I. INTRODUCTION - Over the past two years, global events reshaped the health care industry by shifting the priorities of the industry’s key stakeholders. In the post-Covid-19 economy, quick responses to short-term...more
The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more
Device manufacturers may share patient-specific information from a device with the patient without violating federal privacy requirements....more
As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more