Table 7.

Legal documents from the EU^a.

No	Legal document	Type
1	Penal Code [41,69]	Case law
2	Directive 95/46/EC	Directive [70,71]
3	NISb Directive	Directive [72]
4	The directive on patients’ rights in cross-border health care (Directive 2011/24)	Directive [73]
5	Directive 2009/136/EC amending Directive 2002/58/EC (Privacy Directive)	Directive
6	Data Protection and Privacy in Electronic Communications—e-Privacy Directive (it replaces Directive 97/66/EC) [74]	Directive
7	Directive 99/93/EC	Directive [75]
8	The Patients’ Rights Directive (2011/24/EU) [73]	Directive
9	Recommendation CM/Rec(2019)2 of the Committee of Ministers to member states on the protection of health-related data [76]	Guidelines
10	GCPc	Guidelines [71]
11	Recommendation No. R (97) 5 of the Committee of Ministers to Member States on the Protection of Medical Data	Recommendation [77]
12	GDPRd [16,78-83]	Regulation
13	EU regulation and compliance of national and transborder data flows	Regulation
14	Medical Device Regulation 2017/745 of EU [41]	Regulation
15	Regulation 2014/910 (the eIDASe Regulation) [78]	Regulation
16	A European standardization group for Security and Privacy of Medical Informatics (CEN TC 251/WG6f) [84,85]	Standard
17	GEHRg/CENh standards ENVi 12265 and ENV 13606 [86,87]	Standard

^aEU: European Union.

^bNIS: Network and Information Security.

^cGCP: Good Clinical Practice.

^dGDPR: General Data Protection Regulation.

^eeIDAS: electronic identification and trust services.

^fCEN TC 251/WG6: Commission for European Normalization Technical Committee/Working Group 6.

^gGEHR: Good European Health Record.

^hCEN: European Committee for Standardization.

ⁱENV: Electronic Healthcare Record Communication for the exchange of electronic health records.