H-ISAC and AAMI newsflash: What’s the industry saying?
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.
Read MoreThe 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.
Read MoreThreat 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.
Read MoreThere 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?
Read MoreSixteen 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?
Read MoreSweeping 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.
Read MoreMedical 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.
Read MoreThere 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.
Read MoreThroughout 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.
Read MoreWith 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.
Read MoreWith 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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