Annexes to COM(2022)197 - European Health Data Space - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2022)197 - European Health Data Space. |
|---|---|
| document | COM(2022)197  |
| date | May 3, 2022 |
In order to ensure the effectiveness, efficiency and economy of the Commission controls, the control strategy will be oriented towards a balance of ex-ante and ex-post checks and focus on three key stages of grant/contract implementation, in accordance with the Financial Regulation:
a) Selection of proposals/tenders that fit the policy objectives of the Regulation.
b) Operational, monitoring and ex-ante controls that cover project implementation, public procurement, pre-financing, interim and final payments, management of guarantees.
Ex-post controls at the beneficiaries/contractors’ sites will also be carried out on a sample of transactions. The selection of these transactions will combine a risk assessment and a random selection.
2.2.2.Information concerning the risks identified and the internal control system(s) set up to mitigate them
The implementation of this Regulation focuses on the attribution of public procurement contracts and grants for specific activities and organisations.
The public procurement contracts will mainly be concluded in for the provision of European platforms for digital infrastructures and associated services, and technical assitance for the governance framework.
Grants will mainly be awarded for support the connection of Member States to the European infrastructure, to support interoperability projects and carrying out joint actions. The period of execution of the subsidised projects and activities varies from one to three years mostly.
The main risks are the following:
a) Risk of not fully achievening the objectives of the Regulation due to insufficient uptake or quality/delays in the implementation of the selected projects or contracts.
b) Risk of inefficient or non-economic use of funds awarded, both for grants (complexity of funding rules) and for procurement (limited number of economic providers with the required specialist knowledge entailing insufficient possibilities to compare price offers in some sectors).
c) Reputational risk for the Commission, if fraud or criminal activities are discovered; only partial assurance can be drawn from the third parties' internal control systems due to the rather large number of heterogeneous contractors and beneficiaries, each operating their own control system.
The Commission put in place internal procedures that aim at covering the risks identified above. The internal procedures are in full compliance with the Financial Regulation and include anti-fraud measures and cost-benefit considerations. Within this framework, the Commission continues to explore possibilities to enhance the management and to realise efficiency gains. Main features of the control framework are the following:
1) Controls before and during the implementation of the projects:
a) An appropriate project management system will be put in place focusing on the contributions of projects and contracts to the policy objectives, ensuring a systematic involvement of all actors, establishing a regular project management reporting complemented by on-site-visits on a case by case basis, including risk reports to senior management, as well as maintaining appropriate budgetary flexibility.
b) Model grant agreements and service contracts used are developed within the Commission. They provide for a number of control provisions such as audit certificates, financial guarantees, on-site audits as well as inspections by OLAF. The rules governing the eligibility of costs are being simplified, for example, by using unit costs, lump sums, contributions not linked to costs and other possibilities offered by the Financial Regulation. This will reduce the cost of controls and put the focus on checks and controls in high risk areas.
c) All staff sign up to the code of good administrative behaviour. Staff who are involved in the selection procedure or in the management of the grant agreements/contracts (also) sign a declaration of absence of a conflict of interest. Staff is regularly trained and uses networks to exchange best practices.
d) Technical implementation of a project is checked at regular intervals at the desk on the basis of technical progress reports of the contractors and beneficiaries; in addition contractors'/beneficiaries' meetings and on-site-visits are foreseen on a case by case basis.
2) Controls at the end of the project:
Ex-post audits are performed on a sample of transactions to verify on-the-spot the eligibility of cost claims. The aim of these controls is to prevent, detect and correct material errors related to the legality and regularity of financial transactions. With a view to achieving a high control impact, the selection of beneficiaries to be audited foresees to combine a risk based selection with a random sampling, and to pay attention to operational aspects whenever possible during the on-site audit.
2.2.3.Estimation and justification of the cost-effectiveness of the controls (ratio of "control costs ÷ value of the related funds managed"), and assessment of the expected levels of risk of error (at payment & at closure)
The yearly costs of the suggested level of controls under the third Health programme 2014-2020 represented approximately 4% to 7% of the yearly budget of the operational expenditure. This is justified by the diversity of transactions to be controlled. Indeed, in the area of health, direct management involves the attribution of numerous contracts and grants for actions of very small to very large sizes, and the payment of numerous operating grants to non-governmental organisations. The risk related to these activities concerns the capacity of (especially) smaller organisations to effectively control expenditure.
The Commission considers that the average costs of controls is likely to be the same for the actions proposed under this Regulation.
