United States: FDA Issues Draft Guidance On Postmarket Cybersecurity Of Medical Devices

On January 15, 2016, the Food and Drug Administration ("FDA") released a draft guidance entitled, "Postmarket Management of Cybersecurity in Medical Devices," outlining recommendations that device manufacturers should implement to manage postmarket cybersecurity vulnerabilities. The draft guidance sets forth considerations for assessing and addressing postmarket cybersecurity vulnerabilities, which are continually evolving and not possible for device manufacturers to mitigate solely through premarket controls. The draft guidance also emphasizes that an effective cybersecurity risk management program should cover the premarket and postmarket lifecycle phases, and reminds industry of the recommendations set forth in FDA's 2014 guidance on "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," discussed in a previous Ropes & Gray Alert.

Device manufacturers should review this draft guidance document closely and consider its implications for the postmarket monitoring of their current products. The comment period will remain open for 90 days.

Government Initiatives to Address Cybersecurity Vulnerabilities

The cybersecurity postmarket draft guidance, together with the 2014 premarket guidance, are elements of a larger government initiative to strengthen the nation's cybersecurity systems. In February 2013, the President issued Executive Order 13636 and Presidential Policy Directive 21, which recognize that public and private stakeholders must enhance the cybersecurity and resilience of the nation's critical infrastructure, including within the healthcare and public health sector. Executive Order 13636 also called for the National Institute of Standards and Technology ("NIST") to develop a framework intended to reduce cybersecurity risks to critical infrastructure. The first version of the NIST's framework, released in February 2014, provides a structure that the draft guidance recommends device manufacturers use and adopt, outlining the elements of a cybersecurity risk management program (i.e., identify, protect, detect, respond, and recover). FDA's draft guidance incorporates several key principles of the NIST's framework, as described further below.

In addition, on February 13, 2015, the President issued Executive Order 13691, which encourages the development of Information Sharing Analysis Organizations (ISAOs) to serve as focal points for cybersecurity information sharing and collaboration within the private sector as well as between the private sector and the government. The draft guidance strongly recommends that device manufacturers voluntarily participate in an ISAO as part of a comprehensive proactive approach to managing postmarket cybersecurity threats and vulnerabilities, and to assuring the continued safety and effectiveness of marketed medical devices.

FDA's Recommendations on Postmarket Cybersecurity Management

The draft guidance outlines recommendations for the monitoring, identification, and remediation of postmarket cybersecurity vulnerabilities and exploits. According to the draft guidance, manufacturers' postmarket cybersecurity risk management programs should be implemented as part of the Quality System Regulation (21 C.F.R. Part 820), covering several QSR elements, including complaint handling (21 C.F.R. § 820.198), quality audit (21 C.F.R. § 820.22), corrective and preventive action (21 C.F.R. § 820.100), software validation and risk analysis (21 C.F.R. § 820.30(g)), and servicing (21 C.F.R. § 820.200).

I. Principles of a Postmarket Cybersecurity Management Program

According to the draft guidance, a postmarket cybersecurity risk management program should address vulnerabilities that may permit the unauthorized access, modification, misuse or denial of use of a device, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient, and that may impact patient safety. The critical components of such a program should include:

  • monitoring cybersecurity information sources for identification and detection of cybersecurity vulnerabilities;
  • understanding, assessing, and detecting vulnerabilities;
  • establishing processes for vulnerability intake and handling;
  • defining essential clinical performance to develop mitigations that protect and recover from cybersecurity risks;
  • adopting a coordinated vulnerability disclosure policy and practice; and
  • deploying mitigations that address cybersecurity risks prior to exploitation.

II. Evaluation of Risk to Essential Clinical Performance

The draft guidance explains that not all cybersecurity vulnerabilities present patient safety concerns. Rather, medical device manufacturers should assess the impact of the vulnerability on the "essential clinical performance" of the device, defined as the performance necessary to achieve freedom from unacceptable clinical risk. The draft guidance recommends that device manufacturers define, as part of the postmarket cybersecurity risk management, the essential clinical performance of the device, the resulting severity outcomes if compromised, and the risk acceptance criteria. FDA also recommends that device manufacturers measure the risk to the device's essential clinical performance by considering (i) the exploitability of the cybersecurity vulnerability and (ii) the severity of the potential health impact.

III. Remediating and Reporting Cybersecurity Vulnerabilities

FDA encourages efficient, timely, and ongoing cybersecurity risk management for marketed devices. To this end, the draft guidance states that FDA will not typically require premarket review to clear or approve software updates and patches intended to improve cybersecurity. Similarly, the draft guidance states that changes to strengthen cybersecurity will typically be considered device enhancements that are not required to be reported as removals or corrections under 21 C.F.R. Part 806, unless the cybersecurity vulnerabilities may compromise the essential clinical performance of the device and present a reasonable probability of serious adverse health consequences or death. If the device is approved under a PMA, the manufacturer must submit periodic reports to FDA, which may include newly acquired information concerning cybersecurity vulnerabilities and device changes made as part of cybersecurity updates and patches.

The draft guidance also announces an enforcement discretion policy for changes or other actions to address uncontrolled risks to essential clinical performance. Under this policy, FDA does not intend to enforce reporting requirements under 21 C.F.R. Part 806 if (i) there are no known serious adverse events or deaths associated with the vulnerability, (ii) within 30 days of learning of the vulnerability, the manufacturer identifies and implements device changes and/or compensating controls to bring the residual risk to an acceptable level and notifies users, and (iii) the manufacturer is a participating member of an ISAO.

FDA explains that, in the absence of remediation, a device with uncontrolled risk to its essential clinical performance may be subject to mandatory recall or other agency action.

Consequences for Medical Device Manufacturers

Although FDA's cybersecurity efforts are relatively new, it is by now clear that this is an area of significant and increased FDA focus. Device manufacturers that have not already done so should be carefully assessing and addressing potential cybersecurity vulnerabilities over the lifecycle of their devices. Manufacturers should exercise vigilance in monitoring postmarket cybersecurity information from all sources, assessing identified risks, and appropriately responding to vulnerabilities.

The release of FDA's draft guidance coincides with FDA's public workshop on January 20-21, 2016, to highlight past collaborative efforts, increase awareness of existing maturity models used to evaluate cybersecurity status, standards, and tools, and to identify unresolved gaps and challenges in the progress of medical device cybersecurity. Through the public workshop, FDA is seeking broad public input on strategies for addressing the medical device cybersecurity within the complex medical device ecosystem.

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.

Authors
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.