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FDA Should Reassess Hacking Risk In Medical Devices, GAO Says

Tighter standards are needed to guard against wireless attacks of implantable or body-worn medical devices, but the attack risk should be weighed against potential adverse effects that may arise from security measures meant to address them, according to the Government Accountability Office.

Wireless medical devices should go through more stringent pre-market review and post-market surveillance to protect against information technology security threats that could impact safety and effectiveness, the Government Accountability Office concluded in a report to Congress.

However, the threat of an intentional hacking of a device must be weighed against potential adverse effects that could result from increased security measures, such as limiting a product’s performance or battery life, GAO said in its

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