In the first article of this triptych it was discussed that a so-called "non-medically substantive last amendment to the medical file" cannot result in the file being allowed or required to be kept longer than the standard period of 20 years. Renewal under the regulation of Article 7:454(3) of the Civil Code is only applicable when there are medical-substantive reasons for doing so that concern the patient.
Article 7:455(2) BW.
The legal regulation on the medical treatment agreementBook 7, Title 7, Section 5.
, commonly referred to as WGBOMedical Treatment Agreement Act.
, does not contain a general stipulation that the file may be kept longer for the interests of someone other than the patient. After all, the aforementioned "retention article" 7:454 (3) of the Dutch Civil Code, only mentions good care providership as a reason to keep the file longer, and this concept, given the nature and content of the medical treatment agreement, refers to the patient-provider relationship.This follows from the coherence of article 7:446 paragraph 1 BW and article 7:454 paragraph 1 BW. See also below, paragraph 1.
Parliamentary Papers II 1989/1990, 21561, no. 3
According to the Health Council, which published a thorough analysis of the retention period and regulations of the WGBO in 2004, it is clear from the wording of the provisions concerning the file and retention obligation that these relate to the person from whom the data have been obtained, for the patient's own health interests, i.e. the patient himself. Good care providership under Article 7:453 of the Civil Code relates exclusively to them. 'A possible health interest of relatives has the character of a "third party interest", which in principle offers no ground for longer retention'.Health Council. Patient data retention period. The Hague: Health Council of the Netherlands, 2004; publication no. 2004/08, p. 72
In the subsequent 2006 legislative amendment that changed the record retention period from 10 to 15 years, the legislature took this analysis as its starting point.Parliamentary Papers II, 2004/2005, 30049, no. 3, p. 3.
And with regard to the later extension of the retention period from 15 to 20 years, the legislature noted that it was intended solely to serve the patient's own interests. In short, it follows from the statutory retention rule and legislative history that the medical record is not for the benefit of relativesThe Health Council indicates that even if such a retention requirement did apply, it should be the interests of identifiable relatives and not the potential interest of future family members. Ibidem, p. 73.
of the patient, such as in connection with hereditary diseasesThird interests could include, for example, non-disease-related heredity or parentage questions.
, may be kept longer than the standard 20-year period. The KNMG Guideline on Dealing with Medical Data (the Guideline) is consistent with this conclusion.KNMG Guideline on Handling Medical Data, KNMG, 2024, chapter 8.
By adding in paragraph 3 of article 7: 454 BW that medical records must be kept as long as a person other than the patient has a compelling health interest in doing so
from the 2004 Health Council to make that legal and to equalize the retention and destruction regulations on that pointHealth Council, ibidem, p. 95.
, should finally be seriously considered in the next amendment of the WGBO.Health Council, ibidem, p. 74.
Article 7:455(2) BW.
The legal regulation on the medical treatment agreementBook 7, Title 7, Section 5.
, commonly referred to as WGBOMedical Treatment Agreement Act.
, does not contain a general stipulation that the file may be kept longer for the interests of someone other than the patient. After all, the aforementioned "retention article" 7:454 (3) of the Dutch Civil Code, only mentions good care providership as a reason to keep the file longer, and this concept, given the nature and content of the medical treatment agreement, refers to the patient-provider relationship.This follows from the coherence of article 7:446 paragraph 1 BW and article 7:454 paragraph 1 BW. See also below, paragraph 1.
Parliamentary Papers II 1989/1990, 21561, no. 3
According to the Health Council, which published a thorough analysis of the retention period and regulations of the WGBO in 2004, it is clear from the wording of the provisions concerning the file and retention obligation that these relate to the person from whom the data have been obtained, for the patient's own health interests, i.e. the patient himself. Good care providership under Article 7:453 of the Civil Code relates exclusively to them. 'A possible health interest of relatives has the character of a "third party interest", which in principle offers no ground for longer retention'.Health Council. Patient data retention period. The Hague: Health Council of the Netherlands, 2004; publication no. 2004/08, p. 72
In the subsequent 2006 legislative amendment that changed the record retention period from 10 to 15 years, the legislature took this analysis as its starting point.Parliamentary Papers II, 2004/2005, 30049, no. 3, p. 3.
