Applying the Latest FDA Cybersecurity Regulations Within IoMT

Experts predict that by the end of 2024, the number of connected medical devices worldwide will reach 94.9 million. While these advancements promise to enhance patient care and reduce treatment expenses, they also pose significant challenges, such as vulnerabilities to cyberattacks, system failures, and other negative consequences related to the reliability and security of these devices. For example, a hacker could take control of a patient’s critical medical device, or a ransomware attack could shut down a hospital’s entire network, stopping vital medical services.

In this article, we will explore the concept and usage of advanced medical devices known as Internet of Medical Things and provide an overview of the latest FDA regulations, focusing on healthcare cybersecurity measures. Additionally, we will outline the benefits of these regulations and provide key steps to ensure FDA compliance for medical devices.

What is IoMT? 

The Internet of Medical Things (IoMT) is a subfield of the Internet of Things (IoT) that focuses on healthcare. It connects medical devices using sensors, software, and the internet to share data. 

IoMT includes a large variety of advanced medical equipment used in daily patient treatment. Thanks to IoMT, healthcare professionals are able to provide more accurate diagnoses, and convey important information about each patient’s health.

Why is IoMT important?

Among the many reasons why IoMT is important, some of the most crucial uses include tracking medication, managing hospital beds, providing smart diagnostics, and enabling telemedicine. 

By connecting devices in the medical field, information can be stored in the cloud, making it easier to access and share patient records while continuously monitoring health conditions.

Where is IoMT being used?

Here are some examples of IoMT solutions already in use worldwide:

Wearables

Wearable medical devices are tools worn on the body that include trackers, sensors, and other tools to monitor biometric data and physical activity, sending real-time alerts about specific conditions. These devices can be in the form of necklaces, watches, glasses, and even clothing.

Epidemiological surveillance

IoMT can track health data globally, identifying trends and potential outbreaks. This technology is crucial for epidemiological surveillance, helping professionals, governments, and organizations in predicting, combating, and treating diseases.

General health analysis

Beyond combating epidemics, IoMT helps monitor general health conditions like diabetes and cardiovascular diseases. By analyzing patient data, healthcare professionals can create average profiles and develop strategies to improve overall public health.

Robotic surgery

Robots can now mimic human movements during surgery and even enable telesurgery with a local support team. They also serve as valuable teaching tools, significantly improving the healthcare network.

Patient monitoring

IoMT devices enable remote monitoring and telemedicine, reducing the need for travel and ensuring continuous care for patients with chronic conditions. In emergencies, these devices can automatically alert medical services, improving patients’ quality of life and providing peace of mind for families and doctors. Additionally, IoMT can assess mental health by regularly analyzing a patient’s mood and physical condition, helping to diagnose depression and other psychological issues.

The latest FDA regulations

The Food and Drug Administration (FDA) is a federal agency under the Department of Health and Human Services that ensures the security of a set of products, such as:

• Human and veterinary drugs
• Biological products
• The nation’s food supply
• Cosmetics
• Radiation-emitting products
• Medical devices

On September 27, 2023, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” was released by the FDA. 

5 key updates in the FDA’s new cybersecurity guidance for medical devices

The new FDA guidance, while similar to the April 8th, 2022 draft, includes several significant updates listed below.

1. New substantive sub-sections in security risk management

In the new guidance, the FDA added two sub-sections to the original IoMT security risk management section:

• Cybersecurity risk assessments

This section focuses on the exploitability of vulnerabilities within a device or system and the methods for scoring risks pre- and post-mitigation.

• Interoperability considerations

This section addresses healthcare cybersecurity issues arising from interfaces with other medical devices, healthcare infrastructure, and general-purpose computing platforms.

2. Appendix for documentation in premarket submissions

A new appendix outlines specific documentation elements recommended for inclusion in premarket submissions, also applicable to IDE (Investigational Device Exemption) submissions.

3. Definitions of cybersecurity terms

The guidance includes a new appendix defining key cybersecurity terms adapted from recognized sources like NIST, ISO/IEC, and CNSSI 4009-2015.

4. Secure Product Development Framework (SPDF)

As recommended in the 2022 draft, the FDA continues to advocate for the implementation of a “Secure Product Development Framework” (SPDF), which focuses on:

• Security risk management
• Security architecture
• Cybersecurity testing

The guidance refers to IEC 81001-5-1 as a possible framework for the SPDF and recommends including an IoMT security risk management report in premarket submissions to demonstrate device safety and efficacy.

5. Considerations for interoperability

The new guidance section on interoperability considerations advises manufacturers to:

• Implement cybersecurity controls to ensure safe and effective information exchange.
• Assess the need for additional security controls for common technology and communication protocols like Bluetooth and network protocols.
• Reference the FDA’s guidance on design considerations and premarket submission recommendations for interoperable medical devices.

Benefits of complying with FDA requirements

The FDA’s guidelines outline the essential responsibilities for medical device manufacturers using off-the-shelf (OTS) software, emphasizing the importance of maintaining cybersecurity. Here’s how following these guidelines can benefit manufacturers:

Manufacturers understand their responsibilities

By adhering to the FDA guidelines, manufacturers can ensure their networked devices remain safe and effective, even when using OTS software.

Maintains devices’ safety and effectiveness

Manufacturers must take proactive steps to protect their devices from vulnerabilities in OTS software. Ensuring medical device cybersecurity is crucial for companies as these vulnerabilities can compromise the safety and effectiveness of medical devices.

Maintains standard of data quality

The FDA’s Quality System rule requires manufacturers to investigate quality data sources and address or prevent quality issues. This rule mandates that software updates and fixes be validated to ensure they meet user needs and perform reliably.

Streamlined software updates

Most software patches are considered design changes that do not require prior FDA approval. This allows manufacturers to implement necessary updates quickly while ensuring they comply with the Quality System rule by validating these changes.

Quality control process is significantly improved

Manufacturers are encouraged to create and follow a structured plan for implementing software modifications. This approach ensures that all changes are well-documented and validated, enhancing the overall quality control process.

Steps to ensure FDA compliance for medical devices

While there is no universal solution, implementing tailored security practices and maintaining awareness of device vulnerabilities can significantly enhance the protection of networked medical devices and the sensitive data they contain.

The FDA’s cybersecurity guidelines for networked medical devices outline essential measures to manage and enhance device security. 

Key steps include: 

• integrating robust security features directly into devices
• minimizing access by enabling all available access-control tools 
• replacing default usernames and passwords with unique credentials 
• customizing security protocols for each device based on its specific needs and the type of data it handles
• maintaining up-to-date firmware to prevent unauthorized access 
• encrypting data stored on devices
• securing communication channels to protect against network eavesdropping

To sum it up

Keeping up with FDA cybersecurity regulations for medical devices can be overwhelming. 

With strict requirements on healthcare cybersecurity, safety, and effectiveness, ensuring compliance with the FDA is crucial but often complex. This is where Kanda steps in to simplify the process.

Whether you need advanced cybersecurity or integrated systems to manage device security, Kanda has you covered. Our goal is to make your compliance journey as easy and stress-free as possible, so you can focus on delivering high-quality healthcare solutions.

Ready to simplify your journey to FDA compliance? Talk to our experts today and see how Kanda can help you stay on top of regulations with ease.