Digitalization and innovation

Digitalization plays an increasingly important role for Fresenius – whether in health care facilities, in direct contact with patients, or in production. It is a driving force behind the implementation of innovative technologies and treatment concepts and can help us to find solutions to many challenges in the health care sector and help unlock trapped value. For us, the focus is on the opportunities offered by digital solutions. Through innovative, safe, and user-friendly products and systems, we can further improve the quality and efficiency of treatments.

Focus on health care facilities

The demands on health care facilities are changing dynamically, as shown, for example, by the introduction of digital patient files and innovations in the field of telemedicine. These facilitate new ways of interacting between physicians and patients, while also allowing health data to be transmitted and interpreted more quickly. Inpatient and outpatient treatment can be linked more effectively. We want to play an active role in these developments – and contribute to sustainable future concepts for medical care.

Digitalization is also opening up other opportunities for Fresenius: the Internet of Things (IoT) makes more resource-efficient maintenance of machines possible. Complex virtual models (building information modeling – BIM), meanwhile, allow us to simulate and optimize the entire life cycle (planning, development, construction, and operation) during the design and construction of new health care facilities.

Digitalization as an opportunity in health care

Fresenius has been pressing ahead with digitalization initiatives in its business segments for many years. On the one hand, these initiatives are aimed at getting closer to patients and better integrating them into preventive care and therapies. On the other hand, numerous applications help medical professionals to achieve even better treatment results even more efficiently and safely.

This is in line with the results of a representative poll conducted for Fresenius by the polling organization Allensbach Institut für Demoskopie in Germany, Spain, and the United States. According to a large part of the respondents, the increase in digitalization offers opportunities for the health care system. People associate digitalization with a whole range of positive effects, above all easier communication between doctors, easier access to health information, and improved diagnosis and treatment options. Furthermore, shorter waiting times, cost savings through improved efficiency, and an increase in the quality of health care are expected as positive effects of digitalization in medicine.

Important indicators for Fresenius’ digital offering are the answers to the question of what people specifically want: the introduction of digital medical records, the expansion of telemedicine services, and the use of patient data for diagnosis are considered desirable by a large part of the population in Germany, Spain, and the United States. Around one-third of the population in each of these three countries also consider it desirable that more and more personal health data be recorded by means of apps, smartwatches, and fitness bracelets.

The three-country study showed that we are already well on the way with our diverse approaches and initiatives for more digitalization in all business segments. Existing internal assumptions, such as the importance of telemedicine, were validated by the results of the study. At the same time, the insights gained are a good compass that we can use to align our approaches. Fresenius Vamed, for example, has evaluated and developed strategies for digitalization in the health care market, particularly in Germany, based on this and other common trend and innovation studies.

Our approach

Our markets are changing rapidly; this is particularly true with regard to digital trends in health care, which have been further accelerated by COVID-19. We are seeing increasing demand from patients, health insurance companies, and health care institutions for new digital services along the entire value chain. Patients want remote treatment and on-demand health care services. Data-driven decision-making is becoming increasingly important, for example in predictive maintenance of dialysisDialysisForm of renal replacement therapy where a semipermeable membrane – in peritoneal dialysis the peritoneum of the patient, in hemo­ dialysis the membrane of the dialyzer – is used to clean a patient’s blood. machines and analysis of patient data. At the same time, cybersecurity risks have made us aware of the need for standardized and resilient IT infrastructures.

In order to drive digitalization and innovation at Fresenius, we take different approaches in the four business segments – from independent R & D strategies to active innovation management, as described in the Group Management Report in the chapter Research and development. We also involve external partners such as research institutions and start-up companies in this work. One of our priorities is developing innovative products that not only meet stringent quality requirements, but also affordability requirements. In doing so, we are responding to the growing demand worldwide for high-quality yet cost-effective products and outcome-based services.

Many of our stakeholders, especially our patients and our employees, are directly affected by the changes resulting from the advance of digitalization. Our R & D activities are closely linked to digitalization and are an integral part of our growth strategy. Our aim here is to improve products and processes as well as to develop innovative therapies and integrated health care services; however, we do not conduct fundamental research.

Our products and therapies are designed to help promote human health. Benefits and risks must be carefully evaluated. Whether it is in clinical approval studies or in clinical research projects, the Fresenius Group wants to create opportunities to improve the quality of treatment, especially in the area of critical illnesses and chronic diseases.

All new or improved products and services are subject to internal quality requirements as well as external regulations and regulatory requirements. In the case of digital developments, we pay particular attention to the requirements of the European Union (EU)’s General Data Protection Regulation (GDPR); for more information see the chapter Data protection of this report. We also observe European directives such as the EU Medical Devices Regulation (MDR) in the medical technology sector. We address possible risks such as hacker attacks on sensitive data and systems, by implementing comprehensive cybersecurity concepts, as described in the chapter Cybersecurity.

Group-wide IT transformation

In 2021, Fresenius began implementing a new, Group-wide IT program to strengthen cooperation in the IT area and increase value creation in the Group. All organizations of the Fresenius Group have participated in the development of the program and are accompanying the transformation process in the Global IT Board.

We want to further develop our IT in such a way that it supports existing business models and enables the development of new ones. Our vision is to digitally transform Fresenius for improved patient care and a successful future for our Group.

The first step in the transformation process was the restructuring of the responsibilities of Fresenius SE & Co. KGaA, the business segment Fresenius Kabi, and the Group’s own IT service provider Fresenius Digital Technology (formerly Fresenius Netcare) in 2021. Fresenius Kabi now handles, for example, company-specific applications and IT services for production, while Fresenius Digital Technology is responsible for all cross-segment services.

