Security & Quality

Security by design!

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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myoncare security & quality

More than just a promise!

myoncare security excellence

myoncare ensures top security: End-to-end encrypted data transfers, GDPR-compliant German servers, Class IIa medical device, ISO 27001/13485 certified ONCARE QMS with TÜV Süd audits, and patented blockchain solution. 

End-to-end encryption

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.
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The data is encrypted during transmission and is only decrypted on the patient's smartphone or the doctor's device.

Optional use of our blockchain

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.
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‍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

Certified quality

myoncare platform adheres to EN ISO 13485, ISO 27001, MDR IIa, FDA, and German 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.
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  • In addition, our QMS is certified to ISO 13485: 2016 and ISO 27001: 2022 and is subject to regular audits by our certification body for critical review and continuous improvement.
  • QMS Class IIa Medical Device Regulation
  • EN ISO 27001: 2022
  • EN ISO 13485:2016

Information Security Policy

The information Security Policy on ONCARE GmbH is to ensure:
  • Confidentiality of the information.
  • Maintenance of the integrity of information.
  • Availability of information to the authorized users.

Quality Policy

Quality Policy of ONCARE GmbH is:
  • High levels of customer satisfaction with respect to product quality, user-friendliness, service and support.
  • High-quality solutions with excellent performance all over the world.
  • Improving patient care by integrating innovations into the clinical workflow.
  • We want to promote self-reliant and responsible behavior among our employees.
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Trusted By

myoncare platform

Patient-centered communication
& automation of care.

One platform connecting patients, care teams, and data. myoncare automates risk assessments, health monitoring, reminders, education, and telecommunication - all in one compliant infrastructure.

We’ve invested over 800,000 hours

to get the tech, compliance, and infrastructure right
– so you don’t have to.

Create medical
content in no time

with our ai-powered content management system & pathway builder.

100+ features combined in one platform.

Choose from numerous modules to create customized solutions:​

Regulatory-ready
& easy to integrate.

Designed to meet the highest standards for compliance, interoperability, flexibility, and research-driven collaboration.

Certifications

Quality & data security by design.

MDR Class IIa​

myoncare is certified under the MDR​

The platform myoncare is certified according to MDR (Regulation (EU) 2017/745 on medical devices) for Class IIa medical devices.​
ISO 13485: 2016​

Quality Management for Medical Devices​

This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry. ​
ISO/IEC 27001: 2022​

Information Security Management System​

The information security management of ONCARE is based on the ISO 27001 principles and ensures the security of information assets whether in-house or entrusted to us by our customers.​
FDA Approval​

myoncare is approved in the US according to FDA​

The healthcare platform myoncare is approved in the US in accordance with FDA standards. ​
GDPR Conformity​

IITR Certified Data Protection​

Our data protection complies with the privacy requirements of the EU GDPR and DSGVO, confirmed and certified by the Institute for IT Law (IITR). ​
ISO 14971​

Application of Risk Management to Medical Devices​

The standard describes the processes for identifying the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.​
IEC 62304​

Medical Device Software Lifecycle Processes​

The quality management system of ONCARE  implements IEC 62304 as a framework throughout the software life cycle processes.​
IEC 82304​

Health Software Product Safety​

The standard applies to the safety and security of stand-alone health software products and points to ISO 14971 and IEC 62304 for risk and SW lifecycle processes.​
IEC 62366​

Medical Device Usability​

Relevant parts of the standard are used during risk management activities and UI/UX design.​
The standards and certifications mentioned here refer to the QMS and ISMS of ONCARE GmbH. ONCARE is responsible for the development of the myoncare healthcare platform. 
FAQ​

We answer your questions
about myoncare

What is myoncare ?

How can myoncare help me? ​

In which areas can myoncare be used?  ​

How does the content management system work?  ​

The content management system is the heart of myoncare. Using the CMS, content can be easily created, stored with automation rules and combined into treatment paths. The user interface of the CMS has been designed to be particularly intuitive so that it can also be easily operated by users without programming knowledge.

I don't have time to create content myself, is there a solution for this? ​

What does Class IIa medical device mean? What are the advantages?  ​

What are the technical requirements?​