Fresenius SE & Co. KGaA
Investor Relations & Sustainability
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Digitalization plays an increasingly important role for Fresenius – whether in health care facilities 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. 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.
The demands on health care facilities are changing rapidly. Dynamic changes can occur, for example, with the introduction of digital patient files or due to 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), for example, 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.
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. 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 services. In response to the COVID-19 pandemic, we continued to drive the Group's digital transformation through new processes and solutions implemented at short notice.
Many of our stakeholders, especially our patients and our employees, are directly affected by the changes resulting from progressive digitalization. Our research and development 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.
All new or improved products and services are subject to our 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 General Data Protection Regulation (GDPR) of the European Union (EU). We also observe European directives such as the EU Medical Devices Directive (MDD) 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 section Cybersecurity.
In order to grow continuously in its core business and move into new business areas, Fresenius Medical Care works with a global R&D strategy and a network of external partners; in particular, the business segment invests in young start-up companies. Among other things, Fresenius Medical Care is developing new technologies for home therapies and is committed to advancing the development of telemedicine applications. These offer great potential for providing patients with clinical care between visits to their doctors and avoiding unnecessary hospital stays. Fresenius Medical Care attaches great importance to carefully addressing ethical issues in all its R&D activities.
Fresenius Medical Care manages worldwide R&D activities centrally in the Global Research and Development (GRD) business segment.
Fresenius Medical Care will focus on shaping the future of health care for chronically and critically ill patients across the entire spectrum of kidney disease. In 2020, for example, Fresenius Medical Care strengthened its position in acute dialysis. 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.) approved Novalung®, a cardiopulmonary support system for the treatment of acute lung and heart-lung failure. Fresenius Medical Care also strives to continuously identify new opportunities in value-creating technologies and approaches, for example through the Fresenius Medical Care Ventures Fund.
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 in compliance with regulatory requirements on a future-proof basis. Fresenius Kabi develops devices and applications in various medical fields to support its customers’ ongoing digitalization.
Fresenius Kabi’s development expertise includes all related components, such as the drug raw material, 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.
Fresenius Kabi has standard operating procedures for the development and design of products and for cybersecurity of its devices. The responsibility for innovation and development is anchored in the divisional organizations of the company. Fresenius Kabi continuously addresses advancing technological changes. Employees work together in cross-organizational and cross-functional teams to develop innovative solutions for medical needs.
The potential of digitalization is key for Fresenius Helios to ensure the sustainability of its hospitals and to improve the quality of health care and the service provided to patients.
In 2020, the business segment introduced a new process for managing digitization projects in Germany and established the Helios Digitization Board to manage and centrally evaluate proposals for digitization projects. To this end, ideas are being collected in the clinics and outpatient facilities of Helios Germany and in the Fresenius Group. A clearing function and other committees at Fresenius Helios review the proposals. The Digitization Management Board (DIGI Board) then makes the strategic classification of the digitization projects and, with the help of specialist working groups, the so-called DIGI-AGs (working groups), decides what will be implemented. All digitization projects, including rejected project ideas, are published in the "Helios.Digital" project database via myHelios. The degree of digitalization at hospitals in Germany is measured using the Electronic Medical Record Adoption Model Score (EMRAM Score)
Helios Spain's IT and process strategy aims to further improve patient interaction by digital means, such as video conferencing rounds and chats, at which patients can present their medical history, as well as protocols and automated tests for specific diagnoses. To ensure that the IT strategy is implemented gradually, 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). For each of the three pillars, key figures have been established to indicate progress in digitalization and acceptance thereof, which, for example, sees data collected for 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 business segment evaluates the data on a monthly basis and can thus compare the evolution of digitalization in the various hospitals in Spain.
Having established Digitalization as a strategic business area, Fresenius Vamed is now undertaking numerous initiatives and projects in this area. For example, patient services for digital assistance systems that support ambient assisted living (AAL) and digital rehabilitation services are being developed. To this end, Fresenius Vamed has set up pilot projects that are being evaluated on an ongoing basis. In the project business, digital solutions known as virtual Building Information Modeling (BIM) concepts are used to simulate and optimize the entire life cycle (planning, development, construction and operation) of a health care facility during the planning phase. 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 area regularly reports progress to the Management Board.