The successful restructuring set the foundation for further transformation to drive innovation and business value. One core activity is to implement and leverage state-of-the-art platforms and tools at scale, i.e., Cloud Computing. Hereby, Fresenius Digital Technology is collaborating with a strategic partner to drive the technological change quickly.

In addition to the redesign of the IT landscape, Fresenius Digital Technology has initiated further internal changes. In order to increase its own innovative capacity, the company will deliberately focus on diversity in the future. Teams will be put together internationally and work on solutions and new ideas across the globe. This approach is also reflected in the new leadership team, for which people with very different biographies and professional backgrounds were deliberately selected. Employees can also launch initiatives for more diversity and equality in the company.

Clinical Research and Innovative Treatment Management

Fresenius Medical Care

Fresenius Medical Care’s Global Medical Office aims to enhance its patient-focused care delivery business model. This function, led by the Global Chief Medical Officer on Fresenius Medical Care’s Management Board, aims to achieve the best clinical outcomes for patients, their families, and the payor community. This office is tasked with evaluating coordinated data from clinical science research and medical practice. This includes facilitating cooperation and knowledge transfer across the entire network of Fresenius Medical Care. More information can be found in the Annual Medical Report, which is available online.

The business segment continuously engages in the research and development of innovative products and enhanced therapies. For example, it facilitates clinical trials, which are a crucial step in developing new treatments. Fresenius Medical Care is also further exploring non-interventional methods by means of mathematic modeling and virtual clinical trial simulations. The research and development activities follow regulatory guidance for clinical research practices. Additionally, they are conducted in compliance with ethical standards. In a global statement, Fresenius Medical Care outlined the principles with which the business segment commits to advancing health care and managing related risk, as well as advocating for patient rights, patient well-being, and animal welfare. The business segment plans to make this publicly available in 2022. It is of importance, that research partners follow similar bioethics guidelines as the company itself.

The business segment's Frenova Renal Research division provides research services to third parties and has also started enrolling patients in a new initiative to develop the largest renal-focused genomic registry in the world. It aims to enroll over 100,000 patients by 2025. This new registry will contain genetic data from chronic kidney disease patients worldwide and help researchers improve their understanding of kidney disease.

Fresenius Kabi

At Fresenius Kabi, the knowledge and expertise from experts in clinical nutrition, pharmaceuticals, and medical devices are embedded in research and innovation projects with the goal of improving patients’ health and quality of life. As a manufacturer of generic drugs, clinical nutrition products, and infusion and transfusion therapies, as well as biosimilarsBiosimilarsA biosimilar is a drug that is “similar” to another biologic drug already approved. and medical devices used to administer these products, Fresenius Kabi conducts clinical studies by commissioning qualified external contract research organizations (CROs) and university scientific institutions to do so. For some products, clinical studies sponsored by Fresenius Kabi must meet regulatory approval requirements. In addition, further studies are conducted regarding patient safety, in order to gain new medical-scientific insights or comparative clinical studies with other products available on the market. The clinical studies sponsored by Fresenius Kabi are always carried out in accordance with strict legal requirements, including, for example, the guidelines of the International Council of Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), of Good Clinical Practice (GCP), and of the relevant pharmaceutical regulatory authorities such as the U.S. Food and Drug Administration (FDAFDA (U.S. Food & Drug Administration)Official authority for food observation and drug registration in the United States.), the European Medicines Agency (EMA), the Declaration of Helsinki, and the EU General Data Protection Regulation. Fresenius Kabi sponsors studies for registration in close cooperation with various CROs, scientists, and physicians and supports investigator-initiated trials. These studies pursue the goal of generating new scientific knowledge that is significant for patient care using approved and new products.

Fresenius Kabi has a Chief Medical Officer and a Global Trial Committee that reviews, evaluates, and approves clinical trials before they begin. Responsibility for clinical study management is aligned with Fresenius Kabi’s product groups and is anchored in the divisional organizations. Compliance with the applicable regulations and guidelines prior to, during, and after clinical studies is ensured by a risk-based auditing program. Here, safety of the study participants and validity of the study data are considered the most important criteria. No clinical trials are conducted without a positive vote by the responsible ethics committee and approval from the respective competent authority, where required.

CROs contracted for the management of Fresenius Kabi-sponsored clinical studies are audited by the Quality Assurance Department of Fresenius Kabi to ensure that the applicable regulations and standards are followed throughout the duration of the clinical studies; Fresenius Kabi also conducts internal process and document audits regarding clinical studies as well as audits of investigator sites. Every two years, employees involved in clinical research receive training on regulations to ensure a uniform understanding of the requirements of Good Clinical Practice (GCP). In addition, employees receive training on the procedures applicable to clinical studies at Fresenius Kabi.

When selecting study participants, Fresenius Kabi also takes diversity into account concerning the population group for which a product in question is intended. Fresenius Kabi does not conduct studies without a prior positive benefit / risk assessment. Furthermore, safety events occurring during a clinical study are constantly monitored and evaluated. Study participants are fully informed prior to the start of the study and are enrolled only with their consent. Internally, clinical studies are documented in a central database and the results are published in accordance with the applicable regulations.

To foster clinical research into malnutrition in countries around the world, Fresenius Kabi established the initiative United for Clinical Nutrition in 2014. This multinational initiative seeks to reduce hospital malnutrition through education, data collection, and clinical assessment in various regions. In 2018, the commitment continued in Europe, with a special focus on critically ill patients with the aim of gaining knowledge on the use of clinical nutrition in intensive care units of European hospitals, as well as assessing calorie and protein balance in critically ill adult patients. The relationship between clinical nutrition therapy and patient outcomes is also being investigated.

