Table 3. Main involved legislations, regulations and recitals.
GDPR=General Data Protection Regulation.
| Europe | GDPR–specific
articles and recitals |
Portugal | Finland | Norway | The Netherlands |
|---|---|---|---|---|---|
| General Data
Protection Regulation (GDPR)- Regulation of the EU 2016/679 |
Article 4/2 GDPR;
Article 4/5 GDPR; Article 4(11) GDPR; Article 4(13) GDPR; Article 4(14) GDPR; Article 4(15) GDPR |
58/2019 Act,
August 8, 2019; Article 31/4 of 58/2019 Act August 8 2019 |
Act on the
Secondary Use of Health and Social Data (552/2019), March 13, 2019 |
Act of 15 June 2018 No.
38 on personal data (Personal Data Act) Lov om behandling av personopplysninger (personopplysningsloven) |
General Data
Protection Regulation Implementation Act, May 25, 2018 “Uitvoeringswet Algemene Verordening Gegevensbescherming” (UAVG) |
| Article 16 of the
Treaty on the Functioning of the European Union, 2000 |
Article 6 GDPR;
Article 6(1) GDPR; Article 6(1)(a) GDPR Article 6/1 b)-c) GDPR; Article 6(1)(e) GDPR; Article 6(1)(f) GDPR; Article 6(2) GDPR; 6(1)(e) GDPR |
Article 80 of
Portuguese Civil Code, 1966 |
Data Protection
Act (1050/2018), December 5, 2018 |
Act of 20 June 2008
No. 44 on Medical and Health Research (Health Research Act) Lov om medisinsk og helsefaglig forskning (helseforskningsloven) |
Aanpassingswet
Algemene Verordening Gegevensbescherming, May 25, 2018 |
| Recommendation
CM/Rec (2019)2 of the Committee of Ministers to member states on the protection of health- related data |
Article 9 GDPR;
Article 9/1 GDPR; Article 9/1/a) GDPR; Article 9(2) GDPR; Article 9/2/i) GDPR; Article 9(2)ij) GDPR; Article 9(2)(h) GDPR; Article 9(2)(j) GDPR; Article 9/1/a) GDPR; Article 9/2/g GDPR; Article 9/2/i) GDPR; Article 9(4) GDPR |
Constitution of
the Portuguese Republic, 1976; Article 35 Constitution of Portugal, April 10, 1976 |
Act 556/1989 | Act of 28 April 2017
No. 23 on Ethics and Integrity in Research (Research Ethics Act) Lov om organisering av forskningsetisk arbeid (forskningsetikkloven) |
Afdeling 5 van Boek 7
BW |
| Recommendation
No. R(97) 18 of Council of Europe |
Article 86 GDPR | Organization
and Functioning of the National Commission of data protection – 43/2004 Act, August 18, 2004 |
Laki sosiaali- ja
terveystietojen toissijaisesta käytöstä, 552/2019 |
Act of 15 June 2018 No.
38 on personal data (Personal Data Act) Lov om behandling av personopplysninger (personopplysningsloven) |
Article 7:457 lid 3 BW |
| Recommendation
CM/Rec (2010)13 adopted by the Committee of Ministers of the Council of Europe on November 23, 2010 |
Recital 159 GDPR | Personal genetic
information and health information – 12/2005 Act, January 26, 2005 |
Section 2, Act on
the Openness of Government Activities (621/1999 |
Act of 20 June 2014 No.
43 on Personal Health Data Filing Systems and the Processing of Personal Health Data (Personal Health Data Filing System Act) Lov om helseregistre og behandling av helseopplysninger (helseregisterloven) |
Article 7:458 BW |
| Convention for
the processing of individuals with regard to Automatic Processing of Personal data |
Recital 26 GDPR | 21/2014 Act,
April 16, 2014- legal regime of clinical research |
Laki
viranomaisten toiminnan julkisuudesta, 621/1999 |
Act of 1 January 2021
No. 133 on Amendment in Personal Health Data Filing System Act / Lov om endringer i helseregisterloven m.m |
Kamerstukken 31765 |
| Article 2/b) of
the Modernised Convention for the protection of individuals on processing of Personal data, of the 18th of May 2018 |
Article 89(1) GDPR;
Article 89/2 GDPR |
26/2016 Act,
August 22, 2016 |
Tietosuojalaki,
1050/2018 (Data Protection Act (1050/2018)) |
Act of 21 June 2019 No.
