Work Package 7: ELSI - Ethical, Legal and Social Implications

A project like DigiMed Bayern requires an ethical and legally considered implementation. Therefore, all protocols and methods are based on fundamental ethical principles. National and international regulations are strictly followed. Moreover, DigiMed Bayern is setting important milestones in new territory for P4 medicine to protect the interests of the affected patient groups and the people in the country in general.

An essential part of DigiMed Bayern is also the accompanying and scientifically explorative examination of ethical and legal questions in P4 medicine, because the rapid technical developments and potential of P4 medicine pose new challenges for the established standardization processes in medicine. For instance, it is important to investigate the concept of informed consent for the patient, as to whether and how it covers the subsequent evaluation of existing data and examination, for example for extensive genetic traits. This short-term task is guided by a further question, namely the relationship between the idea of solidarity with other patients and the previous model of consent and data protection, which is primarily geared towards the specific patient. To what extent can the previous procedure, which was to design the ethical standardization in medicine from the individual, be revised or expanded? How could and should this be implemented legally?

WP7.1 Society and Ethics

The fundamental ethical principles of medicine are based on individual ethics. This becomes clear when looking at the four principles that have become part of the standard established by Tom L. Beauchamp and James F. Childress in their Principles of Biomedical Ethics: respect for autonomy, non-maleficence (“non-damage” or the avoidance of damage and injury), beneficence (care or charity) and justice. The first three are obviously norms that apply between physician and patient. But the last principle, i.e. justice, formulates the individual right of a patient to receive a fair distribution of the health goods. This is a health care claim addressing the health care system in which the patient is treated. P4 medicine, in which one of the "Ps" stands for "personalized", initially accommodates this individual ethical approach. The third principle of (individualized) care seems to be even easier to fulfill, because - here the second principle comes into play - side effects can be avoided better with this approach.
However, if you take a closer look at DigiMed Bayern, it becomes clear that paths are being taken that go beyond the level of individual patient and physician. Because the path to personalized medicine, which works preventively and predictively, goes through an accurate recording, evaluation and digitization of case-related patient data, but also of data records obtained for example from routine examinations. The precise, personalized treatment or the prediction or prevention should be achieved by exactly this, a comparison of a large statistical number of comparable partners. Such a comparison also enables conclusions to be drawn about those, who are closely related - or who have the same genetic characteristics, even if they do not yet show any symptoms of the disease. P4 medicine may even create a link between a specific disease and a genomic composition.

It is obvious that this can no longer be grasped with individual ethical principles. Rather, the ethical reflection must be expanded to this. Thus, the action in the field of P4 medicine should be designed in such a way that not only the protection of the individual decision is ensured, but also the balance between the different perspectives, and the new, ethically relevant similarities are adequately recorded. It is therefore particularly important to reflect on the extent to which collective interests can or must be taken into account, which so far have not had a proper place in the established standards of bioethical judgment. In particular, questions arise about social goods that are preserved with the help of P4 medicine, and that need to be considered when making decisions.

P4 medicine primarily implies two extensions to the care concept. On the one hand, in view of the amount of data required for research and supply (big data), the term "data solidarity", to which the individual should be committed, has been added to the equation. The sometimes a bit contradicting term of “data sovereignty” was also brought up. Both call for a negotiation of the relationship between the individual and differentiated dimensions of the community, society and forms of political coexistence. On the other hand, care includes a common concept of health. The extent to which demands for "data solidarity" can therefore be justified depends on the value of "health" as a common good, as well as on the institutional, legal and political-economic forms in which data is processed and used accordingly.

This sheds a different light on the principle of justice, as outlined by Beauchamp and Childress. If a liberal model of justice based on fair exchange relationships was the foundation of their classic model (and thus of the model dominating for western societies), with P4 medicine, now the critics of this model have their say. They refer to theories of communitarianism, and highlight the fact that societies function not only through individual balancing processes, but only through shared ideas about the good - and at the same time always refer to certain, definable communities. This means that the question of a fair relationship between an individual and its community is raised again by P4 medicine, and requires coherent answers.

Thinking through the modifications or revisions of the classic medical-ethical paradigms presents a major challenge on the theoretical level, but also on the level of the professional ethos. Doctors and researchers come into focus not only as advocates for individual patients, but also as advocates for the common good. The ELSI work package in DigiMed Bayern therefore regards itself as a continuous interlocutor which stands for the further development of ethical paradigms in exchange with other projects, and which initiates an ethical discourse with the public.

Accompanying research accordingly faces several tasks that expand the group of addressees:

  • The first level of addressees lies within the project: It is particularly important to sensitize the project staff to the fact that the established standards of the doctor-patient relationship, which are based on the individual-ethical paradigm, must be considered in the project, and at the same time reach their limits. In addition, there is a regular exchange about this within the project.
  • Due to the problems arising in the project, the four principles of medical ethics must be further developed. Since these are questions concerning all of us, a transparent, well-founded and above all participative dialogue with the public is to be sought in close coordination with WP8.
  • Finally, on the basis of concrete research results, the fundamental ethical questions are to be discussed, which relate to the individual-society relationship, and between medicine and culture, and which are newly posed with this project. Public conferences, lectures and publications are planned for this approach.

(updated: Dec. 2019)

Further information:
TTN edition 2019: Gemeinwohl, Polis, Individuum. Bioethik im Kontext.

WP7.2 Legal aspect

P4 medicine is characterized by four elements, each of them within a legal area of conflict.