Fresenius Helios

Fresenius Helios conducts clinical trials at many sites to promote innovation processes in clinical treatment, medication, and interdisciplinary exchange. The business segment’s innovative strength in clinical study management strongly influences its future success in therapy and inpatient treatment. Among other things, studies are conducted to determine how effective and safe medicines are and whether medical devices are suitable for approval in accordance with internationally applicable ethical and scientific standards, such as Good Clinical Practice or the Declaration of Helsinki of the World Medical Association. In addition, the division encourages its employees to engage in scientific and technological research activities. The aim is for them to develop personally and use their findings to enhance the well-being of patients.

Projects funded by public grants are also being carried out at the German Helios hospitals – supported by the Innovation Fund of the Joint Federal Committee (G-BA), the German Federal Ministry of Education and Research (BMBF), or ministries of further German federal states, among others. These projects serve the benefit of both Helios’ employees and patients; they mostly focus on the development of new therapies, care, and treatment pathways. In cooperation with manufacturers, the focus is also on testing specially designed patient rooms (e.g., for dementia patients) or assessing new technologies in the sterilization of medical equipment. Helios Germany provides data on severe acute respiratory infections (ICOSARI) to the Robert Koch Institute (RKI) in order to monitor the appearance of influenza virus and coronavirus in hospitals.

Clinical research projects

In Germany, the Helios Center for Research and Innovation (HCRI) is the point of contact for all employees of Helios clinics and its subsidiaries who want to conduct research – whether with patient data, by participating in clinical drug and medical device studies, or by developing new apps. Before a clinical research project takes place in a clinic, it is ensured, for the protection of the participating patients, that scientific, ethical, and legal requirements are met and that the project complies with Fresenius Helios’ guidelines and quality standards. These requirements are listed in the Helios Group Regulation Research and Science. This Group regulation also specifies the framework conditions within which Helios specifically promotes research projects of its own employees that are expected to have a high level of benefit for patients.

A total of 48 hospitals or integrated health care facilities are involved in at least one research project. The respective Helios clinics or facilities in question employ what are referred to as investigators and study assistants – specially trained staff such as biologists, chemists, or natural scientists with doctorates, but also nurses. They determine on-site the costs associated with a study and the benefits to patients and to Fresenius Helios. In addition, the HCRI supports the research clinics of Helios Germany along with employees in studies initiated by the clinics themselves (known as investigator-initiated studies, IITs).

HCRI, as the central office with experts in regulatory principles and methodology and in contract management, is supported by the Central Data Protection Service and has been conducting the central study review since 2019. More information on data protection can be found in the respective chapter about Data protection.

In the wake of the COVID-19 pandemic, Helios-wide analyses based on routine data were conducted several times; they substantiated, for example, the changed number of patients for various acute conditions (myocardial infarction, mental disorders, major tumor surgery) during the pandemic.

Departments or clinics have special certifications, e.g., as certified organ cancer centers or as oncology centers of the German Cancer Society. Certification is based, for example, on quality of treatment or sufficient participation of patients in clinical trials. If a Helios clinic is selected by an external sponsor for a study, external audits are conducted in accordance with the sponsor’s respective guidelines. Likewise, individual Helios clinics are inspected according to the respective selection procedures of the state authorities.

The performance of clinical studies is subject to strict requirements. These include the Group’s internal Clinical Research Policy as well as numerous external guidelines, national regulatory requirements, and the Declaration of Helsinki issued by the World Medical Association.

All clinical studies are reviewed by independent experts from the ethics committee. The independent ethics committees are constituted according to state law and are responsible for the respective state or the state medical association there. For research projects of Helios physicians with university affiliation, the ethics committee of the responsible university is responsible for the review of a study, depending on the state regulations. Within experimental studies, investigations can be carried out in the laboratory, e.g., using tissue samples or blood material, and are also reviewed by an ethics committee. All studies using sample material from patients must also be evaluated by the ethics committee. Exceptions may be made in the case of completely anonymous processing of samples; this is reviewed on a case-by-case basis.

If patients are interested in participating in a clinical trial, they discuss all questions in advance with the responsible investigator. These discussions follow a guideline that includes study-specific patient information and a declaration of consent. External sponsors are responsible for preparing these documents themselves. After evaluation by the ethics committee, the investigator may use the documents. In this way, discussions are documented for the protection of the patients. The data protection requirements must be complied with.

Research makes Fresenius Helios more attractive to physicians and employees who are interested in improving existing forms of treatment and therapy and who thus have an affinity for research. For the organ cancer centers and oncology centers, participation in studies is a mandatory requirement for certification. Patients research on the Internet to find out which hospitals are running studies and then make a conscious decision to participate. By participating in studies, Helios patients can access innovative drugs or medical devices earlier and benefit from the latest scientific standards of treatment.

Progress and measures in 2021

Under the Horizon 2020 research program of the European Union, the Helios Leipzig Heart Institute is coordinating PROFID, a large international research project on prediction and prevention of sudden cardiac death after myocardial infarction. The project started in January 2020, is scheduled for five years, and brings together more than 20 top partners from 12 European countries including key academic institutions, the European Society of Cardiology, public health insurance bodies, health economic experts, and patient organizations. The Fresenius entities involved are the Helios Leipzig Heart Center and Helios Spain. The assessment of risk factors for sudden cardiac death is based on machine-learning approach using approximately one million patient datasets. The findings will be subsequently validated in two international clinical trials that are currently the largest clinical trials worldwide in the field of cardiac devices.

Evaluation

In 2021, a total of 424 studies were conducted in the Helios clinics in Germany, the majority of those with the goal to improve therapies for patients. For example, under the leadership of Helios ENDO-Klinik Hamburg, an international group of experts from over 40 countries developed guidelines and algorithms under which a safe return to normal operations and the performance of elective orthopedic surgery was possible. The study results were publicated in spring 2021.

Further, Helios Germany conducted 34 COVID-19-related studies in its clinics.

