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- Faculty Publications (114)
- 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...
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Keywords:
New Medicines;
Regulatory Approval;
Health Care and Treatment;
Research and Development;
Governing Rules, Regulations, and Reforms;
Markets;
Expansion;
Pharmaceutical Industry
Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
- 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...
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Keywords:
Connected Digital Products;
Telehealth;
Remote Monitoring;
Health Testing and Trials;
Research;
Governing Rules, Regulations, and Reforms;
Information Technology
Marra, Caroline, William J. Gordon, and Ariel Dora Stern. "Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials." BMJ Open 11, no. 6 (2021).
- 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.
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Keywords:
Antitrust Law;
Health Care and Treatment;
Consolidation;
Price;
Spending;
Cost Management;
Governing Rules, Regulations, and Reforms;
Competition;
United States
Dafny, Leemore S. "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." Government Testimony, Washington, DC, United States, April 2021.
- 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...
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Keywords:
Health Care;
COVID-19;
Regulation;
Health Care and Treatment;
Health Pandemics;
Governing Rules, Regulations, and Reforms;
Investment
Herzlinger, Regina E., and Eugene Schneller. "Ten Year Sunset Rule for Healthcare Regulation Is a Nonstarter and Discouragement to Post-COVID-19 Investment." Journal of Health Care Finance 47, no. 4 (Spring 2021). (Special Commentary.)
- 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...
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Keywords:
Physician Compensation;
Surgeons;
Health Care and Treatment;
Business Model;
Compensation and Benefits
Gallani, Susanna, Mary Witkowski, Lauren Haskins, Haley Jeffcoat, Vinita Mujumdar, and Frank Opelka. "Today's Surgeon Compensation Models Fall Short: Aligning Incentives to Create More Equitable and Value-based Compensation Models." Bulletin of the American College of Surgeons 106, no. 4 (April 2021): 33–39.
- 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...
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Keywords:
Trichloroethylene;
Toxicity;
Lobbying;
Chemicals;
Health Disorders;
Governing Rules, Regulations, and Reforms;
Policy;
Ethics;
Business and Government Relations;
Chemical Industry;
United States
Pons, Vincent, Rafael Di Tella, and Galit Goldstein. "The Trouble with TCE." Harvard Business School Case 721-031, March 2021. (Revised January 2023.)
- 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...
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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
Kaplan, Robert S., Mary Witkowski, Toby E. Emanuel, and Syed S. Shehab. "New England Baptist Hospital: Getting Paid for Value." Harvard Business School Case 121-036, February 2021.
- October 8, 2020
- Article
What Values and Priorities Mean for Health Reform
By: Katherine Baicker and Amitabh Chandra
Baicker, Katherine, and Amitabh Chandra. "What Values and Priorities Mean for Health Reform." New England Journal of Medicine 383, no. 15 (October 8, 2020).
- 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...
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Keywords:
COVID-19 Pandemic;
Health;
Health Pandemics;
Organizational Change and Adaptation;
Organizational Structure;
Safety;
Governing Rules, Regulations, and Reforms;
Working Conditions
Neeley, Tsedal. "Does Your Company Need a Chief Medical Officer?" Harvard Business Review (website) (October 1, 2020).
- 2021
- Working Paper
Development of CAR-T Therapies: Case Histories of Significant Medical Advances
By: Amar Bhidé and Srikant M. Datar
In 2017, the US Food and Drug Administration (FDA) approved an immunotherapeutic treatment, called CAR-T therapy, for two kinds of blood cancers—acute leukemia (ALL) and a lymphoma. We describe 1) how CAR-T works; 2) the foundational advances and discoveries; 3)...
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Keywords:
Immunotherapy;
Health Care and Treatment;
Innovation and Invention;
Research and Development;
Governing Rules, Regulations, and Reforms
Bhidé, Amar, and Srikant M. Datar. "Development of CAR-T Therapies: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 21-035, August 2020. (Revised May 2021.)
- September 2020
- Article
Regulatory Sandboxes: A Cure for mHealth Pilotitis?
