{"title":"Opting Out of Scientific Research with Health Data: The Limits of the EHDS and the GDPR.","authors":"Maret Kruus","doi":"10.1163/15718093-bja10141","DOIUrl":"https://doi.org/10.1163/15718093-bja10141","url":null,"abstract":"<p><p>In the future, the European Health Data Space (EHDS) Regulation will enhance the secondary use of electronic health data in the EU, including for scientific research purposes. From the data subjects' perspective, the EHDS introduces a significant change, a new opt-out mechanism for the secondary use of data, in which data subjects shall have the right to opt out at any time without stating reasons. However, not all scientific research with health data will be covered by the opt-out rules of the EHDS. This article aims to clarify the effects of the EHDS' opt-out mechanism and its scope of application. It also suggests a balanced approach for Member States to implement the EHDS opt-out mechanism and reassess the implementation of the GDPR's right to object that remains relevant in the future in addition to the opt-out introduced by the EHDS.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"1-25"},"PeriodicalIF":0.6,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143812667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"From Family Court to Protection Court.","authors":"Marco Bo","doi":"10.1163/15718093-bja10142","DOIUrl":"https://doi.org/10.1163/15718093-bja10142","url":null,"abstract":"<p><p>According to Italian Law on informed consent and advance directives claims regarding parents' refusal of treatment in favor of a child must be referred to Protection Courts. This paper described some recent decree by District Appeal Courts called to settle the conflict of jurisdiction between Family Courts and Protection Courts in claims regarding the refusal of medical treatment in favor of minors. The decrees by the Court of Appeal confirmed that Protection Courts are entitled to manage claims regarding refusal of medical treatment by parents except when elements of neglect or maltreatment rise. They also established that the refusal of a medical treatment is not sufficient to override parental responsibility when there are no proofs of neglect. The new Italian law marks a difference between the Italian jurisdiction and the ones of other European countries and significantly limited the cases when overriding parents' responsibility is legal.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"1-17"},"PeriodicalIF":0.6,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143812665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"ECJ 2025/1 Republic of Slovenia 5 September 2024 (Case C-447 P).","authors":"Herman Nys","doi":"10.1163/15718093-12423568","DOIUrl":"https://doi.org/10.1163/15718093-12423568","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"32 1","pages":"83-110"},"PeriodicalIF":0.6,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143711494","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"European Court of Human Rights.","authors":"Joseph Dute, Tom Goffin","doi":"10.1163/15718093-bja10140","DOIUrl":"10.1163/15718093-bja10140","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"65-82"},"PeriodicalIF":0.6,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143493966","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A Critical Appraisal of Informed Consent in English Medical Law: A Patient-Centred Approach Against Medical Paternalism: Who Gets to Decide What Is Best for Me?","authors":"Lisa Kachina Poku","doi":"10.1163/15718093-bja10138","DOIUrl":"10.1163/15718093-bja10138","url":null,"abstract":"<p><p>This article seeks to discuss informed consent in English law. The attitudes on informed consent have shifted to a more patient-centred approach following Montgomery v Lanarkshire Health Board [2015] UKSC 11, [2015] AC 1430, as opposed to the long-standing Bolam decision where clinical judgment was more widely accepted. Thus, following on from the decision in Montgomery a patient is required to know about material risks regarding the proposed treatment and not what the doctor thinks would be the best practice as has been the long-standing consensus since Bolam was decided back in 1957 with subsequent cases following suit. The Montgomery principle has allowed more transparency in the patient-doctor relationship, allowing for a discussion between the doctor and the patient to be the central focus. The outcome of Montgomery was a much needed change in healthcare because prior to this it could be seen that patients were having decisions made on their behalf, and if they had been informed accordingly regarding the risks involved may have decided not to go ahead with the procedure. In the case of Diamond v Royal Devon & Exeter NHS Foundation Trust [2019] EWCA Civ 585 the case highlights the issue of causation in medical negligence action if a doctor does not warn of risks and advise treatment alternatives this would not result in a claim for damages because the patient in this case as was held would have gone ahead with the mesh repair in any case, and thus failing to establish causation could result in no remedy as it did in Diamond. Furthermore, the recent case of McCulloch and others v Forth Valley Health Board [2023] UKSC 26 adds a bit of salt to the wounds of those who had thought or believed that Montgomery had already clarified the position regarding disclosure of alternative treatments to a patient, and to our dismay to learn of that once again English courts have ruled in favour of 'Bolam'.