ECRA Member Merle Freye:

"My research goal is to evaluate the role and suitability of (informed) consent in the field of health applications."

Health applications between Public healthcare and informational self-determination:

Digital networking is revolutionising medicine and rapidly spreading in the health sector. The use of health applications can provide fast and cheap access to health-promoting measures for a large number of people. The user is thus at the centre of these applications. The more astonishing is the fact that discussions on the development of health applications have largely focussed on technology up to now – not on the user.

The technological impact requires an interdisciplinary assessment from an ethical, legal and social perspective. The law and especially the data protection law has an important control function to enhance the informational self-determination of the user. However, it frequently lags behind technical progress.

Since legal research has only just begun, the market for health applications is mostly unregulated in Europe and data processing is mainly based on the (informed) consent of the user. Nevertheless, the role of consent has always been controversial in the history of data protection law and consequently raises questions in the field of health applications as well. Consent is associated with risks for the main actors – users, health insurance funds and companies providing services. Based on the three main actors this project is structured into three levels, each of them evaluating the role, advantages and disadvantages of consent.

3-level approach:

The first level is focussed on the chances, risks and requirements of consent from the perspective of the health application user. Research will start with adult users and then go on to discuss underage users – a category which is determined by protection of minors. On the one hand, the protection of minors argues for extensive restrictions of data processing. On the other hand, one should bear in mind that these technophile generations are the main customers for certain applications.

At the centre of the second level is the question whether app-based insurances can contribute to preventive health care and health care provision and which risks are associated with its use. In this context, the Digital Provision Act (2019) is currently the subject of some controversy: researchers are to be given access to health data of members of statutory health insurance in Germany without their consent being required. Health applications are to be supported by health insurance funds, even though technical testing of existing applications has identified numerous data protection deficiencies. It is important to create a balance between medical progress and the right to informational self-determination, without undermining fundamental principles of social law such as the principle of solidarity and disadvantaging individual health insurance members.

The third level is concerned with the perspective of the third actor: private companies with health application business models. They also have a direct influence on the digital participation in health-promoting measures. Companies frequently merge or are bought by other companies; a recent example is the acquisition of Fitbit by Google. The subsequent treatment of the health data as an essential company asset and the corresponding technical and legal requirements are often of secondary importance in these transactions focussed on economic considerations.

Research Goal:

The final monograph will evaluate whether informed consent is suitable for all health applications and which alternatives might be more convincing.

Back to the project overview



Professor Dr Hajo Zeeb
E-Mail: zeeb(at)
Tel: +49 421 21856902
Fax: +49 421 21856941

Project Office

Dr. Moritz Jöst
E-Mail: joest(at)
Tel: +49 421 21856755
Fax: +49 421 21856941


Rasmus Cloes
E-Mail: cloes(at)
Tel: +49 421 21856780
Fax: +49 421 21856941




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