FDA Issues Unprecedented Alert Over Medical Device Cyber Security Risk

by Snell & Wilmer

A fictional cyber-terrorist weaponizing a medical device by hacking into it has become a familiar plot premise in recent Hollywood dramas.  Unfortunately, the risk of harm from medical device hacking has now become an actionable, real-world concern.

In an unprecedented move, on July 31 the U.S. Food & Drug Administration issued an Alert to health care facilities to discontinue using the Hospira Symbiq Infusion System due to “cybersecurity vulnerabilities” The FDA Alert followed an earlier advisory posted by the Department of Homeland Security’s Industrial Controls Systems Cyber Emergency Response Team (ICS-CERT), which reported the discovery of those cybersecurity vulnerabilities in the device, and Hospira’s confirmation of the information.

In its Alert, the FDA described the affected medical device as follows:

  • The Hospira Symbiq Infusion System is a computerized pump designed for the continuous delivery of general infusion therapy for a broad patient population.  It is primarily used in hospitals, or other acute and non-acute health care facilities, such as nursing homes and outpatient care centers. This infusion system can communicate with a Hospital Information System (HIS) via a wired or wireless connection over facility network infrastructures.

The FDA then described the specific cybersecurity concern:

  • Hospira and an independent researcher confirmed that Hospira’s Symbiq Infusion System could be accessed remotely through a hospital’s network. This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies

Meanwhile, DHS’ ICS-CERT advised that while “no known public exploits specifically target this vulnerability”, it could be exploited by “an attacker with medium skill”.

Fortunately, the FDA noted that neither it nor Hospira are currently aware of any patient adverse events or unauthorized access of one of these systems in a health care setting.  Hospira posted a statement about “Infusion Device Cybersecurity” on its own website, which can be found here, in which it stated that “there are no known instances of cybersecurity breaches of Hospira devices in a clinical setting.” Hospira also remarked that in order to exploit the cybersecurity vulnerabilities, a hacker would also have to penetrate “several layers of network security enforced by the hospital information system, including secure firewalls.” In other words, the hospital also has responsibility for providing cybersecurity.

Both the FDA and ICS-CERT stated that the manufacturer has already retired the product, due to unrelated issues.  Nonetheless, the FDA urged hospitals to transition to other infusion systems as soon as possible: “we strongly encourage that health care facilities transition to alternative infusion systems, and discontinue use of these pumps”. In addition, although the particular product is in limited use in North America, the FDA is wary of the secondary market for pre-owned medical devices.  Accordingly, the FDA “strongly discourages the purchase of the Symbiq Infusion System” from resellers.


  • The FDA now views cybersecurity risks just as seriously as defective product risks.

Upon learning of a confirmed cybersecurity weakness that can be remotely exploited (i.e., hacked) to cause patient harm, the FDA response appears to be similar to how it would respond to a confirmed design or manufacturing product defect. In this case, perhaps because the manufacturer had already “retired” the product from distribution, and there were no known injuries due to the device being hacked, the FDA’s response focused on public notification of the risk and on encouraging hospitals to stop using the product at issue as soon as possible, rather than requiring a recall.

It is worth noting that this FDA Alert comes two years after the FDA issued a more general Cybersecurity Safety Communication in which it “recommended that medical device manufacturers and health care facilities take steps to assure that appropriate safeguards are in place to reduce the risk of failure due to cyberattack.”   So the FDA already staked out cyberspace as an area of enhanced attention.

  • Responsibility for addressing cybersecurity vulnerabilities likely falls on both the device manufacturer and the healthcare facility computer network.

In the past, some health care facilities and device manufacturers have argued over who is responsible for updating malware protection and cybersecurity when it comes to medical devices, as if cybersecurity is a hot potato.  In reality, in order to exploit cybersecurity weaknesses in a medical device that is connected to a health care facility’s network, the hackers would likely have to first infiltrate the hospital network.   Thus, depending on the circumstances, a successful cyber-attack on a medical device in a health care facility could be attributed to both the facility and the manufacturer for insufficient cybersecurity measures.  As the FDA has previously advised, cybersecurity is a mutual concern, and is best addressed proactively.

  • Healthcare cybersecurity requirements will vastly expand as more devices are connected to more networks across the internet.

Previously, the focus of healthcare cybersecurity was almost exclusively on data breaches in which patient healthcare records were stolen or illegally accessed.  However, this FDA Alert makes it clear that the cyber risk in the healthcare space is not limited to disclosure of medical records.

Moreover, the cyber risk with medical devices likely isn’t limited to their use in healthcare facilities.  Just as our population ages and requires more medical monitoring and treatment, medical technology is evolving to allow those functions to occur far away from traditional healthcare facilities.  Cardiac devices, insulin pumps, pain medicine pumps, muscle stimulators, neurotransmitters, bionic limb devices and other implanted or wearable devices not yet invented will be connected wirelessly, perhaps to home networks, or networks at the office, or in the car, or wherever there is an internet connection.  All of these devices and networks will require vigilant cybersecurity management in order to keep the hackers at bay and to allow the devices to work as intended.

Stay tuned.

Written by:

Snell & Wilmer

Snell & Wilmer on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.