United States: Medical Devices And Cybersecurity: FDA Calls For Comprehensive Risk Management Programs

The Food and Drug Administration (FDA), with the issuance of its recent 2016 Draft Guidance "Postmarket Management of Cybersecurity in Medical Devices," continues to step up its involvement with medical devices having a software component. This is consistent with the Office of Inspector General's 2016 Work Plan, wherein the OIG specifically intends to focus on the vulnerability of networked, as well as software-driven medical devices.

This is just the latest move in the FDA's focus on medical device software, which began as early as 2002, when the agency published its Guidance on Software Validation. Since that time, the use of software in medical devices has increased and become more complex. This has coincided with the emergence of the mobile medical app industry. This market growth, along with the growing sensitivity on cyber safety, has caused the FDA to turn its attention to cybersecurity and protecting public health from vulnerabilities presented by the increasing use of software in medical devices.

Premarket management of cybersecurity

The FDA has approached the management of cybersecurity risks from both a premarket position, as well as a postmarket management perspective. In October 2014, the FDA published a Guidance entitled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," which aimed at assisting companies submitting 510(k) premarket notifications, Premarket Approvals (PMA), Product Development Protocols (PDPs) and Humanitarian Device Exemption (HDE) submissions to ensure that all such submissions adequately address cybersecurity considerations. This guidance suggests that entities filing a premarket submission with the FDA include the following components in the filings:

  • Identification of cybersecurity assets, threats and vulnerabilities 
  • Assessment of the impact of these threats and vulnerabilities on device functionality and the consumer, customer or patient
  • Assessment of the likelihood of a threat or vulnerability being exploited
  • A determination of the risks levels and suitable mitigation strategies
  • An assessment of residual risk and risk acceptance criteria

This list is not all inclusive, and each point requires a consideration of the nature and function of the device that is subject to the premarket submission. The FDA has implemented a risk-based approach to these analyses. In these submissions, medical device manufacturers are directed to consider cybersecurity risks, assess the vulnerabilities and identify how they will protect against exploitation of those vulnerabilities. The submissions should include preemptively designed measures that proportionally deal with the identified vulnerabilities, the risk those vulnerabilities pose if exploited, and the potential impact on consumers or patients. The FDA recommends that medical device companies spend a significant amount of time in their submissions addressing these vulnerabilities while justifying all controls and mitigating efforts in light of the vulnerabilities and risks they address. In the analysis of these vulnerabilities, the FDA envisions that these analyses will be divided into two stages:

  1. Identify and Protect: Pre-emptive measures to identify possible vulnerabilities and proactively implement controls to reasonably prevent exploitation.
  2. Detect, Respond, Recover: These steps are implemented to respond when a vulnerability is exploited, responding to the exploit to minimize the risk to the device and the patient or user, and recover information from the device so that further exploitation can be prevented.

Under this final Guidance, premarket submissions require manufacturers and developers to possess a significant understanding of how their products will be used in the market, what access is available to those devices for vulnerability exploitation, and how they can properly address these issues during the design of the product itself. Since the inception and finalization of this premarket submission guidance, the FDA has further examined the role of cybersecurity and developed/adopted industry vocabulary and applied it to susceptible medical devices.

A new postmarket guidance scheme, a new vocabulary

As the FDA has considered the issue of cybersecurity, it has refined the risk-based concepts by dealing with risks in ways proportional to their potential impact. The FDA has accomplished this by drafting another guidance, yet to be finalized, which it issued on Jan. 22, 2016 wherein it addresses Postmarket Management of Cybersecurity in Medical Devices. The FDA's approach, as reflected in this draft Guidance, is evidenced in a new set of terms the FDA has defined in order to help the industry deal with cybersecurity issues with a clear set of parameters. Among the most important concepts are:

  • Compensating Controls: A safeguard or countermeasure external to the device employed by the end user in the place of sufficient controls implemented by the manufacturer. These Compensating Controls provide sufficient protection for the medical device such that it is not necessary for the control to be implemented within the device itself. Compensating Controls may be used for a variety of reasons, but the FDA envisions them being used where it is more efficient for the end user to provide the control rather than the manufacturer.
  • Cybersecurity Routine Updates and Patches: Medical devices, like any other piece of modern technology, utilize firmware and software that may contain bugs or vulnerabilities that the manufacturer must fix via patches or updates. They may also impact the product instructions for use and labeling. Generally, these are not considered a repair and are not required to be reported to the FDA. Not included are those updates, patches or repairs that are associated with a reasonable probability that use of or exposure to the medical device will cause serious adverse health consequences or death.
  • Controlled Risk: A risk is considered controlled when steps taken by the manufacturer, through capabilities of the device itself or through Compensating Controls, are effective such that there is sufficiently low risk that the device's essential clinical performance could be compromised by a cybersecurity vulnerability. A risk becomes an Uncontrolled Risk where there exists an unacceptable risk that the device could be so compromised as to impair its essential function.
  • Cybersecurity Signal: A Cybersecurity Signal is any indication or information that indicates the potential for or confirmation of a cybersecurity vulnerability or exploit that could affect a medical device. Such signals may include internal monitoring, business partners, postmarket surveillance, customer complaints, researchers and Information Sharing and Analysis Organizations (or ISAOs).
  • Essential Clinical Performance: Performance levels necessary to achieve freedom from unacceptable clinical risk as defined by the manufacturer. If the Essential Clinical Performance is compromised, users may be exposed to harm or may require intervention to prevent that harm.
  • Exploit, Threat, Vulnerability: The FDA has defined several classes of risks to medical devices and software that result from vulnerabilities in the software that may be exploited, intentionally or unintentionally, and represent a threat to the essential clinical performance of the medical device or software. It is this three-step system of risk identification that the FDA's cybersecurity efforts revolve around.
  • Remediation: Any action taken to reduce the risk to a medical device or software's essential clinical performance. These may include through patches and updates or compensating controls. Complete remediations are actions that entirely address a risk to sufficiently categorize it as a Controlled Risk. Any other remediation is considered an incomplete risk.

This draft guidance emphasizes the FDA's concerns about the risk to medical devices and therefore public health when medical device manufacturers and health care providers are not vigilant as to cybersecurity vulnerabilities and breaches. This then is what has led to the FDA's recommendation within the draft Guidance that medical device manufacturers implement a "comprehensive cybersecurity risk management program." These programs will have to be designed to include a reporting requirement for the most serious risks that pose safety issues, as well as a patching requirement for the less serious risks. Critical components of each of these management programs will have to include: monitoring; assessing and detecting risks; handling of the vulnerabilities once identified or realized; and mitigation strategies to respond and recover from cybersecurity breaches.

The filing of premarket submissions for medical devices which carry a cybersecurity risk, as well as the drafting of the postmarket management plan noted above, require the involvement of experienced regulatory counsel in coordination with cybersecurity counsel. Thompson Coburns' Life Science and Cybersecurity practices have a coordinated approach in assisting our medical device clients in complying with not only these regulatory requirements, but assisting them in responding should a cybersecurity breach occur. If you have any questions about cybersecurity matters, or any other content on this blog, contact the authors at Thompson Coburn where we have attorneys experienced in medical device compliance, FDA compliance programs, cybersecurity breaches and related counselling.

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.