MedicalOne Connect: Frequently Asked Questions
From the initial idea to DiGA approval—here you’ll find answers to the most important questions about our services, technical solutions, and regulatory support.
MedicalOne Connect: Frequently Asked Questions
In this FAQ, you’ll find answers to the most important questions about our services, our technical solutions, and our support throughout the entire DiGA process. Whether you’re currently in the planning phase or already working on implementation, here you’ll get a clear overview of how we can guide you on your path to a successful DiGA.
Frequently Asked Questions
Whether it’s technical implementation, regulatory requirements, or the integration of existing systems—in our FAQs, you’ll find concise answers to the most common questions about MedicalOne Connect. This will give you a quick overview of how we support developers of digital health applications in development, approval, and further refinement.
Our DiGA services are a comprehensive all-in-one package that combines all the technical components needed to implement a digital health application (DiGA) in accordance with the guidelines set by BfArM and gematik.
The service package includes, among other things, the ePA service, which provides a secure interface to the telematics infrastructure (TI) and thus enables connection to the electronic patient record (ePA). The GesundheitsID service ensures seamless user authentication via the gematik Health ID. The MIO service supports the creation, validation, and export of Medical Information Objects (MIO) to the ePA. The offering is complemented by code validation, interoperability, and MIO mapping, as well as integrated billing.
Yes. Our team will advise you on structuring the MIO data export and ensure that the implementation runs smoothly and complies with the current BSI TR-03161 and gematik specifications.
All DiGA services are fully compliant with gematik’s guidelines, BfArM regulations, and the DiGAV. In addition, they meet the security requirements specified in BSI TR-03161.
From a technical standpoint, we rely on a microservices-based architecture that is modular, scalable, and easily adaptable.
We hold ISO 13485 certification for quality management in the medical technology sector and—together with our sister company BAYOOCARE—also hold ISO 27001 certification for information security management.
Yes. We provide ready-to-use REST API interfaces that can be implemented regardless of programming language or framework. This makes integration into existing systems quick and easy.
Upon request, we’ll handle the entire application process with gematik, so you don’t have to worry about a thing. In addition, all necessary updates resulting from regulatory changes are already included in the service—so you remain compliant at all times without any additional effort.
We provide all relevant DiGA services from a single source—from telematics infrastructure connectivity and ePA integration to billing.This means: no coordination issues with multiple service providers, a seamless technical solution, and a significantly shorter time to market.
Yes. Upon request, we can handle the entire technical implementation—from interface connectivity to final integration into your application.
Yes. In addition to comprehensive solutions, we also offer targeted consulting services—both technical and regulatory. These include, among other things, BSI TR-03161, gematik processes, and the BfArM application process.
Our services are available within 48 hours of signing the contract. The implementation phase typically takes between one and four weeks, depending on the client’s capacity.
To get things moving, we’ll provide sample code and organize an implementation kick-off meeting with your developers.
Was your question not listed?
Every DiGA project comes with its own unique requirements. Feel free to reach out to us—we’ll provide personalized advice and work with you to find the right solution for your project.
Miriam Schulze
CEO
Contact us
Do you still have questions, or would you like to explore specific topics in more depth? If so, please feel free to contact us directly. Our team will support you with in-depth technical and regulatory expertise and guide you through the process of successfully implementing a compliant DiGA.
Contact form
Miriam Schulze
CEO
Contact us
Do you still have questions, or would you like to explore specific topics in more depth? If so, please feel free to contact us directly. Our team will support you with in-depth technical and regulatory expertise and guide you through the process of successfully implementing a compliant DiGA.