MedTech Europe perspective on the German draft law on Digital Care Modernisation (DVPMG)

MedTech Europe would like to share some considerations on the German draft digital care modernisation law (“Digitale Versorgung und Pflege Modernisierungs Gesetz, or DVPMG), supporting the position of our German member association BVMed articulated on 15 March 2021.

Recommendations

To advance patients’ access to their data, improve healthcare delivery, and support the implementation of the EHDS, we would suggest taking the following recommendations into account:

• To allow for appropriate transition times. The envisaged transition time of two years is too short, given that the development, testing and approval cycles for new medical devices take at least three to four years. Advanced connected medical technologies are made for a global market. Manufacturing devices to new specifications will present considerable barriers for the European and international medical technology industry to providing them to national healthcare systems. A transition period of a mere two years could lead to a disruption of supply for German patients.
• To ensure compliance with international consensus standards. Advanced connected medical technologies are designed for a global market. Country-level regulations requiring local adaptions to the device design to comply with additional local specifications present considerable challenges and constitute a barrier to the launch of medical technology solutions on the German market. The broader impact of the current draft requirements should be considered, and a regulatory approach is favoured where the German requirements are aligned with robust and recognised international consensus standards.
• To work with industry. When ensuring health data transfers, the medical technology industry should be considered a partner in the process. Instead of requiring manufacturers to create interoperable interfaces (“interoperable Schnittstellen”), we recommend that the law defines the objectives, and the Government supports the established interoperability organisations and mechanisms like those of Integrating the Healthcare Enterprise (IHE).

We are ready to discuss any questions and look forward to supporting further improvements to the draft German “DVPMG” and Europe’s digital transformation of healthcare.

To know more, please download the complete document here below.