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Towards a European Health Data Ecosystem

Published online by Cambridge University Press:  09 October 2020

Nadina IACOB and
Felice SIMONELLIOpen the ORCID record for Felice SIMONELLI[Opens in a new window]
Nadina IACOB
Affiliation:
Researcher, Centre for European Policy Studies (CEPS), Brussels, Belgium; email: nadina.iacob@ceps.eu.
Felice SIMONELLI
Affiliation:
Senior Research Fellow, Centre for European Policy Studies (CEPS), Brussels, Belgium; email: felice.simonelli@ceps.eu.
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Abstract

The digital health ecosystem is rife with opportunities to improve healthcare through data-driven services in the European Union (EU). The value of health data, in the multiple forms in which they come (from health records to lifestyle data collected by smartphones or wearables), can truly emerge when they are allowed to flow in the ecosystem within a governance framework supported by all relevant stakeholders, with trust as the common and clear thread underpinning it. The coronavirus pandemic has provided an additional impetus for change, showing the importance of coordination and adequate communication between Member States and quality data to inform decision-making. Significant challenges remain, however, in order to achieve a fully integrated European digital health ecosystem, including: (1) the potentially diverging rules set by Member States at the national level and the need for an EU framework for the secondary use of health data; (2) the need for transparency and accountability for sustaining a data-sharing framework involving public authorities, research organisations, industry and citizens; and (3) the need for interoperable data and processes. Taking stock of these challenges, this article puts forward policy recommendations to enable the provision of pan-European data-driven healthcare services and to build a transparent and trustworthy framework for citizens.

Information

Type
Articles
Information
European Journal of Risk Regulation , Volume 11 , Special Issue 4: Beyond COVID-19: Towards a European Health Union , December 2020, pp. 884 - 893
Copyright
© The Author(s), 2020. Published by Cambridge University Press

I. Introduction

In what was, with hindsight, an extremely timely initiative, the European Commission committed to supporting the creation of a European Health Data Space, one of the nine data spaces laid out in the February 2020 Communication on a European Strategy for Data.Footnote 1 In the following months, the COVID-19 pandemic revealed the stark need for cooperation and quality data exchanges in the European Union (EU) to design the appropriate policy response in the face of threats that know no borders.

In the wider context of the potential of data for healthcare, what the EU needs, perhaps more than a health data space, is a true European Health Data Ecosystem to bring to fruition the opportunities presented by digital health and to improve health outcomes. A health data ecosystem is a complex interplay between the ecosystem stakeholders, data infrastructure and governance framework. In a well-functioning ecosystem, data flows in a standardised manner between interoperable systems against a clear framework of rules for data sharing (including data protection, privacy, accountability, liability and cybersecurity) through the interactions of public authorities, the healthcare sector, patient associations, insurance systems, the consumer health sector, research organisations and individuals who provide their data and are ultimately the beneficiaries of improved healthcare outcomes. As became apparent during the crisis, a resilient European Health Data Ecosystem that can both improve healthcare outcomes and help tackle future threats to public health must be based on EU-wide cooperation. While negotiations on the new EU budget and the Recovery Plan resulted in cuts to a new health programme (EU4Health) compared to the Commission’s proposal, the EU budget can still be effectively harnessed to contribute to a European Health Data Ecosystem, especially through the new Digital Europe Programme to which €6.8 billion were allocated.Footnote 2

Recent papers have stressed the importance of EU cooperation for capitalising on the value of health data. Auffray et al emphasise the need for research infrastructure, methods, skills and a regulatory framework to support the use of Big Data in health research,Footnote 3 and Salas-Vega et al make the case for EU action to enhance the use of Big Data in healthcare.Footnote 4 In light of the COVID-19 crisis, Renda and Castro call for stronger EU governance to manage the health crisis, including in areas such as data sharing.Footnote 5

Against this background, the present article aims to identify the policy interventions that are needed at the EU level to create a well-functioning and fully integrated European Health Data Ecosystem. In more detail, it outlines the prerequisites to that end, pinpoints the main opportunities and policy drivers in the field, discusses key challenges and proposes policy recommendations for building a European Health Data Ecosystem.

II. Major opportunities

The widening spectrum of healthcare-related data (including medical, behavioural, environmental and lifestyle data) opens opportunities for innovation in healthcare. Such opportunities will be multiplied if data are shared and used EU-wide, enabling larger datasets for research, facilitating cross-border public health and fostering the development of digital health in all Member States. In addition, with enhanced data infrastructures, standardised processes and cooperation, the capacity of the EU to respond to public health crises will also be improved.

