5 Takeaways from FDAs Draft Guidance

March 21, 2016

Read the full article (MDDI DeviceTalk) >

Data are becoming an increasingly integral component of medical technologies, including medical devices. However, the sensitive nature of healthcare data increases the risk that device companies and their partners will be targets of cyberattacks and heightens the consequences of a breach.

The FDA’s guidance doesn't cover all regulatory risks related to cyberattacks and provides no safe harbor for device makers.

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Richard Martinez

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