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"26-45"},"PeriodicalIF":0.6,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143493959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The European Union's Influence on the Organisation of National Healthcare Systems. Navigating the Trends after the COVID-19 Pandemic.","authors":"Zuzanna Zapotoczna","doi":"10.1163/15718093-bja10137","DOIUrl":"10.1163/15718093-bja10137","url":null,"abstract":"<p><p>The COVID-19 pandemic has hit national healthcare systems on an unprecedented scale. At the same time, European societies are witnessing an ongoing war, growing migration and climate crisis. In order to respond to the global challenges facing national healthcare systems, the European Union (EU) is stepping up its actions to promote resilience of national healthcare systems. This is to ensure adequate availability of healthcare services in times of health crises through numerous actions. Despite limited powers in health, the EU legal system creates a multidimensional order for protection of various health-related interests which touch upon the organisation of the Member States' healthcare systems. This paper navigates the ongoing trends with regard to the EU's health policy and presents the perspective on 'standardisation' of the Member States' healthcare systems.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"1-25"},"PeriodicalIF":0.6,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143493971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Legal Issues Regarding the Reimbursement of Drugs Used to Treat Muscular Atrophy and the Actual Situation in the Slovak Republic.","authors":"Katarína Zajác Ševcová","doi":"10.1163/15718093-bja10139","DOIUrl":"10.1163/15718093-bja10139","url":null,"abstract":"<p><p>This article explores the legal problems regarding reimbursing drugs used to treat muscular atrophy. The article highlights the importance of insurance coverage for patients with muscular atrophy and the need for more uniform policies. In the Slovak Republic, the state health insurance company refused to reimburse the medicine several times, although it made an exception for other children in the past. The patient asked the civil court to order an urgent measure. The court granted this proposal and ordered the insurance company to pay for the drug Zolgensma. The article analyzes the legal nature of this case considering fundamental human rights.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"46-64"},"PeriodicalIF":0.6,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"ECJ 2024/5, Auken and Others v Commission, 17 July 2024 (case t-689/21) and Courtois and Others v Commission, 17 July 2024 (case t-761/21).","authors":"An Baeyens","doi":"10.1163/15718093-12423567","DOIUrl":"https://doi.org/10.1163/15718093-12423567","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"31 5","pages":"557-566"},"PeriodicalIF":0.6,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142873012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"An Assessment on Innovator's Ability for Consent-Free Health Data Reuse, In the Context of the GDPR and EHDS: The Netherlands Case Study.","authors":"Maryam Afra","doi":"10.1163/15718093-bja10136","DOIUrl":"10.1163/15718093-bja10136","url":null,"abstract":"<p><p>Considering the difficult procedure of obtaining consent, consent-free health data reuse is believed to be one major contributor towards the creation of thriving health innovation ecosystem. While classic researchers are supported by the GDPR to reuse health data without consent, the innovator's situation remains unclear, and this uncertainty continues to exist upon the introduction of the EHDS. To shed light on grey areas, positions of GDPR and EHDS on the ability of innovators for consent-free health data reuse were assessed. The study concludes that, while academicians are able to reuse health data without consent, a private company's ability has been impeded by individual member states' deviations from Article 9(2) GDPR. Furthermore, in contracts to EHDS (2022) which appeared in favour of innovators through the elimination of consent mechanism, EHDS (2024) with the inclusion of opt-out mechanism, and exclusion of private sector bodies from the Article 35(f), has negatively affected private companies.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"475-496"},"PeriodicalIF":0.6,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142733333","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"European Court of Justice.","authors":"Herman Nys","doi":"10.1163/15718093-12423566","DOIUrl":"10.1163/15718093-12423566","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"548-556"},"PeriodicalIF":0.6,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142630137","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}