Standards Assist with Medical Device Cybersecurity

 The technology expansion is pushing the options for medical device connectivity. The options and configurations used to be relatively limited. Connectivity continues to grow in its different forms. While this is great for the industry, doctors, and patients, applied cybersecurity also needs to be addressed in every step of the way.

These connected devices connect to the network using Bluetooth, BLE, or WIFI for communications. If configured correctly and cybersecurity being incorporated throughout the process, generally this should work well. To assist with this and provide guidance there are standards for medical devices (e.g., IEC 62304, ISO 14971, and FDA guidance). These provide directed guidance. The key though is documentation. The documents need to show not only you have secured these standards but have implemented them. Part of the plan and implementation includes the product’s risk analysis. I mention this specifically is the risk analysis or TARA is the bedrock for risk analysis. When thorough this will show the vulnerabilities, which need to be addressed. This system’s review will build a solid cybersecurity plan and product for your customers.

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Chicago Children's Hospital Targeted

 

There’s been a lot written about medical facilities being targeted and compromised over the last five years. The compromises have varied with their penetration into the network and data. The greater the attack’s expanse, the more potential for patient suffering. In late January/early February, Lurie Children’s Hospital system was compromised. This was rather significant with their phones, email, internet service, and medical equipment affected. These systems are in different operational areas in their network, which indicates this was a bit more than the usual attack. The department for penetration in the different systems is notable.

The timeframe for the affected systems was relatively short, at two days. This was still devastating for the staff and patients. The situation was further complicated by the data from the operations that did continue having to be merged into existing data sets.

With hospitals holding so much valuable data, this trend will continue if not grow. There is ample to do with all the patient PII, insurance information, medical history, and other data the hospitals have accumulate every day.

To rebound from this is much more than getting the systems up. The security staff needs to also understand the attack vector and how it was implemented, what systems were breached (not only the ones that were overly noticed), and what data was accessed.

The hospital has much work to do with the incident response. This unfortunately is a prime example of what can happen. Systems need not only be secured but monitored and the tooling reviewed at a regular cadence. Just like the industry is dynamic, so is the tolling. There may be better options or configurations available in the next review cycle.

 

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Repository=Malware Depository

 Not too long ago, repositories were not targeted. If you used a library or repository, there was a reasonable assumption it could be trusted and used without an issue. There started to be a trend around 2017 with malicious packages being placed in the Python Package Index (PyPI). There was also the case of the University of Minnesota sending buggy packages to Linux as a research experiment. Somehow this was approved by their research ethics board. The University was banned for their behavior from the repository.

In January 2024, more malicious packages were detected in the PyPI. One piece of malware noted this time around was the White Snake Stealer. These were uploaded by a bad actor named “WS”. The malware is designed to harvest data from web browsers, cryptocurrency wallets, and apps.

This is one reason not to blindly trust the repositories. You never know. Generally, you will be fine. As President Reagan is often quoted, “Trust, but verify.” There are several tools openly available to scan these for vulnerabilities. The last thing you want is to poison your elegant code with malicious code from a “trusted” repository. 

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Medical IoT Devices

 The technology with medical devices and the protocols continue to improve. For example, we started with WIFI, moved to BlueTooth, and improved to BLE (BlueTooth Low Energy). There are many other examples throughout the products. One of the latest pushes is for AI integration. This has vast potential to improve the entire device’s operations and security. The full integration of IoT into medical devices cannot be overlooked.

There are several factors driving this. There is an increasing demand for remote patient monitoring. Our population is aging. The demographics are clear. The aging population has more chronic diseases, which tends to need more of this remote patient monitoring. These can provide real-time monitoring for the patient’s vital signs, for example. This allows for ease of collecting data and proactive management for chronic diseases.

The connectivity has also been beneficial. The updated protocols allow for the ease of data transmission. These also have greater security, which likewise is a bonus.

With the vast amount of data collected, the patient’s doctors can provide a much more specialized level of patient care. The diagnosis and treatment have the potential to be specifically tailored for them.

With the ease of use, functionality, and improved security, these may be used in many more types of facilities. This includes hospitals, rehabilitation centers, homes, and other facilities.

 

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Energy Sector's Criticality

 

The attacks on the energy sector have been increasing. This is a critical vulnerability for the nation. A successful attack on, for example, the electrical grid would be a disaster from every view. I still remember the time when the grid in the NE region of the US went down in the early 2000s. This was unintentional yet if you lived in the region and was out of power, both consumers and commercial clients, the effect was devastating.

Looking to recent events, there have been attacks that continue to show the vulnerabilities and the effects from these, both financial and human. We can remember the 2021 Colonial Pipeline ransomware attack. The company experienced large financial losses and disrupted their operations. On the attacker’s side, they removed without authorization (i.e., stole) approximately 100GB of data and received $4.4M. A significant portion of this was retrieved, however overall, this had direct negative impacts on the business.

This isn’t a US issue, but global. In 2022, European oil refining ports and storage facilities were targeted. This included 17 terminals. This industry needs the blue team cybersecurity attention. Without this, we will have direct issues affecting our daily lives. 

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Hyundai works through breach

 

From the published accounts, there seems to be an uptick in attacks against the automakers. This could be focused on their sales platform, data warehouse, R&D, or other areas holding some form of data. Nissan was a recent victim as Hyundai India is.

Recently the automaker published a breach through their defenses. The breach allowed the attacker(s) in and allowed them to find data or other useful (e.g., expensive) data. The attacker’s focus for this successful attack had been sensitive customer information (i.e., names, addresses, email addresses, telephone numbers, vehicle specifics, and other client data points) for Hyundai India customers only. A portion of the data is very useful. Other data (e.g., registration numbers, colors, engine numbers, and mileage) could also be used for fraud or other cases of misuse.

This has been corrected; however, the events do provide guidance for us. Even if the business is large and global, there is still the need for SAST and DAST. There are areas and dependencies the programmers will do their best to account for and state it’s good, but it just takes one or two vulnerable areas in all the code to create an issue and RUE (Resume Updating Event). 

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 charles.parker@mielcybersecurity.net 810-701-5511

EHR as a critical target

 

In the enterprise/traditional IT, there are the production networks. These must be up and operating at all costs. Without this in the business operations, not much is produced or sold. As a tool to defend against ransomware and other attacks, there are dedicated backups, policies, and procedures. In a perfect world, these would be checked periodically not only to verify they are present but also the backup data is viable when used.

In hospitals, there are EHRs (Electronic Health Records) used several times a day by the nursing staff for patient care. Among other data, these hold the patients’ prescriptions and dosage, which the nursing staff cannot get wrong. Liberty Hospital in MO recently had a cybersecurity issue with their HER. They were able to get this back up and running. This purely exemplifies the need for HER backups. Imagine you are the administrator for the hospital or rehabilitation center. You get the call at 4pm on Friday from IT. The staff member starts with “We have a problem.” Of the next few sentences, all you remember is “encrypted” and “ransomware”.

While taking time and resources to try the backup, this option is certainly better than finding out the backups are not viable after the attack begins. Wondering if the backups are viable in our present environment is not optimal. 

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Enterprise and Embedded System Cybersecurity Engineering & Architecture

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Vulnerability Management   |   Tabletop Exercises (TTX)   | 

Embedded Systems Architecture   |   Threat Intelligence   | 

TARA (Threat Assessment and Remediation Analysis) |

Supply Chain Cybersecurity Review 

Reverse Engineering

 charles.parker@mielcybersecurity.net 810-701-5511