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Hospitals and their legal operator
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Entwickler & Hersteller von Medizintechnik
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Test labs & Notified Bodies
Also deriving from improving regulatory requirements, amt:consult offers basic consulting and performing of vulnerability tests on medical devices and matching infrastructure. This services addresses Research and Development companies as well as manufacturers in the field of medical devices. But also test houses, hospitals and further users.
Not long ago, threatening medical devices was subject of science-fiction novels. "Cyber Security" was reserved for staff in corporate it departments and content of fictional movies. But the situation has massively changed.
Everywhere is threat potential. From so called Script-Kiddies up to ordered cyber criminals organized in networks. All try outbound intrusion with the goal to long information, threat systems and/or cause heavy damage. Last but not least: Discontent coworkers with blackmailing intention who put the cyber security inbound to the test.
Using pre-built scripts in modular style - easy to find on the internet these days – even Jane and John Doe manage to really cause damage.
Indeed, not only existence threating damage in a financial sense but also live endangering scenarios are applicable in the field of Cyber-Security with medical devices.
Cybersecurity for Medical Devices and Hospital Networks
Read more…Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems
Read more…Premarket Submissions for Management of Cybersecurity in Medical Devices
Read more…FDA sets guidelines for medical devices' cybersecurity
Read more…
Following guidelines of german Federal Office for Information Security and american FDA authority, amt experts check compliance of documentation and it risk assessment of medical devices and infra structure. Together with companies' dedicated it security professionals.
Applicable basics and deriving steps are slightly deviating. Only in the risk analysis the point of view has massive impact on the mitigations possible.
After the analytic phase, which defines distinct attacking scenarios and potential threats for hospital infrastructure, connected systems as PDMS and dedicated medical devices, so called vulnerability tests are performed.
The vulnerability assessment lights up all the issues with optimization potential in medical devices, data systems and infrastructure. With vulnerability tests being performed, device owners, developers or manufacturers have no 100 % safety. Vulnerability tests also do not imply that it will never be possible to hack a very device.
But: IT security professionals of hospitals, RnD departments and manufacturers can use the results for enhancement of their IT risk assessment and improvement of the mitigation list.
Together with special skilled IT partners, amt can help with comprehensive supervision afterwards. Also providing the ability for customers to directly cooperate with external IT professionals.
Of course there are plenty of IT specialists and Cyber-Security Experts, helping to find the individual threats and optimization potentials at the Point-of-Care and in the infrastructure.
amt's big benefit is our medical device network and connections to all big players in medical device world; focussing on OR and intensive care.
