HTA Coordination Group Adopts Guiding Principles on Data Transparency
The Member State Coordination Group on Health Technology Assessment (HTA CG) has adopted a new document titled “Guiding Principles on Data Transparency” pursuant to Regulation (EU) 2021/2282 on Health Technology Assessment (HTAR). The document was adopted on 14 May 2026.
According to the HTA CG, the document provides general principles for assessing confidentiality requests submitted by health technology developers in the context of Joint Clinical Assessments (JCAs) and Joint Scientific Consultations (JSCs).
The guidance applies to medicinal products, medical devices, and in vitro diagnostic medical devices that fall within the scope of HTAR Article 7.
Commercially Confidential vs Non-Confidential Information
The document states that commercially confidential information refers to information that is not publicly available, where disclosure may undermine the legitimate economic interests of the health technology developer and where there is no overriding public interest in disclosure.
Examples of information that may be considered commercially confidential include:
trade secrets,
formulas and proprietary processes,
unpublished aspects of CE marking,
patents,
chemical structures and analytics,
and company development plans.
The HTA CG also states that the following information is generally considered non-confidential:
information already in the public domain,
clinical trial methodologies,
clinical trial results and other clinical data,
patient characteristics,
efficacy and safety data,
health-related quality of life data,
and evidence synthesis approaches.
Publication of Joint Clinical Assessment Documentation
The document reiterates that Joint Clinical Assessment reports, summary reports, and the underlying dossiers will be published on the HTA IT platform after completion of the assessment process.
For medicinal products, publication will occur after the granting of marketing authorisation by the European Commission.
For medical devices and in vitro diagnostic medical devices, the document states that joint clinical assessments will only take place after the devices have been placed on the market, in accordance with Implementing Regulation (EU) 2025/2086.
Confidentiality Justifications
The guidance also refers to Article 11(5) of HTAR 2021/2282, under which health technology developers must identify information they consider confidential and justify its commercially sensitive nature.
In addition, the document references Implementing Regulation (EU) 2024/1381, which describes the process by which the European Commission assesses confidentiality requests before publication of documentation related to joint clinical assessments.
Read the full document below.
