Malpractice in Scandinavia

The article describes the special Scandinavian patient insurance system which secures compensation for patients in malpractice cases. For all practical purposes, the insurance based systems have replaced ordinary tort law rules in malpractice cases in Scandinavia. Thus, the basic feature of these systems is that proof of fault is not a requirement for obtaining compensation. Other criteria which are more favourable to the patient are applicable. The article concludes that in general the compensations systems have been successful in making it easier for the patients to obtain compensation. However, the systems also face challenges, some of which stem from the ongoing European harmonization process

Position paper on management of personal data in environment and health research in Europe

Management of datasets that include health information and other sensitive personal information of European study participants has to be compliant with the General Data Protection Regulation (GDPR, Regulation (EU) 2016/679). Within scientific research, the widely subscribed'FAIR' data principles should apply, meaning that research data should be findable, accessible, interoperable and re-usable. Balancing the aim of open science driven FAIR data management with GDPR compliant personal data protection safeguards is now a common challenge for many research projects dealing with (sensitive) personal data. In December 2020 a workshop was held with representatives of several large EU research consortia and of the European Commission to reflect on how to apply the FAIR data principles for environment and health research (E&H). Several recent data intensive EU funded E&H research projects face this challenge and work intensively towards developing solutions to access, exchange, store, handle, share, process and use such sensitive personal data, with the aim to support European and transnational collaborations. As a result, several recommendations, opportunities and current limitations were formulated. New technical developments such as federated data management and analysis systems, machine learning together with advanced search software, harmonized ontologies and data quality standards should in principle facilitate the FAIRification of data. To address ethical, legal, political and financial obstacles to the wider re-use of data for research purposes, both specific expertise and underpinning infrastructure are needed. There is a need for the E&H research data to find their place in the European Open Science Cloud. Communities using health and population data, environmental data and other publicly available data have to interconnect and synergize. To maximize the use and re-use of environment and health data, a dedicated supporting European infrastructure effort, such as the EIRENE research infrastructure within the ESFRI roadmap 2021, is needed that would interact with existing infrastructures

Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape

Despite the increasing availability of direct-to-consumer (DTC) genetic testing, it is currently unclear how such services are regulated in Europe, due to the lack of EU or national legislation specifically addressing this issue. In this article, we provide an overview of laws that could potentially impact the regulation of DTC genetic testing in 26 European countries, namely Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the Netherlands and the United Kingdom. Emphasis is placed on provisions relating to medical supervision, genetic counselling and informed consent. Our results indicate that currently there is a wide spectrum of laws regarding genetic testing in Europe. There are countries (e.g. France and Germany) which essentially ban DTC genetic testing, while in others (e.g. Luxembourg and Poland) DTC genetic testing may only be restricted by general laws, usually regarding health care services and patients’ rights