US FDA Medical Device Cybersecurity Awareness, Standards and Guidance Documents

Medical devices are increasingly connected to the Internet, hospital networks, and other medical devices to provide features that improve health care and increase the ability of health care providers to treat patients. These same features also increase the risk of potential cybersecurity threats. Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device.

Threats and vulnerabilities cannot be eliminated; therefore, reducing cybersecurity risks is especially challenging. The heath care environment is complex, and manufacturers, hospitals, and facilities must work together to manage cybersecurity risks.

Medical device manufacturers (MDMs) and health care delivery organizations (HDOs) should take steps to ensure appropriate safeguards are in place.

  • Medical device manufacturers (MDMs) are responsible for remaining vigilant about identifying risks and hazards associated with their medical devices, including risks related to cybersecurity.

  • Health care delivery organizations (HDOs) should evaluate their network security and protect their hospital systems.

  • Both MDMs and HDOs are responsible for putting appropriate mitigations in place to address patient safety risks and ensure proper device performance.

US FDA medical device cybersecurity guidance

  • There are two essential FDA medical device software cybersecurity documents to be aware of and plus one standard, if sell in the US.

  • US FDA Guidance – Content of premarket submissions for management of cybersecurity in medical devices-2014

  • US FDA Guidance – Postmarket management of cybersecurity in medical devices-2016

  • UL2900-2-1 – Safety Software Cybersecurity for Network-Connectable Products-2018

Internationally recognized medtech cybersecurity standards and guidance

  • IMDRF WG/N60: Principles and practices for medical device cybersecurity-2020

  • ISO/IEC 27001:2013 – Information security management-2013

  • IEC 62304:2006– Medical device software life cycle processes-2015

  • AAMI TIR97:2019 – Principles for medical device security: Postmarket risk management-2019

  • AAMI TIR57:2019 – Principles for medical device security—Risk management-2019

Other medical device cybersecurity-related standards.

Many additional product-specific software development documents exist, with just a few notable examples below.

Source: U.S. FDA

Contact us at:

Recent Posts