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      • 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...  View Details
      Keywords: Recalls; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry
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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
      • 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...  View Details
      Keywords: App Development; Renewable Energy; Electricity Usage; Regulations; VC; Technology; Customer Acquisition Cost (CAC); Scalability; Energy Industry; United States; California; Texas; Europe
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      Rayport, Jeffrey F., Jennifer Fonstad, and Nicole Tempest Keller. "OhmConnect: Energizing the Future." Harvard Business School Case 823-065, January 2023.
      • December 2022 (Revised January 2023)
      • Case

      Marfrig's Quest for Greener Beef

      By: Jose B. Alvarez, Pedro Levindo and Ruth Costas
      Marfrig, one of the world’s leading meatpackers, strived to comply with its commitment to have a deforestation-free value chain in Brazil by 2030. The company also pledged to reduce its emissions of greenhouse gases in accordance with the guidelines set by the...  View Details
      Keywords: Agribusiness; Animal-Based Agribusiness; Plant-Based Agribusiness; Acquisition; Family Business; Communication Strategy; Environmental Management; Climate Change; Environmental Regulation; Environmental Sustainability; Bonds; Food; Global Strategy; Goods and Commodities; Government and Politics; Political Elections; Leading Change; Marketing; Product Marketing; Product Positioning; Supply Chain; Supply Chain Management; Corporate Social Responsibility and Impact; Business and Government Relations; Business and Stakeholder Relations; Partners and Partnerships; Strategy; Adaptation; Business Strategy; Commercialization; Competitive Strategy; Corporate Strategy; Diversification; Expansion; Agriculture and Agribusiness Industry; Food and Beverage Industry; Brazil; Latin America; Argentina; Uruguay; North America; United States; Europe; Asia; China
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      Alvarez, Jose B., Pedro Levindo, and Ruth Costas. "Marfrig's Quest for Greener Beef." Harvard Business School Case 523-073, December 2022. (Revised January 2023.)
      • December 2022
      • Case

      Iberdrola: Leading the Energy Revolution

      By: Juan Alcácer and Emer Moloney
      At the end of 2019, Ignacio Galán, the Chairman and CEO of the world's third largest utility, Iberdrola, relected on his almost 20 years at the company. He managed a portfolio of three very different businesses, each with their own specific opportunities and...  View Details
      Keywords: Energy; Energy Generation; Energy Sources; Non-Renewable Energy; Renewable Energy; Engineering; Innovation and Management; Innovation Leadership; Innovation Strategy; Technological Innovation; Leadership; Growth and Development Strategy; Market Timing; Industry Growth; Mission and Purpose; Strategy; Energy Industry; Green Technology Industry; Utilities Industry; Transportation Industry; Auto Industry; Spain; United Kingdom; United States; Brazil; Mexico
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      Alcácer, Juan, and Emer Moloney. "Iberdrola: Leading the Energy Revolution." Harvard Business School Case 723-398, December 2022.
      • December 2022 (Revised January 2023)
      • Case

      Cann: High Hopes for Cannabis Infused Beverages

      By: Ayelet Israeli and Anne V. Wilson
      Founded in 2018 by Jake Bullock and Luke Anderson, Cann sold “social tonics,” or cannabis-infused beverages. By 2022, the company had several notable celebrity investors and talent partners, had sold over 10 million beverages to consumers, was distributing in six...  View Details
      Keywords: Stigma; Product Innovation; Product Introduction; Product Differentiation; New Products; New Product Marketing; New Product Management; Brand Management; Branding; Packaging; Positioning; Growth Strategy And Execution; Growth; Cannabis Industry; Purpose; Purpose Brands; LGBTQ; Direct-to-consumer; DTC; Regulations; Channels Of Distribution; Product Development; Product Marketing; Product Positioning; Product; Innovation and Invention; Brands and Branding; Marketing; Marketing Communications; Marketing Channels; Advertising; Advertising Campaigns; Digital Marketing; Market Entry and Exit; Governing Rules, Regulations, and Reforms; Consumer Products Industry; Food and Beverage Industry; United States; Canada; North America
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      Israeli, Ayelet, and Anne V. Wilson. "Cann: High Hopes for Cannabis Infused Beverages." Harvard Business School Case 523-074, December 2022. (Revised January 2023.)
      • December 2022
      • Article

      Competition, Contracts, and Creativity: Evidence from Novel Writing in a Platform Market

