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All HBS Web
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- Faculty Publications (114)
- April 2020
- Article
Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning
By: Ariel Dora Stern and W. Nicholson Price, II
In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging...
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Keywords:
Machine Learning;
Causal Inference;
Health Care and Treatment;
Safety;
Governing Rules, Regulations, and Reforms
Stern, Ariel Dora, and W. Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.
- 2020
- Working Paper
Cutting the Gordian Knot of Employee Health Care Benefits and Costs: A Corporate Model Built on Employee Choice
By: Regina E. Herzlinger and Barak D. Richman
The U.S. employer-based health insurance tax exclusion created a system of employer-sponsored insurance (ESI) with limited insurance choices and transparency that may lock employed households into health plans that are costlier or different from those they prefer to...
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Keywords:
After-tax Income;
Consumer-driven Health Care;
Health Care Costs;
Health Insurance;
Income Inequality;
Tax Policy;
Health Care and Treatment;
Cost;
Insurance;
Employees;
Income;
Taxation;
Policy;
United States
Herzlinger, Regina E., and Barak D. Richman. "Cutting the Gordian Knot of Employee Health Care Benefits and Costs: A Corporate Model Built on Employee Choice." Duke Law School Public Law & Legal Theory Series, No. 2020-4, December 2019. (Revised January 2021.)
- Article
Economic Principles for Medicare Reform
By: Amitabh Chandra and Craig Garthwaite
In this article, we develop an economic framework for Medicare reform that highlights trade-offs that reform proposals should grapple with but often ignore. Central to our argument is a tension in administratively set prices, which may improve short-term efficiency but...
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Keywords:
Medicare;
Value-based Care;
Health Care Reform;
Markets In Health Care;
Health Care and Treatment;
Value;
Governing Rules, Regulations, and Reforms
Chandra, Amitabh, and Craig Garthwaite. "Economic Principles for Medicare Reform." Annals of the American Academy of Political and Social Science 686, no. 1 (November 2019): 63 – 92.
- 2021
- Working Paper
Coronary Artery Bypass Grafting: Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant M. Datar and Fabio Villa
We describe how Coronary Artery Bypass Grafting (CABG, or more popularly, “bypass”) operations revolutionized the treatment of coronary disease (that can produce fatal heart attacks and debilitating angina). We first provide a simplified overview of coronary disease...
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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 Fabio Villa. "Coronary Artery Bypass Grafting: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-010, July 2019. (Revised May 2021.)
- 2021
- Working Paper
Computed Tomography: Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins
We describe how Computed Tomography (CT) scanners—that combine x-rays and computers to image soft tissues of the brain and other organs—have become a widely used diagnostic tool. Specifically, we chronicle the: 1) the initial development of CT technology and markets...
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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. "Computed Tomography: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-004, July 2019. (Revised May 2021.)
- 2021
- Working Paper
Development of Ultrasound Scanning: Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins
We describe how efforts on multiple fronts, including advocacy, training and technological development made ultrasound the second most used diagnostic imaging technology (after X-rays). Specifically, we chronicle: 1) ultrasound’s development and introduction in the...
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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. "Development of Ultrasound Scanning: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-003, July 2019. (Revised May 2021.)
- 2021
- Working Paper
Eradicating Helicobacter Pylori Infections to Treat Ulcers: Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins
We describe how a chance discovery of bacteria that infect stomach linings completely changed how physicians treat ulcers. Specifically, we chronicle how: 1) two Australian physicians brought the bacterial infection to the world’s attention and challenged the...
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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. "Eradicating Helicobacter Pylori Infections to Treat Ulcers: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-006, July 2019. (Revised May 2021.)
- 2021
- Working Paper
Gastrointestinal Endoscopy: Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins
We describe how endoscopy transformed the diagnosis of ulcers, cancerous polyps and other diseases of the alimentary canal and enabled “minimally invasive” surgeries to treat such diseases. Specifically, we chronicle how: 1) flexible glass fiber instruments in the...
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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. "Gastrointestinal Endoscopy: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-005, July 2019. (Revised May 2021.)
- 2021
- Working Paper
HIV Tests and AIDS Treatments: Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins
We describe how a diverse cast of characters including public health organizations, research laboratories, for-profit health care companies, activists and regulators, rolled back the outbreak of HIV/AIDS in just fifteen years. Moreover, as the case history shows, a...
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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. "HIV Tests and AIDS Treatments: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-007, July 2019. (Revised May 2021.)
- 2021
- Working Paper
Laparoscopy: Case Histories of Significant Medical Advances
By: Amar Bhidé, Caitlin N. Bowler and Srikant M. Datar
We describe how operations through laparoscopes—tubular instruments inserted into abdominal cavities—revolutionized gynecological and other surgeries inside the abdomen such as gall bladder removal. Specifically, we chronicle the: 1) foundational technologies and...
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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, Caitlin N. Bowler, and Srikant M. Datar. "Laparoscopy: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-008, July 2019. (Revised May 2021.)
- 2021
- Working Paper
Magnetic Resonance Imaging: Case Histories of Significant Medical Advances
By: Srikant M. Datar, Amar Bhidé and Katherine Stebbins
We describe how and why Magnetic Resource Imaging (MRI) came to complement – and partially replace -- computed tomography (CT) imaging of soft tissue. Specifically we chronicle: 1) the development of foundational techniques and prototypes (through the 1970s); 2)...
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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
Datar, Srikant M., Amar Bhidé, and Katherine Stebbins. "Magnetic Resonance Imaging: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-001, July 2019. (Revised June 2021.)
