Is it permissible to provide access to a DiGA app before insurance approval?

Question

We are developing a DiGA app and would like to allow users to start using the app before their insurance company has approved their access (i.e., before they receive the code that allows us to invoice the insurance). Our reasoning is that the insurance approval process can take a while, and we want to prevent users from becoming frustrated or losing interest while waiting for approval. We understand that this carries the risk of not being paid if insurance denies access, but we are willing to accept that risk.
From a regulatory perspective, is it allowed to provide users with access to a DiGA app before they have received insurance approval?

Dr. Oliver Eidel · Accepted Answer

If your DiGA app is CE-marked and complies with MDR, you can make it available to users based on the intended purpose, regardless of insurance approval. DiGA status affects reimbursement by health insurance, not the ability to put the app on the market. However, you should not expect insurance to pay for users who access the app before official DiGA listing or without a prescription.

Answer

Some DiGA apps, like Kalmeda, use a freemium model where users can access the app before insurance approval. However, be aware that you cannot use emails or push notifications to encourage non-DiGA users to convert to DiGA users or seek a prescription, as this may be considered advertising under current regulations.

Answer

The main regulatory requirement is that if your app is considered a medical device, it must comply with the MDR. The MDR does not specify when or how payment is made, only that the device meets the necessary standards. So, from a regulatory standpoint, providing access before insurance approval is allowed as long as your device is compliant.

Is it permissible to provide access to a DiGA app before insurance approval?

3 Answers

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