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National health platform: Editorial content creation

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Intro

The national health platform’s purpose should be to enhance, not replace, existing information services.

Who bears responsibility for the content on a national healthcare platform?

When it comes to the question of who bears responsibility for the content provided on a national health platform, it comes down to the nature of the content in question. The platform operator is initially accountable for their own content. However, if the platform operator assumes responsibility for third-party content –  by evaluating it before making it public or by expressing a willingness to take on such responsibility – then the platform operator may be held accountable.

If an entity other than the platform operator assumes responsibility for assessing content before it is published, this might require a different legal assessment. In such cases, it’s possible that the platform operator could be held liable or share the responsibility for external content. This means that the platform operator must establish a mechanism for users to report false or unlawful information.

How should the creation of original content be assessed from a competition law perspective?

Evaluating the creation of original content for a national health platform in terms of competition law is complex, especially when government actors are involved. In principle, government initiatives should only be introduced when a form of market failure is evident. This means either insufficient information is being communicated or information in the healthcare sector is not being adequately transparent.

Past experience has shown that digital healthcare service providers are quite capable of meeting this demand. The national health platform’s purpose should be to enhance, not replace, existing information services. This should benefit not only users but also providers of digital information services in the health sector.

What insights can we gain from this for the platform’s content strategy?

When it comes to shaping the national health platform’s content strategy, it’s important to bear in mind that creating or asserting ownership of content and disseminating it can be, in terms of competition law, challenging to justify, especially when government bodies are involved in the project. In this context, it seems preferable to prioritize the distribution of third-party content, meaning content generated by civil society or private-sector organizations. The providers of such information should be given fair and transparent access to the platform.

Disclaimer

The statements made in this interview are relevant exclusively to the German legal context. They offer a framework for guidance and should not be interpreted as providing legal counsel beyond the scope of the Trusted Health Ecosystems project.

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Expert

While completing her doctoral studies, Prof. Dr. Laura Schulte gained experience in the field of constitutional law as a research assistant. Her doctoral thesis focused on data protection law, and she conducted further research on this subject at various institutions, including the Queen Mary School of Law in London. From 2020 to 2023, she was employed as an attorney at BRANDI Rechtsanwälte in Bielefeld, specializing in IT and data protection law. Since August 2023, she has held the position of professor of business law at the Hochschule Bielefeld.

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    Initial thoughts on the technical structure of the national health platform

    Dr. Matthias Koch
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    The software architecture of a digital platform illustrates its structure, but also offers information regarding expected costs and the technical feasibility of certain requirements. In the case of the national health platform outlined here, the architecture will follow the basic pattern of other intermediary platforms, but can be elaborated in detail only once all requirements necessary for implementation have been defined and all open questions conclusively answered. During the concept development stage, some questions were deliberately left unanswered so as to provide flexibility and avoid building any premature decisions into the process. However, the conceptual decisions already made, along with the determination of roles and tasks of the platform in the digital ecosystem, make possible an initial overview of the required components and their interactions.

    Based on the preliminary conceptual considerations (see Conceptual considerations: an overview), system boundaries can be identified that clarify what lies within the scope of the national health platform, as well as which directly neighboring systems are to be connected via interfaces. However, the considerations described here do not represent an implementation-ready software architecture that already encompasses all relevant architecture drivers and technological aspects. Their identification and refinement will be the subject of further conceptual work.

    Participating ecosystem actors

    The focus here is on the national health platform as a technical backbone brokering context-specific digital health information and services. The platform has the task of providing the essential functions needed to manage users and content. It also constitutes the technical link between the various ecosystem actors. Apart from the platform operator, these actors include:

    • Providers of health information – for instance, information on diseases, prevention, health care structures and so on, in various formats.
    • Providers of health-related services – for instance, online appointment scheduling, hospital search tools, pain diaries, etc.
    • Providers of contextual information – personal information that provides clues regarding patients’ situational information needs.
    • Developers of pathway models – indication-specific templates describing the expected trajectory of informational needs, along which specific health information is presented to individual patients as it becomes relevant.
    • Patients

    The platform and its interfaces

    The core task of the national health platform is to relay health information and health-related services to the right people at the right time. This will usually be triggered by events, for instance a visit to the doctor or the expiration of a time period such as “six weeks after taking sick leave.” Such events will in turn be derived from incoming contextual information, which triggers the national health platform to deliver the appropriate information and services to patients along one or more currently relevant pathway models (see Conceptual considerations: an overview). This core functionality of brokering health information and services requires a number of interfaces, which are presented below:

    • Interface for the inclusion of health information: This interface makes it possible to store health information on the platform so that it can be associated with patients’ situational informational needs based on certain characteristics and made available in a personalized feed (see Discover more, search less – prototype of a national health platform). In addition, this information can be retrieved via a semantic search.
    • Interface for the inclusion of services: The inclusion of services is analogous to the inclusion of health information. Services are also made available to patients on a situational basis.
    • Interface for the inclusion of individual contextual information: The transmission of individual contextual information about patients requires interfaces that allow for automated communication between systems. The exchange of data via these interfaces takes place exclusively on the basis of patients’ differentiated consent, as given to the provider of this contextual information; this could include the electronic health record (ePA) or various providers of fitness and health data. At the interfaces for the transfer of contextual information, the platform can check whether user consent has been given before allowing the transfer to take place. Different contextual information from different providers may require customized interfaces in each case, with the national health platform subsequently harmonizing the incoming data.
    • Interface for managing pathway models: The templates are created via a graphical user interface and stored on the platform. The same interface can be used to manage, revise and improve pathway models. Likewise, it facilitates collaborative modeling involving multiple creators.
    • Interface for patients: Patients access the functionalities of the national health platform via a graphical user interface – for example, in the form of a website or app for mobile devices – most typically to obtain health information or access health-related services. Additional access methods other than this traditional interface can be used, especially voice-based user interfaces. Patients are authenticated via the healthcare-sector digital identity planned for inclusion in the Telematics Infrastructure 2.0, which ensures that all data can be associated reliably with specific patients, and accessed only by them.

     

    Interface for the inclusion of health information

    Health information is made available by certified providers by means of a dialogue-based process. This helps the various providers submit their information to the platform in such a way that it can be linked to pathway models and displayed to patients or found by them via a search. The actual content – such as an informational text or a video – is not transferred to the platform in this process, but remains with the provider. Instead, a link is created and enriched with metadata such as the date of creation or the sources used.

    The health information is transmitted to the national health platform through the previously mentioned interface. This interface can be implemented in two forms. On the one hand, the platform itself can provide a graphical user interface. This website or application would be usable by health information providers, and would support them in submitting their information and entering all the necessary details.

    On the other hand, this interface can also be designed to accept data from other systems without any active intervention by users. This requires supplementary interfaces on the part of the health information providers, specifically in the content management systems within which the information is originally prepared. These systems transmit authorized information to the platform. This has the advantage that providers do not have to engage with an additional system, and can remain in their familiar working environments.

    Interface for the inclusion of health-related services

    Health-related services are handled similarly to health information. This means that certified providers will be given support in linking their services to the national health platform. As with the health information, the services are not transferred completely to the platform. Rather, a linking strategy is used: The platform receives a reference to a service, including descriptive metadata, in order to display this to patients along a pathway model.

    Interface for the inclusion of individual contextual information

    Throughout the healthcare system, various actors accumulate contextual information that sheds light on patients’ situational information needs. Capturing this in a uniform format aligned with existing standards is critical to the success of the national health platform. I will discuss one such possible standard below. The basis for this uniformity is the interface specified by the platform, through which third-party systems transmit data. Currently, the most important data provider is Gematik, the state digital agency, which bundles all the data that doctors’ practices, pharmacies and clinics pass on via their various administrative systems in the form of the electronic health record.

    The interface should allow the integration of other sources of contextual information in addition to the electronic health record. This could include health insurance companies or health data platforms such as Google Health or Fitbit, for example. Assuming that patient consent has been secured, the various actors would transmit this data to the national health platform. Since the exact formats of the data from the different providers are not yet known, it is likely that different types of interfaces will be offered for various groups of providers. As a result, the data may subsequently be harmonized on the national health platform.

