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.
CLSI, AUTO11-A – IT Security of In Vitro Diagnostic Instruments and Software Systems
ISO/TR 80001-2-2:2012 – Application of risk management for IT networks incorporating medical devices – Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
IEC TS 62443-1-1 Edition 1.0 2009-07 – Industrial communication networks – Network and system security – Part 1-1: Terminology, concepts and models.
IEC 62443-2-1 Edition 1.0 2010-11 – Industrial communication networks – Network and system security – Part 2-1: Establishing an industrial automation and control system security program
IEC/TR 62443-3-1 Edition 1.0 2009-07 – Industrial communication networks – Network and system security – Part 3-1: Security technologies for industrial automation and control systems.
Source: U.S. FDA
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