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All HBS Web
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- Faculty Publications (89)
- August 2020 (Revised January 2022)
- Case
1928 Diagnostics: Fighting Antibiotics Resistance
By: Ariel D. Stern and Daniela Beyersdorfer
In 2019, the co-founders of the Swedish medical start-up 1928 Diagnostics, CEO Dr. Kristina Lagerstedt and COO Dr. Susanne Staaf, had to pick the right business model to commercialize their novel technology to hospitals and health care providers. Developed in...
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Keywords:
Health Care and Treatment;
Entrepreneurship;
Leadership;
Science-Based Business;
Growth and Development Strategy;
Business Growth and Maturation;
Business Model;
Information Technology;
Digital Platforms;
Health Disorders;
Market Entry and Exit;
Value Creation;
Business and Stakeholder Relations;
Health Industry;
Medical Devices and Supplies Industry;
Technology Industry;
Europe;
Sweden
Stern, Ariel D., and Daniela Beyersdorfer. "1928 Diagnostics: Fighting Antibiotics Resistance." Harvard Business School Case 621-025, August 2020. (Revised January 2022.)
- Article
Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study
By: Noy Alon, Ariel Dora Stern and John Torous
BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous...
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Keywords:
Mobile Health;
Smartphone;
Food And Drug Administration;
Risk-based Framework;
Health Care and Treatment;
Mobile and Wireless Technology;
Applications and Software;
Framework
Alon, Noy, Ariel Dora Stern, and John Torous. "Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study." JMIR mHealth and uHealth 8, no. 10 (October 2020).
- 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).
- Other Article
How to Make Remote Monitoring Tech Part of Everyday Health Care
By: Samantha F. Sanders, Ariel Dora Stern and William J. Gordon
Remote patient monitoring is a subset of telehealth that involves the collection, transmission, evaluation, and communication of patient health data from electronic devices. These devices include wearable sensors, implanted equipment, and handheld instruments. During...
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Keywords:
Health Care and Treatment;
Information Technology;
Analytics and Data Science;
Technology Adoption
Sanders, Samantha F., Ariel Dora Stern, and William J. Gordon. "How to Make Remote Monitoring Tech Part of Everyday Health Care." Harvard Business Review (website) (July 2, 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.
- Article
Quantifying the Use of Connected Digital Products in Clinical Research
By: Caroline Marra, Jacqueline L. Chen, Andrea Coravos and Ariel D. Stern
Over recent years, the adoption of connected technologies has grown dramatically, with potential for improving health care delivery, research, and patient experience. Yet, little has been documented about the prevalence and use of connected digital products (e.g.,...
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Keywords:
Connected Digital Products;
Clinical Trials;
Health Testing and Trials;
Information Technology;
Research
Marra, Caroline, Jacqueline L. Chen, Andrea Coravos, and Ariel D. Stern. "Quantifying the Use of Connected Digital Products in Clinical Research." Art. 50. npj Digital Medicine 3 (2020).
- 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.
- March 2020
- Case
Maven Clinic: Women's Health in the Digital Age
By: Ariel D. Stern and Sarah Mehta
In late 2017, Kate Ryder, the founder and CEO of digital women’s health telemedicine company Maven Clinic, faced an important decision. Maven offered both a direct to consumer (D2C) product that anyone could use to book virtual appointments with health practitioners...
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Keywords:
Business Growth and Maturation;
Business Model;
Business Startups;
Entrepreneurship;
Health;
Health Care and Treatment;
Strategy;
Information Technology;
Applications and Software;
Health Industry;
Technology Industry;
United States
Stern, Ariel D., and Sarah Mehta. "Maven Clinic: Women's Health in the Digital Age." Harvard Business School Case 620-035, March 2020.
