One thing is certain: your data is safe.
One thing is certain: your data is safe.
Good treatment
also for your data
All components of the ESYSTA system are medical devices, including the ESYSTA app and the ESYSTA portal. Why? Because we offer you and your treatment team a particularly high standard of security and data protection. In Germany, medical data must be handled with particular care and strict confidentiality. In addition to these legal requirements, the entire ESYSTA system is certified in accordance with ISO/IEC 27001, the international standard for information security. Compliance with this standard is audited annually by TÜV Rheinland.
Medical devices
The requirements for apps recognized as medical devices, such as the ESYSTA app, or internet applications, such as the ESYSTA portal, are very high. As the manufacturer, we guarantee the quality of the application. This means that we do not simply program an app and place it in the app store, but that the app must first be put through its paces before it is published.
We have developed a robust test procedure for this and only when technicians, doctors and test patients have given their approval do we make the app available to the user. All of this is crucial, as doctors are only allowed to recommend or use CE-compliant medical devices for therapy management as part of their duty of care. One of the core benefits of ESYSTA is its valid use in remote treatment, which would not be possible without medical device approval.
Medical devices must also demonstrate a medical benefit of the application and that they pose no additional risk to the user. We fulfill both requirements. Therefore, the use of ESYSTA can help medically, which is also proven by our studies.
The ESYSTA app is registered as a medical device under the number DE/ CA76/H00075/04 CE, the ESYSTA portal under DE/ CA76/H00075/05 CE.
Certified according to
ISO/IEC 27001
Your data is considered medical data and is subject to particularly strict regulations: We must ensure that this data does not leave Germany and that it is stored on high-security servers. In addition, third parties must not gain unauthorized access to them. Regular backup copies of all data must be created so that they can be easily restored in the event of a natural disaster, for example.
In addition, you need robust concepts for encryption, procedures, updates, redundancies, closed security gaps, external protection, and, and, and. Of course, there is a standard for this – the internationally valid ISO/IEC 27001, which is also known as the “gold standard of IT security” due to its high requirements and close monitoring.
ISO/IEC 27001 certification requires particularly stringent information security requirements to be met.
For us at Emperra, this means extra work. However, we are happy to do so. Firstly, because we identify with medical confidentiality and secondly, because we also want our data to be handled in accordance with this standard.
Conclusion: The entire ESYSTA system is certified to ISO/IEC 27001 and is regularly monitored by TÜV Rheinland and an external and independent data protection officer.
Safety for your
treatment team
As the ESYSTA app and the ESYSTA portal are medical devices, they may be used as “tools to supplement therapy”. This means that, with your consent, your treatment team may use this data for your treatment.
Background: Data from apps or similar applications that are not medical devices are considered unreliable and therefore useless for recommending treatment. Their use can have legal consequences for treatment teams and health consequences for patients. We will be happy to answer any questions you may have.
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Copyright by Empera GmbH E-Health Technologies 2019. All rights reserved.
Copyright by Empera GmbH E-Health Technologies 2019. All rights reserved.