ESRS S-Company-specific Digital transformationS-Company-specific

Impacts, risks, and opportunities [SBM-3] Material impacts, risks, and opportunities and their interaction with strategy and business model

Impacts, risks, and opportunities

Within the scope of the materiality analysis, Fresenius has identified one material impact and material opportunities related to Digital transformation:

Approach [MDR-P] Policies adopted to manage material sustainability matters

Digitalization strategies

Digitalization is opening up – new opportunities in automation, big data, and artificial intelligence (AI). For example, in the MedTech market, the focus is increasingly shifting toward connectivity and integration capabilities. In patient care, paper-based documentation has been replaced by digital patient records, and the direct – digital – channel to the patient is becoming increasingly important. The tech paradigm shift is driven by advancements in technologies like AI, the Internet of Medical Things (IoMT), and predictive analytics. The combination of improved availability of real-time health data and advanced analytics will significantly improve prognosis, personalization, prevention, and participation in future health delivery.

Therefore, Fresenius strives to use digital processes and applications to optimize internal processes throughout the Group as well as along the upstream and downstream value chain, and is implementing corresponding digitalization strategies.

Fresenius wants to advance digitalization in the Group and aims to increase value and efficiency in the daily handling of products and services. Further, it contributes to the improvement of quality of treatments in the hospital business. This not only has a positive impact on patient care, but is also intended to strengthen Fresenius’ position as an attractive employer and to support the recruitment and retention of qualified professionals and their engagement.

This means that important medical decisions, e.g., are increasingly supported by digital assistance and integrated into everyday clinical practice as a process. This enables Fresenius to improve medical treatment outcomes. Further information can be found in topical standard S4 Consumers and end-users, Health and safety section.

In the production area, the focus is on the application of digital products and services along the entire value chain, e.g., in the areas of innovation, production, and delivery. In the hospital segment, the focus is on further digitalization and automation of previously manual internal treatment and administrative processes. Overarching topics along the upstream value chain are preventive services and appointment scheduling; in the downstream value chain, these include the management of discharges after treatment and the area of medical aftercare. Fresenius wants to create significant added value for key stakeholder groups with process efficiency through digital solutions. The overall time savings create capacities that can be used to further develop the business. At the same time, the aim is to maintain the safety and quality of products and services in the value chain and in own operating business at a high level, thereby giving more people access to healthcare. In addition, healthcare products can be offered at more affordable prices through cost-efficient production processes.

Fresenius is also increasingly using digitalization to provide information for customers and patients, e.g., through web-based information and support programs, training or whistleblowing systems.

In addition to the development of internal standards, Fresenius also conducts analyses to develop new approaches within its industry. Fresenius monitors peers and takes the feedback provided from stakeholders, e.g., customers, into account.

Group-wide governance and responsibilities

Within the Management Board, the Chief Executive Officer (CEO) is responsible for Group strategy and thus also for the overarching digitalization strategy. Global coordination and strategic approaches in the area of digitalization are managed by the Corporate Development Group function. Experts in the associated specialist functions Group Digital and Medical Office evaluate new technologies, prioritize and track Group investments in selected future growth areas of Fresenius, and assess the effectiveness of the actions taken with the Operating Companies. Operational implementation takes place within the Operating Companies and their businesses. It is anchored in the local organizations and managed by the respective management functions. Responsibility for digitalization, e.g., is regulated via a business allocation plan. The Corporate Development Group function is responsible for the strategic framework within which the digitalization strategy is implemented globally. The Head of Group Digital as expert from this Group function reports to the CEO on a regular basis and is also in contact with the Management Board through various internal committees. Those responsible at the Corporate Development Group function and the responsible Operating Companies’ managers coordinate if required and on specific topics. For its meetings, the Management Board is informed monthly about relevant developments from the Operating Companies or receives resolutions for approval.

The Chief Financial Officer (CFO) is responsible for the Fresenius Digital Technology division and the Group function Cybersecurity. She leads the IT transformation of the Group.