Under the third Health Programme 2014-2020, on a 5-year basis, the error rate for the on-the-spot audits of grants under direct management was 1.8% while for procurement contracts it was below 1%. This level of error is considered acceptable, as it is under the materiality level of 2%.
The proposed actions will not affect the way the appropriations are currently managed. The existing control system proved to be able to prevent and/or to detect errors and/or irregularities, and in case of errors or irregularities, to correct them. It will be adapted to include the new actions and to ensure that residual error rates (after correction) remain below the threshold of 2%.
2.3.Measures to prevent fraud and irregularities
Specify existing or envisaged prevention and protection measures, e.g. from the Anti-Fraud Strategy.
As for its activities in direct management, the Commission shall take appropriate measures ensuring that the financial interests of the European Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportional and deterrent penalties. To this effect, the Commission adopted an anti-fraud strategy, latest update of April 2019 (COM(2019)196), covering notably the following preventive, detective and corrective measures:
The Commission or its representatives and the Court of Auditors shall have the power of audit, on the basis of documents and on-the-spot, over all grant beneficiaries, contractors and subcontractors who have received Union funds. OLAF shall be authorised to carry out on-the-spot checks and inspections on economic operators concerned directly or indirectly by such funding.
The Commission also implements a series of measures such as:
a) decisions, agreements and contracts resulting from the implementation of the Regulation will expressly entitle the Commission, including OLAF, and the Court of Auditors to conduct audits, on-the-spot checks and inspections and to recover amounts unduly paid and, where appropriate, impose administrative sanctions;
b) during the evaluation phase of a call for proposals/tender, the applicants and tenderers are checked against the published exclusion criteria based on declarations and the Early Detection and Exclusion System (EDES);
c) the rules governing the eligibility of costs will be simplified in accordance with the provisions of the Financial Regulation;
d) regular training on issues related to fraud and irregularities is given to all staff involved in contract management as well as to auditors and controllers who verify the beneficiaries' declarations on the spot.
3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE
3.1.Heading(s) of the multiannual financial framework and expenditure budget line(s) affected
·Existing budget lines
In order of multiannual financial framework headings and budget lines.
| Heading of multiannual financial framework | Budget line | Type of expenditure | Contribution | |||
| Number | Diff./Non-diff. 66 | from EFTA countries 67 | from candidate countries 68 | from third countries | within the meaning of Article 21(2)(b) of the Financial Regulation | |
| 1 | 02 04 03 - Digital Europe Programme - Artificial Intelligence | Diff. | YES | YES | YES | NO |
| 2b | 06 06 01 - EU4Health Programme | Diff. | YES | YES | YES | NO |
| 7 | 20 02 06 Administrative expenditure | Non-diff. | NO | NO | NO | NO |
3.2.Estimated financial impact of the proposal on appropriations
3.2.1.Summary of estimated impact on operational appropriations
–◻ The proposal/initiative does not require the use of operational appropriations
– The proposal/initiative requires the use of operational appropriations, as explained below:
EUR million (to three decimal places)
| Heading of multiannual financial framework | 1 | Single Market, innovation and digital |
| DG CNECT | Year 2022 69 | Year 2023 | Year 2024 | Year 2025 | Year 2026 | Year 2027 | Subsequent years (yearly) | TOTAL 2023-2027 | ||
| • Operational appropriations | ||||||||||
| 02 04 03 - Digital Europe Programme - Artificial Intelligence | Commitments | (1a) | 10.000 | 20.000 | 20.000 | 50.000 | ||||