In order to record the tolerance of COVID-19 vaccinations, Helios Klinikum Hildesheim started a study within its workforce at the beginning of 2021. Under the title Helios Hildesheim COVID-19 Vaccination Study (HelCO-Vac), vaccination reactions after a first and second vaccination were systematically recorded from January to June and, in addition, the protective antibodies formed in the blood after vaccination were measured at different points in time. The evaluated data of more than 1,200 study participants allows initial conclusions to be drawn: no serious vaccination reactions occurred; however, vaccination resulted in complaints leading to sick leave in a low percentage of recipients. It was also clearly shown that certain vaccines led to significantly different frequencies of mild to moderate vaccination reactions when given for the first or second time and in different combinations.

In August 2020, Helios published the first Germany-wide study on COVID-19 intensive care patients. This had been being conducted by physicians from the Helios clinics Group and the Brandenburg Medical School (MHB) since February 2020. The team of experts evaluated data from 1,904 patients who had been treated for COVID-19 in a total of 75 Helios Group hospitals since the beginning of the pandemic. The analysis showed, for example, that two out of three COVID-19 intensive care patients in Germany require artificial ventilation and that one in three ventilated intensive care patients dies. In another important representative study, Helios evaluated the number of cancer treatments in its hospitals in early 2020. The results confirmed that significantly fewer cancer treatments had been delivered during the initial coronavirus lockdown and shortly thereafter. In total, about 69,000 cases were analyzed and a significant decrease in treatments of 10% to 20% on average was established.

In 2021, Helios Spain participated in 1,230 clinical trials, more than 370 observation studies, and more than 600 research initiatives, with COVID-19 as a major focus. Apart from that, the most important area of research has been oncology with approximately 40% of all clinical trials performed. A total of 44 hospitals in the business segment were involved. Some of the results have already been published this year; one example was a study in which Helios Spain participated. Two Helios Spain hospitals, one in Madrid and one in Barcelona, and two Latin American hospitals, one in Colombia and one in Peru have been selected by a pharmaceutical company to perform clinical trials on vaccine effectiveness.

Fresenius Vamed

At Fresenius Vamed’s Institute for Gender Medicine, all health issues that lead to an extension of the healthy years of life and to the improvement of quality of life are researched, with a particular focus on gender-specific aspects with regard to individualized medicine. These research activities encompass prevention, acute care, rehabilitation, and nursing.

Gender-specific medicine

The well-being of patients is Fresenius’ top priority. Within the Fresenius Group, great importance is therefore attached to a gender-specific view of people in research, prevention, diagnostics, and therapy.

From a medical perspective, women and men differ, for example, in their chromosomal makeup, sexual characteristics, and hormonal balance. These purely biological differences, as well as societal aspects such as environmental conditions, upbringing, culture, or social circumstances, have an impact on human health. This results, for example, in differences in the symptoms and courses of diseases and in the effectiveness of medications. Until the end of the 20th century, these differences were largely ignored in medical research and practice. The resulting knowledge gap needs to be closed in order to be able to offer our patients individually tailored advice, diagnosis, and treatment. In the business segments, we pursue gender-specific approaches corresponding to the respective business activities.

Fresenius Helios investigates gender-specific issues as part of its studies and research projects. In 2021, for example, Fresenius Helios conducted a study on the gender- and age-specific effects of COVID-19 vaccines. In addition, several studies addressed gender differences in COVID-19 patients: for example, differences in the course of the disease during hospitalization, the occurrence of thrombosis, and the effectiveness of cortisone treatments in COVID-19 patients were analyzed. On the basis of the results, individual therapies can be developed. At the same time, open questions for more profound research were identified. Helios Germany also makes various gender-specific offers, such as heart consultation for women at the Heart Center Leipzig.

Fresenius Vamed operates the first Institute for Gender Medicine in Austria in cooperation with the Medical University of Vienna. This application-oriented research is intended to generate new approaches to this important topic. Currently, research projects are underway, including on prediabetes and diabetes, as well as on enhanced stress management through dietary restriction and biofeedback intervention. In this process, non-sensory physical processes are measured and reported back to the patient by means of an acoustic or visual signal. Patients can thus learn to better detect and control muscular tension, for example. The findings from the studies are incorporated into Fresenius Vamed’s prevention and rehabilitation programs. In addition, Fresenius Vamed offers health services specifically for women in its own “la pura” health resort in Austria.

Digitalization and innovation in the business segments

Fresenius Medical Care

Digitalization plays an important role for both health care services and products. The business segment continually develops products and digital services that improve access to health care, which has become more critical during the pandemic.

Fresenius Medical Care’s Global Research and Development division manages the global research and development activities related to product engineering. The Global Medical Office is responsible for the clinical digitalization strategies and the use of digital clinical data for research and operations. The basis of this commitment to continuous innovation is articulated in the Code of Ethics and Business Conduct.

Progress and measures in 2021

• Telehealth care
  In North America, Fresenius Medical Care has established telehealth platforms aimed at giving extra support to patients on home dialysis. For example, the cloud-based solutions for home dialysis are designed to keep patients connected to their care teams, with better access to recent treatment data. By making this data more easily accessible to clinicians, care teams can resolve treatment issues earlier and reduce hospitalization. For the peritoneal dialysis patient education experience app, the business segment was awarded two Bronze Awards for Excellence in Technology by the research and analyst firm Brandon Hall Group.

• Digital product innovations
  The business segment has expanded its digital options to facilitate better access to information for the patients under its care. The digital platforms enable virtual contact, which has, for example, reduced the risk of infection for patients and staff during the pandemic. Keeping patients and care teams connected and giving them access to recent treatment data is vital for continuously improving medical outcomes, user experience, and the effectiveness of care. The business segment has two main platforms, that are provided via apps. One is used predominantly in North America and the other is accessible across more than 20 countries in Europe, Africa, Asia-Pacific, and Latin America. Combined, these apps had more than 26,000 active users in December 2021. The business segment use digital platforms in more than 20 countries to overcome the challenges presented by COVID-19. In the United States, Fresenius Medical Care recorded over 410,000 remote visits between patients, care teams, and physicians by the end of 2021.

