DiPA sind wie die bekannten DiGA digitale (medical) products, namely applications to assist with long-term care via smartphone, tablet or desktop.
Following the publication of the first DiPA guideline by the BfArM on 2 December 2022, the electronic application portal has now been opened. Applications for inclusion of a DiPA in the DiPA directory can be submitted via this portal. To submit an application, the medical device manufacturer requires a completed conformity assessment procedure with the corresponding documentation:
- for safety and functionality,
- on data protection,
- for data security,
- for interoperability,
- Proof of the benefit of care (study)
Proof of the care benefit is likely to be the biggest obstacle and must be proven by a study. According to the definition of the DiPAV (DiPAV (Digital Care Applications Ordinance) , a care benefit consists of reducing impairments to the independence or abilities of the person in need of care or counteracting a worsening of the need for care.
The DiPA is used to support the person in need of care exclusively in a domestic context. It is not a DiPA if the digital application is primarily used to provide support with general tasks or general lifestyle, to impart knowledge, to apply for benefits and to provide information or advice on the selection and utilisation of social benefits or other assistance. The maximum reimbursement limit is currently €50 per month per person in need of care for DiPA expenses.
We at BEO BERLIN can also help you with DiPA from A-Z. We are familiar with many verification and procedural issues and the hidden pitfalls from our daily work with DiPA-, HMV-, CE- and QM requirements.
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