Informed consent to the use of personal health data: Dresden research group develops standardised approach

International initiatives such as the European Health Data Space, which is currently being created, are also taking self-generated health data into account for the first time. An EU-wide platform will bring together traditional health data from the healthcare system and self-generated health data for use in patient care and research. In Germany, the corresponding national course will be set via the Health Data Utilisation Act. The role of citizens in consenting to the transfer of data is the subject of controversial debate. The sharing of health data and data platforms is a topic that is associated with great expectations for patient care and medical innovation - but also with concerns about the lack of citizen involvement and data capitalism. Our publication proposes a universal and standardised consent approach in which citizens themselves control the sharing of their health data," explains Stefanie Brückner, research associate in the Medical Device Regulatory Science research group led by Prof. Stephen Gilbert at the Else Kröner Fresenius Centre for Digital Health at TU Dresden. 

In the recently published paper „The Social Contract for Health and Wellness Data Sharing Needs a Trusted Standardised Consent” in the Mayo Clinic Proceedings: Digital Health, the researchers propose a new, simple approach to managing consent options for health data use. The Health Consent Standard is intended to unify and standardise the currently fragmented consent practices of apps and digital health services. At the centre is a digital, personal profile with a consent cockpit that allows citizens to see who they share which app health data with and to adjust their consent at any time. The consent processes for sharing health data in the apps should also be standardised and simplified so that citizens can actually make informed decisions.

For doctors and secondary data users such as researchers, this approach ensures that the data generated by patients themselves can be shared with them on the correct legal basis and can therefore be used safely. Proven identity and authorisation management technologies are used for the technical implementation of Standard Health Consent. These systems are already used as standard in other industries with highly sensitive data, for example in banking apps such as PayPal or Stripe. Stefanie Brückner comments: "Healthcare stakeholders and policymakers face the major challenge of building public trust in the use of health data. We see the active involvement of citizens via a standardised consent approach and a clear data governance and communication strategy as key elements for sustainable trust building.

Publication:
Stefanie Brückner, Toralf Kirsten, Peter Schwarz, Fabienne Cotte, Michael Tsesis, Stephen Gilbert: The Social Contract for Health and Wellness Data Sharing Needs a Trusted Standardised Consent; Mayo Clinic Proceedings: Digital Health, Volume 1, Issue 4, December 2023, Pages 527-533; 

https://doi.org/10.1016/j.mcpdig.2023.07.008 

Research article from "EHEALTHCOM" from 17 November 2023