By: Abhishek Bhatia, Rahul Matthan, Tarun Khanna and Satchit Balsari
Mobile health (mHealth) and related digital health interventions in the past decade have not always scaled globally as anticipated earlier despite large investments by governments and philanthropic foundations. The implementation of digital health tools has suffered...
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Keywords:
COVID-19;
mHealth;
Digital Health;
Design Thinking;
Regulation;
Intervention;
Regulatory Sandbox;
Health Care and Treatment;
Technological Innovation;
Design;
Governing Rules, Regulations, and Reforms;
India
Bhatia, Abhishek, Rahul Matthan, Tarun Khanna, and Satchit Balsari. "Regulatory Sandboxes: A Cure for mHealth Pilotitis?" Journal of Medical Internet Research 22, no. 9 (September 2020).
- Article
Do We Spend Too Much on Health Care?
By: Katherine Baicker and Amitabh Chandra
Health system reforms—such as changes in insurance design, patient cost sharing, payment reform, or price regulation—should be judged by whether they move us toward higher-value use of resources, rather than by whether they reduce spending.
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Keywords:
Health Care and Treatment;
Cost;
Governing Rules, Regulations, and Reforms;
Value Creation
Baicker, Katherine, and Amitabh Chandra. "Do We Spend Too Much on Health Care?" New England Journal of Medicine 383, no. 7 (August 13, 2020): 605–608.
- Article
Germany's Digital Health Reforms in the COVID-19 Era: Lessons and Opportunities for Other Countries
By: Sara Gerke, Ariel D. Stern and Timo Minssen
Reimbursement is a key challenge for many new digital health solutions, whose importance and value have been highlighted and expanded by the current COVID-19 pandemic. Germany’s new Digital Healthcare Act (Digitale–Versorgung–Gesetz or DVG) entitles all individuals...
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Keywords:
COVID-19;
Reimbursement;
Digital Health Reforms;
Health Pandemics;
Health Care and Treatment;
Internet and the Web;
Governing Rules, Regulations, and Reforms;
Germany
Gerke, Sara, Ariel D. Stern, and Timo Minssen. "Germany's Digital Health Reforms in the COVID-19 Era: Lessons and Opportunities for Other Countries." Art. 94. npj Digital Medicine 3 (2020).
- July 2020
- Article
Lessons from the Impact of Price Regulation on the Pricing of Anticancer Drugs in Germany
By: Victoria D. Lauenroth, Aaron S. Kesselheim, Ameet Sarpatwari and Ariel Dora Stern
Worldwide spending on prescription drugs has increased dramatically in recent years. Although this increase has been particularly pronounced in the U.S., it remains largely unaddressed there. In Europe, however, different approaches to regulating drug prices have been...
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Keywords:
Pharmaceuticals;
Prescription Drug Costs;
Drug Pricing;
Access To Care;
Cost Reduction;
Health Care and Treatment;
Price;
Governing Rules, Regulations, and Reforms;
Cost Management;
Germany
Lauenroth, Victoria D., Aaron S. Kesselheim, Ameet Sarpatwari, and Ariel Dora Stern. "Lessons from the Impact of Price Regulation on the Pricing of Anticancer Drugs in Germany." Health Affairs 39, no. 7 (July 2020): 1185–1193.
- 2021
- Working Paper
Cephalosporins: Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant Datar and Katherine Stebbins
Our case history describes the development of three generations of cephalosporins—antibiotics that have significantly reduced hospital infections. After providing an overview of antibiotic development and its challenges we describe how: 1) Early (pre-cephalosporin)...
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Keywords:
Health Care and Treatment;
Technological Innovation;
Innovation Strategy;
Technology Adoption;
Collaborative Innovation and Invention;
Innovation and Invention;
Governing Rules, Regulations, and Reforms
Bhidé, Amar, Srikant Datar, and Katherine Stebbins. "Cephalosporins: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-133, July 2020. (Revised May 2021.)
