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No headaches due to DiGAV compliance

Plan B:
Instant update for your DiGA

mHealth Suite instead of expensive improvements

Transfer your digital health application (DiGA) to the mHealth Suite infrastructure platform – in the timeframe of around 2 to 3 months.
After switching to the mHealth Suite, you will be compliant without any additional effort.

BSI TR-03161 for Cybersecurity

You were not prepared for the demanding Data Security requirements according to BSI TR-03161 and, like other DiGA manufacturers, have to budget several 100,000 EUR to upgrade your systems?
After switching to the mHealth Suite, you will be compliant without any additional effort.

Test criteria for Data Protection DiGA and DiPA (BfArM)

The Data Protection certificate, which will be mandatory in future, will not only professionally verify GDPR compliance. The specific requirements of the DiGAV with regard to health ID and ePA integration (ePA: electronic patient file) require significant adjustments to data storage, usage concepts and workflows.
After switching to the mHealth Suite, you will be compliant without any additional effort.

Is your DiGA fit for the latest requirements?

New technical and regulatory deadlines apply to all DiGAs. There is a way for DiGA manufacturers to master this challenge quickly and cost-effectively: with the mHealth Suite.

  • As of January 1, 2025
    Proof of requirements for additional BSI certificate Data Security is mandatory
  • Previously from 01.08.2024 (will be redefined if necessary)
    Proof of requirements for additional certificate Data Protection is mandatory

Benefit from conformity as a standard

Modular System for DiGAs

The mHealth Suite fulfills:

  • Requirements for the Data Protection certificate
  • Requirements for the BSI Data Security certificate
    (mandatory from 01.01.2025)
  • Conformity with European Medical Device Regulation MDR
  • Conformity with Digital Health Applications Ordinance DiGAV

This is the secret of the value-creating sustainability of our technology

1. automation in the documentation process

Based on a specific medical purpose, we can create MDR-compliant technical documentation in the shortest possible time with the help of our structured and highly automated requirements and documentation management.

2. customized product cutting

The developed indication-agnostic modules are linked to the specific medical content and therapy logic. You receive a customized and specific product – and not just a “sample container” based on a standard template.

Innovation with advantages for DiGA manufacturers

Advantage of cost efficiency

This methodology of scalable MDR-compliant software development can greatly reduce the effort required for product development and further development. We are therefore able to offer an extremely cost-efficient pricing model

Timeline advantage

The development time and thus the time-to-market are also greatly reduced. Product developments, enhancements and scaling can be planned and internal resources are conserved. CE-ready in 8 weeks is a standard.

Advantage of conformity as standard

We offer the mHealth Suite as a license model. This means that we take care of operation and hosting for you AND that your product is always up to date thanks to technical maintenance and regulatory updates. We support content updates, making it much easier for you to bring your expertise to digital healthcare.

Advantage of patient-centeredness

The mHealth Suite aims to provide the best possible communication of medical content and treatment plans. We offer proven concepts for indication-specific therapeutic approaches with a focus on added value for patients. We use our expertise from 12 years of experience with mobile software to achieve this. Because only user-friendliness that can be experienced can create adherence in patients – and thus the prerequisite for the effectiveness of the therapy.

Advantage of vertical scalability

The regulatory-compliant and modular architecture enables the rapid integration of patient feedback, expansion of medical content and entry into new markets (vertical scaling) without the need for complete redevelopment.

Advantage of horizontal scalability

High-speed technology enables the rapid creation of a broad digital portfolio (horizontal scaling).

These services are included in mHealth Suite's license fee

  • Development
  • Maintenance costs for apps
  • Maintenance costs for servers
  • Hosting for servers
  • Operation of servers
  • Third-level support
  • Technical assistance with second-level support
  • Further development (limited): Your content adaptations, optimized approach to patients, possibly supplementary exercises, up to improvement of therapy concept
  • Achievement, monitoring of conformity plus any necessary adjustments*:
    • Medical Device Regulation (MDR)
    • Digital Health Applications Ordinance (DiGAV)
    • BSI TR-03161 – Technical Guideline Cybersecurity
    • Data Protection test criteria for DiGAs and DiPAs (BfArM) including establishment of GDPR processes with the help of ready-made templates

* excl. certain manufacturer obligations that we as a supplier cannot/may not assume

Send us a short message - and we will get back to you

Making contact - simple and personal

We will be happy to answer your questions in a personal consultation and can give you an idea of how our technology solution and your therapy concept fit together.

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