    The interface outlined here is utilized by a number of systems. It is not used by patients themselves, and does not provide a graphical user interface, since individual contextual information is automatically generated and transmitted by the information providers. In the absence of automation, it would not be feasible to keep such a large quantity of data sufficiently up to date. Nevertheless, this interface must also contain authentication mechanisms, thus ensuring that only authorized systems can transmit their data to the national health platform.

    Interface for pathway model management

    Creating models for patient information pathways requires expertise regarding the trajectory of patient informational needs and knowledge of the typical stages of a disease. For this reason, the templates are created exclusively by certified actors (see Conceptual considerations: an overview). At the same time, pathway models are expected to be complex, making it useful to have a visualization. The graphical user interface for interacting with pathway models will be accessible on the national health platform to appropriately certified stakeholders or their institutions.

     

    Interface for patients

    Finally, we consider the perspective of the patients, who are presented with relevant health information and services based on their individual contextual information. They use the platform’s user interface to access the digital ecosystem in order to obtain information and services relevant to them along pathway models or – based on their individual needs – to search for information and services of verified quality. In addition, to ensure respect for data privacy, patients are given the ability to control how their data is used. This can be done via a privacy dashboard, such as the one being developed and tested in the D’accord research project (https://daccord-projekt.de).

    Patients are authenticated via the digital identity provided for in the Telematics Infrastructure 2.0. This authentication facilitates the link to personal data from the electronic health record, which could serve as a primary source of contextual information, especially at the outset. In addition to this avenue of access, other mechanisms can be created to engage patients in the digital ecosystem. For example, authorized service providers might send SMS text messages that allow for direct links to the national health platform’s user interface.

    Further conceptual steps

    The final selection of suitable frameworks and technologies should be based on a requirements analysis and a detailed architectural design that expands upon and refines the broadly sketched requirements identified thus far. Non-functional requirements must be given special consideration in this regard. The topic of IT security was addressed in the previous section. Performance and scalability are also extremely important, as high user numbers can be expected, given that the platform is to be available to all patients in Germany. The large number of users means in turn that there will be a very large inflow of data to be processed by the platform. Given such loads, the technologies selected for implementation and the underlying infrastructure must allow for scaling.

    Another essential non-functional requirement to be considered is the user experience (UX). Since the national health platform is open to all patients, and should be easy to use for everyone, consideration must be given to the special needs and preferences of different user groups, some of which are particularly vulnerable. These include elderly people or patients with a cognitive impairment, for example. Special attention should be paid to these groups during the design process.

    The requirements analysis also determines the platform’s additional functionalities, including user and authorization management, pathway model management, and the instantiation of pathway models for patients. This refers to the assignment of specific health information and services to certain individuals, and their display via the platform, based on those individuals’ contextual information.

    Framework for deployment and hosting

    The core of the national health platform is the software itself, which must be made functional via distribution to one or more servers. This process is called “deployment.” In addition, it is required to operate the runtime environment for the software, which is referred to as “hosting.” Moreover, the platform will process or convey large quantities of data, ranging from user data and identifiers to links to health information and services to contextual information. Some of this must be present on the platform itself in order to be processed appropriately. All this data must also be stored, or hosted, on one or more servers.

    The hosting of the platform and all stored data must of course be carried out in a technologically state-of-the-art way. This means that data handling must comply with the requirements of the General Data Protection Regulation (GDPR), and in the case of health-related data, with the requirements of the special protective measures defined by the GDPR. As the platform’s IT architecture is further refined, a number of decisions must be made regarding deployment. For example, a number of issues must be resolved, including which parts of the overall system are to be deployed where, and how this is to be done; and which organizational units are to be responsible for hosting them in each case. For example, the software hosting can be separated from the data hosting, with security measures put into place on both sides. Monitoring data flows on both the software and database sides and physically separating the servers will make it more difficult to compromise the system as a whole. Measures of this kind would help achieve a higher level of security and data-handing reliability

    Specific analyses of potential attack scenarios are additionally needed in order to protect the national health platform. These must be carried out as the software architecture is designed. In principle, one goal should be for the hosting, including the storage of backups, to take place in Europe. Moreover, this should be handled by an entity recognized within the healthcare sector as being trustworthy.

    Event-driven architecture

    Health information and services are largely provided using the push principle – that is, patients receive the information relevant to them along the pathway models without having to take action themselves. Regardless, patients can also use a traditional search function. When matching search hits to queries, the platform can use all available contextual information to display matching results. This information can be used to create an individually tailored ranking of search results analogous to that provided by established search engines. In contrast to these, however, the national health platform can as needed report transparently on what specific contextual information, with which weighting, has led to a particular ranking of search results. This helps to gain the trust of both patients and the providers of health information and services.

    A system like the national health platform outlined here can be technically represented using what is called an “event-driven architecture.” An architecture of this kind focuses on the communication between different components in the overall system that takes place as events occur. Each event is triggered by an event producer, and is then processed by an “event handler.” This technical subsystem determines the subsequent actions based on the producer, timing, type and content of the event – for example, it may determine the appropriate health information to display to a patient.

    Event-driven architectures are an established concept in software engineering, with a number of technical frameworks already in existence that can facilitate implementation. The Apache Kafka message broker (https://kafka.apache.org) offers one such example of a possible implementation strategy. Apache Kafka is a versatile technology that does not incorporate domain-specific features. In contrast, frameworks also exist that incorporate or define specific standards and functionalities for handling health-related data. Stanford University provides an open source framework for building healthcare-sector ecosystems called Spezi (https://github.com/StanfordSpezi). This framework defines an architecture that facilitates the exchange of health-related data with other systems by implementing the HL7®-defined FHIR® standard for the exchange of health-related data (https://www.hl7.org/fhir/). It would be conceivable – after an in-depth analysis of the requirements and the framework – to build selected parts of the platform on Spezi.

    Feasible and open to new ideas

    The considerations presented here regarding the technical implementation of a national health platform outline the basic functionality and establish the technical feasibility of the concept. At the same time, we show that the “brokering” model – that is, the provision of health information and services based on patients’ individual contextual information – is feasible. This is especially true if the platform can build on standards and open-source frameworks such as Stanford’s Spezi, as this can reduce effort and costs while decreasing dependence on proprietary solutions.

    In addition, according to the concept, the national health platform is limited at its core to serving as an intermediary for the brokering of relevant information and digital services. This means the platform itself does not engage in the editorial creation of health information, the development of services or the acquisition of individuals’ contextual information. This constellation, which is typical of digital ecosystems, makes it possible to distribute responsibilities, and thus focus resources on quality assurance and the automated presentation of relevant information and offerings to patients.

    The remarks in this paper deliberately do not specify a specific system architecture, and do not offer any preliminary technical definitions. The final determination of the appropriate architecture and technologies to realize the platform and its interfaces will be made after the functional and non-functional requirements have been worked out in detail and documented.

    Author

    Dr. Matthias Koch is a software engineer at Fraunhofer IESE, where he heads the Digital Innovation Design department. He has been designing innovative software solutions since 2012, with clients from the business community and in research projects. He has focused in particular on the areas of requirements and user experience engineering, as well as on the implementation of innovation workshops. Koch’s work involves the design of methods and tools for building digital platforms, especially in the area of digital ecosystems.

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    Discover more, search less – prototype of a national health platform

    The core service of the national health platform outlined here is to provide personalized information pathways that adapt to changing information needs and have the capacity to facilitate the handling of health-related information. To illustrate our concept, we have developed a prototypical design that shows what this platform might look like one day. Increasingly, patients are using the internet to gather information from sources beyond the traditional healthcare system. Currently, they rely primarily on major search engines for this task.

