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October is National Cybersecurity Awareness Month. This year's overarching message - OWN IT. SECURE IT. PROTECT IT –  will focus on key areas including citizen privacy, consumer devices, and e-commerce security. The FDA believes this is a good time to reinforce the importance of medical device cybersecurity and the role we all play in medical device safety. For general tips and information about cybersecurity and cyber safety, visit the Department of Homeland Security's, National Cybersecurity Awareness Month 2019 Campaign website.

You can also find more information about FDA's medical device cybersecurity activities on this page, including a fact sheet that separates myths from facts and links to the latest guidances for industry regarding the premarket and postmarket management of medical device cybersecurity.

All legally-marketed medical devices have benefits and risks. The FDA allows devices to be marketed when there is a reasonable assurance that the benefits to patients outweigh the risks.

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.

On This Page


Mitigating 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.
Cybersecurity Fact Sheet Thumbnail

FDA Fact Sheet:
THE FDA'S ROLE IN MEDICAL DEVICE CYBERSECURITY
Dispelling Myths and Understanding

Download the Fact Sheet (PDF - 175kb)


Cybersecurity Guidances

Date Title Description
10/18/2018 Draft Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Provides recommendations to industry regarding cybersecurity device design, labeling, and documentation to be included in premarket submissions for devices with cybersecurity risk.

The recommendations are intended to supplement these guidance documents:
12/27/2016 Final Guidance: Postmarket Management of Cybersecurity in Medical Devices Provides recommendations to industry for structured and comprehensive management of postmarket cybersecurity vulnerabilities for marketed and distributed medical devices throughout the product lifecycle.
10/02/2014 Final Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

In addition to the specific recommendations contained in this guidance, manufacturers are encouraged to address cybersecurity throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device.

The recommendations are intended to supplement these guidance documents:

1/14/2005 Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software A growing number of medical devices are designed to be connected to computer networks. Many of these networked medical devices incorporate off-the-shelf software that is vulnerable to cybersecurity threats such as viruses and worms. These vulnerabilities may represent a risk to the safe and effective operation of networked medical devices and typically require an ongoing maintenance effort throughout the product life cycle to assure an adequate degree of protection. The FDA issued guidance to clarify how existing regulations, including the Quality System (QS) Regulation, apply to such cybersecurity maintenance activities.

Cybersecurity Safety Communications

In each of the following cases, the FDA is not aware of any patient injuries or deaths associated with cybersecurity incidents, nor are we aware that any specific devices or systems in clinical use have been purposely targeted. However, these vulnerabilities could allow unauthorized users to remotely access, control, and issue commands to compromised devices, potentially leading to patient harm. Health care facilities can reduce the risk of unauthorized access by implementing recommendations in the safety communications listed below.

Date Safety Communication Description
10/01/2019 Urgent/11 Cybersecurity Vulnerabilities May Introduce Risks During Use of Certain Medical Devices The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software.
06/27/2019 Certain Medtronic MiniMed Insulin Pumps Have Potential Cybersecurity Risks: FDA Safety Communication The FDA has become aware of potential cybersecurity risks in certain Medtronic MiniMed Paradigm insulin pumps. The FDA recommends patients replace affected pumps with models that are better equipped to protect them from these potential risks.
03/21/2019 Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication The FDA became aware of cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication between Medtronic's implantable cardiac devices, clinic programmers, and home monitors. The FDA recommends that health care providers and patients continue to use these devices as intended and follow device labeling.
10/11/2018 Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers Medtronic released a software update to address the cybersecurity vulnerabilities associated with Medtronic's cardiac implantable cardiac device programmers.
04/17/2018 Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly St. Jude Medical) Implantable Cardiac Devices Abbott released an additional firmware update to address premature battery depletion and confirmed cybersecurity vulnerabilities identified in Abbott's (formerly St. Jude Medical) implantable cardiac devices
08/29/2017 Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott's (formerly St. Jude Medical's) Implantable Cardiac Pacemakers Abbott released a firmware update to address cybersecurity vulnerabilities identified in Abbott's (formerly St. Jude Medical) implantable cardiac pacemakers. The firmware update continues Abbott's efforts to mitigate confirmed vulnerabilities discovered by an independent research firm in 2016.
01/09/2017 Cybersecurity Vulnerabilities Identified in St. Jude Medical's Implantable Cardiac Devices and Merlin@home Transmitter The FDA became aware of cybersecurity vulnerabilities in these devices after an independent research firm released information about these vulnerabilities.
05/13/2015 LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira - Security Vulnerabilities The FDA and Hospira became aware of cybersecurity vulnerabilities in these infusion systems after an independent researcher released information about these vulnerabilities. On July 31 2015, Hospira and an independent researcher confirmed that it is possible to access the Symbiq Infusion System remotely through a hospital's network.
06/13/2013 Cybersecurity for Medical Devices and Hospital Networks The FDA recommends that medical device manufacturers and health care facilities take steps to ensure that appropriate safeguards are in place to reduce the risk of device failure due to cyber attack.

To receive safety communications on medical devices, including cybersecurity-related safety communications, subscribe to our Medical Devices Safety and Recalls emails.

Reporting Cybersecurity Issues to the FDA

As a part of our surveillance of medical devices on the market, the FDA encourages reports of cybersecurity issues with devices.

Memoranda of Understanding on Cybersecurity in Medical Devices

The table below provides an overview of the cybersecurity information sharing agreements that FDA has with various stakeholders to help us further protect and promote the public health.

