How Offline QR Authentication Enhances Medical Device Cybersecurity
As medical technology evolves, so do the cyber threats that target it. In this landscape, authentication methods must be both robust and adaptable, even in offline environments. One particularly innovative solution is the use of QR-based authentication powered by digital certificates. In this blog post, we’ll explore a real-world implementation of this strategy in a […]
Medical Device Cybersecurity: Regulations & Best Practices
Medical device cybersecurity is crucial for safeguarding connected healthcare systems against ever-evolving cyber threats. As more medical devices integrate with hospital networks and rely on software, the risk of cybersecurity vulnerabilities increases significantly. Ensuring compliance with FDA, MDR guidelines, and international standards like ISO 27001 is not just about regulatory fulfillment about protecting patient safety […]
What is IoMT? Internet of Medical Things explained
The Internet of Medical Things (IoMT) are medical devices that can communicate over the Internet to transmit patient information. It is the fastest and most optimal way to make hospitals more efficient, provide doctors with the most relevant patient information and speed up medical processes. Benefits and impact of IoMT on healthcare IoT in healthcare […]
An overview of cybersecurity regulation/guidance’s evolution in the medical industry
Introduction The last decades have been surrounded by many cybersecurity attacks around the world, many of them in Hospitals or Medical Devices. For example, on September 12th, 2022, the FBI warned that many medical devices with outdated software could be targeted. For this reason, many Regulatory Organizations, such as the Food and Drug Administration (FDA) […]
The transition period for the latest EMC standard for medical devices, IEC 60601-1-2 4.1, will end soon
Introduction In the article below, we will cover the importance of keeping up to date with regulatory standards. A reminder of the final transition date for the EMC collateral norm in the IEC 60601 medical device standard and a brief introduction to the most prominent changes. FDA – Electromagnetic Compatibility (EMC) A medical […]
81001-5 a simple overview
Introduction The scope of this post is to give an overview about the IEC 81001-5 which is a new compulsory regulation, that the MedTech manufacturer shall take into account for their new health software and for legacy device that should be recertificated under the new MDR. This post is part of a series which will […]
SECURING API’s: Best Practices and Strategies
Introduction As more and more applications are moving to the cloud, the use of APIs (Application Programming Interfaces) is getting more and more popular. APIs is a great way to provide access to our resources, information and services to other applications making it easier to build complex applications with many features, but they also present […]
How to Implement a Secure Bootloader in an Embedded Device (Case Study)
Example in RT1050 EVK This is the continuation of the previous post. To test all this theory into a practical case, we are going to use and RT1050 evaluation board. As application we will use the hello_world example, as bootloader we will use the SBL (Secure Bootloader) project and to generate a signed firmware we […]
How to Implement a Secure Bootloader in an Embedded Device
IOT (Internet of Things) is quite a thing nowadays, from small home devices such as lamps or coffee machines to bigger home appliances like washing machines or refrigerators. All devices tend to be connected to internet, you can now control them when you are outside your home or get different notifications on your phone. In […]
Cyber Security Standards: IEC 81001-5-1 and IEC 60601-4-5
The aim of this article is to give an overview about the main standards which regulate the cyber security of a Medical Device, they are: IEC 80001-1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software – Part 1: Application of risk management. IEC 81001-5-1 (not published): […]