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All HBS Web
(115,548)
- Faculty Publications (90)
- Article
Ein Booster für die Pharmabranche [A Booster for the Pharmaceutical Industry]
By: Ariel Dora Stern, Timo Minssen, W. Nicholson Price, II and Christoph Grimpe
mRNA technology has just helped to develop vaccines against COVID-19. Now, like Apple's iOS, it could provide the basis for new innovation platforms.
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Keywords:
mRNA;
COVID-19;
Vaccines;
Health Care and Treatment;
Health Pandemics;
Innovation and Invention;
Health Industry
Stern, Ariel Dora, Timo Minssen, W. Nicholson Price, II, and Christoph Grimpe. "Ein Booster für die Pharmabranche [A Booster for the Pharmaceutical Industry]." Harvard Business Manager (July 2022).
- April 18, 2022
- Article
Will mRNA Technology Companies Spawn Innovation Ecosystems?
By: Christoph Grimpe, Timo Minssen, W. Nicholson Price, II and Ariel Dora Stern
The mRNA technologies that helped rapidly create effective COVID-19 vaccines could become technology platform businesses, which has tremendous implications for players in the world of drug development. These platforms could attract other companies interested in...
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Keywords:
Health Care;
Digital Health;
Technology;
Innovation;
Health Care and Treatment;
Technological Innovation;
Digital Transformation;
Health Industry;
United States
Grimpe, Christoph, Timo Minssen, W. Nicholson Price, II, and Ariel Dora Stern. "Will mRNA Technology Companies Spawn Innovation Ecosystems?" Harvard Business Review (website) (April 18, 2022).
- April 2022
- Article
AI Insurance: How Liability Insurance Can Drive the Responsible Adoption of Artificial Intelligence in Health Care
By: Ariel Dora Stern, Avi Goldfarb, Timo Minssen and W. Nicholson Price II
Despite enthusiasm about the potential to apply artificial intelligence (AI) to medicine and health care delivery, adoption remains tepid, even for the most compelling technologies. In this article, the authors focus on one set of challenges to AI adoption: those...
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Keywords:
Artificial Intelligence;
Medicine;
Health Care and Treatment;
Legal Liability;
Insurance;
Technology Adoption;
AI and Machine Learning
Stern, Ariel Dora, Avi Goldfarb, Timo Minssen, and W. Nicholson Price II. "AI Insurance: How Liability Insurance Can Drive the Responsible Adoption of Artificial Intelligence in Health Care." NEJM Catalyst Innovations in Care Delivery 3, no. 4 (April 2022).
- March 2022 (Revised August 2022)
- Case
Proximie: Using XR Technology to Create Borderless Operating Rooms
By: Ariel D. Stern and Alpana Thapar
In mid-January 2022, Nadine Hachach-Haram, founder and CEO of Proximie, was thinking about the company’s growth plans. Launched in 2016, Proximie was a platform that enabled clinicians, proctors, and medical device company personnel to be virtually present in operating...
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Keywords:
Growth and Development Strategy;
Technological Innovation;
Partners and Partnerships;
Strategic Planning;
Health Care and Treatment;
Analytics and Data Science;
Digital Platforms;
Health Industry;
Lebanon;
United Kingdom;
United States
Stern, Ariel D., and Alpana Thapar. "Proximie: Using XR Technology to Create Borderless Operating Rooms." Harvard Business School Case 622-082, March 2022. (Revised August 2022.)
- Article
Advancing Digital Health Applications: Priorities for Innovation in Real-World Evidence Generation
By: Ariel Dora Stern, Jan Brönneke, Jörg F Debatin, Julia Hagen, Henrik Matthies, Smit Patel, Ieuan Clay, Bjoern Eskofier, Annika Herr, Kurt Hoeller, Ashley Jaksa, Daniel B Kramer, Mattias Kyhlstedt, Katherine T Lofgren, Nirosha Mahendraratnam, Holger Muehlan, Simon Reif, Lars Riedemann and Jennifer C Goldsack
In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a “Fast-Track” regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can...
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Stern, Ariel Dora, Jan Brönneke, Jörg F Debatin, Julia Hagen, Henrik Matthies, Smit Patel, Ieuan Clay, Bjoern Eskofier, Annika Herr, Kurt Hoeller, Ashley Jaksa, Daniel B Kramer, Mattias Kyhlstedt, Katherine T Lofgren, Nirosha Mahendraratnam, Holger Muehlan, Simon Reif, Lars Riedemann, and Jennifer C Goldsack. "Advancing Digital Health Applications: Priorities for Innovation in Real-World Evidence Generation." Lancet Digital Health 4, no. 3 (March 2022): e200–e206.
- Article
Health App Policy: International Comparison of Nine Countries' Approaches
By: Anna Essén, Ariel Dora Stern, Christoffer Bjerre Haase, Josip Car, Felix Greaves, Dragana Paparova, Steven Vandeput, Rik Wehrens and David W. Bates
An abundant and growing supply of digital health applications (apps) exists in the commercial tech-sector, which can be bewildering for clinicians, patients, and payers. A growing challenge for the health care system is therefore to facilitate the identification of...
