Diegeler A
Herz- und Gefäßklinik Bad Neustadt, Salzburger Leite 1, 97616, Bad Neustadt an der Saale, Deutschland.
Herz. 2016 Mar;41(2):120-4. doi: 10.1007/s00059-016-4411-y.
Cardiology is rapidly developing on many levels. New treatment methods are introduced at ever decreasing intervals. Against the background of economization of other areas in medicine, dangers are lurking here for patients if safety, usefulness and sustainability of the treatment methods cannot be sufficiently proven. The German Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) aims to adjust the regulatory framework for the approval of new medical products to the legal requirements of the European Union. With the establishment of the Institute for Quality Assessment and Transparency in Health Care (Institut für Qualitätssicherung und Transparenz im Gesundheitswesen, IQTIG) more precise quality controls should be carried out. Implantation registers will be soon implemented and the routinely performed quality control of different interventions will be coordinated across different healthcare sectors in order to achieve a better understanding of long-term results. Medicine in general and the safety of patients in particular, ultimately benefit from more stringent controls, neutrality and transparency in the assessment of new methods.
心脏病学正在多个层面迅速发展。新的治疗方法推出的间隔时间越来越短。在医学其他领域节约成本的背景下，如果治疗方法的安全性、有效性和可持续性不能得到充分证明，患者就会面临危险。德国联邦卫生部旨在使新医疗产品审批的监管框架符合欧盟的法律要求。随着医疗保健质量评估与透明度研究所（Institut für Qualitätssicherung und Transparenz im Gesundheitswesen, IQTIG）的成立，应进行更精确的质量控制。植入登记即将实施，不同医疗部门将协调对不同干预措施进行常规质量控制，以便更好地了解长期效果。总体而言，医学尤其是患者的安全最终将受益于对新方法评估中更严格的控制、中立性和透明度。
