Dramatic increases in health expenditures have led to a substantial number of regulatory interventions in the markets for devices over the last years. However, little attention has been paid thus far to the regulation of medical devices and its effects. This article explore the policies pursued...

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, where pioneer entrants spend 34 percent (7.2 months) longer than follow-on...

In the United States, the safety and efficacy of medical devices are regulated by the US Food and Drug Administration (FDA), which must successfully navigate a crucial tradeoff between speed and safety in approving applications for new devices. Although a shorter (and potentially less thorough)...

This paper analyzes how features of the procurement system laid down by the EU Procurement Directives affect the analysis of competition in public procurement markets. It presents the bidding systems allowed under the EU rules and provides a general framework to assess competition concerns for...

This Article studied the actual effect of the United States Supreme Court's decision in Ashcroft v. Iqbal on the cohort of more than 264 federal pharmaceutical and medical device cases of every type, released from the day of the decision in Iqbal through August 31, 2010. The results of this...

Stipulations on de-identification and scientific research in the European General Data Protection Regulation (GDPR) help research organizations to use personal data with fewer restrictions compared to data collection for other purposes. Under these exemptions, organizations may process specific...