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- 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...
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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.
- April 24, 2024
- Editorial
Absolute Presidential Immunity Threatens National Security
By: Louis Caldera, George W Casey, Jr., Thad Allen, Deborah Lee James, Carlton Fulford, Craig McKinley, Sean O'Keefe and John Jumper
Caldera, Louis, George W Casey, Jr., Thad Allen, Deborah Lee James, Carlton Fulford, Craig McKinley, Sean O'Keefe, and John Jumper. "Absolute Presidential Immunity Threatens National Security." Stars and Stripes (April 24, 2024).
- April 24, 2024
- Other Article
Presidents Don’t Need Criminal Immunity to Take Bold Action: National Security Is Better Served by a Lawful President Than a Lawless One
By: Louis Caldera
Caldera, Louis. "Presidents Don’t Need Criminal Immunity to Take Bold Action: National Security Is Better Served by a Lawful President Than a Lawless One." If You Can Keep It (April 24, 2024).
- April 2024
- Article
Loneliness and Emotion Regulation in Daily Life
By: Lameese Eldesouky, Amit Goldenberg and Kate Ellis
There is a growing understanding that emotion regulation (ER) abilities can be an important buffer for loneliness. However, most of this research is cross-sectional. Thus, it is unknown whether loneliness is associated with ER in momentary evaluations and can predict...
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Eldesouky, Lameese, Amit Goldenberg, and Kate Ellis. "Loneliness and Emotion Regulation in Daily Life." Art. 112566. Personality and Individual Differences 221 (April 2024).
- April 2024
- Article
Pay-As-You-Go Insurance: Experimental Evidence on Consumer Demand and Behavior
By: Raymond Kluender
Pay-as-you-go contracts reduce minimum purchase requirements which may increase market participation. We randomize the introduction and price(s) of a novel pay-as-you-go contract to the California auto insurance market where 17 percent of drivers are uninsured. The...
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Kluender, Raymond. "Pay-As-You-Go Insurance: Experimental Evidence on Consumer Demand and Behavior." Review of Financial Studies 37, no. 4 (April 2024): 1118–1148.
- March 2024
- Case
Funderbeam: Teaming Up or Going Alone?
By: Paul A. Gompers, Elena Corsi and Orna Dan
Funderbeam, a global platform founded in Estonia to enable start-ups to run private syndications and secondaries while offering liquidity for private equity investors, was at a crossroads. Over its ten-year run, the company had expanded its services and areas of...
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Keywords:
Decision Making;
Business Exit or Shutdown;
Transition;
Leading Change;
Business or Company Management;
Organizational Change and Adaptation;
Law;
Mergers and Acquisitions;
Financing and Loans;
Cross-Cultural and Cross-Border Issues;
Ownership Stake;
Expansion;
Business Startups;
Venture Capital;
Financial Services Industry;
Estonia;
Republic of Ireland;
United Kingdom;
Singapore
- 2024
- Working Paper
Product Liability Litigation and Innovation: Evidence from Medical Devices
By: Alberto Galasso and Hong Luo
We examine the relationship between product liability litigation and innovation by systematically
combining data on product liability lawsuits with data on new product introductions in a panel dataset of
leading medical device firms. We first document a decline in...
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Keywords:
Lawsuits and Litigation;
Product Development;
Technological Innovation;
Safety;
Governing Rules, Regulations, and Reforms;
Medical Devices and Supplies Industry
Galasso, Alberto, and Hong Luo. "Product Liability Litigation and Innovation: Evidence from Medical Devices." Harvard Business School Working Paper, No. 24-063, March 2024.
- March 2024
- Case
Governing OpenAI
By: Lynn S. Paine, Suraj Srinivasan and Will Hurwitz
In late November 2023, OpenAI’s new board of directors took stock of the situation. The company, which sought to develop artificial general intelligence (AGI)—computer systems with capabilities exceeding human abilities—was looking to regain its footing after a chaotic...
