Annex 2 - Policy framework

	A	B
1	ODI Manifesto area	Success indicators
2
3	Infrastructure	Success indicators
4	Datasets
5	Burden of Disease registries	National illness and disease registries are established with >75% of relevant patient population data recorded
6	Biobank and genomic data centralisation	Established biobank and genomics database centralised all structured diagnostic results
7	Patient health records	Interoperable formats and standards for EHR are adopted by all countries and records able to be shared securely
8	Medicine/pharmaceutical registers	National registers include adverse drug reaction registers, feed into European-wide registers and match FAIR framework
9	Patient reported outcomes data	Interoperable formats and standards created and stored at national and European level matching FAIR framework
10	Open science/open clinical data	FAIR Framework for open science and open clinical data adopted, and sharing of data enabled
11	Insurance claims data	National registers on health insurance claims feed into a European-wide register with data on cross-border insurance claims available
12	Employment sickness and social security data	National registers on illness and sickness, including social security financing and costs of illness on workplace participation, feed into a European-wide data collection system that meets FAIR framework principles
13	Personal and health technologies data	National systems for standardising and collecting and enabling personal health data from wearables, fitness trackers, remote patient monitoring and software as a medical service managed using a FAIR framework
14
15	Technology and standards
16	Real World Data (RWD) infrastructure	All RWD captured in consistent standardised formats with advanced data-curation systems in place, enabling exploration, cleaning, enrichment, and standardisation
17	Real World Evidence (RWE) infrastructure	Health Technology Assessment (HTA) bodies and policymakers have established a clear framework for the use of RWE in decision making
18	Adoption of open standards	Health data policies confirm the importance of using open standards for health datasets and ministries of health are committed to their adoption
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20	Policies and processes
21	Legal framework for sharing of secondary use of data	A legal framework is articulated that balances the protection of personal data and the use of de-identified data to benefit society
22
23	Capability	Success indicators
24	Evaluation framework for health technologies	A robust, ethical, and community-participatory HTA process is adopted across Europe and in each member state
25
26	Innovation	Success indicators
27	Investment in EHR systems	Training is resourced and incentives are available to healthcare institutions and data ecosystem stakeholders to encouarge adoption of standard and data sharing, including use of EHRs
28	Secondary use of health data policy is a national priority	Specific policy is developed that recognises the value of secondary use of health data and all stakeholders are encouraged to participate in ecosystem networks, with strategic investment available to foster best practices
29
30	Equity	Success indicators
31	Equity considerations addressed	Policies recognise the uneven distribution of health resources and seek to leverage secondary use of health data to address inequity
32	Privacy Regulation	Robust privacy regulation is in place that allows pharmaceutical industry access and use of high-quality healthcare data within agreed privacy constraints
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34	Ethics	Success indicators
35	High level of trust in data-informed healthcare	There is regular reporting on the use and value being generated from new personal data technologies. Personal healthcare data privacy regulatory oversight and management is reported regularly
36	Ethical/accountability framework for secondary use of health data	Clear reporting, methods of redress and consequences
37
38	Engagement	Success indicators
39	Public/patient participation	Investment to support facilitation and participation of citizens and healthcare communities in decision-making
40	Sustainable and trustworthy data institutions	Strategic investment in data institutions able to steward data infrastructure and report on implementation and capabilities
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