Opportunities in the field can relate to the primary use of health data (ie the provision of healthcare services to a patient) by enabling more science-based and personalised therapies. They can also have a wider impact when data are used for secondary purposes, contributing to, inter alia, research, public health and the development of private services.Footnote 6

As for the provision of healthcare services, digital health apps and devices can significantly increase the availability of both health data and behavioural and lifestyle data about patients to improve disease management and lifestyle in a personalised way.Footnote 7 Digital advice, resembling telemedicine but consisting of lifestyle advice instead of pure medical advice (which only a medical practitioner can deliver), could support lifestyle changes and improve overall health.Footnote 8 The secondary use of health data can provide more research opportunities. Through digitisation and enhanced interoperability, real-world dataFootnote 9 coming from a variety of sources, such as electronic health records, registries and digital devices, can become sources of evidence for the effectiveness of therapies,Footnote 10 such as by complementing randomised controlled trials in clinical research and bridging data gaps.Footnote 11

III. Right time

This year started on a high note for the digital agenda of the European Commission with the launch of the Communication on a European Strategy for Data in February 2020.Footnote 12 This Communication is an important step towards the creation of a European Health Data Ecosystem, whose functioning would be fully supported by the data protection framework established by the General Data Protection Regulation (GDPR).Footnote 13 In fact, the rules for data protection in the EU provide the foundation of trust on which a health data ecosystem can develop. Aspects such as the consent of the data subject (Article 6 GDPR), the protection of sensitive data, including health data (Article 9 GDPR), as well as the rights of the data subject, including the right to data portability (Article 20 GDPR), bring to the forefront the key principle of user-centricity and the standards for the protection of individuals and their data. These factors play an important role in enhancing trust in data sharing. Some early evidence of the impact of the GDPR on the willingness of individuals to share health data shows that this Regulation has a positive effect by virtue of its focus precisely on user-centricity.Footnote 14

While the sudden outbreak of COVID-19 has brought the economy into a recession and disrupted the policy process, the pandemic has also placed a larger emphasis on some of the policy priorities defined before the crisis. Among these, the need for coordination in the area of health data and digital healthcare is now more apparent than ever. The seemingly straightforward act of recording the number of COVID-19 cases and fatalities has revealed fundamental gaps in communication and coordination across the EU, as Member States follow different reporting criteria. The European Centre for Disease Prevention and Control warned that the reported rates of cases and mortalities should not be used to “directly compare” countries, as several factors could affect the comparability of data, including the different testing strategies and capacities of Member States.Footnote 15 Heterogeneous data limit the possibility of coordinated EU action and joint responses to the crisisFootnote 16 and may pave the way for mistrust.Footnote 17 As data inform crucial decisions for managing the pandemic (eg instating lockdown measures, preparing de-confinement strategies, limiting travel to regions considered to be at risk), the need for more transparent and harmonised reporting is clear.Footnote 18

The lessons of the past months can be turned into an opportunity to enhance cooperation between Member States on health data sharing to facilitate comparison, research and decision-making in the context of COVID-19 and beyond, building long-term resilience. In addition, the coronavirus experience has emphasised once more that, while data may hold substantial value for tackling public health threats, such data must be collected and analysed responsibly. Otherwise, the risk is that privacy and public trust are undermined and the public become less prone to following public health recommendations.Footnote 19

IV. Outstanding challenges

Many challenges still need to be addressed in order to create a European Health Data Ecosystem, where data can be shared among stakeholders and used, against a clear framework of rules underpinned by trust, to provide new data-based health services, enhance the functioning of national health systems and, ultimately, improve healthcare outcomes for all Europeans. To that end, a wide range of issues need to be tackled, ranging from setting up liability rules in the context of digital health to establishing responsibility for the quality of health data; from enhancing the transparency and accountability of institutions and market players to defining a framework for the secondary use of health data; and from promoting interoperability and common standards to avoiding fragmentation among Member States. In this context, the following three issues are the most urgent to be addressed at the EU level.

1. Diverging national rules for the secondary use of health data

A European Health Data Ecosystem should enable the effective use and reuse of health data across borders. The GDPR provides a horizontal framework for collecting and processing personal data and ensures that special requirements are abided by when processing health data. Based on the provisions related to sensitive data, the processing of health data is generally prohibited, unless the data subject provides “explicit consent” for one or more specific purposes (Article 9(2) lit. (a) of the GDPR). The GDPR also lists several cases in which the processing of sensitive data can take place without the explicit consent of the data subject, including research purposes (Article 9(2) lit. (j) of the GDPR), provided that appropriate safeguards are in place and the principle of data minimisation is respected.

