The BfArM updates the DiGA guidelines regularly. Unfortunately, there is no detailed change history available for this yet. We therefore continuously review all changes to the DiGA guidelines and prepare them for you. We present all changes here in a clear format with images and comments.
The current DiGA guidelines from the BfArM are available here.
Legend: Color coding to illustrate the changes
In the screenshots taken from the respective version of the DiGA guide, all changes are highlighted in color. The following colors are used to indicate the type of change.
| Color | Type of change |
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Additions |
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Deletions |
Changes between version 3.5 and version 3.4 of the DiGA guidelines
Changes to section 2.2.1.3 “Information for service providers”:
The second last point in the list “Information relevant to the regulation” has been supplemented with the addition “and specified maximum amount.”
New version 3.5:
Old version 3.4:
pure addition of new information – no equivalent in old version
Changes to section 3.4.2 “Safety as a process”:
In the FAQ section, the requirement to perform penetration tests as part of the security process has been tightened.
New version 3.5:
Old version 3.4:
pure addition of new information – no equivalent in old version
Addition of a new section 3.5.4.4 “Writing the DiGA into the ePA/implementation of the Health ID”:
The new requirement for all manufacturers, namely to include DiGA in the ePA and implement the Health ID, is explained. The implementation deadline for this is April 30, 2024.
New version 3.5:
Old version 3.4:
No equivalent in old version, as new chapter
Changes to section 4.2.2 “Specification of the positive pension effect”:
A new note clarifies the BfArM’s requirement regarding the demonstration of multiple positive effects on healthcare. According to this, DiGA manufacturers must first demonstrate at least one positive effect on healthcare, as required by a BfArM decision during the provisional approval process, before further positive effects on healthcare can be taken into account.
New version 3.5:
Old version 3.4:
pure addition of new information – no equivalent in old version
Changes to Section 4.3 “Use of DiGA data”:
The possibility of using an analysis of one’s own, already prescribed DiGA during the trial period for the submission of evidence for final inclusion has been specified. It is permitted to use an analysis of your own data collected during the trial period in close proximity to care as support for providing evidence for permanent inclusion. It is important to ensure that the procedure has been defined in advance and described in detail in a separate study report.
New version 3.5:
Old version 3.4:
Changes to section 4.3.3 “Transferability of study results”:
In the section “Conduct of the study in Germany,” the BfArM has specified three criteria to demonstrate the transferability of the study results to the healthcare context in Germany.
New version 3.5:
Old version 3.4:
Changes to section 5.2.2 “Change to the DiGA designation”:
It should be noted here that a change in the name of a DiGA constitutes a significant change and must be reported to the BfArM.
New version 3.5:
Old version 3.4:
pure addition of new information – no equivalent in old version
Changes to section 5.2.3 “Short name and PZN”:
A new note has been added to the “Pharmaceutical Central Number” sub-section: When the short name of a DiGA is changed, a new Pharmaceutical Central Number (PZN) is assigned.
New version 3.5:
Old version 3.4:
pure addition of new information – no equivalent in old version
Changes to section 5.2.4 “Reference to transition periods”:
The new deadlines for the transition are listed in section 3.5.4.4.
New version 3.5:
Old version 3.4:
pure addition of new information – no equivalent in old version
Further changes to the DiGA guidelines
We update this article with every update to the DiGA guidelines.
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