Article 105
Entry into force and application
In short: The priority categories of data, as specified by both the EHDS as well as its delegated acts, shall be supported by either
2029 (patient summaries, electronic prescriptions/dispensations) or 2031 (imaging studies and reports, medical test results, discharge reports).
(Please note that content related to secondary use of data has been removed from the text below)
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall apply from 26 March 2027.
However, Articles 3 to 15, Article 23(2) to (6), Articles 25, [Chapter II]
26,
27,
47,
48 and
49 [Chapter III] shall apply as follows:
- (a) from 26 March 2029 to priority categories of personal electronic health data referred to in Article 14(1), points (a), (b) and (c),
and to EHR systems intended by the manufacturer to process such categories of data;
- (b) from 26 March 2031 to priority categories of personal electronic health data referred to in Article 14(1), points (d), (e) and (f),
and to EHR systems intended by the manufacturer to process such categories of data;
- (c) from one year from the date established in a [Art. 14(2)] delegated act to be adopted pursuant to Article 14(2) for each amendment of the main
characteristics of personal electronic health data set out in Annex I,
provided that that date is subsequent to the date of application
referred to in points (a) and (b) of this subparagraph for the categories of personal electronic health data concerned.
Chapter III shall apply to EHR systems put into service in the Union referred to in
Article 26(2) [systems developed by healthcare provider organizations themselves, and systems available as-a-service] from 26 March 2031.
The implementing acts referred to in Article 13(4), Article 15(1), Article 23(4) and Article 36(1) shall apply from the dates referred
to in the third paragraph of this Article depending on the categories of personal electronic health data referred to in Article 14(1), points (a), (b) and (c),
or Article 14(1), points (d), (e) and (f), respectively.
From the EHDS FAQ:
In practical terms:
- As a patient, you will be able to use the health data access services and exercise your rights in primary use
from entry into force by 26 March 2029 for the first group of priority categories (patient summary,
electronic prescriptions, electronic dispensations) and from 26 March 2031 for the remaining categories.
- As a manufacturer of EHR systems, from 26 March 2029, you will only be allowed to place on the market [the first making available of a product on the Union market]
EHR systems that comply with the common specifications for the harmonised components for systems
processing the first group of priority categories, and from 26 March 2031 for systems processing the
remaining categories
Discussion
The wording of these articles aligns with the
generic EU product rules, which defines the terms 'put into service',
'placing on the market', and 'substantive change'.
To summarize the various timing requirements:
- For brevity, we'll refer to the requirements related to patient rights defined in articles 3 to 15 as 'Chapter II', and the EHR System requirements in articles 23 up to 49 as 'Chapter III'.
- Chapter II requirements (on the member state infrastructure as a whole) shall apply from March 2029 onwards for data in the first priority categories,
and from March 2031 onwards for data in the remaining priority categories. The patient should be able to exercise their rights
via the Health Data Access Service (HDAS) regardless of the fact whether or the backend healthcare software applications have implemented the
the EHDS harmonized components, and regardless of whether such applications support the EEHRxF or not.
Applications, in combination with third party systems or national infrastructure components, are required to meet the functional requirements listed in Chapter II.
- Note that all of these patient rights apply both within the member state of the patient (via the member state infrastructure) as well as (via MyHealth@EU) to other member states.
- Most member states will have some kind of national infrastructure which acts as the linking pin between the various healthcare applications used within that member state and the HDAS used by a patient.
Chapter II affectively amounts to a requirement for all applications (new or existing, which hold any data which falls within the priority data categories) to hook up (in some way) to the national infrastructure.
- Technical details can be found in the Article 17 Implementing Act.
- Chapter III requirements (on EHR Systems developed by manufacturers) shall apply from March 2029 onwards for the first priority categories,
and from March 2031 onwards for the remaining priority categories. After those dates, new applications, or existing applications which have undergone substantive changes (thus creating a new application)
shall be capable to exchange data using the EEHRxF. Systems that were put on the market prior to these dates are not required to implement the harmonized components.
- For systems developed by healthcare provider organizations, or EHRs-as-a-service (as specified in article 26(2)) are subject to a deferred
deadline: the Chapter III requirements only apply (to new systems) after March 2031 for all priority categories.
- Vendors may (e.g. at the request of a customer) choose to support the EHR System requirements, even if they're not required to do so by the EHDS regulation.
- Individual member states (notably those that have well established national infrastructures) may pass legislation which mandates specific categories of existing (not just: new) applications
to support the Chapter III requirements at an earlier point in time than the one stipulated in the EHDS.
For example: a member state could create a mandate for EHRs (in the general sense of the word, not the EHDS formal term) and other applications which aggregate data to support the harmonized components by March 2029.
The member state could also define 'EHDS EHR System conformance' as a requirement for any RFPs.
- The EHDS requires compliance of EHRs (compliant harmonized components have to be present), but doesn't require actual use of these harmonized components.
- Technical details can be found in the Article 36 Implementing Act.
Example 1: a vendor introduces a new Laboratory system in 2030. The data produced by this system is within scope of the Patient Summary data category.
- The introduction of the system occurs after the March 2029 applicability date for the Patient Summary category, which means that the application has to fulfill all of the Chapter III requirements,
which includes support for the harmonized components and support of the EEHRxF format.
- The Chapter II requirements apply: the system will have to ensure that (somehow) a patient has the ability to access the Patient Summary data and exercise all of the rights listed in Chapter II.
Given that the system supports the harmonized interoperability component and EEHRxF it would seem likely that the national infrastructure of a member state would use
this component to ultimately make data available to the patient via the HDAS.
Example 2: a vendor introduced a new Allergy Testing application in 2020. The data produced by this system is within scope of the Patient Summary data category.
- The introduction of the system occurred before the March 2029 applicability date for the Patient Summary category, which means that the application does not have to support the Chapter III requirements.
- The Chapter II requirements apply: the system will have to ensure that (somehow) a patient has the ability to access the Patient Summary data and exercise all of the rights listed in Chapter II.
Given that the system does not support the harmonized interoperability component nor EEHRxF it would seem likely that the national infrastructure of a member state would use
some other means (a member state specific way, e.g. using HL7 version 2 messages from the system to a national clinical repository, which in turn creates PDFs which include the allergy information)
to ultimately make data available to the patient via the HDAS.
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ehds@ringholm.com should the information on this page be incorrect or incomplete; we welcome your suggestions to improve its content.
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