| Payments | (2a) | 5.000 | 15.000 | 10.000 | 10.000 | 10.000 70 | 50.000 | |||
| Appropriations of an administrative nature financed from the envelope of specific programmes 71 | ||||||||||
| Budget line | (3) | |||||||||
| TOTAL appropriations for DG CNECT | Commitments | =1a+1b+1c +3 | 10.000 | 20.000 | 20.000 | 50.000 | ||||
| Payments | =2a+2b+2c +3 | 5.000 | 15.000 | 10.000 | 10.000 | 10.000 | 50.000 | |||
| The contributions from the Digital Europe Programme as of 2023 are indicative, and will be considered in the context of the preparation of the respective Work Programmes. Ultimate allocations will be subject to the prioritisation for funding in the context of the underpinning adoption procedure and agreement of the respective Programme Committee. |
• TOTAL operational appropriations | Commitments | (4) | 10.000 | 20.000 | 20.000 | 50.000 | ||||
| Payments | (5) | 5.000 | 15.000 | 10.000 | 10.000 | 10.000 | 50.000 | |||
| • TOTAL appropriations of an administrative nature financed from the envelope for specific programmes | (6) | |||||||||
| TOTAL appropriations under HEADING 1 of the multiannual financial framework | Commitments | =4+ 6 | 10.000 | 20.000 | 20.000 | 50.000 | ||||
| Payments | =5+ 6 | 5.000 | 15.000 | 10.000 | 10.000 | 10.000 | 50.000 |
| Heading of multiannual financial framework | 2b | Cohesion, resilience and values |
| DG SANTE | Year 2022 72 | Year 2023 | Year 2024 | Year 2025 | Year 2026 | Year 2027 | Subsequent years (yearly) | TOTAL 2023-2027 | ||
| • Operational appropriations | ||||||||||
| 06 06 01 - EU4Health Programme | Commitments | (1a) | 26.000 | 25.000 | 34.000 | 35.000 | 50.000 | 15.000 | 170.000 | |
| Payments | (2a) | 13.000 | 25.500 | 29.500 | 34.500 | 67.500 | 15.000 | 170.000 | ||
| Appropriations of an administrative nature financed from the envelope of specific programmes 73 | ||||||||||
| Budget line | (3) | |||||||||
| TOTAL appropriations for DG SANTE | Commitments | =1a+1b+1c +3 | 26.000 | 25.000 | 34.000 | 35.000 | 50.000 | 15.000 | 170.000 | |
| Payments | =2a+2b+2c +3 | 13.000 | 25.500 | 29.500 | 34.500 | 67.500 | 15.000 | 170.000 |
• TOTAL operational appropriations | Commitments | (4) | 26.000 | 25.000 | 34.000 | 35.000 | 50.000 | 15.000 | 170.000 | |
| Payments | (5) | 13.000 | 25.500 | 29.500 | 34.500 | 67.500 | 15.000 | 170.000 | ||
| • TOTAL appropriations of an administrative nature financed from the envelope for specific programmes | (6) | |||||||||
| TOTAL appropriations under HEADING 2b of the multiannual financial framework | Commitments | =4+ 6 | 26.000 | 25.000 | 34.000 | 35.000 | 50.000 | 15.000 | 170.000 | |
| Payments | =5+ 6 | 13.000 | 25.500 | 29.500 | 34.500 | 67.500 | 15.000 | 170.000 |
Heading of multiannual financial framework | 7 | Administrative expenditure |
This section should be filled in using the 'budget data of an administrative nature' to be firstly introduced in the Annex to the Legislative Financial Statement (Annex V to the internal rules), which is uploaded to DECIDE for interservice consultation purposes.
EUR million (to three decimal places)
| Year 2022 | Year 2023 | Year 2024 | Year 2025 | Year 2026 | Year 2027 | Subsequent years (yearly) | TOTAL 2023-2027 | |||
| DG SANTE | ||||||||||
| • Human resources | 3.289 | 3.289 | 3.289 | 3.289 | 3.289 | 3.289 | 16.445 | |||
| • Other administrative expenditure | 0.150 | 0.150 | 0.250 | 0.250 | 0.250 | 0.250 | 1.050 | |||
| TOTAL DG SANTE | Appropriations | 3.439 | 3.439 | 3.539 | 3.539 | 3.539 | 3.539 | 17.495 |
| TOTAL appropriations under HEADING 7 of the multiannual financial framework | (Total commitments = Total payments) | 3.439 | 3.439 | 3.539 | 3.539 | 3.539 | 3.539 | 17.495 |
EUR million (to three decimal places)
| Year 2022 | Year 2023 | Year 2024 | Year 2025 | Year 2026 | Year 2027 | Subsequent years (yearly) | TOTAL 2023-2027 | |||
| TOTAL appropriations under HEADINGS 1 to 7 of the multiannual financial framework | Commitments | 29.439 | 38.439 | 57.539 | 38.539 | 73.539 | 18.539 | 237.495 | ||
| Payments | 16.439 | 33.939 | 48.039 | 48.039 | 91.039 | 18.539 | 237.495 |
