Browsing by Author "Stern, Ariel"
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Advancing Digital Health Applications: Priorities for Innovation in Real-World Evidence Generation
Stern, Ariel; Brönneke, Jan; Debatin, Jörg F; Hagen, Julia; Matthies, Henrik; Patel, Smit; Clay, Ieuan; Eskofier, Bjoern; Herr, Annika; Hoeller, Kurt; Jaksa, Ashley; Kramer, Daniel B; Kyhlstedt, Mattias; Lofgren, Katherine T; Mahendraratnam, Nirosha; Muehlan, Holger; Reif, Simon; Riedemann, Lars; Goldsack, Jennifer C (Elsevier BV, 2022-03)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 ... -
Assessing the Food and Drug Administration’s Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study
Alon, Noy; Stern, Ariel; Torous, John (JMIR Publications Inc., 2020-10-26)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, ... -
Association of the Meaningful Use Electronic Health Record Incentive Program with Health Information Technology Venture Capital Funding
Lite, Samuel; Gordon, William Joseph; Stern, Ariel (American Medical Association (AMA), 2020-03)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, ... -
Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries
Stern, Ariel; Gordon, William J; Landman, Adam B; Kramer, Daniel B (BMJ, 2019-06)Objectives: To more clearly define the landscape of digital medical devices subject to US Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the ... -
Digital Health Reimbursement Strategies of 8 European Countries and Israel: Scoping Review and Policy Mapping
van Kessel, Robin; Srivastava, Divya; Kyriopoulos, Ilias; Monti, Giovanni; Novillo-Ortiz, David; Milman, Ran; Zhang-Czabanowski, Wojciech Wilhelm; Nasi, Greta; Stern, Ariel; Wharton, George; Mossialos, Elias (JMIR Publications Inc., 2023-09-29)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. ... -
Essays in the Economics of Health Care and the Regulation of Medical Technology
Stern, Ariel Dora (2014-06-06)The first chapter of this dissertation explores how the regulatory approval process affects innovation incentives in medical technologies. While prior studies of medical innovation under regulation have found an early mover ... -
Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses
Weitzman, Rachel E.; Stern, Ariel; Kramer, Daniel B. (Ovid Technologies (Wolters Kluwer Health), 2021-01)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, ... -
Germany’s Digital Health Reforms in the COVID-19 Era: Lessons and Opportunities for Other Countries
Gerke, Sara; Stern, Ariel; Minssen, Timo (Springer Science and Business Media LLC, 2020-07-10)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–Verso ... -
Health App Policy: International Comparison of Nine Countries’ Approaches
Essén, Anna; Stern, Ariel; Haase, Christoffer Bjerre; Car, Josip; Greaves, Felix; Paparova, Dragana; Vandeput, Steven; Wehrens, Rik; Bates, David W. (Springer Science and Business Media LLC, 2022-03-18)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 ... -
The Impact Of Price Regulation On The Availability Of New Drugs In Germany
Stern, Ariel; Pietrulla, Felicitas; Herr, Annika; Kesselheim, Aaron S.; Sarpatwari, Ameet (Health Affairs (Project Hope), 2019-07)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 ... -
Innovation under Regulatory Uncertainty: Evidence from Medical Technology
Stern, Ariel (Elsevier BV, 2017-01)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, ... -
Lessons from the Impact of Price Regulation on the Pricing of Anticancer Drugs in Germany
Lauenroth, Victoria D.; Kesselheim, Aaron S.; Sarpatwari, Ameet; Stern, Ariel (Health Affairs (Project Hope), 2020-07-01)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 ... -
The Past, Present, and (Near) Future of Gene Therapy and Gene Editing
Pian, Julia; Chandra, Amitabh; Stern, Ariel (Massachusetts Medical Society, 2020-09)Emerging gene therapy and gene-editing technologies will have a growing impact on patient lives and health-care delivery. We analyzed a decade of data on clinical trials and venture capital investments to understand the ... -
Quantifying the Use of Connected Digital Products in Clinical Research
Marra, Caroline; Chen, Jacqueline L.; Coravos, Andrea; Stern, Ariel (Springer Science and Business Media LLC, 2020-04-03)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 ... -
Regulatory Considerations to Keep Pace with Innovation in Digital Health Products
Torous, John; Stern, Ariel; Bourgeois, Florence T. (Springer Science and Business Media LLC, 2022-08-19)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 ... -
Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
Chandra, Amitabh; Kao, Jennifer; Miller, Kathleen L.; Stern, Ariel (Harvard Kennedy School, 2022-12)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 ... -
Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning
Stern, Ariel; Price, W Nicholson (Oxford University Press (OUP), 2020-04)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 ... -
Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring
Brönneke, Jan Benedikt; Müller, Jennifer; Mouratis, Konstantinos; Hagen, Julia; Stern, Ariel (MDPI AG, 2021-07-20)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, ... -
Remote Patient Monitoring — Overdue or Overused?
Mecklai, Keizra; Smith, Nicholas; Stern, Ariel; Kramer, Daniel B. (Massachusetts Medical Society, 2021-04-15)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 Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials
Marra, Caroline; Gordon, William J; Stern, Ariel (BMJ, 2021-06)<b>Objectives:</b> 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. ...