secondary use of well being knowledge within the EHDS framework – European Legislation Weblog – Cyber Information

Blogpost 17/2024

In accordance with the European knowledge technique the European Fee gave its proposal for the Regulation on European Well being Information House (EHDS) in Could 2022. The aim of the EHDS is to ascertain a compulsory cross-border infrastructure which makes it potential for residents to entry their digital well being knowledge anyplace in Europe for well being care functions and use such knowledge for reimbursement functions and comparable functions (major use). Moreover, EHDS creates a compulsory cross-border infrastructure for the secondary use of digital well being knowledge, comparable to digital affected person data, genetic knowledge, socio-economic knowledge and knowledge processed in relation to healthcare providers.  The secondary makes use of cowl every thing from public well being, planning and statistical functions, scientific analysis, growth and innovation actions, coaching and testing of algorithms and offering personalised healthcare.

Every nation shall have one central public sector well being knowledge entry physique which shall assess the purposes for accessing digital well being knowledge and problem knowledge permits for accessing pseudonymised knowledge units or solutions to knowledge requests in anonymised statistical format. It should additionally keep a public data system and fulfil obligations in the direction of pure individuals as required by the EHDS Regulation and the GDPR.  Holders of digital well being knowledge are obliged to grant entry to their knowledge by the entry physique when knowledge allow is granted or reply to knowledge request is offered.

Given the delicate nature of well being knowledge, choosing the well being knowledge area as the primary of a number of knowledge areas to be instituted inside EU was a daring transfer from the Fee. This could possibly be defined by the necessity to make it potential for Europeans to hunt well being care inside the EU and from the urgent have to harmonise interpretation of the GDPR and nationwide legal guidelines with regard to finishing up EU-wide well being analysis tasks, in addition to the need of the pharmaceutical business to acquire giant quantities of EU-originated well being knowledge. The up-coming European elections in June 2024 have put strain on totally different establishments to reach to a standard place in relation to the proposed regulation. The Council of Ministers and the EU Parliament each have been capable of provide you with negotiating mandates in December which made it potential to begin with the Trilogue negotiations between totally different EU establishments already in then.

The scope of proposed secondary makes use of of digital well being knowledge is broad. In line with the unique Fee proposal the rights of information topics would depend on the GDPR and the one further safeguard can be the safe technical processing surroundings for private well being associated knowledge. The extent to which knowledge topics ought to management the secondary use of their well being associated knowledge within the EHDS has turned out to be one of the contentious points dividing the Council and the Parliament.

Within the following weblog I shall first talk about totally different types of management envisaged for knowledge topics over the secondary use of their well being knowledge. Thereafter I’ll describe the respective positions of various establishments and talk about them in mild of the Finnish legislation referring to the secondary use of well being and social knowledge which has acted as one the fashions of the EHDS proposal.


Choose-out or -in versus proper to object

When contemplating the diploma of management the information topics have over the secondary use of their well being knowledge we should always make a distinction between the GDPR primarily based consent and proper to object, on the one hand, and the basic rights and ethics primarily based consent (opt-in) and its lighter model opt-out, then again. Briefly, the GDPR primarily based consent pertains to the processing of private knowledge and is proposed by the Parliament for genetic, genomic and proteomic knowledge. The Fee and the Council don’t suggest a consent for any kind of secondary use of processing.

The precise to object when it comes to the GDPR offers the information topic the proper to object, on grounds referring to their specific state of affairs, at any time to processing of their private knowledge when such processing is predicated on public curiosity (Article 6 para 1(e)) or reliable curiosity (Article 6 para 1(f)). After the objection the controller can not course of the private knowledge until it will possibly exhibit, i.a. compelling reliable grounds which override the pursuits, rights and freedoms of the information topic. (Article 21 para 1) For scientific or historic analysis or statistical functions the proper to object is legitimate until the processing is critical for the efficiency of a activity carried out for causes of public curiosity. (Article 21 para 6) In different phrases, the information topic can’t train their proper to object until they offer a private motive to such objection and for scientific or statistical use this might not be sufficient if the processing is deemed to be essential for public curiosity causes. Proper to object is thus conditioned by disclosing private causes by the information topic, that’s extra  private knowledge, and the eventual overriding pursuits of the controller.

