After DiGA now DiPA: Care app for the elderly in Germany

Health tech start-ups on the rise in the german healthcare sector

Author: Fiona Schönbohm, attorney for start-ups in Hamburg and Berlin

After the german healthcare market also opened up for so-called digital health applications (DiGA for short) in 2020, the founding of startups in the health tech sector has increased significantly. Since 2022, DiGA in the care sector - so-called digital care applications (in short: DiPA) - are now also reimbursable under certain conditions. The most important facts in brief:

DiGA: Certification and confirmation of the positive care effect under german law

First, a bit of background information: DiGA are apps that support german patients in the detection, monitoring, treatment and/or alleviation of complaints and diseases.

They can already be prescribed by the doctor and reimbursed by the health insurance in Germany since 2020, if they

1. Have received the CE certificate from the EU confirming the requirements for safety, functional capability and quality,
2. provide proof that they meet the European requirements for data protection and data security, and
3. the German Federal Institute for Drugs and Medical Devices (BfArM) confirms the existence of a positive supply effect either for the medical benefit of the patient or recognises a patient-relevant structural or procedural improvement in Germany.

If these conditions are met, DiGAs are included in the german DiGA directory of the German Federal Institute for Drugs and Medical Devices (BfArM). There, users can view various information on the DiGA in german practice. If a positive care effect has not yet been sufficiently proven under german law, inclusion can also take place on a trial basis for 12, maximum 24 months.

Since 2022: Digital care applications (DiPA) under german law

DiPA are a subtype of DiGA. DiPAs include technology-based applications that serve to determine, monitor or improve the state of health of older people in Germany. After the German cabinet passed the digital reform for care in January 2022, DiPA can now also be reimbursed by the long-term care insurance fund in german practice.

This includes, for example, apps that offer exercises to improve mental and physical fitness - to improve limited mobility or combat dementia, for example. But there are also apps on the german market to improve communication with relatives, outpatient care services, care professionals and doctors in Germany.

Prerequisite for DiPA under german law: nursing benefit

Just like DiGA, DiPA must also fulfil the european requirements in medical law for safety, functional suitability and quality within the framework of CE certification as well as the prerequisites of data protection.

Instead of the positive care effect for inclusion in the german DiPA list, the so-called "nursing benefit" is used for the DiPA; instead of the patient-relevant procedural and structural improvement, in nursing it is the improvement of the "organisation and management of everyday nursing care".

This also includes those DiPAs that are used by caring relatives and not by the persons concerned themselves in Germany. The latter are explicitly to be relieved in the organisation of home care.

Procedure: Applying for DiPA reimbursement in Germany

Unlike DiGA, which is often only reimbursable on a doctor's prescription, DiPA is intended to work without a doctor's prescription in german practicte. Moreover, not only the persons concerned but also their authorised representatives can apply to the long-term care insurance fund for reimbursement in Germany.

Upon request, long-term care insurance funds can also cover the costs of digital care applications in Germany that are not listed with the BfArM as a voluntary benefit.

Entitlement to reimbursement: Who is entitled to DiPA in Germany?

Persons in need of care of all care levels who receive home care benefits from the long-term care insurance are entitled to the use of a DiPA and, if necessary, also to necessary supplementary support services from an outpatient care service in german practice.

The entitlement is a maximum of 50 euros per month. If a DiPA is to be used in Germany, the costs of which exceed the remuneration amounts, the persons concerned must bear the additional costs themselves. For 2022 alone, the german long-term care insurance funds expect expenditures of 30 million euros for DiPA alone.