And with regard to the later extension of the retention period from 15 to 20 years, the legislature noted that it was intended solely to serve the patient's own interests. In short, it follows from the statutory retention rule and legislative history that the medical record is not for the benefit of relativesThe Health Council indicates that even if such a retention requirement did apply, it should be the interests of identifiable relatives and not the potential interest of future family members. Ibidem, p. 73.
of the patient, such as in connection with hereditary diseasesThird interests could include, for example, non-disease-related heredity or parentage questions.
, may be kept longer than the standard 20-year period. The KNMG Guideline on Dealing with Medical Data (the Guideline) is consistent with this conclusion.KNMG Guideline on Handling Medical Data, KNMG, 2024, chapter 8.
By adding in paragraph 3 of article 7: 454 BW that medical records must be kept as long as a person other than the patient has a compelling health interest in doing so
from the 2004 Health Council to make that legal and to equalize the retention and destruction regulations on that pointHealth Council, ibidem, p. 95.
, should finally be seriously considered in the next amendment of the WGBO.Health Council, ibidem, p. 74.
There may even be the opposite.From my own practice as a hospital lawyer, I recall the destruction request of a patient who wanted the designation "mentally unstable" removed from the record. She indicated that this no longer applied to her v There may even be evidence to the contrary.
From my own practice as a hospital lawyer, I remember a patient's request to have the designation "mentally unstable" removed from the file. She indicated that this no longer applied to her, but that this designation caused the cause of her physical complaints to be wrongly sought on the psychological plane. As a result, there had been a late correct diagnosis.
It also follows from the content and nature of the medical treatment agreement. Pursuant to Article 7:446(1) of the Civil Code, the care provider has undertaken to perform "acts in the field of medicine, directly related to the patient. The medical treatment agreement is a species of assignment agreement, which means that the care provider has to comply with the specifically formulated assignment mentioned.Asser/Tjong Tjin Tai 7-IV 2022/83
In my opinion, this is not met when the medical file is kept (longer) for a purpose other than medical treatment concerning the patient, such as scientific research. And because retention for a longer period of time carries additional privacy risks for the patient, however theoretical they may be, the caregiver would not meet the standard of good caregiver conduct for that reason either.Article 7:453 BW.
Thus, it also does not follow from the legal retention regulationsthat medical records may be kept for the purpose of scientific research longer than the standard 20-year period. The Directive does not comment on this issue.Article 5(1)(c) AVG.
Problem with this, however, is that sometimes it is only with the passage of time based on advancing insight that it becomes clear that data are relevant to a medical examination.Cf. Health Council, ibidem, p. 64.
In view of this phenomenon inherent to (medical) science, should, as the Health Council advocates, long retention periods be chosen by default?Health Council, ibidem, p. 91
There are several advantages and disadvantages to both situations from an information security perspective.
The data stored in the examination file do not fall under the description of Article 7:454 (2) of the Civil Code regarding the medical file and are therefore not part of it. With respect to this data, a specific, for the concerning scientific research necessary retention period must be established. 'Concerning'; in particular from article 7:458 paragraph 1 sub b. and paragraph 2 sub b. BW reveal that article 7:458 BW does not constitute a licence to provide patient data for scientific research in the field of public health in general - thus also for future research. After all, the test that must be carried out on the basis of the two paragraphs, 'nature and purpose of the research' and 'the research cannot be carried out without the data in question' respectively, cannot but relate to a specific research.Thanks to colleague Jantien Hovingh for reading along and for the critical question on this.
The Directive does seem to imply this but could provide more clarity on this.Health Research Code of Conduct January 2022, Research Regulatory Commission Foundation, COREON, pp. 155 and 156.
Reference is then made to the statutory custody provision of Article 7:454 (3) of the Civil Code.Health Council, ibidem, p. 94.
In today's age of providing health data for international scientific research worldwideSee, for example, Laura Bradford, Mateo Aboy, Kathleen Liddell, International transfers of health data between the EU and USA: a sector-specific approach for the USA to ensure an 'adequate' level of protection, Journal of Law and the Biosciences, Volume 7, Issue 1, January-June 2020, lsaa055, https://doi.org/10.1093/jlb/lsaa055
, information and transparency obligations will also need to pay due attention to this.Directive, ibidem, p. 39.
Under Article 7:468 of the Civil Code, it is possible (within the framework of professional guidelines) to interpret the medical treatment agreement in favor of the patient.
and that the basis is in any case good counseling. After all, being a good social worker also implies that the social worker adheres to the professional standard applicable to him or her, and the Guideline is part of that.Article 7:453 BW.
