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- All HBS Web (1,020)
- Faculty Publications (767)
- 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.
- June 2003 (Revised September 2003)
- Case
Peabody Elementary School (B)
By: Rosabeth M. Kanter and Kevin Morris
After six months as principal of the school, Marty Pettigrew has commenced a series of reform initiatives to improve its academic performance and culture. As the school year ends, he must assess his progress and decide on his strategies for the following year. He... View Details
- 07 Mar 2016
- Working Paper Summaries
Net Neutrality: A Fast Lane to Understanding the Trade-offs
- 2024
- Working Paper
Ultrasound Imaging--Cheap, Versatile, and Safe: Case Histories of Transformational Advances
By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins
This case history describes how efforts on multiple fronts, including advocacy, training, and technological development, made ultrasound the second most commonly used diagnostic imaging technology (after X-rays). Specifically, we chronicle 1) ultrasound’s development... View Details
Keywords: Health Care and Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation and Invention; Innovation and Invention; Governing Rules, Regulations, and Reforms
Bhidé, Amar, Srikant M. Datar, and Katherine Stebbins. "Ultrasound Imaging--Cheap, Versatile, and Safe: Case Histories of Transformational Advances." Harvard Business School Working Paper, No. 20-003, July 2019. (Revised May 2024.)
- August 2011
- Article
Coming Clean and Cleaning Up: Does Voluntary Self-Reporting Indicate Effective Self-Policing
By: Michael W. Toffel and Jodi L. Short
Regulatory agencies are increasingly establishing voluntary self-reporting programs both as an investigative tool and to encourage regulated firms to commit to policing themselves. We investigate whether voluntary self-reporting can reliably indicate effective... View Details
Keywords: Environmental Sustainability; Governing Rules, Regulations, and Reforms; Programs; Governance Compliance; Corporate Disclosure; Law Enforcement
Toffel, Michael W., and Jodi L. Short. "Coming Clean and Cleaning Up: Does Voluntary Self-Reporting Indicate Effective Self-Policing." Journal of Law & Economics 54, no. 3 (August 2011): 609–649.
- April 2017
- Case
Planetary Resources Inc., Property Rights, and the Regulation of the Space Economy
By: Matthew Weinzierl and Angela Acocella
Planetary Resources, Inc. (PRI) had a bold, some said crazy, vision: to mine asteroids. One might have assumed that developing the right technology would be the greatest challenge facing PRI. But even if the fledgling company could develop and deploy the sophisticated... View Details
Keywords: Property; Rights; Governing Rules, Regulations, and Reforms; Aerospace Industry; Mining Industry
Weinzierl, Matthew, and Angela Acocella. "Planetary Resources Inc., Property Rights, and the Regulation of the Space Economy." Harvard Business School Case 717-053, April 2017.
- 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
Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." NBER Working Paper Series, No. 30639, December 2022.
- Forthcoming
- Article
The Credit Rating Agency Market in Africa: Landscape and Future Research Directions
By: Saveshen Pillay and Anywhere Sikochi
We explore the role of credit ratings in global markets and highlight potential opportunities for research on the African credit rating agency market. We trace the evolution of credit ratings and conduct a comprehensive literature review of existing studies globally... View Details
Keywords: Credit Rating; Credit Rating Agencies; Credit; Conflict of Interests; Governing Rules, Regulations, and Reforms; Financial Markets; Africa
Pillay, Saveshen, and Anywhere Sikochi. "The Credit Rating Agency Market in Africa: Landscape and Future Research Directions." Journal of Financial Reporting (forthcoming). (Pre-published online April 18, 2024.)
- 18 May 2016
- Working Paper Summaries
The Impact of Mass Shootings on Gun Policy
- 2007
- Chapter
Postcards from the Edge: A Review of the Business and Environment Literature
By: Andrew A. King and Luca Berchicci
Environmental issues, while of growing interest, have been outside the main focus of business scholarship. This position on the periphery may have been a good thing. It allowed scholars of business and the environment to consider unusual theories and evaluate... View Details
Keywords: Corporate Governance; Governing Rules, Regulations, and Reforms; Research; Environmental Sustainability; Competitive Advantage
King, Andrew A., and Luca Berchicci. "Postcards from the Edge: A Review of the Business and Environment Literature." In The Academy of Management Annals, edited by James P. Walsh and Arthur P. Brief, 513–547. Lawrence Erlbaum Associates, 2007.
