Over 45 scientists attended the seminar of March 15th on the changes in the European data protection regime. The purpose was to explain what is certainly coming and what possible changes might be very detrimental to observational research, and to discuss how those possible negative consequences might be averted. Evert-Ben van Veen started with a presentation of the GDPR as it stands now. The presentation, in Dutch, can be downloaded here. The last half hour was dedicated to a discussion about strategies to prevent rigid privacy rules blocking European health research. On-going initiatives, also from patient organisations, were presented and new initiatives were discussed. Some of the conclusions were that researchers should address all three main actors and that the focus should not be on the exemption of informed consent for research but rather on rules which provide for sufficient flexibility to allow observational research to go forward based on a general understanding of the data subjects and their trust, as has been evidenced in empirical research, that data will be used diligently to further health and health care in Europe.

MedLawconsult has a small role as partner in BBMRI-LPC project. BBMRI-LPC sent a letter of concern to the chair of LIBE concerning the proposed General Data Protection Regulation and especially the changes as proposed by LIBE. As the BBMRI-LPC site is still rather rudimentary, the letter can be found here as well.

Op 19 februari heeft het College Bescherming Persoonsgegevens de ‘Richtsnoeren informatiebeveiliging persoonsgegevens’ gepubliceerd. Meer over deze richtlijnen later. Nu al aardig om op te merken dat Graham Kennett de cursus ‘informatiebeveiliging in de zorg’ gaat volgen.

De richtsnoeren gaan voornamelijk in op beveiliging van gegevens die er al zijn maar noemt ook de PIA, de privacy impact assesment. Een PIA heeft veeleer betrekking op het stadium daarvoor: moeten deze persoonsgegevens wel in deze vorm en op deze wijze worden verzameld? Met de NOPROS formule zoals beschreven in de Notitie “Big data en nog grotere misverstanden” reik ik enkele praktische criteria aan voor een PIA. NOPROS staat dan voor ‘noodzakelijk, proportioneel en subsidiair. Dat laatste betekent dat steeds moet worden bezien of ICT niet andere, minder verstrekkende mogelijkheden biedt om het beoogde doel, dat uiteraard rechtmatig moet zijn, te bereiken.

Evert-Ben van Veen

The Seminar on March 15 on the General Data Protection Regulation (GDPR) and the draft proposals of LIBE in this respect, is now fully booked. Regretfully we cannot accept any new entries.
Speaking of the GDPR: the UK Data Protection Authority, the Information Commissioner’s Office (ICO) has issued a detailed analysis of the draft GDPR as proposed by the Commission. ICO’s approach shows a well balanced mix of concerns based on privacy rights and the practical implications of the proposal, and was a very pleasant read after the LIBE report. There are many similarities with my comment on the LIBE draft report but we seem to differ on pseudonymised data and art. 10 of the GDPR. I hope to come back to the latter issues in a scientific publication soon.
Evert-Ben van Veen

Working till the small hours of the night, as there were the needs of paying clients as well, Evert-Ben van Veen finished the report on LIBE’s proposed changes to the General Data Protection Regulation. See under publications. The challenges were, amongst other things, to summarise LIBE’s many pages and sometimes confusing texts into a readable format without omitting anything important and, next to criticism, to indicate briefly what is at present the ethical and practical basis for much public health research in Europe which couldn’t continue under LIBE.

On the 15th of March MedLawconsult will organise a seminar for researchers and patient organisations where the GDPR will be further explained and initiatives to save public health research in Europe will be discussed. Professor Paul van der Maas will chair the seminar.

On 29th January 2013, gave a short presentation at the seminar on the new medical devices regulation. The seminar was organised by TILEC and Lexxion, and Evert-Ben van Veen’s subject was about the relation between PMS and Data Protection. The presentation can be downloaded here.
All the speakers at the seminar were highly critical of the draft General Data Protection Regulation.

Het Rapport ‘Big Data in de Zorg: geheimhouding en privacy’ heeft op een aantal sites nogal de aandacht getrokken. Nuanceringen zijn echter noodzakelijk. Het is bepaald niet zo dat nu mag wat we veelal niet voor mogelijk hielden. Caveats en nuanceringen zijn opgenomen in de onderhavige notitie. Met de slotopmerkingen wordt beoogd in positieve zin bij te dragen aan de verdere discussie over verder gebruik van patiëntgegevens ten behoeve van een houdbaar en solidair systeem van gezondheidszorg.

Evert-Ben van Veen contributed to a ‘Position Paper’ of the EUROCOURSE group on the proposed EU General Data Protection Regulation (DPR). The position is moderately positive about the proposed DPR but sees potential pitfalls for cancer registration and medical research as well. The paper can be found here.
It is interesting to read this paper in conjunction with an earlier paper of this group about the necessity to use detailed data, which hence can never be considered anonymous, for cancer research. That paper is also available here.

De werkconferentie over ‘best practices’ rond de FEDERA Gedragscode ‘Goed Gebruik’ (van lichaamsmateriaal voor wetenschappelijk onderzoek) op 29 juni was een groot succes. Het verslag met de presentaties komt binnenkort op biobanking.nl.

Onze eerste Nieuwsbrief van 2012. Hierin niet alleen informatie over MedLawconsult met recente ontwikkelingen en toekomstige plannen maar ook een bredere blik met commentaar op op dat moment actueel nieuws over privacy in de gezondheidszorg.
Deze nieuwsbrieven worden aan onze relaties gestuurd en na enige tijd hier op onze website geplaatst. Aan de volgende nieuwsbrief wordt al gewerkt.
Wilt u ook onze nieuwsbrief per email ontvangen, laat het ons weten.

On the 24th of November at the EUROCOURSE summit in Brussels Evert-Ben van Veen gave a presentation of the main aspects of his research done for WP 2 of EUROCOURSE and his drive behind such legal research. Several of his main themes came back in those 15 minutes, such as the distinction between interventional and observational research, the prevailing emphasis on autonomy in academic medical law and solidarity and citizenship as counterbalancing values and good research governance.

It’s here finally, our Report on Patient data for health research. For more information click here. (meer…)