The healthcare system is facing considerable challenges. The constant cost pressure, the over-bureaucratization of treatment processes and the shortage of specialists are causing problems for medical care. Digitization, networking and technology can help improve this situation. The future 6G mobile communications standard will play an important role in this. In the 6G Health project funded by the German Federal Ministry of Education and Research (BMBF), VDE is working with 18 partners to make future 6G technology usable for medical devices and medical systems.
6G networked systems are characterized by a significant increase in speed, capacity and reliability compared to 5G networked systems. The project partners are investigating what performance characteristics the next generation of mobile communications must have in order to best meet the requirements of medical care.
The development of 6G is still in its infancy. The first networks based on the 6th mobile communications generation will probably not be available in Europe until 2030. In addition, 6G networks will be more than just radio networks, because as a "network of networks," the new 6G mobile communications standard integrates sensors, mobile communications and computing power on site, or "edge computing. This makes it possible to link the real world with virtual worlds. This integration also requires the use of artificial intelligence (AI) in network technology. In medical applications, communication and interaction between humans and machines will play an important role, for example in the close-meshed monitoring of patients under harsh real-time conditions, such as cardiac patients, who until now could only be cared for as inpatients over several years. This requires particularly low latency, which can be realized in 6G networks. In addition, more energy-efficient network operation can be implemented with 6G technology.
Medical applications of 6G networks (use cases)
From the medical-clinical perspective, the initial focus is on 3 application examples:
Patient monitoring: Biosignals collected directly from patients, such as blood pressure, body temperature, respiratory rate and other vital signs, are tracked remotely in real time. The goal is to ensure clinical collaboration - even after discharge from the hospital. For this purpose, innovative, non-invasive sensor technology for extended clinical applications in the perioperative and telemedical area will be realized as "Remote Monitoring" and "Remote Patient Management". Novel sensor technology will be combined here with advanced 6G mediated network intelligence.
Collaborative teamwork in medical care: Doctors and nurses will be able to work together better in the future using enhanced network functionalities. Using AR (augmented reality) or telemedical functionalities, doctors can, for example, view three-dimensional representations of organs and tissues for preparation before operations or consult specialists for complex interventions.
Smart Hospital: This is about networking medical devices and the communications infrastructure for the digital and networked hospital. 6G mediated services and systems enable new types of processes so that treatment and logistics processes can be made more efficient and safer.
The potential of 6G networks in medicine and medical technology is huge and extremely promising due to their technical characteristics. The 6G Health project will therefore also lay the foundation for a large number of other 6G mediated applications that have great benefits for medical care and beyond. The identification, elaboration and specification of these 6G Health use cases will therefore be continuously expanded.
Compliance requirements for 6G networks in medicine and medical technology: laws, standards and rules
A number of regulatory and normative issues arise in the development and use of 6G networks in medical applications. As the complexity of technologies increases worldwide, so does the scope of corresponding (technical) rules and regulatory requirements. Technologies with medical applications are particularly affected by this development, as the aim here is always to reduce patient risks as far as possible. In the European Union market in particular, compliance requirements have increased significantly in recent years and have ultimately also become an innovation-determining step. If it is not possible in the research and development phase to take into account subsequent compliance requirements with regard to technical solutions, design features, software architecture or clinical characterization from the outset and to develop appropriate solutions, there is a high risk that the market access of a new technology will fail for regulatory reasons. Therefore, the goal is to address compliance requirements as early as possible through our VDE "Conformity-by-Design" approach and to consistently incorporate them into technology and application development. This enables us to significantly accelerate the transfer of new technologies into medical applications. This also applies to all aspects of IT security (cybersecurity), because the type and volume of data that are processed require IT security to be included from the very beginning. Cybersecurity cannot simply be "built in" at the end.
Standards play a key role in the compliance requirements of 6G networks with medical applications. Standards have a dual function: on the one hand, they enable technologies to function according to specifications by specifying interfaces, communication profiles or performance parameters, for example. In this way, they create the appropriate framework conditions for the subsequent market, because only technology that meets the specifications of the standards can interact with other components within a system and be successfully marketed. On the other hand, the specifications of standards represent an essential part of the state of the art in the regulatory sense, i.e. essential regulatory requirements, e.g. with regard to safety and performance, are based on standards and must also be proven accordingly for approval. In addition to standards, there are also a large number of guidance documents, sub-normative technical rules and recommendations that also reflect the state of the art and can be just as important in individual cases as, for example, an internationally valid standard. In addition, there is the multitude of laws and other legal acts, such as the European Medical Devices Regulation ((EU) 2017/745 (MDR)), whose application is mandatory.
The work carried out in the 6G Health project represents both technological and regulatory uncharted territory. Currently, there are no 6G networked systems with medical applications and no corresponding technical regulations that are explicitly geared to these applications. VDE will therefore work with the project partners to drive forward the international standardization and approval processes for 6G medical systems.
6G Health project partner
- Berlin Heart GmbH
- Charité medical university
- CTC advanced GmbH
- ERNW Research GmbH
- Fraunhofer HHI (Heinrich-Hertz-Institut)
- Infineon Technologies AG
- inomed Medizintechnik GmbH
- NXP Semiconductors Germany GmbH
- SectorCon GmbH
- Siemens AG
- Smart Mobile Labs AG
- SurgiTAIX AG
- University Bremen
- University Halle-Wittenberg
- University Leipzig (medical university and ICCAS)
- University Rostock
- VDE e.V.
- Vodafone GmbH (Coordinator)
Are you dealing with questions about 6G networks in medicine and medical technology as well as the realization of potential use cases? Feel free to contact us! The 6G Health project also serves to prepare a corresponding stakeholder platform to systematically develop and specify 6G technology and corresponding application scenarios.