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- May 2024
- Article
Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms
By: Caroline Marra and Ariel D. Stern
Digital health technologies (DHTs) can enable more patient-centric therapeutic development by generating evidence that captures how patients feel and function, enabling decentralized trial designs that increase participant inclusivity and convenience, and collecting...
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Keywords:
Health Care and Treatment;
Technological Innovation;
Product Development;
Health Testing and Trials;
Governing Rules, Regulations, and Reforms
Marra, Caroline, and Ariel D. Stern. "Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms." Clinical Pharmacology & Therapeutics 115, no. 5 (May 2024): 988–992.
- April 2024
- Case
Dr. Tom Mihaljevic and Cleveland Clinic
By: Linda A. Hill and Lydia Begag
In December 2022, Dr. Tomislav (“Tom”) Mihaljevic, CEO and President of Cleveland Clinic, was reflecting on the last few years at the hospital, marked both by unprecedented challenges and remarkable achievements. Cleveland Clinic had recently been ranked the world’s...
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Keywords:
Recruitment;
Retention;
Analytics and Data Science;
Digital Transformation;
Digital Platforms;
Innovation and Management;
Innovation Leadership;
Human Capital;
Leadership;
Leadership Development;
Leadership Style;
Leading Change;
Organizational Culture;
Organizational Structure;
Organizational Change and Adaptation;
Mission and Purpose;
Outcome or Result;
Performance;
Performance Evaluation;
Health Industry;
Cleveland;
London;
Abu Dhabi;
Florida;
Ohio
Hill, Linda A., and Lydia Begag. "Dr. Tom Mihaljevic and Cleveland Clinic." Harvard Business School Case 424-031, April 2024.
- April 2024
- Case
Unleashing Human Magic at Best Buy
By: Leonard A. Schlesinger, Sunil Gupta and Amram Migdal
The case examines the transformation of Best Buy under CEO Hubert Joly's leadership from 2012. Facing significant business challenges, including competition from online and physical retailers, Joly implemented the "Renew Blue" turnaround strategy, which focused on...
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Keywords:
Change;
Change Management;
Transformation;
Transition;
Communication Intention and Meaning;
Communication Strategy;
Customer Focus and Relationships;
Customers;
Health;
Digital Transformation;
Digital Strategy;
Job Cuts and Outsourcing;
Labor;
Leadership;
Leadership Development;
Leadership Style;
Leading Change;
Management;
Management Practices and Processes;
Management Style;
Business or Company Management;
Crisis Management;
Mission and Purpose;
Organizational Change and Adaptation;
Organizational Culture;
Outcome or Result;
Failure;
Success;
Personal Development and Career;
Strategy;
Strategic Planning;
Adaptation;
Competition;
Retail Industry;
Minneapolis;
Minnesota;
United States
Schlesinger, Leonard A., Sunil Gupta, and Amram Migdal. "Unleashing Human Magic at Best Buy." Harvard Business School Case 524-072, April 2024.
- May 2024
- Technical Note
Health Care Payment in the United States
By: Robert S. Huckman, Jeff Charca and Craig Garthwaite
This document provides an overview of how various actors (e.g., physicians, hospitals, and other health care providers) are paid in the United States health care system. It is particularly focused on features of the payment system that contribute to strategic decisions...
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- February 2024
- Teaching Note
AB InBev: Brewing Up Forecasts during COVID-19
By: Mark Egan and C. Fritz Foley
Teaching Note for HBS Case No. 224-020. 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...
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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).
- November 2023 (Revised March 2024)
- Technical Note
Customer Data Privacy
By: Eva Ascarza and Ta-Wei Huang
This note provides an overview of the evolving landscape of customer data privacy in 2023. It highlights two pivotal aspects that make privacy a central concern for businesses: building and maintaining customer trust and navigating the intricate regulatory...
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Keywords:
Customer Relationship Management;
Governance Compliance;
Governing Rules, Regulations, and Reforms;
Risk and Uncertainty;
Reputation;
Trust;
Information Management;
Retail Industry;
Technology Industry;
Financial Services Industry;
Telecommunications Industry;
Europe;
United States
Ascarza, Eva, and Ta-Wei Huang. "Customer Data Privacy." Harvard Business School Technical Note 524-005, November 2023. (Revised March 2024.)
- November 2023
- Case
Will Fintechs and Central Banks Play in Emtech's Sandbox?
By: Daniel Isenberg and William R. Kerr
In February 2023, Emtech’s founder Carmelle Cadet is facing a dilemma. Rapidly running out of cash, Cadet has a term sheet from a leading VC but has a choice of how to structure the investment. The decision will have significant implications for Cadet’s own stake, as...
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Keywords:
Cryptocurrency;
Business Startups;
Venture Capital;
Cash Flow;
Currency;
Governing Rules, Regulations, and Reforms;
Digital Platforms
Isenberg, Daniel, and William R. Kerr. "Will Fintechs and Central Banks Play in Emtech's Sandbox?" Harvard Business School Case 824-096, November 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:
Clean Tech;
Digital;
Carbon Credits;
Carbon Offsetting;
Climate Change;
Entrepreneurship;
Energy Sources;
Environmental Sustainability;
Health;
Market Design;
Business Startups;
Transition;
Environmental Regulation;
Policy;
Energy Industry;
Consumer Products Industry;
Africa;
Kenya;
Rwanda
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;
Markets;
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
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