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

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

Our markets are changing rapidly – particularly with regard to the current digital trends in the healthcare sector. We are seeing growing demand for digital services along the entire value chain. Patients are increasingly using the option of remote diagnosis and healthcare services on demand. Data-driven decision-making will supplement diagnoses in the future and become standard in everyday clinical practice. The proportion of digital components in medical devices is also increasing. The associated cybersecurity risks also require standardized and resilient IT infrastructures. This increasing use of digital solutions or applications is accompanied by impacts, risks, and opportunities both in our business segments and in our downstream value chain, which we want to manage and exploit with foresight.

The digitalization of processes in healthcare facilities enables us to reduce the time pressure on doctors and nursing staff. This improves treatment performance and simultaneously increases capacity for our healthcare services. We thereby promote a positive impact on treatment experiences and on patients’ experiences in our hospitals. Increased process efficiency also results in medium-term financial opportunities. If we use advanced technologies, train our employees in these technologies and use them to provide information and high-quality services digitally, we can build stronger customer relationships and facilitate access to our services. While maintaining the same high quality of consultation and treatment, we can thus achieve an increase in patient numbers.

It should be noted that the use of new technologies also leads to changes in work processes that can have a negative impact on the workforce. For example, certain activities or jobs may no longer be required in their previous form. At the same time, there is an increased risk that the shortage of skilled workers will delay the introduction and use of new technologies in the healthcare sector, as there are not enough qualified personnel available for new digital work formats. Increasing digitalization can also lead to higher energy requirements and thus potentially to negative effects on the environment; further details can be found in the topical standard E1 Climate change. The risk of cyberattacks and data loss also increases. These aspects are explained in detail in the company-specific standard Cybersecurity and in the topical standard S4 Consumers and end-users, section Privacy.

Economic aspects must also be taken into account: If we lose touch with the competition in the field of digitalization or fail to meet customer expectations, it can result in competitive disadvantages that will have a medium- to long-term impact.

The same also applies to our attractiveness as an employer. As a healthcare Group, we are dependent on a qualified and motivated workforce. If we are not perceived as a modern company, this can hinder us in attracting and retaining talent and have a negative financial impact on our business in the medium-term. Details on personnel measures can be found in the section Recruitment in the topical standard S1 Own workforce.

Our approach [MDR-P] Policies adopted to manage sustainability matters

Digitalization strategies

Digitalization is opening up new opportunities in automation, big data, and artificial intelligence (AI). The MedTech market is shifting towards a focus on connectivity and integration. 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.

At Fresenius, we are therefore striving to use digital processes and applications to optimize our internal processes throughout the Group. We want to advance digitalization in the Group and aim to increase value and efficiency in the daily handling of products and services.

In the production area, we focus on the application of digital products and services along the entire value chain; in the hospital segment, we focus on 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. We want to create significant added value for key stakeholder groups with process efficiency through digital solutions. The overall time savings create capacities that we can use to further develop our business. The aim is to maintain the safety and quality of products and services in the value chain and in our own operating business at a high level, thereby giving more people access to healthcare.

We are also increasingly using digitalization to provide information for customers and patients, e.g. through dedicated web-based information and support programs, training or whistleblowing systems. In Spain, for example, we can use an app to support patients in their daily check-ups at home after hospital treatment, evaluate the data and make changes to the treatment plan if necessary. This reduces the need for repeated visits to the hospital, saves staff and patients time, and also enables faster intervention if values change.

In the operating companies, we are also rethinking our approaches to innovation, production, delivery, sales, and customer support. For example, at Fresenius Kabi we focus on treatment concepts, at Fresenius Helios on more effective processes in healthcare facilities through increased digitalization automation of previously manual processes. Additionally, we are increasingly leveraging insights from comprehensive analyses of the data generated at Fresenius. Our goal is to improve and streamline operations with digital capabilities that are both cohesive and efficient. Our strategy also includes creating new offerings through the introduction of innovative digital products and services.

We focus on using data from interactions with business partners, medical professionals and patients in order to understand and improve their experience of our services as well as our products. The data helps with more effective customer communication through both digital and non-digital channels. At the same time, it helps support the use of our products, and thereby patient safety. At Fresenius Kabi we use feedback processes as part of Homecare Business to identify irregularities in patient care. For this purpose, the therapy documentation and follow-up of patients is randomly checked during the annual quality reporting for our permanent providers and freelancers. At Fresenius Helios, the direct interaction with patients or their relatives during their hospital stay helps us. Also, the results of patient surveys are an important source for our data-driven processes. You can find further information in the topical standard S4 Consumer and end-users, section Health and safety.

In addition to the development of internal standards, we also conduct analyses, to develop new approaches within our industry. We monitor our peers and take the feedback provided from stakeholders, e.g. customers, into account.

