Cegedim Health Data’s Post

Last week we received the joyful💫 news about the AGREEMENT on the European Health Data Space 🎉. Now💥our NFDI4Health experts on health law✅, data protection🛡, and digital medicine📲 have the floor: 👉 "NFDI4Health welcomes the agreement on the EHDS at the European level, as the current initiative strikes an appropriate balance between protecting sensitive patient data on the one hand and the public interest in using such data for scientific purposes on the other. In particular, the opt-out procedure and information obligations comply with the principles of the EU Data Protection criteria. NFDI4Health considers this development to be a significant step for the future of health research." We are looking forward 👀 to be part🙏 of the further developments⏭ in advancing🔝 #FAIR health research. Ulrich Sax Prof. Dr. Dennis-Kenji Kipker Benedikt Buchner Alessandra Kuntz Juliane Fluck

📌 Registration is now open for the upcoming free webinar on 'The changing data protection landscape and challenges in the use and disclosure of patient health information for research and innovation' 10 October 2024  1400 - 1530 BST The challenges of protecting the privacy of identifiable health information (PHI) are universal, yet jurisdictions have very different approaches to regulating access and disclosure. Particularly where the abundance of clinical and public health research data has the potential to unlock important and valuable future advances in healthcare, regulation of the use and transfer of PHI and rapidly emerging new technologies - that support collection and use of a wide variety of data from clinical, genomic, social and behavioral, environmental, and financial sources - will have a great impact on realising the full potential of such data to advance healthcare delivery and innovation. This webinar addresses this topic from a legal perspective as well as an industry perspective. BOOK NOW: https://lnkd.in/dMWaJgGJ #IBAevents #dataprotection #healthcare #healthtechnology #technology #law

The European Council (the Ambassadors in COREPER) approved earlier today the text of the European Health Data Space regulation #EHDS resulting from the political agreement reached last week. I skimmed through it and oh boy, are we going to have a whole new face of health services in the EU? It looks like it! There are so many interesting bits and pieces, check out for instance: ✔ the new right of people to obtain information, including through automatic notifications, on any access to their personal electronic health data (Article 8f as currently numbered); ✔ a specific right to data portability to transmit electronic health data to another healthcare provider of the individual's choice "immediately, free of charge and without hindrance" (current Article 8d); ✔ the designation of "Digital Health Authorities" in Member States (current Article 10); ✔ the establishment of "MyHealth@EU" by the Commission, a central interoperability platform for Digital Health to provide services to support and facilitate the exchange of personal electronic health data between Member States (current Article 12) 🤔 Also - is this the first time we are seeing the symbol @ in a EU legislation? ✔ Electronic Health Record systems have a bunch of new obligations in order to be put into EU market; ✔ There is a whole chapter dedicated to the secondary use of health data, which actually contains an obligation for data holders to make specific electronic health data available for secondary use! Lots of nuggets in this one! You can also find the text buried at the bottom of this press release here - https://lnkd.in/gmNes6WR Enjoy reading! #EHDS #GDPR #HealthData #ElectronicHealthData

❗ My fellow researchers, scientists, and healthcare professionals, ❗ The Council and European Parliament have reached a provisional political agreement on the European Health Data Space (#EHDS). The main highlights of this regulation include: • Putting individuals at the center of healthcare, giving them full control over their data. • Opening up data for research and public health uses. This is exciting news as this political agreement will potentially offer safe and secure health data exchange, use, and re-use (under strict conditions), while ensuring compliance with #GDPR. The secondary use of health data has long been a concern in local scientific communities due to a lack of privacy regulations and numerous privacy-related questions. Now, this aspect will be regulated by this new law once it enters into force. Another highlight of #EHDS is the possibility to inform individuals in case of clinically significant findings. But what does it mean for individuals? 🔏 Anticipated changes in cross-border access to health data may soon allow tourists to obtain prescriptions in foreign countries or enable doctors to access health information of patients receiving treatment abroad. ✈ Under the new regulation, it is expected that individuals will have the ability to better control and access their health data, request corrections of incorrect data, receive information on who accessed their data, and object to accessing their data in both primary and secondary use, with reasonable exceptions. Ultimately, #EHDS ensures the right to opt out for secondary usage of data. What’s next? 🤔 The agreement is awaiting endorsement before formal adoption and implementation. Following formal adoption, the regulation will enter into force 20 days after publication in the EU’s Official Journal. Truly, what a week! 💯

