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All HBS Web
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- Faculty Publications (118)
- December 2022
- Technical Note
Risks and Opportunities from the Transition to a Low Carbon Economy: A Business Analysis Framework
By: George Serafeim
The transition to a low carbon economy introduces many risks and opportunities for businesses. Risks emerge from regulatory actions, such as carbon taxes and cap and trade systems, technological innovation that develop alternatives for customers making existing...
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Keywords:
Risk Assessment;
Opportunities;
Environmental Sustainability;
Carbon Footprint;
Risk Management;
Competitive Dynamics;
Business Analysis;
Climate Change;
Accounting;
Finance;
Valuation;
Business and Shareholder Relations;
Technological Innovation;
Transition;
Product Positioning;
Renewable Energy;
Analysis
Serafeim, George. "Risks and Opportunities from the Transition to a Low Carbon Economy: A Business Analysis Framework." Harvard Business School Technical Note 123-014, 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...
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Keywords:
Technological Change;
Innovation;
Qualitative Methods;
New Categories;
Entrepreneurship;
Technological Innovation;
Governing Rules, Regulations, and Reforms;
Risk and Uncertainty;
Strategy
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.
- 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...
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Keywords:
DTC;
Internet and the Web;
Marketing Channels;
Customer Value and Value Chain;
Governing Rules, Regulations, and Reforms;
Competitive Strategy;
Service Delivery;
Growth and Development Strategy;
Pharmaceutical Industry;
Health Industry;
Retail Industry
Herzlinger, Regina E., and Tiffany Farrell. "The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales." Harvard Business School Case 323-031, November 2022.
- October 2022 (Revised September 2023)
- Supplement
SolarWinds Confronts SUNBURST (B)
Supplements the (A) case, describing actions taken by SolarWinds as well as by regulatory agencies in the aftermath of the immediate crisis. The case also includes reflections by SolarWinds managers on the choices they made with respect to disclosure, media relations,...
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Keywords:
Cyberattacks;
Cybersecurity;
Corporate Disclosure;
Crisis Management;
Customer Focus and Relationships;
Legal Liability;
Governance Compliance;
Business and Government Relations;
Information Technology Industry;
United States
Nagle, Frank, George A. Riedel, William R. Kerr, and David Lane. "SolarWinds Confronts SUNBURST (B)." Harvard Business School Supplement 723-368, October 2022. (Revised September 2023.)
- October 2022
- Background Note
Note on Cyberattacks and Regulatory Regimes
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...
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Keywords:
Regulations;
Regulatory Agencies;
Cyberattacks;
Governance;
Corporate Disclosure;
Cybersecurity;
Information Technology Industry;
Information Technology Industry;
Information Technology Industry;
Information Technology Industry;
United States
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...
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Keywords:
Autonomous Vehicles;
Market Entry and Exit;
Opportunities;
Governing Rules, Regulations, and Reforms;
Consumer Behavior;
Business Model;
Auto Industry;
Transportation Industry;
France;
United States
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.)
- 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...
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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
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.)
- August 2022
- Case
Air Wars: Deregulating the U.S. Airline Industry
By: Tom Nicholas and James Weber
In the early decades of the twentieth century, the U.S. government assisted in the development of an airline industry by subsidizing the delivery of mail and allowing mail carriers to also fly passengers. Because the government awarded mail routes to the lowest...
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Keywords:
Government Regulation;
Deregulation;
Change Management;
Economics;
Entrepreneurship;
Financial Management;
Business History;
Human Resources;
Compensation and Benefits;
Labor;
Labor Unions;
Leading Change;
Leadership Style;
Crisis Management;
Industry Structures;
Operations;
Strategy;
Adaptation;
Competition;
Air Transportation;
Air Transportation Industry;
United States
- 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).