3.2.2.Estimated output funded with operational appropriations
Commitment appropriations in EUR million (to three decimal places)
| Indicate objectives and outputs ⇩ | Year 2022 | Year 2023 | Year 2024 | Year 2025 | Year 2026 | Year 2027 | Subsequent years (yearly) | TOTAL 2023-2027 | ||||||||||
| OUTPUTS | ||||||||||||||||||
| Type 74 | Average cost | No | Cost | No | Cost | No | Cost | No | Cost | No | Cost | No | Cost | No | Cost | Total No | Total cost | |
| SPECIFIC OBJECTIVE 1 | ||||||||||||||||||
| Development and maintenance of the European core platform for MyHealth@EU and support for Member States | 16.400 | 18.000 | 28.000 | 10.000 | 38.000 | 8.000 | 110.400 | |||||||||||
| Subtotal for specific objective 1 | 16.400 | 18.000 | 28.000 | 10.000 | 38.000 | 8.000 | 110.400 | |||||||||||
| SPECIFIC OBJECTIVE 2 | ||||||||||||||||||
| Database for EHR systems and wellness applications | 3.100 | 3.000 | 3.000 | 3.000 | 2.000 | 2.000 | 14.100 | |||||||||||
| Subtotal for specific objective No 2 | 3.100 | 3.000 | 3.000 | 3.000 | 2.000 | 2.000 | 14.100 | |||||||||||
| SPECIFIC OBJECTIVE 3 | ||||||||||||||||||
| Development and maintenance of the European core platform for HealthData@EU and support for Member States | 6.500 | 14.000 | 23.000 | 22.000 | 30.000 | 5.000 | 95.500 | |||||||||||
| Subtotal for specific objective 3 | 6.500 | 14.000 | 23.000 | 22.000 | 30.000 | 5.000 | 95.500 | |||||||||||
| TOTALS | 26.000 | 35.000 | 54.000 | 35.000 | 70.000 | 15.000 | 220.000 |
3.2.3.Summary of estimated impact on administrative appropriations
–◻ The proposal/initiative does not require the use of appropriations of an administrative nature
– The proposal/initiative requires the use of appropriations of an administrative nature, as explained below:
EUR million (to three decimal places)
| Year 2022 | Year 2023 | Year 2024 | Year 2025 | Year 2026 | Year 2027 and subsequent years | TOTAL | |
| HEADING 7 of the multiannual financial framework | |||||||
| Human resources | 3.289 | 3.289 | 3.289 | 3.289 | 3.289 | 16.445 | |
| Other administrative expenditure | 0.150 | 0.150 | 0.250 | 0.250 | 0.250 | 1.050 | |
| Subtotal HEADING 7 of the multiannual financial framework | 3.439 | 3.439 | 3.539 | 3.539 | 3.539 | 17.495 |
| Year 2022 | Year 2023 | Year 2024 | Year 2025 | Year 2026 | Year 2027 and subsequent years | TOTAL | |
| Outside HEADING 7 75 of the multiannual financial framework | |||||||
| Human resources | |||||||
| Other expenditure of an administrative nature | |||||||
| Subtotal outside HEADING 7 of the multiannual financial framework |
| Year 2022 | Year 2023 | Year 2024 | Year 2025 | Year 2026 | Year 2027 and subsequent years | TOTAL | |
| TOTAL | 3.439 | 3.439 | 3.539 | 3.539 | 3.539 | 17.495 |
The appropriations required for human resources and other expenditure of an administrative nature will be met by appropriations from the DG that are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.
3.2.3.1.Estimated requirements of human resources
–◻ The proposal/initiative does not require the use of human resources.
– The proposal/initiative requires the use of human resources, as explained below:
Estimate to be expressed in full time equivalent units
| Year 2022 | Year 2023 | Year 2024 | Year 2025 | Year 2026 | Year 2027 and subsequent years | ||
| • Establishment plan posts (officials and temporary staff) | |||||||
| 20 01 02 01 (Headquarters and Commission’s Representation Offices) | 16 | 16 | 16 | 16 | 16 | ||
| 20 01 02 03 (Delegations) | |||||||
| 01 01 01 01 (Indirect research) | |||||||
| 01 01 01 11 (Direct research) | |||||||
| Other budget lines (specify) | |||||||
| 20 02 01 (AC, END, INT from the ‘global envelope’) | 9 | 9 | 9 | 9 | 9 | ||
| 20 02 03 (AC, AL, END, INT and JPD in the delegations) | |||||||
| XX 01 xx yy zz 76 | - at Headquarters | ||||||
| - in Delegations | |||||||
| 01 01 01 02 (AC, END, INT - Indirect research) | |||||||
| 01 01 01 12 (AC, END, INT - Direct research) | |||||||
| Other budget lines (specify) | |||||||
| TOTAL | 25 | 25 | 25 | 25 | 25 |
06 is the policy area or budget title concerned.
