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• W2992765176 abstract "There is potential for enormous health benefits with the advent of implantable medical devices (IMDs); however, this also leaves open the possibility for adverse outcomes such as loss of privacy, identity theft, and major security concerns.1Armstrong DG Kleidermacher DN Klonoff DC et al.Cybersecurity regulation of wireless devices for performance and assurance in the age of Medjacking..J Diabetes Sci Technol. 2015; 10: 435-438Crossref PubMed Scopus (11) Google Scholar In an ideal world, there are 2 basic commitments electronic medical device manufactures should be able to make: safety and security. That is, the device must prevent accidental failures (safety) while also ensuring that it can protect the user against attempts to inflict purposeful damage (security).1Armstrong DG Kleidermacher DN Klonoff DC et al.Cybersecurity regulation of wireless devices for performance and assurance in the age of Medjacking..J Diabetes Sci Technol. 2015; 10: 435-438Crossref PubMed Scopus (11) Google Scholar By their nature, electronic devices, medical or otherwise, will have software flaws. Typically, these flaws do not lead to safety issues—that is, a pacemaker or insulin pump is still going to continue to do its job effectively regardless of software issues. Unfortunately, these software issues do create vulnerabilities for security breaches such as hacking. On June 28, 2019, the U.S. Food and Drug Administration (FDA) recalled certain MiniMed insulin pumps owing to “potential cybersecurity risks.”2Mulero A. FDA, DHS alert to cybersecurity flaws affecting Medtronic cardiac devices, programmers, monitors. Regulatory Focus, Regulatory Affairs Professionals Society, 22 March 2019,https://www.raps.org/news-and-articles/news-articles/2019/3/fda-dhs-alert-to-cybersecurity-flaws-affecting-me. Accessed 10 Nov. 2019.Google Scholar On March 21, 2019, the Department of Homeland Security issued an alert “describing 2 types of computer-hacking vulnerabilities in 16 different models of implantable defibrillator devices.”2Mulero A. FDA, DHS alert to cybersecurity flaws affecting Medtronic cardiac devices, programmers, monitors. Regulatory Focus, Regulatory Affairs Professionals Society, 22 March 2019,https://www.raps.org/news-and-articles/news-articles/2019/3/fda-dhs-alert-to-cybersecurity-flaws-affecting-me. Accessed 10 Nov. 2019.Google Scholar Cybersecurity as a concept is not news, but cybersecurity of implantable medical devices, where the consequences of a security breach could be grave and even fatal, is of great interest to many. There is general agreement that implantable devices are vulnerable to hackers, although it must be noted that as of now there has never been a medical device that has been hacked for malicious purposes. Rather, medical devices have been hacked for the purpose of demonstrating their vulnerabilities in an effort to elucidate the issue. In fact, it was a live demonstration of the ability to hack Medtronic devices by a group of professional hackers that ultimately got the attention of the FDA, the organization in charge of regulating IMDs. Now, the challenge lies in how to respond to these vulnerabilities. As is true in so many other situations, the agility of technological development has far outpaced the ability of the FDA to mount a response. Original legislation simply does not account for the technological complexity of IMDs. The current regulations on IMDs are weak and power has increasingly been turned over to the manufacturers of the devices. As it stands now, medical devices are owned and patented by their manufacturers, so patients and doctors are not allowed to access these devices to test their security. Furthermore, a 2008 Supreme Court ruling effectively prohibited patients harmed by defects in FDA-approved devices from seeking damages against manufacturers. The FDA has moved forward with a “Medical Device Safety Action Plan”3U.S. Food and Drug Administration. Center for Devices and Radiological Health. https://www.fda.gov/about-fda/cdrh-reports/medical-device-safety-action-plan-protecting-patients-promoting-public-health. Published Sept. 2019. Accessed Nov. 5 2019.Google Scholar that offers modern enhancements to FDA oversight of device safety and that reflects steps taken to enhance infrastructure to assess and assure IMD safety. The program involves multiple “enhancements” ranging from establishing a unique device identification and evaluation system to recalibrating the benefit-risk framework for device oversight in the pre- and post-market settings. This new framework endorses being more patient-centric and flexible. One thing is certain: This problem is not going away. As the technology industry continues to create life-saving implantable devices, addressing the need to provide protection to the people housing these devices is paramount. Complete protection may not be feasible as this is often the case with technology, but developing the best security possible for implantable devices is very important. Dr. Abd-Elsayed is a consultant for Medtronic, StimWave, Avanos, and Sollis." @default.
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• W2992765176 date "2020-06-01" @default.
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• W2992765176 title "Implantable Medical Devices: A New Frontier for Security" @default.
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• W2992765176 doi "https://doi.org/10.1053/j.jvca.2019.11.046" @default.
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