Why is Cybersecurity Important for Medical Devices?

The increasing connectivity of medical devices to wearables and medical applications or software has exposed devices to cybersecurity threats and attacks. Any vulnerabilities in medical devices allow unauthorized users to access and control devices, which can lead to a serious risk to patients, specifically in class B and C medical devices. Hence, healthcare organizations, regulators, and medical device manufacturers are concerned about the potential impact on clinical care and patient safety.

Why cybersecurity for medical devices is the need of the hour?

Critical functionality

Medical devices control the life of the patient. It has critical functions and sensitive data

Replication

Medial devices are mass-produced in thousands or millions of identical devices. One successful attack may be replicated to multiple devices

Long lifecycle

The life cycle of the medical device ranges from 15 to 20 years. So, developing a device that meets the security needs of the next two decades is a big challenge

Siloed

End-user cannot monitor the device’s security or make changes easily

Due to the rise of cybersecurity threats and data breaches, medical device manufacturers should understand the risks associated with medical device security and consider implementing effective cybersecurity practices while designing and developing medical devices. Let’s understand cybersecurity attacks and possible resolutions: 

• Software Attacks: Software attacks are carried out on the system by executing a custom piece of code known as Malware on the system which leads to custom (unexpected) behavior of the device.
• Firmware clone
  • Overview/Use-case: An attacker can clone medical device hardware using reverse engineering and can also clone firmware directly from flash media
  • Risks:
    • Duplication of device
    • Reverse engineering of the firmware
  • Resolutions:
    • Design firmware licensing mechanism robust enough so that it’s hard to bypass
    • Use data protection mechanisms and encrypted firmware
• Brute Forcing
  • Overview/Use-case: The secure medical device asks for authentication before accessing device functionality for cloud services and/or human interface (HMI). The attacker systematically checks all possible passwords and passphrases until the correct one is found
  • Risks:
    • Access to device services and user data
  • Resolutions:
    • Limit the number of login trials
    • Increase delay between an authentication trial
• Firmware update
  • Overview/Use-case: Medical devices aftermarket launch are periodically updated by offline media (like USB, OTG cable) or over the internet. This allows the attacker to update custom or corrupted firmware(malware) on the device
  • Risks:
    • Full/Partial access to the device
    • Device firmware corruption
  • Resolutions:
    • Design/implement a Secure firmware update mechanism using encryption and signature
• Communication stack (IoT based devices)
  • Overview/Use-case: Medical devices use BLE, Wi-Fi, or any RF technology for communication over mobile applications or IoT-based software. Attackers may use technology loopholes and modify communication data
  • Risks:
    • Unexpected system behavior based on data modification
    • Unauthorized sale and/or blackmail of personal data
  • Resolutions:
    • Use a firewall for internet access
    • Use latest and secure technology; for example, in the case of Bluetooth, use v4.1 onwards
    • Use strong pairing and authentication mechanisms for starting communication and thereafter use encrypted data for communication
• Sensitive firmware and data
  • Overview/Use-case: Some parts of the firmware need special protection: for example the cryptographic algorithm or a third-party library. Besides, selected data may need enhanced protection if they are considered as valuable assets (cryptographic keys). The internal memory content must be protected against external accesses (such as communication interfaces) and internal accesses (other software processes). The memory attributes like read and write access for different memory segments and the firewall are the main protections for process and data isolation
  • Risks:
    • Sensitive firmware copy or data theft
  • Resolutions:
    • Use Execute-only access right (XO)
    • Use Memory protection unit
    • Use Secure area
    • Use Encryption of external memory