- 22 Aug 2024
- Research & Ideas
Reading the Financial Crisis Warning Signs: Credit Markets and the 'Red-Zone'
A year ago, most experts thought the US economy was thundering headlong toward recession, as the Federal Reserve moved at a historic pace to slow inflation by bridling interest rates. Yet, despite recent tremors in the stock market, no recession has materialized. Part... View Details
- August 2022
- Article
Availability of New Medicines in the U.S. and Germany From 2004 to 2018
By: Katharina Blankart, Huseyin Naci and Amitabh Chandra
Importance: Germany's unique approach to coverage determination and pricing has ensured that effective medicines remain on the market, often at prices reduced through negotiation. However, less is known about trade-offs of this approach with regard to initial... View Details
Keywords: Market Entry and Exit; Price; Market Timing; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; United States; Germany
Blankart, Katharina, Huseyin Naci, and Amitabh Chandra. "Availability of New Medicines in the U.S. and Germany From 2004 to 2018." e2229231. JAMA Network Open 5, no. 8 (August 2022).
- 21 Sep 2009
- Research & Ideas
Excessive Executive Pay: What’s the Solution?
intervention are quick to point out that more than two decades of well-meaning attempts to constrain ever-soaring corporate pay and to reform governance through legislation,... View Details
Keywords: by Roger Thompson
- 03 Feb 2020
- Working Paper Summaries
Competition in Pricing Algorithms
Keywords: by Zach Y. Brown and Alexander MacKay
- 01 Aug 2018
- What Do You Think?
Are Free Trade and Free Markets Quaint Ideas From the Past?
regulations, domestic content requirements, anti-dumping rules, and, if necessary, even selective tariffs to protect industries and workers. In other words, something far short... View Details
Keywords: by James Heskett
- March 2010
- Article
Information Content of Insider Trades before and after the Sarbanes-Oxley Act
By: Francois Brochet
This paper examines the information content of Form 4 filings under the more timely disclosure regime introduced by Section 403 of the Sarbanes-Oxley Act of 2002 (SOX). Abnormal returns and trading volumes around filings of insider stock purchases are significantly... View Details
Keywords: Stocks; Corporate Disclosure; Governing Rules, Regulations, and Reforms; Government Legislation; Lawsuits and Litigation; Market Transactions; Volume; Sales
Brochet, Francois. "Information Content of Insider Trades before and after the Sarbanes-Oxley Act." Accounting Review 85, no. 2 (March 2010): 419–446.
- November 2010 (Revised December 2010)
- Background Note
HR 3509
By: David F. Hawkins
HR 3509 ("2010 Health Reform Bill") imposition of a fee in pharmaceutical sales and an excise tax on medical device sales raises accounting issues. View Details
Keywords: Accounting; Governing Rules, Regulations, and Reforms; Government Legislation; Taxation; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States
Hawkins, David F. "HR 3509." Harvard Business School Background Note 111-056, November 2010. (Revised December 2010.)
- spring 1983
- Article
The Evolution of International Banking Competition and Its Implications for Regulation
By: D. B. Crane and Samuel L. Hayes III
Crane, D. B., and Samuel L. Hayes III. "The Evolution of International Banking Competition and Its Implications for Regulation." Journal of Bank Research 14, no. 1 (spring 1983).
- Article
Considering Concessions: A Survey Experiment on the Colombian Peace Process
By: Aila M. Matanock and Natalia Garbiras-Díaz
Designing peace agreements that can be signed and sustained can be difficult in civil conflict. Many recent cases of successful settlements include electoral provisions, often for rebel groups to participate as political parties. Engaging the electoral process,... View Details
Keywords: Peace Process; Political Parties; Politics; Government; Agreements; Political Backlash; Political Discourse; Civil Unrest; Civil War; Political Issues; Governing Rules, Regulations, and Reforms; Government and Politics; Policy; Conflict and Resolution; Latin America; Colombia
Matanock, Aila M., and Natalia Garbiras-Díaz. "Considering Concessions: A Survey Experiment on the Colombian Peace Process." Conflict Management and Peace Science 35, no. 6 (November 2018): 637–655.