Digital law: draft endangers innovative digital health applications

19.07.2023 12:59

“The practical relevance is crucial: the successful integration of the electronic patient record as a central element of digital, patient-centered healthcare depends on its effective implementation in real applications,” comments Dr. Hubertus Cranz, General Manager of the BAH, presented the draft bill for the Digital Act (DigiG).

From BAH's perspective, the current draft contains many sensible approaches. Particularly in digital medication management, which for the first time also includes over-the-counter medicines and nutritional supplements, it is crucial to ensure intelligent and user-oriented implementation.

“We support the possibility of classifying digital health applications as Class IIb medical devices in the future. However, austerity measures must not lead to a threat to innovative service areas,” says Cranz and warns against a one-sided view of the DiGA’s costs.

The current draft law provides for a significant restriction on the DiGA manufacturers' claim to remuneration within the framework of the benefit in kind principle. The DiGA manufacturers' claim to remuneration is limited by, for example, no remuneration if an insured patient states within a defined period that they will not use the DiGA permanently. Mandatory pay-for-performance models in the area of DiGA also prove to be counterproductive: “One-sided cost-containment measures take the principle of cost-effectiveness into the absurd and thus endanger the offer of innovative services, which in turn threatens the further development of innovative therapy options,” says Cranz . The establishment of DiGA in standard care is still an ongoing process. Therefore, the application of existing price determination measures is sufficient. “Additional regulations would be disproportionate given the current manageable turnover of 49 million euros for digital health applications,” said Cranz.