Organization and responsibilities

Within the Management Board, the Chairman of the Management Board is responsible for Group Strategy and thus also for the overarching digitalization strategy. Overarching coordination and strategic approaches in the area of digitalization are managed by the Corporate Development function. Experts in the associated specialist functions Medical Office and Digital Projects evaluate new technologies, prioritize and track Group investments in selected future growth areas of Fresenius, and evaluate the effectiveness of the actions taken with the business segments. Operational implementation takes place within the business segments and their units. It is anchored in the local organizations and managed by the respective management functions. Responsibility for digitalization, for example, 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. An expert from the Group function reports to the Chairman of the Management Board on a daily basis and is also in contact with the Management Board as a whole through various internal committees. Those responsible for Corporate Development and the responsible business segments’ managers align if required and on specific topics. In the context of Management Board meetings, the entire Management Board is informed monthly about relevant developments from the business segments or receives resolutions for approval.

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

Special IT working groups are set up across the Group, consisting of executives from the business segments 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.

Our employees are directly involved in the implementation of our digital transformation concepts through the application of digital processes as part of their work. We therefore regularly inform them about our approaches and progress, e.g. as part of quarterly and annual presentations and reports.

Ethics in digitalization

Within the Group, a working group for AI is responsible for creating a Group-wide framework for the use of AI and for developing corresponding guidelines. The working group is also tasked with ensuring that the ethical standards and values of Fresenius are taken into account in the development and implementation of applications in which AI is used at Fresenius.

A guideline on the responsible use of AI was published on the intranet to sensitize the employees to possible risks and to define key points to watch out for. Business segments also inform employees about this topic in written form.

The working group is made up of the Group functions Cybersecurity and Risk & Integrity and representatives from the business segments. It is led by the Corporate Development Group function.

Digital processes and applications

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

Accordingly, we are 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. We have already implemented various solutions and identified potential savings that can be successively realized.

The digitalization of our manufacturing facilities is an ongoing process, driven by advancing technological progress and continuous innovation in the manufacturing sector. Our current strategy is to roll out digital tools and platforms across all global manufacturing sites by 2032. Given the pace of technological development, we are taking a flexible, iterative approach to ensure that our solutions remain up to date and can be continuously developed as new innovations emerge. We already have a portfolio of advanced applications and data platforms, but the scope of our digital transformation will evolve to incorporate new technologies as they become available. In accordance with the possible negative impacts of the digital transformation described in section Our impacts, risks and opportunities in this company-specific standard, work processes and therefore our own employees are primarily affected. We are countering these potential impacts through the activities described in the S1 Own workforce topical standard on employee retention and our working conditions in our Group.

Digital patient care

Based on our experience in everyday clinical practice, we are seeing increasing demand for new digital services along the entire value chain. Patients increasingly want to receive remote diagnosis and healthcare services on demand. We are taking these interests into account by increasingly integrating data-driven decision-making into everyday clinical practice and using more digital components in medical devices.

We develop digital applications as well as new IT and process strategies for medical professionals and patients with various objectives: They are intended to support the quality of treatment, improve care and the quality of life of patients, open up new areas of business, and ensure compliance with regulatory requirements. This is achieved, for example, through video conferences in which patients can present their medical history, but also through protocols and automated tests for certain diagnoses. The result is digital patient care, known as the Digital Patient Journey or a holistic patient experience. This requires the digitalization of a large number of interdependent processes, as well as digital applications such as the patient portals of Helios Germany and Helios Spain.

Via our digital patient portals, our patients can access treatment documents such as findings, book appointments online, or attend video consultations around the clock and from home. The clinics benefit from central data storage and improved data transmission, as well as coordination between medical staff.

In almost all of the German and Spanish Helios clinics, integrated software solutions already issue warnings of possible interactions with other drugs and can thus further increase patient safety. The expansion of the Germany-wide telematics infrastructure, ordered by the government, into which the EPF (electronic patient file) will be integrated in the future, can also lead to better quality of care.

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

In the reporting year, no significant actions were taken at Group level to address the identified material impacts, risks, or opportunities associated with digitalization. Instead, our main activities are focused on the ongoing transformation process to optimize our operations in order to effectively manage impacts, seize opportunities, and address risks in the short-, medium-, and long-term. Our focus is on our two future key fields: improving digital supply structures and optimizing digital business processes.

Digital healthcare structures

We are already pursuing various initiatives for digitalization in our hospitals. The focus is on the expansion of the IT infrastructure and digital services, such as the online patient portal or the EPF. Another essential part is the use of AI-supported technologies to achieve better examination results, e.g. in the assessment of image diagnoses or digital pathology. We have prioritized corresponding actions for the hospitals in Germany and Spain. Actions for our locations in Germany have been set out in 2023 in a three-year plan that formulates ambitions up to 2026. With this plan, we have defined concrete goals in the three areas of online documentation, digital employee services, and digitally supported medical decisions. Further information is explained in more detail in the section Our goals and ambitions in this company-specific standard.

