Changes from plenary report to adopted text

RemovedEXPLANATORY STATEMENT

RemovedThe rapporteurs welcome the Commission’s proposal on the European Health Data Space and its high ambition. Using the power of health data through a safe and secure exchange environment within the EU for both primary and secondary use will be important to ensure more efficient and high-quality care for patients, to improve decision-making by healthcare professionals, and to ensure science-based and reliable responses to future health crises such as a possible new pandemic.

RemovedSince the proposal concerns sensitive personal data, processing of which is allowed only for specific purposes, it is important to clarify the relationship between the provisions in the EHDS proposal and the GDPR, the EU Charter of Fundamental Rights and Member State laws on data protection. The level of data protection guaranteed by the GDPR shall be the benchmark to the level of data protection guaranteed within the EHDS.

RemovedPrimary use of health data

RemovedThe rapporteurs consider that the simplified and uniform exchange of health data for primary use will be of essence for the provision of high-quality and innovative healthcare across the Union and for the rights of patients to effectively access and assess their personal health data. The portability of health data should facilitate cross-border healthcare for Union citizens exercising their right of free movement across the Union and will reinforce the possibility for patients to access healthcare in other Member States as laid down in Regulation No 883/2004 and Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare.

RemovedThe rapporteurs consider that harmonisation of health data needs to be further clarified to ensure true interoperability of health systems. The rapporteurs consider that some of the rights of patients as data subjects should be clarified. Notably, the right to obtain free and digital copies of their health data should apply on top of the rights established by Article 15 of the GDPR.

RemovedIt is furthermore necessary that representatives of healthcare professionals and patients are represented in the digital health authority of each Member State to ensure their interests are duly taken into account in the implementation of these actions.

RemovedSecondary use of health data

RemovedThe rapporteurs consider that the secondary use of health data can significantly contribute to the public health objectives of the Union, thanks to policy makers, researchers, innovators and enterprises activities. Secondary data must be representative, reliable and available to serve the use in the public interest of the data. At the same time, patients’ and public trust in the processing of such data must be strong. Further clarifications of the purposes of such processing much hence be provided.

RemovedThe rapporteurs consider it necessary to lay down that no processing of health data for secondary use should be allowed to the detriment of persons or groups in economic activities, most notably in the labour market or in the provision of financial services.

RemovedThe rapporteurs consider that the prescribed processes through which data permits for secondary use must be granted after a decision by the health data access body, after a substantiated and vetted application is a necessary safeguard for public trust in the use of their data and that such processing fulfils the necessary criteria. However, such direct access may be necessary in cases such as to manage an epidemic or for pharmacovigilance purposes. Any access to such data from the data holder should hence be limited to the cases necessary for public health purposes and limited to public sector bodies.

RemovedThe rapporteurs note that the obligation to provide data for secondary use also covers data that contain intellectual property rights and trade secrets. This obligation may create insecurity of their confidentiality for health industry actors such as pharmaceutical and medical device companies. It is therefore important to introduce measures to preserve the confidentiality of intellectual property rights, strictly and uniformly applied across the Union, notably to avoid some applicants seeking access to data for secondary use in one Member State where controls of such confidentiality may be less stringently enforced. The rapporteurs will favourably consider strengthened provisions for IP rights and trade secrets with legal clarity for all concerned actors and that can ensure uniform application across the Union.

RemovedThe rapporteurs consider that Chapter IV on secondary use of health data as proposed by the Commission requires certain amendments to align better with aforementioned fundamental rights framework. Article 8(2) of the Charter of Fundamental Rights emphasizes individuals’ power over and protection of their personal data. The principle of proportionality requires that the more sensitive personal data are, the stricter the processing requirements are. This is reflected in Article 6 and especially Article 9 of the GDPR. Health data are among the most sensitive personal data of all, processing of which is subject to strengthened safeguards and conditions under Article 9 of the GDPR. It is therefore necessary to further clarify the relationship between the conditions for processing of health data under that article and articles 34 under the proposal. It is commendable that Article 1(4) states that the EHDS is without prejudice to the rules of the GDPR. Recital 37 suggests that the catalogue of processing purposes of Article 34 EHDS concretizes Article 9(2) (h), (i) and (j) GDPR. However, the purposes of Article 34 EHDS proposal are formulated in a broader and vaguer way than Article 9(2)(h), (i) and (j) GDPR. Hence the purposes of processing under 9(2) should be directly integrated in Article 34.

RemovedConsent is the legal basis for the processing of health data in some Member States. Hence, processing health data for secondary use without consent of the data subject means a significant shift in data protection law as applied and would create an important precedent for further legal acts on secondary data use. The participation of the data subjects must be ensured. Therefore, a right to a partial or entire opt-out for some or all of the purposes of secondary use should be provided and to ensure the right to object provided by Article 21(6) of the GDPR.

RemovedGovernance

RemovedThe rapporteurs welcome the establishment of a European Health Data Space Board. The rapporteurs would like to furthermore extend its tasks to enable it to give recommendations to ensure actual interoperability between health data systems to avoid inconsistencies in application between Member States.

RemovedIt is also necessary to expand the composition of the Board to representatives of health stakeholders including representatives of patients, health professionals and the health industry, the latter being appropriate as the Board does not directly take supervisory decisions as regards economic operators. It is furthermore reasonable to give a permanent seat in the Board to representatives of the most concerned Union agencies and other bodies, being the European Medicines Agency, European Centre for Disease Prevention and Control, a representative of the European Data Protection Board, and a representative of the European Data Protection Supervisor.

RemovedMiscellaneous

RemovedDue to the sensitive character of health data and the necessity for Union and Member States authorities to supervise the storage of such data, the rapporteurs consider it necessary to provide that electronic health data should be stored in the territory of the Union. Such a storage requirement should however not preclude the transfer of such data insofar as such transfers are allowed under Chapter V of the GDPR.

RemovedThe rapporteurs consider that wellness applications have a role in the digital health landscape, which is still in an early and developing stage. It is therefore appropriate to make the labelling of wellness applications compatible with EHR systems voluntary at this moment. The data of wellness applications for secondary use would provide for data of lower quality for secondary use and may not cover the entire population, but may still be of relevance together with other data. The rapporteurs do however see other privacy concerns regarding the sharing of health data under such applications. Such concerns must be addressed through the enforcement by responsible authorities under the GDPR and other applicable law.

RemovedThe successful and timely implementation of the EHDS across all Member States will require sufficient funding from Union sources. Member States are not equally advanced in the digitisation of their health systems and previous experience in harmonising the exchange of health data and ensuring the interoperability of systems within Member States show that costs and timelines are often not fully met. Furthermore, not all Member States are in the same financial and/or administrative position to successfully implement all the requirements of the proposal, which could jeopardise the benefits for all other Member States and financial support in this regard hence has a genuine European added value is needed.

RemovedThe rapporteurs note with some concern the relatively restrictive budget allocated for the EHDS in the Legislative Financial Statement and sees the risk that the allocated budget may not be sufficient in fully meeting the objectives of the proposal. Furthermore, it is the position of the Parliament that new Union initiatives should be met with fresh financial resources, while there is a genuine concern that the EHDS will compete with other actions under the EU4Health and Digital Europe programmes foreseen at the adoption of the 2021-2027 Multiannual Financial Framework. The Commission should therefore analyse the need for strengthening the budget allocated to the implementation of the EHDS as part of any revision of the MFF and in the proposal for a new MFF in the period after 2027.