Member States, however, can introduce stricter rules and limitations to the use of health data (Article 9(4) of the GDPR). The prospect of additional measures taken at the national level could hamper research and may also impact the way in which cross-border data sharing develops.Footnote 20 Given the horizontal nature of the GDPR and the fact that additional rules may be implemented at the national level, the current framework provides only limited support to the secondary use of health data. Enabling the secondary use of health data while also ensuring a high level of data protection and privacy, however, is crucial for building a well-functioning health data ecosystem. In particular, research could benefit from a framework facilitating the sharing of health data across borders and thus enabling the creation of a larger pool of data that can then be used to carry out studies.

2. Limited interoperability and lack of standards

The increasing amount of health data generated by a variety of sources holds great potential for a European Health Data Ecosystem. The potential of such data, however, cannot be realised without common definitions, data models and processes for sharing data. Interoperability and data standards are the backbones of a future health data ecosystem, allowing different systems to communicate and data to flow. A host of areas within digital health can be significantly enhanced with more interoperable data. For instance, COVID-19 has shown the importance of reliable and comparable data for the management of a public health crisis. Interoperable data can enhance international cooperation and the coordinated response to such threats. Research could also benefit from increased amounts of data, both by pooling data across different organisations and by enabling the use of data collected via wearable devices or smartphone apps. Finally, clearly structured data could also improve the functioning of algorithms for artificial intelligence applications in healthcare and mitigate against errors in computation.Footnote 21

At the EU level, the limited interoperability of health data is a recurrent barrier.Footnote 22 The Communication on a European Strategy for Data emphasises the need to deploy “data infrastructure, tools and computing capacity” to make data more interoperable as a central action to facilitate the creation of a European Health Data Space.Footnote 23 At the heart of the issue lies semantic interoperability (ie the ability of systems to exchange information with unambiguous meaning). Problems such as large amounts of unstructured data, data stored in silos, different terminologies and a variety of data standards and formats limit opportunities for utilising data to their fullest potential. In addition, progress in the implementation of interoperability measures at the national level has been slow and often fragmented,Footnote 24 with the notable exception of the 2019 Recommendation on a European Electronic Health Record Exchange Format,Footnote 25 which promotes a set of principles and common technical specifications for the cross-border exchange of certain types of health data.Footnote 26

3. Insufficient transparency and accountability

A well-functioning health data ecosystem needs to be underpinned by trust, which raises the question: how can public trust in digital health be fostered to ensure that the benefits of new technologies can be reaped? Recent controversies, such as Google’s plans for acquiring Fitbit, met with warnings of potential detrimental effects on consumers with regard to the use of data,Footnote 27 and the privacy concerns related to digital solutions to contain the coronavirusFootnote 28 have shown that gaining and maintaining public trust is no easy feat.

Together with data protection, transparency and accountability are essential for building relations of trust, especially in the context of emerging technologies and data-based services. From the moment of data collection, accountability mechanisms should provide evidence that the practices of data controllers do indeed comply with data protection principles and that the purposes for processing collected data are not unduly overstepped.Footnote 29 Accountability becomes even more important as machine-learning algorithms are deployed to analyse substantial amounts of data and draw insights informing medical advice and public health. The “black-box medicine” holds promise for innovation in healthcare, but it also brings up the need for algorithmic accountability to mitigate the fact that the functioning of such tools is, in the end, opaque to most individuals.Footnote 30 As a result, verification mechanisms are necessary to assure the public of the trustworthiness of these novel applications.

V. Policy solutions

As the challenges are evident, the opportunities held by digital health for improving healthcare systems and health outcomes can be brought to fruition with timely policy interventions at the EU level aiming to remove cross-border barriers, foster interoperability and build a transparent and trustworthy framework for citizens.

1. Ensuring harmonised implementation of data protection rules

By introducing a level playing field for data protection across the EU, the GDPR fosters trust in a European Health Data Ecosystem and data-based health services. Implementation at the national level, however, can still cause fragmentation. Differences in national regimes can be hurdles and translate into compliance burdens for all players in a European Health Data Ecosystem. The EU should oversee the implementation of data protection rules, continue to provide guidance through the European Data Protection Board and ensure coordination for harmonised legislation in all Member States.

