The fragmented and divergent administrative governance systems for health data in the member states have been identified as an obstacle in the creation of the European Health Data Space (EHDS). One of the aims of the EHDS is therefore to create a legal framework of trusted governance mechanisms within the EU and the member states. In order to ensure access to electronic health data for the benefit of the society, the EHDS regulation introduces advanced administrative governance structures to be applied at the national level. The societal interest of access to health data must however be balanced against the rights and interests of the individual concerned. This chapter analyses the efficiency of the governance structures from the perspective of protecting rights and interest of the individuals concerned via two sets of administrative tools for balancing the competing interests. The first set of tools are legal, technical and organisational safeguards to protect the right to informational privacy. The second set consists of general administrative guarantees for protecting individual interests in the handling of their matters before a public administration, the right to good administration.

Det förvaltningsrättsliga landskapet i Sverige har under de senaste decennierna blivit allt mer sammanlänkat med Europarätten, dvs. EU-rätten, Europakonventionen samt annat material från Europarådet. För att som svensk jurist kunna arbeta med förvaltningsrättsliga frågor är det nödvändigt att ha en grundläggande förståelse för hur Europarätten påverkar de svenska rättsliga strukturerna. I boken presenteras förutsättningarna för Europarättens genomslag i Sverige, samt vad gäller EU, hur förvaltningsorgan från EU och Sverige samverkar inom fyra områden:

• handläggningsregler för förvaltningsmyndigheter

• offentlighet och sekretess

• dataskydd

• rätt till domstolsprövning.

Denna andra upplaga av Europeisk förvaltningsrätt i Sverige är uppdaterad med ny lagstiftning och praxis fram till och med november 2024. Boken utgör ett komplement till annan grundläggande litteratur om allmän förvaltningsrätt och riktar sig till såväl studenter som yrkesverksamma jurister.

With the European Strategy for Data, launched in 2020, the Commission has envisioned the EU as a leader in a data-driven society, where important societal benefits can be achieved by ‘unleashing the data’. The aim is to create a single market for data, allowing data to flow freely within the EU and across sectors, for the benefit of businesses, researchers and public administrations. European and national administrative authorities play a central role in achieving these goals. Building on the GDPR, several new acts regulating the data-driven society and AI continues to shape a European composite administration for data based on the cooperation of European and national public authorities. The executive strategy of the composite administration combines a compliance-based approach, guidance and capacity building, with strong deterrents, high administrative fines. This developing composite administration can be expected to have important influences on core areas of democratic policymaking, including collecting and making accessible information and personal data, defining prerequisites for research and technical development. Focusing on the GDPR, the AI Act and the European Heath Data Space Regulation, this chapter investigates whether the European composite administration for data is adequately construed to respond to the constitutional requirements of the representative democracies of the EU and its Member States. More concretely, how can the European composite administration fulfil the two basic tasks of the executive under the rule of law, to ensure that the aims and contents of the legislation are realised and that constitutional restraints of public powers are upheld? The conclusions drawn are that the constitutional setting of the composite administration and the allocation of tasks and competences in institutional and procedural responsibilities remain underdeveloped. It is therefore difficult to foresee how this administrative organisational model can uphold the requirements stemming the rule of law, to ensure that the law is applied efficiently and that public power is limited, predictable and performed in accordance with the law.

The organisation of the Swedish administration departs from what is traditional in the Western hemisphere, as Swedish public authorities are organisationally separated from the Government and legally semi-independent. Administrative authorities at the national level may thus only be commanded and controlled by the Government as a whole, not by any individual minister (Chap. 7, Sect. 3 Instrument of Government (IG)). Further, all authorities, both state and municipal, are granted a constitutionally protected sphere of independent decision-making (Chap. 12, Sect. 3 IG). An important part of the Swedish administrative model is the principle of transparency and access to official documents. The administration is thus to act transparently and in accordance with the law. The unique traits of the Swedish administrative model have had an impact on the Swedish Administrative Procedures Act (APA). Content-wise, the APA reflects the traditional Swedish understanding of the role that public authorities have in the Swedish administrative model. The partially independent authorities are to use the public powers bestowed on them to guide and assist the public and the individuals whose matters are being processed. In older legal doctrine, it was often emphasised that the administrative authorities should take the individual by the hand and guide them. Beyond these service-oriented features of the Swedish APA, the interest in legal certainty for individuals has increased.

Scientific research is a crucial tool for advancing healthcare and public health. In cross-border research collaborations, researchers need to navigate a complex pool of different requirements, which potentially hamper scientific research.This chapter aims to map the current legal landscape in seventeen Member States of the European Economic Area in the context of the secondary processing of health and genetic data for scientific research purposes. It critically assesses the transposition of GDPR in the national legal order of each State and its interplay with other applicable legislations. Our research findings show that only a handful examined Member State shave a dedicated Act on secondary use, as the majority rely on provisions of different laws. Consent, which has been traditionally relied upon for the processing of healt hand genetic data for scientific research purposes, still remains the most commonly used legal basis. However, there is an increasingly common stance among experts towards the lack of appropriateness of consent as legal basis and a preference overusing it as additional safeguard. Most Member States have enabled the derogation from the exercise of data subject rights under art 89(2) GDPR, while providing a series of appropriate safeguards, mostly including anonymisation, pseudonymisation and encryption.

Biobanks’ activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first–hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four‐step checklist aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU.

Förslaget om att skapa ett digitalt hälsodataområde i EU förhandlas just nu mellan EU:s ministerråd och Europaparlamentet. Syftet med förslaget är att ge medborgare större kontroll över sin hälsodata och bättre tillgång till datan för bland annat vårdgivare, institutioner och forskare. Förslaget innebär en svår balansgång mellan möjligheter och risker. 

I detta  avsnitt av Sieps Podcast samtalar vi om förslaget till förordning om att hälsodataområde med Jane Reichel, professor i förvaltningsrätt vid Stockholms universitet och medlem i Sieps insynsråd, David Fåhraeus, doktorand i europarätt vid Uppsala universitet och Michel Silvestri, enhetschef på E-hälsomyndigheten.  

Varför behövs ett europeiskt hälsodataområde? Hur kan man förbättra skyddet av personliga hälsodata samtidigt som den blir mer tillgänglig? Och hur bred ska definitionen av hälsodata egentligen vara? Vi tittar också närmare på vilka utmaningar och möjligheter förslaget innebär för Sverige. 

Se vidare Europapolitiska analysen The European Health Data Space: Challenges and Opportunities av Jane Reichel, David Fåhraeus och Santa Slokenberga, Sieps 2024:2epa

In this chapter, the codification of administrative law in Sweden is presented. As will be shown, Swedish administrative law has a long history and is well developed in terms of codification. It may be stated already at this point that the Swedish administrative model differs from those in other countries dealt with in this volume. The differences are most significant in relation to the Anglo-Saxon countries, although some common, central administrative law principles can be found, such as the principles of legality, legal certainty and equality or objectivity. From a European perspective, European Union (EU) law has had a major impact, meaning that several principles of good administration, which are seen in the contributions from other European countries, are also included in Swedish law. Principles of good administration emanating from the European Convention on Human Rights (ECHR), as interpreted by the European Court of Human Rights, as well as other documents from the Council of Europe, have also affected the national administrative orders. The European Court of Human Rights draws inspiration from legal 242orders beyond Europe, both international law and domestic law, which also trickle down into the legal orders of the Member States. In this context, it can be noted that Sweden belongs to the East Nordic public law system together with Finland, including Åland. This system differs from that in West Nordic legislation seen in Denmark, including the Faroe Islands, and Greenland, Iceland and Norway.