Fresenius Kabi

As a global health care company that offers lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition, digitalization and innovation are of great importance to Fresenius Kabi. The digitalization of processes is a cornerstone in the development of innovations and an important aspect in effective care for critically and chronically ill patients, as well as compliance with regulatory requirements. Fresenius Kabi develops devices and applications in various medical fields to support its customers’ ongoing digitalization. Devices not only have to be optimized in their core functions but increasingly need to be embedded into the IT systems of hospitals, clinics, and plasma centers. Fresenius Kabi wants to benefit from this trend and will focus on the constant development of its portfolio, while acknowledging the increasing role of software in medical technology and its application area. This is part of the Fresenius Kabi Vision 2026, which was developed in 2021 and adopted in the fourth quarter.

In order to take even greater advantage of the opportunities of digital transformation and to develop digital business models, Fresenius Kabi has started to realign its IT organization as part of the Group-wide IT program. The digital transformation is thus to be driven forward and the value contribution of digital applications for the company and customers increased. The business segment is increasingly using intelligent automation and artificial intelligence to improve business processes in administrative functions. In production and quality management, Fresenius Kabi is using digital platforms to implement process control systems, monitor plant efficiency, and manage data and support workflows in laboratories. This also enables the business segment to access data to analyze and automate decision-making processes. Digital solutions are constantly being developed along the entire value chain to make internal work processes more efficient and simpler.

Fresenius Kabi develops digital applications for health care professionals and patients to support the quality of treatment and improve patient care and quality of life, as well as to open up new business areas. In addition, the business segment uses digital solutions for what are known as track-and-trace systems for the traceability of products. These applications also enable information to be shared with customers and support, for example, the monitoring of inventories in hospitals.

At Fresenius Kabi, responsibility for digitalization is anchored in the central, divisional, and regional organizations; steering responsibility lies with the Fresenius Kabi IT Executive Board, which is chaired by the responsible member of the Management Board and the head of the global IT department. Other relevant functions are also represented on this board.

Product innovation

In product development, Fresenius Kabi’s expertise includes all related components, such as the raw material for drugs, the pharmaceutical formulation, the primary packaging, the devices needed for application of drugs and infusions, and the related production technology. In the field of biosimilars, Fresenius Kabi focuses on autoimmune diseases and oncology. More information on R & D can be found in the Group Management Report in the chapter Research and development.

The business segment has standard operating procedures for the development and design of products and for the cybersecurity of its devices; for more information see the Cybersecurity section. The responsibility for innovation and development is anchored in the divisional organizations of the company. Fresenius Kabi constantly addresses the advancement of scientific findings. Employees work together in cross-organizational and cross-functional teams to develop innovative solutions for medical needs.

Progress and measures in 2021

Digital transformation

Fresenius Kabi started to implement the business segment’s new governance structure as part of the Group-wide IT program for digital transformation in 2021. Fresenius Kabi has thus had an integrated IT organization for business-specific applications and IT services since October 2021 and in this way aligns them even more closely with the requirements of the business model and its customers and patient

Digital product innovations and digital applications

Digital applications can help to ensure patient safety and regulatory compliance. For example, Fresenius Kabi introduced radio frequency identification (RFID) technology, known as smart labels, for drugs in the United States in 2020. The smart label enables hospitals to automatically identify, locate, and manage their inventories. Following the successful launch of the first RFID-labeled product in the United States, two more products with smart labels were launched there in 2021.

In the area of device products, the company works on solutions for interoperability between pump devices, infusion-specific systems, and hospital IT systems in order to improve efficiency and effectiveness in the treatment of patients. Furthermore, devices are constantly being improved with regard to new cybersecurity requirements and insights. Fresenius Kabi, for example, offers an infusion management system for the controlled administration of drugs and fluids. To ensure the safety and correct functioning of the devices, the medical pumps are equipped with an automatic test.

In the area of transfusion medicine and cell therapies, Fresenius Kabi is constantly developing its systems for collecting blood components and using new technologies to increase efficiency and efficacy. Systems are continuously being optimized to support the processing of technical information. The applications for data management of the networked devices will also be expanded to support customers in their digital transformation initiatives.

With digital technical services, Fresenius Kabi helps improve the efficiency of processes in hospitals and care facilities. Digital technical service applications accelerate maintenance and can reduce the downtime of medical devices due to maintenance work. In this context, Fresenius Kabi aims to offer its solutions to its customers in as many countries around the world as possible.

In 2021, Fresenius Kabi launched a digital application for field staff in the United States to digitize and modernize the maintenance of equipment for transfusion medicine and cell therapy. This app is already in use in Italy and Poland and was also made available in Spain and Portugal in 2021, for example. The application will be made available for use in further countries.

In the enteral nutritionEnteral nutritionApplication of liquid nutrition as a tube or sip feed via the gastrointestinal tract. product segment, Fresenius Kabi has launched the website www.fresubin.com in many languages and is continuously working to expand this offering in more languages. In 2021, the online offering was expanded to include practical instructions for enteral medical devices to support health care professionals in using them. The business segment also offers interactive self-learning training on the enteral pump systems to ensure professional training on the products even in the event of COVID-19-related restrictions on visiting opportunities. The training is aimed at health care professionals in hospitals, nursing homes, and home care.