The human resources required will be met by staff from the DG who are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.
Description of tasks to be carried out:
| Officials and temporary staff | 12 AD FTE (10 in policy unit and 2 in IT unit of DG SANTE) and 4 AST FTE (3 in the policy Unit and 1 in the IT Unit of DG SANTE) will be required to perform the tasks related to the development and functioning of the EHDS, namely for the: a)management of cross-border digital infrastructure MyHealth@EU; b)management of cross-border digital infrastructure for secondary uses; c)standardisation of electronic health records and health data exchanges; d)data quality of electronic health records and health data exchanges; e)access to health data for secondary uses; f)complaints, infringements, and compliance checks; g)logistic support for governance framework (physical and online meetings); h)horizontal tasks on communication, stakeholder management and inter-institutional relations; i)internal coordination; j)management of activities. 6.5 AD FTE and 4 AST FTE will be covered with staff currently working on digital health and health data exchanges, under Article 14 of Directive 2011/24/EU and in the preparations for the EHDS Regulation. The remaining 5.5 AD FTE will be covered with internal redeployment from DG SANTE. |
| External staff | For the performance of the tasks enumerated above, AD and AST personnel will be supported by 5 AC and 4 END at DG SANTE. 4 AC FTE and 3 END FTE will be covered with staff currently working on digital health and health data exchanges, under Article 14 of Directive 2011/24/EU and in the preparations for the EHDS Regulation. The remaining 1 AC FTE and 1 END FTE will be covered with internal redeployment from DG SANTE. |
3.2.4.Compatibility with the current multiannual financial framework
The proposal/initiative:
– can be fully financed through redeployment within the relevant heading of the Multiannual Financial Framework (MFF).
Appropriations will be redeployed within the financial envelope allocated to the EU4Health programme and to the Digital Europe Programme in the MFF 2021-2027.
–◻ requires use of the unallocated margin under the relevant heading of the MFF and/or use of the special instruments as defined in the MFF Regulation.
–◻ requires a revision of the MFF.
3.2.5.Third-party contributions
The proposal/initiative:
– does not provide for co-financing by third parties
–◻ provides for the co-financing by third parties estimated below:
Appropriations in EUR million (to three decimal places)
| Year N 77 | Year N+1 | Year N+2 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | Total | |||
| Specify the co-financing body | ||||||||
| TOTAL appropriations co-financed |
3.3.Estimated impact on revenue
– The proposal/initiative has no financial impact on revenue.
–◻ The proposal/initiative has the following financial impact:
–◻ on own resources
–◻ on other revenue
–please indicate, if the revenue is assigned to expenditure lines ◻
EUR million (to three decimal places)
| Budget revenue line: | Appropriations available for the current financial year | Impact of the proposal/initiative 78 | ||||||
| Year N | Year N+1 | Year N+2 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | ||||
| Article …………. |
For assigned revenue, specify the budget expenditure line(s) affected.
Other remarks (e.g. method/formula used for calculating the impact on revenue or any other information).
(1) European Commission. European Data Strategy (2020). https://ec.europa.eu/info/strategy/priorities-2019-2024/europe-fit-digital-age/european-data-strategy_en.
(2) As mentioned in the mission-letter-stella-kyriakides_en.pdf (europa.eu) .
(3) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
(4) European Commission, Assessment of the EU Member States’ rules on health data in the light of the GDPR , 2021.
(5) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross border healthcare (OJ L 88, 4.4.2011, p. 45).
(6) Regulation (EU) 2021/953 of the European Parliament and of the Council of 14 June 2021 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) to facilitate free movement during the COVID-19 pandemic (OJ L 211, 15.6.2021, p. 1–22).
(7) European Commission, European Interoperability Framework .
(8) European Commission, Europe’s digital decade: digital targets for 2030 .
(9) European Commision, Initiative on Declaration of Digital Principles – the ‘European way’ for the digital society .
(10) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1–175).
(11) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176–332).
(12) Proposal for a Regulation laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) COM/2021/206 final .
(13) Proposal for a Regulation on European data governance (Data Governance Act) COM/2020/767 final .
(14) Proposal for a Regulation on harmonised rules on fair access and use of data (Data Act) COM/2022/068 final .