In our Spanish hospitals, the Casiopea project was continued in the reporting year 2024. As part of the Casiopea project, we implemented a system platform through which all processes can be digitally controlled centrally. A high level of digitalization has already been achieved in recent years, which is to be improved by further innovative applications. Where this resulted in a need for training, we developed and implemented appropriate plans. In addition, we strive to continuously adapt Casiopea to new circumstances.

In the interest of a continuous transfer of knowledge, findings from the Casiopea project were examined to determine to what extent they could lead to an improvement in process quality for other hospitals in our Group.

Digital Operations

We believe that standardization and innovation are key success factors for maintaining our competitive advantage. Depending on which process steps are affected, they can also have an impact on the upstream or downstream value chain. We are therefore working with digital solutions to achieve sustainable innovations and improve efficiency in our manufacturing entities, while maintaining the high quality of our products and compliance of our operations. To this end, we work closely with our manufacturing entities and quality organizations. The Digital Operations project organization is responsible for initiating and implementing our actions to optimize digital business processes. Digital Operations supports digitalization projects in our entities worldwide.

Our actions cover all manufacturing plants and quality organizations. We integrate digital solutions into production processes to reduce materials and energy consumption while ensuring higher production quality. In doing so, we aim to promote sustainable practices in our global manufacturing network. We summarize these actions 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, we are working to identify issues early and proactively in the production cycle, significantly reduce the scrap rate, and ensure more efficient use of materials.

In addition to the data platform, we offer a continuously expanding portfolio of 15 applications to support manufacturing optimization. These tools enable our teams to refine processes, minimize downtime, and drive performance improvements across the board. This enables us to support the relationship with key customers in the downstream value chain.

Implementing the measures of the Digital Operations project will take place over the coming years.

As the actions described are implemented in the ongoing business process, 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.

In 2024, Fresenius did not initiate a Group-wide digitalization action plan. Activities in the operating companies are described in this company-specific standard.

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

We have set ourselves the goal of optimizing and accelerating our internal processes throughout the Group through the use of digital processes and applications. We also aim to increase the value and efficiency of our products and services on a daily basis. To this end, all business segments have defined specific digitalization ambitions for their markets or define respective plans. Our goals are derived from the requirements of our markets as well as from learnings in communication with key stakeholder groups, e.g. business partners, customers and patients.

Digitalization targets of Fresenius Kabi

At Fresenius Kabi, we want to provide our 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 further develop production, distribution, and logistics and thus also patient care. It is essential that digitalization is a continuous process geared towards the needs of patients. However, the digitalization process goes hand in hand with social change. Changes are difficult to predict, which makes it difficult to set specific time frames when formulating our goals.

Digitalization targets of Fresenius Helios

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

Fresenius Helios in Germany has set itself three digitalization targets in 2023 that the segment plans to achieve by 2026. The first year of applicability was 2024. No numerical reference value was defined; the target value refers to full fulfillment of each target. The reference year is 2023, the year in which the target was communicated.

• 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 will be able to download their documents and book appointments online for each facility. We achieved this goal 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, is still lagging behind our expectations. We are therefore working on additional measures: We will make more appointments available in the portal and simplify the booking process. Moreover, we are continuing to work on digitizing services such as meal bookings, feedback solutions, and treatment diaries to incentivize usage. We want to achieve an active usage rate of our digital services of 50%. In the reporting year, the active usage rate for digital services was 5.3%. To measure the target, we look at three key figures: 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. The targets were communicated in 2023 with applicability starting in 2024.
• 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. We use 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 to assess target achievement. Since the beginning of 2024, we have been providing employees with all pay-related documents digitally.
• Digital assistance with essential medical decisions: As a third goal, Fresenius Helios in Germany has set itself the target of making all key medical decisions that result in medical treatment with digital assistance by the end of 2026. For the measurement, we evaluate the percentage of availability of digital assistance in the main medical specialties. We define these in particular on the basis of patient volume: digital radiology, digital pathology, general risk prediction, general digital process support, and the emergency department. In 2025, we will review for each specialist group 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.

Fresenius Helios in Spain has also defined the target of implementing the digital care management system and the Casiopea patient portal in at least 80% of its Spanish hospitals by 2024. Three key measures were evaluated for this purpose:

• Arrangements of medical tests, appointments and surgeries
• Signing of consent forms
• Surgical checklists

The registered patient numbers in the respective department and the derived usage ratio are therefore the basis for calculation and evaluation.

The target was achieved and the quota was even exceeded with a final result of 100.0%.

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 users who have performed at least one action within the portal. 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 order to calculate the digital usage rate. In the reporting year, the digital usage rate was 70.0%.