Special IT working groups are set up across the Group, consisting of executives from the Operating Companies and the Group division Fresenius Digital Technology. They work on topics that directly contribute to the corporate goals. In this way, they jointly develop the global IT transformation for Fresenius.

Information on responsibilities and requirements for the Management Board as well as the Supervisory Board are explained in standard ESRS 2 General disclosures, section GOV-1 Sustainability organization.

Fresenius’ employees are directly involved in the implementation of the digital transformation concepts through the application of digital processes as part of their work. They are therefore regularly informed about the approaches and progress, e.g., as part of quarterly and annual presentations and reports.

AI Governance Policy

AI is rapidly transforming the way people live and work. It plays a pivotal role in how Fresenius develops and delivers healthcare solutions. As such, AI will be a key driver in the current Rejuvenate-phase of #FutureFresenius, especially in strengthening the core businesses and further digitalizing the hospitals and Care Provision Platform. AI-powered products are among the driving forces of future healthcare and form an essential part of Fresenius’ strategy.

Compliance with the obligations arising for manufacturers and users of AI applications and / or AI models from the new EU AI Act require the implementation of a governance framework that ensures risk assessment and continuous oversight of all deployed AI solutions. At the corporate level, a project was established to implement the EU AI Regulation in the reporting year 2025. This project was led by the legal department and consisted of representatives from the corporate functions Cybersecurity and Risk & Integrity, as well as from the Operating Companies. The process responsibility is now with the Corporate Development function. The project members were responsible for creating a Group-wide framework for the use of AI and for developing corresponding guidelines. This topic is also communicated in writing within the Operating Companies.

The aim of the AI Governance Policy introduced in 2025 is to to establish a governance framework that defines roles, responsibilities, and processes for the lawful, secure, and ethical use of AI within the Fresenius Group. The framework is designed to ensure organizational alignment by establishing consistent standards at Fresenius, fostering innovation, and promoting transparency and coordination at Group level for all AI use cases developed or implemented within the Operating Companies. The defined processes are intended to support the use of AI applications in compliance with applicable legal obligations, while also reflecting Fresenius ethical standards and values. A key element of these processes is a standardized risk assessment, which serves as the basis for decisions regarding the procurement or development of new AI assets. A comprehensive AI inventory provides a complete listing of all AI applications currently in use at Fresenius. It helps ensure compliance, identify potential synergies across the Group, and maintain oversight of overall AI usage.

The Policy was approved by the Management Board and has been mandatory across the Fresenius Group since April 1, 2025. The implementation is supported by internal communication measures and mandatory employee training progams.

Digital processes and applications

As part of the digitalization strategy, digital solutions are being designed and developed to make internal work processes more efficient and simplify them.

Accordingly, the Group is increasingly relying on intelligent automation and AI in business areas such as compliance, supply chain, purchasing, production, and distribution to improve business processes in administrative functions, e.g., by using chatbots, digital document processing, or recommendation and prediction applications. Fresenius has already implemented various solutions and continues to work on successively realizing the identified savings potential.

The digitalization of Fresenius Kabi’s manufacturing facilities is an ongoing process, driven by advancing technological progress and continuous innovation in the manufacturing sector. The current strategy is to roll out digital tools and platforms across all global manufacturing sites by 2032, the corresponding measures are described in section Actions, see Digital Operations, in this standard. Given the pace of technological development, Fresenius Kabi is taking a flexible, iterative approach to ensure that the solutions remain up to date and can be continuously developed as new innovations emerge. Fresenius Kabi already has a portfolio of advanced applications and data platforms. But the scope of digital transformation will evolve within the company to incorporate new technologies as they become available.

Digital patient care and healthcare structures

The experience in everyday clinical practice incidcates an increasing demand for new digital services: Ever more patients want to receive remote diagnosis and healthcare services on demand. To improve patient experience is one of four concrete impacts of digitalization within the hospital setting. In addition, the company focuses on quality of treatment, employee engagement as well as efficiency gains.

