Digital health application: The app on prescription
This is an opportunity for you to advance digital healthcare, expand your portfolio, and gain access to a reimbursement pathway that is unique on an international scale. This is because, under the Digital Healthcare Act (DVG), individuals with public health insurance are now entitled to DiGA services, which can be prescribed by doctors and psychotherapists and reimbursed by health insurance providers. Alternatively, patients can apply for reimbursement for a DiGA directly through their health insurance provider.
In what ways do DiGAs provide support?
DiGA provide support in areas such as the treatment of diseases and the management of medical conditions, and—since the latest update—may also include telemedicine services. They can take the form of a smartphone app or a web application accessible via a browser.
However, before a DiGA enters the market, the Federal Institute for Drugs and Medical Devices (BfArM) verifies that it meets all requirements. Learn more in our blog post about the six key facts that manufacturers should definitely keep in mind.
Would you like to bring a DiGA to market?
The Federal Institute for Drugs and Medical Devices (BfArM) will add your DiGA to the DiGA directory if it meets all requirements, including those related to safety, usability, quality, medical benefit, data protection, and data security.
Here’s what the process looks like for a digital health application to be included in the DiGA directory (BfArM):
The positive supply effect
The positive care effect of digital health applications
Medical Benefits
- Improvement in health status
- Shortening the duration of illness
- Extended survival
- Improved quality of life
Improvements to structure and processes relevant to patients (including, among others):
- Coordination of treatment procedures
- Facilitating access to care
- Patient safety
- Building health literacy
The requirements and development of DiGA
Pursuant to Section 3(1) of the DiGAV, the CE marking is deemed to provide evidence of compliance with the requirements for safety and functionality.
Manufacturers meet data protection and security requirements through a self-declaration
- The declaration is based on Appendix 1 of the DiGAV
- BSI Standards 200-1, 200-2, and 200-3 provide guidance
- Implementation of a comprehensive ISMS in accordance with ISO 27001
- BfArM does not verify compliance with data protection laws (risk of misjudgment)
Exchange of data over networks in a specific format; the electronic health record (ePA) serves as the central data hub
- Export in a human-readable and printable format
- Export to a machine-readable, interoperable format
- Hardware connectivity (sensor)—use of an interoperable interface
Assessment of user-friendliness for the intended user groups (including those with limited digital experience); accessibility: All DiGA listed in the directory must either:
- include accessibility features for people with disabilities, or
- support the accessibility features offered by the platform (support for every type of disability—hearing, vision, and motor skills)
Penetration Testing in the Development of DiGA
With the entry into force of the DVPMG, penetration tests are no longer required only for DiGA applications with increased security needs, but are now mandatory for all DiGA applications. The goal of penetration tests is to identify security vulnerabilities at an early stage and ensure a high level of data security. We are happy to assist you in developing the test plan in accordance with the BSI’s implementation guidelines for penetration tests and taking into account the current OWASP Top 10 security risks. To ensure the tests are conducted independently, all penetration tests are performed by our BAYOOTEC experts.
Do you have an idea for a DiGA?
We know the regulatory requirements for developing and obtaining approval for DiGAs. From interoperability to data protection and cybersecurity—BAYOOMED’s experienced team will work with you to develop and implement your DiGA.
Standard features such as onboarding, DiGA code validation, a diary, connectivity, as well as modules for patient information and interoperability are already part of the MedicalOne Connect platform —which helps shorten the development time to market.
From the Field: Projects That Make a Difference
How we help pharmaceutical, medtech, and healthcare companies safely bring digital medical devices to market.
Behind each of these stories was an initial conversation. Write your success story with us and tell us what you’re currently working on.