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      Successfully establishing health ecosystems – models from abroad

      Dr. Tobias Silberzahn
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      A health ecosystem, such as the one envisaged by the “Trusted Health Ecosystems” project, must fulfill several requirements if it is to bring value to stakeholders within a health system. International models have demonstrated that a successful operational model combines the active participation and coordination among involved actors with common technical standards.

      Digital ecosystems have transformed traditional business models across various industries, generating added value for customers and market participants. For instance, e-commerce-platform providers and prospective buyers can now directly interact, which leads to more efficient transactions. Open ecosystems of this type could also play a role in digital healthcare. Key characteristics of such ecosystems are:

      A multi-stakeholder network. An open ecosystem brings together different actors with varying interests. In healthcare, these actors may encompass patients, health service providers, payers and providers of products and services.

      Co-creation. The development of information, products and services does not rest solely with the platform operator. Third parties or stakeholders “on the platform” also contribute to this process. This principle serves as the basis for “app stores” provided by mobile phone companies, where external developers offer downloadable applications.

      Self-reinforcing effects. Value drives adoption, and platform activity attracts new users. This mechanism is well-known from social networks, which can rapidly expand once a critical mass of users is reached. Similar self-reinforcing effects could occur within a digital healthcare ecosystem. As more citizens use a digital health service, its relevance for healthcare service providers increases, and vice versa.

      Key considerations in designing health ecosystems: Four success factors from an operating model perspective

      Active participation of stakeholders constitutes a pivotal aspect of a successful ecosystem. An additional element is proper organizational design to unlock the ecosystem’s full potential. Here, four factors assume a central role, as illustrated by examples from other countries:

       1. End-to-end patient “pathways”

      From a user perspective, the seamless integration of stakeholders and services is critical: Patient pathways need to be designed end-to-end and thus ensure the harmonious orchestration of multiple services in a user-friendly way, e.g., a journey encompassing appointment booking, (tele-)consultations, e-prescriptions and medication delivery. Foundational “enabler applications,” such as electronic patient records, facilitate seamless care by maintaining consistent data across systems without necessitating changes.

      Case example: The Health Village in Finland

      Developed by Finnish university clinics, the Health Village comprises virtual hubs for a variety of care categories, including emergency care, rehabilitation and mental health. These hubs are brought together as required based on a patient’s diagnosis. Empowered by physician referrals, participants can access digital health services such as video-based consultations and self-help programs via smartphones. This innovative approach has introduced more than 400 distinct care pathways to complement on-site healthcare.

       2. User centricity

      To achieve widespread adoption, the offerings within the ecosystem must cater to user needs. User centricity means involving ecosystem participants in the development and enhancement of services, thus fostering stronger user loyalty.

      Case example: “Sundhed.dk” in Denmark

      Sundhed.dk, the Danish health portal, actively involves patients in developing and improving e-health applications through a dedicated “user panel.” Through methods like focus groups, interviews and questionnaires, targeted user feedback is collected. These insights, including feedback on existing solutions and requests for new functionalities, contribute to refining the user experience and ultimately benefiting patients.

       3. Governance to involve stakeholders

      Effective governance mechanisms are essential for the functionality of an ecosystem. Typically, the ecosystem operator assumes the role of orchestrator, overseeing a framework for demand- and solution-oriented interactions.

      Case example: The Well healthcare platform in Switzerland

      Initially founded by health insurers and healthcare providers, the Well platform now incorporates physician networks and other collaborators. The integration of various actors is orchestrated by the Well AG.

       4. Technical interoperability

      Successful ecosystems facilitate seamless information exchange between stakeholders through standardized interfaces. These interfaces are typically established by the ecosystem orchestrator and are based on international standards. For example, the Fast Healthcare Interoperability Resource (FHIR) standard creates a basis for national and cross-border data exchanges in the healthcare sector.

      Case example: FHIR in Israel

      Israel relies on the FHIR standard within the healthcare domain, enhancing the usability of health data through a mix of incentives and requirements. This includes the Israeli Health Maintenance Organizations (which operate like integrated insurers, service providers and hospital operators), research institutes, startups, and additional healthcare providers. These organizations all benefit from improved health data exchange.

      The future of open healthcare ecosystems

      Open healthcare ecosystems possess the potential to better connect healthcare stakeholders with citizens. Such ecosystems can build up on existing structures: For example, a Germany’s national health infrastructure known as “Telematikinfrastruktur.” Electronic patient records and e-prescriptions can serve as foundational elements for health data exchange within an open healthcare ecosystem.

      Building successful open ecosystems demands a multi-faceted approach: User-centric concepts, effective governance mechanisms and standards are needed. To achieve this, an organization can be established to develop the ecosystem’s strategic direction, oversee orchestration and provide stakeholders and third-party providers with participation opportunities.

      Author

      Tobias Silberzahn holds a doctorate in biochemistry and is a Partner at the Berlin office of McKinsey & Company, Inc. His work focuses on healthcare innovation and the digital transformation of healthcare. Tobias also leads the global Health Tech Network, which brings together more than 1,800 health tech CEOs and founders, along with 250 investors and 300 corporations. He is co-publisher of the annual “eHealth Monitor,” a publication distributed by MWV publishing house that focuses on the digitalization of the German healthcare system. Within McKinsey, Tobias also co-manages a comprehensive health and well-being program that encompasses aspects such as sleep, nutrition, fitness, and stress management.

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        InfoCure: Making quality visible

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        Our vision of a national health platform is all about trust. This includes ensuring that users can rely absolutely on the quality of the content and services being offered. But how can this goal be realized in an era of disinformation and conspiracy theories? In a subproject called InfoCure, we explore the issue of how good information quality can be made visible, and how disinformation can be contained.

        More and more people today use the internet to inform themselves about health-related issues, often using major social media platforms such as YouTube, TikTok, Facebook and Telegram. Through these networks, disinformation and false information can spread faster than ever before. At the same time, the platform operators’ algorithms generate lists of continuously refreshed content that build on previous search patterns and confirm users in their previously held assumptions and attitudes. These “reinforcement loops” are themselves enhanced by the digital network’s social environments, which often reflect users’ own opinions back to them, and thus create fertile soil for disinformation and conspiracy theories.

        “The rapid spread of health misinformation through digital platforms has become a serious threat to public health globally.“

        Andy Pattison, WHO (2021)

        Information quality as brand essence

        Trust is formed in digital worlds through the responsible handling of personal data or appropriate measures to increase data security, for example. Yet ensuring that the information and services offered are reliable and of high quality is another basic prerequisite for the development of trust in digital infrastructures. To date, social networks have provided virtually no means of indicating the trustworthiness or credibility of an information source, making it very difficult to ascertain the methodological quality of the information delivered. The same is true of digital services. A national health platform must make a clear difference here.

        Quality-assurance strategies for health information today have focused primarily on the review of individual informational elements such as texts or videos. However, this approach demands considerable human and financial resources, and costs one thing above all: time. Yet digital ecosystems and their platform approaches are so successful precisely because they provide their services largely digitally, and can thus grow very quickly within a very short period of time.

        Provider certification

        To keep up with this rapid pace, platform operators need a quality assurance approach that evaluates the providers of information rather than focusing on individual  information. Structural aspects (e.g., expertise) and criteria relating to process quality (e.g., use of certain methods) could be used in these assessments. However, a voluntary commitment to quality assurance is unlikely to be enough to give platform users a sufficient level of confidence. Instead, an external audit by an independent body in the sense of a  certification procedure  would be required. A multistage audit-based procedure is a good way of obtaining a reliable assessment of a provider’s structures and processes.

        This kind of quality-oriented selection of trustworthy information providers could reduce the risk of disinformation and misinformation to a minimum. In combination with other instruments such as user feedback and digital review procedures, the platform’s information and service quality as a whole could come to be regarded as a trusted space, supporting users and providing them with significant relief in their search for credible information.

        Diverse applications possible

        By becoming certified, health information and service providers could qualify for participation in the national health platform’s digital ecosystem. However, this certification does not have to be limited to this access-granting: Indeed, once a provider is certified, the digital certificate could be used for many other purposes.

