Cyber Security Plan for Software as Medical Device(SaMD) become more competent in accessing, analyzing, communicating, and automation to improve the speed and quality of patient care. However, advancements with technological advances arise new risks and concerns. The risk of threats in both network and software is unavoidable through hackers. To assist manufacturers in developing adequate controls, the FDA introduced guidance for pre-market and post-market cybersecurity to protect patients and users. The primary step to improving device cybersecurity is incorporating processes and procedures into your quality management system. In addition, an appropriate and specific cybersecurity plan should be outlined to ensure the safety and security of the medical device.
The key elements of cybersecurity protection are:
In the early stages of design development and at the initial phase of the risk management process, we need to identify the device’s essential safety and performance requirements to understand and assess the cybersecurity risks.
The implementation of protections must be practicable. Assessing the exploitability and harms as a process assists in determining mitigations and can be carried out to reduce the cybersecurity risk. Protections include:
- Limit Access to Trusted Users and tampering
- Password security – strong password requirements
- Layered authorizations based on user role
- User authentication
- Physical locks on devices and/or communication ports
- Automatic timed methods to terminate sessions
- Ensure Trusted Content
- Restrict software or firmware updates to authenticated code
- Systematic procedures for authorized users to download software and firmware only from the manufacturer
- Ensure proficiency in secure data transfer, use of encryption
Proper implementation of features that allow for security terms to be detected, recognized, logged, timed, and acted upon during regular use. Develop and provide information to the end-user concerning appropriate actions to take upon the detection of a cybersecurity event. For example, prior methods for retention and recovery should be provided to allow recovery of device configuration by an authenticated privileged user.
Response and Recovery
Identifying a cybersecurity vulnerability leads to the establishment of rectification and reporting steps. Emends may involve a software update, bug fixes, patches, “defence-in-depth” strategies to remove malware, or covering an access port to reduce the vulnerability. Report being done as FDA 21 CFR 806.