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Detailed Change Proposals to EHDS

According to European Parliament’s (EP) EHDS schedule, fractions and their “shadow reporters” can propose changes to the first draft of the comittee report on EHDS, until March 23, 2023. The time for proposing such changes is now.

We have been asked by someone from an EP fraction, to propose such changes until end of February. As there was no time for coordinationg a group response, I answered personally.

Unfortunately we were unable to put our requirements into this document within one or two weeks. We are only activists working in our free time. We think this kind of work should be done by professionals like you. Our statement, in which you can find a lot of hints, is here: https://patientenrechte-datenschutz.de/ehds-position-paper/

But anyway, I have entered some of our suggestions into the report, using the correction function of MS Word. This is my personal contribution, not one of our group. Please note that we see two lines of defense with EHDS. Therefore, if I would have had more time I had to make two sets of changes to the document, one for each line of defense. In the attached document, both lines of defense are combined, which makes things a little clumsy. One must know more about the power relationships behind the proposal before deciding which way to go.

Line of defense 1: Privacy of medical data means, protecting the doctor-patient relationship in the same way and with the same rigidity as the relationship between lawyer and client. The principle of line 1 is that medical data don’t leave the doctor’s office except with consent from the patient. In this line, the argument that there is no competency of the EU for a regulation like this is most important. The set of changes, on this line, would mean wiping out around half of the proposal’s text.

Line of defense 2: Secondary use of health data cannot be prevented, or (according to some) should be facilitated. In this case, a lot of detail improvements to the proposal must be requested. I entered some of them in the attachment. A lot more could be done, with more time. I propose an online meeting between some experts to find out how to proceed.

Due to MS Word malfunctions, it is difficult to find the changes in the attachment, so here is a list:

  • Recitals 1, 8, 16a, 49a
  • Articles 3 par 1, 7, 35a

Hopefully, we can create much more proposals and improve these ones. There is no necessary conflict between these two lines of defense, they can be followed in parallel. One example is the proposal of strict liability and a compensation scheme for secondary use of health data, which belongs to line of defense 2.

EHDS Information Exchange

This site is about EU’s legislative project EHDS (European Health Data Space) and similar projects in member states.

There is a menu on the upper right hand side, with our page’s structure. You can explore other pages. On these pages you’ll find a lot of links to documents.

The commission’s proposal of a regulation is here. It is currently discussed in EU’s parliament and council. A joint opinion on it by EU’s data protection authorities has been given.

The parliament’s time schedule for processing this file with names of reporters and fraction’s shadow reporters is here. The parliament’s comittees involved are Civil Liberties, Justice and Home Affairs (LIBE) and Environment, Public Health and Food Safety (ENVI). Current status is that the first version of a comittee report has been drafted.