Publications

January 2018
Article

The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials

By: Aaron V. Kaplan and Ariel D. Stern

The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of... View Details

Keywords: Health Testing and Trials; Business and Government Relations; Governing Rules, Regulations, and Reforms; Information Publishing; Medical Devices and Supplies Industry; United States

April – May 2010
Article

Banking Deregulations, Financing Constraints and Firm Entry Size

By: William R. Kerr and Ramana Nanda

We examine the effect of US branch banking deregulations on the entry size of new firms using micro-data from the US Census Bureau. We find that the average entry size for startups did not change following the deregulations. However, among firms that survived at least... View Details

Keywords: Business Startups; Financing and Loans; Governing Rules, Regulations, and Reforms; Market Entry and Exit; Banking Industry; United States

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September 2008 (Revised September 2011)
Background Note

Note: Credit Rating Agencies

By: William E. Fruhan

The note examines the role of credit rating agencies in capital markets, with emphasis on the role of these agencies in the recent credit crisis and recommendations for change. View Details

Keywords: Financial Crisis; Capital Markets; Credit; Governing Rules, Regulations, and Reforms; Standards

14 Dec 2016
Working Paper Summaries

The State of Small Business Lending: Innovation and Technology and the Implications for Regulation

Keywords: by Karen Gordon Mills and Brayden McCarthy; Financial Services

Forthcoming
Article

Antitrust Platform Regulation and Entrepreneurship: Evidence from China

By: Ke Rong, D. Daniel Sokol, Di Zhou and Feng Zhu

Many jurisdictions have launched antitrust enforcement and brought in regulation of large tech platforms. The swift and strict implementation of China’s Anti-Monopoly Guidelines for the Platform Economy (Platform Guidelines) provides a quasi-natural experiment... View Details

Keywords: Platform; Antitrust; Regulation; Entrepreneurship; Venture Capital; Governing Rules, Regulations, and Reforms; Competition; Market Entry and Exit; Supply and Industry; China

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February 2025
Case

Abiomed: A Change of Heart

By: Satish Tadikonda, Faith Robertson and William Marks

After acquiring Impella CardioSystems AG in May 2005, Abiomed Inc., a company focused on cardiac care, ran into a dilemma. Its Impella 2.5 device was approved for use in the European Union, but CEO Michael Minogue had seemingly bet the company's future on the ability... View Details

Keywords: Mergers and Acquisitions; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Business and Government Relations; Medical Devices and Supplies Industry; European Union; United States

July, 2024
Article

Consumer Protection in an Online World: An Analysis of Occupational Licensing

By: Chiara Farronato, Andrey Fradkin, Bradley Larsen and Erik Brynjolfsson

We study the demand and supply implications of occupational licensing using transaction-level data from a large online platform for home improvement services. We find that demand is more responsive to a professional's reviews than to the professional's... View Details

Keywords: Occupational Licensing; Consumer Protection; Perception; Experience and Expertise; Public Opinion; Governing Rules, Regulations, and Reforms; Demand and Consumers

Article

Does Your Company Need a Chief Medical Officer?

By: Tsedal Neeley

With the Covid-19 pandemic still raging but businesses trying to remain operational, organizations now have a life or death role to play in protecting the health of employees, customers, and the public. That means they need a new executive in the C-suite: a chief... View Details

Keywords: COVID-19 Pandemic; Health; Health Pandemics; Organizational Change and Adaptation; Organizational Structure; Safety; Governing Rules, Regulations, and Reforms; Working Conditions

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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

December 2019 (Revised September 2020)
Case

Facebook Faces the Regulators

By: Debora L. Spar

In the fall of 2019, Facebook and its CEO Mark Zuckerberg are facing increased scrutiny on multiple fronts. Regulators from around the globe are threatening the company with punitive measures. Users are organizing against it. But there is little consensus around what,... View Details

Keywords: Facebook; Regulation; Media; Internet and the Web; Governance; Governing Rules, Regulations, and Reforms; Business and Government Relations; Social Media; Europe

April 2012 (Revised July 2012)
Supplement

Man Group (B)

By: Robert C. Pozen and Thomas M. Clay

The Man Group was a huge and successful UK-based hedge fund and fund of funds manager. Through acquisitions, the company had consciously diversified its portfolio of investment products. In 2007 Man had to decide whether or not to spin off its brokerage business. Man... View Details

Keywords: Hedge Funds; Asset Management; Governing Rules, Regulations, and Reforms; Investment Funds; Corporate Strategy; Growth and Development Strategy; Financial Services Industry; United Kingdom

October 2009 (Revised November 2016)
Case

Generation Health: A Pioneer in Genetics Benefit Management (A)

By: Robert F. Higgins, Jeffrey D. Marrazzo and Rachel Gordon

Generation Health, a pioneer in the new field of genetics benefit management and a newly formed company, faces many strategic issues. CEO Per Lofberg is in the midst of negotiating a partnership with a major pharmacy benefit management company. As part of these... View Details

Keywords: Business Startups; Entrepreneurship; Governing Rules, Regulations, and Reforms; Growth and Development Strategy; Partners and Partnerships; Genetics; Health Industry; Insurance Industry

2005
Chapter

Environmental Federalism in the European Union and the United States

By: David Vogel, Michael W. Toffel and Diahanna Post

The United States (US) and the European Union (EU) are federal systems in which the responsibility for environmental policy-making is divided or shared between the central government and the (member) states. The attribution of decision-making power has important policy... View Details

Keywords: Governing Rules, Regulations, and Reforms; Policy; Government Legislation; Natural Environment; Pollutants; Climate Change; European Union; United States