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- February 26, 2024
- Article
Making Workplaces Safer Through Machine Learning
By: Matthew S. Johnson, David I. Levine and Michael W. Toffel
Machine learning algorithms can dramatically improve regulatory effectiveness. This short article describes the authors' scholarly work that shows how the U.S. Occupational Safety and Health Administration (OSHA) could have reduced nearly twice as many occupational...
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Keywords:
Government Experimentation;
Auditing;
Inspection;
Evaluation;
Process Improvement;
Government Administration;
AI and Machine Learning;
Safety;
Governing Rules, Regulations, and Reforms
Johnson, Matthew S., David I. Levine, and Michael W. Toffel. "Making Workplaces Safer Through Machine Learning." Regulatory Review (February 26, 2024).
- 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).
- 2023
- Working Paper
The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina
By: Sebastian Calónico, Rafael Di Tella and Juan Cruz Lopez Del Valle
We document the diffusion of nebulized ibuprofen in Argentina as a treatment for COVID-19. As the pandemic spread, this clinically unsupported drug reached thousands of patients, even some seriously ill, despite warnings by the regulator and medical societies. Detailed...
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Keywords:
COVID-19;
Health Care and Treatment;
Health Pandemics;
Adoption;
Behavior;
Governing Rules, Regulations, and Reforms;
Learning
Calónico, Sebastian, Rafael Di Tella, and Juan Cruz Lopez Del Valle. "The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina." NBER Working Paper Series, No. 31781, October 2023.
- June 2023
- Case
Biogen and the Aduhelm Melee
By: Amitabh Chandra and Lauren Gunasti
Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.
This... View Details
This... View Details
- 2023
- Article
Conduit Incentives: Eliciting Cooperation from Workers Outside of Managers' Control
By: Susanna Gallani
Can managers use monetary incentives to elicit cooperation from workers they cannot reward for their efforts? I study “conduit incentives,” an innovative incentive design, whereby managers influence bonus-ineligible workers’ effort by offering bonus-eligible employees...
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Keywords:
Organizational Behavior Modification;
Peer Monitoring;
Persistence Of Performance Improvements;
Crowding Out;
Implicit Incentives;
Compensation;
Healthcare;
Social Pressure;
Image Motivation;
Incentives;
Motivation;
Performance;
Behavior;
Motivation and Incentives;
Compensation and Benefits;
Governing Rules, Regulations, and Reforms;
Organizational Culture;
Health Industry;
California
Gallani, Susanna. "Conduit Incentives: Eliciting Cooperation from Workers Outside of Managers' Control." Accounting Review 93, no. 3 (2023): 1–28.
- April 2023 (Revised January 2024)
- Background Note
Note on Healthcare in Ghana
By: Regina E. Herzlinger and Ben Creo
This note provides an overview of the healthcare system in Ghana. It discusses the public and private sector as well as traditional medical practice. It also discusses the country’s pharmaceutical industry. It is recommended as a companion to Professor Regina...
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Keywords:
Africa;
Pharmaceutical Companies;
Pharmacy Benefit Manager;
Health Care;
Health Care Costs;
Health Care Delivery;
Health Care Entrepreneurship;
Telehealth;
Health Equity;
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Business and Government Relations;
Health Industry;
Health Industry;
Ghana
Herzlinger, Regina E., and Ben Creo. "Note on Healthcare in Ghana." Harvard Business School Background Note 323-112, April 2023. (Revised January 2024.)
- 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...
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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.
- 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.
- 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;
Health Industry;
Health Industry;
Health 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.
- 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).
- June 9, 2023
- Article
A Radical Treatment for Insulin Pricing
By: Leemore S. Dafny
In 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar for long-acting insulin, which many hoped would be substantially cheaper than the reference branded product. I explain why prices have barely changed, and argue that a...
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Keywords:
Biosimilars;
Rebates;
Pharmaceuticals;
Health Care and Treatment;
Price;
Governing Rules, Regulations, and Reforms;
Pharmaceutical Industry;
United States
Dafny, Leemore S. "A Radical Treatment for Insulin Pricing." New England Journal of Medicine 386, no. 23 (June 9, 2023): 2157–2159.
- January 2022
- Article
Global Behaviors, Perceptions, and the Emergence of Social Norms at the Onset of the COVID-19 Pandemic
By: Lukas Hensel, Marc Witte, Stefano Caria, Thiemo Fetzer, Stefano Fiorin, Friedrich M. Goetz, Margarita Gomez, Johannes Haushofer, Andriy Ivchenko, Gordon T. Kraft-Todd, Elena Reutskaja, Christopher Roth, Erez Yoeli and Jon M. Jachimowicz
We conducted a large-scale survey covering 58 countries and over 100,000 respondents between late March and early April 2020 to study beliefs and attitudes towards citizens' and governments' responses at the onset of the COVID-19 pandemic. Most respondents reported...
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Keywords:
COVID-19;
Government Regulation;
Social Norms;
Health Pandemics;
Governing Rules, Regulations, and Reforms;
Behavior;
Perception;
Global Range;
Surveys
Hensel, Lukas, Marc Witte, Stefano Caria, Thiemo Fetzer, Stefano Fiorin, Friedrich M. Goetz, Margarita Gomez, Johannes Haushofer, Andriy Ivchenko, Gordon T. Kraft-Todd, Elena Reutskaja, Christopher Roth, Erez Yoeli, and Jon M. Jachimowicz. "Global Behaviors, Perceptions, and the Emergence of Social Norms at the Onset of the COVID-19 Pandemic." Journal of Economic Behavior & Organization 193 (January 2022): 473–496.
