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- February 26, 2024
- Article
Making Workplaces Safer Through Machine Learning
By: Matthew S. Johnson, David I. Levine and Michael W. Toffel
Machine learning algorithms can dramatically improve regulatory effectiveness. This short article describes the authors' scholarly work that shows how the U.S. Occupational Safety and Health Administration (OSHA) could have reduced nearly twice as many occupational...
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Keywords:
Government Experimentation;
Auditing;
Inspection;
Evaluation;
Process Improvement;
Government Administration;
AI and Machine Learning;
Safety;
Governing Rules, Regulations, and Reforms
Johnson, Matthew S., David I. Levine, and Michael W. Toffel. "Making Workplaces Safer Through Machine Learning." Regulatory Review (February 26, 2024).
- 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...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Technology Adoption;
Technological Innovation;
Safety;
Medical Devices and Supplies Industry;
United States
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "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." Art. 29. npj Digital Medicine 7 (2024).
- 2023
- Article
Dynamic HTA for Digital Health Solutions: Opportunities and Challenges for Patient-Centered Evaluation
By: Jan B. Brönneke, Annika Herr, Simon Reif and Ariel D. Stern
Germany’s 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the health care delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital...
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Keywords:
Digital Transformation;
Applications and Software;
Product Development;
Insurance;
Policy;
Health Industry;
Germany
Brönneke, Jan B., Annika Herr, Simon Reif, and Ariel D. Stern. "Dynamic HTA for Digital Health Solutions: Opportunities and Challenges for Patient-Centered Evaluation." International Journal of Technology Assessment in Health Care 39, no. 1 (2023).
- October 2023 (Revised March 2024)
- Case
KOKO Networks: Bridging Energy Transition and Affordability with Carbon Financing
By: George Serafeim, Siko Sikochi and Namrata Arora
The problem was massive: two million hectares of African forests were lost annually to charcoal production for cooking, an area equivalent to 13 times Greater London, resulting in one billion tons of carbon emissions yearly. At the same time, an estimated 700,000...
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Keywords:
Africa;
Clean Tech;
Energy;
Sustainability;
Health;
Digital;
Carbon Credits;
Carbon Offsetting;
Market Design;
Regulation;
Climate Change;
Entrepreneurship;
Energy Industry;
Consumer Products Industry;
Africa
Serafeim, George, Siko Sikochi, and Namrata Arora. "KOKO Networks: Bridging Energy Transition and Affordability with Carbon Financing." Harvard Business School Case 124-022, October 2023. (Revised March 2024.)
- 2023
- Working Paper
The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina
By: Sebastian Calónico, Rafael Di Tella and Juan Cruz Lopez Del Valle
We document the diffusion of nebulized ibuprofen in Argentina as a treatment for COVID-19. As the pandemic spread, this clinically unsupported drug reached thousands of patients, even some seriously ill, despite warnings by the regulator and medical societies. Detailed...
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Keywords:
COVID-19;
Health Care and Treatment;
Health Pandemics;
Adoption;
Behavior;
Governing Rules, Regulations, and Reforms;
Learning
Calónico, Sebastian, Rafael Di Tella, and Juan Cruz Lopez Del Valle. "The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina." NBER Working Paper Series, No. 31781, October 2023.
- October 2023
- Case
Vida Health: Transforming Chronic Disease Treatment
By: William Sahlman and Nicole Tempest Keller
San Francisco based Vida Health, founded by Stephanie Tilenius, former vice president of Commerce and Payments at Google, was a B2B digital health startup focused on the treatment of cardiometabolic conditions, such as diabetes and obesity. Its innovative digital...
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Keywords:
Corporate Strategy;
Growth and Development Strategy;
Demand and Consumers;
Health Care and Treatment;
Product Marketing;
Risk and Uncertainty;
Technological Innovation;
Health Industry;
Health Industry;
United States;
California;
San Francisco
Sahlman, William, and Nicole Tempest Keller. "Vida Health: Transforming Chronic Disease Treatment." Harvard Business School Case 824-001, October 2023.
