Published on 11.11.2021 11.11.2021

TEHDAS proposes ways to regulate data quality in the European Health Data Space

Data quality is essential to ensuring that data is reliable and is fit for purpose. European regulation is needed to harmonise how data holders are audited, data is processed and meta data published in the European Health Data Space.

Data quality is more important than ever as technology advances ever more rapidly and the use of data is rapidly increasing for the benefit of public health and healthcare.

Legislation should be used to ensure that data quality assurance is achieved and maintained by the different actors in the data quality process. This is a prerequisite for reliable data that can then be used in research and policymaking.

The latest report of the Joint Action Towards the European Health Data Space (TEHDAS) identifies three aspects of data quality that should be regulated in the upcoming European Health Data Space (EHDS) legislative proposal which is expected to be published in March 2022.

Auditing data holders

The report recommends European legislation on auditing data holders’ procedures on ensuring data quality and that national authorities require these audits based on common European framework (Data Quality Assurance Framework in the European Health Data Space).

The data holder has been defined in Data Governance Act as a legal person or data subject who has the right to grant access to or to share certain personal or non-personal data under its control.

EU-wide implementation of a common framework for data quality would harmonise local, regional, and national systems of collecting and auditing data and thereby facilitate wider use of quality data.

Data processing

To ensure complete transparency in data processing, data holders should be obligated to publish their data preparation procedures. The EHDS legal proposal should define what, when and how the data processing procedures should be published.

Meta data catalogues

The report states that data holders should be obligated to publish meta data about their data collections including information on data origin, the relevance and coverage, the timeliness and how accurate and reliable the information is.

The report also defines several phases in the user journey for cross-border health data sharing that should be subject to EU-wide recommendations.

TEHDAS project continues its work on data quality based on these initial findings. A final concluding document will be published in spring 2022.

Download report