Alex

FDA Releases Draft Guidance for Medical Device Cybersecurity

It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called “Internet of Things.” Medical devices are increasingly becoming connected as well, and like any connected device, they are at risk of getting hacked.  In 2014, the U.S. … Read more

OIG Finds Exclusive Lab Arrangement May Violate Anti-Kickback Statute

Yesterday the Office of Inspector General for the Department of Health and Human Services  (the “OIG”) issued Advisory Opinion 15-04 (“Advisory Opinion”) in which it found that an exclusive arrangement between a laboratory and a physician practice could potentially generate prohibited remuneration under the Anti-Kickback Statute and also subject the laboratory to certain administrative sanctions.  Notably, the OIG also … Read more