DiGA Development Services

The main steps in DiGA development include project planning, UI/UX design and prototyping, technical verification and deployment to production, clinical validation, MDR certification, BfArM submission, support and maintenance, and post market surveillance. All steps in this process should be performed in accordance with MDR regulations for medical devices.

A good UI/UX is one of the major technical requirements for DiGAs, as it is imperative that they are user-friendly. DiGAs need to fulfil the main principles and requirements of usability and accessibility. The user interface needs to be clear and intuitive to give patients full control over the application. Each DiGA needs to be designed to address the needs of a specific population group or patients with specific conditions. Each DiGA also needs to have a relevant user interface for better patient outcomes.

You need to make sure that your digital health application meets requirements in the following areas:

• Incorporating interoperability features, including integration with the ePA/Gematik infrastructure.
• Fulfilling the specific requirements for DiGA code activation and integration with insurance companies to establish the reimbursable status of your app.
• Ensuring data protection and information security by utilising secure cloud hosting, implementing anonymization techniques to protect user privacy, leveraging analytics for valuable insights, and ensuring compliance with the latest data protection requirements.

In order to become a DiGA, health apps need to present health data using an open, internationally recognized interoperability standard called FHIR (Fast Healthcare Interoperability Resources) to ensure digital exchange of patient data. To be approved by BfArM for interoperability, DiGA providers might need to consult with a technology partner that has enough expertise implementing FHIR solutions. Achieving interoperability is a challenge, but successful implementation can be a significant advantage in making your DiGA compatible on the market.

DiGA providers need to integrate their applications with insurance companies that provide coverage in order to generate invoices. Currently, the application programming interfaces (APIs) provided by insurance companies have poor coverage of necessary integrations and often require DiGA providers to deal with issues such as technical debts and mistakes in calculations. To successfully integrate with the insurance ecosystem, DiGA providers might want to bring on a third-party service provider that has expertise and experience with these kinds of integrations.

The Federal Ministry of Health requires DiGA manufacturers to provide data security and data protection at all times. To ensure data protection and security, the BSI (Office for Information Security) has developed guidelines that ensure confidentiality, integrity, and availability. BSI developed these regulations to make sure that DiGAs meet requirements for information security. This includes security regulations for the purpose of use, the architecture, source code, third-party software, encryption and authentication, data protection, chargeable resources, and security regulations for network communication and resilience.