- 2021
- Working Paper
Mammography: Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins
We describe how the development of x-ray-based techniques and equipment (“mammography”) lead to widespread screening for breast cancer and enabled “minimally invasive” biopsies of breast tumors. Specifically, we chronicle how: 1) the protocols and equipment, developed...
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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. "Mammography: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-002, July 2019. (Revised May 2021.)
- 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.
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Keywords:
Medical Devices;
Healthcare;
Health Care;
Health Care and Treatment;
Applications and Software;
Governing Rules, Regulations, and Reforms;
Medical Devices and Supplies Industry
Gordon, William J., and Ariel Dora Stern. "Challenges and Opportunities in Software-Driven Medical Devices." Nature Biomedical Engineering 3, no. 7 (July 2019): 493–497.
- July 2019
- Article
The Impact of Price Regulation on the Availability of New Drugs in Germany
By: Ariel Dora Stern, Felicitas Pietrulla, Annika Herr, Aaron S. Kesselheim and Ameet Sarpatwari
The 2011 German Pharmaceutical Market Restructuring Act (“AMNOG”) subjected branded, non-rare disease drugs to price regulation based on an assessment of their clinical benefit. Assessment outcomes range from “major added benefit” to “less benefit than the appropriate...
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Keywords:
Regulation;
Pharmaceuticals;
Healthcare;
Health Care and Treatment;
Price;
Governing Rules, Regulations, and Reforms;
Pharmaceutical Industry;
Germany
Stern, Ariel Dora, Felicitas Pietrulla, Annika Herr, Aaron S. Kesselheim, and Ameet Sarpatwari. "The Impact of Price Regulation on the Availability of New Drugs in Germany." Health Affairs 38, no. 7 (July 2019): 1182–1187.
- May 16, 2019
- Article
To Improve Food Inspections, Change the Way They're Scheduled
By: Maria Ibanez and Michael W. Toffel
Health inspections are an important tool to increase food safety, but there are still 48 million cases of food-borne illnesses and 128,000 hospitalizations every year in the United States. Our research finds that inspectors reported fewer health code violations as they...
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Keywords:
Inspection;
Scheduling;
Food;
Safety;
Health;
Governing Rules, Regulations, and Reforms;
Performance Improvement
Ibanez, Maria, and Michael W. Toffel. "To Improve Food Inspections, Change the Way They're Scheduled." Harvard Business Review (website) (May 16, 2019).
- January 2019 (Revised June 2019)
- Technical Note
U.S. Commercial Health Insurance Industry
By: Susanna Gallani, Mary Witkowski and Harry B. Wolberg
This note describes the role of commercial payers in the U.S. healthcare industry. We begin with a review of the historical evolution of commercial payers and their role in the market, from the beginning to the Affordable Care Act and beyond. Every wave of reforms in...
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Keywords:
Health Care and Treatment;
Insurance;
Governing Rules, Regulations, and Reforms;
Organizational Change and Adaptation;
Health Industry;
Health Industry;
United States
Gallani, Susanna, Mary Witkowski, and Harry B. Wolberg. "U.S. Commercial Health Insurance Industry." Harvard Business School Technical Note 119-064, January 2019. (Revised June 2019.)
- October 2018 (Revised January 2019)
- Case
The Financial Crisis: Timothy Geithner and the Stress Tests
In February and March 2009, the U.S. economy was in the midst of a terrifying financial and economic crisis. Between the beginning of 2008 and early 2009, four of the 25 largest U.S. financial institutions had failed, and nine of these 25 institutions had taken...
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Keywords:
Bailout;
Regulation;
Stress Test;
Financial Crisis;
History;
Economy;
Policy;
Governing Rules, Regulations, and Reforms;
Decision Making;
Banking Industry;
Financial Services Industry;
Real Estate Industry;
United States
Hanson, Samuel G., Robin Greenwood, David Scharfstein, and Adi Sunderam. "The Financial Crisis: Timothy Geithner and the Stress Tests." Harvard Business School Case 219-038, October 2018. (Revised January 2019.)
- 2020
- Working Paper
The Impact of CEOs in the Public Sector: Evidence from the English NHS
By: Katharina Janke, Carol Propper and Raffaella Sadun
Abstract
Governments worldwide have sought to reform the delivery of public services by mimicking private sector governance models that grant CEOs greater autonomy and give them responsibility for meeting key government targets. We examine the effectiveness of this...
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Janke, Katharina, Carol Propper, and Raffaella Sadun. "The Impact of CEOs in the Public Sector: Evidence from the English NHS." Harvard Business School Working Paper, No. 18-075, March 2018. (Revised September 2020.)
- 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...
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Keywords:
Health Testing and Trials;
Business and Government Relations;
Governing Rules, Regulations, and Reforms;
Information Publishing;
Medical Devices and Supplies Industry;
United States
Kaplan, Aaron V., and Ariel D. Stern. "The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials." JAMA Cardiology 3, no. 1 (January 2018): 5–6.
- 2017
- Working Paper
Creating the Market for Organic Wine: Sulfites, Certification, and Green Values
By: Geoffrey Jones and Emily Grandjean
This working paper examines the history of organic wine, which provides a case study of failed category creation. The modern organic wine industry emerged during the 1970s in the United States and Western Europe, but it struggled to gain traction compared to other...
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Keywords:
Product Launch;
Failure;
Problems and Challenges;
Complexity;
Governing Rules, Regulations, and Reforms;
Agriculture and Agribusiness Industry;
Food and Beverage Industry
Jones, Geoffrey, and Emily Grandjean. "Creating the Market for Organic Wine: Sulfites, Certification, and Green Values." Harvard Business School Working Paper, No. 18-048, December 2017.