MDR, DiGAV, BSI TR-03161 and data protection test criteria for DiGAs
Homecare:
How to make your homecare medical technology eligible for reimbursement
MedTech manufacturers are showing a growing interest in getting their medical technology-supported homecare offerings reimbursed by statutory and many private health insurers as digital health applications (DiGA). In the DiGA model, the devices are not aid supplies and are cross-financed via the DiGA reimbursement. Medical technology for homecare is suitable for therapeutic or diagnostic DiGAs.
with the mHealth Suite
DiGA-ready in 8 weeks
For MedTech companies
as a digital health manufacturer
The mHealth Suite is a platform for a plannable and strategic digital portfolio.
The mHealth Suite converts therapeutic or diagnostic business cases into digital mHealth application formats.
The product is developed in full compliance with the requirements of the MDR, the DiGAV, the BSI TR-03161 for data security and the test criteria for data protection for DiGAs and DiPAs (BfArM) – prerequisites for approval as a digital health application (DiGA) by the BfArM.
Demand for DiGAs in homecare
Diagnostics / tertiary prevention
Chronic diseases
Networked therapies or therapy support
In the homecare sector, there is a need for healthcare for continuous monitoring, treatment or alleviation of illnesses or impairments.
Which medical devices are suitable for DiGA applications?
Suitable for digital health applications (DiGAs) are medical devices that record health data or the detection of pathological conditions and transmit them to the accompanying app. By analyzing the data in the DiGA app, patients receive personalized therapy adjustments, recommendations for action, diagnoses or warnings.
DiGAs are approved by the Federal Institute for Drugs and Medical Devices (BfArM). The treatments are prescribed by a doctor and are reimbursed by all statutory and many private health insurance companies.
Product development with the mHealth Suite
The mHealth Suite reduces costs and timeline
✔ Data protection and data security
DiGA products by mHealth Suite fulfill the requirements for proof of data protection according to the test criteria of the BfArM (Federal Institute for Drugs and Medical Devices) – as well as for data security according to the Technical Guideline TR-03161 of the BSI (Federal Institute for Information Security).
✔ MDR and DIGAV conformity
A DiGA product by mHealth Suite meets the requirements of the MDR and DiGAV at all times. It is therefore also possible to launch the product as a lifestyle product – with certification as a medical device and application for DiGA approval at a later date, without any new development. Boost your business case with mHealth Suite Products, flexible, scalable, fast.
✔ Carefree package
These services are regularly included in the license price of the mHealth Suite
- 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
What is conceivable is now also feasible
Digital expansion of your homecare healthcare offering
Always on the safe side
DiGA for MedTech - safe and fast product development
- Product development incl. Hosting and maintenance
- All regulatory standards for medical devices and DiGA
- Brings homecare medical technology as DiGA in prescription with reimbursement