Siemens Healthineers

We welcome the opportunity to provide our contribution to the European Commissions digital policy work, particularly in the context of the upcoming Digital Simplification Package. We welcome the Commissions commitment to enhancing Europes competitiveness and resilience through regulatory streamlining and simplification, and we fully support the ambition to reduce administrative burdens and improve coherence across…

Siemens Healthineers is a leading provider of medical technology, principally active in the areas of imaging, diagnostics, cancer care and minimally invasive therapies augmented by digital technology and artificial intelligence.

Siemens Healthineers welcomes the European Commissions call for evidence on the EU public procurement rules which are key to our ecosystem. In order to secure the healthcare sector competitiveness and foster innovation, we have identified crucial points which we believe should be considered: Moving towards value-based procurement with value criteria being the most prominent aspect of the tenders rather than a…

Siemens Healthineers would warmly welcome a review of the Public Procurement Directive (Directive 2014/24/EU). In order to secure the healthcare sector competitiveness and foster innovation, we have identified crucial points which we believe should be considered when further discussing the topic: Moving towards value-based procurement with value criteria being the most prominent aspect of the tenders and…

We appreciate the opportunity to contribute to the European Commissions targeted evaluation of the EU Medical Device Regulation (MDR, EU 2017/745) and In Vitro Diagnostic Regulation (IVDR, EU 2017/746). This initiative is critical to addressing structural challenges that have emerged since implementation and to ensuring that the regulatory framework continues to safeguard patient safety while supporting innovation…

Siemens Healthineers is a leading provider of medical technology, principally active in the areas of imaging, diagnostics, cancer care and minimally invasive therapies augmented by digital technology and artificial intelligence.

As a company committed to building a sustainable future, Siemens Healthineers welcomes the efforts undertaken by EFRAG and the European Commission to simplify the European Sustainability Reporting Standards (ESRS).

Siemens Healthineers welcomes the initiative of the European Commission to set a global benchmark for deployment of ethical and legal artificial intelligence (AI) applications. AI has already brought numerous advancements to the field of healthcare by providing assistance to medical professionals in tasks as diverse as diagnosis, treatment, therapy, monitoring patients’ health, and even the management of hospitals…

Siemens Healthineers welcomes the Commissions overarching objective to strengthen the Unions competitiveness while reducing unnecessary regulatory burdens, and at the same time ensuring a high level of cybersecurity and resilience across the EU.

Siemens Healthineers is a leading provider of medical technology, principally active in the areas of imaging, diagnostics, cancer care and minimally invasive therapies augmented by digital technology and artificial intelligence.

Siemens Healthineers welcomes the initiative of the European Commission to facilitate access to and use of data, including business-to business and business-to-government. We too share the ambition and support the measures which would ensure fairness in the digital environment, stimulate a competitive data market, open opportunities for data-driven innovation and make data more accessible for all.

Siemens Healthineers welcomes the European Commission’s goal of creating a framework enabling access to health data and health data sharing across the European Union. It is a timely and highly anticipated initiative which empowers patients, while setting the building blocks for a European single market for (digital) health and tackling barriers which impede sharing of (health) data.

Siemens Healthineers appreciates the European Commissions ongoing efforts towards simplification of the CBAM, which should be maintained and further strengthened. We particularly welcome the introduction of the 50t de minimis threshold and the use of default values for emissions calculation, both of which are essential in reducing unnecessary administrative burdens for companies and ensuring proportionality.

Siemens Healthineers welcomes the European Commissions initiative to introduce horizontal cybersecurity requirements for products with digital elements. We believe that cybersecurity by design is crucial for the security of EU citizens, in particular for patients in Europe, as well as for safe and responsible innovation in healthcare.

Siemens Healthineers welcomes the European Commissions Call for Evidence on cardiovascular health checks and strongly supports the development of an EU-level protocol under the Safe Hearts Plan. Cardiovascular diseases, including stroke, remain the leading cause of death in the EU and continue to place a significant burden on citizens, health systems and economies.

Siemens Healthineers welcomes the opportunity to provide input to the Commission's plan to adapt the liability rules against the background of new technology developments and artificial intelligence (AI). From a Siemens Healthineers perspective, AI as a technology used in medical devices per se does not pose any danger or harm.

Siemens Healthineers welcomes the opportunity to comment on the technical requirements under the European Health Data Space Regulation and supports the objective of a harmonized, interoperable framework for the primary and secondary use of electronic health data across the Union. Our detailed comments are set out in the attached position paper.