Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. This vulnerability increases as medical devices are increasingly connected to the Internet, hospital networks, and to other medical devices.
All medical devices carry a certain amount of risk. The FDA allows devices to be marketed when there is a reasonable assurance that the benefits to patients outweigh the risks. While the increased use of wireless technology and software in medical devices also increases the risks of potential cybersecurity threats, these same features also improve health care and increase the ability of health care providers to treat patients.
Addressing cybersecurity threats, and thus reducing information security risks, is especially challenging. Because cybersecurity threats cannot be completely eliminated, manufacturers, hospitals and facilities must work to manage them. There is a need to balance protecting patient safety and promoting the development of innovative technologies and improved device performance.
FDA recommendations for mitigating and managing cybersecurity threats include:
- Medical device manufacturers and health care facilities should take steps to ensure appropriate safeguards. Manufacturers are responsible for remaining vigilant about identifying risks and hazards associated with their medical devices, including risks related to cybersecurity. They are responsible for putting appropriate mitigations in place to address patient safety risks and ensure proper device performance.
- Hospitals and health care facilities should evaluate their network security and protect their hospital systems.
We look for and encourage reports of cybersecurity issues through our surveillance of devices already on the market.
The FDA’s ongoing efforts to protect the public health from cybersecurity vulnerabilities include:
- On January 22, 2016, the FDA released the Postmarket Management of Cybersecurity in Medical Devices Draft Guidance to outline steps manufacturers should take to continually address cybersecurity risks with their devices in order to better protect the public health. The draft guidance outlines the agency’s expectations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market.
- The FDA issued two safety communications discussing cybersecurity vulnerabilities of two Hospira Infusion Pump Systems:
- On May 13, 2015, the FDA issued a Safety Communication on vulnerabilities of Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems. The FDA and Hospira became aware of security vulnerabilities in these infusion systems after an independent researcher released information about these vulnerabilities.
- On July 13, 2015 Hospira and an independent researcher confirmed that it is possible to access the Symbiq Infusion System remotely through a hospital’s network.
In both 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 control the infusion pump and modify the dosage it delivers, potentially leading to over- or under-infusion of critical patient therapies. Health care facilities can reduce the risk of unauthorized access by implementing recommendations in the safety communications.
- On October 29, 2014, the FDA held a webinar on the guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Stakeholders were invited to learn more about the guidance and ask questions.
The final guidance, issued on October 2, 2014, contains recommendations for medical device manufacturers on cybersecurity management and information that should be included in a pre-market submission. The recommendations are intended to supplement the following FDA guidance documents:
- On October 21-22, 2014, the FDA held a public workshop, Collaborative Approaches for Medical Device and Healthcare Cybersecurity, to seek input from the health care and public health sector on medical device and health care cybersecurity. The goals of the workshop were to encourage collaboration among stakeholders, identify challenges and discuss strategies and best practices for promoting medical device cybersecurity.
- On August 26, 2014, the FDA entered into a Memorandum of Understanding (MOU) with the National Health Information Sharing and Analysis Center (NH-ISAC). NH-ISAC is a non-profit health sector-led organization that provides member organizations with actionable information on cybersecurity and coordinates cybersecurity incidence response.
The goal of the FDA’s collaboration with NH-ISAC includes:
- Fostering stakeholder collaborations and communication;
- Creating awareness about the National Institute of Standards and Technology voluntary cybersecurity framework;
- Encouraging health care public health stakeholders to develop innovative strategies to assess and mitigate cyber security vulnerabilities, and,
- Building a foundation of trust within the health care public health sector that encourages the timely sharing of cybersecurity vulnerabilities that can have a negative effect on patient safety.
- On June 13, 2013, the FDA issued a safety communication, Cybersecurity for Medical Devices and Hospital Networks, in which 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.
- Federal Register notice of availability: Postmarket Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and FDA
Postmarket Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff(PDF - 1.1MB)
- FDA outlines cybersecurity recommendations for medical device manufacturers: FDA Press Release
Cybersecurity Vulnerabilities of Hospira Symbiq Infusion System: FDA Safety Communication Vulnerabilities of Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems: FDA Safety Communication
FDA Voice - FDA and the Cybersecurity Community: Working Together to Protect the Public Health
- Information for Health care Organizations about FDA’s “Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software”
National Institute of Standards and Technology’s Preliminary Cybersecurity Framework