- 2021
- Working Paper
SSRIs and Non-SSRIs (through 1999): Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins
Our case history describes the development of Prozac, a blockbuster drug that transformed the treatment of depression – and became a cultural phenomenon in the United States. Specifically, we chronicle the: 1) prior treatments for depression and the research that...
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Keywords:
Health Care and Treatment;
Technological Innovation;
Innovation Strategy;
Technology Adoption;
Collaborative Innovation and Invention;
Innovation and Invention;
Governing Rules, Regulations, and Reforms
Bhidé, Amar, Srikant M. Datar, and Katherine Stebbins. "SSRIs and Non-SSRIs (through 1999): Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-135, July 2020. (Revised June 2021.)
- 2021
- Working Paper
Tamoxifen: Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant Datar and Katherine Stebbins
Our case history describes the development of tamoxifen, considered a “gold standard” treatment for millions of breast cancer patients. Specifically, we describe breast cancer treatments prior to tamoxifen’s development; the initial development of tamoxifen from 1960...
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Keywords:
Health Care and Treatment;
Technological Innovation;
Innovation and Invention;
Innovation Strategy;
Technology Adoption;
Collaborative Innovation and Invention;
Governing Rules, Regulations, and Reforms
Bhidé, Amar, Srikant Datar, and Katherine Stebbins. "Tamoxifen: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-134, July 2020. (Revised May 2021.)
- June 2020 (Revised February 2021)
- Supplement
Accounting for Leases at American Airlines (B)
By: Jonas Heese, Gerardo Pérez Cavazos and Julia Kelley
This is a supplement to the “Accounting for Leases at American Airlines (A)” case. The (B) case describes American Airlines’ financial results for the first quarter of 2020, as well as the continuing effects of coronavirus on the airline industry.
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Keywords:
Accounting;
Financial Reporting;
Financial Statements;
Finance;
Governance;
Corporate Accountability;
Corporate Governance;
Governing Rules, Regulations, and Reforms;
Governing and Advisory Boards;
Leasing;
Health Pandemics;
Accounting Industry;
Air Transportation Industry;
North and Central America;
United States
Heese, Jonas, Gerardo Pérez Cavazos, and Julia Kelley. "Accounting for Leases at American Airlines (B)." Harvard Business School Supplement 120-113, June 2020. (Revised February 2021.)
- June 2020
- Article
How Scheduling Can Bias Quality Assessment: Evidence from Food Safety Inspections
By: Maria Ibanez and Michael W. Toffel
Accuracy and consistency are critical for inspections to be an effective, fair, and useful tool for assessing risks, quality, and suppliers—and for making decisions based on those assessments. We examine how inspector schedules could introduce bias that erodes...
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Keywords:
Assessment;
Bias;
Inspection;
Scheduling;
Econometric Analysis;
Empirical Research;
Regulation;
Health;
Food;
Safety;
Quality;
Performance Consistency;
Governing Rules, Regulations, and Reforms
Ibanez, Maria, and Michael W. Toffel. "How Scheduling Can Bias Quality Assessment: Evidence from Food Safety Inspections." Management Science 66, no. 6 (June 2020): 2396–2416. (Revised February 2019. Featured in Harvard Business Review, Forbes, Food Safety Magazine, Food Safety News, and KelloggInsight. (2020 MSOM Responsible Research Finalist.))
- 2020
- Working Paper
How Should U.S. Bank Regulators Respond to the COVID-19 Crisis?
Drawing on lessons from the 2007–2009 Global Financial Crisis (GFC) and a simple conceptual framework, we examine the response of U.S. bank regulators to the COVID-19 pandemic. We argue that the current regulatory strategy of “watchful waiting”—the same strategy that...
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Keywords:
COVID-19;
Bank Regulation;
Recapitalization;
Health Pandemics;
Banks and Banking;
Governing Rules, Regulations, and Reforms;
Strategy;
Risk Management;
United States
Blank, Michael, Samuel G. Hanson, Jeremy C. Stein, and Adi Sunderam. "How Should U.S. Bank Regulators Respond to the COVID-19 Crisis?" Hutchins Center Working Paper, No. 63, June 2020.