In line with the GDPR the proper to object should be explicitly dropped at the eye of the information topic and shall be offered clearly and individually from every other data on the time of the primary communication with the information topic. The info topic might train this proper by automated means and utilizing technical specs. (Article 21 para 4)

An opt-out is utilized in many areas of legislation and every needs to be regarded individually. In line with the  the French Senate secondary processing of well being knowledge ought to require a consent from the information topic however that consent could possibly be deemed to have been given if individuals after having been knowledgeable of the secondary use haven’t against it. The European knowledge safety board (EDPB) states that in instances the place consent shouldn’t be the idea for processing of private knowledge it will possibly nonetheless be used as a safeguard for processing. Furthermore, a proper to ban direct advertising when it comes to Article 21.2 GDPR is an unconditional proper to ban using private knowledge for direct advertising and is usually known as an opt-out. Accordingly, an opt-out could possibly be described as a safeguard for the processing of particular classes of private knowledge inside the EHDS when consent shouldn’t be required. Equally, an opt-in or so known as moral consent, when it isn’t the used because the authorized foundation for processing of private knowledge could possibly be described as a safeguard when it comes to the GDPR.


Council negotiating mandate: totally different variations of the proper to object

The Council mandate for the negotiations is written in a fashion which leaves the troublesome points of the Regulation to Member States’ nationwide laws. This pertains, specifically, to the train of rights of information topics. The precise to object to the secondary processing of their knowledge is a core instance. If the essential points are left to the Member States or, as proposed by the Fee, to the GDPR, the present state of affairs with regard to making use of the GDPR for cross-border analysis and growth tasks shall be reproduced inside the EHDS and every nation will find yourself making use of their very own model and interpretation of the legislation.

Even the position of the proposed proper to object for secondary makes use of is fluid. In line with the Council ‘[i]t is suitable to go away Member States free to resolve to introduce and modulate such a proper because it entails a steadiness between particular person autonomy and the provision of well being knowledge for secondary use functions, which is finest made at nationwide degree, taking into consideration Member States’ particular conditions and historic experiences.(recital 37a)The place a Member State doesn’t introduce a selected proper to object in accordance with article 35F of this regulation, solely Article 21 of Regulation (EU) 2016/679 will apply.’

The Council Mandate proposes a brand new Article 35f through which totally different choices for introducing proper to object in Member States are given. First you will need to emphasize that based on the Council introducing any form of proper to object past Article 21 GDPR on the nationwide degree can be voluntary and as much as Member States. Probably the most complete opt-out model is the one based on which pure individuals may train their proper to object, at any time and with out stating causes, in a easy and accessible method, together with by digital means.

The Council additionally highlights the opportunity of a Member State to limit the proper to object beneath the situations set out in Article 23 GDPR in case a Member State chooses to not implement the total opt-out with regard to secondary makes use of of well being knowledge. This might be potential, specifically,  in relation to functions associated to the safety of public well being and occupational security and  actions guaranteeing excessive ranges of high quality and security of healthcare and of security of medicinal merchandise or medical gadgets. Member States must implement applicable and efficient measures to tell knowledge topics about such restrictions to their proper to object.

To sum up, the Council place appears to be that Member States may select to introduce a full or partial proper to object offering knowledge topics higher management over the secondary makes use of of their well being knowledge, or to not introduce any particular proper to object past Article 21 GDPR.