The four business segments take different, segment-specific, approaches to the area of digitalization and innovation. For example, in Germany, Fresenius Helios plans to introduce digital patient files by the end of 2022 – i.e., a health database as required by the law – and a patient portal for all hospitals. In the future, a standardized IT solution (Electronic Medical Records Adoption Model – EMRAM, or a German model within the framework of the German Hospital Future Act) is set to evaluate how digitalization is progressing at Fresenius Helios' German hospitals. Over the past six years, Helios Spain's Corporate Quality department has set corporate targets for all hospitals – including in digitalization. The management of each hospital is responsible for enforcing these targets and for checking the extent to which the targets are being achieved. The results are to be submitted to the Helios Spain steering committee. Fresenius Vamed manages digitalization and innovation ambitions as part of the VAMED strategy.
Connectivity is a key element of Fresenius Medical Care's development strategy to support the expansion of home therapies. Patients who are in close contact with their clinicians are less likely to be hospitalized. As more patients are treated at home, it is essential for to optimize workflows for clinicians and reduce the burden for patients. To this end, Fresenius Medical Care launched its Kinexus™ Therapy Management Service (“Kinexus”), a cloud-based home patient management solution, in Chile and the U.S. in 2020. Its features include remote dialysis monitoring, treatment workflow management, personalized prescription programming, and daily treatment reporting to clinicians. Kinexus allows Fresenius Medical Care to improve patients’ home therapy experience and support those caring for them, with the goal of keeping them at home for longer.
For Fresenius Medical Care, modern analytical tools open up new opportunities for enhancing and automating the end-to-end delivery of dialysis treatments. They can be used to determine the optimal treatment for individual patients and to automate the respective treatment sequence. Moreover, these tools make it possible to not only evaluate the vital parameters of patients but also to monitor and optimize the functional state of machines or related services. Fresenius Medical Care Data Solutions Care GmbH is working on these approaches and solutions with the aim of allowing physicians to focus even more on patients and the course of the disease itself.
In 2020, Fresenius Kabi introduced radio frequency identification technology (RFID) smart labels for drugs in the United States. Since the fourth quarter of 2020, these RFID smart labels have been used on the market. The smart label enables hospitals to automatically identify, locate, and manage their inventory.
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 regards to new cybersecurity requirements and insights.
Also, 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 the efficiency and effectiveness of the systems. They are continuously optimized to support the processing of technical information. In addition, the applications for data management of the networked devices will be expanded to support customers in their digital transformation initiatives.
A digital file with doctor's letters, findings and complete clinical imaging is available at almost every workstation in the clinics and creates added value for treatment providers and patients. As one of the pioneers in the German health care market, Fresenius Helios has set up a patient portal that now enables patients in around 50% of clinics to access treatment documents, book appointments online, and have video consultations from home. By 2022, other medical data such as nursing documentation and medication will also be available in the digital patient file.
The digital patient file will make many processes more efficient and improve medical quality. One example here is e-medication: electronic prescriptions can be uniquely assigned and tracked by all parties involved – e.g., medical practices and pharmacies – and can also be sent digitally, such that they are not easily lost. Integrated software solutions issue warnings when there are possible interactions with other drugs, which increases patient safety. Patients can make their own decisions on the distribution of information, since they receive key parts of the patient record themselves and can thus maintain an overview.
In many Helios Germany and Spain hospitals, nurses go to the patient's bedside with small medical devices, measure fever or blood pressure, or enter other vital signs. These spot check monitors transfer the data to the electronic patient file ‑ without physical slips of paper, transmission errors can be reduced. By the end of 2022, these solutions will be in use at all Helios Germany clinics.
In the United States, Fresenius Medical Care launched its connected health platform TheHub at the end of 2019. This improves collaboration between patients, care teams, and providers via an app. In 2020, more than 1.7 million sessions in the app were documented. In various countries in Europe, Africa, Asia-Pacific and Latin America, Fresenius Medical Care is using the mycompanion app as a new channel to reach our patients. During the COVID-19 pandemic in 2020, telehealth also played a critical role in reducing the exposure risk for patients and health care workers. By enabling virtual contact, Fresenius Medical Care minimized the risk of infection on both sides. At the same time, digitization raises the bar when it comes to protecting patient data.
2019 saw the Helios Patient Portal introduced at Helios Germany hospitals for the first time. It is currently available in 38 of the 86 hospitals and will be available at all sites by the end of 2022. The portal enables patients to view medical letters and reports (among other things) outside of hospital and outpatient department opening hours. There is also the option to go online to book appointments at hospitals and medical centers. Patients can reach the portal via the hospital websites.