In the biosimilars product segment, Fresenius Kabi also offers the support program KabiCare®, which is aimed at health care professionals and patients who use or are treated with Fresenius Kabi’s biosimilars products. The program provides users with educational materials on the management or treatment of the disease. With KabiCare®, Fresenius Kabi thereby aims to support the optimal care of patients and treatment by health care professionals. KabiCare® is available in numerous countries and was launched in six additional countries in 2021.

The KetoApp supports patients with chronic kidney disease with information on nutrition and the nutritional values of foods, in order to enable a varied diet despite the restrictions caused by the disease. The app was launched in an initial pilot phase in Mexico in 2021. To support patients with chronic kidney disease, the business segment also offers patients information and services on the website www.chronic-kidney-disease.com. To tailor this even better to the users’ needs, Fresenius Kabi relaunched the website in 2021.

In compliance with data protection regulations, Fresenius Kabi is also working to use the data generated by the apps to improve patient care. For example, the aim is to identify potential risks for patients and improve the decisions made by patients or health care professionals.

Efficient and mobile working at Fresenius Kabi

Fresenius Kabi is continuously expanding its skills to increase the digitalization of its work processes, in order to make them even more efficient and contribute to the company’s growth. One important step in the digital transformation is the intelligent automation project. Fresenius Kabi intends to automate large parts of the overall process using both innovative new processes, such as robotic process automation (RPA) or artificial intelligence (AI), and proven technologies, such as enterprise resource planning (ERP) systems. The combination of technologies is intended to increase the efficiency of the processes. In the field of artificial intelligence, the focus is on established application areas such as chatbots, intelligent document processing, or recommendation and forecasting engines. The overall goal is to provide the organization with access to automation solutions as easily as possible. There are various offerings for Fresenius Kabi’s different organizations. These range from the implementation of individual use cases to a transformative value-added approach. Global business process experts are an important part of the project governance. Intelligent automation and the efficiency it gains are used as drivers of the further harmonization and standardization of business processes. Fresenius Kabi consciously relies on a network of technology, IT infrastructure, and automation partners to implement its solutions. In 2021, workshops were held in the areas of procurement, sales and marketing, finance, IT, and compliance and treasury to identify further use cases for intelligent automation. In parallel, solutions for initial use cases have already been implemented and the first use cases in the area of artificial intelligence have been piloted in the business segment.

The business segment also initiated a global digitization project in 2021 to further standardize and harmonize the processes for planning and managing the supply chain network in transfusion and cell therapy production, by leveraging the latest ERP technology and a modern cloud infrastructure. The three-year program aims to deliver an enhanced value case for the transfusion and cell therapy production network through improved data transparency and optimized oversight, stronger and better connectivity between the production network and sales organizations, connectivity to business partners’ systems, and faster decision-making processes.

Fresenius Helios

Digitalization is key for Fresenius Helios to ensure the sustainability of its hospitals and outpatient facilities, and to improve the quality of health care and the service provided to patients.

Since 2020, the business segment has used a newly developed process for managing digitalization projects in Germany via the Helios Digitalization Board (Helios DIGI) to manage and centrally evaluate proposals for digitalization projects. Proposals are collected in the clinics and outpatient facilities of Helios Germany and in the Fresenius Group and then rated. The Board decides on the approval of project proposals. All digitalization projects, including rejected project ideas, are published in the “Helios.Digital” project database via the intranet "myHelios".

Helios Spain’s IT and process strategy aims to further improve digital patient interaction such as video conferencing and chats, where patients can present their medical history, protocols, and automated tests for specific diagnoses. To ensure that the IT strategy is gradually implemented, the business segment has introduced a competence model called Digital Stars at Spanish hospitals. This model is based on three pillars: Digital Customer (patients), Digital Professional (employees), and Digital Organization (administration). Each of the three pillars has key figures to indicate progress in digitalization and its acceptance, and collects data, for example on the number of patients making use of digital medical consultations, the number of electronic prescriptions issued by employees, and the number of invoices automatically generated. The data is evaluated on a monthly basis and enables comparison of the state of evolution of digitalization in the various hospitals in Spain.

The Helios patient portal

Fresenius Helios started introducing a patient portal at its clinics in 2019. Patients can now access treatment documents such as diagnoses, book appointments online, or attend video consultations at 50 German clinics, around the clock and from home. The portal can be accessed via the websites of the respective clinics. In 2021, the patient portal recorded 130,000 registered users, 300,000 documents exchanged via the portal and nearly 85,000 online appointments.

Many users already access Helios Spain’s patient portal. Nearly all Spanish hospitals are connected. The hospitals benefit from a central data repository and improved data transmission and coordination. Via the digital portal, patients of Helios Spain can track the progress of their own clinical treatments and view recommended therapeutic measures. They have direct access to 3D radiological images and can contact their responsible specialists and interact via web formats. In addition, it is possible to digitally request an appointment for most of the examinations available and to read up on the risks associated with an examination. Prior to a procedure, patients can also sign a consent form electronically via the portal.

Electronic patient file (EPF)

A digital patient file with doctor’s letters, findings, and complete clinical imaging is available at the majority of workstations in the clinics; this creates added value for both treatment providers and patients. By 2022, other medical data such as nursing documentation and medication will also be available in the digital patient file at Fresenius Helios. In about half of the Helios clinics, integrated software solutions already issue warnings of possible interactions with other drugs, which increases patient safety.

In general, this makes many processes more efficient and improves medical quality. The expansion of the Germany-wide telematics infrastructureTelematics infrastructureThe telematics infrastructure is intended to network all those involved in the German health care system and enable a secure exchange of information across sectors and systems. , ordered by the government, into which the electronic patient file will be integrated in the future, focuses on improving the quality of care and the efficiency of care and administrative processes. This project aims to modernize the technical infrastructure in the German health care system up until 2025.