- Article
Association of the Meaningful Use Electronic Health Record Incentive Program with Health Information Technology Venture Capital Funding
By: Samuel Lite, William J. Gordon and Ariel Dora Stern
IMPORTANCE
Although the Health Information Technology for Economic and Clinical Health (HITECH) Act has accelerated electronic health record (EHR) adoption since its passage, clinician satisfaction with EHRs remains low, and the association of HITECH with... View Details
Although the Health Information Technology for Economic and Clinical Health (HITECH) Act has accelerated electronic health record (EHR) adoption since its passage, clinician satisfaction with EHRs remains low, and the association of HITECH with... View Details
Keywords:
Health Care and Treatment;
Information Technology;
Laws and Statutes;
Innovation and Invention;
Entrepreneurship;
Venture Capital
Lite, Samuel, William J. Gordon, and Ariel Dora Stern. "Association of the Meaningful Use Electronic Health Record Incentive Program with Health Information Technology Venture Capital Funding." JAMA Network Open 3, no. 3 (March 2020).
- February 2020
- Teaching Note
Ariadne Labs: Building Impactful Partnerships
By: Ariel D. Stern and Sarah Mehta
Teaching Note for HBS No. 619-017.
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- January 2020
- Article
The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System
By: Peter P. Monteleone, Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry and Mark J. Pirwitz
Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has...
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Monteleone, Peter P., Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry, and Mark J. Pirwitz. "The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System." Journal of Invasive Cardiology 32, no. 1 (January 2020).
- December 2019
- Technical Note
Technical Note on Bayesian Statistics and Frequentist Power Calculations
By: Amitabh Chandra and Ariel Dora Stern
This Technical Note provides an introduction to Bayes’ Rule and the statistical intuition that stems from it. In this note, we review the concepts that underlie Bayesian statistics, and we offer several simple mathematical examples to illustrate applications of Bayes’...
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Chandra, Amitabh, and Ariel Dora Stern. "Technical Note on Bayesian Statistics and Frequentist Power Calculations." Harvard Business School Technical Note 620-032, December 2019.
- October 2019
- Article
Adaptive Platform Trials: Definition, Design, Conduct and Reporting Considerations
By: Derek C. Angus, Brian M. Alexander, Scott Berry, Meredith Buxton, Roger Lewis, Melissa Paoloni, Steven A. R. Webb, Steven Arnold, Anna Barker, Donald A. Berry, Marc J. M. Bonten, Mary Brophy, Christopher Butler, Timothy F. Cloughesy, Lennie P. G. Derde, Laura J. Esserman, Ryan Ferguson, Louis Fiore, Sarah C. Gaffey, J. Michael Gaziano, Kathy Giusti, Herman Goossens, Stephane Heritier, Bradley Hyman, Michael Krams, Kay Larholt, Lisa M. LaVange, Philip Lavori, Andrew W. Lo, Alexander J. London, Victoria Manax, Colin McArthur, Genevieve O’Neill, Giovanni Parmigiani, Jane Perlmutter, Elizabeth A. Petzold, Craig Ritchie, Kathryn M. Rowan, Christopher W. Seymour, Nathan I. Shapiro, Diane M. Simeone, Bradley Smith, Bradley Spellberg, Ariel Dora Stern, Lorenzo Trippa, Mark Trusheim, Kert Viele, Patrick Y. Wen and Janet Woodcock
Researchers, clinicians, policymakers, and patients are increasingly interested in questions about therapeutic interventions that are difficult or costly to answer with traditional, free-standing, parallel-group randomized controlled trials (RCTs). Examples include...
