"The Federal Cabinet today missed an opportunity to integrate digital health applications (DiGA) more deeply into healthcare. While the planned expansion of DiGAs for certain medical devices is welcome, the potential of in-vitro diagnostics has been completely neglected," says VDGH Managing Director Dr. Martin Walger. "It is incomprehensible why DiGAs are excluded in connection with in-vitro diagnostics (IVD). Chronically ill patients in particular, such as diabetics, could use digital applications to manage their disease much better themselves and thus delay a worsening of their illness. With over 8 million diabetics, this could make care much more efficient and save healthcare expenditure elsewhere. Improvements to the Digital Act are needed here."
Dr. Walger points out that digital care applications (DiPAs) could also benefit greatly from the inclusion of in-vitro diagnostics. "Enormous potential is being wasted here so that people in need of care can remain in their home environment for as long as possible with the support of DiPAs. It would also make sense for DiPAs to include in-vitro diagnostics in the legislative initiative in order to noticeably improve care provision and make it more efficient," says the VDGH's Managing Director.
The association welcomes the decision to consolidate data protection in transnational health research projects with a lead data protection supervisory authority. "A uniform interpretation of data protection will promote innovation in the healthcare sector," emphasizes Dr. Walger. The planned purpose-based access to pseudonymized health data is also seen as an important step forward.
It is now important to ensure that this data is stored in accordance with international standards and that data retrieval does not cause any unnecessary additional bureaucracy. "Legislation should create an environment that does justice to both data protection and the innovative capacity of the German healthcare industry," says the association's CEO.