        Operators of major search engines could use this information as a means of identifying reputable providers for the first time, and incorporate this new knowledge when calculating the relevance of search results. Platforms and search engines could label trustworthy information providers accordingly, and background information on the providers would be visible to users. This would reward all those providers who go to great effort to ensure the quality of their information .

        Of course, a single set of rules cannot cover all types of information. For example, patient descriptions of personal experiences can convey valuable information that relates to the psychosocial aspects of dealing with a disease. Different criteria must therefore be taken into account when evaluating the quality of such offerings. A similar logic applies to socio-legal information, which must meet completely different quality requirements than medical content.

        Finally, it should be noted that in addition to pure information offerings, the health-related internet is full of digital services such as online appointment functions, databases, video-based online doctor visits and second-opinion services, all of which must be considered on their own terms. In the medium to long term, the original certification for medical patient information can and should be expanded in a modular way to include additional areas of application.

        International approach

        Assuring the quality of health-related information in the digital age is a challenge that cannot be addressed solely at the national level. For this reason, international standards must be taken into consideration, and must be strictly adhered to in the interests of interoperability. Furthermore, in order to achieve impact beyond national borders, the development of new quality standards should take place in the context of an international expert dialogue.

        In our search for relevant standards and projects, we became aware of an initiative led by the U.S. National Academy of Medicine (NAM). In 2021, with input from an independent advisory group of scientists, this project developed and published a set of basic principles and attributes that could be used to identify credible sources of health information. The goal of the initiative was primarily to provide social networks and platforms with criteria for identifying providers of trustworthy health information.

        The principles  state that, to be considered credible, sources should be   science-based objective, transparent and accountable, hence they provide a good foundation for the evaluation of information providers. However, to use these as the basis for a certification procedure, further operationalization is required. In the course of dialogue with international specialized partners and the World Health Organization (WHO), the idea has emerged of translating these principles into a concrete indicator system that could serve as the basis for an audit-based certification process for health information providers. The idea will be realized via a clear and familiar division of tasks: The frameworks and standards will be defined consensually at the international level, while the actual certification will be performed by national-level institutions or organizations.

         

        Working group has begun its activity

        Numerous past initiatives have focused on the assessment, description and development of information quality in the health sector. These provide a very good starting point in developing a set of such indicators. The current project differs from these existing initiatives in its clear focus on providers and international standardization, and in the fact that major tech companies are today facing mounting pressure to deal with disinformation. The approach described above offers a valuable opportunity to make high-quality information more accessible to patients and support healthy decisions through good information, and thus to make a major contribution to the promotion of health literacy.

        „Digital platforms have a uniquely powerful opportunity to enable worldwide access to high-quality health information.“

        Victor J. Dzau, NAM (2021)

        In 2023, the Bertelsmann Stiftung, together with the German Network for Evidence-Based Medicine and Health Literacy Germany, established an international working group that will define the tasks ahead in the context of a scientific discussion paper, and additionally draw up initial proposals for the development of an indicator system. In the medium term, the creation of InfoCure is intended to provide an international certification system for credible providers of health information and services that will initially be implemented in Germany, and then scaled up internationally in a subsequent step.

        Bibliography

        Burstin H, Curry S, Ranney M L, Arora V, Boxer Wachler B, Chou W-Y S, Correa R, Cryer D, Dizon D, Flores E, Harmon G, Jain A, Johnson K, Laine C, Leininger L, McMahon G, Michaelis L, Minhas R, Mularski R, Oldham J, Padman R, Pinnock C, Rivera J, Southwell B, Villarruel A, Wallace K (2023). Identifying Credible Sources of Health Information in Social Media: Phase 2—Considerations for Non-accredited Nonprofit Organizations, For-profit Entities, and Individual Sources. NAM Perspectives. Discussion Paper, National Academy of Medicine, Washington, DC. https://doi.org/10.31478/202305b

        Kington R, Arnesen S, Chou W-Y S, Curry S, Lazer D, Villarruel A (2021). Identifying Credible Sources of Health Information in Social Media: Principles and Attributes. NAM Perspectives. Discussion Paper, National Academy of Medicine, Washington, DC. https://doi.org/10.31478/202107a

        Schaeffer D, Berens E-M, Gille S, Griese L, Klinger J, de Sombre S, Vogt D, Hurrelmann K (2021). Gesundheitskompetenz der Bevölkerung in Deutschland – vor und während der Corona Pandemie: Ergebnisse des HLS-GER 2. Interdisziplinäres Zentrum für Gesundheitskompetenzforschung (IZGK), Universität Bielefeld. Bielefeld. DOI: https://doi.org/10.4119/unibi/2950305

        WHO (2021). WHO online consultation meeting to discuss global principles for identifying credible sources of health information on social media. Meeting Summary. Abrufbar unter: Summary-Global principles for identifying credible sources of health information on social media (who.int) (Zugriff am 25.07.2023).

        WHO (2022). WHO and NAM encourage digital platforms to apply global principles for identifying credible sources of health information. WHO Departmental News, 24. Februar 2022. Abrufbar unter: WHO and NAM encourage digital platforms to apply global principles for identifying credible sources of health information (Zugriff am 25.07.2023).

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          Ecosystem design: Benefits for all

          Dr. Marcus Trapp
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          Dr. Matthias Naab
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          To thrive in today’s market, digital platform operators need to consider the interests of all ecosystem participants. By delivering benefits and creating advantages for everyone involved, they can unlock the potential of network effects and scalability. This principle holds true even for a non-profit national health platform.

          In successful systems, the user journey or customer journey is designed to ensure optimal satisfaction at every interaction. Each touchpoint is intentionally crafted to meet users’ needs as much as possible. It’s no surprise, then, that successful providers tend to prioritize user and customer orientation when developing a new system or service.

          When examining new digital business models that operate on platform-economy principles, determining the precise identity of can be challenging. Digital ecosystems like Airbnb, Uber and Schüttflix serve as virtual marketplaces that facilitate the exchange of various “assets” such as overnight accommodations, transport and bulk goods by ecosystem operators. More often than not, these platforms function as multi-sided marketplaces, commonly comprising two sides and occasionally incorporating three or more.

          In each digital ecosystem, some ecosystem partners (providers) offer products and services (assets), while others consume these assets (consumers). For example, Airbnb brokers the exchange of overnight accommodations (asset) between private hosts (providers) and travelers (consumers), while Uber brokers transportation services (assets) between private drivers (providers) and passengers (consumers). The vision of a national health platform presented here follows a similar principle, enabling the brokerage of digital information and services between providers and patients.

          For ecosystem designers, the diversity of participants and multi-sided marketplaces involved in such an environment can have far-reaching implications. It’s easy to focus solely on the consumer journey, but they would do well to pay just as much attention to providers as to consumers and equally prioritize their respective needs. The very thing that attracts consumers to a digital ecosystem is its large number of providers; conversely, an ecosystem’s attractiveness for providers will also grow as the number of consumers increases.

          Balancing participants' interests

          Patients take center stage in the national health platform presented here. In other words, benefits for patients will always be the highest priority. Through the curation and consolidation of information and services, the platform seeks to foster health literacy, streamline information management and empower patients to actively engage in their treatment journeys.

          However, the only way to actually achieve these vital patient-centric benefits is to make certain that providers of healthcare information and digital services also actively participate in the ecosystem.  Consequently, ecosystem operators must ensure an optimal provider journey, one that is as seamless and beneficial as possible. This inclusive approach treats all partners equally, fostering incentives for every participant within the ecosystem.

          Voluntary, not coerced participation

          The importance of generating benefits for all participants within an ecosystem stems from the fact that participation is voluntary and no one can be forced to join. Even if it were possible to enforce participation, such as through government authority, experience has shown that this approach is generally ineffective. Those individuals and/or entities forced to participate often find ways to delay processes or obstruct them in some other manner. Conversely, when all participants derive benefits from their participation, this usually leads to good outcomes.

