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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... View Details
Keywords: Demographics; Product Development; Health Care and Treatment; Medical Devices and Supplies Industry
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  • 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... View Details
Keywords: Connected Digital Products; Telehealth; Remote Monitoring; Health Testing and Trials; Research; Governing Rules, Regulations, and Reforms; Information Technology
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  • Forthcoming
  • Article

Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation

By: Amitabh Chandra, Jennifer Kao, Kathleen L. Miller and Ariel Dora Stern
Regulators of new products confront a tradeoff between speeding a product to market and collecting additional product quality information. The FDA's Breakthrough Therapy Designation (BTD) provides an opportunity to understand if regulators can use new policy to... View Details
Keywords: Innovation and Invention; Governing Rules, Regulations, and Reforms; Government Administration; Research and Development; Pharmaceutical Industry
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  • 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... View Details
Keywords: Medicare; Remote Monitoring; Reimbursement; Health Care and Treatment; Health Industry
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  • 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... View Details
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
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  • 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
Keywords: Health Care and Treatment; Information Technology; Laws and Statutes; Innovation and Invention; Entrepreneurship; Venture Capital
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