Publicação
Physical and Digital Cross-Border Health Services
| Resumo: | This dissertation examines the regulatory and operational challenges that exist in cross-border health services between the European Union and the United States, with a particular focus on compliance frameworks that cover the topic of personal health data. The analysis of data sharing between the United States and the European Union was chosen for two reasons. First of all, the volume of data transfers between these two jurisdictions is high. The U.S and the EU have some of the largest markets in the world, which result in substantial cross-border data flows on a daily basis. Secondly, the United States and the European Union have different models of data regulation, which makes them a useful case study to examine if they can function together to provide efficient and legally compliant cross-border data transfers. As healthcare providers, research institutions and medical technology companies decide to conduct business internationally with business partners in other countries, they need to increasingly rely on cross-border data flows, and therefore need to navigate a complex regulatory landscape. The dissertation analyzes to what extent regulatory frameworks help or limit cross-border health data transfers, the secondary use of health data, and the development of new medical technologies. To more clearly assess how regulations work in practice, the dissertation includes a comparative legal analysis of the current regulations on an EU and US level and current developments in this area with the Draghi report, the European Health Data Space and the Digital Omnibus. An attempt to include an empirical component was also made, consisting of structured interviews and a survey of companies that are currently engaged, or wish to engage in cross-border services. However, due to lack of responses and companies being unwilling to provide their opinions on the current regulatory landscape, the findings should be viewed in light of their methodological limitations. Therefore, other larger studies conducted by European institutions were also analyzed in order to be able to come to conclusions. Finally, in order to assess the implications of all of this in practice, a hypothetical case study was created that mimics the current realities. This hypothetical real-life example is meant to show how startups and SMEs can navigate the current regulatory landscape, and could use this is a template. |
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| Autores principais: | Budny, Caroline Emily |
| Assunto: | Cross-border data flows data privacy data protection GDPR HIPAA medical technology compliance legal frameworks |
| Ano: | 2026 |
| País: | Portugal |
| Tipo de documento: | dissertação de mestrado |
| Tipo de acesso: | acesso embargado |
| Instituição associada: | Universidade Nova de Lisboa |
| Idioma: | inglês |
| Origem: | Repositório Institucional da UNL |
| Resumo: | This dissertation examines the regulatory and operational challenges that exist in cross-border health services between the European Union and the United States, with a particular focus on compliance frameworks that cover the topic of personal health data. The analysis of data sharing between the United States and the European Union was chosen for two reasons. First of all, the volume of data transfers between these two jurisdictions is high. The U.S and the EU have some of the largest markets in the world, which result in substantial cross-border data flows on a daily basis. Secondly, the United States and the European Union have different models of data regulation, which makes them a useful case study to examine if they can function together to provide efficient and legally compliant cross-border data transfers. As healthcare providers, research institutions and medical technology companies decide to conduct business internationally with business partners in other countries, they need to increasingly rely on cross-border data flows, and therefore need to navigate a complex regulatory landscape. The dissertation analyzes to what extent regulatory frameworks help or limit cross-border health data transfers, the secondary use of health data, and the development of new medical technologies. To more clearly assess how regulations work in practice, the dissertation includes a comparative legal analysis of the current regulations on an EU and US level and current developments in this area with the Draghi report, the European Health Data Space and the Digital Omnibus. An attempt to include an empirical component was also made, consisting of structured interviews and a survey of companies that are currently engaged, or wish to engage in cross-border services. However, due to lack of responses and companies being unwilling to provide their opinions on the current regulatory landscape, the findings should be viewed in light of their methodological limitations. Therefore, other larger studies conducted by European institutions were also analyzed in order to be able to come to conclusions. Finally, in order to assess the implications of all of this in practice, a hypothetical case study was created that mimics the current realities. This hypothetical real-life example is meant to show how startups and SMEs can navigate the current regulatory landscape, and could use this is a template. |
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