2. Limiting fragmentation due to diverging national rules

Even with fully harmonised data protection rules, cross-border fragmentation is still likely to occur, as health law is not harmonised in the EU, and neither is contract law, beyond the existence of guidelines issued by the Commission for specific issues, such as sharing private-sector data.Footnote 31 To limit fragmentation, the Commission can play a coordinating role, monitoring how rules in the field of digital health evolve in the Member States and promoting a coherent approach to facilitate the provision of data-based health services across borders.

3. Developing an EU framework for the secondary use of health dataFootnote 32

Legal uncertainty and cross-border fragmentation are impinging on the secondary use of health data. With the rise of Big Data, opportunities in this field can be significant, but without clear rules, risks can also proliferate. The Finnish national law on the secondary use of health and social dataFootnote 33 is an example of policy actions supporting legitimate developments in this field. Introducing a framework for the secondary use of health data at the EU level can bolster research and innovative data-based applications. An EU framework for the secondary use of health data is a necessary building block of a European Health Data Ecosystem.

4. Promoting cooperation for living and dynamic standards

Technical solutions enabling data exchanges are the backbone for effective health data sharing in a European Health Data Ecosystem. Cooperation is essential to ensure the uptake of standards and technical specifications. In particular, at the EU level, the impact of the Recommendation on a European Electronic Health Record Exchange FormatFootnote 34 should be closely monitored to ascertain that common standards are adopted by Member States. More generally, continued cooperation for standards in the field of digital health should be fostered. As the field is continually evolving, agreeing on a given set of standards at a given point in time will likely not be enough. The solution would rather be a “living and dynamic standard” – or “living dictionary” – that also captures the liveliness of the field: new terms and developments should be incorporated and outdated ones should be discarded flexibly and rapidly to keep up with innovation in the field.Footnote 35 In this context, the Commission’s planned interoperability strategyFootnote 36 for the EU should provide the framework to bolster cooperation on standards and to support the creation of a European Health Data Ecosystem. The strategy should provide targeted recommendations for governments at all levels (EU, national, local) and ensure that interoperability is embedded in the design and delivery of public services, including healthcare.

5. Establishing accountability mechanisms for increased transparency

To gain the trust of individuals for data sharing, mitigating their concerns about what happens to their data, who has access to them, how they are protected, who is responsible for data privacy breaches and who one can appeal to in case of problems is important. In this regard, accountability mechanisms for stakeholders sharing and using health data should consist of internal control systems producing evidence such as audit reports, which can be presented not only to data subjects (individuals), but also to supervisory bodies and other stakeholders. For effective communication, information provided, particularly to individuals, should be as clear and concise as possible, answering questions punctually rather than overloading individuals with information. This mechanism would serve both as a means to fulfil any legal requirements related to data processing and as a proactive approach by data users to address upfront privacy and security concerns, mitigating fears of data misappropriation and uncertainties about what can be done with data.Footnote 37

6. Setting up feedback loops for the sustained engagement of individuals in data sharing

Particularly in a research setting, a feedback loop providing information to participants about research results could enhance transparency.Footnote 38 This is a tool that researchers can embed in their research process independently and, depending on the scope and needs of the project, be used to build more trust and generate more involvement and engagement of individuals throughout the process.

7. Establish a “privacy label” for apps

To increase transparency and address potential concerns around data privacy and security, introducing a “privacy label” for health apps should be considered. Such a label could contain information about the underlying technology and the level of privacy of the application in a clear and distilled fashion, similarly to nutrition labels. Privacy labels could either be introduced by public authorities as a requirement for health apps to be allowed on the market or they could be a self-regulatory measure implemented independently by app developers, allowing them to distinguish themselves through the importance that they give to the security and privacy of user data that are shared through the app.

VI. Concluding remarks

To face the health challenges of the future, it is time to tap into the momentum for change. Fostered by the opportunities to improve healthcare outcomes and drawing from the lessons of the COVID-19 crisis, a European Health Data Ecosystem can now become a reality. This article is only a preliminary analysis identifying a number of EU interventions that could contribute to the creation of such a data ecosystem. The next step should be an in-depth analysis of upcoming opportunities as well as existing market deficiencies and regulatory barriers, followed by a detailed action plan to guide EU and national policymakers in tackling key challenges, including those outlined in this article. Such an approach could also be replicated in other strategic domains (eg energy, mobility, finance) to make the most of European data and to generate substantial benefits for EU companies and citizens.

