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.

EU-MDR IIa, ISO 27001, BSI C5 Can be used for any indication No installation, get started right away
Security excellence

More than just a promise

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 Product Service GmbH & TÜV Süd Management Service audits, and patented blockchain solution.

Übersicht der Sicherheitsmerkmale von myoncare
Data transmission

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.

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

Schema: Daten werden verschlüsselt übertragen und erst auf dem Gerät von Patient und Arzt entschlüsselt
Optional use

Use of our blockchain

Blockchain technology makes data transfers secure and traceable – particularly for collaboration in networks, for research purposes and in epidemiology. Based on the Hyperledger Fabric Framework, we have developed our own solution for the healthcare sector, for which we already hold two patents. Our “Private & Permissioned” blockchain transfers data between two parties via a private channel: the rest of the network can only see that a transaction has taken place – without access to any details.

Important to know: As a user, you are free to choose whether you want to use the blockchain.

Private & Permissioned

How a transaction works

Schema einer privaten, permissioned Blockchain-Transaktion
  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.
Quality management

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.
  • 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.
MDR-Zertifikat, Seite 1
MDR-Zertifikat, Seite 2

QMS Class IIa Medical Device Regulation

Zertifikat EN ISO 27001:2022
TÜV Süd Product Service GmbH

EN ISO 27001: 2022

Zertifikat EN ISO 13485:2016, Seite 1
Zertifikat EN ISO 13485:2016, Seite 2
TÜV Süd Product Service GmbH

EN ISO 13485: 2016

BSI C5-Testat der ONCARE GmbH

BSI C5

Information Security Management System

Information Security ­Policy

ONCARE GmbH develops and operates cloud-based digital healthcare solutions and processes information in support of healthcare providers, patients and other stakeholders. Information security is essential to protecting patient information, customer information and company assets.

ONCARE GmbH is committed to:

Quality Management System

Quality Policy

Quality Policy of ONCARE GmbH is:

Standards & certifications

Quality & data security by Design.

MDR Klasse IIa

myoncare ist nach der MDR zertifiziert

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

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).

FDA listed

myoncare is listed in the US according to FDA

The healthcare platform myoncare is listed in the US in accordance with FDA standards.

ISO 13485

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

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.

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.

Trusted By

Good to know

Your questions,answered

myoncare is a CE-marked health platform consisting of a web app & desktop app for careteams for clinical teams and a smartphone or web app for patients. Digital content can be created in the backend and then sent to patients in the smartphone app. From their dashboard, clinical teams can manage their patients, filter by a range of criteria, track health and communicate with patients directly, by video call or chat.

With myoncare you can easily create digital care pathways that give your patients additional support along their health journeys. myoncare can help support adherence, identify risks and complications early, capture health data in a structured way, reduce patient uncertainty and support satisfaction. The dashboard gives you a clear overview of your patients, lets you filter them by various criteria and lets you interact with them directly by chat, video call or data transfer.

myoncare can support doctors and patients across all indications. The only exception[DM1.1] is conditions that make using a smartphone impossible and the use within critical care. Digital content can also be created to support patients taking medicines or using medical devices, or to provide insured members or employees with preventive content. The range of possibilities is very wide.

The content management system is the heart of myoncare. In the CMS, content can be created easily, given automation rules and combined into care pathways. The CMS interface was deliberately designed to be intuitive, so that it can also be used easily by people without programming knowledge.

If you do not have the time or the inclination to create content yourself, you can refer your patients into an existing health program run by our subsidiary [DM2.1][TH2.2]myon.clinic. This lets you offer your patients extensive digital support with minimal effort on your side. Alternatively, you can draw on the services of our content team, which can support you in creating individual content. Please get in touch for more information.

Classifying our platform as a Class IIa medical device brings a number of advantages, both for us as the manufacturer and for you as the user. For you it means added safety, because myoncare is developed and continuously improved in line with the latest quality and safety standards. This is assured by regular audits by TÜV SÜD Product Service GmbH. Classification as a Class IIa medical device is also a basic prerequisite for digital health applications to be used for monitoring and diagnostic support. Successful Class IIa certification does, however, require considerable financial and staffing investment.

As of September 2026: Using myoncare requires Windows 11 (or later), macOS 15.06 (or later) or Ubuntu 22.04 (or later), a stable internet connection of at least 10 Mbit/s with a maximum latency of 200 ms, and the latest version of the Chrome or Firefox browser. To use it on a tablet you need at least iOS 18.3.1 or Android 13.0. Your instance is hosted on an EU server of a company validated by us — with nothing for you to do. Your patients need a smartphone with an internet connection and at least iOS 18.3.1 or Android 13.0. Setting up interfaces to a hospital information system or other systems involves additional effort and cost.[

The certified platform formodern care

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