- Article
Supporting Value-Based Health Care—Aligning Financial and Legal Accountability
By: Mark M. Zaki, Anupam B. Jena and Amitabh Chandra
U.S. health care payment and delivery-system reforms have focused on improving care by making organizations accountable for outcomes, quality, and costs. Payers have supported the implementation of accountable care organizations (ACOs), bundled-payment models, and...
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Zaki, Mark M., Anupam B. Jena, and Amitabh Chandra. "Supporting Value-Based Health Care—Aligning Financial and Legal Accountability." New England Journal of Medicine 385, no. 11 (September 9, 2021): 965–967.
- June, 2021
- Article
Learning from Deregulation: The Asymmetric Impact of Lockdown and Reopening on Risky Behavior During COVID-19
By: Edward L. Glaeser, Ginger Zhe Jin, Michael Luca and Benjamin T. Leyden
During the COVID-19 pandemic, states issued and then rescinded stay-at-home orders that restricted mobility. We develop a model of learning by deregulation, which predicts that lifting stay-at-home orders can signal that going out has become safer. Using restaurant...
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Keywords:
COVID-19;
Lockdown;
Reopening;
Impact;
Coronavirus;
Public Health Measures;
Mobility;
Health Pandemics;
Governing Rules, Regulations, and Reforms;
Consumer Behavior
Glaeser, Edward L., Ginger Zhe Jin, Michael Luca, and Benjamin T. Leyden. "Learning from Deregulation: The Asymmetric Impact of Lockdown and Reopening on Risky Behavior During COVID-19." Journal of Regional Science 61, no. 4 (June, 2021): 696–709.
- Article
Regulating Hospital Prices Based on Market Concentration Is Likely to Leave High-Price Hospitals Unaffected
By: Maximilian J. Pany, Michael E. Chernew and Leemore S. Dafny
Concern about high hospital prices for commercially insured patients has motivated several proposals to regulate these prices. Such proposals often limit regulations to highly concentrated hospital markets. Using a large sample of 2017 US commercial insurance claims,...
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Keywords:
Health Care Providers;
Hospitals;
Insurance Market Regulation;
Price Regulation;
Markets;
Health Care and Treatment;
Cost;
Quality;
Insurance;
Price;
Governing Rules, Regulations, and Reforms
Pany, Maximilian J., Michael E. Chernew, and Leemore S. Dafny. "Regulating Hospital Prices Based on Market Concentration Is Likely to Leave High-Price Hospitals Unaffected." Health Affairs 40, no. 9 (September 2021): 1386–1394.
- 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).
- 2021
- Working Paper
Fecal Microbiota Transplants (FMT): Case Histories of Significant Medical Advances
By: Amar Bhide and Srikant M. Datar
By 2013, after many decades of very slow development and adoption, Fecal Microbiota Transplantation procedures were attracting widespread attention. This case history chronicles the: 1) pioneering fecal transplants performed in the 20th century; 2) development of the...
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Keywords:
Health Care and Treatment;
Innovation and Invention;
Governing Rules, Regulations, and Reforms
Bhide, Amar, and Srikant M. Datar. "Fecal Microbiota Transplants (FMT): Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 21-132, June 2021.
- Article
The Covid-19 Pandemic Should Not Delay Actions to Prevent Anticompetitive Consolidation in U.S. Health Care Markets
By: Leemore S. Dafny
This article describes potential regulatory and legislative reforms to assist antitrust enforcement agencies in halting anticompetitive acquisitions and practices, and preserving and promoting competition in health care markets.
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Keywords:
Health Care and Treatment;
Markets;
Competition;
Governing Rules, Regulations, and Reforms
Dafny, Leemore S. "The Covid-19 Pandemic Should Not Delay Actions to Prevent Anticompetitive Consolidation in U.S. Health Care Markets." Promarket (June 10, 2021).
- Article
The CMS New Rule on Ambulatory Surgical Centers Earns Only Partial Credit
By: Junaid Nabi and Robert S. Kaplan
The Centers of Medicare and Medicaid Services (CMS) recently announced that it will be removing more...
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Keywords:
Ambulatory Care;
Payment Policy;
Health Care and Treatment;
Governing Rules, Regulations, and Reforms
Nabi, Junaid, and Robert S. Kaplan. "The CMS New Rule on Ambulatory Surgical Centers Earns Only Partial Credit." Health Affairs Blog (June 2, 2021).
- Article
Biosimilars and Follow-On Products in the United States: Adoption, Prices, and Users
By: Ariel Dora Stern, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup and Ernst R. Berndt
Biologic drugs account for a disproportionate share of the increase in pharmaceutical spending in the U.S. and worldwide. Against this backdrop, many look to the expanding market for biosimilars—follow-on products to biologic drugs—as a vehicle for controlling...
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Keywords:
Pharmaceuticals;
Drug Spending;
Drug Pricing;
Health Care and Treatment;
Spending;
Price;
Markets;
Cost Management;
United States
Stern, Ariel Dora, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup, and Ernst R. Berndt. "Biosimilars and Follow-On Products in the United States: Adoption, Prices, and Users." Health Affairs 40, no. 6 (June 2021): 989–999.