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Connected Health

A complete medical product security suite for every stage of the lifecycle ensuring patient safety and broad regulatory compliance

Who do we serve?

The more connected devices out there, the larger the attack surface and corresponding cybersecurity risks. Designing security into your devices and maintaining proactive post-market security risk management are not simple tasks, so why not leave them to professionals? 

Whether you are a start-up or an established manufacturer of medical devices, Irdeto will ensure your products satisfy today’s cybersecurity requirements in the world’s largest markets. 

And if you are an established manufacturer, don’t reinvent the wheel, start growing your business now. 

Protecting large numbers of connected devices across large hospital systems is already a complex endeavor. Patient data theft and ransomware are two of the largest threats HDOs face daily. Thankfully, there are new solutions that can drastically improve your security posture. 

Irdeto will help you get the visibility you need to immediately identify existing and new vulnerabilities in your healthcare systems and arm you with the threat intelligence to prevent intrusion and exploitation.  

Stay proactive, manage ongoing risks and empower your organization to defend its products against cyberattacks. 

One trusted partner to navigate you through the murky waters of an increasingly complex cybersecurity environment

The more effort you invest in getting your cybersecurity right before developing a product, the more costs and trouble you’ll spare yourself in the long run.  

  • Make sure your product is resilient for any future attacks. 
  • Make sure all your devices conform to the latest cybersecurity FDA/MDR requirements. 
  • Perform software architecture reviews, penetration testing and threat modeling. 
  • Protect your medical device against hacking and reverse engineering. 

More third-party components in your medical product means more security risks. While the threats evolve over time, your devices do not. 

  • Monitor threats, assess the blast radius of exploits and take appropriate actions.  
  • Adapt to new threats and renew security barriers throughout your product lifecycle. 
  • Ensure the confidentiality, integrity and availability of user data, device operations and critical functions. 
  • Monitor your SBOMs and get expert assessments for potential new vulnerabilities. 

Why Irdeto?

Our wide spectrum of cybersecurity technologies is used by over 400 clients across the globe.

50+ years of expertise

6+ billion devices & apps secured

 361 patents

Our partners

Frequently asked questions

Got questions? We have answers!

What are the regulatory requirements for medical devices and software?

Medical device regulations are complex, and, depending on where you will be marketing your device, you will need to meet regulations from the governing bodies. In the European Union, the date of application for the new EU MDR was May 26, 2021. These new regulations are intended to make sure medical devices and software are safe and will perform their intended function. The devices and software must be approved by accredited notified bodies in order to be deemed safe and to be marketed in the EU.

In the United States, the Food and Drug Administration (FDA) provides similar pre- and post-market guidance for medical devices that inform the design, development and commercialization of new devices and software.

What is SBOM and why is SBOM important for medical devices?

SBOM stands for Software Bill of Materials. Consider it the list of every ingredient that is part of a medical device ecosystem, including third-party components. There is an ongoing global effort to require SBOMs for all medical devices and to create structure and uniformity around the documentation and sharing of SBOMs for increased safety of connected devices.

How is Software as a Medical Device (SaMD) different from medical device software?

Software as a medical device (SaMD or SaaMD) is software or a mobile app that is created to fulfill on one or more medical function including treating, diagnosing, curing, mitigating, or preventing disease. It is not associated with a physical device. Medical device software – or Software in a Medical Device (SiMD) is software that works with a physical device and does not have a medical purpose by itself. Both are vulnerable to cyber attacks, but given that speed at which SaMD development happens, it has its own set of cybersecurity needs.

Why is cybersecurity important for early-stage companies?

  • A recent Irdeto has found that 82% of healthcare organizations have experienced at least one IoT-focused cyberattack since 2018, with 30% of attacks resulting in compromised end-user safety
  • By 2023, 68% of all medical devices will be connected, and they become the new threat vectors to access hospital networks
  • Other than hackers try to steal data, as a side effect of the process of intrusion or even as a direct target, cyberattacks to medical devices can put patient and user safety at serious risk

How can MedTech start-ups ensure compliance with FDA Cybersecurity and EU Medical Device Regulations?

Healthcare 4.0 redefines continuum of care through connecting people, processes and platforms and empowering the healthcare ecosystem to access data-driven insights in real-time. As connectivity in medical and healthcare environments proliferates, the FDA has proposed more robust cybersecurity measures for IoT (Internet of Things) - enabled medical devices to protect patient safety and maintain product functionality.

What is the future of connectivity, IoT, and medical devices?

Want to learn more about how Irdeto can help you protect your medical device from attacks?

Contact us

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