In addition to the overarching expansion of the IT infrastructure, Fresenius focuses on the following aspects of its digitalization strategy in the hospital segment:

• Standardizing the hospital information system to streamline and improve processes and ensure scalability

• Establishing AI-supported platforms and competence centers to achieve better examination results, e.g., in the assessment of image diagnoses, digital pathology and in the emergency department

• Exploring the expansion of robotics-assisted treatment approaches

• Automation of medical reports and patient consultation documentation as well as digital documentation of nursing and treatment services in Germany

• Closed-Loop-Medication-Management in Germany

• Definition of quality and productivity targets through data standardization

• Introduction of digital services for patients such as the online patient portal or the electronic patient record (ePA), as well as central information and service portals for employees and referring physicians

Specific projects in hospitals in Germany and Spain are intended to support treatment quality, improve care and patients’ quality of life, open up new business areas, and ensure compliance with regulatory requirements.

For digital patient care, the so-called Digital Patient Journey or holistic patient experience, Fresenius Helios uses, for example, video consultations where patients can present their medical history, as well as protocols and automated tests for certain diagnoses. This requires the digitalization of numerous interdependent processes and digital applications such as the patient portals of Fresenius Helios.

Integrated software solutions already provide alerts on potential drug interactions in almost all Helios hospitals in Germany and Spain, thereby further enhancing patient safety. In addition, the legislator-mandated expansion of the nationwide telematics infrastructure in Germany, into which ePA will be integrated in the future, can also help improve the quality of care.

Through the digital patient portals, patients can access treatment documents such as medical findings around the clock and from home, book appointments online, or take advantage of video consultations. The hospitals benefit from centralized data storage and improved data transmission and coordination among medical staff.

In the Spanish hospitals, the hospital information system Casiopea is the core element of the digitalization strategy and was expanded in 2025 to include the AI-based application Scribe. Scribe is a digital assistant designed to support medical consultations between healthcare professionals and patients. The application analyzes conversations in real time, extracts clinically relevant information, and automatically generates structured reports. In addition, Scribe guides physicians to cover all relevant topics during the visit. Irrelevant content is filtered out, while important clinical data such as symptoms and recommendations are directly integrated into the ePA. The report is reviewed and released by the responsible physician. This way, the application can relieve physicians of administrative tasks and improve the quality of care. Scribe now supports more than 40 medical specialties in the outpatient area across all Spanish hospitals.

As part of continuous knowledge transfer, insights gained from the implemented activities are reviewed to determine the extent to which they can also contribute to improving process quality at additional hospital sites of Fresenius Helios.

Data analytics for product and service optimization

Fresenius increasingly leverages insights from comprehensive analyses of data generated across the Group. The objective is to enhance and streamline operational processes through coherent and efficient digital capabilities. The strategy also aims to create new offerings by introducing innovative digital products and services.

Fresenius focuses on utilizing data from interactions with business partners, healthcare professionals, as well as patients to understand their experience with the services Fresenius offers and thereby improve them. These data support more effective customer communication across both digital and analog channels. At the same time, they help ensure proper handling of Fresenius products and thus contribute to patient safety.

At Fresenius Kabi, feedback processes are used in the Homecare business to identify irregularities in patient care. For this purpose, as part of the annual quality reporting, therapy documentation and patient progress monitoring are reviewed on a sample basis for both employed caregivers and freelance staff.

At Fresenius Helios, direct interaction with patients or their relatives during hospital stays plays an important role. In addition, the results of patient surveys are a key source for data-driven processes.

Further information can be found in topical standard S4 Consumers and end-users, section Health and safety.

Helios Safe Medical Data Platform

The Helios Safe Medical Data (HeSaMeDa) platform is designed to promote healthcare research and patient recruitment, as well as the development of new and improved treatment methods and patient enrollment for clinical studies. It aggregates medical data from Helios clinics in Germany based on patients’ consent to the use of their data for healthcare research.

