United States: Hacking Of Medical Devices Is No Longer Just An Outlandish Movie Plot

Last Updated: March 30 2017
Article by Erica C. Mallon

2016 was a big year for health care data breaches with 106 major hacker-attributed breaches reported to the federal government, exposing 13.5 million individuals' records.1According to a June Ponemon Institute/IBM report on data breaches, loss of a single record cost health care institutions an average of $402, which adds up to $2.8 billion spent on 2016 hacking incidents.2

Between November 2015 and August 2016, five entities alone agreed to pay the Department of Health and Human Services Office for Civil Rights (OCR) $16 million related to electronic patient data breaches.3 2015 was a busy year as well with 80 million Anthem members' data compromised in January, 11.2 million Premera BlueCross BlueShield members' and business affiliates' data compromised in March, and 1.1 million CareFirst BlueCross BlueShield members' data compromised in May. And on February 16, 2017, OCR announced a $5.5 million settlement with Memorial Healthcare System regarding potential violations of the Health Insurance Portability and Accountability Act (HIPAA), the second largest settlement in history for potential HIPAA

Violations4 Hackers are becoming more creative in their methods of infiltration, and there is significant concern that hacking of medical devices and hospital networks will be the tactic of the future.

According to a January 2015 Federal Trade Commission (FTC) report titled Internet of Things: Privacy & Security in a Connected World, in 2009, for the first time, the number of "things" connected to the Internet surpassed the number of people in the world.5 In early 2016, technology consulting firm Gartner projected that 6.4 billion connected things would be in use worldwide by the end of the year, up 30% from the previous year, and that the number of connected things would grow by more than three times, to nearly 21 billion by the year 2020.6 While these devices can significantly improve the lives and health of consumers worldwide, significant risks exist as well.

Experts have expressed concern that cybersecurity is not keeping pace with medical technology advancement, and that unlike the hacking of a bank account or email server, such cybersecurity risks can truly mean life or death for a victim. Some experts allege that one thing health care recruiters are missing, but their counterparts in other industries are not, is getting a head start on recruiting and developing cybersecurity talent specializing in the health care industry.7 This is a niche industry for which there will be a growing need as medical technology continues to advance.

The issue of medical device hacking made headlines in August 2016 when cybersecurity and research company MedSec Holdings Ltd. (MedSec) discovered potential security vulnerabilities in St. Jude Medical Inc.'s (St. Jude) pacemakers and defibrillators.8 Instead of disclosing these vulnerabilities, MedSec reportedly went to Muddy Waters Capital LLC, an investment firm, with a money-making proposal. MedSec reportedly suggested that it would provide data proving the medical devices were vulnerable to life-threatening hacking, with Muddy Waters short-selling St. Jude's stock after the vulnerability was announced.9 According to published reports, MedSec's fee for the information increased as the price of St. Jude's shares fell, and both Muddy Waters and MedSec made a generous profit when more than 25 million shares were traded after the security vulnerability was announced.10

St. Jude disputed the vulnerability claims and filed suit alleging that the entire scheme had been made up to manipulate its stock price and that MedSec and Muddy Waters, as well as three other individuals, falsely reported such vulnerabilities and risks.11 The Food and Drug Administration (FDA), in collaboration with the Department of Homeland Security, launched an investigation into the vulnerabilities in August 2016. On January 9, 2017, the FDA issued a Safety Communication confirming vulnerabilities in St. Jude Medical's implantable cardiac devices and Merlin@home Transmitter.12 Shortly thereafter, St. Jude Medical, which has since been acquired by Abbott Laboratories (Abbott), released an update for certain medical devices containing a patch for vulnerabilities made public in the MedSec and Muddy Waters controversy. While no patients were injured by the alleged vulnerability, the allegation rocked St. Jude's reputation, threatened to derail its transaction with Abbott, and revealed a new money-making strategy for short-sellers and cybersecurity firms that uncover potential vulnerabilities.

As the St. Jude controversy unfolded, Johnson & Johnson became the first medical device manufacturer to warn patients about a cyber vulnerability when it advised patients in October 2016 that one of its older model insulin pumps had a cybersecurity bug that a hacker could exploit to overdose diabetic patients with insulin.13 The company provided guidance on how patients could fix the problem to prevent hacking and no patients were injured.

While some of the concern lies with a risk to patients if their devices are hacked, perhaps the greatest risk lies in the ability of hackers to access hospital networks through the hacking of medical devices. Hospital networks are prime targets for hackers because many contain expansive amounts of highly personalized and confidential data.

