AMIA's Important Role

So, I was meandering through the landfills that are the internet and came across an eye opening problem that I see as only going to get worse.  Most articles posted online are considered unofficial unless the work is published in a peer-reviewed journal of some sort; however, most clinician's are now using mobile media devices to gather medical information to disseminate to their patients. This, then begs the question of, "Who is to regulate this medium?"

AMIA, the association for infromatics professionals, met with the FDA to discuss this very topic.  At this meeting the AMIA directed the FDA's attention to the applications that provide direct CDS, clinical decision support, in an autonomous way that directly affects patients.  The AMIA cautioned the FDA that the time of applications and devices for clinicians versus for patients will begin to merge.  Furthermore, they see a need for these applications and software to be regulated.  They even went as far as naming a few software's and applications, some of which are on current smartphones.  The main talking points of the meeting were as follows:

• The need for the FDA to articulate how it characterizes and defines "CDS".
• The need to coordinate efforts among federal agencies and public- and private-sector research and practice communities.
• The potential limitations if FDA focuses too narrowly on CDS, and considers CDS on mobile devices as somehow separate from CDS based on other delivery methods or contexts.
• The importance of addressing rapidly emerging and converging technologies and devices along with new and evolving forms of patient care delivery (such as medical homes and accountable care organizations) and payment methods.

Here is a link to the article, which has a link for the full transcript of the event.  http://www.amia.org/news-and-publications/press-release/amia-advises-fda