🔒Your health data is a gold mine. The new European #HealthData Centre is ensuring it's used for the benefit of all, not just a select few. Learn more about how this impacts you: https://lnkd.in/eiQnciWQ #NTTDATA #DataSecurity #DigitalHealth #GDPR

The most striking detail is the spesific right to data portability for the health sector. This means EHDS regulation is beyond a sole regulation of the organisation of the health data space, but also it is a sectoral data regulation within the horizontal framework of the Data Act. This entails that similar provisions can well be implemented witihin the European Agricultural Data Space regulation, and thus, the remaining sector specific issues after the Data Act (See in detail at https://lnkd.in/eXTthZHm - Horizontal intervention, sectoral challenges: Evaluating the data act's impact on agricultural data access puzzle in the emerging digital agriculture sector) can be addressed sooner instead of expecting a signal from the Commission or Member States to design a completely separate sectoral data regulation after the Data Act.

Join me with the International Bar Association on 10 October for a webinar examining #dataprotection and #PHI for use in research and innovation, from the perspective of #UAE, #Turkey, #KSA, #Japan, and #UK. . . to name a few!

Symbolic sun set on the European Parliament this evening. Not only comes the legislative term to an end ahead of the European elections in June. It is also the evening of final political negotiations on the European Health Data Space #EHDS. The stakes couldn’t be higher. EHDS is the first of a number of #dataspaces that the EU wants to develop with the ambition to drive innovation and progress for the benefit of citizens and the EU single market. EHDS holds the promise of more and better health data from across the EU, to create better healthcare systems, care delivery and innovation. Yet, many topics are politically unresolved between Parliament and the EU Member States ahead of tonight’s meeting. Some issues to watch for in the final text: 👉🏼 1. Clear definitions that are consistent with other legislations. For example the concept of ‘data holder’ and what constitutes an ‘Electronic Health Record’. 👉🏼 2. Clear rules on the interactions of the EHDS with other legal frameworks such as the Data Act, AI Act, Medical Device Regulation and others and avoidance of duplication of regulatory requirements. 👉🏼 3. EU-wide harmonisation of the new rules to avoid legal fragmentation and promote clarity, interoperability and simplicity for operators and users of the EHDS. 👉🏼 4. Avoidance of country-by-country diverging opt-out clauses for secondary use of health data that would create a secondary use patchwork across the EU. 👉🏼 5. Avoidance of data protectionism such as excessive data localisation rules that would inhibit international partners to deliver innovation to European patients 👉🏼 6. Clear provisions that protect intellectual property rights and trade secrets, so that life sciences companies can expect clear returns on investment when developing innovations in Europe for the world. Many observers are concerned that the time pressure of the closing term will lead to an imperfect outcome that will leave the details to secondary legislation in the years to come and scrambling healthcare stakeholders that struggle with implementation of the new rules. Position of the Healthcare Coalition including MedTech Europe and COCIR https://lnkd.in/dR8X4D_8 Position American Chamber of Commerce to the European Union (AmCham EU) https://lnkd.in/d-3dbWRJ

Thanks to all attendees and my co-presenters at Baker McKenzie’s Healthcare Compliance Forum in Zurich on April 9. Our session was dedicated to current EU "big data" legislation beyond AI, i.e. the draft European Health Data Space (EHDS) Regulation, the EU Data Act, the NIS2 Directive (thx Michael Schmidl) and the Swiss Information Security Act (thx Johanna Moesch). We greatly enjoyed the Q&A foreshadowing further discussions on the legislation's impacts on the medical devices and pharma industries. #EHDS #EuropeanHealthDataSpace #DataAct #NIS2 #FAISC #HealthTech #HealthDataSecurity

Cross-border data sharing in the healthcare sector is crucial for advancing medical research, improving patient care, and fostering global health initiatives. It enables access to diverse data, accelerating medical progress. However, this practice raises considerable concern, particularly in terms of privacy and compliance with both local and international standards. The legal complexities of cross-border data sharing in healthcare require striking a fine balance between maximizing the benefits of shared data and protecting against potential risks. In this article, our Partner, Amala Umeike, and Associates, Chizitereihe Oti, Emmanuel Ughanze, and Justina Okachi, explore the intricacies of cross-border data transfer within the healthcare sector, examining legal considerations such as data protection regulations, transfer mechanisms, and consent. Click the link below to read the full publication and reach out to contact@strenandblan.com for further inquiries and consultation. https://lnkd.in/dZJBYiQa #strenandblanpartners #commerciallawfirm #crossborderdata #healthcaresector #datatransfer