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Lessons from the Impact of Price Regulation on the Pricing of Anticancer Drugs in Germany
(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 ...
Assessing the Food and Drug Administration’s Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study
(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, ...
Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials
(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. ...
Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning
(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 ...
The Past, Present, and (Near) Future of Gene Therapy and Gene Editing
(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 ...
Health App Policy: International Comparison of Nine Countries’ Approaches
(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 ...
Innovation under Regulatory Uncertainty: Evidence from Medical Technology
(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, ...
Germany’s Digital Health Reforms in the COVID-19 Era: Lessons and Opportunities for Other Countries
(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 ...
Quantifying the Use of Connected Digital Products in Clinical Research
(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 ...
Remote Patient Monitoring — Overdue or Overused?
(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 ...