This book chapter assesses the EU medical devices legal framework in light of the EU cybersecurity policy objectives and the complexity aspects inherently characterizing the healthcare sector. First, it outlines the core cybersecurity-related elements in the EU Medical Devices Regulation (MDR) and offers critical remarks on the Medical Device Coordination Group’s Guidance on medical device cybersecurity. Second, the chapter illustrates other relevant pieces of the EU legislation that become applicable in the context of medical devices’ cybersecurity, namely the NIS Directive, the Cybersecurity Act, the GDPR, the Radio Equipment Directive. Third, the chapter offers critical remarks concerning the possible regulatory challenges stemming from their interaction with the MDR. Here, the analysis finds that regulatory challenges persist due to regulatory specialization, possibly leading to regulatory overlapping, fragmentation risks, regulatory uncertainty and duplication. In its final section, the chapter provides recommendations for EU lawmakers dealing with the cybersecurity of medical devices in the EU.
{"title":"Cybersecurity of Medical Devices: Regulatory Challenges in the EU","authors":"E. Biasin, Erik Kamenjašević","doi":"10.2139/ssrn.3855491","DOIUrl":"https://doi.org/10.2139/ssrn.3855491","url":null,"abstract":"This book chapter assesses the EU medical devices legal framework in light of the EU cybersecurity policy objectives and the complexity aspects inherently characterizing the healthcare sector. First, it outlines the core cybersecurity-related elements in the EU Medical Devices Regulation (MDR) and offers critical remarks on the Medical Device Coordination Group’s Guidance on medical device cybersecurity. Second, the chapter illustrates other relevant pieces of the EU legislation that become applicable in the context of medical devices’ cybersecurity, namely the NIS Directive, the Cybersecurity Act, the GDPR, the Radio Equipment Directive. Third, the chapter offers critical remarks concerning the possible regulatory challenges stemming from their interaction with the MDR. Here, the analysis finds that regulatory challenges persist due to regulatory specialization, possibly leading to regulatory overlapping, fragmentation risks, regulatory uncertainty and duplication. In its final section, the chapter provides recommendations for EU lawmakers dealing with the cybersecurity of medical devices in the EU.","PeriodicalId":382396,"journal":{"name":"POL: European Markets (Topic)","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128745291","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}
Pub Date : 2017-02-27DOI: 10.1007/978-3-319-99226-6_3
A. Biondi, Oana Stefan
{"title":"The Notice on the Notion of State Aid: Every Light has its Shadow","authors":"A. Biondi, Oana Stefan","doi":"10.1007/978-3-319-99226-6_3","DOIUrl":"https://doi.org/10.1007/978-3-319-99226-6_3","url":null,"abstract":"","PeriodicalId":382396,"journal":{"name":"POL: European Markets (Topic)","volume":"7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2017-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134313730","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}
News paper editorial, pointing out that EU policymakers are always one step behind economic needs.
报纸社论指出，欧盟政策制定者总是落后于经济需求一步。
{"title":"Think Small 1st – How Alternative Investment Markets Lecture the EU","authors":"C. Lange","doi":"10.2139/ssrn.1649128","DOIUrl":"https://doi.org/10.2139/ssrn.1649128","url":null,"abstract":"News paper editorial, pointing out that EU policymakers are always one step behind economic needs.","PeriodicalId":382396,"journal":{"name":"POL: European Markets (Topic)","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129455731","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}
On the global stage, competitive advantages are gained by creating, transferring and exploiting competences across operations and locations internationally. In consequence, conglomerates are redesigning their strategies to focus on core businesses, yet with a global scope. De-diversification and internationalization thus complement each other in a process of "globalfocusing". This discussion paper outlines the shifts in the relative barriers to entry to countries and industries that have been driving these processes of change in corporate strategies on the global stage. On this basis, implications of the change in global strategy are derived for decision makers in both business and politics, reflecting the challenges of the global financial crisis.
{"title":"Corporate Strategies under Pressures of Globalization: Globalfocusing","authors":"K. Meyer","doi":"10.2139/ssrn.1373022","DOIUrl":"https://doi.org/10.2139/ssrn.1373022","url":null,"abstract":"On the global stage, competitive advantages are gained by creating, transferring and exploiting competences across operations and locations internationally. In consequence, conglomerates are redesigning their strategies to focus on core businesses, yet with a global scope. De-diversification and internationalization thus complement each other in a process of \"globalfocusing\". This discussion paper outlines the shifts in the relative barriers to entry to countries and industries that have been driving these processes of change in corporate strategies on the global stage. On this basis, implications of the change in global strategy are derived for decision makers in both business and politics, reflecting the challenges of the global financial crisis.","PeriodicalId":382396,"journal":{"name":"POL: European Markets (Topic)","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2009-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131305743","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}
Comparisons by countries and by sectors of mergers and acquisitions have usually been performed in separate fields of research. A first group of studies, focusing on international comparisons, has explored the role of corporate governance systems, investor protection laws and other countries’ regulatory institutions as the main determinants of takeovers around the world. A second group of contributions has attributed a central role to variations in industry composition, documenting that, in each country, mergers occur in waves and within each wave clustering by industry is observed. This paper aims to integrate both perspectives and to make comparisons by countries and by sectors, thus exploring the role of various driving forces on takeover activities. It also intends to consider the specific influence that technological regimes and their innovation patterns may exert in reallocating assets and moving capital among sectors. This will be done by examining the European experience of the last few years (2002-2005). We found that even in countries where transfer of control is a frequent phenomenon, mergers are less frequent in those sectors where innovation is a cumulative process and where takeovers may be a threat to the continuity of accumulation of innovative capabilities.
{"title":"Mergers, Acquisitions and Technological Regimes: The European Experience over the Period 2002-2005","authors":"M. Damiani, F. Pompei","doi":"10.2139/ssrn.1117496","DOIUrl":"https://doi.org/10.2139/ssrn.1117496","url":null,"abstract":"Comparisons by countries and by sectors of mergers and acquisitions have usually been performed in separate fields of research. A first group of studies, focusing on international comparisons, has explored the role of corporate governance systems, investor protection laws and other countries’ regulatory institutions as the main determinants of takeovers around the world. A second group of contributions has attributed a central role to variations in industry composition, documenting that, in each country, mergers occur in waves and within each wave clustering by industry is observed. This paper aims to integrate both perspectives and to make comparisons by countries and by sectors, thus exploring the role of various driving forces on takeover activities. \u0000It also intends to consider the specific influence that technological regimes and their innovation patterns may exert in reallocating assets and moving capital among sectors. This will be done by examining the European experience of the last few years (2002-2005). We found that even in countries where transfer of control is a frequent phenomenon, mergers are less frequent in those sectors where innovation is a cumulative process and where takeovers may be a threat to the continuity of accumulation of innovative capabilities.","PeriodicalId":382396,"journal":{"name":"POL: European Markets (Topic)","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2008-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132857851","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}
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