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Angus, Derek C., Brian M. Alexander, Scott Berry, Meredith Buxton, Roger Lewis, Melissa Paoloni, Steven A. R. Webb, Steven Arnold, Anna Barker, Donald A. Berry, Marc J. M. Bonten, Mary Brophy, Christopher Butler, Timothy F. Cloughesy, Lennie P. G. Derde, Laura J. Esserman, Ryan Ferguson, Louis Fiore, Sarah C. Gaffey, J. Michael Gaziano, Kathy Giusti, Herman Goossens, Stephane Heritier, Bradley Hyman, Michael Krams, Kay Larholt, Lisa M. LaVange, Philip Lavori, Andrew W. Lo, Alexander J. London, Victoria Manax, Colin McArthur, Genevieve O’Neill, Giovanni Parmigiani, Jane Perlmutter, Elizabeth A. Petzold, Craig Ritchie, Kathryn M. Rowan, Christopher W. Seymour, Nathan I. Shapiro, Diane M. Simeone, Bradley Smith, Bradley Spellberg, Ariel Dora Stern, Lorenzo Trippa, Mark Trusheim, Kert Viele, Patrick Y. Wen, and Janet Woodcock. "Adaptive Platform Trials: Definition, Design, Conduct and Reporting Considerations." Nature Reviews: Drug Discovery 18, no. 10 (October 2019): 797–807.
- October 14, 2019
- Article
How Artificial Intelligence Is Changing Health Care Delivery
By: Samantha F. Sanders, Mats Terwiesch, William J. Gordon and Ariel Dora Stern
The development of intelligent machines holds great promise for making health care delivery more accurate, efficient, and accessible, but challenges remain for incorporating AI into clinical and administrative settings.
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Keywords:
Artificial Intelligence;
Health Care and Treatment;
Service Delivery;
Technological Innovation;
AI and Machine Learning
Sanders, Samantha F., Mats Terwiesch, William J. Gordon, and Ariel Dora Stern. "How Artificial Intelligence Is Changing Health Care Delivery." NEJM Catalyst (October 17, 2019).
- September 2019
- Supplement
Adaptive Platform Trials: The Clinical Trial of the Future? (B)
By: Ariel D. Stern and Sarah Mehta
This case provides an update to the (A) case, which introduces students to adaptive platform trials, an ambitious, more efficient type of clinical trial that increases access to therapies. The (A) case centers on Dr. Brian Alexander’s efforts to launch an adaptive...
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Keywords:
Clinical Trials;
Drug Trials;
Drug Testing;
Cancer Trials;
Glioblastoma;
Platform Trials;
Adaptive Trials;
Adaptive Platform Trials;
Health Testing and Trials;
Health Care and Treatment;
Financing and Loans;
Business Strategy;
Health Industry;
United States
Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future? (B)." Harvard Business School Supplement 620-001, September 2019.
- Article
Managing the Use and Dissemination of Information about Biomarkers: The Importance of Incentive Structures.
By: Ariel Dora Stern
The use of biomarkers holds great promise for the development of new therapeutics and the acceleration of clinical research. However, biomarkers must be validated—a complex and costly endeavor. Importantly, biomarker validation is meaningfully shaped by economic and...
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Stern, Ariel Dora. "Managing the Use and Dissemination of Information about Biomarkers: The Importance of Incentive Structures." Journal of Law, Medicine & Ethics 47, no. 3 (September 2019): 396–397.
- 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.
- 2019
- Working Paper
Who Drives Digital Innovation? Evidence from the U.S. Medical Device Industry
By: Cirrus Foroughi and Ariel Dora Stern
Does the large-scale technological change that is characteristic of an industry-wide digital transformation entrench industry leaders or enable the rise of new entrants? We offer a novel approach to this question by studying the medical device industry, a unique...
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Keywords:
Innovation;
Medical Devices;
Digitization;
Medical Technology;
Technological Innovation;
Applications and Software;
Market Entry and Exit;
Industry Growth;
Medical Devices and Supplies Industry;
United States
Foroughi, Cirrus, and Ariel Dora Stern. "Who Drives Digital Innovation? Evidence from the U.S. Medical Device Industry." Harvard Business School Working Paper, No. 19-120, June 2019.
- Article
Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries
By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer
Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
Keywords:
Digital;
Medicine;
FDA;
Health Care and Treatment;
Applications and Software;
Safety;
Cybersecurity;
Medical Devices and Supplies Industry
Stern, Ariel Dora, William J. Gordon, Adam B. Landman, and Daniel B. Kramer. "Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries." BMJ Open 9, no. 6 (June 2019).