CODE OF CONDUCT

Public consultation on the first draft of the EU ‘Code of Conduct for health data sharing and reuse in the medical research sector’

Have your say on the draft Code of Conduct!

The DataTools4Heart Consortium announces the achievement of one of the project’s major milestones: the completion of the first draft of a GDPR Code of Conduct for health data sharing and reuse in the medical research sector.

The document builds on the extensive legal work carried out since the very start of the project, focusing on the interpretation and application of the complex European regulatory landscape – including, among others, the GDPR, the AI Act, and the EHDS – as well as on targeted assessments aimed at identifying the main regulatory gaps and barriers affecting the sharing and, in particular, the reuse of health data. The resulting analyses and proposed solutions have now been consolidated into a single, structured text.

Drawing on the accountability tool provided by Article 40 of the GDPR, which enables the development of agreed sector-specific rules for personal data processing – in this case within scientific and medical research – the Consortium, under the coordination of legal partner Panetta Consulting Group and a team led by Lorenzo Cristofaro, has translated into one operational document a set of proposed solutions addressing some of the most recurrent challenges. Many of these issues have already been examined in major European policy and technical initiatives, including TEHDAS outputs and and Mario Draghi’s report on the future of European competitiveness.

The draft now released does not constitute a fully complete Code of Conduct containing all elements required by the GDPR and will not be submitted for approval to any supervisory authority or to the EDPB. Rather, it is intended as a project legacy output that DataTools4Heart aims to make available – at the project’s conclusion in October 2026 – to sector operators and the scientific community, as a foundation for further initiatives and future developments.

In this spirit, all stakeholders who may be interested or impacted are invited to submit comments, feedback, suggestions and contributions on the draft by 30 June 2026, enabling the Consortium to prepare a second and final consolidated version of the Code of Conduct.

To share your feedback, please:

• download the document available at this link;
• send your inputs to office@panetta.it;
• use “DataTools4Heart Code of Conduct” as the subject of the email.

Please note that any contributions consisting of revisions to the document will only be considered if made using track-changes mode.