Tuttlingen – MedicalMountains GmbH has presented a position paper on the planned content of the Digital Supply and Care Modernization Act (DVMPG). Even after the most recent hearing in the Bundestag Health Committee, questions remain unanswered.
It is undisputed that digitization in the healthcare sector should and must progress. However, the paths taken by the federal government at the DVMPG are causing concern. The position paper takes up criticisms that have been expressed in relation to the integration of open and standardized interfaces in aids and implants. In the previous draft legislation, Section 374a states that medical device manufacturers must provide any data from implants and aids that require a digital health application (DiGA) via interfaces. "This would affect, for example, cardiac pacemakers, defibrillators and insulin pumps," says MedicalMountains Managing Director Julia Steckeler. The planned retrofit met with a lack of understanding. "An integration of open interfaces should only apply to new aids and implants, everything else would be unrealistic," says Julia Steckeler.
A public hearing on the planned DVPMG took place in the Bundestag Health Committee last week. From the point of view of MedicalMountains GmbH, the results have remained rather vague. "There are still ambiguities, especially with regard to the possible retrofitting of interfaces," says Julia Steckeler. There is some relaxation with the timeline. The draft law had previously assumed a deadline of 2023. "The integration of interfaces should only be mandatory for those products that are certified from July 1, 2025 at the earliest and declared reimbursable by the health insurance company," is the demand in the position paper. Now an extension to 2024 seems to be in the offing.
The position paper is available at this link .