The underlying concept allows pseudonymised patient data, health insurance data and biomaterials, as well as diagnostic and therapeutic information, to be used for multiple research purposes where appropriate. This approach serves the long-term observation of treatment processes and also meets the prevailing security standards through the pseudonymization and internal processing of the data. The high IT standards, the solid legal data protection basis, and experience in handling health data, coupled with the trust of patients, form a robust foundation for further advancing research and innovation at Fresenius Helios and beyond.

In the future, Fresenius Helios medical care centers and community-based medical practices will be connected to the platform in order to close the gap between inpatient and outpatient care and thus understand and analyze the treatment paths of patients more holistically and in depth. In the next step Fresenius Helios also strives to implement an AI-based chat solution that enables medical professionals to ask questions about the data and work interactively on solutions with AI.

Actions [MDR-A] Actions and resources in relation to material sustainability matters

The main activities of the Group functions Corporate Development and Group Digital focused on the ongoing strategy process. The Operating Companies define activities to optimize operational business in order to effectively manage impacts and seize opportunities in the short-, medium-, and long-term. Data analytics, including the HeSaMeDa platform from Fresenius Helios, also contribute to this effort. At Fresenius Kabi and Fresenius Helios, actions are being implemented or planned. These are explained in the following.

Digital Operations

At Fresenius Kabi, the digitalization of business processes relevant to sustainability aspects focuses on production sites and quality organizations. Depending on which process steps are affected, the actions may also impact upstream or downstream parts of the value chain. Fresenius Kabi integrates digital solutions into production processes to reduce materials and energy consumption while ensuring higher production quality. In doing so, Fresenius Kabi aims to promote more sustainable practices in the global manufacturing network. These actions are summarized as Advanced Manufacturing Operations (AMO) – Digital Operations. A key initiative in this context is the implementation of a comprehensive data platform. This platform aggregates manufacturing and quality-specific data from sites worldwide, enabling real-time analysis and decision-making. By using this data, Fresenius Kabi is working to identify issues early and proactively in the production cycle, significantly reduce the scrap rate, and ensure more efficient use of materials.

Implementing the actions of the Digital Operations project will take place over the coming years. The project plan outlines numerous activities through 2032 that will drive the digitalization of production processes and support the collection, analysis, and use of data, including improved forecasting capabilities. Provided all activities are carried out, substantial investments are anticipated. However, the exact scope of these investments can only be specified over the course of 2026 due to the current stage of planning. This will replace the original plan from 2024.

The actions described will be implemented in the ongoing business process, therefore, progress is not measured on an annual basis. It is important to ensure at all times that the implementation of digitalization projects does not delay the ability to deliver or the production of medicinal products.

Digital healthcare services

As part of the legislative initiative known as the Hospital Future Act (Krankenhauszukunftsgesetz – KHZG), Fresenius Helios in Germany received funding; in 2025 about €77 million were utilized. These financial resources are intended to support specific investments in the areas of digitalization and infrastructure, and are used also for multi-year projects. As part of this, Fresenius Helios launched tenders for various projects, such as the use of AI in imaging, the introduction of digital pathology, and the pilot use of a tool for clinical decision support. The funding represents an opportunity to optimize patient care, simplify the daily work of employees, and strengthen Fresenius’ market position.

Goals and ambitions [MDR-T] Tracking effectiveness of policies and actions through targets

Fresenius has set itself the goal of optimizing and accelerating critical processes through the targeted use of digital applications. The Group also aims to increase the value and efficiency of products and services on a daily basis. To this end, all Operating Companies have defined specific digitalization ambitions for their markets or define respective plans. The goals are derived from the requirements of markets as well as from learnings in communication with key stakeholder groups, e.g. business partners, customers, and patients.

Digitalization targets of Fresenius Kabi

Fresenius Kabi wants to provide its customers with the best possible products and associated services and thus further improve the quality of medical care. Thanks to data-driven insights and digitalized processes, Fresenius Kabi can drive production, distribution, and logistics and thus further develop patient care. It is essential that digitalization is a continuous process geared towards the needs of patients.