      By: Yanhui Wu and Feng Zhu
      A growing number of people today are participating in the gig economy, working as independent contractors on short-term projects. We study the effects of competition on gig workers' effort and creativity on a Chinese novel-writing platform. Authors produce and sell...  View Details
      Keywords: Gig Workers; Platform-based Markets; Novel Writing; Creative Production; Platform Bias; Employment; Digital Platforms; Creativity; Books; Competition; Contracts
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      Wu, Yanhui, and Feng Zhu. "Competition, Contracts, and Creativity: Evidence from Novel Writing in a Platform Market." Management Science 68, no. 12 (December 2022): 8613–8634.
      • December 2022
      • Article

      Does Industry Employment of Active Regulators Weaken Oversight?

      By: Jonas Heese
      I study whether industry employment of active regulators weakens oversight. To examine this question, I exploit that the Financial Reporting Enforcement Panel (FREP), the German capital-market regulator responsible for enforcing public firms’ compliance with accounting...  View Details
      Keywords: Conflict-of-interest Policies; Directorships; Enforcement Actions; Industry Employment; Self-regulatory Organizations; Governance Compliance; Governing and Advisory Boards; Policy; Conflict of Interests
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      Heese, Jonas. "Does Industry Employment of Active Regulators Weaken Oversight?" Management Science 68, no. 12 (December 2022): 9198–9218.
      • 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
      Keywords: Research and Development; Governing Rules, Regulations, and Reforms; Product Development
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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...  View Details
      Keywords: Technological Change; Innovation; Qualitative Methods; New Categories; Entrepreneurship; Technological Innovation; Governing Rules, Regulations, and Reforms; Risk and Uncertainty; Strategy
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      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.
      • 2022
      • Working Paper

      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...  View Details
      Keywords: AI and Machine Learning; Health Care and Treatment; Governing Rules, Regulations, and Reforms; Technological Innovation; Medical Devices and Supplies Industry
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      Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." NBER Working Paper Series, No. 30639, December 2022.
      • November 2022 (Revised December 2022)
      • Case

      Replika AI: Monetizing a Chatbot

      By: Julian De Freitas and Nicole Tempest Keller
      In early 2018, Eugenia Kuyda, co-founder and CEO of San Francisco-based chatbot Replika AI, was deciding how to monetize the app she had built. Launched in 2017, Replika was a consumer AI “companion app” developed by a team of AI software engineers originally based in...  View Details
      Keywords: Mental Health; Subscriber Models; TAM; Monetization Strategy; Marketing Strategy; Product Marketing; AI and Machine Learning; Applications and Software; Product Positioning; Health Disorders; Technology Industry
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      De Freitas, Julian, and Nicole Tempest Keller. "Replika AI: Monetizing a Chatbot." Harvard Business School Case 523-016, November 2022. (Revised December 2022.)
      • November 2022 (Revised December 2022)
      • Supplement

      JUUL and the Vaping Revolution: A 2022 Update

      By: Michael W. Toffel and Sarah Mehta
      This slide deck provides a brief update (2019-2022) on the rise and fall of JUUL Labs, the maker of the popular JUUL e-cigarette.  View Details
      Keywords: Electronic Cigarettes; E-Cigarettes; Vaping; Nicotine Replacement; JUUL; Juuling; Government Regulation; Advertising; Advertising Campaigns; Digital Marketing; Customers; Innovation and Invention; Innovation Strategy; Marketing; Ethics; Brands and Branding; Marketing Communications; Marketing Strategy; Product Marketing; Corporate Social Responsibility and Impact; Social Issues; Technology Industry; California
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      Toffel, Michael W., and Sarah Mehta. "JUUL and the Vaping Revolution: A 2022 Update." Harvard Business School PowerPoint Supplement 623-012, November 2022. (Revised December 2022.)
      • November 2022 (Revised December 2022)
      • Supplement

