Cybersecurity in the Medical Device Industry

As medical devices become more advanced and the Software as a Medical Device (SaMD) industry booms, it is crucial to make sure your medical devices are cyber-secure. Like all technologies, anytime a medical device includes software, vigilance is required to become vulnerable to cybersecurity threats and attacks. The healthcare industry has long been the target of cyber-attacks because of their vast amounts of health information and data such as patient health, product performance, or data from other devices connected to the same network.

Why is healthcare a target for cybersecurity attacks?

  • Private patient information is worth a lot of money.
  • Healthcare facilities are a target because they act as storage for an immense amount of confidential patient data, which can be sold for large sums of money.
  • Outdated technology means the healthcare industry is unprepared for attacks.
  • Because of budget limitations and the hesitance to learn/teach new systems, many healthcare facilities have outdated technology.
  • Medical devices are an easy entry point for attackers, as most medical devices are legacy without a security layout.
  • Medical devices and SaMD play a critical role in modern healthcare.  But for those in charge of online security and patient data protection, new devices open up more entry points security breaches.
  • Healthcare staff is not educated about online risks.
  • Because of time, budget, and resource restraints, medical professionals are not trained to deal with online threats. It is a difficult task for healthcare industry staff to be fluent in cybersecurity best practices.
  • The number of devices used in hospitals makes it difficult to stay on top of security.
  • Healthcare organizations are responsible for large amounts of patient data and, more often than not, an extensive network of medical devices, all acting as potential security threats.


What can medical device developers do?

Strategies for improving cybersecurity

Due to the rise of cybersecurity threats and the financial impact of data breaches, medical device manufacturers are incorporating strategies to ensure that their medical devices and, therefore, organizations remain securely protected. Developers should integrate effective cybersecurity plans during their early stages of development and maintain security throughout the device lifecycle. An effective plan should include both premarket and postmarket cybersecurity phases and risk management from device conception to disposal to help prevent costly changes or delays downstream.

According to the International Medical Device Regulatory Forum, medical device manufacturers can improve their cybersecurity by implementing the following:

Secure Communications: The manufacturer should consider how the device will interfere with other devices/networks, communicate with devices supporting a less secure communication, and prevent unauthorized access/modification when it comes to data transfer to and from the device.

Data Protection: The manufacturer should consider whether a level of protection or encryption is required for data stored or transferred on the device and if the device needs confidentiality risk control measures.

 Device integrity: The manufacturer should consider risks that affect the device’s integrity, evaluate the system-level architecture to look for necessary design features, and consider anti-malware controls.

User Authentication: The manufacturer should consider user access controls that determine who can use the device or grant privileges to user rolls.

Software Maintenance: The manufacturer should consider the communication process when implementing regular updates, how the software will be updated or controlled, how it will update the device to secure it against other vulnerabilities, the required connections to conduct updates, and the use of code signing for the authenticity of the connection. 

Physical Access: The manufacturer should consider implementing controls that prevent access to the device by an unauthorized person. 

Reliability and Availability: The manufacturer should consider inputting design features that allow the device to detect, resist, respond, and recover from cybersecurity attacks.


In addition to these recommendations, medical device companies should stay informed on new cybersecurity strategies and practices. It is vital in preserving and protecting devices along with the sensitive health data gathered by these devices. In the long run, this will safeguard patient information and fortify device organizations. Medical device companies are responsible for ensuring that their devices are secured and equipped with the proper cybersecurity. MedDev Soft has security experts that can develop secured software, advise you on the vulnerabilities of your software device and guide you with mitigation strategies. MedDev Soft offers secured software development services and support in both Pre-Market and Post-Market . Cybersecurity regulations and finds the best approach to take with your device.

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