Digitalization targets of Fresenius Helios

Increasing digitalization at Fresenius Helios can streamline processes and improve treatments in the hospitals. In this way, Fresenius Helios wants to increase employee and patient satisfaction and reduce costs at the same time. The goals and ambitions not only serve to drive forward digitalization within the Group. They also help Fresenius to achieve the goals of other relevant topics, such as patient satisfaction and treatment outcomes.

Fresenius Helios in Germany set itself three digitalization targets in 2023 that should be achieved by 2026. The reference year is 2023, whereby the reference value was not numerically defined; the target value refers to full fulfillment of each target.

The first year of applicability was 2024.

• Digital documents and services for patients:
  To achieve this digitalization goal, all documents and services for Fresenius Helios patients in Germany are to be offered digitally by 2024. All patients registered in the patient portal should be able to download their documents and book appointments online for each facility. This goal was achieved in 2024 to the extent that functions are technically available. Usage, i.e. the proportion of registered users compared to the total number of patients, was still behind expectations. Fresenius Helios therefore worked on additional activities in 2025. With the requirements of Fresenius Helios and the Hospital Future Act (KHZG) as well as the experience of the Spanish hospital subsidiary Quirónsalud, a product concept was created to increase utilization and improve patient involvement in treatment. The piloting of the first further developments of the patient portal is planned for 2026 as action. The Operating Company wants to achieve an active usage rate of the digital services of 50%. In the reporting year, the active usage rate for digital services was 5.9% (2024: 5.3%). To measure the target, three key figures are considered: the proportion of clinics connected to the patient portal, the clinics connected to the document upload and download, and the outpatient clinics connected to the appointment booking system in the respective year.

• Digital documents and services for employees:
  The second goal of the three-year plan relates to employees. Fresenius Helios employees in Germany shall receive all relevant documents and services relating to personnel, payroll, and salary data exclusively in digital form by the end of 2025. The degree of roll-out of employee access to the digital HR system and duty scheduling system as well as the proportion of processes and documents integrated into the systems is used to assess target achievement. Since the beginning of 2024, Fresenius has been providing employees with all pay-related documents digitally. In 2025, this goal was achieved as duty scheduling or vacation times are organized digitally.

• Digital assistance with essential medical decisions:
  As a third goal, Fresenius Helios in Germany has set itself the target of making key medical decisions that result in medical treatment with digital assistance by the end of 2026. For the measurement, Fresenius Helios evaluates the percentage of availability of digital assistance in the main medical specialties. These are in particular defined on the basis of patient volume: digital radiology, digital pathology, general risk prediction, general digital process support, and the emergency department. In 2025, each specialist group reviewed whether further medical decisions should be included. A large number of pilot projects such as AI-supported colorectal cancer screening are already underway in the clinics.

Beyond the objectives of the three-year plan, Fresenius Helios in Germany pursues the following medium-term ambitions: The expansion of the patient portal is planned to be completed by 2030, and the selection and replacement of the hospital information systems by 2035.

Fresenius Helios in Spain has achieved its goal of implementing the digital care management system and the Casiopea patient portal in at least 80% of Spanish hospitals by 2024. The further improvement of Casiopea through additional digital features is described in section Digital patient care and healthcare structures in this standard.

Metrics [MDR-M] Metrics in relation to material sustainability matters

Usage rate of the digital care management system and patient portal Casiopea

Fresenius Helios in Spain quarterly surveys the utilization rate of the digital services offered based on the total number of patients treated and the number of active users. Active users are defined as patients which have performed a medical episode in the period and have used the Portal within the last 6 months. To this end, the Spanish facilities record how often the digital services were used by patients in relation to the total number of patients treated. In the reporting year, the digital usage rate was 75.4% (2024: 70.0%), exceeding the previous year’s rate.