The definition of science in the Digital Omnibus
Debate on science versus good science
A new debate is brewing around the proposed Digital Omnibus Act, specifically concerning how the EU should define ‘scientific research’. In a recent paper, Evert-Ben van Veen sharply criticizes the European Commission’s proposed definition and offers an alternative. While I appreciate the critical look at the EC’s drafting, I fundamentally disagree with his proposed solution. In his paper, Van Veen argues that a definition of scientific research should include normative criteria, such as adhering to “applicable regulations” and “generally accepted standards of research integrity,” in order to distinguish “good science from bad science.” From a dogmatic and strategic legal perspective, this is a dangerous conflation of two very different things. Here is why we shouldn’t overload the definition of ‘scientific research’:
Three reasons why not to define like this
1️⃣ Ontology vs. Normativity: Defining what an activity is, is fundamentally different from defining how it should be lawfully executed. We do not need a restrictive, normative definition of “science” to prevent bad data practices.
2️⃣ We already have the regulatory tools: If a researcher wants to use health data unethically or excessively, that project shouldn’t be stopped by claiming “this isn’t science.” It should be stopped because it violates the core principles of the GDPR (proportionality, subsidiarity, purpose limitation), fails ethical committee (METC) reviews, or doesn’t meet the stringent funding criteria of bodies like ZonMw or Horizon Europe.
3️⃣ Academic Freedom: Article 13 of the EU Charter guarantees the freedom of the arts and sciences. If the legislator starts defining ‘science’ based on vague, politically sensitive criteria like contributing to societal “wellbeing” or adhering to fluid “ethical standards”, we risk encroaching on academic freedom. The state regulates the lawful use of data; it should not hold the monopoly on defining what constitutes legitimate knowledge creation.
Let’s keep definitions neutral and rely on the actual legal frameworks (GDPR, EHDS) to ensure compliance.
The EHDS prescribes a comprehensive and uniform assessment by the HDAB. A separate ethical assessment adds nothing and hinders science.
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The EHDS has been in effect for a year. From PFAS to chronic complaints: this is how the reuse of health data works in practice.
