Our aspiration
Security & Trust
As a manufacturer of medical devices in the psychotherapeutic environment, we bear a special responsibility when it comes to data protection and information security.
Certified medical devices
elona therapy is a CE-marked medical device (Class I, MDD).
Information security
Elona Health is certified as a manufacturer of medical devices and digital solutions according to ISO 27001 by TÜV Süd.
Data protection compliance
Elona Health complies with the highest European data protection standards for health data in accordance with the GDPR.
Certified medical devices
elona therapy is a CE-marked class I medical device according to the MDD.
Information security
Elona Health is certified according to ISO EN 27001 by TÜV Süd. Our solutions meet the highest standards of the GDPR.
Data protection compliance
Elona Health meets the highest European data protection standards for health data.
Certified medical devices
Regulatory framework for quality and safety
The trustworthiness and reliability of our products is our highest priority. We therefore adhere to EU-wide standards and regulations such as the Medical Device Regulation (MDR). elona therapy is labeled as a class 1 medical device (MDD) and the safety and performance of the product were tested as part of the conformity assessment.
In addition, we regularly conduct post-market surveillance testing and evaluation of our products, incorporating the latest information from literature, safety data, our own clinical studies, or user feedback into development and compliance testing.
Further information
You can find out more about our medical quality assurance and our clinical studies here.
Our commitment
Highest standards for data security and data protection
Health data are a valuable asset - especially when it comes to our mental health. We are committed to your personal data and believe that the sovereignty over your data should always be with you. Your personal data is immediately pseudonymized and encrypted on all products to ensure the highest possible data security. You always remain in full control.
Elona Health does not share your data with third parties at any time. If you choose to share your data, only your therapist can access certain information that is relevant to your treatment. The data is stored on servers in Germany that are specially secured for health data. No data is left unencrypted on your individual terminal device.
Privacy by design
Our products are developed according to the principle of "privacy by design/default". This means that we always implement privacy-friendly technology design, data minimisation and organisational protection measures.
Encryption
We only use proven methods (TLS, AES 128-bit encryption) for data transmission. The data is stored in ISO 27001, ISO 27701, BSI C5 and HIPPA certified data centres.
Data storage
We separate user data from health information. Each type of data is stored separately on servers within the EU.
Audit trails
The audit trail ensures that every action on your data is thoroughly tracked and time-stamped to provide solid evidence of access, verification and signature.
Read more
Our handling of data
Our privacy policy describes in detail how we handle and protect your data. Our external data protection officer regularly reviews our data protection-related control measures and ensures that our processes and products always meet the highest requirements of the GDPR.
You can find out more about our privacy policy for the elona therapy mobile application (patients) and elona therapy web application (practitioners) in our resource centre.
Delete data
Upon request, we can delete all personal data from our systems. However, data that is subject to a legal hold can only be deleted once the legal hold process has been completed.
To request data deletion, please contact our supportteam.
Our certifications
Audited and certified information security
Security is not only an integral part of our products, but also integrated into our infrastructure and corporate processes. With our Information Security Management System (ISMS), we ensure a holistic security programme that encompasses both IT and information security.
We are proud that this self-commitment to the highest possible security has been audited and certified by TÜV Süd in accordance with the internationally recognised ISO 27001 standard.
An excerpt from our safety programme
Audits
External experts and internal experts regularly check our processes and safety measures. This ensures that we comply with the relevant regulations and standards at all times.
Risk management
We conduct regular risk analyses in which we assess potential security risks and proactively initiate measures to avert damage.
Friendly Fire
We regularly try to penetrate our own security architecture (e.g. through so-called penetration tests) in order to identify and remedy vulnerabilities.
Training
Information security affects every team member. Therefore, we regularly conduct training and awareness-raising sessions with our employees.
Certified partners
Our partners and suppliers undergo an extensive safety check and commit to additional safety measures if required. We conduct a review of our partners at least once a year.
Continuous improvement
We are not satisfied with the status quo, but always follow the latest security standards and best practices.
Safety at Elona Health
Meet our Team
Magnus
Schückes
IT & Information Security Officer
(TÜV-certified)
Laura-Sophie Everding
Data Protection Officer
Kirill
Bikowez
Regulatory Affairs Manager
Resource Centre
Find out more in our privacy policy, general terms and conditions, imprint and FAQs.