          The benefits gained from the ecosystem need not be solely monetary in nature. Other advantages, such as access to a larger market, increased visibility of products and services, and access to key data and analytics, can sometimes be more valuable to participants than short-term financial gains. In a best-case scenario, the advantages accrued by one participant would lead to further benefits for patients. For example, healthcare service providers would greatly benefit from accessing contextual information, enabling them to customize their services to better meet the needs of their target groups.

          Holistic digital ecosystem design

          When digital ecosystems emerge, they typically don’t introduce entirely new services, but rather utilize their own digital ecosystem service to offer a vastly improved experience in ways that revolutionize entire industries. They usually achieve this improvement by cleverly exploiting digital opportunities in ways never seen before in that sector.

          For instance, digital platforms for booking accommodations existed prior to Airbnb’s launch, and transportation services were already being organized before Uber was founded. However, Airbnb and Uber have offered participants so many advantages and so much added value that they have both significantly transformed their respective markets.

          The art of creating a digital ecosystem lies in implementing a holistic design that takes into account the interests of everyone involved. As these ecosystems usually enter an already established market in its respective business domain, it is important to carefully consider which benefits can be created for all relevant participants so that they are sufficiently motivated to participate in the ecosystem. This step is critically important when considering the design of a national health platform, especially given the partially regulated nature of the healthcare market and the presence of strong, established players.

          The introduction of a new ecosystem will undoubtedly transform existing healthcare structures and processes. It’s important to acknowledge that not all changes will be universally beneficial, and some market participants may perceive them as disadvantages. Additionally, there is a risk that the governing organization may exploit its position of power, seeking exclusive benefits from the platform. Such a scenario would undermine the motivation of all other participants and thus endanger the platform’s success.

          Ecosystem design in practise

          In developing the vision for the digital ecosystem presented here, we adopted a methodological framework that ensures a holistic design and integrates the interests and needs of all participants. In order to gain an overview of the status quo, our first step was to assemble and prioritize the actors relevant to the ecosystem. After that, we conducted anonymous interviews with representatives of these participants. We also reviewed publications and analyses and obtained expert assessments, all in an effort to gain a better understanding of the needs, issues and challenges facing individual actors.

          In order to ensure that the ecosystem outlined here generates sufficient benefits to motivate potential participants to actively engage with the system, we created a so-called Motivation Matrix (Nass, Trapp, Villela 2018).  (Nass, Trapp, Villela 2018). Our first step was to examine what benefits each individual actor would garner from the introduction of the national health platform, but also to determine how they could contribute and/or what role they could play in the ecosystem. In addition to benefits and incentives, we also discussed the possible disadvantages that individual actors might encounter as a result of the implementation of the ecosystem and its platform, including disadvantages both real and imagined.

          As mentioned above, a benefit analysis highlights more than just monetary gains, chiefly because the idea of benefits can take on so many forms. By drawing on the Motivation Matrix throughout the entire concept-development process, we were able to determine the extent to which the anticipated expectations of various actors interested in participating in the ecosystem could be fulfilled. If and when the expectations of key actors were not met, we redesigned the ecosystem accordingly in an iterative process. The result is a benefit model associated with the national health platform presented here. This model makes one thing quite clear: even in a healthcare system characterized by diverse authorities, significant diversity and special interests, it is possible to craft a vision that generates added value for all participants while also creating tangible benefits and generating welfare effects

          Tangible Ecosystem Design (TED) method

          Digital ecosystems are significantly more complex than software systems operating under the control of a single company. The implications stemming from technology, business, and legal aspects are notably harder to anticipate when designing products and services that will be exchanged across multiple companies and sectors

          The multitude of diverse participant categories results in complex relationships, making it challenging to assess the impact of even the slightest change on the entire ecosystem. This is what makes it so challenging – especially in the design phase – to get a “big-picture” overview of the ecosystem. The big picture, however, is the most important tool when communicating with potential participants about diverse aspects (business, technology, legal) and seeking to form a common understanding as quickly as possible.

          The “Tangible Ecosystem Design” method takes on precisely these challenges and encourages cooperation in the process of defining, designing and analyzing a digital ecosystem. Participants take part in workshops where they model a digital ecosystem using Playmobil® toys and other templates, all of which serve to make the concept more tangible and provide hands-on experience in the true sense of the word.

          Bibliography

          Nass, C, Trapp, M, Villela, K (2018). Tangible design for software ecosystem with Playmobil®. NordiCHI ’18: Proceedings of the 10th Nordic Conference on Human-Computer Interaction. September 2018. 856–861.

          Koch, M, Krohmer, D, Naab, M, Rost, D, Trapp, M (2022). A matter of definition: Criteria for digital ecosystems. Digital Business 2, 100027.

          Authors

          Dr. Marcus Trapp and Dr. Matthias Naab, co-founders of Full Flamingo, an eco-tech startup, aim to leverage the power of the platform economy for the greatest possible impact on sustainability. Before 2022, they held senior executive positions at Fraunhofer IESE, where they played a pivotal role in developing and overseeing the field of “Digital Ecosystems and the Platform Economy.”

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            Creating vs. brokering editorial content: Where does the content come from?

            Prof. Dr. Laura Schulte
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            The vision of a national health platform outlined in the “Trusted Health Ecosystems” project raises questions about the origin of the content and services offered there. A demand-driven offering requires a diverse range of information and services, which a single provider may struggle to fulfill alone. However, the platform operator does not have to create the content on their own. The following considerations explore whether the platform operator should generate their own information or focus on facilitating third-party information.

            The challenge

            The dissemination of information involves certain legal requirements that differ in principle depending on who authors the content. The question of attribution depends on the perception formed by users of an information offering regarding the authorship or responsibility for the content. Relevant legal requirements in this context may involve preventive obligations to verify the accuracy of content, obtaining permission for third-party content, provider identification obligations, and the removal of unlawful content.

            For most information offerings, it is assumed that there is no obligation to check the accuracy and legality of third-party information in advance. However, the provider may be required to do so if there are indications of a potential violation of the law. The situation is different when the provider adopts third-party content as its own, especially if it appears that the provider has independently verified the information or deemed it correct on another basis.

            In addition to these liability considerations, the trade-off involved with generating one’s own content versus relying on third-party content and service offerings is also relevant with respect to the legal justification of the proposed national health platform. It’s important to take into account that opting to create original content, especially by a primarily publicly funded operator, could affect the range of opportunities available to private sector actors and potentially put market-active companies at a disadvantage. State information initiatives are always subject to the condition that they must serve a governmental purpose, among other requirements (see The state as a provider of information).

            The distribution of quality-monitored health-related information is clearly in the interest of health education and, by extension, in the interest of state healthcare policy. However, as of today, there is no state-issued mandate or explicit legal assignment of tasks regarding the operation of a national information hub in Germany.

            Background

            The first question that arises – irrespective of copyright attribution issues – involves identifying who is responsible for the information provided through an external entity. This can include a legal entity that has obtained the information through a licensing agreement or other arrangements with third parties, for example.

            From a German legal perspective, online information offerings are classified as telemedia services and are subject to the regulations specified in the German Telemedia Act (TMG). According to § 5 TMG, all telemedia services are required to disclose the provider’s information in an imprint or legal notice. To the extent that a telemedia service offers journalistic or editorial content, it is required to appoint an individual who will be held legally responsible for the content, separate from the information platform itself.

            These transparency obligations serve to identify an institution or individual against whom claims can be pursued in the event of legal disputes. However, being a provider doesn’t necessarily imply that all information or content must originate from that same provider. Being identified as a provider is initially a formality designed to to ensure that the responsibility for each telemedia offering is clearly delineated. It is crucial to distinguish between responsibility for the technical platform and responsibility for the content disseminated on that platform. Although a single entity may be held legally responsible for both aspects, this is not mandatory.

            Providers, as defined under the German Telemedia Act, can include institutions or individuals who have had no substantive influence on the information and merely offer it as third-party content. The provider thus serves as the primary point of contact for their own as well as third-party content. However, variations emerge in terms of responsibility, including the ability to claim removal or seek damages in cases involving the publication of unlawful or false content.

