[Legal regulation of digital public health interventions-hindrance or stimulus?] / Digitale Gesundheitstechnologien ­ das Recht als Hemmschuh oder Wegbereiter?

The potential benefits of digital health technologies in population-based health research depend mainly on whether and to what extent these technologies can be based on the processing of personal health data. However, there needs to be more certainty in the application and interpretation of the relevant legal regulations on the processing of research data using digital health technologies. Research practice primarily uses consent as a legitimation basis for data processing, although the information model of the German and European legislator, with its ambitious requirements for voluntary and informed consent, is unrealistic and needs to be revised. Even the concepts of broad consent, dynamic consent, and meta consent, which represent alternatives to the classic consent solution, cannot remedy all the deficits of the consent model.In order to guarantee the informational self-determination of the persons concerned and, at the same time, keep an eye on the interests of research in the public health sector, data protection for research purposes must be further developed. Solutions should not only be tailored to consent behavior but must also consider the legitimization of research data processing without consent or aim to remove the personal reference of the data irretrievably. To date, the law has only fulfilled its task of striking an appropriate balance between the interests of all stakeholders to a limited extent. However, improvement is in sight, especially given current regulatory initiatives and new legal solutions. This discussion article illustrates the ambivalent role of law: on the one hand, health data protection law is often perceived as an obstacle to innovation, but on the other hand, law can pave the way for digital health technologies if further developed.

[Data infrastructures for health research : Ethical framework and legal implementation]. / Dateninfrastrukturen für die Gesundheitsforschung : Ethische Rahmenbedingungen und rechtliche Umsetzung.

The role of data infrastructures for health research is not limited to acting as a service or interface for data exchange between data producers and data users. Rather, the infrastructure itself is an actor in the process of data sharing and therefore also bears responsibility for this process.This applies first of all to the lawfulness of personal data processing. If data processing is based on the consent of the data subject, the infrastructure must also ensure that all data processing is covered by this consent. If the data processing is based on a statutory basis, the infrastructure must ensure the highest possible level of data protection, in particular through technical and organizational measures. In addition, the infrastructure is also responsible for implementing the rights of data subjects, such as the right to information, rectification or erasure of data, and dealing with incidental or additional findings.The question of how researchers regard their involvement in infrastructure projects and how private companies should be involved in such projects must be based on the principle of public welfare. This is accompanied by the obligation of infrastructures to take into account the principles of participation, transparency, and scientific communication as far as possible. Observing all these ethical and legal aspects is especially important because only by doing so can the trust of all stakeholders be established and thus the central basis for the successful construction and operation of data infrastructures be provided.

[Contact-Tracing Apps in Contact Tracing of COVID-19]. / Contact-Tracing-Apps als unterstützende Maßnahme bei der Kontaktpersonennachverfolgung von COVID-19.

Contact tracing is currently one of the most effective measures to contain the COVID-19 pandemic. In order to identify persons that would otherwise not be known or remembered and to keep the time delay when reporting an infection and when contacting people as short as possible, digital contact tracing using smartphones seems to be a reasonable measure additional to manual contact tracing. Although first modelling studies predicted a positive effect in terms of prompt contact tracing, no empirically reliable data are as yet available, neither on the population-wide benefit nor on the potential risks of contact tracing apps. Risk-benefit assessment of such an app includes investigating whether such an app fulfils its purpose, as also research on the effectiveness, risks and side effects, and implementation processes (e. g. planning and inclusion of different participants). The aim of this article was to give an overview of possible public health benefits as well as technical, social, legal and ethical aspects of a contact-tracing app in the context of the COVID-19 pandemic. Furthermore, conditions for the widest possible use of the app are presented.

[Tasks, regulations, and functioning of ethics committees]. / Aufgaben, Regularien und Arbeitsweise von Ethikkommissionen.

Our constitutional order provides comprehensive protection of the freedom of scientific research; any interference with this freedom requires justification. With regard to the obligatory involvement of ethics committees in the research process, this justification is based on a careful balancing of scientific freedom on one hand and the legal interests of study participants, such as the protection of life, health, and self-determination, on the other. How this is achieved, and with what results, is shown below for two areas. The first of these are clinical trials in pharmaceutical and medicinal product law, which are subject to extensive regulations regarding the involvement of ethics committees. Following the amendments at European level, this area has been comprehensively restructured, in particular with regard to the function and importance of ethics committees. Subsequently, the role of ethics committees in university research is discussed as far as this research is not regulated by the German Medicines Act (AMG) and the German Act on Medical Devices (MPG), but instead is mostly subject to university self-government. It is shown, using statistics as an example, that a line must be drawn between legitimate control of scientific research and a sweeping "ethicization" of science. To conclude, this very boundary is examined from a philosophical perspective.

Research with minors in Germany.

The European GCP Directive has been implemented into German law in sect. 40 ff. AMG (German pharmaceutical law). Unlike the Directive, German pharmaceutical law basically differentiates between three constellations of clinical trials on minors: clinical trials on healthy minors, clinical trials on ill minors with an individual benefit for the individual participant, and clinical trials on ill minors without direct benefit for the individual participant, but with a so-called "group benefit". Particularly the latter possibility of conducting clinical trials on minors even if no individual benefit can be expected is not a matter of course in Germany since due to historical experiences a sceptical attitude towards clinical research on humans prevailed for a long time. German legislature has availed itself of the option granted by Article 3 of the GCP Directive to establish a higher level of protection of clinical trial subjects than the European level.

Industry-sponsored medical education--in the quest for professional integrity and legal certainty.

Industry-sponsored medical education is a much disputed issue. So far, there has been no regulatory framework which provides clear and definite rules as to whether and under what circumstances the sponsorship of medical education is acceptable. State regulation does not exist, or confines itself to a very general principle. Professional regulation, even though applied frequently, is rather vague and indefinite, raising the general question as to whether self-regulation is the right approach at all. Certainly, self-regulation by industry cannot and should not replace other regulatory approaches. Ultimately, advertising law in general and the European Directive 2001/83/EC specifically, might be a good starting point in providing legal certainty and ensuring the independence of medical education. Swiss advertising law illustrates how the principles of the European Directive could be implemented clearly and unambiguously.