Footnotes

1 European Commission, Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A European strategy for data, COM/2020/66 final <https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1593073685620&uri=CELEX%3A52020DC0066> (last accessed 17 July 2020).

2 J Núñez Ferrer, “Reading between the lines of Council agreement on the MFF and Next Generation EU” (2020) 2020-18 CEPS Policy Insights <https://www.ceps.eu/ceps-publications/reading-between-the-lines-of-council-agreement-on-the-mff-and-next-generation-eu/> (last accessed 11 September 2020).

3 C Auffray et al, “Making sense of big data in health research: Towards an EU action plan” (2016) 8(71) Genome Medicine <https://doi.org/10.1186/s13073-016-0323-y> (last accessed 17 July 2020).

4 S Salas-Vega, A Haimann and E Mossialos, “Big Data and Health Care: Challenges and Opportunities for Coordinated Policy Development in the EU” (2015) 1(4) Health Systems & Reform 285–300 <https://doi.org/10.1080/23288604.2015.1091538> (last accessed 17 July 2020).

5 A Renda and R Castro, “Towards Stronger EU Governance of Health Threats after the COVID-19 Pandemic” (2020) 11(2) European Journal of Risk Regulation 273–82 <https://doi.org/10.1017/err.2020.34> (last accessed 17 July 2020).

6 C Safran et al, “Toward a national framework for the secondary use of health data: an American Medical Informatics Association White Paper” (2007) 14(1) Journal of the American Medical Informatics Association 1–9 <https://doi.org/10.1197/jamia.M2273> (last accessed 17 July 2020).

7 G Fagherazzi and P Ravaud, “Digital diabetes: Perspectives for diabetes prevention, management and research” (2018) 45(4) Diabetes & Metabolism 322–29 <https://doi.org/10.1016/j.diabet.2018.08.012> (last accessed 17 July 2020).

8 X Wu, X Guo and Z Zhang, “The Efficacy of Mobile Phone Apps for Lifestyle Modification in Diabetes: Systematic Review and Meta-Analysis” (2019) 7(1) JMIR mHealth and uHealth e12297 <https://doi.org/10.2196/12297> (last accessed 17 July 2020).

9 LP Garrison Jr et al, “Using Real-World Data for Coverage and Payment Decisions: The ISPOR Real-World Data Task Force Report” (2007) 10(5) Value in Health 326–35 <https://doi.org/10.1111/j.1524-4733.2007.00186.x> (last accessed 17 July 2020).

10 B Collins, “Big Data and Health Economics: Strengths, Weaknesses, Opportunities and Threats” (2016) 34 PharmacoEconomics 101–06 <https://doi.org/10.1007/s40273-015-0306-7> (last accessed 17 July 2020).

11 VR Suvarna, “Real world evidence (RWE) – Are we (RWE) ready?” (2018) 9(2) Perspectives in Clinical Research 61–63 <https://doi.org/10.4103/picr.PICR_36_18> (last accessed 17 July 2020).

12 European Commission, supra, note 1.

13 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, pp 1–88.

14 M Karampela, S Ouhbi and M Isomursu, “Exploring users’ willingness to share their health and personal data under the prism of the new GDPR: implications in healthcare” (2019) 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), Berlin, Germany, 2019, pp 6509–12 <https://doi.org/10.1109/EMBC.2019.8856550> (last accessed 17 July 2020).

15 European Centre for Disease Prevention and Control, “Resurgence of reported cases of COVID-19 in the EU/EEA, the UK and EU candidate and potential candidate countries” (2020), p 8 <https://www.ecdc.europa.eu/sites/default/files/documents/RRA-Resurgence-of-reported-cases-of-COVID-19-in-the-EU-EEA.pdf> (last accessed 17 July 2020).

16 Renda and Castro, supra, note 5.

17 By way of examples, see: B Moens, “Why is Belgium’s death toll so high?” (POLITICO, 19 April 2020) <https://www.politico.eu/article/why-is-belgiums-death-toll-so-high/> (last accessed 17 July 2020); L Ponciau, “Le Luxembourg, en zone orange, est-il victime de son dépistage massif?” (Le Soir Plus, 13 July 2020)

<https://plus.lesoir.be/312991/article/2020-07-13/le-luxembourg-en-zone-orange-est-il-victime-de-son-depistage-massif> (last accessed 17 July 2020).

18 Joint European Roadmap towards lifting COVID-19 containment measures, p 9 <https://ec.europa.eu/info/sites/info/files/communication_-_a_european_roadmap_to_lifting_coronavirus_containment_measures_0.pdf> (last accessed 17 July 2020).

