Canada: Cybersecurity Risks In Medical Devices – Health Canada Adopts Guidance Document

Last Updated: November 5 2019
Article by David Krebs

Cybersecurity and data breaches are topics of high concern for Canadians. As discussed in previous blog articles, data breaches in Canada, North America and Europe have illustrated how financially motivated hackers and human error can put personal data at risk, thereby causing potential reputational and financial harms such as identity theft, fraud and humiliation.  Immediate physical harm resulting from cybersecurity risks have been less frequently highlighted as acute areas of concern but as this entry will discuss, they are certainly not going unnoticed as they relate to medical devices.

To address cybersecurity risks in medical devices, Health Canada has recently released a Guidance Document: "Pre-market requirements for Medical Device Cybersecurity." Canada is not alone. The US Food and Drug Administration ("FDA") had previously released similar guidance, and, just a few weeks ago, the French authorities, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), released draft guidance intended to enhance the existing European framework for medical devices (the Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017 /746).

What are the risks?

A recent communication by the FDA is a clear example of how grave the consequences are of cyber vulnerabilities in medical devices. A glitch or error in many other industries may cause harm to personal data, corporate intellectual property and perhaps even indirect physical consequences (cyber infrastructure attacks causing power outages and delays in food supply, to name two), but none so direct and immediate as the risks associated with, for example, being able to hack a medical device and remotely change dosages or otherwise manipulate the delivery of care.

In this case, the manufacturer was made aware of a vulnerability in the wireless communication between its insulin pumps and certain other devices (such as blood glucose meters and continuous glucose monitoring systems), which would make it possible for a bad actor to access the device and make changes to the dosing of insulin that a patient receives. There have been no reports of any actual harm to patients, nor knowledge of actual attempts to access the device, but the potential for serious physical harm was such that the devices have been recalled and patients urged to switch to other models, in both the US and Canada.

Responsibility for cybersecurity in medical devices

According to Health Canada's "Guidance Document: Pre-market Requirements for Medical Device Cybersecurity," the primary responsibilities fall on the manufacturer of the medical device, stating that:

"Manufacturers should incorporate cybersecurity into the risk management process for every device that consists of or contains software. Manufacturers are also encouraged to develop and maintain a framework for managing cybersecurity risks throughout their organizations."

One such framework is ISO 14971-07:2007 Medical devices – Application of risk management (ISO 14971. The Guidance Document describes how manufacturers are to incorporate the elements of this framework into their operations and manufacturing life-cycle. Manufacturers are also encouraged to adopt (and adapt) relevant aspects of the NIST "Framework for Improving Critical Infrastructure Cybersecurity" as a "blueprint of best practices to guide their cybersecurity activities, including those related to risk management." Early-stage consideration of potential threats, similar to the principles underlying "Privacy by Design," are also highlighted as part of a 'cybersecurity by design' approach.

The FDA's guidance document on this issue also highlights the responsibility of the manufacturer but makes a clear statement that it goes beyond the device itself, noting that "[t]he heath care environment is complex, and manufacturers, hospitals, and facilities must work together to manage security risks."

Regulatory requirements

The Guidance Document applies to all Classes (I, II, III, and IV), although not every requirement will be relevant to every device type. Class III and Class IV applications will need to submit evidence of adherence to these standards as part of their licence applications. The core elements are as follows:

  • Secure Design
  • Device-specific risk management
  • Verification and Testing
  • Ongoing monitoring and response to risks (including information sharing about known or potential risks).1

Secure Design principles include: a) secure communications between device and other networks devices; b) data integrity and confidentiality, for example, encryption of data; c) user access – different privileges for different required levels of access; d) software maintenance – to secure emerging risks; e) hardware and physical design; f) reliability and availability – designed to recover from attacks and are somewhat familiar from what the expectations would be from a privacy perspective, where these devices process personal health information or other personal data.

Summary

As the general threats of cybersecurity become more well-known and top-of-mind, so will the  expectations of patients, hospitals, and the regulators that specific threats related to medical device security will be appropriately addressed by manufacturers. The Guidance Document only became effective June 26, 2019, and companies should be monitoring how it will be interpreted and implemented by Health Canada.

Footnote

1 The FDA encourages self-reporting of known issues with cybersecurity of devices.

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
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
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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.

Disclaimer

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.

General

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