Filter Results:
(332)
Show Results For
- All HBS Web (388)
- Faculty Publications (234)
Show Results For
- All HBS Web (388)
- Faculty Publications (234)
Sort by
- 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).
- 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
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.
- Forthcoming
- Article
Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
By: Amitabh Chandra, Jennifer Kao, Kathleen L. Miller and Ariel Dora Stern
Regulators of new products confront a tradeoff between speeding a product to market and collecting additional product quality information. The FDA's Breakthrough Therapy Designation (BTD) provides an opportunity to understand if regulators can use new policy to... View Details
Keywords: Innovation and Invention; Governing Rules, Regulations, and Reforms; Government Administration; Research and Development; Pharmaceutical Industry
Chandra, Amitabh, Jennifer Kao, Kathleen L. Miller, and Ariel Dora Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." Review of Economics and Statistics (forthcoming). (Pre-published online March 18, 2024.)
- 2023
- Working Paper
Much Ado About Nothing? Overreaction to Random Regulatory Audits
By: Samuel Antill and Joseph Kalmenovitz
Regulators often audit firms to detect non-compliance. Exploiting a natural experiment in the lobbying industry, we show that firms overreact to audits and this response distorts prices and reduces welfare. Each year, federal regulators audit a random sample of... View Details
Antill, Samuel, and Joseph Kalmenovitz. "Much Ado About Nothing? Overreaction to Random Regulatory Audits." Working Paper, August 2023.
- 24 Jul 2014
- Op-Ed
Reform Tax Law to Keep US Firms at Home
in restricting the ability of firms to locate where it makes sense for them to be, but rather to create tax reform that makes US firms more competitive. Chairman Wyden, Ranking Member Hatch, and Members of the Committee, it is a pleasure... View Details
- Apr 2010
- Conference Presentation
Organizational Scope and Governance in Private Regulatory Enforcement
- 2006
- Chapter
Coerced Confessions: How Regulatory Deterrence Drives Self-Policing
By: Jodi L. Short and Michael W. Toffel
Short, Jodi L., and Michael W. Toffel. "Coerced Confessions: How Regulatory Deterrence Drives Self-Policing." In Best Paper Proceedings of the Sixty-fifth Annual Meeting of the Academy of Management, edited by K. Mark Weaver. Academy of Management, 2006. (Winner of Charles H. Levine Award for Best Conference Paper presented by Academy of Management. Previously titled "Turning Themselves In: Why Some Firms Self-disclose Regulatory Violations".)
- 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.)
- Spring 2024
- Article
The Evolution of Banking in the 21st Century: Evidence and Regulatory Implications
By: Samuel Gregory Hanson, Victoria Ivashina, Laura Nicolae, Jeremy C. Stein, Adi Sunderam and Daniel K. Tarullo
As revealed by the failures of three regional banks in the spring of 2023, bank runs are not a thing of the past. To inform the ongoing discussion of the appropriate regulatory response, we examine trends in the banking industry over the last twenty-five years. On the... View Details
Keywords: Financial Instruments; Financial Crisis; Assets; Governing Rules, Regulations, and Reforms; Financial Condition; Banking Industry
Hanson, Samuel Gregory, Victoria Ivashina, Laura Nicolae, Jeremy C. Stein, Adi Sunderam, and Daniel K. Tarullo. "The Evolution of Banking in the 21st Century: Evidence and Regulatory Implications." Brookings Papers on Economic Activity (Spring 2024): 343–389.
- 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.
- January 1986
- Case
Telecommunications in Transition: Managing Business and Regulatory Change
Vietor, Richard H.K. "Telecommunications in Transition: Managing Business and Regulatory Change." Harvard Business School Case 986-001, January 1986.
- 23 Nov 2009
- Research & Ideas
Management’s Role in Reforming Health Care
think we can stop health-care reform if and when we come to agreement about an optimal insurance model," says Bohmer. "For me, insurance reform is a necessary but not sufficient component of... View Details
- March 2016 (Revised August 2018)
- Case
JPMorgan Chase after the Financial Crisis: What Is the Optimal Scope of the Largest Bank in the U.S.?
By: David Collis and Ashley Hartman
When Jamie Dimon took over as CEO of JPMorgan Chase & Co. (JPMorgan Chase) in 2005, he reaffirmed the commitment to pursue a "universal bank" strategy—providing a full range of products and services to both retail and wholesale clients. Yet the merits of the universal... View Details
Keywords: Scope; Regulatory Reforms; Universal Banking; Synergy; Optimization; Simplification; Finance; Strategy; Business Strategy; Financial Crisis; Consolidation; Corporate Strategy; Diversification; Governing Rules, Regulations, and Reforms; Banking Industry; Financial Services Industry
Collis, David, and Ashley Hartman. "JPMorgan Chase after the Financial Crisis: What Is the Optimal Scope of the Largest Bank in the U.S.?" Harvard Business School Case 716-448, March 2016. (Revised August 2018.)
- November 2010
- Teaching Note
Citigroup 2007: Financial Reporting and Regulatory Capital (TN)
By: Edward J. Riedl, Suraj Srinivasan and Sharon Katz
Teaching Note for 111041. View Details
- 01 Oct 2015
- Working Paper Summaries
Efficiencies and Regulatory Shortcuts: How Should We Regulate Companies like Airbnb and Uber?
- 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
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.
- 2022
- Article
Regulatory Treatment of Changes in Fair Value and the Composition of Banks' Investment Portfolios
By: Michael Iselin, Jung Koo Kang and Joshua Madsen
In their implementation of Basel III, U.S. bank regulators are again including changes in the fair value of available-for-sale (AFS) debt securities in Tier 1 capital, but only for the largest U.S. banks. This paper investigates a potential impact of expanding this... View Details
Keywords: Fair Value Accounting; SFAS 115; Basel III; Governing Rules, Regulations, and Reforms; Banks and Banking; Debt Securities; Credit; Risk and Uncertainty; Investment Portfolio; Decision Making; Banking Industry; United States
Iselin, Michael, Jung Koo Kang, and Joshua Madsen. "Regulatory Treatment of Changes in Fair Value and the Composition of Banks' Investment Portfolios." Journal of Financial Reporting 7, no. 1 (2022): 123–143.
- August 1984
- Case
Work of a Regulatory Agency: The EPA and Toxic Substances (Condensed)
By: Joseph L. Bower
Bower, Joseph L. "Work of a Regulatory Agency: The EPA and Toxic Substances (Condensed)." Harvard Business School Case 385-063, August 1984.
- 2003
- Chapter
Regulatory Laws and Political Culture in the United States and Germany
By: Arthur A. Daemmrich