In September, we had the great honor of welcoming Prof. Dr. Karl Broich as a speaker at our fireside chat. As the President of the Federal Institute for Drugs and Medical Devices (BfArM), Prof. Dr. Broich has played a significant role in shaping the digitalization of the German healthcare system in recent years. During this time, the BfArM has acquired new competencies and demonstrated that regulatory institutions can and want to explore new avenues.
For manufacturers of Digital Health Applications (DiGA), the BfArM has become an indispensable player in the digital health scene. With the implementation of the DiGA Fast Track for the approval of DiGAs and the maintenance of the DiGA directory, Mr. Broich has shown that Germany can also be a pioneer – hardly any other Digital Health sector is perceived as positively abroad as in Germany.
In a conversation with our Managing Director, Laura Wamprecht, he also reminded us that we must continue to pursue this role ambitiously because other countries are poised to overtake us. For example, diagnostic DiGAs and DiGAs of higher medical risk classes, as already provided for in the PECAN model for reimbursement in France, play a role in this competition.
Furthermore, the Research Data Center (FDZ) was discussed, another milestone in the digitalization of healthcare. In this context, Karl Broich outlined his goal of creating a user-friendly application process because the ambitious goal of 300 research proposals in three years was formulated in the Ministry of Health’s digital strategy. All stakeholders are aware that this requires a powerful infrastructure and streamlined processes.
In addition to these two aspects, many other forward-looking topics were discussed, such as the use of AI at the BfArM, digitalization of clinical trials, and decentralized study designs, the provision of innovative drugs in the context of personalized medicine for conditions like diabetes or Alzheimer’s, and the question of when we might have more of a “medical ecosystem” in which the various components of pharmaceuticals, medical devices, in-vitro diagnostics, and digital medicine are interlinked.
Sustainability was also a prominent theme, as it will increasingly play a role in approval processes, and concepts like “green added value” are becoming more popular.
Our guests also had interesting questions for Prof. Dr. Karl Broich, including incentives that should be created for healthcare professionals to use digital medicine, whether the acceptance of evidence is created through real-world data (RWD), how the quality assurance of health data is structured, and whether it should be considered a public good. As future prospects for the coming years, significant progress in the digitalization of the pharmaceutical sector, which includes the use of Large Language Models (LLMs), as well as the scaling of telemedicine and the growing importance of DiGAs and interoperability between different tools, were emphasized.
At Flying Health, we eagerly anticipate the future development of these topics and look forward to innovative advances in digitalization. Many thanks to Prof. Dr. Broich for the multifaceted fireside chat and to our wonderful guests who, as always, brought exciting perspectives and arguments to the discussion.