[Innovations in cardiology. We are too fast with new methods].

Area of Science:

• Cardiovascular medicine
• Health policy and regulation

Background:

• Rapid advancements in cardiology introduce new treatments frequently.
• Economic pressures in healthcare necessitate robust evaluation of treatment safety, efficacy, and sustainability.
• Existing regulatory frameworks require updates to align with European Union standards.

Purpose of the Study:

• To enhance the regulatory framework for approving new medical products in cardiology.
• To implement more precise quality controls for medical interventions.
• To improve the understanding of long-term outcomes for cardiovascular treatments.

Main Methods:

• Alignment of German regulatory framework with European Union legal requirements.
• Establishment of the Institute for Quality Assessment and Transparency in Health Care (IQTIG) for precise quality controls.
• Implementation of implantation registers and coordinated quality control across healthcare sectors.

Main Results:

• Anticipated establishment of implantation registers for better long-term data collection.
• Coordinated quality control of interventions across healthcare sectors to understand long-term results.
• Strengthened quality controls, neutrality, and transparency in assessing new medical methods.

Conclusions:

• Stricter controls and transparency in assessing new cardiology treatments benefit patient safety.
• The establishment of IQTIG and implantation registers will enhance quality assessment.
• Adapting regulatory frameworks ensures the safety and sustainability of innovative cardiovascular therapies.