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. 2022 May 25;9(2):e30050. doi: 10.2196/30050

Table 9.

Legal requirement used in the study.

No Requirement Count, n (%) Reference
1 GDPRa 13 (21.67) [16,78-82,88-94]
2 Directive 95/46/EC 10 (16.67) [65,70,71,74,75,95-99]
3 Norwegian Personal Health Data Filing System Act 3 (5) [16,100,101]
4 Act relating to Patients’ Rights 2 (3.33) [16,101]
5 Act relating to the Processing of Personal Data 2 (3.33) [16,101]
6 Directive 2011/24/EU on patients’ rights in cross-border health care 2 (3.33) [73,90]
7 Health Care Personnel Act 2 (3.33) [16,101]
8 Act relating to Public Supervision of the Health Service 1 (1.67) [101]
9 Data protection and privacy in electronic communications—e-Privacy Directive 1 (1.67) [75]
10 Directive 2002/58/EC 1 (1.67) [65]
11 Directive 2009/136/EC 1 (1.67) [74]
12 Directive 99/93/EC 1 (1.67) [75]
13 EU regulation and compliance of national and transborder data flows 1 (1.67) [89]
14 GEHRb/CENc standards ENVd 12265 and ENV 13606 1 (1.67) [102]
15 Good Clinical Practice 1 (1.67) [71]
16 Health Research Act 1 (1.67) [16]
17 IECe 80001-1:2010 1 (1.67) [97]
18 ISOf 27001 1 (1.67) [89]
19 Medical Device Regulation 2017/745 of EU 1 (1.67) [41]
20 Ministry Of Government Administration, Reform and Church affairs’ Requirements specification for PKIg for the public sector 1 (1.67) [65]
21 Penal Code 1 (1.67) [41]
22 Recommendation CM/Rec(2019)2 of the Committee of Ministers to member States on the protection of health-related data 1 (1.67) [76]
23 Recommendation No. R (97) 5 of the Committee of Ministers to Member States on the Protection of Medical Data 1 (1.67) [77]
24 Regulation 2014/910 (the “eIDAS Regulation”) 1 (1.67) [103]
25 Regulation of the Minister of Health of the Republic of Indonesia Number 269/2008 on Medical Record 1 (1.67) [83]
26 Regulations relating to the Processing of Personal Data 1 (1.67) [101]
27 The Ghana Health Services Patient’s Charter 1 (1.67) [104]
28 The Ghana National Health Insurance Regulations of 2004 1 (1.67) [104]
29 The National Identification Authority Act 707 1 (1.67) [104]
30 The Republic of Ghana’s constitution 1 (1.67) [104]
31 The Universal Declaration of Human Rights 1 (1.67) [104]
32 UNDANG-UNDANG No.36/2009 and Pasal 103 ayat 1 1 (1.67) [105]
33 Undang-undang republik, Indonesia nomor 29, Tahun 2004 tentang, Praktik kedokteran 1 (1.67) [106]

aGDPR: General Data Protection Regulation.

bGEHR: Good European Health Record.

cCEN: European Committee for Standardization.

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

eIEC: International Electrotechnical Commission.

fISO: International Organization for Standardization.

fPKI: public key infrastructure.