E-medication is one planned aspect of the telematics infrastructure. It will enable electronic prescriptions to be transmitted digitally to parties outside the hospital – e. g., medical practices and pharmacies – and to be uniquely assigned and tracked. Patients can make their own decisions on the distribution of information.

In Spain, the electronic patient file contains discharge papers, issued by medical or nursing staff, along with medication information and prescriptions. Thanks to this paperless process, patients can go directly to the pharmacy with their smartphone. Prior to an appointment at the hospital, they fill out a form online and then receive notifications and directions. At the clinic they are navigated directly to the treatment room via the app.

Digitalization of hospital routines

Many patients in Spain come to hospitals from primary care – e.g., family doctors’ practices. 65% of them are assigned to one of around 350 protocols depending on their health status. These protocols are used to define the laboratory tests that are immediately necessary prior to a treatment consultation, to arrange appointments, and to ensure that the responsible physician receives all diagnoses and information prior to the consultation. This saves time, because patients can start treatment immediately after the consultation or go home if no further action is needed.

The availability of real-time test results or existing patient data ensures that 30% of patients can be discharged directly after an initial consultation.

Due to digitalization, meetings in the oncology outpatient clinicOutpatient clinicInterdisciplinary facility for outpatient care, managed by physicians. The responsible body of a medical care center includes all service providers (such as physicians, pharmacists, health care facilities) that are authorized to treat patients with statutory health insurance. have decreased by 60%. Patients are also staying for less time – no longer eight hours on average, but only around two. In the area of reproductive medicine, the length of stay has also been reduced, by 60%.

Digital support in nursing care

In many Helios hospitals in Germany, nurses use digital devices for support – such as mobile monitors that can be moved directly to a patient’s bedside – and vital signs can be inserted digitally. These spot-check monitors transfer the data to the electronic patient files; transmission errors are thereby reduced. By the end of 2022, these solutions will be in use at all Helios Germany clinics.
Helios Spain has developed an algorithm based on Artificial Intelligence that is used in the emergency room, among other places: it is used to determine the likelihood of bilateral pneumonia based on laboratory test variables and other patient parameters – before the X-ray shows it. The algorithm is used to rank the condition of COVID-19 patients. Another algorithm can diagnose pneumonia based on real-time X-ray images.

Digital support for treatments

Fresenius Helios health care facilities conduct video consultations. A significant boost in the use of such video consultations resulted from contact restrictions during the COVID-19 pandemic. In 2021, Helios Spain conducted 7,000 video and 750,000 telephone consultations and answered 15,000 chat inquiries. Helios Germany has also started online consultations in the pre-stationary sector. The business segment also plans to introduce digital measures to shorten waiting times. In addition, Helios Germany is expanding its offer of digital follow-up care via its own outpatient centers – for example, for wound management following surgery. Thus, specialists from Fresenius Helios digitally accompany patients throughout their treatment path – regardless of whether they are at the hospital or being treated at an outpatient center. Clinical sessions are held online within the network of all Helios Spain hospitals, including in Colombia and Peru.
Experts at Helios Germany have been using online conferences, referred to as tumor boards, to review and discuss oncological diagnoses collectively across locations and disciplines, determine the best possible treatment, and thus improve medical quality during cancer treatment.

Modern operating theaters with hybrid systems

Helios Spain has 12 operating theaters with imaging and robotic equipment at its disposal, making it one of the pioneers of this technology in Spain. The latest addition here is the Kinevo 900 surgical microscope, which has been in use in neurosurgery at the Teknon Hospital (in Barcelona) since September 2020 and provides a hybrid endoscope and exoscope function, capturing detailed images of microstructures inside and outside the body. This allows operations to be projected directly onto a high-resolution screen and be viewed in 3D.
The growth of robotic surgery in our Spanish hospitals continued in 2021, both in spinal surgery and other surgical specialties. By the end of 2021, more than 700 robot surgeries had been performed, 9% more than in the entire year 2020 and almost 10% more than in 2019.

Curalie: digital health applications

The Fresenius subsidiary Curalie pursues the goal of encouraging people to follow a healthy lifestyle in the long term and supporting them along the way. A key focus of the health app is therefore prevention and user information. To that end, in October 2021, a digital symptom-check and a telemedical consultation were integrated into the app as a freely accessible service. Interested users can thus book and conduct telemedical consultations with experienced medical experts from the Helios network via Curalie. Since 2022, Curalie releases freely accessible programs for continuous health improvement on a monthly basis. The focus is on lifestyle-related topics such as exercise, relaxation, and nutrition.

Curalie also offers fully digitized blended careblended careCombination of classic therapy approaches with digital offers solutions to support and treat chronically ill patients in the following areas: cardiac conditions and health risks, diabetes, orthopedics, hypertension, obesity, and renal insufficiency (The renal program will be discontinued during 2022.). As part of chronic care, Curalie is also developing digital offerings for rehabilitation and aftercare for orthopedic and cardiac patients. Current platform partners and health providers for the digital health solutions are pharmaceutical companies, inpatient and outpatient rehabilitation facilities or other health facilities, health insurers and pension insurance companies.

The digital health care application Curalie is open to all healthcare providers and makes it possible to connect medical devices, as well as selected hospital information systems, and enables communication via chat and video call. Curalie provides digital treatment plans as well as real-time analysis of users' health parameters under the highest security standards.

So far, around 300 health professionals have used Curalie for the treatment of more than 6,000 patients in about 11,000 consultations. With its freely accessible services and functionalities, such as the symptom check and the telemedical video consultation, Curalie has been able to inspire around 100,000 users since the beginning of 2021.

