Yazar
İrem ŞEVİK
Arş. Gör. Dr., Ege Üniversitesi Halk Sağlığı AD, İzmir (ORCID No: 0000-0001-6536-1665)

Özet

  • Bu çalışma, dijital sağlık alanındaki veri düzenlemelerini sağlık verisinin üretim, dolaşım ve kullanım biçimleri üzerinden ekonomi-politik ve etik bir çerçevede değerlendirmektedir. Sağlık hizmetlerinin dijitalleşmesi, teknik bir altyapı dönüşümü olmasının yanında verinin yeni bir birikim aracı olarak konumlandığı yapısal bir dönüşümün içinde konumlanmaktadır. Bu dönüşümde, kamu yararı söylemiyle meşrulaştırılan veri paylaşım mekanizmaları, sıklıkla özel sektörün çıkarlarıyla iç içe geçmekte, veriyi üreten bireylerin emeği görünmezleşmekte ve bu süreçten doğan ekonomik değerlerin topluma adil geri dönüşü göz ardı edilmektedir. Verinin hem kişisel biçimleri hem kişisel olmayan biçimleri bireyler ve toplumlar üzerinde etkiler yaratabilmektedir; ancak mevcut düzenlemeler genellikle yalnızca kişisel verilerin gizliliğine odaklanmakta, kişisel olmayan verilerin kullanımından doğabilecek zararları yeterince dikkate almamaktadır. Avrupa Sağlık Veri Alanı (EHDS) gibi girişimler, sağlık verisinin birincil ve ikincil kullanımını yaygınlaştırmayı, rıza mekanizmalarını daha esnek hale getirerek verinin dolaşımını kolaylaştırmayı ve tek bir dijital sağlık pazarı oluşturmayı hedeflemektedir. Ancak bu yönelim, bireysel mahremiyetin yanı sıra, rızanın özgür, bilinçli ve spesifik olmasını garanti altına almayı güçleştirmekte; kamu yararı söyleminin belirsiz sınırları içinde toplumsal meşruiyetin göz ardı edilmesi riskini taşımaktadır. Özel sektörle veri paylaşımının arttırılması hedefi, veri fedakârlığını teşvik eden politikaları tartışmalı hale getirmekte, EHDS’nin gelecekteki başarısının yalnızca yasal uygunlukla değil, toplumsal güven ve katılımla birlikte değerlendirilmesi gerektiğini ortaya koymaktadır. Bu makaleye göre adil bir dijital sağlık hizmeti sunumu için veri üretimi, dolaşımı ve kullanımına ilişkin düzenlemelerin veri üretiminde emeği tanıması, üretilen ekonomik ve ekonomik olmayan değerlerin adil paylaşımını gözetmesi ve toplumsal meşruiyeti temel alması gerekmektedir.  

Summary

  • This study evaluates data regulations in digital health through a political economy and ethical framework, focusing on the generation, flow, and use of health data. The digitalization of healthcare represents not only a technical transformation but also a structural shift in which data becomes a new means of accumulation. In this transformation, data-sharing mechanisms legitimized through the discourse of public interest are often intertwined with private interests, obscuring the labor of individuals who produce the data and disregarding the fair redistribution of the resulting economic value. Both personal and non-personal data can impact individuals and communities; however, current regulations predominantly focus on the privacy of personal data, failing to adequately address potential harms arising from the use of non-personal data. Initiatives such as the European Health Data Space (EHDS) aim to expand the primary and secondary use of health data, to ease its flow by making consent mechanisms more flexible, and to create a unified digital health market. However, this approach complicates the guarantee of free, informed, and specific consent, while also neglecting social license within the vagueness of the public interest discourse. The growing role of the private sector raises concerns about policies promoting data altruism, suggesting that the legitimacy of such frameworks depends not only on legal compliance but also on public trust and participation. This article argues that ensuring fairness in digital health requires regulation mechanisms that acknowledge the labor behind data production, guarantee equitable distribution of both economic and non-economic benefits, and prioritize social license.        