- Article
Advancing Digital Health Applications: Priorities for Innovation in Real-World Evidence Generation
By: Ariel Dora Stern, Jan Brönneke, Jörg F Debatin, Julia Hagen, Henrik Matthies, Smit Patel, Ieuan Clay, Bjoern Eskofier, Annika Herr, Kurt Hoeller, Ashley Jaksa, Daniel B Kramer, Mattias Kyhlstedt, Katherine T Lofgren, Nirosha Mahendraratnam, Holger Muehlan, Simon Reif, Lars Riedemann and Jennifer C Goldsack
In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a “Fast-Track” regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can...
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Stern, Ariel Dora, Jan Brönneke, Jörg F Debatin, Julia Hagen, Henrik Matthies, Smit Patel, Ieuan Clay, Bjoern Eskofier, Annika Herr, Kurt Hoeller, Ashley Jaksa, Daniel B Kramer, Mattias Kyhlstedt, Katherine T Lofgren, Nirosha Mahendraratnam, Holger Muehlan, Simon Reif, Lars Riedemann, and Jennifer C Goldsack. "Advancing Digital Health Applications: Priorities for Innovation in Real-World Evidence Generation." Lancet Digital Health 4, no. 3 (March 2022): e200–e206.
- Article
Health App Policy: International Comparison of Nine Countries' Approaches
By: Anna Essén, Ariel Dora Stern, Christoffer Bjerre Haase, Josip Car, Felix Greaves, Dragana Paparova, Steven Vandeput, Rik Wehrens and David W. Bates
An abundant and growing supply of digital health applications (apps) exists in the commercial tech-sector, which can be bewildering for clinicians, patients, and payers. A growing challenge for the health care system is therefore to facilitate the identification of...
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Keywords:
Digital Health;
Apps;
Health Care and Treatment;
Internet and the Web;
Policy;
Global Range;
Applications and Software
Essén, Anna, Ariel Dora Stern, Christoffer Bjerre Haase, Josip Car, Felix Greaves, Dragana Paparova, Steven Vandeput, Rik Wehrens, and David W. Bates. "Health App Policy: International Comparison of Nine Countries' Approaches." npj Digital Medicine 5, no. 31 (2022).
- 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.
- 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.
- 2021
- Working Paper
The Value of Data and Its Impact on Competition
By: Marco Iansiti
Common regulatory perspective on the relationship between data, value, and competition in online platforms has increasingly centered on the volume of data accumulated by incumbent firms. This view posits the existence of "data network effects," where more data leads to...
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Keywords:
Online Platforms;
Data Network Effects;
Analytics and Data Science;
Value;
Competition;
Digital Platforms
Iansiti, Marco. "The Value of Data and Its Impact on Competition." Harvard Business School Working Paper, No. 22-002, July 2021.
- July 2021 (Revised February 2022)
- Technical Note
RegTech: A New Way to Manage Risks
By: Aiyesha Dey, Jonas Heese and James Barnett
A note on regulatory technology (RegTech) describing its evolution, use cases, and the competitive environment in 2021.
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Keywords:
Regulatory Technology;
Change;
Financial Management;
Governance Compliance;
Governance Controls;
Technology;
Technology Industry;
Technology Industry;
Technology Industry
Dey, Aiyesha, Jonas Heese, and James Barnett. "RegTech: A New Way to Manage Risks." Harvard Business School Technical Note 122-004, July 2021. (Revised February 2022.)
- 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).
- June 2021 (Revised October 2021)
- Supplement
CFM International (B): LEAPing Into the Future
By: Ranjay Gulati, Yves Doz and Kerry Herman
By 2017, after a long and highly successful run, the joint venture CFM’s and its parent firms’ leadership faces new challenges and must once again reconsider their commitment to the JV. CFM’s engines have come to dominate the narrow body aircraft market, but technology...
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- June 2021
- Case
Mobileye 2021: Robotaxi and/or Consumer AV?
