A Coming Storm: FDA Regulation of Mobile Medical Applications - from The Health Care Blog

By Ryan Minarovich

I recently had the great fortune of attending Health 2.0 in San Francisco. The conference was abuzz with new medical technologies that are harnessing the power of innovation to solve healthcare problems including many new mobile medical application companies showcasing their potential. As I walked and talked around the exhibit floor, one thing caught my ear, or I should say one thing didn’t catch my ear. Among the chatter about these products, the concern about FDA regulation of this product segment, or even FDA regulation in general was noticeably absent. While many of the application developers are well aware of potential FDA involvement, most would be hard-pressed to outline the impact this would have on their companies and products.

Please continue on:  http://thehealthcareblog.com/blog/2012/10/24/a-coming-storm-fda-regulation-of-mobile-medical-applications/

The New Bio-terrorism? Medical Device Hacking

 

By Jane Sarasohn-Kahn

A time-and-technology challenged FDA, proliferation of software-controlled medical devices in and outside of hospitals, and growth of hackers have resulted in medical technology that’s riddled with malware. Furthermore, lack of security built into the devices makes them ripe for hacking and malfeasance.

Scenario: a famous figure (say, a politician with an implantable defibrillator or young rock star with an insulin pump) becomes targeted by a hacker, who industriously virtually works his way into the ICD’s software and delivers the man a shock so strong it’s akin to electrocution.
Got the picture?

Welcome to the dark side of health IT and connected health. Without strong and consistently adopted security technology and policies, this scenario isn’t a wild card: it’s in the realm of possibility. This is not new-news: back in 2008, a research team figured out how to program a common pacemaker-defibrillator to transmit a “deadly 830-volt jolt,” according to Barnaby Jack, a security expert.

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