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Keywords:
Artificial Intelligence;
Board Of Directors;
Board Decisions;
Board Dynamics;
Business Ethics;
Corporate Boards;
Governance Changes;
Governance Structure;
Leadership Change;
Legal Aspects Of Business;
Nonprofit;
Nonprofit Governance;
Open Source;
Partnerships;
Regulation;
Strategy And Execution;
Technological Change;
AI and Machine Learning;
Corporate Governance;
Leadership;
Management;
Mission and Purpose;
Technological Innovation;
Technology Industry;
San Francisco;
United States
- March 22, 2024
- Article
It’s Time to Give Up on Ending Social Media’s Misinformation Problem
By: Scott Duke Kominers and Jesse Shapiro
Kominers, Scott Duke, and Jesse Shapiro. "It’s Time to Give Up on Ending Social Media’s Misinformation Problem." The Atlantic (website) (March 22, 2024).
- 2024
- Book
Deals: The Economic Structure of Business Transactions
By: Guhan Subramanian and Michael Klausner
Drawing on real-life cases from a wide range of industries, two acclaimed experts offer a sophisticated but accessible guide to business deals, designed to maximize value for your side.
Business transactions take widely varying forms—from multibillion-dollar... View Details
Business transactions take widely varying forms—from multibillion-dollar... View Details
Subramanian, Guhan, and Michael Klausner. Deals: The Economic Structure of Business Transactions. Harvard University Press, 2024.
- March 2024
- Article
How Foes Become Allies: The Shifting Role of Business in Climate Politics
By: Irja Vormedal and Jonas Meckling
Firms often oppose costly public policy reforms—but under what conditions may they
come to support such reforms? Previous scholarship has taken a predominantly static
approach to the analysis of business positions. Here, we advance a dynamic theory of
change in...
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Vormedal, Irja, and Jonas Meckling. "How Foes Become Allies: The Shifting Role of Business in Climate Politics." Policy Sciences 57, no. 1 (March 2024): 101–124.
- 2024
- Article
Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway
By: Mateo Aboy, Cristina Crespo and Ariel Stern
Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Technology Adoption;
Technological Innovation;
Safety;
Medical Devices and Supplies Industry;
United States
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway." Art. 29. npj Digital Medicine 7 (2024).
- February 2024
- Case
Compass Pathways: Pioneering Psychedelic Treatment
By: Tiona Zuzul, Kisha Lashley and Gamze Yucaoglu
This case follows Compass Pathways, a pioneering company developing treatment for depression based on psilocybin, the compound found in ‘magic mushrooms.’ Psilocybin was a federally illegal substance in the U.S., and a “Schedule I” drug, defined as a drug “with no...
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Keywords:
Commercialization;
Corporate Strategy;
Competitive Strategy;
Product Launch;
Health Testing and Trials;
Research and Development;
Laws and Statutes;
Pharmaceutical Industry;
Europe;
United States;
United Kingdom
Zuzul, Tiona, Kisha Lashley, and Gamze Yucaoglu. "Compass Pathways: Pioneering Psychedelic Treatment." Harvard Business School Case 724-412, February 2024.
- 2024
- Chapter
Regulating Collective Emotions
By: Amit Goldenberg
When we think of emotion and emotion regulation, we typically think of them as processes occurring at the individual level. Even when emotions are experienced by multiple people who interact with each other, analysis is typically centered around individual-level...
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Goldenberg, Amit. "Regulating Collective Emotions." Chap. 22 in Handbook of Emotion Regulation. Third Edition edited by James J. Gross and Brett Q. Ford, 183–189. Guilford Press, 2024.
- 2024
- Chapter
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...
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Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." Chap. 4 in The Economics of Artificial Intelligence: Health Care Challenges, edited by Ajay Agrawal, Joshua Gans, Avi Goldfarb, and Catherine E. Tucker, 107–138. Chicago and London: University of Chicago Press, 2024.
- 2024
- Working Paper
Private Regulation, Institutional Entrepreneurship and Climate Change: A Business History Perspective
By: Ann-Kristin Bergquist and Geoffrey Jones
Private regulatory systems, including voluntary efforts by firms to restrain their own behavior are the primary form of global climate change governance. However, when environmental challenges first rose up on the scientific and political agendas during the 1970s, the...
