NEWS on implant administration

Concerns about shortages of orthopaedic implants due to the EU Medical Device Regulation

The German Society for Endoprosthetics (AE) is concerned about potential shortages of artificial hip and knee joints. Bureaucratic hurdles urgently need to be removed, as otherwise the EU Medical Device Regulation (MDR) would increasingly jeopardize patient safety, it said today. The MDR, which came into force in 2021, has been...

The doctor-patient relationship and the commercial use of health data in the EU

A common European health data network is planned in the EU (European Health Data Space - EHDS). Problems are seen in the fact that the relationship of confidence and the doctor's duty of secrecy must be maintained. The sovereignty of the data should remain with the patient. The EHDS is...

German implant registry goes into trial operation

The Implant Registry Germany has received the first data on breast implants from hospitals. This marks the start of trial operation, the Federal Ministry of Health (BMG) announced today. Technically, the register has been operational since March 31 of this year. The registry will deal with breast implants, as well...

How the EU Commission nationalizes health data

The healthcare sector needs digitization, that is undisputed. The focus of the public debate so far has been on efficiency gains and cost savings, as well as data-driven improvements in care. The potential is enormous, because digitization creates resilience and strengthens Europe's economic sovereignty, and - most importantly - it...

Reorientation of independent patient counseling in Germany

From 2024, the Independent Patient Counseling Service (UPD) in Germany will no longer be run as a non-profit limited liability company but as a foundation under civil law. Ab 2024 wird die unabhängige Patientenberatung (UPD) in Deutschland nicht mehr als gemeinnützige GmbH sondern im Rahmen einer Stiftung bürgerlichen Rechts geführt....

Germany: Health insurance fund does not have to pay for breast augmentation for psychological reasons

The complaint was filed by a 52-year-old woman, who had already undergone breast augmentation with saline implants at the age of 26. When she visited her gynecologist because of a leaking implant, he diagnosed breast cancer - both implants had to be removed. Two years after the operation, she applied...

More pragmatic randomized studies with a focus on registry-based trials

Background Randomized controlled trials (RCTs) that are highly restrictive in terms of study design, with highly selected participants and conditions, produce results whose applicability to routine clinical care and usefulness for reimbursement decisions is sometimes questioned. Objectives In view of the background mentioned above, do more pragmatic RCTs and registry-based...

EU Commission wants to establish a Europe-wide network of health data

In the future, EU citizens should be able to easily use their health data in all countries of the European Union. The EU Commission today presented a proposal to create a "European Health Data Network".Patients would then be able to share their medical history, test results or prescriptions with hospitals...

2 million joint replacement surgeries recorded in the german endoprosthesis register

Ten years after its launch, the Endoprosthesis Register Germany (EPRD) has now surpassed the two-million mark in the recording of surgical documentation. This can be a reliable database for assessing hip and knee endoprosthetic care in Germany. The voluntary data supplied by more than 780 hospitals cover more than 70...