Your medicine or device can receive a digital companion on a Class IIa platform that clinical teams already use in their care pathways. What patients report there comes back to you as real-world evidence.
FDA-listed
Hosted in the US · HIPAA safeguards
myoncare, Inc. in New York · in use across the US and Europe
Build personalized digital companions for your product, deliver the therapy inside the clinics already treating your patients, and read the results back as structured data.
Complex regimens often break down in everyday life. With myoncare, patients have a digital companion that guides them through their treatment: what to take and when, what to watch for, and what to report back. Patients who stay on therapy are patients your product can work for.
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Every completed task generates structured, scored data. De-identified and collected at scale, it becomes real-world evidence for research, HEOR and value dossiers for US payers, in line with FDA's real-world evidence framework under the 21st Century Cures Act.
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Manage trial participants, electronic patient-reported outcomes (ePROs) and visit schedules in one place. ePROs are captured remotely, aligned with FDA's guidance on digital health technologies for remote data acquisition in clinical investigations. The data comes directly from participants rather than from a site visit, and the cohort logic that defines the study also governs the export.
Patients on your therapy are rarely treated by a single team. myoncare can connect the providers involved in their care like hospital department, specialist practice and referring practice in a structured network that stays with patients across the whole patient journey.
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You provide the therapy, myoncare provides the certified platform, and your clinical partners deliver it to the patients they already treat.
Set the program up yourself in the content management system, or work with our content team. The app and the certifications are already in place.
Your therapy is delivered the way it was designed: at every site and for every patient. That keeps the evidence comparable across the whole population.
Patients join by scanning a QR code at the clinic that already treats them. Enrolment happens where the patients already are.
What patients report becomes structured, de-identified data. At scale, it feeds research and value dossiers and supports your FDA post-market obligations, such as medical device reporting and postmarket surveillance under 21 CFR Parts 803 and 822.
De-identified data scales where identified data stalls: you get results across the whole population without ever seeing an individual, with data designed to follow HIPAA de-identification standards (45 CFR §164.514). That is what opens clinics to your program.
Data is transmitted encrypted and only decrypted on the patient’s smartphone or the treating clinician’s device. Your program never becomes a place where patient data can leak.
Your instance runs on US servers with a provider we have validated, with no setup work on your side. Technical safeguards — encryption, role-based access, traceable activity — are designed to support HIPAA, so your privacy and compliance review has concrete answers it can point to.
Evidence is generated from aggregated analyses, not individual records. What data is made available, and on what legal basis, is agreed per project between the participating institutions. Program content stays consistent with your product's FDA-approved labeling and your medical/legal/regulatory review, and patient support programs are structured with the federal Anti-Kickback Statute in mind.
You start on a regulatory and quality foundation you did not have to build, budget for or wait years to obtain:
Patients join at the point of care, by QR code at the clinic already treating them. No app to market, no program that stalls because nobody signed up.
Every completed task generates structured data. Evidence you would otherwise commission emerges from a program that is already running, usable for research, value dossiers and FDA post-market activities.
myoncare supports clinicians and patients across almost every indication, in Europe and the US. One supplier relationship, one security review, one integration per clinic, reused at every launch instead of rebuilt per product.
The content management system is no-code: your teams create and change patient content themselves, in real time, without development work or release cycles. Multi-language support makes entering a new market a content task, not a development project.
Sites connect myoncare to what they already run: HL7 and FHIR interfaces to EHRs and tumor documentation systems, plus LOINC-conformant mapping for wearable data.
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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.
Patients are enrolled at the point of care by QR code. Sites and satellites mirror how care actually happens: a hospital department can lead the care pathway, while external clinicians join as satellites and see only the patients assigned to them or whose QR code they have scanned. The backend is built to be operated by clinical users without programming knowledge, and connects via HL7 for patient and diagnosis data from the EHR, FHIR for exchange with external health systems, and LOINC-conformant mapping for wearable data. That way sites do not have to re-enter what they already hold.
Not necessarily. The content management system (CMS) is the heart of myoncare: content can be created, given automation rules and combined into care pathways. The interface is deliberately designed so that it can also be operated by users 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. Building your program on a platform that already has this in place takes that work off your program.
myoncare is listed with the U.S. FDA. ONCARE GmbH, which develops the platform, holds ISO 13485:2016 (quality management for medical devices) and ISO/IEC 27001:2022 (information security management system) and applies ISO 14971, IEC 62304, IEC 82304 and IEC 62366. In the US, data is hosted on US servers.
Outside the US, myoncare is CE-marked as a Class IIa medical device under the EU MDR, and GDPR compliance for EU customers is confirmed by the Institute for IT Law (IITR).
The standards and certifications listed refer to the quality management system (QMS) and the information security management system (ISMS) of ONCARE GmbH, which is responsible for developing the myoncare health platform.
As of July 2024:
using myoncare requires Windows 10, macOS 11.11 or Ubuntu 20.0 (or higher), a stable internet connection of at least 10 Mbit/s with a maximum latency of 200 ms, and a current version of Chrome, Firefox or Safari. For use on a tablet you need at least iOS 13.0 or Android 11.0. Your patients need a smartphone with an internet connection and 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.
To connect to existing clinical systems, myoncare supports the established healthcare standards: HL7 for patient and diagnosis data from your EHR, FHIR for exchange with external health systems, and LOINC-conformant mapping for wearable data. Setting up these interfaces involves additional effort and cost.
Bring your product and your patient group. In a short call we will sketch out what a companion for your therapy looks like, which clinical partners it would run in, and what evidence you get back.
Let's talk