ECRI Institute Releases Guidance on How to Protect Your Medical Device Systems
The ECRI Institute released new guidance in its article: “Ransomware Attacks: How to Protect Your Medical Device Systems” on May 18, 2017. The report recommends various protective actions for hospitals to take and points to critical differences in the protection of medical device systems as opposed to general hospital systems.
According to the report, ransomware makes data, software, and IT assets unavailable to users. The report describes ransomware as using the encryption of data to hold systems hostage, where the hacker promises to give the victims access to their data if a ransom is paid. One previous ransomware example reported on the Knobbe Medical Device Blog was the WannaCry virus, a ransomware that caused disruptions for several hospitals in the United Kingdom. The International Business Times reported that security researchers had found that the WannaCry ransomware was not limited to computers but also capable of exploiting medical devices.
The ECRI Institute report explains that an IT department can use new security patches for some medical device systems; however, some systems will remain susceptible because they are based on an older version of an operating system and can’t be upgraded or they have not been validated for clinical use with the latest security patches.
The report includes a list of dos and don’ts for quickly responding to emerging threats. The “Dos” mentioned in the report include:
- Identify medical devices, servers or workstations that may be affected.
- Contact the device vendor.
- Request written copies of the manufacturer’s recommended actions for dealing with a current ransomware threat.
The “Don’ts” mentioned in the report include:
- Don’t overreact.
- Don’t install unvalidated patches. Unvalidated patches can make medical devices faulty or inoperable. Ask the manufacturer for documentation of the validation.
The ECRI Institute is a nonprofit organization that has its U.S. headquarters in Plymouth Meeting, Pennsylvania.
IEEE Releases Med Device Cybersecurity Guidelines
Amid myriad media reports about potential vulnerabilities in medical device cybersecurity and the FDA’s efforts to strengthen medical device cybersecurity, the IEEE Cybersecurity Initiative released a report entitled “Building Code for Medical Device Software Security.” The report sets forth a set of elements aimed at reducing the vulnerability of medical device software to malicious attackers. The report employs a loose definition of “medical devices,” ranging from wearable devices to electronic health record systems.
The report highlights the most common types of software vulnerabilities that are exploited by malicious attackers. The bulk of the report proposes standards for five software implementation considerations in ways to (1) avoid, detect, or remove specific vulnerabilities like using memory-safe languages, secure coding standards, and automated thread safety analysis; (2) ensure proper cryptography; (3) improve software integrity; (4) impede attacker analysis or exploitation; and (5) detect malicious attacks. The report further brings up four software design considerations about maintaining service during or restore service after an attack and supporting privacy requirements, but does not propose any standards. Finally, the report notes that the “building code” itself should be consistent in categorizing particular types of attacks and should be maintained over time.
The IEEE Center for Secure Design has also released “Avoiding the Top 10 Software Security Design Flaws,” to give advice on ways to address particular issues including data authentication, authorization, and validation; cryptography; sensitive data classification; and integrating external software components.
Hacking the Human Body – Medical Device Security
Medical device development, as always, is shooting upwards – and it has just reached the clouds.
According to News Medical, Verizon just announced that it received 510(k) clearance for its Converged Health Management medical device (the first time Verizon has applied for and received FDA clearance). Converged is a remote patient-monitoring medical device based in the cloud and according to the press release should be available in late 2013.
Verizon claims that the new healthcare solution resides in its allegedly “HIPAA-ready cloud” and will provide easy access to nearly real-time patient data from connected medical devices. Theoretically, this will allow nearly constant medical monitoring – for example, you’re driving your car and you begin to display pre-stroke symptoms (which you can’t notice), if you’re hooked up to Verizon’s “HIPAA-ready cloud,” your primary care physician can call you to tell you to make your way to the nearest hospital.
The potential benefits of this technology could be very interesting (it doesn’t take much imagination to think of some). However, there are also potentially significant consequences. Clearance to fully wireless based devices was first granted in 2006. The FDA has recognized that, while it grants clearance to wireless and cloud-based medical devices, such wireless devices may present a significant security risk. On August 13, 2013 (a surprising 7 years after the first wireless based device clearance) the FDA issued “Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff,” a guide that attempts to offer “reasonable assurance of safety.” In recognition of the potential for cyber-attacks on wirelessly connected and internet-enabled medical devices (and the patients connected to them), the Center for Internet Security has publicized a new initiative attempting to better secure such systems from cyber-attacks.
All security systems have vulnerabilities which can be exploited – the question is how small they are and how smart a potential attacker must be to find them. Will Pelgrin, the president and CEO of the Center for Internet Security stated that:
[W]e wanted to be ahead of the curve. Instead of waiting for a major incident to happen, we wanted to provide guidance across the board. . . . As these devices become connected to the internet and networks, they become more than just clinical devices, they become IT systems. As we all know, the weakest node on a network can be your entry point for negative consequences that can affect those devices.
The EE Times points out that many medical devices (which can be connected to networks), such as sport watches, monitoring bracelets, heart rate monitors and pedometers, offer valuable information but would not harm the wearer upon malfunction. However, there are many medical devices which are life-sustaining, such as pacemakers, insulin pumps, defibrillators, and neural implants. If these medical devices were “hacked” through inherent weaknesses or through weaknesses in a node of the network to which they are connected, the consequences could obviously be fatal. According to the article, an insulin pump has already been hacked (by a diabetic white hat hacker demonstrating weaknesses in the system).
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