2023년 11월 15일자로 FDA에서 사이버보안과 관련된 내용을 추가 발표하였다 (Updated).
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November 15, 2023 – The FDA contracted with MITRE to develop the report, Next Steps Toward Managing Legacy Medical Device Cybersecurity RisksExternal Link Disclaimer. Legacy medical devices are those that cannot be reasonably protected against current cybersecurity threats, and these devices can pose significant risks to the health care sector. Legacy devices were legally put on the market and may still be broadly in use. However, cybersecurity controls that may have been effective at their point of purchase may no longer be adequate now. Addressing this issue is complex and must be done in a way that minimizes negative impacts to patient care and safety. This publication outlines practical approaches and recommendations that build on previous work and can further drive sector-wide legacy device cyber risk management efforts.