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The draft text of the European Health Data Space (EHDS) in trilogues sparks deep concerns in the European healthcare ecosystem<\/strong><\/p>\n <\/p>\n 26 February 2024 \u2013 OPTIMA, as part of a coalition of 35 large health stakeholder organisations representing patients, health professionals, researchers and industrial actors in the healthcare ecosystem at both European Union (EU) and Member State level, is expressing its shared concerns about the latest negotiations on the proposed Regulation on the European Health Data Space (EHDS). The EHDS is currently being negotiated at speed by EU institutions to get it \u2018over the line\u2019 before the end of this political term.<\/p>\n There is a real desire by the health stakeholder community for this proposed legislation to be a success. The potential benefits offered by a well-functioning EHDS would be significant. The EHDS is intended to make the functioning of European health systems more efficient, contribute to better health outcomes, and support public health and health research and innovation activities in the EU.<\/p>\n However, despite repeated calls by health stakeholder organisations from across the European healthcare ecosystem (on general recommendations for legislating the EHDS<\/a>, on the challenges of implementing an effective opt-out \/ opt-in mechanism in the EHDS<\/a>, and on raising alarm bells to address significant legislative shortcomings and uncertainties in the EHDS<\/a>), the following ten fundamental issues have not been addressed satisfactorily in the legislative positions that form the bases for the interinstitutional negotiations (trilogues) between Council, the European Parliament and the European Commission.<\/p>\n <\/p>\n The European healthcare ecosystem is concerned that the draft text of the EHDS does not provide the necessary degree of legal certainty and consistency with the existing regulatory frameworks. Recently incorporated or amended key provisions should be carefully considered to avoid unintended negative consequences. A robust health data governance framework is essential for ensuring privacy and security to build and maintain public trust in the EHDS. Therefore, we call on the EU institutions to leverage the expertise of the healthcare ecosystem and take the necessary time to create the EHDS that makes the most of the potential of digital health to provide high-quality healthcare for all in the EU.<\/p>\n Read the full press release here.<\/a><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" The draft text of the European Health Data Space (EHDS) in trilogues sparks deep concerns in the European healthcare ecosystem 26 February 2024 \u2013 OPTIMA, as part of a coalition of 35 large health stakeholder organisations representing patients, health professionals, researchers and industrial actors in the healthcare ecosystem at both European Union (EU) and […]<\/p>\n","protected":false},"author":13,"featured_media":6404,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":" The draft text of the European Health Data Space (EHDS) in trilogues sparks deep concerns in the European healthcare ecosystem<\/strong><\/p> \u00a0<\/p> 26 February 2024 \u2013 OPTIMA, as part of a coalition of 35 large health stakeholder organisations representing patients, health professionals, researchers and industrial actors in the healthcare ecosystem at both European Union (EU) and Member State level, is expressing its shared concerns about the latest negotiations on the proposed Regulation on the European Health Data Space (EHDS). The EHDS is currently being negotiated at speed by EU institutions to get it \u2018over the line\u2019 before the end of this political term.<\/p> There is a real desire by the health stakeholder community for this proposed legislation to be a success. The potential benefits offered by a well-functioning EHDS would be significant. The EHDS is intended to make the functioning of European health systems more efficient, contribute to better health outcomes, and support public health and health research and innovation activities in the EU.<\/p> However, despite repeated calls by health stakeholder organisations from across the European healthcare ecosystem (on general recommendations for legislating the EHDS<\/a>, on the challenges of implementing an effective opt-out \/ opt-in mechanism in the EHDS<\/a>, and on raising alarm bells to address significant legislative shortcomings and uncertainties in the EHDS<\/a>), the following ten fundamental issues have not been addressed satisfactorily in the legislative positions that form the bases for the interinstitutional negotiations (trilogues) between Council, the European Parliament and the European Commission.<\/p> \u00a0<\/p> The European healthcare ecosystem is concerned that the draft text of the EHDS does not provide the necessary degree of legal certainty and consistency with the existing regulatory frameworks. Recently incorporated or amended key provisions should be carefully considered to avoid unintended negative consequences. A robust health data governance framework is essential for ensuring privacy and security to build and maintain public trust in the EHDS. Therefore, we call on the EU institutions to leverage the expertise of the healthcare ecosystem and take the necessary time to create the EHDS that makes the most of the potential of digital health to provide high-quality healthcare for all in the EU.<\/p>\n