Table 1.

Selected key learnings and future legislative changes addressing these

Key Learning	Legislative Change Addressing the Learning
Restricting approvals to only medical devices of class I or IIa narrows the range of potential DiGA applications.	Future regulations will permit class IIb medical devices to qualify as DiGA, albeit with stricter requirements, such as the necessity for demonstrated medical benefits and no accelerated track.
There appears to be a discrepancy between DiGA pricing and their clinical benefits, indicating that the actual success of a DiGA is not adequately reflected in its cost.	Starting in 2026, a minimum of 20% of a DiGA’s reimbursement price will be linked to the achievement of (yet to be defined) success metrics.
Patient access to prescribed DiGA is often delayed, highlighting inefficiencies in delivery systems.	Health insurances will be mandated to provide access to DiGA within two days of prescription, aiming to reduce patient waiting times.
DiGA integration into the broader German healthcare system is currently insufficient.	Increased requirements for DiGA integration into electronic health records systems are anticipated, with an emphasis on interoperability.
A significant number of users discontinue using their prescribed DiGA shortly after initial registration or first use, suggesting issues with user engagement or application efficacy.	A proposed 14-day trial period for DiGA was included in the first versions of the new legislation, but was not included in the final draft.