{"id":50714,"date":"2023-09-30T12:00:45","date_gmt":"2023-09-30T12:00:45","guid":{"rendered":"https:\/\/biomedpharmajournal.org\/?p=50714"},"modified":"2023-10-07T08:22:22","modified_gmt":"2023-10-07T08:22:22","slug":"a-review-of-the-impact-of-cybersecurity-in-high-risk-medical-devices-and-in-vitro-medical-devices-all-over-the-world","status":"publish","type":"post","link":"https:\/\/biomedpharmajournal.org\/staging\/vol16no3\/a-review-of-the-impact-of-cybersecurity-in-high-risk-medical-devices-and-in-vitro-medical-devices-all-over-the-world\/","title":{"rendered":"A Review of the Impact of Cybersecurity in High-Risk Medical Devices and In-Vitro Medical Devices all Over the World"},"content":{"rendered":"\n

Introduction<\/strong><\/p>\n\n\n\n

Latest advancements\nin technology have resulted in the transformation of the healthcare system\nwhich tends to improve patient care. One of the major parts of the healthcare\nsystem is the pharmaceutical sector and having medical devices is their\ncritical aspect1<\/sup>. After implanted in the body or attached to the\npatient externally they serve a critical function by providing continued\nautomated assistance to save lives. The medical devices attached to a single\npatient are commonly referred to as Personalized Medical Devices (PMDs)2<\/sup>.\nThe devices implanted in the patient\u2019s body are called Implantable Medical\nDevices (IMPDs). PMDs are medical devices with small firmware and modern\nhardware. They are wireless, mobile, and user-friendly. And they\u2019re\ninterconnected and interoperable as well. The interconnectivity and\ninteroperability may provide a great benefit but they also expose the medical\ndevice to major risk concerns like cybersecurity breaches and cybersecurity\nvulnerabilities that can be exploited maliciously or triggered intentionally\nthis can affect the device\u2019s performance and they can be harmful to the patient\nby producing illness, injury or death3<\/sup>. So, all the stakeholders\nlike Government, Hospitals, Healthcare organizations, and Medical Device\nIndustries are responsible for maintaining the safety of the Patient as well as\nthe Medical Device.<\/p>\n\n\n\n

 In the case of High-risk medical devices like cardiac\npacemakers, insulin pumps, and implantable pulse generators they can be easily\ncontrolled and monitored using mobiles by using Bluetooth or an internet\nconnection4<\/sup>. Some patients, such as prominent public figures are at\ngreater risk of cybersecurity attacks. These attacks can do greater harm to the\npatients. And if this information is reported in the media it will greatly\ndecrease the reputation of lifesaving medical implants. Usually, private\ninformation about high-risk medical devices is stored in Electronic Health\nRecords (EHS) which has been reported that 90% of medical devices and\nElectronic Health Records have been the victims of cyber attacks5<\/sup>. <\/p>\n\n\n\n

Because of these risks, the software and hardware used in high-risk medical devices require prior marketing approval and Remote monitoring of the High-risk medical devices and IVDs after being marketed to prevent and reduce cyberattacks. And one of the common methods is to apply security standards and policies including cyberattack awareness programs. The trends of cybersecurity can be understood based on 2 aspects:<\/p>\n\n\n\n

Weakness and Bug Detection in the system<\/p>\n\n\n\n

Identifying the cyber hackers and their methods6<\/sup>.<\/p>\n\n\n\n

In this paper, we\nare going to discuss the methods that can be used to enhance safety, security,\nand privacy for medical devices that are controlled by the Internet while at\nthe same time enabling higher mobility and Remote Monitoring.<\/p>\n\n\n\n

Security Threats to Internet-Connected Devices Environment<\/strong><\/p>\n\n\n\n\n\n
\"\"<\/td>\n\n

Figure 1: Security Threats to Internet-Connected Devices Environment<\/strong><\/p>\n

<\/p>\n

Click here to view Figure<\/a><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n

Cybersecurity Incidents<\/strong><\/p>\n\n\n\n

The most impact on\nthe cybersecurity in a medical device is faced by Insulin pumps and Pacemakers. Research from the\nArchimedes \u2013 Ann Arbor Research Center for Medical Device Security at the\nUniversity of Michigan has demonstrated the potential compromise to implanted\ndevices30<\/sup>.\nIt is found that insulin pumps- web interfaces, hard code administration\npasswords, and internet-accessed devices are found to be highly vulnerable in\nthe environment of hospitals. And the internet accessed devices without\nauthentication and encryption are the most vulnerable31, 36<\/sup>. <\/p>\n\n\n\n

Data Transmission in Medical Devices<\/strong><\/p>\n\n\n\n

Nowadays radio frequency is commonly used\nfor data transfer37<\/sup>.\nThe bandwidth of the radio-frequencies for implants and pacemakers is 402-405\nMHz, this bandwidth is common for devices all over the world, so this makes the\ndevices more vulnerable. So, the process of broadcasting or misusing\nradiofrequency is called \u201cradio piracy\u201d11<\/sup>. <\/p>\n\n\n\n

Electromagnetic interference is also one\nof the major concerns in which the non-cardiac external signals will interfere\nwith the cardiac signals and manipulate them, for example, the airport scanners,\nsmartwatches, and mobile phones38<\/sup>. Using filters like Bandpass filters we can filter\nthe unwanted interference of the non-cardiac waves to interfere with medical\ndevices12, 35<\/sup>.<\/p>\n\n\n\n

