Compromise Note on Health Data Exchange
You are drafting a Council working-party note on a proposed EU regulation on cross-border exchange of health data. Four positions are on the table: Member State A wants mandatory annual audits; Member State B says audits duplicate national checks and wants voluntary peer review; a patient NGO wants public registers of all data requests; industry asks for an 18-month transition. The legal service warns that mandatory audits create new administrative obligations and require an impact assessment not yet available. The presidency wants a compromise text before the next working party in 10 days. You have no mandate to reopen the impact assessment.
1. Draft a neutral summary of the state of play in no more than 100 words.
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Draft summary: Member State A supports mandatory annual audits. Member State B prefers voluntary peer review, arguing that audits duplicate national checks. The patient NGO seeks public registers of all data requests. Industry requests an 18-month transition. The legal service advises that mandatory audits create new administrative obligations and require an impact assessment not yet available. The presidency wants a compromise within 10 days. Main open issues are the audit mechanism, the scope of transparency and the transition length.
Reasoning: the summary records positions without endorsing any, and flags the legal constraint as a fact rather than a preference.
2. What is the main procedural constraint, and what next step do you recommend?
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The main constraint is that mandatory audits cannot be introduced in the text as drafted without the missing impact assessment. Your mandate does not allow you to reopen it.
Recommended next step: ask the legal service, in writing, whether a voluntary peer-review mechanism creates new administrative obligations. In parallel, table a compromise that replaces mandatory annual audits with voluntary peer review plus existing national reporting, and adds a review clause. If the presidency insists on mandatory audits, the impact assessment must be commissioned before the text can proceed.
3. How should the NGO's demand for public registers of all data requests be handled in the note?
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Do not simply accept or reject it. Distinguish transparency of categories, purposes and recipients from publication of every individual request. A register of all requests may disclose personal data or commercially sensitive information. Propose a compromise: publish aggregate statistics and a register of request categories, with a legal check on data protection. Record the NGO's objective as legitimate but flag the scope question for the working party.