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- 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).
- 2024
- Chapter
The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives
By: Ariel Dora Stern
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, Catherine E. Tucker, and Ariel Dora Stern, 107–138. Chicago and London: University of Chicago Press, 2024.
- January 2024
- Teaching Note
Somatus: Value-Based Kidney Care (A) & (B)
By: Ariel D. Stern, Robert S. Huckman and Sarah Mehta
This teaching note accompanies case no. 622-009 and 622-045 (Somatus: Value-Based Kidney Care, A and B).
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- 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
- Article
Effects of Remote Patient Monitoring Use on Care Outcomes Among Medicare Patients with Hypertension
By: Mitchell Tang, Carter Nakamoto, Ariel Dora Stern, Jose Zubizarreta, Felippe Marcondes, Lori Uscher-Pines, Lee Schwamm and Ateev Mehrotra
Background: Remote patient monitoring (RPM) is a promising tool for improving chronic disease management. Use of RPM for hypertension monitoring is growing rapidly, raising concerns about increased spending. However, the effects of RPM are still...
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Tang, Mitchell, Carter Nakamoto, Ariel Dora Stern, Jose Zubizarreta, Felippe Marcondes, Lori Uscher-Pines, Lee Schwamm, and Ateev Mehrotra. "Effects of Remote Patient Monitoring Use on Care Outcomes Among Medicare Patients with Hypertension." Annals of Internal Medicine 176, no. 11 (November 2023): 1465–1475.
- November 2023
- Article
Federated Electronic Health Records for the European Health Data Space
By: René Raab, Arne Küderle, Anastasiya Zakreuskaya, Ariel Dora Stern, Jochen Klucken, Georgios Kaissis, Daniel Rueckert, Susanne Boll, Roland Eils, Harald Wagener and Bjoern Eskofier
The European Commission's draft for the European Health Data Space (EHDS) aims to empower citizens to access their personal health data and share it with physicians and other health-care providers. It further defines procedures for the secondary use of electronic...
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Keywords:
Analytics and Data Science;
Cybersecurity;
Information Management;
Knowledge Sharing;
Knowledge Use and Leverage;
Health Industry
Raab, René, Arne Küderle, Anastasiya Zakreuskaya, Ariel Dora Stern, Jochen Klucken, Georgios Kaissis, Daniel Rueckert, Susanne Boll, Roland Eils, Harald Wagener, and Bjoern Eskofier. "Federated Electronic Health Records for the European Health Data Space." Lancet Digital Health 5, no. 11 (November 2023): e840–e847.
- 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).
- July 2023
- Teaching Note
Hello Heart: The Next Generation of Chronic Disease Management Apps
By: Ariel Dora Stern and Kumba Sennaar
Teaching Note for HBS Case No. 622-061.
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- 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).
- May 9, 2023
- Response
Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Yi Zhu and Ariel D. Stern
Everhart, Alexander O., Yi Zhu, and Ariel D. Stern. "Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 18 (May 9, 2023): 1609–1610. (Reply to original paper.)
- February 2023
- Teaching Note
The Brigham and Women’s Hospital Innovation Hub: Driving Internal Innovation
By: Ariel Dora Stern, Robert S. Huckman and Sarah Mehta
A teaching note to accompany the case entitled “The Brigham and Women’s Hospital Innovation Hub: Driving Internal Innovation” (619-026).
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- 2023
- Article
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices...
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Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
- 2022
- Working Paper
Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data
By: Alexander O. Everhart and Ariel D. Stern
Medical devices increasingly include software components, which facilitate remote patient monitoring. The introduction of software into previously analog medical devices as well as innovation in software-driven devices may introduce new safety concerns—all the more so...
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Keywords:
Technological Innovation;
Safety;
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Medical Devices and Supplies Industry
Everhart, Alexander O., and Ariel D. Stern. "Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data." Harvard Business School Working Paper, No. 23-035, November 2022.
- 2022
- Working Paper
Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to...
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Chandra, Amitabh, Jennifer Kao, Kathleen Miller, and Ariel D. Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." NBER Working Paper Series, No. 30712, December 2022.
- 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...
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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.
- November 2022
- Teaching Note
Proximie: Using XR Technology to Create Borderless Operating Rooms
By: Ariel D. Stern, Alpana Thapar and Menna Hassan
Founded by Nadine Hachach-Haram in 2016, Proximie was a digital medicine platform that used mixed reality and a host of digital audio and visual tools to enable clinicians, proctors, and medical device company personnel to be virtually present in operating rooms (ORs),...
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- 2022
- Article
Rapid Growth of Remote Patient Monitoring Is Driven by a Small Number of Primary Care Providers
By: Mitchell Tang, Ateev Mehrotra and Ariel Dora Stern
Growing enthusiasm for remote patient monitoring has been motivated by the hope that it can improve care for patients with poorly controlled chronic illness. In a national commercially insured population in the U.S., we found that billing for remote patient monitoring...
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Keywords:
Remote Monitoring;
Medical Billing;
Health Care Costs;
Telehealth;
Diabetes;
Chronic Disease;
Insurance Claims;
Diseases;
Primary Care Providers;
COVID-19 Pandemic;
Health Care and Treatment;
Insurance;
Cost;
Health Industry;
United States
Tang, Mitchell, Ateev Mehrotra, and Ariel Dora Stern. "Rapid Growth of Remote Patient Monitoring Is Driven by a Small Number of Primary Care Providers." Health Affairs 41, no. 9 (2022): 1248–1254.
- August 2022
- Article
Regulatory Considerations to Keep Pace with Innovation in Digital Health Products
By: John Torous, Ariel Dora Stern and Florence T. Bourgeois
Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a...
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Keywords:
Emerging Technologies;
Governing Rules, Regulations, and Reforms;
Innovation and Invention;
Medical Devices and Supplies Industry
Torous, John, Ariel Dora Stern, and Florence T. Bourgeois. "Regulatory Considerations to Keep Pace with Innovation in Digital Health Products." npj Digital Medicine 5, no. 121 (August 2022).
- September 2022
- Article
Trends in Remote Patient Monitoring Use in Traditional Medicare
By: Mitchell Tang, Carter Nakamoto, Ariel Dora Stern and Ateev Mehrotra
Remote patient monitoring (RPM), the collection by patients of physiological measurements that are automatically sent to their health care practitioners, has been touted as a promising tool for improving chronic disease management. Interest in RPM has grown because of...
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Tang, Mitchell, Carter Nakamoto, Ariel Dora Stern, and Ateev Mehrotra. "Trends in Remote Patient Monitoring Use in Traditional Medicare." JAMA Internal Medicine 182, no. 9 (September 2022): 1005–1006.
- 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).