| Website | Petrosterzis.com |
| Pronouns | he/him |
I blame GDPR and the entire EU regulatory apparatus for making me existentially tired of even contemplating the possibility of filing a complaint for blatantly obvious violations of data protection rules.
My inbox is yours LinkedIn Learning. You won.
Several months ago, I wrote a piece on the strange story of clinical trial data in the European Health Data Space (EHDS) proposal and predicted (it was not so hard) that some - perhaps - naively ambitious and unintentionally radical provisions will draw a lot of attention and redrafting. Well, it happened. For context, it is important to note that, in geneneral, the EPP wants the slightest modifications possible to the EHDS proposal and the EPP (shadow) rapporteurs have, so far, submitted ~50 amendments most of which are minor.
I'm following @beuc's #EHDS #ConsumerDebates online and I still fail to understand this:
Their representative polls found that "the further away from the GP, the less people are willing to share their #HealthData" and yet BEUC concludes that while data use by medical profl's should require #OptIn consent, for secondary use by #BigPharma and #BigTech an #OptOut option is enough. ❓❓❓
The #EHDS provisions on the secondary use of clinical trial data will be a pure 'IP rights vs public interest' battle. Important to think:
1) what data sponsors will be forced to share and at which stage;
2) on what grounds (if any) public sector will be able to access clinical trial data.
More here and comments are welcome: https://www.petrosterzis.com/blog/clinical-trial-data-european-health-data-space
The proposal for a regulation of the European Health Data Space (EHDS) introduces a common framework for the secondary use of health data within the EU. In defining the broad scope of ‘electronic data’, the proposal refers (amongst other categories of helath data) to ‘electronic health data from clinical trials’. This provision seems rather straightforward and leaves little room for interpretation. Accordingly, there are no other provisions or recitals for that matter to interpret what the legislator views as ‘electronic health data from clinical trials’.
Michael Veale
Petros Terzis
Jan Penfrat