Personalization of care pathways – The potential of digital technologies

Although the trends in the German healthcare system point to greater importance of health for insured persons and patients, healthcare is still not sufficiently oriented towards the needs of the individual patient. In particular, the patient perspective is not sufficiently taken into account when choosing diagnostic and therapeutic procedures. The health care researchers presented the current situation at the opening of the 17th German Congress for Health Care Research (DKVF) in Berlin1. Studies have also shown that expectations of concepts such as participatory decision-making (PEF), which are intended to promote the integration of patients, are changing have so far only been inadequately fulfilled and that the medical profession is still a long way from confidently adopting the basic principles of professional conversation and communication for the participation and integration of the patient.2 This means that there is significant potential for increasing the outcome, i.e. the level of impact Health services cannot be increased, and the legal requirements of the Patient Rights Act are not yet met.

>> The convergence of information technology with biotechnology, the so-called "superconvergence"3, and the resulting combination possibilities of (medical) technological innovations and their application trends, allow the potential for integrating patients and, where appropriate, their families to be fully exploited in the form of personalized treatment pathways. Combining suitable components of the respective technologies can lead to the development of Healthcare 4.0 services, which can increase the quality and value of healthcare services (see Figure 1), and enable providers to respond more quickly to market developments and competition (see Figure 2).
Health services 4.0 refer to the integration of
Previously standard healthcare services in the German healthcare system, which are financed by statutory and private health insurance companies and provided by inpatient and outpatient service providers, are being integrated with digitalization technologies. In the resulting cyber-physical processes, key components of digitalization include the consistent use of sensors for biomarker monitoring, the expansion of human-computer interaction, the use of mobile devices (mHealth), big data technologies, and the use of machine learning. Technologies are used that can close the gap between the virtual and the real world and that are capable of interacting with people and things.4 Cyber-physical systems, in conjunction with cloud computing (i.e., information technology resources are provided via networks), represent a cross-sectional technology for real diagnostic, therapeutic, and care services, with which reality-based services can be virtualized, ubiquitously provided in real time, and controlled and communicated via multimedia.5 In this way, previously analogue processes can be digitized, and new, only digitally offered processes – i.e., cyber-physical processes in the narrower sense – and data-driven decision support systems can be developed.
Systems for the real treatment of patients are being used that – while complying with data protection regulations – enable the linking of benefit-enhancing standardized and individualized partial services as Healthcare 4.0 services. The intensive integration of the patient into the joint service provision process represents a crucial lever in this regard.
This creates the potential to transform many existing value chains in the three sectors of healthcare (inpatient, outpatient, and home), to create new ones, and thus provide services that can be individually tailored to the needs and life realities of each patient. Integrating patients and their families more closely into treatment processes fundamentally means individualizing healthcare services as a general conceptual approach geared toward individuals—comparable according to certain criteria—to overcome nonspecific standardization. This generally amounts to the creation of standards for individual groups. Personalization then goes further, pursuing even greater differentiation and detail as a concrete implementation for the individual person or patient with their specific clinical picture and personal circumstances.6
In general, the added value of a service is achieved through the direct interaction of the provider system with the customer's contributions (see Fig. 1). Therefore, directly value-adding treatment processes represent the most important lever for achieving competitive advantages. The personalization of treatment processes – ideally in the form of treatment pathways – thus forms the linchpin for the strategy, organization, implementation, and effectiveness of treatment content and sequences.7 Consistent process management – based on an ethical and moral foundation in view of the importance of a healthcare service and "data literacy," i.e., the ability to competently handle data8 – creates the prerequisites for patient benefit, productivity, and outcomes and thus characterizes the most important value driver to ensure the patient focus in all diagnostic, treatment, and care services.
Potential of digital technologies for the personalization of treatment processes in various medical disciplines
In general, digital technologies have great potential to improve the quality and cost-effectiveness of inpatient, outpatient, and cross-sectoral care. This is achieved both by accelerating communication and coordination processes between patients and service providers, as well as between service providers themselves, and by developing innovative diagnostic and treatment procedures in individual medical disciplines. Examples of technologies that can be used by service providers to personalize a treatment pathway are listed below (see Figure 1).
