United States: FDA Alerts Medical Device Manufacturers And Hospitals To Cybersecurity Risks

On June 13, 2013, the Food and Drug Administration ("FDA") issued an alert and draft guidance recommending that medical device manufacturers and health care facilities take measures to protect against cyberattacks that could compromise device performance and patient safety. The alert identifies specific cybersecurity risks associated with medical devices, including the introduction of malware into medical equipment or unauthorized access to devices' configuration settings. The draft guidance focuses on the development and documentation of cybersecurity management in medical device premarket submissions.

Medical Device Cybersecurity Incidents and Vulnerabilities

FDA's alert is directed to medical device manufacturers, hospitals and other device user facilities, health care IT and procurement staff, and biomedical engineers. It explains that medical devices can be vulnerable to cybersecurity breaches because they often contain configurable embedded computer software and are increasingly interconnected through the Internet, smart phones and hospital networks.

Although FDA is not currently aware of any deaths or patient injuries associated with cybersecurity breaches, or that any device or system has been "purposely targeted," it has become aware of cybersecurity "incidents" and "vulnerabilities." These include the presence of malware, failure to provide security software updates, and uncontrolled distribution of passwords for privileged device access.

According to The Wall Street Journal, Department of Veterans Affairs records indicate that malware has affected at least 327 medical devices at VA hospitals since 2009, and that during a single outbreak in February 2012, the notorious Conficker malware was detected on 104 devices at a VA Hospital in Tampa, Florida.1 Such computer infections can consume a device's processing power or potentially expose patients' names and past medical procedures. In addition, in conjunction with FDA's alert, the Department of Homeland Security issued a separate alert warning that an estimated 300 medical devices from 40 vendors could be vulnerable to hacking and that "the vulnerability could be exploited to potentially change critical settings and/or modify device firmware."2

Mitigating Risk of a Cybersecurity Breach

The FDA alert explains that medical device manufacturers are responsible for identifying cybersecurity risks associated with their devices and recommends specific measures that medical device manufacturers, as well as health care facilities, should take to identify and address potential cybersecurity vulnerabilities. The alert's recommendations to medical device manufacturers developing new devices align with those set forth in the draft guidance. However, the alert signals regulatory flexibility with respect to changes made to existing devices, stating that "FDA typically does not need to review or approve medical device software changes made solely to strengthen cybersecurity."

Draft Guidance on Cybersecurity Development in Premarket Submissions

FDA's draft guidance provides recommendations for device manufacturers to "consider and document" in premarket submissions, including (i) premarket notifications (510(k)s); (ii) de novo petitions; (iii) premarket approval applications (PMAs); (iv) product development protocols (PDPs); and (v) humanitarian device exemption (HDE) applications. It defines cybersecurity as the "process of preventing unauthorized modification, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient." The guidance recommends that cybersecurity controls should be developed during the design phase and suggests that manufacturers define and document cybersecurity measures as part of their risk analysis pursuant to 21 C.F.R. § 820.30(g).

The draft guidance recognizes that the extent of security controls depends on factors such as the design of the device, its environment for use, the risk of security breach, and risk to patients from a security breach. It also notes that medical devices connected to the Internet or to other devices are at a higher risk of a cybersecurity breach.

Based upon such factors, FDA recommends that manufacturers justify in their premarket submissions the security controls chosen for a device. Appropriate security controls may include (i) limiting access to trusted users only; (ii) ensuring the trusted content of software by restricting software and firmware updates to authenticated code, using systematic procedures for authorized users to download the manufacturer's software and firmware, and ensuring secure data transfer to and from the device; and (iii) use of "fail safe" and recovery features that protect the device's critical functionality, even when the device's security has been compromised.

Finally, the draft guidance outlines specific cybersecurity information that medical device manufactures should include in premarket submissions. The information includes identifying specific cybersecurity risks and the corresponding controls designed to mitigate such risks, including submission of a hazard analysis and traceability matrix linking specific cybersecurity risks to specific controls. Additionally, the agency recommends submitting documentation to show that the device will be free of malware when purchased by users, as well as instructions for use and specifications related to recommended antivirus software.

Consequences for Medical Device Manufacturers

FDA's alert and draft guidance have implications that go beyond the premarket submissions. While the draft guidance applies only to premarket submissions, the alert indicates that medical device manufacturers have responsibility for ensuring security of existing devices. Medical device manufacturers may want to consider conducting a retrospective audit of the cybersecurity measures on their existing devices in addition to updating their design control procedures to ensure that cybersecurity is appropriately considered when developing future devices.

Another cybersecurity consideration is the recent application of the HIPAA Security Rule to companies that provide device-related services to HIPAA covered entities such as hospitals and physician offices. In the  HIPAA Omnibus Rule issued in January 2013, the Department of Health and Human Services clarified that medical device manufacturers, and companies that service medical devices, will be considered business associates of covered entities when they service devices that provide access to protected health information. As business associates, such entities will be subject to additional cybersecurity requirements. Business associates will have until September 23, 2013, to determine, and adopt, the steps needed for compliance.

Recommendations for Health Care Facilities

As part of its alert, FDA also reminds health care facilities to evaluate their own network security and protect their computer systems that are used in connection with medical devices. FDA's recommendations to health care facilities are consistent with the HIPAA Security Rule, already applicable to covered entities, and include (i) restricting unauthorized access to the network and networked medical devices; (ii) making certain appropriate antivirus software and firewalls are up-to-date; (iii) monitoring network activity for unauthorized use; (iv) protecting individual network components through routine and periodic evaluation, including updating security patches and disabling all unnecessary ports and services; and (v) developing and evaluating strategies to maintain critical functionality during adverse conditions. In addition, health care providers are advised to contact the medical device manufacturer if they believe there might be a cybersecurity problem related to a device.


1See "Patients Put at Risk By Computer Viruses", WSJ.com (June 13, 2013, subscription required) available here.

2See Alert (ICS-ALERT-13-164-01), Medical Devices Hard-Coded Passwords (June 13, 2013) available here .

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
Patterson Belknap Webb & Tyler LLP
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Patterson Belknap Webb & Tyler LLP
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions