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  • 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...  View Details
Keywords: Technological Innovation; Safety; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Medical Devices and Supplies Industry
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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
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  • 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 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 technological innovation...  View Details
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
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  • 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...  View Details
Keywords: Emerging Technologies; Governing Rules, Regulations, and Reforms; Innovation and Invention; Medical Devices and Supplies Industry
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  • 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...  View Details
Keywords: COVID-19; Government Regulation; Social Norms; Health Pandemics; Governing Rules, Regulations, and Reforms; Behavior; Perception; Global Range; Surveys
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  • 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...  View Details
Keywords: Value-based Health Care; Accountability; Health Care and Treatment; United States
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  • 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...  View Details
Keywords: COVID-19; Lockdown; Reopening; Impact; Coronavirus; Public Health Measures; Mobility; Health Pandemics; Governing Rules, Regulations, and Reforms; Consumer Behavior
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  • 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,...  View Details
Keywords: Health Care Providers; Hospitals; Insurance Market Regulation; Price Regulation; Markets; Health Care and Treatment; Cost; Quality; Insurance; Price; Governing Rules, Regulations, and Reforms
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  • 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...  View Details
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
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  • 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...  View Details
Keywords: Health Care and Treatment; Innovation and Invention; Governing Rules, Regulations, and Reforms
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  • 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.  View Details
Keywords: Health Care and Treatment; Markets; Competition; Governing Rules, Regulations, and Reforms
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  • 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...  View Details
Keywords: Ambulatory Care; Payment Policy; Health Care and Treatment; Governing Rules, Regulations, and Reforms
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  • 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...  View Details
Keywords: Pharmaceuticals; Drug Spending; Drug Pricing; Health Care and Treatment; Spending; Price; Markets; Cost Management; United States
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  • 2021
  • Working Paper

Regulatory Approval and Expanded Market Size
By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality...  View Details
Keywords: New Medicines; Regulatory Approval; Health Care and Treatment; Research and Development; Governing Rules, Regulations, and Reforms; Markets; Expansion; Pharmaceutical Industry
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  • Article

Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials
By: Caroline Marra, William J. Gordon and Ariel Dora Stern
Objectives: In an effort to mitigate COVID-19 related challenges for clinical research, the U.S. Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of...  View Details
Keywords: Connected Digital Products; Telehealth; Remote Monitoring; Health Testing and Trials; Research; Governing Rules, Regulations, and Reforms; Information Technology
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  • 2021
  • Government Testimony

How Health Care Consolidation Is Contributing to Higher Prices and Spending, and Reforms That Could Bolster Antitrust Enforcement and Preserve and Promote Competition in Health Care Markets
By: Leemore S. Dafny
Reforms to antitrust law and enforcement can help to address rising healthcare prices and spending.  View Details
Keywords: Antitrust Law; Health Care and Treatment; Consolidation; Price; Spending; Cost Management; Governing Rules, Regulations, and Reforms; Competition; United States
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  • Article

Ten Year Sunset Rule for Healthcare Regulation Is a Nonstarter and Discouragement to Post-COVID-19 Investment
By: Regina E. Herzlinger and Eugene Schneller
U.S. healthcare delivery has not benefitted from the same productivity growth as many other service industries, such as bricks and mortar retailing, a loss that has gravely diminished cost control and access. Regulatory capture, which creates barriers to venture...  View Details
Keywords: Health Care; COVID-19; Regulation; Health Care and Treatment; Health Pandemics; Governing Rules, Regulations, and Reforms; Investment
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  • April 2021
  • Article

Today's Surgeon Compensation Models Fall Short: Aligning Incentives to Create More Equitable and Value-based Compensation Models
By: Susanna Gallani, Mary Witkowski, Lauren Haskins, Haley Jeffcoat, Vinita Mujumdar and Frank Opelka
Modern medicine is undergoing a transformation that involves innovative surgical approaches, increased medical treatment options, clinical care pathways that require collaboration beyond hospital walls, and health data captured by electronic health records and other...  View Details
Keywords: Physician Compensation; Surgeons; Health Care and Treatment; Business Model; Compensation and Benefits
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  • March 2021 (Revised January 2023)
  • Case

The Trouble with TCE
By: Vincent Pons, Rafael Di Tella and Galit Goldstein
Trichloroethylene, or TCE, was a chemical used by tens of thousands of businesses in the United States. It was an affordable tool for many. Yet, TCE had been associated with important health risks, including cancer and autoimmune disease. TCE potentially posed other...  View Details
Keywords: Trichloroethylene; Toxicity; Lobbying; Chemicals; Health Disorders; Governing Rules, Regulations, and Reforms; Policy; Ethics; Business and Government Relations; Chemical Industry; United States
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  • February 2021
  • Case

New England Baptist Hospital: Getting Paid for Value
By: Robert S. Kaplan, Mary Witkowski, Toby E. Emanuel and Syed S. Shehab
New England Baptist Hospital (NEBH), a national leader in adult orthopedic care, has the lowest rate of complications and 30-day readmissions in New England, but gets paid 30% less for its surgeries than nearby institutions. NEBH introduces, with several large...  View Details
Keywords: Healthcare; Healthcare Spending; Healthcare Innovation; Healthcare Industry; Health Care Outcomes; Health Care Delivery; Health Care Reform; Bundled Payments; Health Care and Treatment; Spending; Innovation and Invention; Value Creation; Strategy; Health Industry; North America
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