Recommendations for Creating Codes of Conduct for Processing Personal Data in Biobanking Based on the GDPR art.40

Abstract

Personal data protection has become a fundamental normative challenge for biobankers and scientists researching human biological samples and associated data. The General Data Protection Regulation (GDPR) harmonises the law on protecting personal data throughout Europe and allows developing codes of conduct for processing personal data based on GDPR art. 40. Codes of conduct are a soft law measure to create protective standards for data processing adapted to the specific area, among others, to biobanking of human biological material. Challenges in this area were noticed by the European Data Protection Supervisor on data protection and Biobanking and BioMolecular Resources Research Infrastructure–European Research Infrastructure Consortium (BBMRI.ERIC). They concern mainly the specification of the definitions of the GDPR and the determination of the appropriate legal basis for data processing, particularly for transferring data to other European countries. Recommendations indicated in the article, which are based on the GDPR, guidelines published by the authority and expert bodies, and our experiences regarding the creation of the Polish code of conduct, should help develop how a code of conduct for processing personal data in biobanks should be developed.

UPO Biobank: The Challenge of Integrating Biobanking into the Academic Environment to Support Translational Research

“…The nature of data processing is a critical issue for the rights and freedoms of subjects, mainly for particular categories of data, such as genetic ones. On this topic, the GDPR, which was adopted by the European Union (EU) in 2016 and came into force in 2018, has proven to be challenging for the biobank community [ 70 , 71 ].…”

Az érzékeny kutatási adatok megosztása a személyre szabott orvoslás gyakorlatában

“…A BBMRI-ERIC Directory (címtár) a világ legnagyobb biobank-katalógusa, amelyben a gyűjteményeket kezelő, együttműködésre nyitott biobankok aggregált, összesített információkat osztanak meg magukról. A BBMRI-ERIC hálózatában az egyes regionális központokat a nemzeti csomópontok (national nodes) alkotják, amelyek segítenek az egyedi gyűjteményeket gondozó biobankok regisztrációjában, és ezzel elősegítik láthatóvá válásukat a hasonló érdeklődésű kutatások számára [11,12]. A Semmelweis Egyetem 2021-ben csatlakozott a BBMRI-ERIC-hez a magyar csomóponton keresztül, amelynek alapító tagjai a négy orvosegyetem: a Semmelweis Egyetem, a Debreceni Egyetem, a Pécsi Tudományegyetem és a Szegedi Tudományegyetem, valamint a Dél-pesti Centrumkórház és a Richter Gedeon Nyrt.…”

Management of Onsite and Remote Communication in Oncology Hospitals: Data Protection in an Era of Rapid Technological Advances

“…Similar standards are just beginning to be discussed in the Czech Republic. In Poland, medical facilities can adhere to guidelines set forth in three main documents: (1) the code of conduct for the healthcare sector [16], (2) the GDPR code of conduct for small medical facilities [17], and (3) the GDPR guidelines in healthcare (GDPR guidelines) [18]. While the first code of conduct was positively evaluated by the President of the Personal Data Protection Office in 2021, it has not yet been formally approved.…”