Fresenius Vamed

Fresenius Vamed has established digitalization as a strategic business area with the aim of implementing digitalization initiatives and projects, coordinating digitalization activities within the Vamed Group, driving digital innovation, and generating new digital solutions and services. Among other things, Fresenius Vamed is developing patient services for digital assistance systems that support ambient assisted living (AAL) and digital rehabilitation services. In the project business, Fresenius Vamed has long used complex virtual models (Building Information Modeling - BIM) in the planning and operation of health care facilities, which enable to simulate and optimize the entire life cycle (planning, design, construction, operation, and maintenance) of a health care facility. Additionally, Fresenius Vamed is also undertaking internal digitalization projects in the areas of project business, high-end services, and general operations management. The management of the digitalization strategic business unit regularly reports to the Management Board on progress.

Progress and measures in 2021

In 2021, the management approach and the governance structure of the digitalization strategic business unit of Fresenius Vamed remained as reported in 2020. Progress focused on various digitalization projects and initiatives in the areas of high-end services, overall operations management, and project management.

• Digital support for treatments
  Fresenius Vamed is making rehabilitation and after-care services widely accessible to patients with its digital solutions: telemedical services allow more flexibility, including in terms of location. Fresenius Vamed is thus making a contribution to improving health care, especially in regions with weak structures. The company has developed digital treatment pathways, evaluated technical solutions, and launched pilot projects in the area of digital tele-post-acute aftercare services. Examples are the technical solutions from Curalie and an app developed by Fresenius Vamed.

COVID-19 and digital solutions

In 2021, the COVID-19 pandemic accelerated the digital transformation processes across all Fresenius business segments. One particular concern of patients during the pandemic has been suffering an infection in the hospital. We have been able to address these and other concerns thanks to our versatile digital solutions and improved patient information.

At Helios Spain, patient registration on mobile terminals, a digitalized process in the patient portal, and automated calls for appointment reminders, for instance, all proved helpful. Electronic prescriptions also helped to alleviate concerns and shorten transmission routes, with QR codes enabling patients to pick up their medications without making physical contact. In addition, Helios Spain has identified measures that can be implemented online as standard – such as communication of non-pathological test results, monitoring of endocrine pathologies in pregnant women, or monitoring of cardiac arrhythmia and hypertension. At the Fresenius Helios hospitals in Madrid, radiology is supported by a system based on artificial intelligence, enabling the radiologists to diagnose symptoms of COVID-19 at an early stage and identify affected areas. At Fresenius Vamed, specific projects in connection with COVID-19 were implemented internationally. Thanks to existing digital solutions, online services such as virtual consultations, online videos, and training could be offered to Fresenius Vamed health care providers at short notice.

Our ambitions

The Fresenius Group diligently works on expanding its competencies and developing new areas of business in order to offer digital solutions to the challenges faced by the health care sector.

The four business segments take different, segment-specific, approaches to the area of digitalization and innovation. In the care of critically ill patients, the demands on treatment success are becoming ever higher. The demand for effective therapies together with intelligent medical applications and devices will rise steadily.

Fresenius Medical Care is improving its portfolio through product innovation. To access the latest technologies, the business segment invests in research and development and collaborates with external partners, including academic institutions. Fresenius Medical Care also invests in startups that develop products, technologies, and therapies in the health care sector.

Fresenius Kabi wants to be the preferred partner for physicians and caregivers responsible for the treatment of critically and chronically ill patients. As part of Fresenius Kabi’s digital transformation, the business segment is orienting its IT organization more strongly toward added value for customers and its own organization – with the intention of using digital applications to provide important benefits to customers, patient care, and the digitalization of the health care system.
We assess the level of digitalization at the German Helios clinics based on the internationally used Electronic Medical Records Adoption Model (EMRAM) Score. Over the past six years, Helios Spain’s Corporate Quality department has set corporate targets for all hospitals – including in digitalization. Each hospital implements these targets and assesses the extent to which the targets are achieved. The results are submitted to the Helios Spain steering committee.

Fresenius Vamed manages digitalization and innovation ambitions as part of the VAMED strategy.

Evaluation

All business segments have their own approach to digitalization and innovation and are currently developing key performance indicators (KPIs). As a material aspect, digitalization and innovation is also included in the variable remuneration of the Group Management Board. Further information is included in the Corporate Governance Report of the Annual Report 2021, see the Compensation Report.

In 2021, Fresenius Medical Care started the process of further integrating specific environmental criteria in its research and development activities. The business segment is also working to include sustainability topics in the early stages of innovation projects.

Fresenius Kabi continuously reviews its progress in the area of digitalization. In 2021, the business segment reviewed the structure of its IT organization. Responsibility for business-specific IT applications and services for medical professionals and patients are thus anchored directly in the business segment and decisions are accelerated. In this regard, Fresenius Kabi intends to make even greater use of artificial intelligence applications and to exploit the possibilities of analyzing digital information for the benefit of the company and its customers.

In 2021, no critical events with a significant impact on the safety of study participants or compliance with the applicable requirements and standards became known.

In the hospital sector, Helios Germany measures the degree of digitalization using the EMRAM Score from the service provider HIMSS Analytics. EMRAM is an eight stage (0 – 7) model that provides transparency on a hospital’s degree of digitalized processes. A fully digitalized hospital would reach stage 7, while a hospital at stage 0 would use paper-based documentation in all departments. The results for 2021 will be available in the first quarter of 2022.

Fresenius Vamed regularly reviews its management approach using standard controlling processes. In addition, the digitalization strategic business area collects data and regularly reports on the status of the respective initiatives and projects in the business segment. Fresenius Vamed uses common trend and innovation studies, e. g., Gartner Hype-Cycle, and in 2021 also the results of the Allensbach study, to formulate and evaluate strategies for digitalization in the health care market. Local publications and trend analyses are also taken into account. In 2021, the business segment increased the use of telehealth solutions and mobile apps.

Overall, the digitalization of processes was driven forward throughout the Fresenius Group in 2021.