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Compliance In Focus
Posted by Michael Marotta on Tue, Aug 5, 2014

We Have the Whole World in our Hands

The amount of information an individual has at their fingertips can be staggering. This can lead to a great deal of empowerment for the consumer in medical, consumer, and We have the whole world in our handssocial interactions.  In the medical field, improvements in technology have led to a dramatic decrease in the cost to process and analyze an individual’s DNA which has resulted in an influx of genetic tests and information available to an individual. Furthermore, the prevalence of mobile devices/apps (including mobile health apps) has grown exponentially giving consumers an awe-inducing number of choices at the buffet of instant information. As one would expect, this rapid progression has not come without growing pains.  Both the FDA and the companies creating/providing this information have had to consistently re-evaluate how and if this content falls under the auspices of Federal Regulations.

In a two-part Blog we will take a look at two different areas of direct to consumer medical information.  Both of these areas have been in the news recently and have a direct impact on providing tools in personalized health decision-making.  In Part One, we will discuss the role of the FDA in Personalized Genomics and direct to consumer genetic tests. As a case study, we will explore the company 23 and Me and how it has had to adjust it’s business model to fit under the umbrella of the FDA. Part Two will revolve around the FDA and Mobile Medical Applications. In this part we will touch on an FDA guidance issued on 25 September 2013 and how this guidance impacts the wave of medical health apps that have hit the market or are in the pipeline of future development. 

So buckle-up and prepare for a ride to the exciting world of personalized medicine!

Photo Credit: rosefirerising

The History of Clinical Research

Topics: Personalized Medicine, Personalized Genomics, FDA


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