Application timeline
When each part of the Regulation applies, under its Article 105. The secondary-use obligations (Chapter IV), those that concern a data space like this one, apply from 26 March 2029.
Entry into force
Twentieth day following its publication in the Official Journal (5.3.2025), Article 105, first paragraph.
General application
The Regulation applies in general. From Chapter IV, these already apply: notifying the Commission of the designated health data access bodies (Article 55(6)), designating the national contact point for secondary use (Article 75(1)), and the Commission's deadlines to adopt, by that date, the implementing acts on the application and permit templates (Article 70), the secure processing environment (Article 73(5)), HealthData@EU (Article 75(12)), dataset descriptions (Article 77(4)) and the data quality and utility label (Article 78(6)).
Secondary use and first group of priority categories
Chapter IV (secondary use: access bodies, applications and permits) applies. Articles 3 to 15, Article 23(2) to (6), Articles 25, 26, 27 and 47 to 49 apply to patient summaries, electronic prescriptions and electronic dispensations (Article 14(1), points (a) to (c)) and to the EHR systems processing them. The implementing acts under Article 70, Article 73(5), Article 75(12), Article 77(4) and Article 78(6) apply, and, for those categories, those under Article 13(4), Article 15(1), Article 23(4) and Article 36(1).
Second group of priority categories
The same articles apply to medical imaging studies, medical test results and discharge reports (Article 14(1), points (d) to (f)), and to the EHR systems processing them. Chapter III applies to the EHR systems put into service referred to in Article 26(2). Article 51(1), points (b), (f), (g), (m) and (p), applies.
Last provision to apply
Article 75(5) applies.
An amendment to Annex I by delegated act (Article 14(2)) applies one year after the date set in that act, where that date is later than those above (Article 105, third paragraph, point (c)).