Office for Human Research Protections (OHRP), United States Department of Health and Human Services’ Post

It was so great to discuss Washington’s My Health My Data Act with Keir Lamont, someone whose work on US privacy law I really admire. This law is a very big deal and I think some elements of the broad drafting and strict requirements could cause some serious compliance headaches. But Keir reminded me of how important the MHMDA's objectives are. If you've got any operations in Washington state, you owe it to your company to check with it's "collecting" 'consumer health data" before this law takes effect. As I discuss with Keir, those terms are very broadly defined. Thanks to Privado.ai for supporting this special episode of The Privacy Corner. https://lnkd.in/gUY7ZvvB

The European Commission has come forward with its policy recommendation to harmonise rules on fair access to and use of data, with The Data Act having entered into force on 11 January 2024 (becoming applicable on 12 September 2025). #TeamSPB reviews and analyses the Data Act Regulation as adopted, addressing the importance in future EU policy discussions. ➡️ https://bit.ly/4915Atl #DataPrivacy | #EUDataPrivacy | #EUDataAct

In response to the impact of the Covid-19 pandemic, Member States of the WHO agreed to a global process to draft a treaty to strengthen pandemic prevention, preparedness and response. Since this process was announced, PI has sought to closely follow and engage with the discussions leading up to the draft treaty, despite the significant limitations to civil society participation in the process. This week the drafting process of the Pandemic Treaty continues with the WHO Intergovernmental Negotiating Body (INB) meeting to discuss the latest version of the text. Available here: https://lnkd.in/ep5K2Gnw Unfortunatele, the Revised Draft is a significant step back to the already weakened previous draft. We are particularly dismayed by the deletion of a principle on privacy, data protection and confidentiality. The reason why we are concerned by this change is because the inclusion of such a provision would affirm the importance that data protection and privacy plays in any effective, modern public health policies. Here is our full analysis and recommendations 👉 https://lnkd.in/eQ3Zxfy8 This current INB session may be the last opportunity for governments negotiating the Pandemic Treaty to fix these shortcomings and put the respect and protection of human rights at the core of future pandemic responses. #pandemictreaty #healthcare #healthtech #healthdata #who @healthgovernance #humanrights #privacy

Even with the upcoming elections, data spaces are likely to stay on top of the EU/UK digital policy agenda’s. But what does the concept really mean? In an article for PLC Magazine, we explore the EU data spaces and UK data schemes, the emerging rules for data-sharing frameworks in the EU and the UK. The article also takes a closer at the various legal instruments that (will) contribute to these data spaces, including the Data Governance Act (#DGA), Data Act, European Health Data Space Regulation (#EHDS), Financial data access regulation (#FIDA) as well as – for the UK - Part 3 of the Data Protection and Digital Information. Interested to read more? You can find the article here (for Practical Law subscribers): https://lnkd.in/eyimPMui Thanks to my co-authors Simon Verschaeve, Muhammed Demircan, James Clark and Laura Dobson for their valued contributions! #dlapiper #dataspaces #DataAct #DGA 

Starting from the days when the European Commission has announced its ambitious data spaces strategy (part of the wider EU Strategy for Data), the EU's (and the UK's) data spaces strategy is under a legal construction. The logic and functioning of data spaces in conjunction with the more general rules arising from the Data Act and the Data Governance Act (not to mention the GDPR) may be hard to grasp at first instance. You may read our article to learn more about how all these projects (and legislations) interplay and what is the current situation. Link: https://lnkd.in/eNy6p3vU

Washington’s My Health My Data Act (MHMDA) is transforming how companies handle health data. That's because the definition of health data is SO broad. And MHMDA imposes strict consumer consent rules for common data collection and processing activities. Our upcoming webinar will show you how to get it right. Join Jodi Daniels and Mike Hintze, Member Partner at Hintze Law PLLC, TOMORROW at 12pm ET for a live complimentary webinar as they dive deep into Washington State’s My Health, My Data Act. You’ll gain insights on: - MHMDA’s requirements, objectives, who’s in scope for it, and its key provisions - How MHMDA impacts different business sectors and health-related products/services - What it means for consumers privacy rights and protections - Practical advice for what you need to do to meet compliance obligations + More! Sign up today: https://lnkd.in/g-berUUz

📊🔬 Processing health data for scientific research in the EU and UK There is no doubt that scientific research is crucial to our society, but it often necessitates handling a significant amount of protected special category personal data. Sarah Tedstone, Nuria Pastor, and Alex Beresford have authored an insightful piece exploring the current legislative landscape for scientific research activities under data protection law in the UK and the EU. The article – first published in the Privacy Laws & Business International Report, June 2024 – also delves into how the forthcoming European Health Data Space (EHDS) and the UK's plans may impact this landscape. Read the full article here: https://lnkd.in/eDJ2sYce. 📅 Additionally, don't miss our webinar later today where Sarah, Nuria, and Alex will discuss this topic in more detail. To find out more about the webinar and to register, please visit: https://lnkd.in/etr2rqaw #HealthData #ScientificResearch #DataAndPrivacy #DataProtection #EHDS #LifeSciences 

With increasing public willingness to share health data, organizations can now access transformative data sets. This shift promises faster trial results and more adaptive designs. But, trust and data security are key. Transparency and ethical data use can drive innovation in #ClinicalTrials. Dive into the full article.

📣 Read our latest EU & Belgian Data Protection and TMT update! 📅 On June 20, the European Data Protection Supervisor will host a summit titled “Rethinking Data in a Democratic Society” in Brussels. This event will bring together experts and policymakers to discuss the role of data protection in democratic societies. 🍪 On 13 June, Google was hit with a complaint by Austrian advocacy group NOYB for allegedly tracking users of its Chrome Web browser. 🖥 On 12 June, following a public consultation, the CNIL has published its recommendations on open data and the re-use of data published on the Internet. 📄 On 11 June, the European Agency for Fundamental Rights published a report analysing the challenges national data protection authorities face in the GDPR implementation. 🏥 In spring 2024, the European Parliament and the Council reached a political agreement on the European Health Data Space. This agreement sets the foundation for improved cross-border access to health data, enabling individuals to have better control over their personal health information and allowing it to be reused for public interest, policy support, and research. 📌 Links in comments section #dataprotection #AIregulation #privacymatters #EUregulations #legalupdates #simmons

Washington's MHMDA, effective 3/31/24, could reshape health data privacy nationwide. Porzio’s latest life sciences newsletter breaks down its implications. #MHMDA #HealthDataPrivacy #DataPrivacyLaw