Medical device manufacturers generally are not the first group of businesses that come to mind when one thinks of HIPAA, privacy and security. However, in the world of “Big Data,” the functioning of medical devices increasingly involves the use of wireless, Internet- and network- connections and the frequent electronic exchange of medical device-related health information. Yes, medical information about you (if you use such a device of course)!
Recognizing this, the Food and Drug Administration (FDA), the federal agency that approves certain medical devices for use in the marketplace, issued draft guidance for medical device manufacturers, following some earlier pronouncements. The FDA is quick to point out that if approved this guidance would not be not authoritative, but only contains suggestions; suggestions that likely will shape the FDA’s approval process.
So why bring this to you. Well, developments like these help to point out how much we are and will continue to be surrounded by electronic devices – some for our health, others for our entertainment or communication – that collect, store and transmit confidential and personal information, very often without our even knowing.