda Partners: A Step Ahead
By: Ashish Nanda and Lisa Rohrer
Elite Chinese law firm Fangda Partners has steered Alibaba and other Chinese and international clients through the complex legal, corporate, and regulatory challenges associated with executing international transactions. “Fangda has traveled a long distance in a short... View Details
Keywords: Law Firm; Law Firms; Growth; Legal Industry; Regulation; Professional Services; Law; Leadership; Growth and Development; Strategy; Governing Rules, Regulations, and Reforms; Legal Services Industry; China
Nanda, Ashish, and Lisa Rohrer. "Fangda Partners: A Step Ahead." Harvard Business School Case 719-406, June 2019.
- 2011
- Article
Bias in Search Results?: Diagnosis and Response
By: Benjamin Edelman
I explore allegations of search engine bias, including understanding a search engine's incentives to bias results, identifying possible forms of bias, and evaluating methods of verifying whether bias in fact occurs. I then consider possible legal and policy responses,... View Details
Keywords: Prejudice and Bias; Motivation and Incentives; Outcome or Result; Markets; Legal Liability; Policy; Search Technology; Performance Evaluation; Governing Rules, Regulations, and Reforms
Edelman, Benjamin. "Bias in Search Results?: Diagnosis and Response." Indian Journal of Law and Technology 7 (2011): 16–32.
- 2018
- Book
American Fair Trade: Proprietary Capitalism, Corporatism, and the 'New Competition,' 1890–1940
By: Laura Phillips Sawyer
American Fair Trade explores the contested political and legal meanings of the term fair trade from the late nineteenth century through the New Deal era. This history of American capitalism argues that business associations partnered with regulators to... View Details
Keywords: Economic Systems; Competition; Policy; Fairness; History; Governing Rules, Regulations, and Reforms; United States
Phillips Sawyer, Laura. American Fair Trade: Proprietary Capitalism, Corporatism, and the 'New Competition,' 1890–1940. New York: Cambridge University Press, 2018.
- 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
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.
- August 2023 (Revised May 2024)
- Case
Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations
By: Satish Tadikonda and Amanda McEwen
The success or failure of Dicerna Pharmaceuticals (Dicerna) as an emerging pharmaceutical company would likely hinge on its lead drug candidate Nedosiran and the company’s ability to see it successfully through clinical development. Ralf Rosskamp, Chief Medical... View Details
Keywords: Business Strategy; Health Testing and Trials; Product Development; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry
Tadikonda, Satish, and Amanda McEwen. "Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations." Harvard Business School Case 824-018, August 2023. (Revised May 2024.)