Anahtar Sözcükler / Keywords

  • TR: Dijital sağlık, sağlık verisi, veri yönetişimi, veri kapitalizmi, kamu yararı
    EN: Digital health, health data, data governance, data capitalism, public interest

Kaynaklar / References

  • Aitken, M., ve ark. (2018) Who benefits and how? Public expectations of public benefits from data-intensive health research, Big Data & Society, 5(2). Erişim Tarihi 11 Temmuz 2025, https://doi.org/10.1177/205395171881672 Aksu Tanık, F. (2022) Vaccine research and production during the COVID-19 pandemic under the dominance of profit-making capitalist rules. Centre for Research & Education in Public Health, Health Policy and Primary Health Care. https://healthpolicycenter.gr/en/publications/vaccine-research-and-production-during-the-covid19-pandemic-under-the-dominance-of-profit-making-capitalist-rules Apple (2015) Apple introduces ResearchKit, giving medical researchers the tools to revolutionize medical studies, Apple Newsroom, 9 Mart. Erişim Tarihi 11 Temmuz 2025, https://www.apple.com/newsroom/2015/03/09Apple-Introduces-ResearchKit-Giving-Medical-Researchers-the-Tools-to-Revolutionize-Medical-Studies/ Avrupa Birliği (2016) Gerçek kişilerin kişisel verilerinin işlenmesi ve bu tür verilerin serbest dolaşımı hakkında Avrupa Parlamentosu ve Konsey’in 27 Nisan 2016 tarihli ve 2016/679 sayılı Tüzüğü (Genel Veri Koruma Tüzüğü), AB Resmî Gazetesi, L 119, 1–88. Erişim Tarihi 11 Temmuz 2025, https://eur-lex.europa.eu/eli/reg/2016/679/oj Avrupa Komisyonu. (2012). eHealth Action Plan 2012–2020: Innovative healthcare for the 21st century. [Erişim 11 Temmuz 2025]. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52012DC0736 Avrupa Komisyonu Reuse of health data. [Erişim 11 Temmuz 2025]. https://health.ec.europa.eu/ehealth-digital-health-and-care/reuse-health-data_en Avrupa Birliği Konseyi. Digital single market for Europe. [Erişim 11 Temmuz 2025]. https://www.consilium.europa.eu/en/policies/digital-single-market/ Avrupa Komisyonnu. (2018). Communication 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). Brussels. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52018DC0233 Barber, G. (2020) Google and Apple change tactics on contract tracing tech, Wired, 1 Eylül. Erişim Tarihi 11 Temmuz 2025, https://www.wired.com/story/google-apple-change-tactics-contact-tracing-tech/ Bedenik, T., Cahir, C. ve Bennett, K.E. (2025) I don’t mind my information going to the Moon, but I don’t want any letters from Mars: A qualitative exploration of the challenges with secondary use of health data in Ireland, Archives of Public Health, 83: 50. https://doi.org/10.1186/s13690-025-01524-4 Blenner, S.R., ve ark. (2016) Privacy policies of Android diabetes apps and sharing of health information, Journal of the American Medical Association, 315(10): 1051–1052. Brückner, S., ve ark. (2023) The social contract for health and wellness data sharing needs a trusted standardized consent, Mayo Clinic Proceedings: Digital Health, 1(4): 527–533. https://doi.org/10.1016/j.mcpdig.2023.07.008 Bull, S., Roberts, N. ve Parker, M. (2015) Views of ethical best practices in sharing individual-level data from medical and public health research: A systematic scoping review, Journal of Empirical Research on Human Research Ethics, 10(3): 225–238. https://doi.org/10.1177/1556264615594767 Carter, P., Laurie, G.T. ve Dixon-Woods, M. (2015) The social licence for research: Why care.data ran into trouble, Journal of Medical Ethics, 41(5): 404–409. https://doi.org/10.1136/medethics-2014-102374 Cervera de la Cruz, P. ve Shabani, M. (2025) Conceptualizing fairness in the secondary use of health data for research: A scoping review, Accountability in Research, 32(3): 233–262. https://doi.org/10.1080/08989621.2023.2271394 Cheung, S. (2020) Disambiguating the benefits and risks from public health data in the digital economy, Big Data & Society, 7(1). https://doi.org/10.1177/2053951720933924 Correia, M., Rego, G. ve Nunes, R. (2021) The right to be forgotten and COVID-19: Privacy versus public interest, Acta Bioethica, 27(1): 59–67. https://doi.org/10.4067/S1726-569X2021000100059 