Data & Privacy
AI & Trust
Cybersecurity
Digital Services & Media
CHAPTER I
GENERAL PROVISIONSArticles 1 — 2
CHAPTER II
PRIMARY USEArticles 3 — 24
CHAPTER III
EHR SYSTEMS AND WELLNESS APPLICATIONSArticles 25 — 49
CHAPTER IV
SECONDARY USEArticles 50 — 81
CHAPTER V
ADDITIONAL ACTIONSArticles 82 — 91
CHAPTER VI
EUROPEAN GOVERNANCE AND COORDINATIONArticles 92 — 96
CHAPTER VII
DELEGATION OF POWERS AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER VIII
MISCELLANEOUSArticles 99 — 104
CHAPTER IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
ANNEXES
The technical documentation referred to in Article 37 shall contain at least the following information, as applicable to the harmonised software components of an EHR system in the relevant EHR system:
A detailed description of the EHR system including:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
A detailed description of the system in place to evaluate the EHR system performance, where applicable.
The references to any common specification used in accordance with Article 36 and in relation to which conformity is declared.
The results and critical analyses of all verifications and validation tests undertaken to demonstrate conformity of the EHR system with the requirements laid down in Chapter III, in particular the applicable essential requirements.
A copy of the information sheet referred to in Article 38.
A copy of the EU declaration of conformity.