Publications

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... View Details

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... View Details

Keywords: by Sean Silverthorne; Financial Services

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

Keywords: by Dina Gerdeman; Food & Beverage

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. View Details

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... View Details

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

Educators

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... View Details

Keywords: by Joseph Lassiter; Energy

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... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technology Adoption; Technological Innovation; Safety; Medical Devices and Supplies Industry; United States

Forthcoming
Article

Sending a Message: An Empirical Assessment of Responses to Punitive and Non-punitive Compliance Messaging Strategies

By: Jodi L. Short, Michael W. Toffel, Elizabeth A. Keenan and Melissa Ouellet

Regulators operate in an increasingly hostile political environment. The U.S. Supreme Court is ramping up efforts to curtail the authority of administrative agencies. The second election of Donald Trump to the presidency has unleashed a torrent of anti-regulatory... View Details

Keywords: Field Experiment; Compliance; Compliance Programs; Compliance Policies; Regulatory Enforcement; Environmental Regulation; Environmental Policy; Government Experimentation; Governance Compliance; Government Administration; Governing Rules, Regulations, and Reforms; Business and Government Relations; Construction Industry; Public Administration Industry; California; United States

SSRN

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

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

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.... View Details

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

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.... View Details

SSRN

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... View Details

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. View Details

Keywords: Medical Devices; Healthcare; Health Care; Health Care and Treatment; Applications and Software; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry

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... View Details

Keywords: by Michael Blanding

12 Feb 2016
News

Fast Fashion: Livia Firth Takes A Stand, Encouraging Eco-Conscious Clothing With #30Wears Campaign

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

Register to Read

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

Keywords: Research and Development; Governing Rules, Regulations, and Reforms; Product Development