Source: EURLEX
Language: en
Format: md

**Council of the**
**European Union**

**Interinstitutional File:**

**2022/0140(COD)**

**Brussels, 26 May 2023**
**(OR. en)**

**9368/23**

**SAN 244**
**PHARM 76**
**COMPET 434**
**MI 400**
**DATAPROTECT 138**
**CODEC 856**
**IA 106**

**NOTE**

From: General Secretariat of the Council

To: Permanent Representatives Committee/Council

Subject: Proposal for a Regulation on the European Health Data Space

              - _Progress report_

Delegations will find in the annex a progress report on the abovementioned proposal, to be

presented at the EPSCO (Health) Council meeting on 13 June 2023, with a view to inviting the

Council to take note of it.

This report has been drawn up under the responsibility of the Presidency and is without prejudice to

particular points of interest or further contributions from individual delegations. It sets out the work

done so far by the Council’s preparatory bodies and gives an account of the state of play as regards

the examination of the abovementioned proposal.

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**ANNEX**

## **Information from the Presidency on the progress achieved in the examination** **of the proposal for a Regulation on the European Health Data Space**

**I.** **INTRODUCTION**

1. On 3 May 2022, the Commission submitted a proposal for a Regulation on the European

Health Data Space **[1]** (EHDS), which was accompanied by an impact assessment and a

communication. It is the first of the European common data spaces proposed in the 2020

communication ‘A European strategy for data’ **[2]**, which announced the creation of nine sector

and domain-specific data spaces. The proposal for a Regulation on the EHDS has a legal basis

in Articles 16 and 114 of the Treaty on the Functioning of the European Union and is

considered a key pillar of the European Health Union.

2. The proposal aims to improve individuals’ access to and control over their personal electronic

health data (primary use of data), at both national and EU levels, and to facilitate data reuse

(secondary use of data) for research, innovation, regulatory and public policy purposes across

the EU. It also aims to improve the functioning of the single market, in particular for the

development, marketing, and use of digital health services and products (e.g. electronic health

record (EHR) systems). To this end, the proposal provides for a health-specific data

environment, including common rules, infrastructure and a governance framework.

**1** 8751/22 + ADD 1 + ADD 2.

**2**
[COM(2020) 66 final.](https://ec.europa.eu/info/sites/default/files/communication-european-strategy-data-19feb2020_en.pdf)

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3. On 26 September 2022, the European Economic and Social Committee adopted its opinion **[3]**

on the proposal, while the European Committee of the Regions delivered its opinion **[4]** on

8 February 2023.

4. On 13 July 2022, the European Data Protection Board and the European Data Protection

Supervisor issued a joint opinion **[5]** on the proposal.

5. Member States' National Parliaments were consulted on the compliance of the proposed

provisions with the principle of subsidiarity and proportionality. The Portuguese Parliament **[6]**

submitted an opinion stating that the proposal complied with the principles of subsidiarity and

proportionality and the Czech Chamber of Deputies and Senate **[7]** delivered two resolutions

respectively raising a number of issues.

**3** 12883/22.
**4** 6403/23.
**5** 11351/22.
**6** 12223/22.
**7** 13836/22 and 13814/22.

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6. At the European Parliament, the Civil Liberties, Justice and Home Affairs Committee (LIBE)

and the Environment, Public Health, and Food Safety Committee (ENVI) are both responsible

for the file. The rapporteurs appointed are MEP Annalisa Tardino (ID, IT) for LIBE and

MEP Tomislav Sokol (EPP, HR) for ENVI. The Committee on the Internal Market and

Consumer Protection (IMCO) and the Committee on Industry, Research and Energy (ITRE),

as associated committees, have also been involved in the work on the file. The rapporteurs

appointed are MEP Andrey Kovatchev (EPP, BG) for IMCO and Chistian-Silviu Busou (EPP,

RO) for ITRE. A draft report was presented on 1 March 2023 and further amendments to the

proposal were tabled until 23 March 2023 for ENVI-LIBE. The ENVI-LIBE committees are

expected to vote on the file in July 2023.

**II.** **WORK WITHIN THE COUNCIL**

7. The French Presidency organised five meetings of the Working Party on Public Health

dedicated to presenting the proposal, evaluating its impact assessment, and starting to

examine it. The Czech Presidency devoted 17 meetings to the file, concluding the first

examination of the proposal and tabling a revised text for Chapters II and III **[8]** .

