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- News (85)
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- 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 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.
- January 2017
- Article
Innovation Under Regulatory Uncertainty: Evidence from Medical Technology
By: Ariel Dora Stern
This paper explores how the regulatory approval process affects innovation incentives in medical technologies. Prior studies have found early mover regulatory advantages for drugs. I find the opposite for medical devices, where pioneer entrants spend 34% (7.2 months)... View Details
Stern, Ariel Dora. "Innovation Under Regulatory Uncertainty: Evidence from Medical Technology." Journal of Public Economics 145 (January 2017): 181–200.
- 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... View Details
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).
- 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... View Details
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).
- 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. View Details
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.)
- 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
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
- 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
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.)
- 1999
- Chapter
Biotechnology, Competitiveness and the Regulatory State
By: Arthur A. Daemmrich
- 2022
- Working Paper
Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data
By: Alexander O. Everhart and Ariel D. Stern
Medical devices increasingly include software components, which facilitate remote patient monitoring. The introduction of software into previously analog medical devices as well as innovation in software-driven devices may introduce new safety concerns—all the more so... View Details
Keywords: Technological Innovation; Safety; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Medical Devices and Supplies Industry
Everhart, Alexander O., and Ariel D. Stern. "Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data." Harvard Business School Working Paper, No. 23-035, November 2022.
- 01 Oct 2015
- Working Paper Summaries
Efficiencies and Regulatory Shortcuts: How Should We Regulate Companies like Airbnb and Uber?
- December 2014
- Article
The Distinct Effects of Information Technology and Communication Technology on Firm Organization
By: Nicholas Bloom, Luis Garicano, Raffaella Sadun and John Van Reenen
Empirical studies on information communication technologies (ICT) typically aggregate the "information" and "communication" components together. We show theoretically and empirically that this is problematic. Information and communication technologies have very... View Details
Bloom, Nicholas, Luis Garicano, Raffaella Sadun, and John Van Reenen. "The Distinct Effects of Information Technology and Communication Technology on Firm Organization." Management Science 60, no. 12 (December 2014): 2859–2885.
- 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... View Details
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).
- September 2024 (Revised March 2025)
- Case
Epic: The Future of Health Information Technology
By: Regina E. Herzlinger and Brian L. Walker
How should the founder and leadership team of a health IT company with more than 45 years of market leadership prepare for the future, while navigating founder transitions and industry changes? Founded by Judy Faulkner in the late 1970s, Epic pioneered electronic... View Details
Keywords: Technological Innovation; Entrepreneurship; Health Care and Treatment; Private Ownership; Customer Focus and Relationships; Information Management; Organizational Change and Adaptation; Business Strategy; Competition; Information Technology Industry; Information Technology Industry; Information Technology Industry
Herzlinger, Regina E., and Brian L. Walker. "Epic: The Future of Health Information Technology." Harvard Business School Case 325-028, September 2024. (Revised March 2025.)
- 2012
- Other Unpublished Work
Environmental corporate strategy and advancements in enhanced oil recovery technology among U.S. firms
By: Shon R. Hiatt
This study seeks to address how collective actors can affect technology development and adoption among organizations by creating regulatory uncertainty. Empirically, this paper focuses on the influence of environmental organizations concerned about climate change on... View Details
- June 2005 (Revised July 2006)
- Background Note
Note on the Convergence Between Genomics & Information Technology
By: David B. Yoffie, Dharmesh M Mehta and Rachel Sha
Focuses on the convergence between the genomics and semiconductor industries, in particular organ printing, DNA computing, biomolecular sensory networks, and DNA microarrays. Explains what this newly converged world looks like based on current research and findings in... View Details
Keywords: Genetics; Information Technology; Business Model; Disruptive Innovation; Information Technology Industry; Information Technology Industry; Information Technology Industry; Information Technology Industry
Yoffie, David B., Dharmesh M Mehta, and Rachel Sha. "Note on the Convergence Between Genomics & Information Technology." Harvard Business School Background Note 705-500, June 2005. (Revised July 2006.)
- 22 Nov 2011
- Working Paper Summaries
Carbon Tariffs: Impacts on Technology Choice, Regional Competitiveness, and Global Emissions
- 12 Oct 1999
- Research & Ideas
Media Metamorphosis: Advertising in the Technology Age
management systems used by direct marketers; software for creating and managing graphics, video, and sound; and convergence technologies such as broadband that provide simultaneous, high-speed transmission of sound, video, and data... View Details
- 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.
- March 2015 (Revised January 2024)
- Case
CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies
By: Regina E. Herzlinger and Andrew Otazo
Duke Rohlen (HBS MBA ’01) hoped to win over a prominent venture capital investor for Series B financing of his firm CVI that was creating a drug-eluting balloon (DES) to treat peripheral arterial disease. As a second-mover, Duke felt he was more likely to acquire... View Details
Keywords: CV Ingenuity; CVI; Drug Eluting Balloon; DEB; Drug Eluting Stent; Angioplasty Balloon; FoxHollow; Medical Device; Medical Device Startup; Premarket Approval; PMA; Lutonix; Stellarex; LEVANT; ILLUMENATE; Clinical Trials; Peripheral Arterial Disease; PAD; Healthcare Startups; Covidien; Health Care and Treatment; Health Testing and Trials; Business Startups; Commercialization; Health Industry; Medical Devices and Supplies Industry; United States; Europe
Herzlinger, Regina E., and Andrew Otazo. "CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies." Harvard Business School Case 315-045, March 2015. (Revised January 2024.)
- 14 Dec 2016
- Working Paper Summaries