#connectedhealth Archives

Medical device security management – what you need to know

by Steeve Huin | Oct 13, 2022 | Healthcare

There is little doubt that the future of healthcare will rely more on always-connected devices, Software as a Medical Device (SaMD), cloud computing and vast amounts of data processing. However, moving medical devices outside of the security provided within a managed hospital network and placing them at our homes increases the risk of cyberattacks. So, how manufacturers can face the ongoing challenge of ensuring security of their devices and the ever-increasing pressure by the regulatory bodies?

H-ISAC and AAMI newsflash: What’s the industry saying?

by Jonathan Beverley | Jun 15, 2022 | Healthcare

The H-ISAC MedTech conference and AAMI eXchange brought us plenty of insight into the key practices within the MedTech field. Here are our top takeaways.

Threat modeling of medical devices made easier

by Steeve Huin | Dec 22, 2021 | Healthcare

Threat modeling is a well-established practice within the cybersecurity industry but is still relatively new within the medtech space, so many are unsure where to start and exactly how to do it. Fortunately, the MITRE Corporation, in conjunction with the FDA and other industry leaders, have just released a very helpful resource.

What’s in the updated FDA’s draft guidance for medical device software in premarket submissions?

by Steeve Huin | Nov 18, 2021 | Healthcare

Sixteen years after release of Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the US Food and Drug Administration (FDA) has published a draft version of an updated Content of Premarket Submissions for Device Software Functions. What’s in the document and why should it concern you?

Are you ready for the new EU MDR cybersecurity requirements?

by Shriekanth Iyer | May 25, 2021 | Healthcare

Sweeping new medical device regulations are about to go into effect in Europe. Among the changes is the increased emphasis on cybersecurity. Whether it’s existing medical devices and software or new ones under development, cybersecurity must now be top of mind for MDMs at all stages of development and the earlier the better.

88% of MedTech Executives Not Prepared for a Cyberattack

by Steeve Huin | Feb 8, 2021 | Healthcare

Medical and healthcare technology is developing at a rapid pace. The COVID-19 pandemic accelerated the connected medical technology revolution with telehealth and remote patient monitoring prioritized as never before.

What is a trustworthy device? How to ensure they are trustworthy and why it’s important?

by Steeve Huin | Sep 1, 2020 | Healthcare

There are stringent criteria medical devices must meet to be classed as trustworthy, alongside the software within them – but what does that consist of? Learn more about the importance of trustworthy medical devices in part one of our Trustworthy Devices blog series.

Telemedicine mobile app data security – why it’s essential in today’s connected world

by Steeve Huin | Aug 7, 2020 | Healthcare

Throughout our Telehealth and Telemedicine blog series, we looked at the differences between connected health technologies, types of connected medical devices, the basics of data security and privacy, key HIPAA compliance regulations, why app developers and vendors should implement strong cybersecurity measures to meet these regulations and the possible repercussions that could occur if they aren’t implemented. In this blog, we review what this all means.

What are the types of connected medical device data? Introduction to data governance and why privacy and security are essential in Telehealth

by Steeve Huin | Jun 9, 2020 | Healthcare

With digital connectivity of medical devices being needed more than ever in healthcare, it is important to learn more about the types of medical devices that connect data, what does data governance mean, and why is privacy and security essential in Telehealth.

Why is product safety critical for respiratory ventilators during the COVID-19 global pandemic?

by Steeve Huin | Apr 14, 2020 | Healthcare

With the increased need for ventilators due to COVID-19, manufactures are ramping up production to meet the soaring demand but are still falling short. Industrial heavyweights such as Ford, GM, Tesla, Dyson, and others have responded to the call by governments to address the ventilator shortage problem. Many have joined forces with MedTech manufacturers to convert their production facilities to assemble parts for ventilators.

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