Data protection and IT security are paramount. By design we safeguard sensitive information, ensuring compliance with the industry regulations. With a strong focus on confidentiality and integrity, users can trust myoncare to prioritize the security of their data at every step.
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End-to-end encrypted data transfer
Class IIa medical device
GDPR-compliant hosted on German servers.
ISO 27001 & ISO 13485 certified QMS of ONCARE
Regular QMS audits by TÜV Süd Product Service GmbH
Use of a specially developed & patented blockchain solution
With the patient's consent to include their doctor as an additional site, a key is also stored on the patient's smartphone and the doctor's laptop, which can be used to decrypt information and data sent between them.
The data is encrypted during transmission and is only decrypted on the patient's smartphone or the doctor's device.
We are convinced that blockchain technology offers enormous potential for making data transfers secure and traceable. This is particularly important for collaboration in networks, as blockchains can significantly improve the exchange and availability of data for research purposes and in epidemiology.
Based on the Hyperledger Fabric Framework, we have therefore developed our own blockchain solution that is specially tailored to the requirements of the healthcare sector - and for which we already hold two patents. Our "Private & Permissioned" blockchain enables data to be exchanged between two parties via a private channel that can only be viewed by the two parties involved. The rest of the network can only see that a transaction has taken place without having access to any details.
Important to know: As a user, you are free to choose whether you want to use the blockchain.
1. Participants can initiate a private transaction
2. Only anonymized data is included in the block
3. The block is sent to the network of nodes
4. The nodes validate the transaction
5. The block is added to the existing blockchain
6. Other participants have no insight into the details of the transaction.
Permissioned - participants are known
Data cannot be corrupted or replaced
Transactions can be verified at any time
myoncare platform adheres to EN ISO 13485, ISO 27001, MDR IIa, FDA, and BSI standards, ensuring quality and compliance in medical device development.
To ensure the highest product quality, we have implemented a quality management system (QMS) that covers all steps of product realization from initial design to post-market surveillance.
Our QMS is certified under the Medical Device Regulation (Regulation (EU) 2017/745 on medical devices) for Class IIa medical devices.
In addition, our QMS is certified to ISO 13485: 2016 and ISO 27001: 2017 and is subject to regular audits by our certification body for critical review and continuous improvement.
QMS Class IIa Medical Device Regulation
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Zertifizierung nach DIN EN ISO 27001: 2017
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EN ISO 13485:2016
Whether you want to design your own digital program from scratch or offer your patients digital support with minimal effort - we have the right solution.
Maximum flexibility for your project. Create and combine your own content and manage patients via the innovative dashboard.
Digital health with minimal effort. Integrate your patients into an existing health program from our partner myon.clinic.
Our team will discuss your project idea with you. Book your non-binding consultation appointment now!
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myoncare is a CE-marked class IIa medical device.
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Rx only. Medical Device Data System. The FDA has recommended enforcement discretion for this device.
ONCARE's QMS is certified in accordance with ISO 27001: 2017 and ISO 13485: 2016.
myoncare is DSGVO and GDPR compliant.
1 With myoncare, you can only use digital treatment paths within the scope of the intended purpose of myoncare. For example, myoncare may not be used for emergencies. Please contact sales@myoncare.com to find out more about myoncare and the possibilities for your project solution. For patient monitoring and diagnostic support, myoncare must currently only be used by healthcare professionals. The respective user/doctor is responsible for the creation of the content. The indications and contra-indications of myoncare must be observed.