Das, S. (2023) Private UK health data donated for medical research shared with insurance companies, The Observer, 12 Kasım. https://www.theguardian.com/technology/2023/nov/12/private-uk-health-data-donated-medical-research-shared-insurance-companies Department of Health and Social Care (2016) Review of health and care data security and consent, GOV.UK, 6 Temmuz. https://www.gov.uk/government/speeches/review-of-health-and-care-data-security-and-consent DSÖ (2021). Health data governance summit: Pre-read – Health data as a global public good. DSÖ (2023) The ongoing journey to commitment and transformation: digital health in the WHO European Region, 2023. Copenhagen: WHO Regional Office for Europe. ESPON (2021). Working together to deliver better digital healthcare. Luxembourg: ESPON EGTC, s. 11. European Data Protection Board (2021) Data concerning health under the General Data Protection Regulation. https://edpb.europa.eu/system/files/2021-07/edpb_guidelines_202007_healthdata_en.pdf Farr, C. (2020) Alphabet’s Verily enters stop loss insurance market, CNBC, 25 Ağustos. https://www.cnbc.com/2020/08/25/alphabet-verily-enters-stop-loss-insurance-market.html Ferretti, A. ve Vayena, E. (2022) In the shadow of privacy: Overlooked ethical concerns in COVID-19 digital epidemiology, Epidemics, 41: 100652. https://doi.org/10.1016/j.epidem.2022.100652 Fitzgerald, M. ve Crider, C. (2020) We need urgent answers about the massive NHS COVID data deal, Open Democracy, 7 Mayıs. https://www.opendemocracy.net/en/ournhs/we-need-urgent-answers-about-massive-nhs-covid-data-deal/ Fylan, F. ve Fylan, B. (2021) Co-creating social licence for sharing health and care data, International Journal of Medical Informatics, 149: 104439. https://doi.org/10.1016/j.ijmedinf.2021.104439 Gellert, R. (2022) Comparing definitions of data and information in data protection law and machine learning: A useful way forward to meaningfully regulate algorithms?, Regulation & Governance, 16: 156. Gilmore, A.B., ve ark. (2023) Defining and conceptualising the commercial determinants of health, The Lancet, 401(10383): 1194–1213. https://doi.org/10.1016/s0140-6736(23)00013-2 Global Mobile Consumer Survey. (2017) US Edition – The Dawn of the Next Era in Mobile, Deloitte. https://www2.deloitte.com/content/dam/Deloitte/us/Documents/technology-media-telecommunications/us-tmt-2017-global-mobile González Fuster, G. (2014) The Emergence of Personal Data Protection as a Fundamental Right of the EU, vol. 16. Springer International Publishing, 253–272. Gross, M.S., ve ark. (2022) Respect, justice and learning are limited when patients are deidentified data subjects, Learning Health Systems, 6(3): e10303. https://doi.org/10.1002/lrh2.10303 Hartman, T., ve ark. (2020) Public perceptions of good data management: Findings from a UK-based survey, Big Data & Society, 7(1). https://doi.org/10.1177/205395172093561 Hoeyer, K., ve ark. (2024) Health in data space: Formative and experiential dimensions of cross-border health data sharing, Big Data & Society, 11(1). https://doi.org/10.1177/20539517231224258 Howe, N., ve ark. (2018) Systematic review of participants’ attitudes towards data sharing: A thematic synthesis, Journal of Health Services Research & Policy, 23(2): 123–133. https://doi.org/10.1177/1355819617751555 Huckvale, K., Torous, J., ve Larsen, M.E. (2019) Assessment of data sharing and privacy practices of smartphone apps for depression and smoking cessation, JAMA Network Open, 2(4): e192542. Işıkara, G. (2023) Capitalism, economics, and externalities: What are externalities external to?, Capitalism Nature Socialism, 34(2): 40–56. https://doi.org/10.1080/10455752.2023.2192954 Kalkman, S., ve ark. (2022) Patients’ and public views and attitudes towards the sharing of health data for research: A narrative review of the empirical evidence, Journal of Medical Ethics, 48(1): 3–13. https://doi.org/10.1136/medethics-2019-105651 MacKenzie, D. (2018) Material signals: A historical sociology of high-frequency trading, American Journal of Sociology, 123(6): 1635–1683. Marelli, L., Testa, G., & van Hoyweghen, I. (2021). Big