Processing of personal data in swedish health care and biomedical research

Implementation of the Data Protection Directive in Relation to Medical Research in Europe

Volumn , Issue , 2017, Pages 381-402

  Rynning, Elisabeth ^a  

^a UPPSALA UNIVERSITY   (Sweden)

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[No Author keywords available]

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EID: 85082444300     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.4324/9781351155960-26     Document Type: Chapter

References (46)

1. Ministry of Justice, Personal Data Protection: Information on the Personal Data Act (Stockholm: Ministry of Justice, 1999), 7.
2. S. Öman and H-O. Lindblom, Personuppgiftslagen-en kommentar (2nd edn., Stockholm: Norstedts Juridik, 2002), 318-319;
3. Parliamentary Report (SOU 1997:39) Integritetoffentlighet - informationsteknik, (Stockholm: Fritzes, 1997), 453 and the Government Bill Regeringens proposition 1997/98:44 Personuppgiftslag,110-111.
4. S. Öman and H-O. Lindblom, n. 5 above, 320.
5. Government Bill 1997/98:44, n. 5 above, 147.
6. Parliamentary Report (SOU 1997: 39), n. 5 above, 457-458.
7. Parliamentary Report (SOU 1997:39), n. 5 above, 458
8. Ordinances (2001: 707-709).
9. Government Bill Regeringens proposition 200212003:50 Etikprovning av forskning, based on Ministerial report DS 2001: 62 Etikprovning av forskning som omfattar miinniskor.
10. See the Ministerial report Genomforande av EG-direktivet om kliniska provningar (Stockholm: The Department of Health and Social Affairs, 2003).
11. Samtycke enligt personuppgiftslagen, Datainspektionen informerar (2003) (Stockholm: Data Inspection Board), 10.
12. S. Öman and H-O. Lindblom, n. 5 above, 61-62.
13. Data Inspection Board, Samtycke enligt personuppgiftslagen, Datainspektionen informerar (Stockholm: The Data Inspection Board, 2003), 9-10.
14. S. Öman and H-O. Lindblom, n. 5 above, 126.
15. S. Öman and H-O. Lindblom, n. 5 above, 96;
16. Parliamentary Report (SOU 1 997:39), n. 5 above, 253.
17. S. Öman and H-O. Lindblom, n. 5 above, 97;
18. Parliamentary Report (SOU 1 997:39), n. 5 above, 160.
19. S. Öman and H-O. Lindblom, n. 5 above, 197.
20. S. Öman and H-O. Lindblom, n. 5 above, 188;
21. Parliamentary report (SOU 1999: 105), 387.
22. Data Inspection Board, Information till registrerade enligt personuppgiftslagen. Datainspektionens allmiinna rad (Stockholm: The Data Inspection Board, 2000), 14.
23. S. Öman and H-O. Lindblom, n. 5 above, 150.
24. S. Öman and H-O. Lindblom, n. 5 above, 154.
25. E. Rynning, ‘Patientuppgifter som forskningsresurs-om integritetsskydd och intresseavviigningar’ (Patient data as resources for research-on privacy rights and the balancing of interests) (2003) Forvaltningsriittslig tidsskrift (Journal of Administrative Law) 95-126, at 115-116.
26. See Government Bills: Regeringens proposition 1 997198: 108 Hiilsodata-och w’lrdregister, 82-84 and Regeringens proposition 1 998/99: 72 Riittspsykiatriskt forskningsregister, 49-51.
27. S. Öman and H-O. Lindblom, n. 5 above, 146-149
28. R. Petersson, and K. Reinholdsson, n. 26 above, 112. See also the Government Bill 1 997/98: 108, n. 48 above, 31.
29. E. Rynning, n. 42 above, 116-120.
30. See also E. Rynning, ‘Public law aspects on the use of biobank samples-privacy versus the interests of research’, in M. G. Hansson and M. Levin (eds.), Biobanks as resources for health (Uppsala: Uppsala University, 2003), 91-128, at 6120 0-101.
31. G. Regner, M. Eliasson, and S. Heuman, Sekretesslagen-en kommentar (Stockholm: Norstedts Juridik, 2002), III: 14-15.
32. For a somewhat different interpretation of the concept of harm, see U. von Essen, ‘Focusing on personal integrity violation-legal guidelines for ethical practice’ in M.G. Hansson and M. Levin (eds.), Biobanks as resources for health (Uppsala: Uppsala 6U8 niversity, 2003), 129-148, at 138-140.
33. See E. Rynning, n. 42 above, 95-126.
34. See The Swedish Medical Research Council, Guidelines for Ethical Evaluation of Medical Research Involving Human Subjects: The policy and organization of research ethics in Sweden (Report 2, Stockholm: Medicinska Forskningsradet 1996 and the English translation 1 999)
35. E. Rynning, ‘The Regulation of Neonatal Research in Sweden’, in S. Mason an d C. Megone (eds.) European Neonatal Research-Consent, ethics committees and law (Aldershot: Ashgate Publishing, 2001) 167-183, at 176-178.
36. See also Government Bill Regeringens proposition 2002103:50 Etikprovning av forskning, 37-40
37. E. Rynning ‘Etisk granskning av medicinska humanforskningsprojekt-lagstiftning behö!' (Ethics review of biomedical research involving humans-a call for legislation !, Liikartidningen 1997: 1771-1774.
38. In these cases, the confidentiality provisions of the Act on Professional Activities in Health and Medical Services are not applicable, see E. Rynning, ‘Biobankema-hog tid for bankinspektion?' (The Biobanks-High Time for Bank Inspection?) Forvaltningsriittslig Tidskrift (1998) 303-333, at 330 and 333.
39. Government Bill Regeringens proposition 2001102:44 Biobanker inom hiilso-och sjukvarden m.m., 32.
40. E. Rynning, no. 61 above, 105-108 and 115-116.
41. Government Bil1 2001102:44, n. 86 above, 31.
42. See for example the Research Directorate-General, Directorate E, Biotechnology, Agriculture and Food ‘Survey on opinions from National Ethics Committees or similar bodies, public debate and national legislation in relation to human Biobanks’ in L. Mathiessen (ed.), Biobanks (Brussels: European Commission, October 2002 update).
43. E. Rynning, n. 61 above, 110-111.
44. E. Rynning, n. 85 above, 326-328.
45. E. Rynning, n. 85 above, 328, footnote 92. The Swedish National Board of Health and Welfare is at present investigating a case where the national so-called PKU biobank released a sample to the police, who were looking to identify a suspect of the recent murder of Swedish Foreign Minister Anna Lindh. The case has caused a vivid public debate concerning the justifiability of such use of samples from the PKU biobanks.
46. E. Rynning, n. 61 above, 103-105. See also the letter to the Swedish Parliament’s Committee on Health and Welfare (Riksdagens socialutskott) 7 March 2002, concerning the Goverment Bill 2001102:44 on Biobanks in health care.