The electronic networking (1) of patients with service providers and between providers offers many opportunities to make service processes in prevention, diagnostics, therapy, and aftercare more efficient and effective, as well as to involve patients more closely in the treatment of chronic diseases through the use of apps and sensors to measure biomarkers. Electronic networking gives patients easier access to their own medical data and medical knowledge, enabling them to become customers in the "healthcare market."9 An example of the possibilities of networking at the system level in Germany is the "Healthy Kinzig Valley" value network10, a collaboration between various general practitioners, specialists, and clinicians, psychotherapists, and nursing and rehabilitation facilities. It plans and coordinates the treatment of insured persons of certain health insurance funds within the framework of an integrated care contract. The focus of the business model here is not on incremental innovations, but on innovations that create new product characteristics in conjunction with new business models and that, using innovative information, communication and big data technologies, are geared towards outcomes, i.e. concrete effects, rather than an increase in the volume of services.
The use of telemedical services (2) was further developed through the amendment to the model professional code of conduct for physicians at the 121st Medical Congress in Frankfurt in 2018, and the relevant benefits for the use of telemedical services – from a physician's perspective – were defined. In the broadest sense, this refers to overcoming temporal and/or spatial distances in the context of medical matters. This primarily involves the measurement, recording, and transmission of information or the application of medical procedures using information and communication technology between physicians and between physicians and patients, possibly involving non-medical specialists.11 There are now a number of application examples, such as remote use for the care and continuous follow-up of patients with heart failure (telecoaching) and outpatient follow-up care for stroke patients (telestroke).12 Specially selected patients with heart failure also benefit significantly from telemedical remote monitoring. They spend fewer days in the hospital due to heart failure and have a lower mortality rate. These are the key findings of the TIM-HF2 study, in which 1,538 patients with NYHA stage II/III heart failure from 113 cardiology practices and centers as well as 87 general practitioner practices across Germany participated.13
Telemedicine services offer great potential for adapting to patient preferences, but the benefits for the physician using them are limited. The physician must provide the service both online and offline, and the setup time for the telemedicine infrastructure must be added.
From the analysis of gene sequences (genomics), epigenetic modifications (epigenomics), RNA transcripts (transcriptomics), proteins (proteomics), and metabolites (metabolomics)14, the so-called OMICS technologies (3), machine learning methods can be used to identify biological and psychosocial subtypes of diseases from large data sets that are incongruent with traditional diagnostic categories. However, based on this classification, predictive therapy recommendations can be made and treatment effects can be predicted with high accuracy.15
An example of the importance of genetic research and the importance of translational approaches for future targeted treatments, for example, for major depressive disorders, is the discovery of 30 new genetic variants associated with depression. Based on further research, more effective medications with fewer side effects can be expected for certain patient groups.16
The treatment of acute lymphocytic leukemia in children and a specific form of lymphoma can be achieved using CAR-T,
The development of "chimeric antigen receptors" is carried out individually for each patient. This allows leukemia cells to be detected and killed. Initial results show complete remission in some cases and the absence of visible tumor signs in CT scans.17 Another advantage of this treatment method is that this form of cancer therapy could replace stem cell transplantation in the future.18
The applications of virtual reality (4), i.e., the imitation of physical reality with all its physical properties in a computer-generated, interactive, virtual environment19, can be used in the training of medical students and in testing personalized treatment approaches. For example, a computational method supported by artificial intelligence can be used to model cardiac function (digital twin20), and the interdisciplinary integration of clinical patient data can be used to test cyber-physically tailored treatments before concrete implementation. The technology can also be used in the treatment of anxiety disorders21 and addiction disorders22.
Nanotechnology (5) can be used to produce tiny devices and particles that are used in the human body for in vivo diagnostics and drug delivery.23
Robotic applications (6) are controlled by computers with artificial intelligence programs. Depending on the software used, they can, for example, serve as support for physically demanding tasks in nursing and rehabilitation, as well as as support systems in the operating room.