EU Parliament negotiating mandate

In distinction to the EU Council the EU Parliament proposes an introduction of a complete opt-out for all secondary makes use of of digital well being knowledge except for genetic, genomic and proteomic knowledge for which a consent in required. This proper to opt-out is anchored in securing the confidential relationship between the affected person and the doctor as confirmed by the European Courtroom of Human Rights. Accordingly, it’s offered that Member States shall present for an accessible and simply comprehensible opt-out mechanism, whereby pure individuals are supplied the likelihood to explicitly specific their want to not have all or a part of their private digital well being knowledge processed for some or all secondary use functions. The train of this proper is not going to have an effect on the lawfulness of the processing that came about beneath EHDS earlier than the person opted-out (Article 35(5).

Given the delicate nature of sure well being associated knowledge and the difficulties referring to anonymizing of such knowledge, it’s additional offered that extracts from human genetic knowledge, genomic and proteomic knowledge, comparable to genetic markers, and knowledge from biobanks and devoted databases can solely be made out there for secondary use after acquiring the consent of the pure individual. Particular person consent can also be required for secondary makes use of of private knowledge obtained from wellness purposes.

The Parliament Mandate supplies additional that well being knowledge entry our bodies make publicly out there and simply searchable and accessible for pure individuals the situations beneath which their digital well being knowledge is made out there for secondary use. Information topics needs to be made conscious of the delicate nature of such knowledge. This could embrace data on, amongst different issues, the authorized foundation beneath which entry is granted to the well being knowledge person and the relevant rights of pure individuals in relation to secondary use of digital well being knowledge, together with the proper to opt-out and the proper to opt-in and detailed data on learn how to train them (Article 38).

Since pure individuals are left the likelihood to opt-out or opt-in for all or a few of the components of their knowledge for all or a few of the secondary makes use of, it’s crucial that they’re conveyed detailed data as to this risk, the character of various makes use of and the methods to train their rights. Learn how to implement these provisions in follow shouldn’t be offered for, however it’s conceivable that such data will be simply given in digital on-line service, through which the likelihood to opt-out or opt-in will be exercised by knowledge topics. Digital data system could possibly be in-built a fashion to robotically acknowledge in reference to the gathering of digital well being knowledge the secondary makes use of permitted for a given private digital well being knowledge.


Clear processing and proper to data as the idea for exercising rights of information topics

Intently linked to the dialogue on whether or not to have an actual opt-out or a nationally utilized proper to object are the provisions of the GDPR referring to the clear processing of private knowledge and facilitating using rights (Articles 12 to 14). In line with the unique proposal of the Fee, well being knowledge entry our bodies should not obliged to supply data to knowledge topics for tasks topic to knowledge allow however they need to present basic public data on all knowledge permits issued pursuant to the Regulation (Article 38(2)).

Transparency of processing of private knowledge shouldn’t be solely compulsory when it comes to the GDPR however based on the European Information Safety Board it will possibly additionally act as an extra safeguard in a state of affairs when circumstances of the analysis don’t permit for a selected consent. This might communicate in favour of stronger data necessities which might make it potential for knowledge topics to know when and for what secondary functions their digital well being knowledge is getting used.

A significant examine carried out in 12 European international locations about digital well being knowledge sharing concluded that individuals need to learn concerning the sharing of their well being knowledge for secondary functions. Individuals additionally needed to be answerable for the sharing of private well being knowledge for various functions. Given some geographical variations of the respondents when it comes to the extent of management, the authors suggest a compromise mannequin reflecting the final angle of the respondents. That is characterised as ‘moral consent’ in a type of dynamic digital consent on a digital platform through which knowledge topics may management using their well being knowledge. This mannequin may additionally embody the opt-out mannequin proposed by the Parliament. If realised as an opt-in mannequin within the EHDS it is also used because the authorized foundation for the processing of private well being knowledge.


Secondary use of well being knowledge and proper to object beneath Finnish legislation

As Finland was one of many foremost advocates for the EHDS having already a comparable framework for well being knowledge secondary makes use of in place, it’s fascinating to see how Finland has included the opt-out risk within the secondary use of well being knowledge laws.