- 2023
- Article
Digital Health Reimbursement Strategies of 8 European Countries and Israel: Scoping Review and Policy Mapping
By: Robin van Kessel, Divya Srivastava, Ilias Kyriopoulos, Giovanni Monti, David Novillo-Ortiz, Ran Milman, Wojciech Wilhelm Zhang-Czabanowski, Greta Nasi, Ariel Dora Stern, George Wharton and Elias Mossialos
Background: The adoption of digital health care within health systems is determined by various factors, including pricing and reimbursement. The reimbursement landscape for digital health in Europe remains underresearched. Although various emergency reimbursement...
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Keywords:
Technology Adoption;
Health Care and Treatment;
Cross-Cultural and Cross-Border Issues;
Price;
Health Industry;
Europe;
Israel
van Kessel, Robin, Divya Srivastava, Ilias Kyriopoulos, Giovanni Monti, David Novillo-Ortiz, Ran Milman, Wojciech Wilhelm Zhang-Czabanowski, Greta Nasi, Ariel Dora Stern, George Wharton, and Elias Mossialos. "Digital Health Reimbursement Strategies of 8 European Countries and Israel: Scoping Review and Policy Mapping." e49003. JMIR mHealth and uHealth 11 (2023).
- September 2023 (Revised January 2024)
- Case
AB InBev: Brewing Up Forecasts during COVID-19
By: Mark Egan, C. Fritz Foley, Esel Cekin and Emilie Billaud
In July 2021, the CEO of AB InBev's European operations and his team strategized to position the company for success post-pandemic. As the world's largest beer company, boasting over 500 brands, revenue of $46 billion, and a workforce of 160,000 in 2020, AB InBev...
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Keywords:
Beer;
Forecasting;
COVID-19;
Decision;
Forecasting and Prediction;
Analytics and Data Science;
Crisis Management;
Decisions;
Financing and Loans;
Investment Return;
Resource Allocation;
Distribution;
Production;
Business Processes;
Strategic Planning;
Health Pandemics;
Digital Transformation;
Food and Beverage Industry;
Belgium;
Europe;
Latin America;
North and Central America
Egan, Mark, C. Fritz Foley, Esel Cekin, and Emilie Billaud. "AB InBev: Brewing Up Forecasts during COVID-19." Harvard Business School Case 224-020, September 2023. (Revised January 2024.)
- September 2023
- Teaching Note
Fighting the Battle of the Bulge—Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment
Teaching Note for HBS Case No. 304-009. The case is part of the first module of the Innovating in Health Care course. Its purpose is to demonstrate how to evaluate the “do good” and do well” potential of a health care innovation.
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- September–October 2023
- Article
Prospective Evaluation of the Cost of Performing Breast Imaging Examinations Using Time-Driven Activity-Based Costing Method: A Single Center Study
By: Aamir Ali, Jordana Phillips, Damir Ljuboja, Syed S. Shehab, Etta D. Pisano, Robert S. Kaplan and Ammar Sarwar
We use time-driven activity-based costing (TDABC) to measure the cost of performing breast imaging using different modalities: full-field digital mammography (FFDM), digital breast tomosynthesis (DBT), contrast-enhanced mammography (CEM), US and MRI exams, and...
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Keywords:
Time-Driven Activity-Based Costing;
Health Care;
Breast Cancer;
Health Care and Treatment;
Cost;
Cost Accounting;
Health Industry
Ali, Aamir, Jordana Phillips, Damir Ljuboja, Syed S. Shehab, Etta D. Pisano, Robert S. Kaplan, and Ammar Sarwar. "Prospective Evaluation of the Cost of Performing Breast Imaging Examinations Using Time-Driven Activity-Based Costing Method: A Single Center Study." Journal of Breast Imaging 5, no. 5 (September–October 2023): 546–554.
