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As medical technology advances, medical devices become increasingly complex and often rely on embedded software to function.
These software-based devices are now required to meet strict regulations set by the Food and Drug Administration (FDA) to ensure their safety and effectiveness.
One critical aspect of this regulation is embedded software security for medical devices.
In this blog post, we will explore FDA medical device requirements and new regulations starting in 2023.
FDA Regulations for Medical Devices
The FDA is responsible for ensuring that all medical devices on the market are safe and effective for patents, including software-based medical devices that are becoming more prevalent in the industry. The FDA has set guidelines and regulations for developing, testing, and approval of these devices to ensure they meet specific quality standards.
When asked about safety for medical devices, most people think of hardware, but one of the critical requirements for medical devices is the assurance of embedded software security. From MRI machines and heart rate monitors in hospitals to pacemakers and drug-infusion pumps inside patient bodies, these devices are expected to protect patients from harm. However, if not coded securely – they can open up patients and hospitals to hackers.
The FDA requires that all software-based medical devices are designed and developed to ensure the device's safety, effectiveness, and reliability.
But what does this mean?
This means that when developing embedded software, medical device manufacturers are now being regulated to "design, develop, and maintain processes and procedures to provide a reasonable assurance that the device and related systems are cybersecure."
In March of 2023, the FDA began requiring cybersecurity plans for medical device submissions (along with SBOM), including "a plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities, and exploits." And in October 2023, the FDA will begin refusing to accept medical devices and related systems over cybersecurity concerns.
The regulation applies to all medical devices that are connected to or rely on a network and requires device manufacturers to:
- Conduct a risk assessment to identify and assess the security risks associated with their devices
- Implement security controls to mitigate the risks identified in the risk assessment
- Provide the FDA with a software bill of materials (SBOM) that lists all the software components that make up the device
- Monitor for and address security vulnerabilities promptly
- Have a plan in place to respond to security incidents
Read More: FDA Will Refuse New Medical Devices for Cybersecurity Reasons on Oct. 1
How To Secure Embedded Software for Medical Devices
Medical device manufacturers must adhere to specific design controls to meet these stricter requirements. In addition, manufacturers must ensure that the software used in their devices is secure and protected against unauthorized access or modifications.
The FDA has published guidance documents that outline the best practices for ensuring embedded software security in medical devices. These guidelines provide a framework for manufacturers to follow when developing and testing software-based medical devices.
Some of the key recommendations include:
- Implementing a risk-based approach to software design and testing that identifies and mitigates potential security vulnerabilities.
- Conducting thorough testing and validation of the software to ensure that it functions correctly and that it is secure.
- Ensuring that the device's software is designed to be resilient to potential attacks and that it can detect and respond to security incidents.
- Establishing processes for monitoring and reporting potential security incidents and taking appropriate corrective action when necessary.
- Conducting ongoing testing and validation of the software throughout the device's life cycle to ensure that it remains secure and effective.
Secure Coding Training for Embedded Software Development
A critical component to passing FDA regulations and protecting healthcare patients is to ensure your developers are all up to date with the latest secure coding training for embedded software development.
Security Journey's AppSec Education Platform offers comprehensive security training for embedded software.
Embedded Development Path includes lessons that cover a wide range of topics, from threat landscape and secure coding standards and techniques to practical guidance on implementing security measures throughout the development lifecycle.
Some examples of Security Journey's Embedded Development lessons include:
- Embedded Threat Landscape
- Fundamentals of Secure Embedded Development
- Secure Firmware Development Lifecycle
- Secure Coding Standards for Embedded Software
- Embedded Security Toolchain
- Threat Modeling Embedded Systems
- Secure Communications with Embedded Systems
Are You Protecting Your Customers?
Embedded software security is a critical aspect of FDA medical device requirements. Medical device manufacturers must ensure that their software-based devices meet specific quality standards and are secure against potential security risks.
By adhering to the FDA's guidelines and implementing best practices for embedded software security, manufacturers can develop safe and effective medical devices that meet the needs of patients and healthcare providers.
