Huge advances in medical and information technology are transforming the healthcare sector in a special way. Innovative approaches in the area of telemedicine – from online consultation hours through to a healthcare app – are changing how doctors and patients interact. Electronically assisted monitoring, online coordination, management and evaluation of treatment methods help to improve the quality and cost effectiveness of patient care and, at the same time, offer possible solutions for the ongoing depletion of medical care in economically weak regions. New personalised production methods such as the 3D printing of drugs or medical devices as well as treatment with gene-modified cell therapies are giving rise to new treatment options while, at the same time, creating challenges for the healthcare system. AI applications already continuously monitor vital functions of their users as well as, increasingly, harmful effects such as excessive solar radiation. In the healthcare system of the future, the treating physicians will only be consulted in a second step, and only in the case of serious illnesses. AI applications will perform the initial diagnosis. At the same time, the doctors will be notified immediately via data transmission if their patients have abnormal health markers and will be able to actively arrange for the necessary action to be taken.
For many years now Gleiss Lutz has been tracking the technical developments as well as the legislator’s activities in the area of digital health. As advisors and experts, our lawyers are heavily involved in the restructuring of the regulatory framework of the healthcare market in the area of drugs and medical devices. They provide their clients with competent advice on all regulatory, medical law, IT and data protection-related matters as well as on issues concerning liability.
Our lawyers’ experience has come from working on large, complex IT infrastructure projects in the healthcare sector (e.g. outsourcing of computer centres), advising on innovations in medical treatment and in the manufacture as well as distribution of drugs and medical devices. We continuously advise healthcare providers in the online sector on the development of new business models. We are very familiar with the relevant questions concerning data storage and transmission between service providers in the medical sector (electronic health card, electronic patient file, electronic doctor’s letter, etc.), the setting up of new communication platforms by social security institutions, evaluation and comparison portals on the internet or the development of new service offerings at interfaces between stationary and outpatient care by means of electronic databases and platforms.