Is Your Phone a Medical Device?
Scholar argues that Congress and FDA should treat risky clinical artificial intelligence tools as medical devices.
FDA Advances Program for Real-World Evidence
FDA’s approach to evidence-based decision-making may not be addressed to the right people.
Underrepresented, Overmedicated, and Misdiagnosed
Experts contend that FDA clinical trials fail to ensure adequate consideration of women’s health needs.
Expanding FDA Incentives to Boost Diversity in Clinical Trials
Exploring FDA’s toolkit for encouraging study sponsors to meet diversity goals.
The Borders of the U.S. Health Care System
Scholars explore regulatory reforms to expand noncitizens’ access to health care.
Cybersecurity Vulnerabilities in Medical Devices
With cyberattacks on medical devices on the rise, scholars examine regulatory challenges and solutions.
Where Are The Midwives?
Scholar argues that COVID-19 has underscored the serious gaps in access to midwifery care.
A Game of Inches for Youth Concussion Regulation
Experts explore the impact of concussion legislation on adolescent health and education.
The Health Risks of Underregulated Factory Farms
Scholars discuss public health harms from the underregulation of factory farms and propose potential solutions.
The Challenges of Regulating Brain-Machine Interfaces
Scholar highlights the fragmented regulatory environment governing advanced neurological technology.
Regulating Supervised Consumption Services
Experts discuss the role of regulations in monitoring experimental overdose prevention programs.
Marketing Formerly Dangerous Drugs
Two scholars find that the removal of FDA health warnings prompts an increase in drug marketing.