The planned extensive data analysis enables the Prediction, i.e. statements related to the risk of illness. The importance of this is shaped by the consequence of risk, disease severity and the possibility of intervention (RSI). From a legal point of view, the right to know and the right to not know are of particular importance in this context. This also affects the prediction of disease risks for family members who have not given their consent to the data analysis (third party concern). The results of this legal assessment will help to shape health education approaches and consent decisions to participate in investigations.

With regard to Prevention, the right to benefits under health insurance regulations opens up, in which the citizen’s/patient's claims to prevention services are anchored. In this environment, possible incentive and sanction options are also legally relevant.

The Personalization of medicine has an important role in e.g. the diagnostics with regard to the suitability of therapies, pharmaceutical applications, efficacy and the benefit of a therapy/medication based on the genetic makeup of the patient, his pharmaceutical metabolism or the genetic characteristics. From a legal point of view, this affects genetic diagnostics as well as the benefit debate and restrictions on the right to diagnosis and drug therapy for different benefit categories.

The Participation of the citizen/patient consists in participation in decision-making processes as an expression of personal freedom and decision-making competence. The requirements for this are sufficient qualification (empowerment), participation in allocation decisions (participation) and participation in research and development (engagement). The legal framework for this is incomplete in Germany. The study will provide evidences and arguments for the further development of participation that can be legally founded.

The planned data collection and analysis affect a large number of Bavarian, German and European regulations and norms: The regulations on the treatment contract in the Civil Code (§ 630 ff. BGB), EU General Data Protection Regulation (GDPR), Federal Data Protection Law (BDSG), Bavarian Data Protection Law (BayDSG), Bavarian Hospital Law (BayKHG), Genetic Diagnostics Law (GenDG), Social Code Book V. (SGB V), Social Code Book X (SGB X), Medical Devices Law (MPG), Medical Device Regulation (MPVO), Professional Code for Bavarian Doctors. This complex legal framework must be presented through a legal analysis and taken into account when designing the project. This ensures that the project is carried out in compliance with the applicable law. It is expected that numerous standards will be changed over the duration of the project. Accordingly, the new versions have to be considered in the legal evaluation of the project, in the results and in the conclusions for the further development of the law. The data protection standards applicable at the Bavarian, German and European level, which have been applicable since May 25, 2018, are of particular importance.

For the data collection within the project, the previously analyzed legal framework is to be applied in close cooperation with WP6. The project will include clinical findings, genetic and self-collected data. Since the clinical findings and other health data are to be combined to form a big data set, an analysis is required of the scope of the consent in the context of the new data protection regulation (keywords: broad consent, research privilege). The legal situation with regard to biomaterials/biobanks must be separated from this and considered independently. In addition, the legal framework for anonymization or pseudonymization of this data must be presented taking into consideration the current discussion about the limitation of defining anonymization.

The processing of the data and the integration of the different data flows must then take place within the defined purpose and in close cooperation with WP6 and WP7.1. Individual rights, group benefits and scientific interests have to be weighed up here. The aim should be to coordinate and, if necessary, adapt the integrated data protection concept with the state’s data protection officer. The connection of the data (keywords: data linkage) requires special attention. The currently discussed legal qualities of the concepts for data analysis should be checked here for their applicability, e.g. the method of controlled remote data processing.

For the expansion and validation of the risk calculator of the German Heart Foundation in WP1.2, and the possible development of health apps in WP4, medical device law is also of high relevance.

From a legal point of view, further project-related tasks must also be performed. This applies, for example, to the implementation of the project results in therapeutic decisions. The measures for quality assurance and liability for data quality must be examined separately. In the course of the project, legal questions will arise regarding the effects on the health insurance law context. It will be examined here how the results can change the citizen’s/patient’s/insured person's right to diagnosis and therapy, or how they justify a claim to data linkage. Here too, external expertise is essential.

In addition, from a practical legal point of view, a structured support for the cooperation of the project partners is required. Cooperation agreements between the parties involved, declarations of consent and the extensive documentation regarding data protection required under the EU GDPR should be considered here.

Finally, it is an important project goal to document experienced legal uncertainties and limitations within the ethical framework, to publish them and, if necessary, to implement them in the political process. This requires a thorough legal analysis of the project results in close cooperation with WP7.1. In particular, it must be examined whether the existing legal framework is sufficient for the requirements resulting from the project for the data-based care of insured persons with atherosclerosis in the future. It must be evaluated whether the results can be transferred to other diseases and what the consequences are for the health care context.

Prof. Dr. med. Heribert Schunkert
Prof. Dr. med. Heribert Schunkert

Wissenschaftlicher Leiter DigiMed Bayern, Direktor der Klinik für Herz- und Kreislauferkrankungen am Deutschen Herzzentrum München

+49 (0) 89 / 1218-4073

Prof. Dr. med. Thomas Meinertz
Prof. Dr. med. Thomas Meinertz

Herzspezialist der Deutschen Herzstiftung

Prof. Dr. Reiner Anselm
Prof. Dr. Reiner Anselm

Lehrstuhl für Systematische Theologie und Ethik

+49 (0) 89 / 2180-5484

Prof. Dr. Ulrich M. Gassner
Prof. Dr. Ulrich M. Gassner

Professor für Öffentliches Recht, Universität Augsburg

+49 (0) 821 / 598-4600

Dr. Jens Wiehler
Dr. Jens Wiehler

Digital Health, Managing Director DigiMed Bayern

+49 (0) 89 / 89 96 79-36