**8** The progress was reported to the Council in 14768/22 + COR 1 of 1 December 2022.

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8. Building on the work done under previous presidencies, the Swedish Presidency tabled

compromises in the form of revised texts for Chapter I and Chapters IV to IX **[9]**, based on

discussions held at the meetings, on written comments from delegations and on clarifications

from the Commission. Nine meetings at technical level were dedicated to examining these

compromises and exchanging views on specific topics that needed in-depth consideration,

such as the definition and scope of EHR systems, the scope of wellness applications, the

possibility of a third-party assessment instead of self-certification for EHR systems, the rights

of natural persons and the possibility of an opt-out on secondary use of data, data categories

for secondary use and possible reciprocity requirements for third-country data users. The

compromises contained a number of adjustments to the Commission proposal, such as

replacing the advisory procedure with an examination procedure in all implementing acts (as

already presented in the Czech compromise on Chapters II and III), deleting delegated acts to

give greater influence to the co-legislators on essential elements of the proposal, introducing

the term ‘health’ before ‘data holder’ and ‘data user’ to specify the concepts of data holders

and users defined in the Data Governance Act and the Data Act, and clarifying the links with

the General Data Protection Regulation (GDPR). In particular, the following changes were

made:

**9** 5302/23, 6627/23 and 7353/23.

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       - In **Chapter IV,** which is dedicated to the secondary use of health data, the Presidency

made some structural changes to give further clarity to the text. Some provisions and

articles were moved (e.g. the duties of health data holders were moved from Article 41

to Article 35b, and Article 54 on mutual recognition was incorporated into Article 46

on data permits) and three new articles were added – on the scope for clarification, on

–
intellectual property rights and trade secrets, and on the duties of health data users

which brought together provisions that had been scattered between different articles.

In Article 46, the Presidency clarified the criteria that must be met before granting

access to electronic health data. The Presidency also deleted Article 48 on making data

available without a permit for public sector bodies and EU institutions and bodies. In

Article 49 on giving access to health data from a single health data holder, the

Presidency gave greater flexibility to Member States by making it optional. Moreover,

regarding joint controllership, the Presidency proposed the deletion of the term ‘joint’

in Article 51 while clarifying the roles of health data holders, health data access bodies

(HDABs) and health data users. As for connecting third countries and international

organisations to the HealthData@EU infrastructure, the Presidency made it clear that

transfers resulting from such a connection must comply with Chapter V of the GDPR.

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       - In **Chapters V to IX**, which focus on horizontal provisions such as additional actions,

governance and deferred application, the Presidency strengthened the requirements

and established a clearer link with the GDPR for obtaining EU funding. In the articles

related to the transfer of electronic health data to third countries, the Presidency

                      changed the term ‘non personal data’ to ‘anonymous data’, as it seemed more

appropriate when referring to natural persons. Concerning the EHDS Board, the

Presidency gave a greater role to Member States by including co-chairing and by

having them adopt the rules of procedure. The Presidency also suggested replacing the

joint controllership group with two steering groups and two fora for both the primary

and secondary cross-border infrastructure. The two steering groups would take

operational decisions regarding the infrastructure and be composed only of

representatives of Member States’ national contact points in order to strengthen

Member States’ power. The fora, on the contrary, would also include other authorised

participants with the aim of exchanging information without taking decisions. The

Presidency also proposed that decisions on accepting participants into and

disconnecting them from the infrastructures would not be taken by the steering groups

but by the Commission, through implementing acts and after a positive compliance

check. Lastly, the Presidency extended the timeframes for when the Regulation would

apply and its transitional provisions, and introduced a specific timeframe for the

application of Chapter IV.

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       - In **Chapter I,** dedicated to the subject matter, the scope and definitions, the Presidency

revised the subject matter and scope to clarify what the proposed Regulation covered.

Additionally, the Presidency deleted some definitions, such as ‘HealthData@EU’, as

they were already described in the articles, and made a number of clarifications, for

example in the definitions of ‘data permit’, ‘health data holder’, ‘electronic health

data’ and ‘personal electronic health data’.

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In general, the revised texts were well received by the delegations, who welcomed the

changes made by the Presidency, though they felt the proposal would still benefit from further

amendments. Some delegations appreciated the new structure as they considered it to have

brought clarity to the text, and deemed that the proposal was better aligned with the GDPR.

