The environment for companies is changing rapidly. The digital transformation is in full swing and is also affecting the diagnostics industry. Ultimately, all areas of the company are affected, from research and development to production, sales and cooperative structures with laboratories. This results in opportunities through the exploitation of efficiency potential, new business areas and better networking in the supply chain.
As far as the increased digitalization of the healthcare system is concerned, the VDGH emphatically welcomes the healthcare policy and legislative activities that are gradually contributing to an accelerated transformation. Patients, the insured, service providers and payers will all benefit from this. For the chronically ill, digital health services can optimize treatment processes and make everyday life considerably easier. This is particularly true for people with diabetes. For hospitals, in-vitro diagnostics are an important component of clinical decision support systems (CDSS). The Hospital Future Act, which came into force in October 2020, explicitly promotes such systems as they drive digitalization in the inpatient sector.
A lot is happening on the product side. Medical apps & co. are conquering the market. They can lead to significant improvements in healthcare in many areas. Fortunately, the legislator has taken this into account and included digital health applications as a new benefit category of statutory health insurance in SGB V. Digital health applications (DiGA) undergo a review process at the Federal Institute for Drugs and Medical Devices (BfArM) and can then be reimbursed by the SHI. The first digital products have already successfully completed this process. Together with other manufacturers' associations, the VDGH regulates the principles of reimbursement in framework agreements with the GKV-Spitzenverband. In the interests of patients, it is to be hoped that further consultations will not lead to restrictive reimbursement practices. The VDGH believes that there is an urgent need for legislation on the legal definition of DiGA. It is incomprehensible that only medical devices are included here, but not in vitro diagnostics. This should be implemented promptly in the next digital legislation for the healthcare sector. Furthermore, it is difficult to understand why medical devices are currently restricted to the lowest risk groups. This restriction hinders beneficial product developments and should therefore be abandoned.
Data protection is important and must be taken seriously - especially when it comes to sensitive health data. However, data protection regulations must not be so restrictive that the opportunities associated with digitalization are thwarted. For example, data-based applications can make a significant contribution to improving diagnostics and therapies through the use of big data analysis and artificial intelligence methods.
Regulated access to health data for private research would enable new research approaches and strengthen Germany as a location for health research. Private research is the driving force behind German research activities. In 2018, around 90 percent of clinical studies came from industry. Real care data from digital apps or electronic health records enable industrial research and product development to be tailored even more precisely to the needs of patients. For this reason, healthcare data should be made available to all research institutions - both public and private - in anonymized or pseudonymized form following patient consent.