Using an interdisciplinary approach combining techniques from neuroengineering, clinical neurology, robotics, and computer simulation, researchers have developed prostheses that allow patients to move more naturally. Electrical impulses are simulated so that the brain interprets them as if they were coming from a natural arm. This allows patients to grasp the object more precisely.24 Individual surgical and support processes can be structured, digitized, and automated with Brainlab. The surgical steps are announced, executed, and documented simultaneously. This results in better outcome quality and greater cost-effectiveness.25
The MicroSurge robotic system was developed at the German Aerospace Center (DLR) for use in minimally invasive procedures. The devices are held by robotic arms and remotely controlled by the surgeon. The system not only provides a visual view of the surgical field but even enables haptic feedback.26 In combination with augmented reality (7) (the user experiences the real world augmented by a virtual component27), complex operations can be practiced and planned in detail, as well as used directly for intraoperative support. SpectoVive converts computed tomography data into a three-dimensional virtual environment in real time, giving the surgeon a realistic image of the surroundings.28
The extraction of new information from all the data that accrues or is generated from the use of these technologies and may also have been collected for other purposes is a core idea of big data concepts.29 These analyses can also contribute to improving treatment directly on the patient in a structured treatment pathway by using predictive analytics31 to derive prognostic statements from the large amounts of information from different sources – stored in so-called big data lakes30 (see Fig. 1).
Previous obstacles and barriers for
digitalized solution concepts
However, there are still significant obstacles and barriers in the German healthcare system that make the adoption and application of innovative and digital services difficult or (still) impossible.
Implementation barriers exist due to the widespread incompatibility of information and communication systems, which complicates the integration of data and its cross-site use due to the (still) lack of structural equality. Universities of excellence and clinical partners have therefore joined forces in the medical informatics initiative DIFUTURE to consolidate the data volumes from various research areas and digital products so that every physician, every researcher, and every patient has access to the information they need.32 In addition to the obstacles regarding data protection and data security, common standards are also lacking, and not all healthcare professionals are convinced of digital technologies and trained in their use.33
A further obstacle to the translation of innovations is that health insurance companies only cover costs once their clinical benefit has been proven, and this is difficult given the relatively small number of cases. A change in reimbursement is currently underway, with Novartis agreeing on a reimbursement model for CAR-T cell therapy with company health insurance funds. Under this model, the insurer will receive a portion of the costs for the drug "Kymriah" if the patient dies within a predefined period.34
While the so-called prohibition clause applies to hospitals regarding the use of innovative methods, the opposite is true for the outpatient sector, with the permit clause.35 New examination and treatment methods (NUB) may be provided in the inpatient sector until the Federal Joint Committee (G-BA) has conducted an evaluation. In the outpatient sector, the permit clause means that services can only be provided after the G-BA has first reviewed, evaluated, and approved them. This gives the G-BA a powerful role, which is viewed critically by many stakeholders due to the composition of the committee. This includes the fact that five representatives of the health insurance funds sit on one bench and five service providers, distributed among hospitals, private practitioners, and dentists, sit on the other bench. This prevents service providers from being viewed as a single entity that could jointly promote innovations. One solution could be the proposal of a "fast lane" for innovations by the Association of Specialist Physicians (SpiFa). According to this, innovations could be introduced and evaluated within the framework of selective contracts – i.e., within contracts between service providers and individual health insurance funds – for a limited period of time and space for five years. The prerequisite is that the Bundestag Health Committee establishes an Innovation Committee, which has the right to submit applications directly to the Institute for Quality and Efficiency in Health Care (IQWiG).36 In the current health policy debate, it is becoming apparent that the Ministry of Health is also criticizing the lengthy decision-making processes of self-administration and is planning changes.37
In general, the close and cross-sectoral cooperation of clinicians with innovative partners, namely research institutions and the medical industry, represents an important value driver for the translation of innovative services (see Fig. 2) and, as an important success factor for patients, offers innovative service variants and choices regarding location, time, actor and methods with high medical quality and at the cutting edge of research.