32 relating to official statistics and Statistics Norway (Statistics Act) Lov om offisiell statistikk og Statistisk sentralbyrå (statistikkloven) |
Article 41 Wet op het
Centraal Bureau voor Statistiek |
| Regulation (EC)
No 1338/2008, December 16, 2008 |
Article 5(1) (b) GDPR ;
Article 5/e) GDPR; Article 5 (2) GDPR |
Regulation
no. 1/2018 by the National commission of data protection, October 16, 2018 |
Section 1, Data
Protection Act (1050/2018), January 1, 2019 |
Regulation on medical
quality health registers - Forskrift om medisinske kvalitetsregistre, of June 21 2019, entered into force on September 01, 2019 |
Article 7:465 BW |
| Paragraph 1 of
Recommendation No. R (97) 18, September 30, 1997 |
Article 8 GDPR;
Article 8 (1) |
Article 31/4 of
Law nº 58/2019 Act, August 8, 2019, The Portuguese Data Protection Act |
Laki
lääketieteellisestä tutkimuksesta, 488/1999 (Medical Research Act (488/1999)) |
Act of 20 June 2008
No. 44 on Medical and Health Research (Health Research Act) Lov om medisinsk og helsefaglig forskning (helseforskningsloven) |
Article 5, GDPR Dutch
implementing Act |
| Article 3/c) of
Regulation (EC) no. 1338/2008, December 16, 2008 |
Article 35 GDPR;
Article 35/1 and 2 GDPR; Article 35/3/b GDPR |
Law nº 21/2014,
of 16 April |
Section 2(1) of
Medical Research Act (488/1999) October 1, 2010 |
Forskrift om barn mellom
12 og 16 år sin rett til selv å samtykke til deltakelse i medisinsk og helsefaglig forskning |
Article 46 Dutch
implementing Act |
| Paragraph 3.3 of the
Recommendation No. R (97)18, September 30, 1997 |
Article 36 GDPR;
Article 36(9) GDPR |
Law nº. 12/2005
of 26 January on Personal genetic information and health information. |
Section 6, Medical
Research Act (488/1999), October 1, 2010 |
Act of 20 June 2014 No.
43 on Personal Health Data Filing Systems and the Processing of Personal Health Data (Personal Health Data Filing System Act) Lov om helseregistre og behandling av helseopplysninger (helseregisterloven) |
|
| Paragraph 6 of
Recommendation CM/Rec (2019)2, March 27, 2019 |
Recital 32 GDPR | Decree-Law No.
97/95, May 10 |
Section 44, Act
on the Secondary Use of Data (552/2019) |
Statistics act §14, Act
of 21 June 2019 No. 32 relating to official statistic and Statistics Norway (Statistics Act). |
|
| Working Party (A29WP) | Recital 40 GDPR | Law nº 81/2009,
of 21 of August |
Act of 21 June 2019 No.
32 relating to official statistics and Statistics Norway (Statistics Act) of 21 June 2019 Lov om offisiell statistikk og Statistisk sentralbyrå (statistikkloven) |
||
| Paragraph 6 of
Recommendation CM/Rec (2019)2, March 27, 2019 |
Recital 162 GDPR | Law nº 53/2017
of 14 July |
Regulations to the
Statistics Act/ Forskrift til statistikkloven av Dec 11th 2020 No 2731 (FOR-2020-12-11-2731) Forskrift til statistikkloven (statistikkforskriften) |
||
| Article 3/c) of
Regulation (EC) no. 1338/2008 |
Recitals 33 GDPR | Law 22/2008, of
13 May |
Act of 1 January 2021
No. 133 on Amendment in Personal Health Data Filing System Act / Lov om endringer i helseregisterloven m.m. |
||
| Regulation (EU)
2016/679 of the European Parliament and of the Council, April 27, 2016 |
Recital 50 GDPR | Article 124 of
Portuguese Civil Code |
Act of 20 June 2008
No. 44 on Medical and Health Research (Health Research Act) Lov om medisinsk og helsefaglig forskning (helseforskningsloven) |
||
| Regulation
(EU)2018/1725; Article 29 |
Recital 54 GDPR | Article 8º / 3,
Decree Law nº 131/2014 of 29 of August |
Act of 20 June 2014 No.
43 on Personal Health Data Filing Systems and the Processing of Personal Health Data (Personal Health Data Filing System Act) Lov om helseregistre og behandling av helseopplysninger (helseregisterloven) |
||
| 43/2004 Act | Recital 32 GDPR | Article 6/3
''Código dos regimes contributivos do sistema previdencial de segurança social'' |
Health Research Act §17,
§9 and 10 |
||
| Article 4/3 of
12/2005 |
Recital 157 GDPR | 14/2013 Decree-
law, January 28, 2013; |
Forskrift om barn mellom
12 og 16 år sin rett til selv å samtykke til deltakelse i medisinsk og helsefaglig forskning |
||
| Recital 159 GDPR | Article 99/1 of
the 4/2007 Act, January 16, 2007 |
||||
| Recital 4 GDPR | Article 3/1 of the
'Despacho n.º 1774-A/2017, February 24, 2017 |
||||
| Article 6/5, of
22/2008 Act, of 13 May |
|||||
| Article 2º of
22/2008 Act, of 13 May |
|||||
| Article 62/2 of
58/2019 Act August 8, 2019 |
|||||
| Article 9, Law
53/2017, of 14 July |
|||||
| Article 16, Law
53/2017, of 14 July |
|||||
| Article 13, Law
53/2017, of 14 July which Creates and regulates the National Cancer Registry (National Oncologic Registry Act) |
|||||
| Article 1/1 of
21/2014 Act, April 16, 2014 |
|||||
| Article 6 of the
21/2014 Act, April 16, 2014; Article 6/1/b) and Article 6/1/d) of the 21/2014 Act, April 16, 2014; Article 6/1/e) of 21/2014 Act, April 16, 2014 |
|||||
| Article 16/1 of
the 21/2014 Act, April 16, 2014 |
|||||
| Article 35 GDPR
and Regulation 1/2018 CNPD |
|||||
| Article 4/4 of
12/2005 Act, January 26, 2005 |
|||||
| Article 124 of
Portuguese Civil Code |
|||||
| Official Gazette
No. 274/1966 |
|||||
| Decree-Law No.
47344 |
|||||
| Decree-Law No.
97/95, May 10 |
|||||
| Article 4/3 of
12/2005 Act, January 15, 2005 |