By: David B. Yoffie, Danielle Golan and Nicole Tempest Keller
In March 2021, Amnon Shashua, co-founder and CEO of Israel-based Mobileye, was preparing to meet with Intel’s new CEO, Pat Gelsinger, to review plans for the future. Mobileye had been acquired by California-based Intel in 2017, but still operated independently....
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Keywords:
Technology Companies;
Robotics;
Autonomous Vehicles;
Strategy;
Decision Making;
Transportation;
Technological Innovation;
Technology Industry;
Technology Industry;
Technology Industry;
Israel
Yoffie, David B., Danielle Golan, and Nicole Tempest Keller. "Mobileye 2021: Robotaxi and/or Consumer AV?" Harvard Business School Case 721-481, June 2021.
- June 2021
- Case
Akira Fukabori and Kevin Kajitani at avatarin (A)
By: Linda A. Hill and Emily Tedards
In 2016, Akira Fukabori and Kevin Kajitani, aeronautical engineers at All Nippon Airways Co., Ltd., began to wonder why, in a world of accelerating globalization and digital connectivity, those who lived in far-remote villages or impoverished urban areas could not...
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Keywords:
Agility;
Ecosystem;
Innovation Ecosystems;
Crowdsourcing;
Open Innovation;
Partnership;
Government;
Collaboration;
Co-creation;
Purpose;
Impact;
Social Impact;
Movement;
Organizational Behavior;
Organizational Ambidexterity;
Ambidexterity;
Culture;
Culture Change;
Global Teams;
Experimentation;
Space;
Airline Industry;
Start-up;
Platform Business;
Platform Strategy;
Platform;
Digital;
Robotics;
Robots;
Mobility;
Strategy;
COVID-19;
Intrapreneurship;
Public-private Partnership;
XPRIZE;
Space Industry;
Avatar;
Telepresence;
Innovation Lab;
Innovation and Invention;
Technological Innovation;
Partners and Partnerships;
Collaborative Innovation and Invention;
Alignment;
Leadership;
Leading Change;
Diversity;
Organizational Culture;
Change Management;
Entrepreneurship;
Digital Platforms;
Transportation Industry;
Aerospace Industry;
Japan
Hill, Linda A., and Emily Tedards. "Akira Fukabori and Kevin Kajitani at avatarin (A)." Harvard Business School Case 421-089, June 2021.
- June 2021
- Case
Akira Fukabori and Kevin Kajitani at avatarin (A) (Abridged)
By: Linda A. Hill and Emily Tedards
In 2016, Akira Fukabori and Kevin Kajitani, aeronautical engineers at All Nippon Airways Co., Ltd., began to wonder why, in a world of accelerating globalization and digital connectivity, those who lived in far-remote villages or impoverished urban areas could not...
View Details
Keywords:
Agility;
Ecosystem;
Innovation Ecosystems;
Innovation;
Crowdsourcing;
XPRIZE;
Open Innovation;
Partnership;
Government;
Collaboration;
Co-creation;
Purpose;
Impact;
Social Impact;
Movement;
Organizational Behavior;
Organizational Ambidexterity;
Ambidexterity;
Culture;
Culture Change;
Global Teams;
Experimentation;
Space;
Space Industry;
Airline Industry;
Start-up;
Platform Business;
Platform Strategy;
Platform;
Digital;
Robotics;
Robots;
Avatar;
Telepresence;
Innovation Lab;
Mobility;
COVID-19;
Intrapreneurship;
Public-private Partnership;
Innovation and Invention;
Technological Innovation;
Partners and Partnerships;
Collaborative Innovation and Invention;
Alignment;
Leadership;
Leading Change;
Diversity;
Organizational Culture;
Change Management;
Strategy;
Entrepreneurship;
Digital Platforms;
Transportation Industry;
Aerospace Industry;
Japan
Hill, Linda A., and Emily Tedards. "Akira Fukabori and Kevin Kajitani at avatarin (A) (Abridged)." Harvard Business School Case 421-085, June 2021.