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All HBS Web
(207)
- News (25)
- Research (158)
- Multimedia (4)
- Faculty Publications (55)
- 2024
- Chapter
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...
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Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." Chap. 4 in The Economics of Artificial Intelligence: Health Care Challenges, edited by Ajay Agrawal, Joshua Gans, Avi Goldfarb, and Catherine E. Tucker, 107–138. Chicago and London: University of Chicago Press, 2024.
- 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...
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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.
- 24 Feb 2011
- Research & Ideas
What’s Government’s Role in Regulating Home Purchase Financing?
going to be easy, but it's critical to privatization. As we increase our regulation of banks and require them to hold more capital, we'll be driving more activity into the less-regulated securitization markets. Our paper identifies a...
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- 16 May 2016
- HBS Case
Food Safety Economics: The Cost of a Sick Customer
product, it can affect the entire supply for that brand. China implemented stricter food safety laws in April 2015, but the country may not have enough qualified enforcement staff. And inspectors don’t always enforce View Details
- May–June 2013
- Article
Can Global Brands Create Just Supply Chains? Response: Promoting Political Mobilization
By: Jodi L. Short and Michael W. Toffel
Codes of conduct indicate that working conditions are improving overall at the factories being monitored by multinational corporations, and that these codes of conduct also create possibilities for political mobilization that can improve labor conditions more broadly.
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Keywords:
Regulation;
Auditing;
Labor Relations;
Occupational Safety;
Environmental Operations;
Environmental Regulation;
Employees;
Labor;
Labor and Management Relations;
Governing Rules, Regulations, and Reforms;
Manufacturing Industry;
China;
Bangladesh;
India;
Honduras;
Nicaragua;
Pakistan;
Guatemala;
Malaysia;
Viet Nam
Short, Jodi L., and Michael W. Toffel. "Can Global Brands Create Just Supply Chains? Response: Promoting Political Mobilization." Boston Review 38, no. 3 (May–June 2013).
- 03 Dec 2015
- Op-Ed
How "New Nuclear" Power Could Save the Planet—If Regulators Would Allow It
driven by the fears of the past: ensuring nuclear safety and radiological health and avoiding nuclear proliferation. However, our actual experience with these issues has been far different than anticipated. Political leaders and voters...
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- 2024
- Article
Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway
By: Mateo Aboy, Cristina Crespo and Ariel Stern
Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Technology Adoption;
Technological Innovation;
Safety;
Medical Devices and Supplies Industry;
United States
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway." Art. 29. npj Digital Medicine 7 (2024).
- November 2017
- Case
The 'Wonder Drug' That Killed Babies
By: Joshua Lev Krieger, Tom Nicholas and Matthew Preble
In the early 1960s, a popular drug taken by patients worldwide for a range of maladies was found to cause severe birth defects and other health problems in babies born to mothers who had taken it during a certain stage of fetal development. As many as 10,000 children...
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Keywords:
Regulation;
Business and Government Relations;
Business and Community Relations;
Business and Stakeholder Relations;
Product Marketing;
Corporate Social Responsibility and Impact;
Business History;
Health;
Government Legislation;
Corporate Accountability;
Ethics;
Governing Rules, Regulations, and Reforms;
Pharmaceutical Industry;
Public Administration Industry;
United States;
United Kingdom;
Australia;
Germany;
Europe
Krieger, Joshua Lev, Tom Nicholas, and Matthew Preble. "The 'Wonder Drug' That Killed Babies." Harvard Business School Case 818-044, November 2017.
- Fall 2016
- Article
The Integrity of Private Third-party Compliance Monitoring
By: Jodi L. Short and Michael W. Toffel
Government agencies are increasingly turning to private, third-party monitors to inspect and assess regulated entities’ compliance with law. The integrity of these regulatory regimes rests on the validity of the information third-party monitors provide to regulators....
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Keywords:
Regulation;
Compliance;
Compliance Policies;
Conflict Of Interest;
Independent Third Party;
Inspection;
Audit Quality;
Auditor;
Audit;
Environment;
Safety;
Conflict of Interests;
Working Conditions;
Labor;
Corporate Social Responsibility and Impact;
Governance Compliance;
Accounting Audits
Short, Jodi L., and Michael W. Toffel. "The Integrity of Private Third-party Compliance Monitoring." Administrative & Regulatory Law News 42, no. 1 (Fall 2016): 22–25.
