Medical Device Security

A recent study published by GAO caused quite a bit of uproar over medical device security. The GAO declared in its report [read more] that the FDA has not put enough oversight in the premarket approval (PMA) of certain medical devices that are susceptible to threats. In the report the GEO referred to an experiment described in the 2008 IEEE Symposium on Security and Privacy. The experiment was conducted by a number of experts in security, medicine and engineering. They demonstrated the potential for a hacker to expose patient information as well as interfere with the correct operation of a medical device. The FDA has agreed to the GAOs insights – however pointed out that there have been no real world threats that have been reported to date.  According to the FDA, it did consider unintentional threats for information security, but did not consider information security risks from intentional threats until recently. In summary, the HHS – governing body for the FDA, concurred with the GAO recommendations and have initiated activity in this direction.  Medical device manufacturers must take the threat of security seriously.

Of all medical devices, devices that are implantable, portable or used in a home health scenario represent a growing concern for security and information privacy. I refer to these classes of devices as embedded medical devices. Developers and manufacturers of embedded medical devices are increasingly exposed to security risks as these devices become more complex and also connected to open networks. The good news is that in responding to this threat they need not operate in a vacuum nor do they need to re-invent the wheel. Best practices exist in other industries that can be leveraged by medical device manufactures. Of them the most straightforward is to design your products with security in mind. In other word, design for security. Here are a few things to think about when you design your medical devices.

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