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Compliance In Focus
Posted by John Lehmann on Fri, Oct 5, 2012

Do Medical Devices Need an FDA Security Plan?

One great aspect of the research industry is being on the cutting-edge of new, innovativeDo Devices Need an FDA Security Plan (2) technologies. Looking back at the history of medical devices, it’s amazing how far technology has brought us. New devices are incorporating more complex technologies than ever before. These medical advances are to help treat patients; however, does the increase in innovation also mean an increase in safety risks?

This is something the US Government Accountability Office (GAO) is taking into consideration. In fact, in a recent report, “FDA Should Expand Its Consideration of Information Security for Certain Types of Devices,” GAO outlines the safety concerns of certain advanced devices as well as the recommendations to best protect patients.

One of the biggest concerns outlined in the report concerns the threats, vulnerabilities, and security risks associated with implantable devices. GAO voices that these devices are more vulnerable to information security risks; issues such as untested software components, limited battery life and other shortcomings. GAO recommends that FDA develop and implement a plan expanding its focus on information security risks which will include four main actions:

  1. Increase its focus on manufacturers' identification of potential unintentional and intentional threats, vulnerabilities, the resulting information security risks, and strategies to mitigate these risks during its PMA review process;
  2. Utilize available resources, including those from other entities, such as other federal agencies;
  3. Leverage its post-market efforts to identify and investigate information security problems; and
  4. Establish specific milestones for completing this review and implementing these changes

While no major public health risks have occurred stemming from these “advanced” devices, the concern still exists. Do you think there is a need for FDA to develop a proactive plan? Or do you think the agency will develop a reactive plan? Let us know what you think below.

Photo Credit: Matteo Paciotti | Photography

Topics: Medical Devices, FDA Security Plan, US Government Accountability Office


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