The wide variety of legal definitions of medical devices as well as the rapidly evolving medical device sector needs to ensure a sustainable set of regulations. Public health systems in the EU need to adapt to meet new needs, said lawyer Mihailova, presenting the different legal definitions of medical devices and their legislative scope. The process of digital transformation and the need to change mindsets are essential for a secure partnership in cross-border medicine. The level of regulation among digital health, digital medicine and digital technology is different and poses different challenges among the industry and healthcare decision makers. According to the pannelists governments are more focusing on technology transformation, which does not lead to digital transformation and there is a huge need to recruit experts, and a comprehensive eHealth and digitalisation strategy for the sector. They also presented various best practices from Germany and France in the area of digital solutions. During the pannel session healthcare professionals presented their perspective on the affordability and necessity of medical devices in precision medicine. New biomarker diagnostics are a prerequisite for high-quality personalized care, but remain a challenge for health care payers and have not been formalized in our health care system. A number of innovative diagnostic solutions are available in many therapeutic areas, but unfortunately are not reimbursed and the patient must pay. Attempts to digitise various processes are being carried out piecemeal and lack an overall strategy – digital solutions should reduce the administrative burden on medical professionals and help them to focus more on clinical and patient needs.
