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.
FDA-listed
Preparation before admission
Follow-up after discharge
Integrates with your EHR
myoncare ensures top security: end-to-end encrypted data transfers, US hosting with HIPAA safeguards, FDA listing, the ISO 27001/13485-certified ONCARE QMS with TÜV SÜD Product Service GmbH audits, and a 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.
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.
myoncare platform adheres to EN ISO 13485, ISO 27001, MDR IIa, FDA, and German BSI standards, ensuring quality and compliance in medical device development.
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:
Ensuring the confidentiality, integrity and availability of information.
Satisfying applicable legal, regulatory, contractual and customer requirements related to information security — in the US including the HIPAA Privacy, Security and Breach Notification Rules and the HITECH Act.
Providing a framework for establishing and reviewing information security objectives.
Continually improving the effectiveness of the Information Security Management System.
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.
The platform meets the standards of the US Food and Drug Administration and is listed for the US market.
US customer data is hosted on servers in the US. Encryption, role-based access and traceable activity are designed to support your HIPAA obligations.
In the EU, the platform is certified as a Class IIa medical device under the Medical Device Regulation (EU) 2017/745.
This internationally recognized standard defines the requirements for a quality management system specifically for the medical device industry. It is also the standard FDA’s Quality Management System Regulation (21 CFR Part 820) incorporates by reference.
Information security at ONCARE is based on the principles of ISO 27001 and safeguards information assets, regardless of whether they are entrusted to us or to our customers.
The standard describes the procedures for identifying hazards associated with the medical device, estimating and evaluating the related risks, and monitoring the effectiveness of controls.
The ONCARE quality management system implements IEC 62304 as the framework for the entire software lifecycle process.
The standard applies to the safety of standalone health software products and refers to ISO 14971 and IEC 62304 for risk and software lifecycle processes.
Relevant parts of the standard are applied in 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
myoncare is an FDA-listed health platform consisting of a backend for care 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, care teams can manage their patients, filter them by a range of criteria, track their health and communicate with them directly, by video call or chat.
With myoncare you can easily create digital care pathways that give your patients additional support along their health journey. myoncare can help to encourage adherence, identify risks and complications early, capture health data in a structured way, reduce uncertainty for patients and improve satisfaction. The dashboard gives you a clear overview of your patients, lets you filter them by a range of 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 is conditions that make using a smartphone impossible, for example diseases of the central nervous system. Digital content can also be created to support patients taking medicines or using medical devices, or to provide health plan members or employees with preventive content. The range of possibilities is very wide.
The content management system is the heart of myoncare. Using 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, our content team can support you in building your own content, and pathways you have built once can be reused as templates. Please get in touch for more information.
myoncare is listed with the U.S. Food and Drug Administration (FDA). The platform is developed by ONCARE GmbH under a quality management system certified to ISO 13485:2016 — the standard that FDA’s Quality Management System Regulation (21 CFR Part 820, in effect since February 2, 2026) incorporates by reference — together with ISO 14971 for risk management and IEC 62304 for the software lifecycle, audited regularly by TÜV SÜD Product Service GmbH. Outside the US, myoncare is CE-marked as a Class IIa medical device under the EU MDR. For you, this means documented and audited development, risk management and post-market processes that your compliance and procurement teams can review.
As of July 2024:
Using myoncare requires Windows 10 (or later), macOS 11.11 (or later) or Ubuntu 20.0 (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, Firefox or Safari browser. To use it on a tablet you need at least iOS 13.0 or Android 11.0. Your instance is hosted on US servers operated by a provider validated by myoncare — with nothing for you to do. Your patients need a smartphone with an internet connection and at least iOS 13.0 or Android 11.0. Setting up interfaces to your EHR or other systems involves additional effort and cost.
Talk to us about certification, data hosting and integration – in a short, personal appointment.
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