- 2015
- Working Paper
The Integrity of Private Third-party Compliance Monitoring
By: Jodi L. Short and Michael W. Toffel
Government agencies are increasingly turning to private, third-party monitors to inspect and assess regulated entities’ compliance with law. The integrity of these regulatory regimes rests on the validity of the information third-party monitors provide to regulators....
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Keywords:
Regulation;
Compliance;
Compliance Policies;
Conflict Of Interest;
Independent Third Party;
Inspection;
Audit Quality;
Auditor;
Audit;
Environment;
Production;
Supply Chain;
Quality;
Government Administration;
Working Conditions;
Safety;
Labor;
Governing Rules, Regulations, and Reforms;
Governance Compliance;
Manufacturing Industry;
Public Administration Industry;
Accounting Industry;
Service Industry;
United States
Short, Jodi L., and Michael W. Toffel. "The Integrity of Private Third-party Compliance Monitoring." Harvard Kennedy School Regulatory Policy Program Working Paper, No. RPP-2015-20, November 2015. (Revised December 2015.)
- August 2019 (Revised February 2020)
- Teaching Note
Sidewalk Labs: Privacy in a City Built from the Internet Up
By: Leslie John and Mitch Weiss
Email mking@hbs.edu for a courtesy copy.
The case serves as a microcosm of issues of digital privacy: the availability of data – personal data in particular – has tremendous potential to improve people’s lives... View Details
The case serves as a microcosm of issues of digital privacy: the availability of data – personal data in particular – has tremendous potential to improve people’s lives... View Details
Keywords:
Privacy;
Privacy By Design;
Privacy Regulation;
Platforms;
Data;
Data Security;
Behavioral Science;
Analytics and Data Science;
Safety;
Entrepreneurship;
Business and Government Relations;
Consumer Behavior;
Digital Platforms
John, Leslie, and Mitch Weiss. "Sidewalk Labs: Privacy in a City Built from the Internet Up." Harvard Business School Teaching Note 820-023, August 2019. (Revised February 2020.) (Email mking@hbs.edu for a courtesy copy.)
- 12 Dec 2012
- Research & Ideas
Power to the People: The Unexpected Influence of Small Coalitions
environmentalists, consumer activists, women's organizations, health-care advocates, and farmers—wield great influence in areas of regulation including trade, product safety, and labor. Read an excerpt from the book. "It's important to...
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Keywords:
by Kim Girard
- July 2019
- Article
Challenges and Opportunities in Software-Driven Medical Devices
By: William J. Gordon and Ariel Dora Stern
The safety and security of medical devices driven by software, the software-development processes, and the need for data collection and privacy, all offer challenges and opportunities for device regulation and clinical care.
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Keywords:
Medical Devices;
Healthcare;
Health Care;
Health Care and Treatment;
Applications and Software;
Governing Rules, Regulations, and Reforms;
Medical Devices and Supplies Industry
Gordon, William J., and Ariel Dora Stern. "Challenges and Opportunities in Software-Driven Medical Devices." Nature Biomedical Engineering 3, no. 7 (July 2019): 493–497.
- 21 May 2012
- Research & Ideas
OSHA Inspections: Protecting Employees or Killing Jobs?
killing jobs at a time when the United States can ill afford to lose them. Few regulatory agencies have a more direct effect on businesses than the Occupational Safety and Health Administration (OSHA), the federal agency responsible for...
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Keywords:
by Michael Blanding
- 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...
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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.
- 08 Sep 2016
- Video
Monitoring global supply chains
- 2008
- Working Paper
Extending Producer Responsibility: An Evaluation Framework for Product Take-Back Policies
By: Michael W. Toffel, Antoinette Stein and Katharine Lee
Manufacturers are increasingly being required to adhere to product take-back regulations that require them to manage their products at the end of life. Such regulations seek to internalize products' entire life cycle costs into market prices, with the ultimate...
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Toffel, Michael W., Antoinette Stein, and Katharine Lee. "Extending Producer Responsibility: An Evaluation Framework for Product Take-Back Policies." Harvard Business School Working Paper, No. 09-026, July 2008. (September 2008.)
- 08 Sep 2016
- News
Monitoring global supply chains
- 28 Mar 2023
- Research & Ideas
The FDA’s Speedy Drug Approvals Are Safe: A Win-Win for Patients and Pharma Innovation
Early in the COVID-19 pandemic, the US Food and Drug Administration faced the task of convincing a skeptical public of the safety of new vaccines when the agency began authorizing them for emergency use less than a year after the pandemic...
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