FDA Cybersecurity Guidance Overview
FDA cybersecurity guidance is essential to help ensure that medical devices need to be secure. That's why there are specific guidelines for medical devices. Here we explain what are the FDA cybersecurity guidelines are and provide guidance for medical devices.
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FDA Cybersecurity Guidance for Medical Devices
The FDA regulates the safety, efficiency, and security of medical devices. This includes FDA guidance on cybersecurity. Medical devices now connect to the internet, hospital networks, and other medical devices. This can lead to FDA cybersecurity vulnerabilities.
Medical devices are integrated into the Internet of Things (IoT). This means that the software in medical devices is now vulnerable to cyberattacks. 93% of healthcare organizations reported a data breach in the past three years. And, the average cost of a data breach is $423 per record or nearly $4 billion in 2019.
That means you need to follow FDA cybersecurity guidance to ensure that your medical devices are secure.
📕 Related Resource: For guidelines on healthcare information exchange, read about FHIR.Back to top
What are the FDA Cybersecurity Guidelines?
The FDA cybersecurity guidelines outline how to keep medical devices secure.
In 2018, the agency published a draft of its latest FDA cybersecurity guidelines. The guidelines help developers ensure that their medical devices are safe and secure. FDA cybersecurity guidance also helps devices meet the requirements for clearance.
The FDA cybersecurity guidelines for medical devices include:
- Provide documentation related to design controls. Specifically, documentation on design validation, software validation, and risk analysis.
- Ensure that all incoming data is not modified in transit or at rest. And, that it is compliant with the specifications.
- Use industry-accepted best practices. These maintain and verify the integrity of code while it's executed by the device.
- Design the medical device to detect and respond to cybersecurity risks. This includes cybersecurity updates and patches. It also includes emergency workarounds.
- Implement medical device features that protect critical functionality and data. Even when the device’s cybersecurity is compromised.
Establishing an effective cybersecurity process can be difficult. Consult the FDA's medical device cybersecurity fact sheet, too.Back to top
How to Follow FDA Cybersecurity Guidelines?
Complying with guidelines is only one aspect of secure medical device development. There are several practices that support cybersecurity. The following is the most relevant for medical device cybersecurity.
Use a Risk-Based Development Strategy for FDA Cybersecurity Guidelines
Under the new guidelines, a medical device will be classified as either:
- Tier 1: Connected devices that could greatly impact patient care if they were compromised by a cyberattack.
- Tier 2: All other devices that cannot be classified as Tier 1.
For both tiers, software development teams will need to:
- Conduct thorough risk assessments to identify vulnerabilities in the code.
- Understand the potential impact that each vulnerability could have.
- Address security vulnerabilities.
- Use design controls to ensure security.
- Establish data integrity requirements.
Risk-based practices should be a part of the development process from the beginning. That way, risks are addressed as they arise rather than after the device has been released.
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FDA Cybersecurity Guidance: 5 Phases of a Secure Development Lifecycle
The secure development lifecycle (SDL) is a software development process. SDL reduces software maintenance costs and increases software security.
The five phases of a standard SDL are:
In the Requirements Phase, security best practices need to integrate into the product. These practices could include industry standards, coding standards, or historic data.
The Design Phase often involves threat modeling. This examines how a feature or system could be compromised by cyberthreats. Based upon each of those potential threats, solutions are then included in the design.
The Implementation Phase simply involves writing the source code. Often secure coding guidelines — such as MISRA and CERT — are used to help define what is expected of the code. And using SAST tools helps identify potential vulnerabilities in the source code.
The Test Phase involves:
- Security functional test plans.
- Vulnerability scanning.
- Penetration testing.
The Release/Response Phase simply involves the device being released. Any problems are addressed as succinctly and efficiently as possible.Back to top
Use SAST Tools to Enforce FDA Cybersecurity Guidance
Static code analyzers — like Klocwork — are an essential SAST tool. It ensures that there are no gaps in a medical device’s cybersecurity. And it demonstrates compliance with FDA cybersecurity guidance.
Static code analyzers inspect your source code for potential quality and security issues.
During these inspections, the tool will identify:
- Programming errors.
- Coding standard violations.
- Security weaknesses.
Klocwork helps you apply and enforce coding guidelines — such as CERT and CWE. This ensures that your medical devices and software are protected against cyberthreats. And it ensures your projects stay in compliance with FDA cybersecurity guidelines.
Medical device developers use Klocwork to improve cybersecurity by:
- Detecting code vulnerabilities, compliance issues, and rule violations earlier in development.
- Accelerating code reviews/manual testing efforts.
- Enforcing industry and coding standards.
- Reporting on compliance over time and across product versions.