Software as a Medical Aid in the GKV Medical Aids Directory
Software can be listed as a medical aid in the GKV medical aids directory. This route is little known among digital health manufacturers, yet it offers direct access to standard care coverage across all statutory health insurers. For eligible products, it is faster than the DiGA pathway and involves less regulatory effort.
Legal Basis
The medical aids directory is based on § 139 SGB V. The GKV-Spitzenverband creates and maintains it. Products are admitted when they demonstrate functional suitability, safety and medical benefit.
Under § 33 SGB V, medical aids are items that secure the success of medical treatment, prevent an impending disability, or compensate for an existing one. The Federal Social Court confirmed in 2001 that software falls within this definition. The directory now covers 42 product groups with around 44,000 products. No dedicated product group for standalone software exists yet. Manufacturers must assign their product to an existing group.
Concrete Example: VISIOcoach
A clear example is VISIOcoach by Odilia Vision GmbH. The training software supports patients with homonymous visual field defects following stroke through compensatory saccade training. It is listed in product group 99 "Miscellaneous" (HMV no. 99.21.01.1002) and prescribed on Form 16. This shows that medical training software has a place in the HMV when the indication and evidence are sound.
Further examples appear in product group 16 "Communication aids", subgroup 5. Eight software products are listed there, including communication aids for people with limited verbal communication.
Process: Five Steps to Listing
The admission process follows a clear structure. First, the manufacturer checks whether the product has the character of a medical aid and fits an existing product group. Second, requirements are met: CE marking as an MDR medical device simplifies the proof of functional suitability and safety, but is not mandatory. Third, the application is submitted online to the GKV-Spitzenverband. Fourth, the GKV-SV reviews the application: completeness check within ten weeks, decision within three months. Fifth, the manufacturer negotiates reimbursement, either by joining existing framework contracts or through individual agreements with each insurer. The entire process takes six to twelve months.
Classification: HMV vs. DiGA
The HMV suits products with the character of a medical aid: they support, replace or relieve a function. DiGA targets therapy-accompanying applications. Both routes guarantee reimbursement by all statutory health insurers. The difference lies in the reimbursement logic: in the DiGA process, the manufacturer negotiates centrally with the GKV-Spitzenverband. In the HMV, the manufacturer joins existing contracts or negotiates with each insurer individually. For eligible products, the HMV route is faster and involves less regulatory effort.
Conclusion
The GKV medical aids directory is an underestimated reimbursement route for software. Manufacturers whose product supports or compensates for a function should check whether a suitable product group exists. When the fit is right, this opens direct access to standard care coverage with manageable effort.
Sources: GKV-Spitzenverband: Procedure for the creation and updating of the medical aids directory pursuant to § 139 para. 7 SGB V, last updated 2023. GKV-Spitzenverband: Update of product group 16 "Communication aids", November 2022.
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