Almost three million users already access Helios Spain’s patient portal. All Spanish hospitals are connected, with the exception of Hospital Miguel Dominguez, Hospital Costa de la Luz and Son Veri. The connected hospitals benefit from a central data repository and from 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 radiological 3D images and can contact their responsible specialists on this basis and interact via web forms. In addition, it is possible to digitally request an appointment for most available examinations as well as to read up on the risks associated with an examination. Before a procedure, patients can also sign a consent form electronically via the portal.
In 2020, the COVID-19 pandemic accelerated the digital transformation processes across all Fresenius business segments. One particular concern of patients during the pandemic is suffering an infection in the hospital, for example. 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 all proved helpful, for instance. 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 conducted 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 damaged areas.
At Fresenius Vamed, the administration department, for example, was able to not only work from home thanks to digital technologies during the COVID-19 pandemic, but also to speed up and streamline central processes. In addition, more online conferences were held. Furthermore, tools such as an electronic signature file with digital signature support virtual collaboration. Concrete projects in connection with COVID-19 were implemented in the international area. These include the development of a COVID-19 management platform, which was made available to our customers. 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.
All Fresenius Helios health care facilities have the necessary technical set-up to conduct video consultations, with some hospitals already offering these kinds of appointments on a regular basis, e.g., policlinic Berlin-Buch, where around 70 Fresenius Helios doctors routinely check in with patients online. 1,800 video consultations have already taken place in Germany. In Spain, Helios has conducted 4,500 video consultations and answered 15,000 chat inquiries. Fresenius Helios has also started online consultations in the pre-outpatient sector. The business segment also plans to introduce digital measures to shorten waiting times and ensure continuity in follow-up care. These will enable specialists from Fresenius Helios to accompany patients digitally 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 Colombia and Perú. In 2020, a total of 22 sessions were held.
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 making a contribution to improving health care, especially in regions with weak structures, for example. The company has developed digital treatment pathways, evaluated technical solutions and launched pilot projects in the area of digital tele-post-acute aftercare services.
Fresenius subsidiary Curalie offers fully digitalized solutions for the treatment of chronically ill patients in the following areas: cardiac diseases and health risks, diabetes, renal insufficiency, hypertension, obesity, and orthopedics. The Curalie digital health care application makes it possible to integrate devices, video calls and chats, references to the hospital information system, treatment plans, and real-time analytics. So far, around 300 health care experts have used Curalie for the treatment of more than 5,000 patients in around 10,000 consultations. Another focus of the health care application is on offers for prevention. Together with medical experts, Curalie develops digital health promotion programs for employers and their employees.
In addition, Curalie develops digital services for rehabilitation and aftercare. For example, Curalie is running a telemedicine lifestyle intervention program for type 2 diabetes in partnership with AOK Rheinland/Hamburg through its TeLiPro health platform. In the year under review, TeLiPro was selected as the leading technology for the official telemedicine offering of the federal state of North Rhine-Westphalia in Germany. The ambition with this is to build a comprehensive telemedical infrastructure in the country, to include an information portal, consulting service, and specialized tele-cardiology and ‑dermatology. Curalie is set to be tied in with the "virtual hospital" project too. The virtual hospital is a web-based portal designed to facilitate digitally supported, telemedical rounds and medical consultations, including digital documentation.
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 to these theaters is the Kinevo 900 surgical microscope. It 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 an operation to (for instance) be projected directly onto a high-resolution screen and be seen in 3D.
Currently, there are only around 20 proton therapy centers in total across Europe. In Madrid, Fresenius Helios completed work on Spain’s first proton therapy center in 2020, investing about €40 million in the construction. Proton therapy is one of the most advanced methods for treating cancer patients. Proton therapy has several advantages over traditional methods of radiation treatment: the proton beam acts with more precision on the tumor, meaning that the tumor can be irradiated with higher doses while at the same time protecting the healthy surrounding tissue. The lower amount of exposure to radiation and side effects also makes proton therapy ideal for the treatment of children.
The Proteus One treatment system is very compact, combining all the necessary instruments in one multifunctional space. The device includes a tumor scanning system that helps the physician to determine the appropriate dose in the area to be treated, as well as modern imaging systems. The device can rotate 360 degrees around the patient, allowing the proton beam to be used from any angle. In the first year of operation, more than 90 patients started treatment.
