FDA Regulation

Regulation Lesson Learned from Theranos

For those who haven’t been following the Theranos drama, it’s a total mess. At first Theranos and its founder, Elizabeth Holmes, were being touted...

The Paperless Healthcare Startup – lol

One of my healthcare IT friends posted this picture and caption to their Facebook page: The past 8 months of my life can be summed up in just under 2k pages of...

What if the FDA Started Regulating EHR?

In the world of mobile health, we’ve often talked about what will happen if the FDA starts to regulate the various mobile health apps out there. In fact...

23andMe Testing Shut Down by FDA

I’ll admit that I’m not an expert on FDA clearance, but I found this notice from the FDA to 23andMe really interesting. As stated in the notice...

   

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