Likewise, many delegations supported the decisions to include the description of the

controller role (Article 51), delete the automatic issuance of a data permit once the time limit

has expired (Article 46), and give flexibility to Member States in deciding if a data permit

could also be given by a single data holder (Article 49). Numerous delegations also welcomed

the extension of the timeframes regarding the entry into force and application of the different

provisions, and the deletion of several delegated acts. The deletion of Article 48 was widely

appreciated by a majority of delegations, although some would support a fast-track procedure

for EU institutions and national authorities in certain cases. Nevertheless, some delegations

were still concerned about the administrative burden resulting from the HDAB reporting

obligations, and the process for providing an answer to data requests and for issuing data

quality labels. Furthermore, the in-depth discussions during the meetings showed that

delegations were divided in their positions on a number of topics, such as what the definitions

of health data user, health data holder and EHR systems should cover, whether a third-party

certification or assessment should be introduced for EHR systems, whether wellness

applications should be included in Chapters III and IV, what the scope of data categories and

of the purposes to be included for secondary use should be, and if an opt-out (or an opt-in)

procedure for secondary data should be added. As regards the possibility of reciprocity for

third countries’ access to data, it became apparent that further discussions were needed. As

regards the priority categories of data for secondary use, some Member States were willing to

keep categories such as data from clinical trials or human genetic, genomic and proteomic

data in the proposal if additional safeguards were added to the text. In addition, several

Member States saw a need for clarification regarding the rights of natural persons in relation

to the secondary use of data in order to ensure transparency and trust.

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9. Taking into account the discussions at the meetings and the written comments from

delegations on the first revised texts, the Presidency has published a second compromise text

encompassing the whole proposal **[10]** . This has been discussed at two technical meetings; two

more meetings are planned for June. The Presidency has introduced substantial changes in

comparison to the original proposal:

       New articles have been added on the rights of natural persons as regards secondary use

of data, covering different scopes and contexts and building on the rights under the

GDPR, including an opt-out solution. For primary use, the provisions related to the

rights of natural persons have been separated out into different articles with the aim of

clarifying the scope of each right.

       New articles have been added grouping together existing provisions to give a clearer

structure to the text and to align the provisions on primary and secondary use, such as

those relating to reporting by digital health authorities, electronic health data access

services, the relationship with data protection regulation for as regards both primary

and secondary use, and templates to support access to electronic health access for

secondary use.

       The order of the articles has been changed in both Chapter II and Chapter III. In

Chapter II, the Presidency has started with the obligation of registration, followed by

access to and exchange of priority categories; Chapter III has been rearranged to start

with the scope, followed by the relationship with other regulations.

       In Chapter I, new definitions have been added for ‘anonymous electronic health data’

and ‘contracting authorities’, for example, and further amendments have been made to

existing definitions, mainly to adjust their scope.

**10** 8171/1/23 REV 1.

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       In Chapter II, the possibility of adding additional priority categories by means of a

delegated act has been removed.

       In Chapter III, the Presidency has introduced a new article stating that Member States

remain free to regulate the use of wellness applications within their healthcare system.

       In Chapter IV, the Presidency has added the option for Member States to decide on

rules for the enrichment of datasets. Prohibited uses have been added and more detail

has been given on the purposes. Regarding HDABs, some tasks and reporting

obligations have been removed to ease their burden. In the event of non-compliance

by health data holders and health data users, the Presidency has strengthened HDABs’

power to take immediate action by revoking the data permit. The Presidency has also

suggested that HDABs should assess various risks when issuing a data permit or a data

request in statistical format. The Presidency has also proposed that the Commission

should issue guidelines on fee policies and structures instead of adopting

implementing acts, and that fees may include costs related to the gathering and

preparation of datasets.

       In Chapters V-IX, the article on the fora has been removed and its provisions have

been integrated into the article on the steering groups. Certain elements have been

added to the penalties to ensure a more harmonised implementation. Regarding the

deferred application, transitional and final provisions, a specific timeframe has been

set to adopt several implementing acts, and the entry into force of Chapter IV has been

staggered depending on the data category.

       The links to the GDPR have been further clarified in recital 37, and those references

removed accordingly from the specific articles.

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Member States’ initial reactions to this new compromise have been positive, indicating that the

changes are going in the right direction. The Presidency believes that the progress that has been

made will be a good basis for follow-up work, although it recognises the need for further fine

tuning and topical discussions on issues such as roles and responsibilities in cross-border

infrastructure, the application of Chapter II to existing EHR systems, the need for European central

services such as an EU HDAB, and the interplay with other legislation such as the NIS Directive

and the Clinical Trials Regulation.

**III.** **CONCLUSIONS**

10. The Council is invited to take note of the progress that has been achieved in the negotiation of

the proposal, confirm that the work carried out by the Presidency provides a good basis for

future discussions, and invite the incoming Presidency to build on the progress made so far.

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