Despite a growing interest, Health Technology Assessment (HTA) is not yet systematically applied in the German health care system. This is mainly due to characteristics peculiar to Germany (e. g. strict separation of office- and hospital-based health care). We analysed the current regulations, impediments and future chances for the generation of HTA studies and the use of their results. Pro-market approval of new technologies is regulated by federal laws for drugs and medical devices. Drugs have to demonstrate safety and efficacy with marginal effects being sufficient for approval. Approved drugs can only be marketed in Germany, whereas medical devices can be sold throughout the European Union. Medical devices have to follow a quality assurance procedure depending on their safety class. The most important requirements for devices are safety and usefulness. Diffusion and implementation of new technologies is separately regulated in the office-based health care sector and in the hospital-based sector. Within the office-based sector, new technologies must be approved by a joint commission of the federal physicians' association and the top organizations of the sickness funds to be reimbursable by the statutory health insurance. This commission is also responsible for approving measures like physical therapy. The threshold for accepting new technologies is usually low but prone to lobbyism. There is no comparable regulation in the hospital sector; new technologies are part of negotiations between hospital and physician associations at a local level with minimal input of scientific evidence. Future options include the optimisation of the approval process for the ambulatory sector and its extension to the hospital sector. Funding of HTA research seems to be reasonable with the aim to improve expertise and to create centers of excellence.