Radiofrequency identification is a part of\nradiofrequency but it differs from Radiofrequency identification can carry more\ndata but the range is shorter comparatively. There are two types \u2013 active and\npassive27<\/sup>.\nActive requires a battery source and is more complex unlike the passive which\ncan deliver fewer data but shorter bandwidth33<\/sup>. And the shorter the bandwidth less\npossibility for hackers to hack as it reduces the surface area of attack\nwhereas longer bands are costly to produce29<\/sup>. But it does not mean that it is not\npossible to hack the devices that transfer data in shorter bands, as we already\nhave a history of hackings like Banking cards which deliver only shorter bands12<\/sup>. <\/p>\n\n\n\n

Ways to Protect our Devices from Cybersecurity Risks<\/strong><\/p>\n\n\n\n

Increasing the security of the weakest link<\/strong><\/p>\n\n\n\n

Hackers usually target the weakest link as\nit requires only a minimum amount of time. So, they will target loopholes and insecure\nareas instead of targeting security areas22<\/sup>.<\/p>\n\n\n\n

Multiple Defense mechanism<\/strong><\/p>\n\n\n\n

Instead of focusing on a single solution, focus\non complex interconnected solutions as if one system fails other interconnected\nsystems will protect the device23<\/sup>.<\/p>\n\n\n\n

Level of trust<\/strong><\/p>\n\n\n\n

The level of trust between the application\ncomponents is essential and proper controls should be maintained to ensure that\na proper level of trust is established between the interactions26<\/sup>.<\/p>\n\n\n\n

Hiding credentials<\/strong><\/p>\n\n\n\n

Keeping the encryption keys and passwords\nhidden is a critical task. So, a depth approach should be established to keep\nthe credentials private and safe25<\/sup>.<\/p>\n\n\n\n

Least privilege principle<\/strong><\/p>\n\n\n\n

each function of a security system should\nbe maintained with the least privilege. As maintaining the least privilege\nprevents\/ reduces any damages occurring from the loopholes of the system19<\/sup>.<\/p>\n\n\n\n

Default security<\/strong><\/p>\n\n\n\n

While designing the systems access\ndecisions should be provided rather than denying it. So, the user will get the\noption to accept or deny the program which is much easier to design and safer21<\/sup>.<\/p>\n\n\n\n

Security Zoning<\/strong><\/p>\n\n\n\n

Encapsulation methods are used to create\nsecurity zones\/ trust zones, to handle the damage created by the trust or\naccess breach20<\/sup>.<\/p>\n\n\n\n

Simple Designs<\/strong><\/p>\n\n\n\n

These designs are systematically\neasy-to-use and verify systems and which is because simpler designs are much\npreferred18<\/sup>.<\/p>\n\n\n\n

Privacy Promotion<\/strong><\/p>\n\n\n\n

Maintain privacy about the instructions\nand processes about the system works which provides hackers with the system\ninformation24<\/sup>.<\/p>\n\n\n\n

Incorrect assumptions<\/strong><\/p>\n\n\n\n

Incorrect assumptions are always a major\nconcern and major loopholes are due to these incorrect assumptions. So, they\nshould be avoided13,14<\/sup>.<\/p>\n\n\n\n

Cybersecurity and Remote Monitoring<\/strong><\/p>\n\n\n\n

The development of implantable medical\ndevices leads to a reduction in their size and they have to typically rely on\nthe software alone for their functioning they are highly internet accessible\ncompared to the old devices17<\/sup>. The implantable medical devices contain radio\ninterfaces that are programmed with wireless communication with the help of\nexternal device programmers34<\/sup>. The benefits are more but this broadens the surface\narea of the attack leaving the device vulnerable28<\/sup>. And wireless attacks are much easier to\nlaunch and whereas analog attacks are comparatively harder because of the narrow\nsurface area for attack35<\/sup>.\nSo, the remote monitoring of medical devices has become essential and medical\ndevices should be monitored periodically15,16<\/sup>.<\/p>\n\n\n\n

Conclusion<\/strong><\/p>\n\n\n\n

The risk of cybersecurity has becoming a major concern and, in this paper, we have learnt about the different types of cybersecurity attacks, and major cybersecurity incidents and the ways to prevent the cybersecurity attacks. Each type of cybersecurity attack requires specific methods of prevention. The need to protect businesses’ digital assets and medical equipment from cyberattacks has grown as a result of the development of the digital landscape. One of the difficulties in project management is balancing investments in security measures with rising development costs. Software testing experts and IT infrastructure staff need to incorporate security testing into their testing processes and regularly learn about security testing technologies and the most recent software and hardware security flaws. Given the multitude of rules, standards, frameworks, guidance documents, technical studies, and best practices on this subject, it has become more and more challenging to gain a clear understanding of regulatory requirements that address the security of connected medical devices and related software. While some standards lack explicit requirements on cybersecurity, they do offer some advice on how security controls should be implemented.  In the software life cycle procedures, cybersecurity has grown to be of the utmost importance. The value of the company’s goods and services can increase by putting in place a proactive security strategy against risks. <\/p>\n\n\n\n

Conflict of Interest<\/strong><\/p>\n\n\n\n

There is no conflict of interest.<\/p>\n\n\n\n

Funding Sources<\/strong><\/p>\n\n\n\n

There are no funding sources.<\/p>\n\n\n\n

References<\/strong><\/p>\n\n\n\n

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