EHDS, Article 105, SE

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall apply from 26 March 2027.

However, Articles 3 to 15, Article 23(2) to (6), Articles 25, 26, 27, 47, 48 and 49 shall apply as follows:

(a)

from 26 March 2029 to priority categories of personal electronic health data referred to in Article 14(1), points (a), (b) and (c), and to EHR systems intended by the manufacturer to process such categories of data;

(b)

from 26 March 2031 to priority categories of personal electronic health data referred to in Article 14(1), points (d), (e) and (f), and to EHR systems intended by the manufacturer to process such categories of data;

(c)

from one year from the date established in a delegated act to be adopted pursuant to Article 14(2) for each amendment of the main characteristics of personal electronic health data set out in Annex I, provided that that date is subsequent to the date of application referred to in points (a) and (b) of this subparagraph for the categories of personal electronic health data concerned.

Chapter III shall apply to EHR systems put into service in the Union referred to in Article 26(2) from 26 March 2031.

Chapter IV shall apply from 26 March 2029. However, Article 55(6), Article 70, Article 73(5), Article 75(1) and (12), Article 77(4) and Article 78(6) shall apply from 26 March 2027; Article 51(1), points (b), (f), (g), (m) and (p), shall apply from 26 March 2031; and Article 75(5) shall apply from 26 March 2035.

The implementing acts referred to in Article 13(4), Article 15(1), Article 23(4) and Article 36(1) shall apply from the dates referred to in the third paragraph of this Article depending on the categories of personal electronic health data referred to in Article 14(1), points (a), (b) and (c), or Article 14(1), points (d), (e) and (f), respectively.

The implementing acts referred to in Article 70, Article 73(5), Article 75(12), Article 77(4) and Article 78(6) shall apply from 26 March 2029.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Official source

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