Attack on Your Device!
The world is witnessing rapid developments in the digital health industry, especially now, when the industry has expanded exponentially with the introduction of connected devices or IoMT – Internet of Medical Things. Experts predict that the digital health space will rise from $52.2 Billion to nearly $136.8 Billion by 2028.
Connected health space is advancing because of the additional features being provided by the manufacturers. Common applications like remote health monitoring, emergency medical notification systems etc., are enhancing the traditional medical devices. This enhancement is possible because of IoMT and connected health applications communicating with vast networks. Patients have the advantage of getting access to time critical health insights as their traditional medical devices are now transformed and connected to various networks and systems that collect, evaluate, and visualise the health results. This connected space is happening now and is no longer a far-sighted vision of possibilities.
As the IoMT ecosystem develops, manufacturers of such MedTech products have a greater responsibility on their shoulders. In order to keep their physicians, patients and end-users safe, companies need to focus on responsible product design, packaging + labelling requirements, effective quality management systems and a lot more activities.
Various countries and organisations are under the process of reviewing and reshaping the regulatory requirements for this space. Quite recently, Medical Device Coordination Group in Europe published Guidance on Cybersecurity for Medical Devices. This guidance provides manufacturers (and actors other than manufacturers) with a view on how to fulfil all the relevant essential requirements of Annex 1 to the MDR and IVDR with regards to cyber security. A similar trend can be seen in the USA, where The Californian IoT Security Law outlines certain expectations for Internet of Things (IoT) devices, including connected medical devices; and new guidance is scheduled for issue by the Food & Drug Administration (FDA) in 2022, which is likely to address software as a medical device (SaMD) and software in a medical device (SiMD).
What is it that the regulators are looking out for?
Despite attractive prospects of the IoMT ecosystem, a double edge sword hangs over the MedTech, Pharma and Diagnostics sectors. This sword has a real-world impact on patient safety and is famously known as 'Cyber-attack.'
Ever-increasing cyber-attacks and cyber threats pose as a 'Red Flag', which can affect the Patient's care. Patients can be victims of incorrect diagnosis whereas the companies risk losing commercially important data. Considering these attacks, regulators worldwide are proactively introducing regulations, guidance and safety check measures for all players of the ecosystem. These protection measures are aimed at
- Protection of networks
- Enhancing Product's Cyber Resiliency
- Protection from loopholes and vulnerabilities
Cyber threat prevails right from product design, development, manufacturing, testing and goes until post-market vigilance, connected systems, connected networks and beyond.
Our experts relentlessly partner with our clients and perform various cyber checks and regulatory compliance. Do you want to protect your digital health product? Contact us NOW! mdd@mddltd.com
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What does this mean for MedTech companies?
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