Expansion of the value chain treatment pathways – dissolving organizational boundaries
In the future, healthcare will take place less in the waiting rooms of private physicians and clinics and more on smartphones.38 The physical dependence of many service processes on the patient's presence can be eliminated under the conditions of digital infrastructure and networking. Sensor technology and smart diagnostic devices at the point of care provide comprehensive diagnostics independent of the respective provider and, ideally, compatible with the relevant systems. Telemedical service processes allow value chains to be further developed and extended in the form of treatment pathways, so that previously unknown or unfeasible methods and new business models can emerge. This significantly increases the options available for mapping healthcare services across all three sectors (outpatient, inpatient, home) in a consistent end-to-end treatment pathway and for individualized treatment (see Figure 1 below). Healthcare services can thus be personalized – oriented towards the optimal process for the patient.39
If the data from the above-mentioned technologies are utilized, we will gain an ever better understanding of how diseases develop and how pathogenic processes in the body of healthy people (i.e., people without symptoms of disease) can be detected early. This will allow for early intervention with increasingly earlier diagnoses and effective interventions, rather than waiting until the disease has already taken hold.40 Alzheimer's dementia, for example, appears to announce itself in some forms long before the actual onset of the disease. This provides time to prevent the disease – possibly even up to 20 years.41 For example, in type 1 diabetes, and following an investigation of genetic risk, active substances can be used even before the onset of the disease.42
Early patient engagement and integration thus allows for reducing the information asymmetry between physician and patient and, with early detection, for early attention to be paid to primary prevention.43
This means that medicine is evolving from reactive medicine with a one-size-fits-all approach to proactive and anticipatory preventive medicine, which can plan treatment more precisely with combinations of therapies, instead of relying on trial-and-error procedures as has often been the case in the past. However, this requires patients to reflect on their own position regarding the handling of data, the risk of knowledge and lack of knowledge (Fig. 1: A), as well as a societal debate about where illness begins, and therefore what belongs in the health insurance benefits catalog.44
For healthcare providers, this means that the chain of contact with potential patients and relatives (customer journey) must begin much earlier in order to identify key touchpoints and proactively point out individual solutions that can be integrated into everyday life without major friction for the patient.
Creating shared value with those affected and their families
A key element of successful treatment is patient involvement in the diagnostic and treatment process, which is also codified in the Patient Rights Act. This is intended to achieve greater knowledge and control over the illness or healthcare service, as well as greater compliance/adherence.
Integration gives providers access to implicit patient knowledge and feedback, from which improvement processes and innovations can be developed.45 Patients and relatives can also act as innovators in their role as users. Their knowledge of the disease represents great potential for process and product innovations, particularly in the area of rare diseases.46 This requires the patient's willingness to take responsibility for their own recovery process and to provide feedback to the healthcare provider (Fig. 1: B).
With digital technologies such as telemedicine healthcare services and the potential use of powerful sensors in conjunction with cloud computing (see Fig. 1), smartphones and wearables—computer systems worn on the body and/or integrated into clothing—can enable patient integration regardless of time and place. They thus represent a significant increase in benefits for patients in the context of prevention, diagnosis, and treatment, who must be willing and able to use the technologies (Fig. 1: C). In the context of modeling a treatment pathway based on a treatment concept, such personalization promotes the relationship between provider and patient in terms of specific customer orientation and creates interactive value creation in the sense of a co-design process.47
With blockchain technology (Fig. 1: D), a system can be built that collects all data and can be released by the data owner only to specific users.48 This could solve key problems such as the scattered nature and security of medical and social data. Blockchain data is more likely to be complete, accurate, trustworthy, and widely available.49 It would then no longer be possible for data to be used for other purposes without the patient's knowledge. This would give patients greater security and autonomy in their dealings with healthcare providers.
This development will fundamentally change the role of the physician. With information and knowledge readily available and accessible to everyone, the physician will no longer be an indispensable knowledge carrier responsible for disseminating knowledge, as was previously the case. Instead, they will assume a more prominent role as a consultant and coach, configuring a personalized preventive and/or treatment path with the patient using Healthcare 4.0 services and guiding the entire process with empathy and ethical clarity, so that the patient does not feel like a "test subject."
Making new knowledge effective
Digitalization will also change the future of work in healthcare, although probably not (yet) as radically as it is for Industry 4.0 with its framework conditions of volatility, uncertainty, complexity, and ambiguity (VUCA).50
Even though the challenges posed by Google, Apple, Facebook, Amazon (GAFA), and many small health apps act as drivers, the forces of inertia in the individual sectors of the healthcare industry appear (still) very strong. In an area so characterized by complexity due to regulations, different incentive and billing systems,
men as well as Qua-
security measures, safeguards
backup routines and data protection
While the German healthcare system has been successfully shaped, the more difficult conditions of Industry 4.0 do not yet apply. Nevertheless, digitalization and the focus on translation are also accompanied by changes in work and organizational structures, as well as a changed leadership culture, in the German healthcare system.