            In principle, the entity responsible for creating the content, such as the author of a text or the organization behind a study or figure, should assume primary responsibility for it. From a legal standpoint, the operator of an information offering is not directly liable for third-party content. Initially, liability applies only to their own content, not to third-party content.

            From a legal point of view, the distinction between one’s own and third-party content depends on how the content is visibly attributed. Authorship is not relevant in this context; what matters is how users encounter the information. If there is no clear distinction in an information offering, users typically assume that all information either originates from the platform provider or that the provider adopts third-party content as their own.

            Third-party content is considered as such only when users can clearly recognize that the online content does not originate from the provider and that the provider does not wish to assume responsibility for it. A reference to its third-party nature can be made by exercising transparency in indicating a different contact or an external source for specific content.

            Past experience shows that private or civil society actors are indeed capable of generating and disseminating relevant information themselves. Given this, it seems advisable for the national healthcare platform to make health-related information from third-party providers easily accessible to the public while leveraging both state and private sector or civil society resources. In sum, the platform operator should not create and disseminate their own content.

            “The national health platform should limit itself to bundling and organizing third-party content.”

            Prof. Dr. Laura Schulte

            From a practical perspective, it will be important to consider how third parties can be motivated to make their content available for further distribution on the platform. Presumably, third parties could be enticed to contribute their content if they are provided a high-quality environment in which they are credited as the source of the information.

            Moreover, a clear definition of guidelines for the inclusion of content and general procedures is crucial. This includes determining how the information should be presented and how frequently updates should occur. In such an environment, offering multiple equivalent options or information can provide users with a comprehensive and unbiased selection to choose from.

            Conclusion

            Aside from legal issues, the decision to adopt and offer information as proprietary content is primarily a strategic one. Providing one’s own information usually involves more significant effort, whether this means creating or acquiring relevant content. Handling third-party content requires less production-oriented effort but involves considerable effort in terms of coordination and alignment activity. The desired quality level is thus essential.

            From the perspective of competition law, adopting an open market approach and offering third-party content is preferable to claiming it as proprietary or creating it from scratch. This approach helps prevent potential infringements on the fundamental rights of information providers (see The State as a Provider of Information). The national health platform should therefore focus on bundling and organizing third-party content and refrain from engaging in the thorough examination of specific content, modifying content, or granting extensive usage and exploitation rights to the platform operator.

            Fact or value judgment?

            The responsibility for editorial content depends, among other things, on whether the content is classified as factual information or a value judgment – both of which are fundamental to the national health platform. Factual information is objectively true or false, which means the provider bears the risk of disseminating information that is factually incorrect. There is no legitimate interest worthy of protection in spreading false information. Such content must therefore be promptly removed or corrected once so identified. Value judgments, on the other hand, are not subject to objective evaluation. They are subjective opinions that cannot be labeled as “true” or “false.” This gives information providers more leeway in terms of managing content on the platform.

            Challenges arise when dealing with mixed forms, especially when opinions are based on verifiable facts. Information providers must therefore carefully monitor the content on their platform and address complaints appropriately (Hofmann, 2022).

            Providing information to the public always involves the risk that some information may, at a later date, be found false or misleading. This risk applies to both self-generated content and information obtained from third parties. In order to manage this risk effectively, precautions can be taken for both self-produced and third-party content.

            (Published on 27.09.2023. The statements in this article refer exclusively to the legal situation in Germany. They represent a guideline and not individual legal advice that goes beyond the Trusted Health Ecosystems project.)

            Bibliography

            Hofmann F (2022). Lauterkeitsrechtliche Haftung von Online-Plattformen. Die neuen Transparenzvorgaben im UWG 2022 im Kontext lauterkeitsrechtlicher Plattformregulierung. in: GRUR Gewerblicher Rechtsschutz und Urheberrecht, Volume 124, June 2, 2022 (11/2022), pp. 780 et seq.

            Author

            While completing her doctoral studies, Prof. Dr- Schulte gained experience in the field of constitutional law as a research assistant. Her doctoral thesis focused on data protection law, and she conducted further research on this subject at various institutions, including the Queen Mary School of Law in London. From 2020 to 2023, she was employed as an attorney at BRANDI Rechtsanwälte in Bielefeld, specializing in IT and data protection law. Since August 2023, she has held the position of professor of business law at the Hochschule Bielefeld.

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            When developing a structural model for a prospective national health platform, it seems reasonable to assume, at least at first, that some kind of state-run service would be the most ideal provider. We should not forget, however, that the provision of information by the state – which we define as the communication of a range of information, warnings and recommendations – is subject to specific legal standards and guidelines. In the following, we examine the extent to which information can and should be provided by the state, if at all, and under what circumstances it is even possible and/or advisable to operate a national health platform in the form of a state-run information service.

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            Ownership: Public or private?

            When establishing a national healthcare platform, it is crucial to identify a suitable legal structure that fulfills all the necessary requirements and effectively supports the ecosystem in which it operates. In terms of ownership, a number of different options are available, each involving a variety of advantages and disadvantages. The first question to arise at this point is whether the platform should be operated by a public or a private-sector actor.

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              Ownership: Public or private?

              Prof. Dr. Laura Schulte
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              When establishing a national healthcare platform, it is crucial to identify a suitable legal structure that fulfills all the necessary requirements and effectively supports the ecosystem in which it operates. In terms of ownership, a number of different options are available, each involving a variety of advantages and disadvantages. The first question to arise at this point is whether the platform should be operated by a public or a private-sector actor.

              The challenge

              The tasks and services involved in a national health platform are complex and diverse. It is therefore absolutely essential that the platform ecosystem be set up in such a way that it can address each task and manage each service in a flexible manner, including any future tasks and services not yet identified today. Herein lies the challenge associated with finding the optimal legal structure for such an ecosystem. In any effort to do so, the following aspects must be taken into account:

              Requirements

              Alignment with the common good

              In principle, the ecosystem should not be commercially oriented. Instead, it should operate on a not-for-profit basis. All forms of revenue generated within the ecosystem should be used to extend the system itself and develop it further.

              Flexibility

              The ecosystem needs to be able to perform as yet unidentified tasks. It should therefore be open to ongoing development and innovation. In addition, both state and non-state actors should be able to work together side-by-side in the ecosystem.

              Transparency

              The actions, decisions and financing of the ecosystem, particularly when it fulfills a legal or public service mandate, should be transparent to the general public.

              Considering these requirements, two key questions arise regarding the organizational form of the ecosystem:

              1. Should an existing legal structure be utilized or should a new legal structure be created?
              2. Should the legal structure be rooted in public or private law?

              While utilizing an existing legal structure is a possibility, creating new legal structures would be more appropriate, given the need for innovation and multifunctionality within the ecosystem. Regardless of whether the ecosystem is governed by public or private law, it is important to distinguish between legal forms with and without legal personality. Legal forms organized under public law, which include the type of public institution known in Germany as an Anstalt des Öffentlichen Rechts, are privileged in a number of ways, for example with regard to their financing. On the other hand, they are also subject to stricter legal obligations than companies organized under private law, for example, in terms of the transparency of their decision-making. In addition, enterprises organized under public law are only permitted to integrate private actors uinder certain instances, which would make it even more difficult to achieve the goal of implementing the most inclusive ecosystem possible. With public enterprises, the focus is also generally on the realization of a public-oriented goal or public-service mandate, which contrasts significantly to primarily for-profit enterprises.

              Irrespective of the question as to whether the ecosystem’s structure should come under public or private law, we can generally distinguish between legal forms that have their own legal personality under the law and those that do not. Legal forms that do not have their own legal personality include, for example, partnerships (Personengesellschaften) and those municipal agencies known in Germany as Regiebetriebe, which are publicly owned and operated. Considering the allocation of multiple complex tasks within an ecosystem, it becomes apparent that legal forms lacking independence are unlikely to be suitable as potential ecosystem structures. This is particularly important as stakeholders need the ability to independently undertake legal actions, including entering into contracts with service providers. On the other hand, corporations (Körperschaften) are recognized as independent legal entities with the capacity to hold rights and obligations. The legal capacity to hold rights and obligations will thus constitute an indispensable prerequisite for the structure of the ecosystem.

