BVMed statement on the Health Data Usage Act: Ensure equal access to data
15.08.2023 14:48
In its statement on the draft bill of the Health Data Usage Act (GDNG), the Federal Association of Medical Technology (BVMed) welcomes the planned establishment of a data access and coordination point for health data and the connection to the regulation on the European Area for Health Data (EHDS). “What remains crucial is an equal treatment of all stakeholders when using data,” demanded BVMed digital expert Natalie Gladkov at the hearing of the Federal Ministry of Health (BMG) on the draft law.
At least 300 research projects are to be carried out or initiated using data from the research data center by the end of 2026, according to the goal of the “Digitization Strategy for Healthcare and Nursing” published in March 2023. The basis for this should be, among other things, the GDNG. BVMed welcomes the regulations provided for in the GDNG as an initial step towards better use of health data. “There are good approaches to research and development of medical technologies that could promote Germany as a healthcare and research location,” says the statement. At the same time, the medical technology association sees a need for optimization.
“In principle, it should be ensured that the data access and coordination office is sufficiently equipped to carry out the necessary tasks described in full and in a timely manner,” says BVMed. When developing a catalog of criteria for prioritizing applications, he calls for equal access for all data users. When it comes to data transfer obligations, the association also advocates for effective protection mechanisms for IP rights, trade secrets and patent applications.
“The focus should be on the intended use in terms of research and development. A contradiction solution for certain groups of actors is contrary to the actual goal of the GDNG,” says BVMed digital expert Natalie Gladkov. It could lead to certain researchers being unintentionally excluded from using the data. “Public-private cooperation projects, as they often occur in medicine, would be made more difficult or even prevented.” Last but not least, in this context, BVMed also demands that manufacturer associations be included in the advisory working group for the design, further development and evaluation of data access.