Digital Therapies or Placebo-apps? Differences between "Health Apps" and DiGAs

For start-ups in the healthcare sector, it is crucial to understand the differences between a conventional health app and a Digital Health Application (DiGA).

While there are over 10,000 health apps, only around 60 (as of early 2025) apps have been able to demonstrate their benefit and safety as DiGAs.

A health app is a mobile application that deals with topics related to the health of users.

It aims to maintain or improve health and can have preventive or health-promoting effects. Health apps are primarily aimed at health-conscious users and offer support in areas such as prevention, education, and health promotion. These products may, but need not be, medical devices.

A Digital Health Application (DiGA) is a CE-marked medical device whose main function is based on digital technologies.

DiGAs support the detection, monitoring, treatment or alleviation of diseases or the detection, treatment, alleviation or compensation of injuries or disabilities. They are used by patients or by healthcare providers (e.g. physicians, psychotherapists, physiotherapists) and patients together and can be prescribed by physicians. The costs for DiGAs are covered by German statutory health insurance.

DiGAs differ significantly from conventional health apps in their regulatory status, reimbursement eligibility, and requirements for evidence. The following table provides an overview of the key distinguishing features:

While health apps offer low-threshold access to the health market, DiGAs place higher demands on developers but also offer the potential for deeper integration into healthcare provision and secure financing through health insurance.

DiGAs are adapted to the prescription practice of healthcare providers. As they can be easily prescribed via the practice information system (PVS), are reimbursed by all statutory health insurance providers, and do not strain the medication and remedies budget (as of 2/2025), they are gaining increasing acceptance. Furthermore, healthcare providers and patients appreciate that they receive professional and technical support. This further increases acceptance.

For start-ups, the decision between a health app and a DiGA means carefully weighing up development effort, market potential and long-term strategy in the healthcare sector.

If you are interested in an evidence-based performance promise, please feel free to arrange an initial non-binding consultation with us. We are here for you!

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