              Background

              In principle, a distinction can be made between two forms of legal association: on the one hand, partnerships – e.g. the civil-law partnership – and, on the other hand, corporations – e.g. the association with legal capacity, the stock corporation or the limited liability companies. In general, there are two forms of legal association, namely partnerships (e.g., a Gesellschaft bürgerlichen Rechts or “GbR” under the German Civil Code) and corporations (Körperschaften), which include associations that have been granted legal capacity, stock corporations and limited liability companies.

              Partnerships (Personengesellschaften) are generally not granted full legal capacity, which means they are restricted in their ability to acquire and exercise rights. In addition, they are at their core focused on the natural persons behind the partnership. This factor tends to make it more difficult for actors to move in and out of a company. In other words, considering the overarching objective of the national health platform in Germany, the reasonable conclusion here would be that partnerships are fundamentally unsuitable as a structural form for the ecosystem.

              Corporations (Körperschaften) are permanent associations of persons for the purpose of achieving a function that goes beyond the individual. In contrast to partnerships, they operate independently of any changes with regard to individual members. Most corporations are legal persons, which means they can be bearers of rights and obligations, that is, they can enter into contracts. Corporations can also be organized under both private and public law.

              Public corporations (Körperschaften des öffentlichen Rechts) are associations created by the act of a sovereign state and tasked with carrying out a public service. These corporations are owned by their members, who have a significant influence on policy and decision-making. Membership can be voluntary, but in some cases it can also be compulsory by law.

              Organizational forms under public law are not available to everyone, however. Instead, they serve exclusively to fulfil a public task or statutory mandate. Accordingly, corporations under public law have certain unique powers and privileges. In particular, they can exercise public authority within the scope of their respective statutory mandate.

              The downside of this privileged public position is a relatively low degree of flexibility, at least in practical terms. For example, as government or quasi-government institutions, they are obliged to comply with fundamental rights. Indeed, corporations under public law are frequently rooted in a legal basis. This means that any change in orientation, competency or task may require an adjustment to their legal basis.

              Public law institutions (Anstalten des öffentlichen Rechts) are aggregations of material resources (e.g., buildings, equipment) and personal resources (personnel) brought together for the purpose of managing a public institution. They are legal persons to whom certain tasks have been assigned, whether by law or by statute, and who have also been entrusted with fulfilling a public mission. As a rule, these public institutions and/or their services are placed at the disposal of citizens. Some examples of institutions under public law in Germany are public broadcasting corporations, universities and savings banks. These public law institutions have their own legal personality that allows them to carry out their activities independently.

              Foundations (Stiftungen) can be organized under both private and public law. In general, foundations are designed to enable the management of assets for the benefit of specific purposes. Foundations under public law are usually created by the state via some kind of law or decree, which makes their establishment and subsequent development a rather bureaucratic process. It is also relatively difficult to integrate private-sector actors, which can be financed by a foundation, but only integrated into its decision-making processes to a limited extent. A foundation under public law is financially dependent on public budgets and grants. In practical terms, this means that it is comparatively difficult to secure a foundation’s long-term financing and thus its long-term operation. Indeed, the performance of such a foundation is likely to be directly dependent upon each new government’s budget.

              “For the role of operator, having the status of a legal person under private law provides flexibility and makes it possible for private and state actors to work alongside one another.”

              Prof. Dr. Laura Schulte

              Organizational forms under public law thus offer very little versatility and are therefore not well-suited to serve as operators of a national health platform. They are frequently rooted in legislation, which means that any increase in their tasks or competencies may require a time-consuming amendment to the law. Furthermore, all forms of organization under public law are directly obliged to comply with fundamental rights.

              The participatory rights of third parties, such as service providers in the health care sector, can also be partially derived from a public law institution’s binding obligation to comply with fundamental rights. Furthermore, public institutions are subject to certain requirements when it comes to any competitive action they undertake, and some of these rules may be stricter than those that apply to non-governmental actors (see The state as a provider of information: What is the government allowed to do?). And, finally, it is often difficult to integrate private actors into organizational forms operating under public law.

              It should be noted, however, that state actors – which include federal, state and municipal governments as well as their individual subdivisions – can also take advantage of organizational forms under private law. In practice, this means that if and when government agencies are participants in the ecosystem, it does not automatically follow that the ecosystem must have a legal structure under public law. The potential legal forms for the ecosystem under private law in Germany include an association (Verein), a limited liability company (GmbH) and a stock company (Aktiengesellschaft or AG).

              Overview - Legal structures under private law in Germany

              Association (Verein)

              In Germany, a Verein is considered to be a voluntary, long-term association of several persons who come together in pursuit of a particular purpose. In principle, state actors and private-sector actors can work side-by-side in a Verein.

              In the case of a Verein, it is only possible to limit liability vis-à-vis third parties to a certain extent. In particular, we should take note here of the general personal liability of the members of the executive board – including the entirety of their private assets – vis-à-vis third parties, at least to the extent that the Verein is held responsible for damages to third parties. The question of how the ecosystem would be financed in the form of a Verein raises some additional challenges; above all, it is likely that membership fees would be insufficient to provide the project with a continuous flow of adequate financial means, especially in its initial phase.

              Limited liability company (GmbH)

              A GmbH is a limited liability company that has its own legal personality and acts as a legal entity via its own corporate bodies. In principle, the liability of a GmbH is restricted to the level of company assets. Shareholders in a GmbH can be natural persons or legal persons. Although the shareholders have a share in the GmbH’s assets, they do not assume any personal liability as a result of their participation in the company.

              Limited liability company (non-profit GmbH)

              A non-profit GmbH is a special form of limited liability company. A non-profit GmbH combines the business advantages and framework of a GmbH with the advantages of non-profit tax law, thus making it an attractive legal form for the social sector. However, the earnings generated by the company may be used solely in the service of achieving the company’s non-profit objectives.

              Stock company (Aktiengesellschaft or AG)

              A stock company known as an Aktiengesellschaft (AG) typically unites a large number of shareholders who have invested their capital in the company in return for dividends taken from the income it generates. The profit-driven mandate of an AG is simply not in line with the non-profit objectives of the ecosystem.

              Stock company (non-profit stock company)

              German law also recognizes companies known as gemeinnützige AGs or gAGs, which are stock companies not aimed at making a profit. The focus on non-profit objectives – such as the promotion of science and research, public health, user information and consumer protection – is rewarded in the form of tax breaks in favour of the gAG. The downside of the special tax status of the gAG is the relatively strict set of regulations associated with non-profit tax law. It should be noted, in particular, that a gAG’s non-profit status would be jeopardized if more than half of its capital were used to finance its administration and fundraising, or if the commercial business operations of a gAG were to enter into competition with non-advantaged, for-profit businesses of the same or similar type to a greater extent than is unavoidable when fulfilling the tax-privileged purposes.

              Otherwise, the legal requirements determining the organization of a gAG correspond to the provisions applicable to a regular AG. In particular, the gAG also has an executive board, a supervisory board and an annual general meeting. The executive board is responsible for the gAG’s management, which must be aimed towards the exclusive and direct fulfilment of the legally defined objectives of the gAG.

              Holding company

              It is possible for the ecosystem’s individual services to be operated by different companies (Gesellschaften), each with a different legal form which, however, could be brought together under the common umbrella of a holding company (Holdinggesellschaften). A holding company is a structural form whose main purpose is to hold an interest in one or several legally independent companies on a long-term basis.

              There are two distinct types of holding companies that could function as “umbrella organizations” for the ecosystem under consideration here: an operative holding and a management holding. An operative holding is comparable to a parent company (Mutterkonzern) upon which subsidiaries are dependent in terms of strategy and personnel. In contrast, a management holding has no operational business of its own, but still determines the strategic objectives of its subsidiaries.