Fresenius Kabi is also working on increasing the digitalization of its own work processes in order to make them even more efficient and thus contribute to the growth of the company. We are continuously expanding the skills required for this. In 2020, the digitalization of workplaces was promoted and various solutions for digital collaboration were made available across the company. Fresenius Kabi is striving to make greater use of cloud environments across the company, not only for internal, but also for customer-oriented processes. In this way, the company wants to act even more data-based and make decisions. The increased use of the possibilities of mobile working during the COVID-19 pandemic accelerated the changes that had already been initiated internally.
Experts at Helios Germany have been using online conferences, referred to as tumor boards, to review oncological findings collectively across locations and disciplines and thus improve medical quality during cancer treatment. This exchange allows them to discuss treatment for cancer patients. Experts from Helios Germany also discuss pathological findings in the context of digital pathology.
Fresenius Medical Care works with research partners to facilitate scientific progress and explore new ways to improve care. In 2020, the business segment was involved in more than 40 key partnerships with academia, research institutes, and peer companies. Focus areas were, for example, cardio-protection, personalized and precise medicine, research and innovation as well as public health. This also includes the impact of COVID-19 on vulnerable patient populations. Fresenius Medical Care is also member of several professional organizations, including the American Nephrology Nurses Association, the American Society of Nephrology, the Renal Physicians Association, and the European Renal Association – European DialysisDialysisForm of renal replacement therapy where a semipermeable membrane – in peritoneal dialysis the peritoneum of the patient, in hemodialysis the membrane of the dialyzer – is used to clean a patient’s blood. and Transplant Association.
Fresenius Kabi supports researchers in the field of clinical nutrition, for example with the JUMPstart research program. The program was announced for the second time in 2020.
Numerous national and international research projects and studies are carried out in the clinics of Fresenius Helios in Germany. These investigate how effective and safe drugs are and whether medical devices are suitable for approval according to internationally recognized ethical and scientific standards (good clinical practice).
Before a clinical research project is carried out, Fresenius Helios in Germany tests the project using a standardized process to ensure the highest possible safety for the participating patients. The focus here is on meeting scientific, ethical and legal requirements, and ensuring that the project complies with Fresenius Helios' guidelines and quality standards. At the Helios clinics in question, employees known as principal investigators and study nurses – specially trained nurses who assist with studies – determine on-site the costs associated with a study and the benefits for patients and for Fresenius Helios. Regional study coordinators and the Central Research & Science Service offer advice too. Helios Germany research clinics and its employees are also supported by the Central Research & Science Service in the form of training, with the latter also carrying out research audits.
Helios provides targeted support to research projects undertaken by employees, on the basis that these projects are anticipated to benefit patients and the business segment itself to a great extent. Research projects funded by Fresenius Helios must always publish their results, regardless of the funding volume. In 2020, Fresenius Helios in Spain honored four researchers for their outstanding work in the fields of anthracycline cardiotoxicity, treatment of anaphylaxis and interventional cardiology, and endocrinology and nutrition.
In 2020, Helios Spain participated in 36 clinical studies, 67 observation studies and 30 research initiatives, with COVID-19 as a major focus. A total of 23 hospitals in the business segment were involved. Some of the results have already been published this year; one example was a study of the effects of COVID-19 in pregnancy, in which Helios Spain participated. Two Helios Spain hospitals one in Madrid and one in Barcelona have been selected by Janssen, to perform clinical trial on the vaccine effectiveness.
For Fresenius Vamed, digitalization and innovation play an important role, especially on the VAMED International Medical Board (IMB). The IMB enables physicians to exchange experiences and competences across regions in the countries in which Fresenius Vamed operates. In addition, the business segment has dedicated itself to gender medicine. Working together with MedUni Vienna, Fresenius Vamed has founded Austria’s first-ever institute specifically for gender medicine.
Each Fresenius business segment has its own approach to digitalization and innovation. We are currently developing key performance indicators (KPIs) for digitalization. At Helios Germany, for example, the DIGI Board will carry out testing and assessment using the degree of digitalization measured via EMRAM in the future. Fresenius Vamed, as another example, regularly reviews its management approach using standard controlling processes. In addition, the Digitalization strategic business area collects data and reports regularly on the status of the respective initiatives and projects in the business segment.
Overall, the digitization of processes was driven forward throughout the Fresenius Group in 2020.
Patient and product safety