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Keywords:
Certification;
Climate Change;
Environmental Regulation;
Business History;
Governing Rules, Regulations, and Reforms;
Policy
Bergquist, Ann-Kristin, and Geoffrey Jones. "Private Regulation, Institutional Entrepreneurship and Climate Change: A Business History Perspective." Harvard Business School Working Paper, No. 24-041, January 2024.
- 2024
- Working Paper
Antitrust Platform Regulation and Entrepreneurship: Evidence from China
By: Ke Rong, D. Daniel Sokol, Di Zhou and Feng Zhu
Many jurisdictions have launched antitrust enforcement and brought in regulation of large tech platforms. The swift and strict implementation of China’s Anti-Monopoly Guidelines for the Platform Economy (Platform Guidelines) provides a quasi-natural experiment...
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Keywords:
Governing Rules, Regulations, and Reforms;
Competition;
Venture Capital;
Market Entry and Exit;
Supply and Industry;
China
Rong, Ke, D. Daniel Sokol, Di Zhou, and Feng Zhu. "Antitrust Platform Regulation and Entrepreneurship: Evidence from China." Harvard Business School Working Paper, No. 24-039, January 2024.
- January 11, 2024
- Article
Understanding the Tradeoffs of the Amazon Antitrust Case
By: Chiara Farronato, Andrey Fradkin, Andrei Hagiu and Dionne Lomax
Regulators in the United States and Europe have been taking on Big Tech, challenging what they say are the companies’ anti-competitive and predatory strategies that harm consumers and third-party users of their platforms. This article examines the FTC’s case against...
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Keywords:
Monopoly;
Governing Rules, Regulations, and Reforms;
Market Design;
Lawsuits and Litigation
Farronato, Chiara, Andrey Fradkin, Andrei Hagiu, and Dionne Lomax. "Understanding the Tradeoffs of the Amazon Antitrust Case." Harvard Business Review Digital Articles (January 11, 2024).
- January 2024
- Supplement
Accounting Red Flags or Red Herrings at Catalent? (B)
By: Joseph Pacelli, ZeSean Ali and Tom Quinn
GlassHouse Research identified accounting red flags at Catalent. Fiat Lux Partners countered most of GlassHouse’s claims. Who was right? This update explores the aftermath of the short seller duel.
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Keywords:
Accounting Audits;
Acquisition;
Budgets and Budgeting;
Business Earnings;
Earnings Management;
Cost Accounting;
Fair Value Accounting;
Financial Reporting;
Revenue Recognition;
Integrated Corporate Reporting;
Fairness;
Moral Sensibility;
Values and Beliefs;
Government Legislation;
Conflict of Interests;
Announcements;
Blogs;
Debates;
Lawsuits and Litigation;
Stocks;
Performance Productivity;
Pharmaceutical Industry;
Accounting Industry;
United States
Pacelli, Joseph, ZeSean Ali, and Tom Quinn. "Accounting Red Flags or Red Herrings at Catalent? (B)." Harvard Business School Supplement 124-055, January 2024.
- 2024
- Case
Christiana Figueres and the Paris Climate Negotiations (A)
By: James K. Sebenius, Laurence A. Green, Hannah Riley-Bowles, Lara SanPietro and Mina Subramanian
This three-part, stop action case study, structured for classroom discussion, centers on Harvard’s Program on Negotiation 2022 Great Negotiator, Christiana Figueres, and her efforts as Executive Secretary of the United Nations Framework Convention on Climate Change...
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Keywords:
Climate Change;
Negotiation;
Environmental Regulation;
International Relations;
Leadership
Sebenius, James K., Laurence A. Green, Hannah Riley-Bowles, Lara SanPietro, and Mina Subramanian. "Christiana Figueres and the Paris Climate Negotiations (A)." Program on Negotiation at Harvard Law School Case, 2024.