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- All HBS Web
(55)
- News (7)
- Research (46)
- Multimedia (2)
- Faculty Publications (22)
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- 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. View Details
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.
- 20 Dec 2016
- First Look
December 20, 2016
years, this paper presents a significant revision of the model of creativity and innovation in organizations published in Research in Organizational Behavior in 1988. This update focuses primarily on the individual-level psychological... View Details
Keywords: Carmen Nobel
- 12 Feb 2019
- First Look
New Research and Ideas, February 12, 2019
Devices: Challenges and Opportunities for U.S. Regulators and Innovators By: Gordon, William J., and Ariel Dora... View Details
Keywords: Dina Gerdeman
- 23 Oct 2018
- First Look
New Research and Ideas, October 23, 2018
Dora Stern Abstract—This study sheds new light on first- and early-mover advantages. Research on this classic topic often assumes that each firm participates in the entirety of... View Details
Keywords: Dina Gerdeman
- 2022
- Working Paper
The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives
By: Ariel Dora Stern
For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with... View Details
Keywords: AI and Machine Learning; Health Care and Treatment; Governing Rules, Regulations, and Reforms; Technological Innovation; Medical Devices and Supplies Industry
Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." NBER Working Paper Series, No. 30639, December 2022.
- 25 Sep 2018
- First Look
New Research and Ideas, September 25, 2018
from Medical Device Recalls By: Ball, George P., Jeffrey T. Macher, and Ariel Dora Stern Abstract—When innovations are successfully... View Details
Keywords: Dina Gerdeman
- 2024
- Chapter
The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives
By: Ariel Dora Stern
For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with... View Details
Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." Chap. 4 in The Economics of Artificial Intelligence: Health Care Challenges, edited by Ajay Agrawal, Joshua Gans, Avi Goldfarb, and Catherine E. Tucker, 107–138. Chicago and London: University of Chicago Press, 2024.
- 21 Aug 2018
- First Look
New Research and Ideas, August 21, 2018
best be applied. Publisher's link: https://www.hbs.edu/faculty/Pages/item.aspx?num=54809 August 2018 Review of Industrial Organization The Impact of the Entry of Biosimilars: Evidence from Europe By: Scott Morton, Fiona M., Ariel View Details
Keywords: Dina Gerdeman
- 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... View Details
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.
- 01 Aug 2017
- First Look
First Look at New Research and Ideas, August 1
Scott Morton, Fiona, Ariel Dora Stern, and Scott Stern Abstract—Biologic drugs (therapeutic proteins or “large-molecule drugs”) represent a... View Details
Keywords: Sean Silverthorne
- 18 Apr 2018
- First Look
First Look at New Research and Ideas, April 18, 2018
The Impact of the Entry of Biosimilars: Evidence from Europe By: Scott Morton, Fiona, Ariel Dora Stern, and Scott Stern Abstract—Biologics... View Details
Keywords: Sean Silverthorne
- 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... View Details
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).
- 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... View Details
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).
- Summer 2008
- Editorial
Will the Stork Return to Europe and Japan? Understanding Fertility within Developed Nations
By: James Feyrer, Bruce Sacerdote and Ariel Dora Stern
Only a few rich nations are currently at replacement levels of fertility and many are considerably below. We believe that changes in the status of women are driving fertility change. At low levels of female status, women specialize in household production and... View Details
Feyrer, James, Bruce Sacerdote, and Ariel Dora Stern. "Will the Stork Return to Europe and Japan? Understanding Fertility within Developed Nations." Journal of Economic Perspectives 22, no. 3 (Summer 2008): 3–22.
- February 2019
- Article
Physician Beliefs and Patient Preferences: A New Look at Regional Variation in Health Care Spending
By: David Cutler, Jonathan Skinner, Ariel Dora Stern and David Wennberg
There is considerable controversy about the causes of regional variations in health care expenditures. Using vignettes from patient and physician surveys linked to fee-for-service Medicare expenditures, this study asks whether patient demand-side factors or physician... View Details
Cutler, David, Jonathan Skinner, Ariel Dora Stern, and David Wennberg. "Physician Beliefs and Patient Preferences: A New Look at Regional Variation in Health Care Spending." American Economic Journal: Economic Policy 11, no. 1 (February 2019): 192–221.
- 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... View Details
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.
- 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. View Details
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.
- 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... View Details
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).
- January 2017
- Article
Innovation Under Regulatory Uncertainty: Evidence from Medical Technology
By: Ariel Dora Stern
This paper explores how the regulatory approval process affects innovation incentives in medical technologies. Prior studies have found early mover regulatory advantages for drugs. I find the opposite for medical devices, where pioneer entrants spend 34% (7.2 months)... View Details
Stern, Ariel Dora. "Innovation Under Regulatory Uncertainty: Evidence from Medical Technology." Journal of Public Economics 145 (January 2017): 181–200.
- 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... View Details
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).