Within the Finnish legislation referring to secondary makes use of of well being and social knowledge, upon which the proposal for the EHDS Regulation for the massive half is fashioned, no specific proper to opt-out is included. It’s potential to train the proper to object when it comes to the GDPR article 21 inside the permission authority, Findata, by registering it within the authorities e-identification scheme and by giving a private motive for the objection. It’s unclear in what sort of conditions the proper to object could possibly be overridden by the applicant of the information allow. In such instances individuals having opted-out needs to be knowledgeable and they’re able to attraction this resolution.

Thus far, roughly 230 individuals out of inhabitants of 5,6 million have used their proper to object. Findata offers data referring to this proper at its web-page.  Different holders of private well being knowledge which put it to use for secondary makes use of should not have as simply obtainable data concerning the likelihood to train the proper to object however the data is included within the basic knowledge safety documentation out there on the web-pages of hospital districts, personal well being care suppliers and the Finnish Institute of Well being and Welfare.

It must also be highlighted that the nationwide Finnish knowledge safety legislation complementing the GDPR requires that  the information controller assesses in every case whether or not it’s essential to not apply the proper to object or different rights for a selected analysis venture when it comes to  Article 89.2 GDPR. The legislation supplies for a number of situations for this, together with finishing up a knowledge safety influence evaluation (DPIA) for the processing of particular classes of information. This additionally presupposes that using the exception for a selected analysis venture is correctly communicated to knowledge topics. That is crucial because the knowledge topic can’t contest the choice both within the court docket or to the information safety authority in the event that they have no idea that their knowledge is getting used despite the objection.



If the Council model of the EHDS Regulation of proper to object is adopted this may very doubtless result in authorized uncertainty when it comes to dealing with the rights in EU extensive knowledge units. An opt-out is a de facto prohibition of sure kind(s) of secondary makes use of of information whereas a proper to object when it comes to Article 21 is a conditional proper the appliance of which is restricted and topic to in casu interpretation. This consists of an obligation to tell the information topics for various processing actions the place the proper to object wouldn’t be permitted, together with the likelihood to attraction that call. Furthermore, the information topic must reveal a private, probably a delicate motive for objecting to the processing within the first place, which motive may reveal additionally their id.

We are able to additionally ask, given the sensitivity of the private knowledge in query and wide selection of secondary makes use of, whether or not a restricted conditional proper to object would fulfil the necessities of Article 52(1) of the Constitution of the European Union, which units the final requisites for proscribing elementary rights for Members States. Such restrictions should be offered by legislation, respect the essence of rights and freedoms and, in case of delicate knowledge, limitations must be strictly essential, and genuinely meet targets recognised by the Union or to guard rights and freedoms of others. For the reason that Council Mandate offers area for various variations of the constraints for knowledge topics’ proper to manage the secondary use of their private knowledge, it might introduce even additional authorized uncertainty inside the EHDS if in some Member States such limitations could possibly be thought to be not being appropriate with the Constitution of Basic Rights.

If individuals have been to have totally different prospects to object to using their private knowledge in numerous EU international locations this is able to additionally quantity to unequal remedy of information topics in numerous Member States. What we don’t need is to breed the current fragmented state of affairs when it comes to interplay of the GDPR and nationwide sectoral legal guidelines regulating processing of well being knowledge for secondary functions. The analysis sector has been notably laborious hit by this. It’s troublesome to share knowledge for bio-medical analysis even between the Nordic international locations which have a really comparable authorized framework.

As a way to give all residents within the EU equal rights to manage the secondary makes use of of their well being associated knowledge within the EHDS framework, clear EU-wide guidelines referring to the proper of the information topic to ban (opt-out) all or sure secondary makes use of of their private well being knowledge as proposed by the Parliament is to be most well-liked on this respect. The sensible implications would nonetheless should be hashed out as to, for instance, whether or not there may be one basic opt-out, or a risk to opt-out just for sure kind(s) of makes use of of private knowledge. The technological infrastructure for doing this could possibly be developed on the European degree in reference to setting-up EHDS technological framework.