19 M Ienca and E Vayena, “On the responsible use of digital data to tackle the COVID-19 pandemic” (2020) 26 Nature Medicine 463–64 <https://doi.org/10.1038/s41591-020-0832-5> (last accessed 17 July 2020).

20 CF Mondschein and C Monda, “The EU’s General Data Protection Regulation (GDPR) in a Research Context” in P Kubben, M Dumontier and A Dekker (eds), Fundamentals of Clinical Data Science (Berlin, Springer 2019) p 59

<https://doi.org/10.1007/978-3-319-99713-1_5> (last accessed 17 July 2020).

21 M Lehne et al, “Why digital medicine depends on interoperability” (2019) 2(79) npj Digital Medicine 2 <https://doi.org/10.1038/s41746-019-0158-1> (last accessed 17 July 2020).

22 See, among others: Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, eHealth Action Plan 2012–2020: Innovative healthcare for the 21st century, COM/2012/0736 final <https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:52012DC0736> (last accessed 17 July 2020); Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society, COM/2018/233 final <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2018%3A233%3AFIN> (last accessed 17 July 2020).

23 European Commission, supra, note 1.

24 eHAction, EU Common Semantic Strategy in eHealth. Proposal Information Paper to eHealth Network (brief note) (2018), p 10 <https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_201811135_co0494_en.pdf> (last accessed 17 July 2020).

25 Commission Recommendation on a European Electronic Health Record Exchange Format, C(2019) 800 final <https://ec.europa.eu/digital-single-market/en/news/recommendation-european-electronic-health-record-exchange-format> (last accessed 17 July 2020).

26 Given the recent adoption of the Recommendation, its impact is still to be assessed.

27 BEUC, Google–Fitbit merger – Competition concerns and harms to consumers (2020) <http://www.beuc.eu/publications/google-fitbit-merger-competition-concerns-and-harms-consumers/html> (last accessed 17 July 2020).

28 A Renda, “Will privacy be one of the victims of COVID-19?” (CEPS In Brief, 23 March 2020) <https://www.ceps.eu/will-privacy-be-one-of-the-victims-of-covid-19/> (last accessed 17 July 2020).

29 European Medicines Agency, “Data anonymisation – a key enabler for clinical data sharing. Workshop Report” (2017), p 10 <https://www.ema.europa.eu/en/documents/report/report-data-anonymisation-key-enabler-clinical-data-sharing_en.pdf> (last accessed 17 July 2020).

30 RA Ford and W Nicholson Price II, “Privacy and Accountability in Black-Box Medicine” (2016) 23(1) Michigan Telecommunications and Technology Law Review <https://repository.law.umich.edu/cgi/viewcontent.cgi?article=1221&context=mttlr> (last accessed 17 July 2020).

31 European Commission, Commission Staff Working Document. Guidance on sharing private sector data in the European data economy, SWD(2018) 125 final <https://ec.europa.eu/digital-single-market/en/news/staff-working-document-guidance-sharing-private-sector-data-european-data-economy> (last accessed 17 July 2020).

32 This recommendation is also echoed in the report of the Strategic Forum for Important Projects of Common European Interest: Strategic Forum on Important Projects of Common European Interest, “Strengthening Strategic Value Chains for a future-ready EU Industry” (2019), p 48 <https://ec.europa.eu/docsroom/documents/37824> (last accessed 17 July 2020).

33 See: “Secondary use of health and social data” (Ministry of Social Affairs and Health, Finland) <https://stm.fi/en/secondary-use-of-health-and-social-data> (last accessed 17 July 2020).

34 Supra, note 25.

35 LM Babrak et al, “Traditional and Digital Biomarkers: Two Worlds Apart?” (2019) 3 Digital Biomarkers 92–102, 96 <https://doi.org/10.1159/000502000> (last accessed 17 July 2020).

36 The strategy, to be published in 2021, was announced as a key action of the Commission’s digital agenda for the coming years. See: Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Shaping Europe’s digital future, COM/2020/67 final <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0067> (last accessed 11 September 2020).

37 Such issues are mentioned in the communication from the Commission on a European strategy for data: European Commission, supra, note 1, p 7.

38 K Spencer et al, “Patient Perspectives on Sharing Anonymized Personal Health Data Using a Digital System for Dynamic Consent and Research Feedback: A Qualitative Study” (2016) 18(4) Journal of Medical Internet Research e66 <https://doi.org/10.2196/jmir.5011> (last accessed 11 September 2020).