(15) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1–30).
(16) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39–98).
(17) Health Emergency Preparedness and Response Authority | European Commission (europa.eu) .
(18) A cancer plan for Europe | European Commission (europa.eu) .
(19) EU Mission: Cancer | European Commission (europa.eu) .
(20) A pharmaceutical strategy for Europe (europa.eu) .
(21) Proposal for a Directive of the European Parliament and of the Council on measures for a high common level of cybersecurity across the Union, repealing Directive (EU) 2016/1148, COM(2020) 823 final.
(22) Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) No 910/2014 as regards establishing a framework for a European Digital Identity COM/2021/281 final .
(23) European Commission, Report on EU border Regions: Living labs of European integration , 2021.
(24) The exclusion of “inferred” data and the limitation to data processed based on consent or contract mean that large amounts of data related to health are outside the scope of the GDPR portability right.
(25) Press corner | European Commission (europa.eu) .
(26) More details in Nivel for European Commission, p. 20.
(27) European Commission (forthcoming study). A study on an infrastructure and data ecosystem supporting the impact assessment of the European Health Data Space, Trasys.
(28) European Commission, public consultation on overcoming cross-border obstacles, 2020.
(29) European Commission (2020). Assessment of the EU Member States rules on health data in the light of GDPR . (Annexes available here : https://ec.europa.eu/health/system/files/2021-02/ms_rules_health-data_annex_en_0.pdf ).
(30) eHealth, Interoperability of Health Data and Artificial Intelligence for Health and Care in the EU, Lot 1 - Interoperability of Electronic Health Records in the EU (2020) .
(31) Study on the use of real-world data (RWD) for research, clinical care, regulatory decision-making, health technology assessment, and policy-making .
(32) Market study on telemedicine .
(33) Preliminary Opinion 8/2020 on the European Health Data Space .
(34) Paragraph 4 of Article 6 of Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’).
(35) The contributions from the Digital Europe Programme as of 2023 are indicative, and will be considered in the context of the preparation of the respective Work Programmes. Ultimate allocations will be subject to the prioritisation for funding in the context of the underpinning adoption procedure and agreement of the respective Programme Committee.
(36) Article 5 of Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240.
(37) Article 3, paragraph 2(a), of Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013.
(38) Article 3, paragraph 2(c), of Regulation (EU) 2021/1153 of the European Parliament and of the Council of 7 July 2021 establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014.
(39) OJ C , , p. .
(40) OJ C , , p. .
(41) Commission Implementing Decision (EU) 2019/1269 of 26 July 2019 amending Implementing Decision 2014/287/EU setting out criteria for establishing and evaluating European Reference Networks and their Members and for facilitating the exchange of information and expertise on establishing and evaluating such Networks (OJ L 200, 29.7.2019, p. 35).
(42) EOSC Portal (eosc-portal.eu) .
(43) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
(44) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
(45) Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic Health Record exchange format (OJ L 39, 11.2.2019, p. 18).
(46) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
(47) Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73).
(48) Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 15).
(49) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(50) Council Regulation (EC) No 723/2009 of 25 June 2009 on the Community legal framework for a European Research Infrastructure Consortium (ERIC) (OJ L 206, 8.8.2009, p. 1).
(51) Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1).
(52) OJ L 123, 12.5.2016, p. 1.
(53) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(54) European Commission, European Interoperability Framework .
(55) Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (Text with EEA relevance) (OJ L 151, 7.6.2019, p. 70)
(56) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1).
(57) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(58) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
(59) Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
(60) As referred to in Article 58(2)(a) or (b) of the Financial Regulation.
(61) Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014
(62) Article 5 of Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240
(63) Article 3, paragraph 2(a), of Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013.
(64) Article 3, paragraph 2(c), of Regulation (EU) 2021/1153 of the European Parliament and of the Council of 7 July 2021 establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014.
(65) Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx
(66) Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.
(67) EFTA: European Free Trade Association.
(68) Candidate countries and, where applicable, potential candidates from the Western Balkans.
(69) Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the expected first year of implementation (for instance: 2021). The same for the following years.
(70) This amount stems from the commitment in 2027 and is not a recurrent payment. It is included in the computation for the total for 2023-2027.
(71) Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
(72) Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the expected first year of implementation (for instance: 2021). The same for the following years.
(73) Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
(74) Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).
(75) Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
(76) Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines).
(77) Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the expected first year of implementation (for instance: 2021). The same for the following years.
(78) As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 20 % for collection costs.