The challenges for providers lie in empowering their organizations and employees to develop their own innovations and to adopt innovative diagnostic, treatment, and care services from pharmaceutical and (medical) technology research institutions. Thus, the management of automated and non-automated treatment processes and their linking to quality and risk management with zero-defect quality become the most important value drivers and, at the same time, the critical success prerequisites for entrepreneurial activity as a healthcare provider (see Figure 2).
The company must continually rebalance the conflicting objectives between exploitation and exploration. Exploitation, as the utilization and utilization of existing knowledge, creates new knowledge through specialization and refinement of existing knowledge in a continuous improvement process; exploration, on the other hand, develops new knowledge by creating (radically) new application and solution possibilities for user needs.51 Both approaches must be pursued by implementing ambidexterity in the organizational structure and leadership behavior—an approach that is also relevant for expert organizations in the healthcare sector in times of digital transformation. This dynamic capability represents a key value driver for healthcare organizations to become and remain sustainably competitive.
Ambidexterity can be implemented in different organizational models – depending on size, available resources and chosen innovation strategy:
• In a cooperative organizational model, exploration is carried out in certain domains, while exploitation is carried out in others (domain ambidexterity), for example in the concept of a dual operating system.52
• In the autonomous organizational model, a company conducts exploration and exploitation in separate organizational units, each managed by autonomous units (structural ambidexterity).
• In the case of temporal ambidexterity, a firm periodically switches between the phases of exploration and exploitation.
• In the integrated organizational model, the business units carry out exploration and exploitation in parallel, ie the responsibility for innovations lies in one hand (contextual ambi-
dextrie).53

All four organizational forms have their justification and potential for success. In Healthcare 4.0, alongside the third, the fourth organizational model represents the greatest potential for success. Organizations in the German healthcare system are subject to a multitude of regulations and budgets that generally do not allow for additional units, so contextual ambidexterity in an integrated organizational model is predominantly appropriate. Ambidexterity has also been well researched in networks54 and is therefore also relevant for transfer to physician networks, which are playing an increasingly large role in the provision of care in the German healthcare system.
Digitalization is creating new forms of collaboration, not only with each other but also with machines and systems in the cyber world, so that even talk of Work 4.0 is already being held.55 Due to the merging of software, hardware, and new diagnostic and treatment services, established thought patterns and routines will generally have to be questioned in order to survive in the competition for more demanding and informed patients. Focusing on a translational approach with the consistent use of innovative diagnostic and treatment methods and their representation in personalized treatment pathways requires a framework that enables innovative thinking and action, consistently processes knowledge, and makes it available to everyone – including patients. The focus is not on the knowledge itself, but on the methodological competence to use that knowledge effectively for the individual healthcare service.56 This fundamentally requires a value-oriented and value-based approach focused on multiple stakeholder groups, in which patient orientation and "clinical credibility"57 are just as firmly anchored as a consistent business orientation. This will require a corporate culture that is geared toward both. Self-organization and participation, a development of teams from the previous hierarchical control to self-management, self-design and even independence58 and entrepreneurship within the company are essential design elements.59
What will be needed is a leadership concept that masters the "slider" of transactional and transformational leadership, that can accompany the change in the range of activities and role models as well as the increasing demands on both the technical and emotional competencies of employees. This brings with it organizational ambidexterity and a "ambidexterity" of leadership,60 a qualification that is based on efficiency and
Excellence (“left hand”) and, on the other hand, more focused on speed and innovation (“right hand”) and can also endure and communicate this balancing act between great openness on the one hand and tight leadership on the other.61
Conclusion
Digital technologies already exist in many industries and are gradually being adopted in medicine, although many legal, health policy, and ethical issues remain completely unresolved, and the discourse surrounding them can barely keep pace with the development of digitalization technologies. This opens up numerous opportunities and legitimate prospects for high-quality, precise, and largely less-side-effect diagnostic and treatment services that can be used proactively and personalized in various business models. Whether these hopes for more cost-effective care can be realized remains to be seen.
In addition to legal and technical issues, the main challenges for providers in competition are to develop process and product innovations themselves in a continuously changing working world and/or to incorporate and integrate (medical) technical and pharmacological innovations from cooperation with research and development into their own service processes.
In times of digital change, the company's ability to achieve ambidexterity in its organization and leadership represents a dynamic capability that provides sufficient flexibility for new developments and sufficient stability for a value- and value-oriented basic attitude.