United States: Unhack My Heart: FDA Issues Guidance To Mitigate Cybersecurity Threats In Medical Devices

Last Updated: July 4 2013
Article by Sharon Klein and Odia Kagan

A new guidance document from the FDA lists considerations and suggested steps to reduce the likelihood of cybersecurity breaches in medical devices.

In an especially edge-of-the-seat episode of the television drama "Homeland," a terrorist succeeds in remotely hacking into the pacemaker of the Vice President of the United States using the device's serial number. The terrorist then proceeds to induce a fatal heart attack by manipulating the device. Despite sounding much like science fiction, due to present-day technology and the connectivity of medical devices, this piece of fiction is indeed not too far from reality.1

On June 14, 2013, the Food and Drug Administration (FDA) issued for comment within 90 days, a draft guidance (Guidance) on the Management of Cybersecurity in Medical Devices.2 The Guidance supplements the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" published on May 11, 20053 and the FDA's "Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (COTS) Software" published on January 14, 2005.4

In the new Guidance, the FDA outlines its current thinking with respect to issues manufacturers of medical devices are to consider in designing medical devices in order to effectively reduce the chance of a cybersecurity breach to the device. The FDA has been vocal in advocating quality initiatives for medical devices containing software or programmable logic that can be vulnerable to cybersecurity incidents.5 Cybersecurity risks are defined in the Guidance as the intentional or unintentional compromise of a device or the data stored in it through 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 FDA is advising health care facilities to evaluate their computer networks to eliminate malware and computer viruses that can contaminate medical devices.

Beyond the design phase, the recommendations in the Guidance specifically address several "premarket submissions" of medical device manufacturers to the FDA, namely: Premarket Notification (510(k)), De novo petitions, Premarket Approval Applications (PMA), Product Development Protocols (PDP) and Humanitarian Device Exemption (HDE) submissions.

The CIA of Information

As a general principle, medical device manufacturers should implement measures in the devices to ensure the confidentiality, integrity, and availability of information stored in them:

  • Confidentiality. This means that data, information, or system structures should be accessible only to authorized persons and entities at authorized times and in an authorized manner.
  • Integrity. This means that data and information should be accurate and complete and should not be improperly modified.
  • Availability. This means that data, information, and information systems would be accessible and usable when needed: on a timely basis in the expected manner.

It would be most efficient, both for the FDA approval process and for the efficiency and effectiveness of managing a device's security, that the cybersecurity issues and risks be addressed and analyzed in the design phase. Among other things, manufacturers are encouraged to document the following, as part of the risk analysis required by FDA rules on design control for medical devices:6

  • What are the assets, threats, and vulnerabilities to the device and what is their expected impact?
  • How likely is it that a vulnerability would be exploited?
  • Is such risk an acceptable one and what are possible mitigation strategies?
  • What are potential residual risk and risk acceptance criteria?

Security Guidelines

The Guidance breaks down the general principles with certain recommended appropriate security controls for the medical devices, especially those that are life-sustaining or connected to hospital networks:

Limiting Access to Trusted Users

  • Authenticate. The device should be accessible only following appropriate user authentication (username, password, smart card, etc.).
  • Compartmentalize. Different parts of the device may be accessible only to certain individuals, depending on their role.
  • Time-Out. The device would have automated log-off (time-out) after a certain time or inactivity.
  • Passwords.Authorized passwords would have sufficient length and complexity.
  • Update Controls. Special controls may be necessary to permit software or firmware updates.
  • Physical Locks. Physical locks may be necessary.

Trusted Content

  • Secure Data Transfer. Data transfer to and from the device should be secured, including accepted methods for encryption, where appropriate.
  • Update Controls. Updates should only be made using authenticated code, including code signature verification.

Fail-Safe and Recovery Measures

  • Identify. It should be possible to recognize, log and act upon security compromises as they happen.
  • Fail-Safe Measures. Even when the device's security has been compromised fail-safe device features should be in place to protect the device's critical functionality.

Access in Emergency

The FDA is wary of medical device security measures doing more harm than good in emergency situations. Therefore, the Guidance specifies that the extent to which security measures would be needed depends on the attributes of the specific device. More extensive measures would be needed for devices capable of connecting to other medical devices, to the Internet or another network, or to portable media (e.g., USB or CD). Security measures should be tailored to the target audience using the device so as not to hinder access to the device during an emergency situation.

When the Joplin tornado hit St. John's hospital in Kansas City in May 2011, causing the electricity to go out, doctors and nurses lost access to many of the vital medicines in the ER and in virtually every other department. The power outage had caused the metal cabinets where the drugs are kept to automatically lock.7 Medical staff would be left in a similar predicament as a result of a hacker compromising software controlling cabinets normally accessed by user names and passwords. Such a hacker could also access the system in order to access contraband and controlled substances.


The Guidance concludes by suggesting manufacturers should provide certain documentation as part of the premarket submission to the FDA. These documents include:

  • Risk Analysis. Hazard analysis, mitigations, and design considerations pertaining to intentional and unintentional cybersecurity risks associated with the device, including: a list of the risks and a list and justification of the controls implemented to address such risks and how they are linked to the risks. (This should be in the form of a traceability matrix).
  • Update Control. A description of the systematic plan for providing validated updates and patches to operating systems or medical device software, as needed, to provide up-to-date protection and to address the product life cycle.
  • Disabling Code.

    • Appropriate documentation to demonstrate that the device will be provided to purchasers and users free of malware, and
    • Instructions for use and product specifications related to recommended anti-virus software and/or firewall use appropriate for the environment of use.

Pepper Point: Manufacturers of medical devices, particularly those with the ability to connect to other devices or to the Internet, are well advised to take into account the FDA's new Guidance as early as possible in the design of their medical devices. Additionally, hospital systems connected to devices should be audited to eliminate malware (which can be transferred to a medical device) and to ensure restricted access to devices. Though the Guidance is presently only a non-binding recommendation, it implements existing legal requirements in connection with data security as well as the FDA premarket authorization process. In addition, beyond the legal prism, devices that are more secure from potential cybersecurity breaches may be better positioned to win the trust, reliance, and purchasing dollars of the relevant institutions and consumers.


1 See e.g.: Barnaby Jack "Broken Hearts": How Plausible Was the Homeland Pacemaker Hack?" at http://blog.ioactive.com/2013/02/broken-hearts-how-plausible-was.html; and Barnaby J. Feder "A Heart Device Is Found Vulnerable to Hacker Attacks" March 12, 2008 at http://www.nytimes.com/2008/03/12/business/12heart-web.html?_r=0.

2 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM356190.pdf.

3 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089593.pdf.

4 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077823.pdf.

5 "U.S FDA Urges Protection of Medical Devices from Cyber Threats" June 13, 2013 at http://www.reuters.com/article/2013/06/13/devices-cybersecurity-fda-idUSL2N0EP1LR20130613.

6 21 CFR 820.30(g).

7 http://www.kansascity.com/2011/06/18/2959600/condition-gray-inside-the-hospital.html#storylink=cpy.

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.

Odia Kagan
Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
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