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Keywords:
Digital Health;
Apps;
Health Care and Treatment;
Internet and the Web;
Policy;
Global Range;
Applications and Software
Essén, Anna, Ariel Dora Stern, Christoffer Bjerre Haase, Josip Car, Felix Greaves, Dragana Paparova, Steven Vandeput, Rik Wehrens, and David W. Bates. "Health App Policy: International Comparison of Nine Countries' Approaches." npj Digital Medicine 5, no. 31 (2022).
- January 2022 (Revised August 2022)
- Case
Hello Heart: The Next Generation of Chronic Disease Management Apps
By: Ariel D. Stern and Danielle Golan
Hello Heart, a hypertension management app debated whether to go deep and cover other heart conditions, or to expand its solution to other chronic conditions.
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Keywords:
Health;
Health Care and Treatment;
Information Technology;
Mobile and Wireless Technology;
Analysis;
Business Startups;
Transition;
Customer Focus and Relationships;
Customer Satisfaction;
Decision Making;
Demographics;
Design;
Entrepreneurship;
Venture Capital;
Technological Innovation;
Growth and Development Strategy;
Product Launch;
Product Design;
Product Development;
Business Strategy;
Competitive Strategy;
Competitive Advantage;
Customization and Personalization;
Business Growth and Maturation;
Business Model;
Strategy;
Applications and Software;
Health Industry;
Technology Industry;
Israel;
United States
Stern, Ariel D., and Danielle Golan. "Hello Heart: The Next Generation of Chronic Disease Management Apps." Harvard Business School Case 622-061, January 2022. (Revised August 2022.)
- January 2022
- Supplement
Somatus: Value-Based Kidney Care (B)
By: Ariel D. Stern, Robert S. Huckman and Sarah Mehta
Set in early 2020, this (B) case provides an update to the (A) case (no. 622-009) and provides additional context regarding the challenges facing Somatus.
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Keywords:
Business Startups;
Disruption;
Entrepreneurship;
Health;
Health Care and Treatment;
Health Disorders;
Medical Specialties;
Innovation and Invention;
Disruptive Innovation;
Management;
Strategy;
Business Strategy;
Value;
Value Creation;
Health Industry;
United States;
Virginia
Stern, Ariel D., Robert S. Huckman, and Sarah Mehta. "Somatus: Value-Based Kidney Care (B)." Harvard Business School Supplement 622-045, January 2022.
- January 2022
- Case
Somatus: Value-Based Kidney Care (A)
By: Ariel D. Stern, Robert S. Huckman and Sarah Mehta
When Dr. Ikenna Okezie founded Somatus, a value-based kidney care provider, his goal had been nothing short of transforming kidney care delivery in the United States. Rather than relying on dialysis, a costly and intensive treatment for late-stage kidney disease, the...
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Keywords:
Business Startups;
Disruption;
Entrepreneurship;
Health;
Health Care and Treatment;
Health Disorders;
Medical Specialties;
Innovation and Invention;
Disruptive Innovation;
Management;
Strategy;
Business Strategy;
Value;
Value Creation;
Health Industry;
United States;
Virginia
Stern, Ariel D., Robert S. Huckman, and Sarah Mehta. "Somatus: Value-Based Kidney Care (A)." Harvard Business School Case 622-009, January 2022.
- October 20, 2021
- Other Article
On the Brink of a Digital Health Care Transformation: What Germany Can Learn from the United States
By: Yoni Goldwasser, William J. Gordon, Jan B. Brönneke and Ariel D. Stern
Goldwasser, Yoni, William J. Gordon, Jan B. Brönneke, and Ariel D. Stern. "On the Brink of a Digital Health Care Transformation: What Germany Can Learn from the United States." Health Affairs Blog (October 20, 2021).
- Other Article
Biosimilars and Follow-On Products: The Authors Reply
By: Ariel Dora Stern and Mark R. Trusheim
Stern, Ariel Dora, and Mark R. Trusheim. "Biosimilars and Follow-On Products: The Authors Reply." Health Affairs 40, no. 9 (September 2021).
- July 2021
- Supplement
Adaptive Platform Trials: The Clinical Trial of the Future? (C)
By: Ariel D. Stern and Sarah Mehta
This (C) case provides an update on the work of the Global Coalition for Adaptive Research (GCAR) and also illustrates how adaptive platform trials can nimbly respond to a global pandemic.
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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;
Business Strategy;
Health Industry;
United States
Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future? (C)." Harvard Business School Supplement 622-012, July 2021.
- Article
Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring
By: Jan Benedikt Brönneke, Jennifer Müller, Konstantinos Mouratis, Julia Hagen and Ariel Dora Stern
In the area of cardiac monitoring, the use of digitally driven technologies is on the rise. While the development of medical products is advancing rapidly, allowing for new use-cases in cardiac monitoring and other areas, regulatory and legal requirements that govern...
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Keywords:
Wearables;
Regulatory Changes;
Medical Technology;
Medical Devices;
Market Access;
Market Entry and Exit;
Information Technology;
Health Care and Treatment;
Governing Rules, Regulations, and Reforms;
United States;
Germany;
Belgium
Brönneke, Jan Benedikt, Jennifer Müller, Konstantinos Mouratis, Julia Hagen, and Ariel Dora Stern. "Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring." Art. 4937. Sensors 21, no. 14 (July 2021).
- Article
Biosimilars and Follow-On Products in the United States: Adoption, Prices, and Users
By: Ariel Dora Stern, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup and Ernst R. Berndt
Biologic drugs account for a disproportionate share of the increase in pharmaceutical spending in the U.S. and worldwide. Against this backdrop, many look to the expanding market for biosimilars—follow-on products to biologic drugs—as a vehicle for controlling...
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Keywords:
Pharmaceuticals;
Drug Spending;
Drug Pricing;
Health Care and Treatment;
Spending;
Price;
Markets;
Cost Management;
United States
Stern, Ariel Dora, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup, and Ernst R. Berndt. "Biosimilars and Follow-On Products in the United States: Adoption, Prices, and Users." Health Affairs 40, no. 6 (June 2021): 989–999.
- 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
- Working Paper
Which Markets (Don't) Drive Pharmaceutical Innovation? Evidence From U.S. Medicaid Expansions
By: Craig Garthwaite, Rebecca Sachs and Ariel Dora Stern
Pharmaceutical innovation policy involves managing a tradeoff between high prices for new products in the short-term and stronger incentives to develop products for the future. Prior research has documented a causal relationship between market size and pharmaceutical...
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Keywords:
Pharmaceuticals;
Medicaid;
Innovation and Invention;
Policy;
Markets;
Research and Development;
Pharmaceutical Industry
Garthwaite, Craig, Rebecca Sachs, and Ariel Dora Stern. "Which Markets (Don't) Drive Pharmaceutical Innovation? Evidence From U.S. Medicaid Expansions." NBER Working Paper Series, No. 28755, May 2021.
- April 15, 2021
- Article
Remote Patient Monitoring—Overdue or Overused?
By: Keizra Mecklai, Nicholas Smith, Ariel Dora Stern and Daniel B. Kramer
As the use of remote patient monitoring services grows—driven by health care limitations imposed by the COVID-19 pandemic—clinicians, payers, and patients face important questions regarding the volume, value, and appropriate use of this care model.
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Mecklai, Keizra, Nicholas Smith, Ariel Dora Stern, and Daniel B. Kramer. "Remote Patient Monitoring—Overdue or Overused?" New England Journal of Medicine 384, no. 15 (April 15, 2021): 1384–1386.
- Article
Ushering in Safe, Effective, Secure, and Ethical Medicine in the Digital Era
By: William J. Gordon, Andrea Coravos and Ariel Dora Stern
From clinical trials to care delivery, advanced, digitally enabled technologies and analytics offer new approaches to how we think about medicine, health, and biology. The COVID-19 pandemic has accelerated this conversation, and forced a roadmap, once measured in years...
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Gordon, William J., Andrea Coravos, and Ariel Dora Stern. "Ushering in Safe, Effective, Secure, and Ethical Medicine in the Digital Era." npj Digital Medicine 4, no. 56 (2021).
- January–February 2021
- Article
Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses
By: Rachel E. Weitzman, Ariel Dora Stern and Daniel B. Kramer
As pressure mounts on the Food and Drug Administration (FDA) to speed its review process for novel devices, and budgetary pressures further strain its resources, the critical role of guidance documents in assuring consistent, rigorous, and scientifically grounded...
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Keywords:
Medical Devices;
FDA;
Health Care and Treatment;
Government Administration;
Information;
Standards
Weitzman, Rachel E., Ariel Dora Stern, and Daniel B. Kramer. "Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses." American Journal of Therapeutics 28, no. 1 (January–February 2021).
- Other Article
Want to See the Future of Digital Health Tools? Look to Germany
By: Ariel Dora Stern, Henrik Matthies, Julia Hagen, Jan B. Brönneke and Jörg F. Debatin
A new law will make it easier to introduce and determine the benefits of new tools. Perhaps its most important provisions are its formalization of “prescribable applications,” which include standard software, SaaS, and mobile as well as browser-based apps, and the...
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Keywords:
Health Care and Treatment;
Transformation;
Internet and the Web;
Technological Innovation;
Germany
Stern, Ariel Dora, Henrik Matthies, Julia Hagen, Jan B. Brönneke, and Jörg F. Debatin. "Want to See the Future of Digital Health Tools? Look to Germany." Harvard Business Review (website) (December 2, 2020).