- August 2023
- Case
Sky Therapeutics: Innovating in Digital Therapeutics
By: Satish Tadikonda and Olivia Reszczynski
Shad Faraz and Alex Youssef were intrigued by the opportunities in the relatively new area of Digital Therapeutics. Despite initial successes, early entrants had struggled with reimbursement and revenue-predictability challenges. However, venture investors still...
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Keywords:
Business Startups;
Entrepreneurship;
Mission and Purpose;
Health Industry;
Health Industry
Tadikonda, Satish, and Olivia Reszczynski. "Sky Therapeutics: Innovating in Digital Therapeutics." Harvard Business School Case 824-023, August 2023.
- 2023
- Article
Building the Business Case for an Inclusive Approach to Digital Health Measurement with a Web App (Market Opportunity Calculator): Instrument Development Study
By: Mitchell Tang, Yashoda Sharma, Jennifer C. Goldsack and Ariel Dora Stern
Background: The use of digital health measurement tools has grown substantially in recent years. However, there are concerns that the promised benefits from these products will not be shared equitably. Underserved populations, such as those with lower education and...
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Keywords:
Demographics;
Product Development;
Health Care and Treatment;
Medical Devices and Supplies Industry
Tang, Mitchell, Yashoda Sharma, Jennifer C. Goldsack, and Ariel Dora Stern. "Building the Business Case for an Inclusive Approach to Digital Health Measurement with a Web App (Market Opportunity Calculator): Instrument Development Study." JMIR Formative Research 7 (2023).
- June 2023
- Case
Biogen and the Aduhelm Melee
By: Amitabh Chandra and Lauren Gunasti
Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.
This... View Details
This... View Details
- June 2023
- Article
Gaining Organizational Adoption: Strategically Pacing the Deployment of Digital Innovations
By: Rebecca Karp
Scholars have long suggested that to foster adoption for their innovative products and services, entrepreneurs should engage with customers to better understand their unmet needs. Yet, customers frequently reside in organizations, and organizational members may not be...
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Keywords:
Entrepreneurship And Strategy;
Digital Innovation;
Healthcare;
Work And Organizations;
Organizational Adoption;
B2B;
Customers;
Technology Adoption;
Innovation Strategy;
Organizational Change and Adaptation
Karp, Rebecca. "Gaining Organizational Adoption: Strategically Pacing the Deployment of Digital Innovations." Academy of Management Journal 66, no. 3 (June 2023): 773–796.
- 2023
- Article
Conduit Incentives: Eliciting Cooperation from Workers Outside of Managers' Control
By: Susanna Gallani
Can managers use monetary incentives to elicit cooperation from workers they cannot reward for their efforts? I study “conduit incentives,” an innovative incentive design, whereby managers influence bonus-ineligible workers’ effort by offering bonus-eligible employees...
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Keywords:
Organizational Behavior Modification;
Peer Monitoring;
Persistence Of Performance Improvements;
Crowding Out;
Implicit Incentives;
Compensation;
Healthcare;
Social Pressure;
Image Motivation;
Incentives;
Motivation;
Performance;
Behavior;
Motivation and Incentives;
Compensation and Benefits;
Governing Rules, Regulations, and Reforms;
Organizational Culture;
Health Industry;
California
Gallani, Susanna. "Conduit Incentives: Eliciting Cooperation from Workers Outside of Managers' Control." Accounting Review 93, no. 3 (2023): 1–28.
- April 2023 (Revised January 2024)
- Background Note
Note on Healthcare in Ghana
By: Regina E. Herzlinger and Ben Creo
This note provides an overview of the healthcare system in Ghana. It discusses the public and private sector as well as traditional medical practice. It also discusses the country’s pharmaceutical industry. It is recommended as a companion to Professor Regina...