MOU/MOA Parties Description
MOU 225-18-028 National Health Information Sharing & Analysis Center, Inc. (NHISAC) and MediSAO (information sharing analysis organization) The goal of these Information Sharing and Analysis Organizations (ISAOs) is to provide manufacturers with the opportunity to share information about potential vulnerabilities and emerging threats with the FDA and to help manufactures protect patients by addressing those issues earlier.
MOU 225-18-030 Health Information Sharing & Analysis Center, Inc. (H-ISAC), formerly known as the National Health Information Sharing & Analysis Center, Inc. (NH-ISAC), and Sensato Critical Infrastructure ISAO The goal of these ISAOs is to provide manufacturers with the opportunity to share information about potential vulnerabilities and emerging threats with the FDA and to help manufacturers protect patients by addressing those issues earlier.
MOA: DHS-FDA Medical Device Cybersecurity Collaboration Department of Homeland Security (DHS) The agreement implements a framework for greater coordination and information sharing about potential or confirmed medical device cybersecurity vulnerabilities and threats. This collaboration between the two agencies is intended to lead to better and more timely responses to potential threats to patient safety.

Workshops and Webinars on Cybersecurity

Date

Topic

Purpose

09/10/2019 Patient Engagement Advisory Committee Meeting: Cybersecurity in Medical Devices -  Communication That Empowers Patients

Provided background to the committee regarding the complexity of integrating medical device cybersecurity risk into health risk communications so that they can provide recommendations to FDA on this topic.

Provide committee recommendations that:

  • address which factors should be considered by FDA and industry when communicating cybersecurity risks to patients and to the public, including but not limited to the content, phrasing, the methods used to disseminate the message and the timing of that communication.
address concerns patients have about changes to their devices to reduce cybersecurity risks as well as the role of other stakeholders such as healthcare providers in communicating cybersecurity risks to patients
01/29-30/2019 Public Workshop: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Brought together diverse stakeholders to discuss, in-depth, the draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices and the sub-topic of the draft guidance regarding a Cybersecurity Bill of Materials (CBOM), which can be a critical element in identifying assets, threats, and vulnerabilities.
05/18-19/2017 Public Workshop: Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis Examined opportunities for FDA engagement with new and ongoing research; catalyzed collaboration among stakeholders to identify regulatory science challenges; discussed innovative strategies to address those challenges; and encouraged proactive development of analytical tools, processes, and best practices by the stakeholder community in order to strengthen medical device cybersecurity.
01/12/2017 Webinar: Postmarket Management of Cybersecurity in Medical Devices Provided information about the guidance and opportunity to ask questions.
01/20-21/2016 Public Workshop, Moving Forward: Collaborative Approaches to Medical Device Cybersecurity Highlighted past collaborative efforts and increased awareness of existing maturity models which are used to evaluate cybersecurity status, standards, and tools in development.
10/29/2014 Webinar: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Provided information about the guidance and opportunity to ask questions.
10/21-22/2014 Public Workshop: Collaborative Approaches for Medical Device and Healthcare Cybersecurity Encouraged collaboration among stakeholders, identified challenges and discussed strategies and best practices for promoting medical device cybersecurity.

Other Collaborations on Cybersecurity in Medical Devices

MITRE Corporation: In October 2018, the FDA supported the development of the MITRE Corporation's Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. The playbook describes the types of readiness activities that will enable health delivery organizations (HDOs) to be better prepared for a cybersecurity incident involving their medical devices and gives product developers more opportunity to address the potential for large scale, multi-patient impacts that may raise patient safety concerns.

Medical Device Innovation Consortium (MDIC): In September 2018, as a member of an MDIC Steering Committee, FDA supported the development of an MDIC's report Medical Device Cybersecurity Report: Advancing Coordinated Vulnerability Disclosure. The report encourages the adoption of coordinated vulnerability disclosure (CVD) policies by medical device manufacturers (MDMs) in an effort to promote medical device cybersecurity and patient safety. CVD policies establish formalized processes for obtaining cybersecurity vulnerability information, assessing vulnerabilities, developing remediation strategies, and disclosing the existence of vulnerabilities and remediation approaches to various stakeholders—often including peer companies, customers, government regulators, cybersecurity information sharing organizations, and the public. This report addresses the importance of CVD policies for MDMs and stakeholders across the medical device ecosystem.

Healthcare and Public Health Sector Coordinating Council (HSCC): FDA serves as a co-chair of the Government Coordinating Council (GCC) for the HPH HSCC. Specifically, this is a public-private partnership among healthcare industry leaders and the government to address the most pressing security and resiliency challenges to the healthcare sector as a whole including cybersecurity. As a co-chair of a task group within the HSCC cybersecurity working group, FDA participated in the development of the Medical Device and Health IT Joint Security Plan (JSP). The JSP is a total product lifecycle reference guide to developing, deploying and supporting cyber secure technology solutions in the health care environment.

International Medical Device Regulator's Forum (IMDRF): FDA serves as a co-chair of the IMDRF working group tasked with drafting a global medical device cybersecurity guide. The purpose of the guide is to promote a globally harmonized approach to medical device cybersecurity that at a fundamental level ensures the safety and performance of medical devices while encouraging innovation. The guide is thus intended to provide medical device cybersecurity advice for stakeholders across the device lifecycle on topics including but not limited to medical device cybersecurity terminology, stakeholders' shared responsibility, and information sharing. The draft guide is available for public comment until December 2, 2019.

Cybersecurity in the News

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