Digital Future
Shaping health together:
The BfArM as a partner in Germany and Europe.
Hardly any other topic is currently shaping the healthcare system as much as digitalisation. It offers enormous opportunities for optimal care, the development of new therapies and efficient healthcare. These innovations should reach patients without unnecessary delay. With its worldwide leading digital competence, the BfArM acts here as a competent partner among the other institutions in charge of the approval and surveillance of medicinal products and medical devices.
The primary goal of all our measures is to increase patient safety. The field we are working in has always been characterised by highly dynamic processes. However, our mission has remained the same at all times: The authorisation and improvement of the safety of medicinal products, the risk identification and assessment of medical devices as well as the monitoring of narcotics and precursors are the core issues that determine our actions.
We are advancing new therapeutic options and using the opportunities of digitalisation. We associate this with very concrete ideas and visions that run through almost all areas of work at the Federal Institute. In our impulse report, we would like to present some of these areas to you; showing how the Federal Institute is already helping to shape these developments today and how it intends to continue to advance them in the future together with its cooperation partners in Germany and Europe.
Prof. Dr. Karl Broich
Digitalisation is in the process of fundamentally altering the nature of healthcare provision. Above all, the rapidly increasing amount of health data offers enormous opportunities: “How we prepare care-related data from many different sources and combine it with the knowledge gained from clinical studies will crucially determine our work in the future,” says Professor Karl Broich, MD, President of the Federal Institute for Drugs and Medical Devices.
Dr. Wiebke Löbker
The development of medicinal products and medical devices is characterised to a significant extent by increasingly dynamic processes and a great potential for innovation. In addition to other aspects, digital products open up completely new possibilities, which need to be explored in the most comprehensive manner. The Innovation Office provides regulatory support to developers while looking ahead into the future of healthcare at the same time.
Dr. Wolfgang Lauer
The dynamic developments in the field of medical devices will continue to pose particular challenges for regulators in the future, as innovations in this area do not stop at boundaries of indication, sector or technology. The BfArM assumes an important role in this context: it supports these innovations while at the same time ensuring that safe medical devices are available in the healthcare system.
Dr. Michael Steffens
The future of medicine and its progress are inseparably linked to the evaluation of a wide range of health-related data and the use of Artificial Intelligence (AI). At the BfArM, AI is already being applied in specific fields. The Federal Institute aims to play a pioneering role for Europe in the use of these methods.
Dr. Stefanie Weber
Digitalisation in the healthcare system would hardly be conceivable without semantics. On the basis of a uniform terminology, it is possible to process data automatically and even to search for specific patterns and information. The BfArM’s experts in cooperation with the World Health Organization (WHO) are working on the development and worldwide advancement of corresponding systems.
Dr. Martina Weise
Healthcare data is naturally not only generated in Germany, but on a global level as well. For the European medicines regulatory network, this poses enormous potential, for example, to support regulatory decisions with evidence from medical practice. The BfArM is part of this network and is involved in the development of appropriate concepts to allow for the efficient use of such data.
Annual Reports
The publications of the Federal Institute for Drugs and Medical Devices offer a further source of information.