However, it criticizes the law's restrictions in the definition of digital health applications (DiGA) and therefore also digital care applications (DiPA).
While the DigiG takes the step of opening up health apps to higher risk classes of the Medical Devices Ordinance, all DiGA and DiPA approved under the IVD Ordinance remain excluded. "The legislator has missed the opportunity to enable better care for patients with DiGA. This hits people with diabetes particularly hard," explains Dr. Martin Walger, Managing Director of the VDGH. "We need a broader view that includes all patients instead of drawing arbitrary boundaries."
In future, diabetes patients with a sensor-based measurement system may benefit from DiGA. However, the majority use test strip-based blood glucose meters. As these are an IVD in the legal sense, a DiGA cannot be used here. The vast majority of the more than 8 million people with diabetes in Germany are left empty-handed.
"Germany is still waiting for the first digital care application. A DiPA that analyzes urine data, for example, could help carers to react more quickly to changes in the condition of those in need of care," explains Walger. "There are already products that are ready for use. The benefits for those in need of care and carers cannot be realized here either, as IVD-based DiPA is also excluded by definition."
In the VDGH's view, the legal definition of digital health applications and digital care applications urgently needs to be completed. "This is the only way we can ensure that all patients and those in need of care benefit from the advantages of digitalization," concludes Walger.