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Keywords:
Africa;
Pharmaceutical Companies;
Pharmacy Benefit Manager;
Health Care;
Health Care Costs;
Health Care Delivery;
Health Care Entrepreneurship;
Telehealth;
Health Equity;
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Business and Government Relations;
Health Industry;
Health Industry;
Ghana
Herzlinger, Regina E., and Ben Creo. "Note on Healthcare in Ghana." Harvard Business School Background Note 323-112, April 2023. (Revised January 2024.)
- April 2023 (Revised September 2023)
- Case
Levels: The Remote, Asynchronous, Deep Work Management System
By: Joseph B. Fuller and George Gonzalez
Levels is a highly innovative startup in the health care space. They intend to revolutionize health by linking behavior—eating, exercise, sleeping, etc.—to changes in metabolism. They believe metabolic health can be managed through careful monitoring of changes in...
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Keywords:
Applications and Software;
Business Startups;
Organizational Culture;
Management Style;
Technology Industry;
United States
Fuller, Joseph B., and George Gonzalez. "Levels: The Remote, Asynchronous, Deep Work Management System." Harvard Business School Case 323-069, April 2023. (Revised September 2023.)
- March 2023
- Case
Moderna
By: Marco Iansiti, Karim R. Lakhani, Hannah Mayer, Kerry Herman, Allison J. Wigen and Dave Habeeb
This multimedia case follows the story of Moderna and its entry into vaccine development in the wake of the COVID-19 pandemic. In summer 2020, Stephane Bancel, CEO of biotech firm Moderna, faces several challenges as his company races to develop a vaccine for COVID-19....
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- March 2023 (Revised June 2023)
- Teaching Note
Ransomware Attack at Springhill Medical Center
By: Suraj Srinivasan and Li-Kuan (Jason) Ni
Teaching Note for HBS Case No. 123-065. In July, 2019, Springhill Medical Center (“SMC”) in Mobile, Alabama fell prey to a malicious ransomware attack that crippled the hospital’s internal network systems and public-facing web page. While the hospital rushed to...
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Keywords:
Disruption;
Communication;
Communication Strategy;
Decision Making;
Decision Choices and Conditions;
Judgments;
Corporate Accountability;
Corporate Disclosure;
Corporate Governance;
Governance Controls;
Policy;
Employees;
News;
Cybersecurity;
Digital Strategy;
Information Infrastructure;
Information Management;
Internet and the Web;
Crisis Management;
Business or Company Management;
Resource Allocation;
Risk Management;
Negotiation Tactics;
Failure;
Business and Stakeholder Relations;
Attitudes;
Behavior;
Perception;
Reputation;
Trust;
Public Opinion;
Social Issues;
Health Industry;
Alabama;
United States
- February 2023
- Case
Ransomware Attack at Springhill Medical Center
By: Suraj Srinivasan and Li-Kuan (Jason) Ni
In July, 2019, Springhill Medical Center (“SMC”) in Mobile, Alabama, fell prey to a malicious ransomware attack that crippled the hospital’s internal network systems and public-facing web page. While the hospital rushed to securely restore the network, medical...
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Keywords:
Disruption;
Communication;
Communication Strategy;
Decision Making;
Decision Choices and Conditions;
Judgments;
Corporate Accountability;
Corporate Disclosure;
Corporate Governance;
Governance Controls;
Policy;
Employees;
News;
Cybersecurity;
Digital Strategy;
Information Infrastructure;
Information Management;
Internet and the Web;
Crisis Management;
Resource Allocation;
Risk Management;
Negotiation Tactics;
Failure;
Business and Stakeholder Relations;
Attitudes;
Behavior;
Perception;
Reputation;
Trust;
Public Opinion;
Social Issues;
Health Industry;
United States;
Alabama
Srinivasan, Suraj, and Li-Kuan (Jason) Ni. "Ransomware Attack at Springhill Medical Center." Harvard Business School Case 123-065, February 2023.