      JUUL and the Vaping Revolution: A 2022 Update

      By: Michael W. Toffel and Sarah Mehta
      This case provides a brief update (2019-2022) on the rise and fall of JUUL Labs, the maker of the popular JUUL e-cigarette.  View Details
      Keywords: Electronic Cigarettes; E-Cigarettes; Vaping; Nicotine Replacement; JUUL; Juuling; Government Regulation; Advertising; Advertising Campaigns; Digital Marketing; Customers; Innovation and Invention; Innovation Strategy; Marketing; Ethics; Brands and Branding; Marketing Communications; Marketing Strategy; Product Marketing; Corporate Social Responsibility and Impact; Social Issues; Technology Industry; California
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      Toffel, Michael W., and Sarah Mehta. "JUUL and the Vaping Revolution: A 2022 Update." Harvard Business School Supplement 623-011, November 2022. (Revised December 2022.)
      • October 21, 2022
      • Article

      Climate Regulations Are About to Disrupt Global Shipping

      By: Willy C. Shih
      Ships that transport goods across oceans are collectively a major generator of greenhouse gases. Rules from the International Maritime Organization and the European Union aimed at curbing these emission promise to make transoceanic and regional shipping more expensive...  View Details
      Keywords: Shipping; Decarbonization; Environmental Regulation; Supply Chain; Disruption; Shipping Industry; Atlantic Ocean; Oceania; Asia; Europe; North and Central America
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      Shih, Willy C. "Climate Regulations Are About to Disrupt Global Shipping." Harvard Business Review Digital Articles (October 21, 2022).
      • October 17, 2022
      • Article

      When Climate Collaboration Is Treated as an Antitrust Violation

      By: Matteo Gasparini, Knut Haanaes and Peter Tufano
      Carbon emissions transcend firms and borders—they are a massive, unpriced externality. Companies across industries are increasingly waking up to the need to cooperate in the fight against climate change but the law might get in the way. Across Europe and the U.S.,...  View Details
      Keywords: Climate Impact; Climate Finance; Antitrust; Anti-trust; Climate Change; Environmental Regulation; Law
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      Gasparini, Matteo, Knut Haanaes, and Peter Tufano. "When Climate Collaboration Is Treated as an Antitrust Violation." Harvard Business Review (website) (October 17, 2022).
      • October 2022
      • Background Note

      Note on Cyberattacks and Regulatory Regimes

      By: Frank Nagle, George A. Riedel, William R. Kerr and David Lane
      Describes common types of cyberattacks on enterprises and their costs, as well as the fragmentary regulatory regimes through which U.S. states and regulatory agencies at the start of 2021 attempted to encourage disclosure of cyberattacks and to pursue enforcement...  View Details
      Keywords: Regulations; Regulatory Agencies; Cyberattacks; Governance; Corporate Disclosure; Cybersecurity; Information Industry; Information Technology Industry; Health Industry; Financial Services Industry; United States
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      Nagle, Frank, George A. Riedel, William R. Kerr, and David Lane. "Note on Cyberattacks and Regulatory Regimes." Harvard Business School Background Note 723-392, October 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...  View Details
      Keywords: Autonomous Vehicles; Market Entry and Exit; Opportunities; Governing Rules, Regulations, and Reforms; Consumer Behavior; Business Model; Auto Industry; Transportation Industry; France; United States
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      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.)
      • September 2022
      • Case

      BancoSol: Financial Inclusion in the Perfect Storm

      By: Michael Chu and Carla Larangeira
      In the pandemic, financial inclusion icon BancoSol faces a government-mandated year-long deferral of all loan payments, followed by the sudden Covid death of its CEO. In a Bolivia mired in political turmoil following a failed presidential election, with clients not...  View Details
      Keywords: Decision Making; Crisis Management; Management Succession; Business Strategy; Innovation Leadership; Risk and Uncertainty; Financing and Loans; Restructuring; Financial Services Industry; Latin America; Bolivia
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      Chu, Michael, and Carla Larangeira. "BancoSol: Financial Inclusion in the Perfect Storm." Harvard Business School Case 323-023, September 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...  View Details
      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
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      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

      Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities

      By: Leemore Dafny, Christopher Ody and Teresa Rokos
      The federal Anti-Kickback Statute prohibits biopharmaceutical manufacturers from directly covering Medicare enrollees’ out-of-pocket spending for the drugs they manufacture, but manufacturers may donate to independent patient assistance charities and earmark donations...  View Details
      Keywords: Cost Sharing; Prescription Drugs; Drug Spending; Medicare; Dual Eligibility; Cost; Health Care and Treatment; Philanthropy and Charitable Giving; Pharmaceutical Industry
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      Dafny, Leemore, Christopher Ody, and Teresa Rokos. "Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities." Health Affairs 41, no. 9 (September 2022).
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