The evolution of IoMT and Connected Medical Devices:
In recent years, the healthcare industry has witnessed a significant shift towards interconnected medical devices, driven by the Internet of Medical Things (IoMT). As the use of these devices becomes more prevalent, the need for robust cybersecurity measures to protect patient data and ensure patient safety has never been more critical.
In this third installment of our series on FDA cybersecurity updates, we explore the US Cyber Trust Mark and its potential implications for the security of IoMT devices in healthcare. In this series, we have tried to cover the entire roadmap of a medical device right from FDA cybersecurity requirements during PMA or 510(k) submissions, cybersecurity recommendations by FDA post-market and now this, the potential of Cyber Trust Mark- another initiative under Omnibus.
A little background before we move towards what if means for the IoMT and Medical Device Companies:
The Birth of the US Cyber Trust Mark: In July 2023, the Biden-Harris Administration introduced the US Cyber Trust Mark, a cybersecurity labeling program designed for Internet of Things (IoT) devices. The primary goal of this initiative, proposed by Federal Communications Commission (FCC) Chairwoman Jessica Rosenworcel, is to empower consumers with cybersecurity assurances when purchasing smart devices for their homes.
This labeling program, similar to the well-known Energy Star program for energy-efficient appliances, is set to feature on devices that meet strict cybersecurity standards established by the National Institute of Standards and Technology (NIST). It will provide consumers with the confidence that the devices they choose adhere to cybersecurity criteria such as strong default passwords, regular software updates, and incident detection capabilities.
Implications of Cyber Security mark on Healthcare:
While the US Cyber Trust Mark program initially targets consumer IoT devices, it has the potential to extend its influence to the realm of healthcare, particularly the Internet of Medical Things (IoMT). This development aligns with the growing need for enhanced security in healthcare, given the increasing use of IoMT devices and telehealth solutions.
IoMT devices, just like consumer IoT devices, collect sensitive patient data and are prone to cyberattacks. The consequences of a breach in the healthcare sector can range from minor inconveniences to critical patient harm, including life-threatening injuries and even patient deaths. Therefore, establishing a trust mark for IoMT devices becomes a crucial step in ensuring patient safety.
Streamlining Security Assurance Processes:
The introduction of the US Cyber Trust Mark marks a shift towards a more active government role in enforcing cybersecurity standards. It signifies the government’s commitment to providing consumers with a reliable indicator of device security, which is a positive development for both consumers and the industry.
While the initial focus is on consumer devices, there’s a growing expectation that IoMT devices will also benefit from this program. As the government refines the program and expands its scope, IoMT devices could see some form of certification as well.
A Complex Landscape that will require industry and technical expertise:
It’s important to note that managing the cybersecurity of IoMT devices is more complex than consumer IoT devices. The lifespan of healthcare devices, such as MRI machines, can span decades, whereas consumer devices like fitness trackers have a shorter lifespan. Additionally, the healthcare industry must adhere to stringent compliance requirements and validation controls.
Thus, while the government prepares for the launch of Cyber Trust market and its certifications, medical device companies must also gear up their Cybersecurity readiness as well as cybersecurity and interoperability testing along with design and security V&V services.
Once these protocols and changes are established, the US Cyber Trust Mark can streamline processes and serve as an additional tool for healthcare delivery organizations (HDOs) to confidently select secure IoMT devices like yours. The certification could help HDOs identify and procure devices with stronger security, ultimately expanding their fleets with greater speed and confidence with your devices.
The way forward:
The future of IoMT security is taking shape with the introduction of the US Cyber Trust Mark. While the government plays a role in setting standards and providing certifications, organizations must continue to take charge of device management and establish internal processes to address security vulnerabilities effectively.
As the program develops and its influence expands, medical device manufacturers and healthcare organizations should closely monitor government certification requirements. By doing so, they can ensure that more secure consumer and hospital-grade devices reach the market quickly.
The US Cyber Trust Mark is a positive development for IoMT security, offering consumers a reliable indicator of device security and potentially transforming the healthcare industry’s approach to cybersecurity.
Irrespective whether you are a start-up looking for FDA approval or an established medical device company trying to establish trust, we at AIMDek can help with your regulatory documentation, V&V Testing as well as Cybersecurity readiness! To understand how we can custom tailor our MedTech service for your organization; connect with our MedTech experts today. Also, don’t forget to inquire about our no-obligation architecture review when you schedule the call!