Connected Health Cybersecurity
Cybersecurity services for the entire product lifecycle of your medical deviceJoin our connected healthcare partners:
Whether you are a start-up or an established medical device manufacturer, Irdeto will ensure your products satisfy today’s cybersecurity requirements in the world’s largest markets.
Medical device manufacturers need intellectual property protection, by building secure products.
Post-Market Cybersecurity
- Legacy IoMT Device Protection
- Software Bill of Materials (SBOM)
- Embedded Endpoint Security
Consulting Suite
- Medical device startups
- Threat Modeling
- Penetration (Pen) Testing
- Advisory Services
Consulting Suite
- Medical device startups
- Threat Modeling
- Penetration (Pen) Testing
- Advisory Services
Software Security
- License Management
- IP Protection
Public Key Infrastructure (PKI)
- Medical Device Certificates
- Code Signing
Public Key Infrastructure (PKI)
- Medical Device Certificates
- Code Signing
Frequently asked questions
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?
- By 2025, the medical device market will completely transform due to increased connectivity, the proliferation of IoT, and AI technology across medical devices and platforms
- The prevalence of remote care models will result in a new paradigm reality in the continuum of care
- New business and care delivery models will drive the change with therapy effectiveness, and resource efficiency will be the outcome of that transition