In June 2015, TrapX, a firm specializing in deception-based cybersecurity defense, released a report finding that attackers targeted and compromised blood gas analyzers and radiology picture archive and communications systems (PACS) to gain access to hospital networks.14 Furthermore, TrapX suggested in its report that an attacker could remotely hack a hospital drug pump and modify the amount of medication to a fatal dose.

In early 2016, Hollywood Presbyterian Medical Center, a California hospital, paid a $16,664 ransom in bitcoins to hackers who infiltrated and disabled the hospital's computer network.15 It is likely other similar attacks have occurred but not been publicized to help maintain public confidence in hospitals' ability to keep information private and secure.

Both the FDA and the FTC have provided guidance on cybersecurity in medical devices. In late 2014, the FDA issued guidance on premarket management of cybersecurity in medical devices, calling for manufacturers to consider cybersecurity risks in designing and developing medical devices.16 In early 2015, the FTC issued guidance on best practices for privacy and security protection, including guidance on the design, deployment, and management of medical devices.17 The FDA issued updated guidance in December 2016 on postmarket management of cybersecurity in medical devices.18

Neither the FTC nor the FDA guidance creates legally enforceable responsibilities related to cybersecurity of medical devices. However, mandatory regulations may be enacted in the future as the risks become more significant and palpable. And whether or not such responsibilities are legally enforceable, it is highly recommended that medical device manufacturers consider such guidance and dedicate significant energy and capital into protecting against cybersecurity threats.

All parties involved in the development and maintenance of medical devices should be aware of the applicable cybersecurity risks. The developers who create these devices, the providers who maintain them, and the consumers who use them need to take appropriate safeguards to ensure patients' safety and privacy. Compliance with the non-mandatory guidance and best practices issued by the FTC and FDA offer a good starting point.

Footnotes

1 Joseph Conn, Vital Signs: How America's Youth is Key to Fixing the Sad State of Cybersecurity, Modern Healthcare, Jan. 20, 2017, available at www.modernhealthcare.com/article/20170120/BLOG/170129995/vital-signs-how-americas-youthis-key-to-fixing-the-sad-state-of

2 IBM, 2016 Cost of Data Breach Study: United States, Ponemon Institute Research Report, June 2016.

3 Dan Mangan, Why 2016 Could be Banner Year for Health-Care Data Breach Fines, CNBC, Aug. 5, 2016, available at www.cnbc.com/2016/08/05/why-2016-could-be-banner-year-for-health-caredata-breach-fines.html.

4 U.S. Department of Health and Human Services, $5.5 Million HIPAA Settlement Shines Light on the Importance of Audit Controls, Feb. 16, 2017, available at https://www.hhs.gov/about/news/2017/02/16/hipaa-settlement-shines-light-on-the-importance-ofaudit-controls.html.

5 U.S. Federal Trade Commission, Internet of Things, FTC Staff Report, Jan. 2015.

6 Julia Boorstin, An Internet of Things That Will Number Ten Billions, CNBC, Feb. 1, 2016, available at www.cnbc.com/2016/02/01/an-internet-of-things-that-will-number-tenbillions.html.

7 Conn, supra note 1.

8 Jordan Robertson and Michael Rile, Carson Block's Attack on St. Jude Reveals a New Front in Hacking for Profit, Bloomberg, Aug. 25, 2016, available at www.bloomberg.com/news/articles/2016-08-25/in-an-unorthodox-move-hacking-firm-teams-up-with-short-sellers.

9 Id.

10 Id.

11 St. Jude Medical v. Muddy Waters Consulting, No. 0:16-cv-03002 (D. Minn. Filed Sept. 7, 2016).

12 U.S. Food & Drug Administration, Cybersecurity Vulnerabilities Identified in St. Jude Medical's Implantable Cardiac Devices and Merlin@home Transmitter, FDA Safety Communication, Jan. 9, 2017.

13 Insulin Pump Vulnerable to Hacking, Johnson & Johnson Warns, NBC News, Reuters, Oct. 4, 2016, available at www.nbcnews.com/health/health-news/insulin-pump-vulnerable-hacking-johnsonjohnson-warns-n659221.

14 TrapX Labs, Anatomy of an Attack, Security Ledger, May 7, 2015.

15 California Hospital Paid $17,000 Ransom in Bitcoins to Hackers, Chicago Trib., Feb. 17, 2016, available at www.chicagotribune.com/news/nationworld/ct-california-hospital-ransom-hackers-20160217-story.html

16 U.S. Food & Drug Administration Center for Devices and Radiological Health, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Oct. 2, 2014.

17 U.S. Federal Trade Commission, supra note 5.

18 U.S. Food & Drug Administration, Postmarket Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, Dec. 28, 2016.

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
Horne LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Horne LLP
Related Articles
 
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
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.

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