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.
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.
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