              The most significant advantage of this type of holding is flexibility, as each subsidiary is able to develop strategies for its own field of business. As a legal structure, the holding company is not regulated by German law and is therefore not bound to a specific legal form. In fact, holding companies are frequently operated in the legal form of a limited liability company (GmbH) or stock company (AG).

              Conclusion

              In order to effectively pursue its objectives and have the legal capacity to act, the ecosystem must have the ability to bear rights and obligations. This means that any legal structure that does not have legal capacity should be automatically ruled out as an option. Partnerships, for example, do not meet the requirements of a participatory infrastructure for the health care system and should not be considered as a legal entity with ownership of the prospective national digital ecosystem.

              While a structure under public law is technically possible, it would pose challenges for private-sector actors when it comes to participating in the project as a whole. To achieve the broadest possible level of participation and a high degree of flexibility, the most ideal organizational framework would therefore involve a legal structure under private law. This would offer a relatively large degree of flexibility with regard to structural adjustments and the cooperation of both private and state actors on the project.

              Furthermore, considering the diverse range of functions performed by the ecosystem, a holding structure appears to be an ideal choice. Under this structure, a parent company would manage subsidiaries, each of which could undertake different tasks within the ecosystem. This allows for efficient coordination and management of the ecosystem’s various functions.

              (Published on 27.09.2023. The statements in this article refer exclusively to the legal situation in Germany. They represent a guideline and not individual legal advice that goes beyond the Trusted Health Ecosystems project.)

              Author

              While completing her doctoral studies, Laura Schulte gained experience in the field of constitutional law as a research assistant. Her doctoral thesis focused on data protection law, and she conducted further research on this subject at various institutions, including the Queen Mary School of Law in London. From 2020 to 2023, she was employed as an attorney at BRANDI Rechtsanwälte in Bielefeld, specializing in IT and data protection law. Since August 2023, she has held the position of professor of business law at the Hochschule Bielefeld.

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              The state as a provider of information: What is the government allowed to do?

              When developing a structural model for a prospective national health platform, it seems reasonable to assume, at least at first, that some kind of state-run service would be the most ideal provider. We should not forget, however, that the provision of information by the state – which we define as the communication of a range of information, warnings and recommendations – is subject to specific legal standards and guidelines. In the following, we examine the extent to which information can and should be provided by the state, if at all, and under what circumstances it is even possible and/or advisable to operate a national health platform in the form of a state-run information service.

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              National health platform: The state as a provider of information
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                The state as a provider of information: What is the government allowed to do?

                Prof. Dr. Laura Schulte
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                When developing a structural model for a prospective national health platform, it seems reasonable to assume, at least at first, that some kind of state-run service would be the most ideal provider. We should not forget, however, that the provision of information by the state – which we define as the communication of a range of information, warnings and recommendations – is subject to specific legal standards and guidelines. In the following, we examine the extent to which information can and should be provided by the state, if at all, and under what circumstances it is even possible and/or advisable to operate a national health platform in the form of a state-run information service.

                The challenge

                All government action – especially any action relating to fundamental rights – is based on the assumption that it have some kind of legal justification that can be verified retroactively by a court of law. This assumption itself is anchored in the principle of the rule of law, which is a key element of the Grundgesetz, Germany’s constitution. Among other things, Article 20 (3) of the Grundgesetz stipulates that “the executive [shall be bound by] law and justice.” Every state action that has the potential to impact the fundamental rights of third parties must therefore be examined to determine its legal legitimacy and justification.

                The provision of information by a state authority must be seen as a form of “state action,” given that the action is aimed at informing the general public. The minimum prerequisite can thus be drawn from the principle of the rule of law, which stipulates that the state authority act within the scope of the task assigned to it. In this regard, the provision of information to the public can be legitimized, at least in principle, as an annex to the government’s performance of tasks (Schoch, NVwZ 2011). However, in and of itself, a general allocation of the task of developing and overseeing a government information service is insufficient to secure the legal basis of the prospective platform.

                Background

                One area in which state action clearly requires legitimization is when the government issues official consumer product warnings as part of its efforts to provide consumer-protection information (Voßkuhle and Kaiser, JuS 2018). These warnings are typically targeted at specific products or providers, which can impinge on the business operations of the manufacturers and/or providers involved. In such instances, the affected companies have the right to invoke their constitutionally protected freedom to pursue their profession (Article 12, Grundgesetz) as well as safeguard their personal rights (such as the right to self-determination and self-preservation).

                In dogmatic terms – that is, as far as Germany’s Federal Constitutional Court is concerned – the state’s action in providing information does not constitute an encroachment carried out in the form of a legal act, at least not in the traditional sense of the term. Still, the impact of the provision of such information is very similar to that of an encroachment in the traditional sense. It is therefore reasonable to interpret such state action as being the equivalent to an encroachment (Voßkuhle and Kaiser, JuS 2018).

                According to criteria set forth by German’s Federal Constitutional Court, it will be necessary to determine whether the provision of information by the government has an impact on market competition.

                “When examining the broader collection of information by government agencies, it is essential to assess the extent to which the state provider competes with private-sector entities.”

                Prof. Dr. Laura Schulte

                In this regard, Germany’s Federal Constitutional Court has laid down the following minimum prerequisites which must be met to ensure the legality of state-run information activities: (1) there must be an identifiable state task to be carried out; (2) the rules of order, procedure and responsibility must be adhered to in the fulfillment of the task;  (3) the information must be factually accurate and its content truthful; and (4) as a whole, the act of providing the information must be appropriate and in proportion to the task.

                And, even if government agencies comply with each and every one of these laws, it is still possible for markets to be impacted by their actions. Indeed, a state often has other means at its disposal when seeking to position itself in front of the general public; for example, it can draw on public funds to finance its efforts. For this reason, the public often considers information provided by state agencies to have greater relevance and credibility than information disseminated by third parties. If a government agency is seen as engaging in a private-sector action, the first step is to determine whether there is any justification for this action and whether their action results in any impact on competitors. It is also important to determine whether the information disseminated to the public comes from the public authority itself or from a third party (see also: Ownership: Public or private?)

                Conclusion

                Given the statements made so far, and especially considering the goal of establishing a platform model firmly rooted in the law, the idea of a national health platform operated by the state must be viewed critically. Although the project is by no means focused on the issuance of product warnings and other direct disadvantages suffered by actors, it is nevertheless true that other providers of digital health information and services could be impacted, if only indirectly.

                It is therefore advisable to advocate for a structural approach that does not involve the direct provision of information by a state-run agency. It should also be noted that the partial funding of a national health platform by the government does not automatically imply that responsibility for the platform must also be in government hands. Instead, an open structural model, managed by civil society actors, could serve as an information “hub” and serve as a foundation for additional services.

                To prevent excessive limitations being placed on the activities of private-sector actors, it is advisable to have a platform that is not administered by the state. Efforts should also be made to ensure that companies operating on the market are not excluded or put at a disadvantage.

                (Published on 27.09.2023. The statements in this article refer exclusively to the legal situation in Germany. They represent a guideline and not individual legal advice that goes beyond the Trusted Health Ecosystems project.)

                Bibliography

                Schoch, NVwZ 2011, 193 (196) with reference to OVG Hamburg, NVwZ-RR 2008, 241.

                Voßkuhle and Kaiser, JuS 2018, 343 (344) with reference to BVerfG, NJW 2002, 2621 – Glykolwei.

                Author

                While completing her doctoral studies, Prof. Dr. Schulte gained experience in the field of constitutional law as a research assistant. Her doctoral thesis focused on data protection law, and she conducted further research on this subject at various institutions, including the Queen Mary School of Law in London. From 2020 to 2023, she was employed as an attorney at BRANDI Rechtsanwälte in Bielefeld, specializing in IT and data protection law. Since August 2023, she has held the position of professor of business law at the Hochschule Bielefeld.

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                Your feedback is important to us

                To contact our project team, please use our form. We look forward to your message and will get back to you as soon as possible.