Tech platforms in health research: Repurposing big data governance in light of the General Data Protection Regulation’s research exemption. Big Data & Society. https://doi.org/10.1177/20539517211018783 McGoey, L. (2015) No Such Thing as a Free Gift: The Gates Foundation and the Price of Philanthropy. Verso. Meszaros, J. ve Chih-Hsing, H. (2019) Building trust and transparency? Challenges of the opt-out system and the secondary use of health data in England, Medical Law International, 19(2–3): 159–181. https://doi.org/10.1177/0968533219879975 Metcalf, K. ve Sadowski, J. (2024) Asserting the public interest in health data: On the ethics of data governance for biobanks and insurers, Big Data & Society, 11(4). https://doi.org/10.1177/20539517241290215 Meyers, G. ve Hoyweghen, I.V. (2018) Enacting actuarial fairness in insurance: From fair discrimination to behaviour-based fairness, Science as Culture, 27(4): 413–438. Microsoft (2022) Microsoft expands healthcare cloud strategy with new solutions and capabilities across data, AI and clinician experiences, Microsoft News Center, 15 Mart. https://news.microsoft.com Neubauer, K. (2017) Health and care in the digital single market [PowerPoint presentation], European Commission, DG Health OECD (2022) Going digital to advance data governance for growth and well-being. Paris: Organisation for Economic Co-operation and Development. https://www.oecd-ilibrary.org/science-and-technology/going-digital-to-advance-data-governance-for-growth-and-well-being_e3d783b0-en Olsen, E. (2021) Amazon partners for fall-detection tech on newly released Alexa Together service, Mobile Health News, 7 Aralık. https://www.mobihealthnews.com/news/amazon-partners-fall-detection-tech-newly-released-alexa-together-service Pan-European Commission on Health and Sustainable Development. (2021). Drawing light from the pandemic: A new strategy for health and sustainable development. Copenhagen: WHO Regional Office for Europe. https://www.euro.who.int/en/health-topics/health-policy/european-programme-of-work/pan-european-commission-on-health-and-sustainable-development Pałka, P. (2023) Harmed while anonymous: Beyond the personal/non-personal distinction in data governance, Technology and Regulation, 2023: 22–34. https://doi.org/10.26116/techreg.2023.003 Patil, S., ve ark. (2016) Public preferences for electronic health data storage, access, and sharing – evidence from a pan-European survey, Journal of the American Medical Informatics Association, 23(6): 1096–1106. Powles, J. ve Hodson, H. (2017) Google DeepMind and healthcare in an age of algorithms, Health and Technology, 7(4): 351–367. https://doi.org/10.1007/s12553-017-0179-1 Prince, A.E.R. ve Schwarcz, D. (2019) Proxy discrimination in the age of artificial intelligence and big data, Iowa Law Review, 105: 1257. Reuters (2018) John Hancock wants to turn life insurance into a wellness game, Reuters, 1 Ekim. https://www.reuters.com/article/us-manulife-financi-john-hancock-lifeins-idUSKCN1LZ1WL Rothstein, M.A. (2021) Big data, surveillance capitalism, and precision medicine: Challenges for privacy, Journal of Law, Medicine & Ethics, 49(4): 666–676. https://doi.org/10.1017/jme.2021.91 Sadowski, J. (2019) When data is capital: Datafication, accumulation, and extraction, Big Data & Society, 6(1). https://doi.org/10.1177/2053951718820549 Sadowski, J., Lewis, K. ve Bednarz, Z. (2024) Risk, value, vitality: The moral economy of a global behavioral insurance platform, Economy and Society, 53: 227–249. Seretis, S. A., ve ark. (2024). COVID-19 Pandemic and Vaccine Imperialism. Review of Radical Political Economics, 57(1), 9-29. https://doi.org/10.1177/04866134241282107 (Original work published 2025) Sharon, T. (2018) When digital health meets digital capitalism, how many common goods are at stake?, Big Data & Society. https://doi.org/10.1177/2053951718819032 Sharon, T. ve Gellert, R. (2024) Regulating Big Tech expansionism? Sphere transgressions and the limits of Europe’s digital regulatory strategy, Information, Communication & Society, 27(15): 2651–2668. https://doi.org/10.1080/1369118X.2023.2246526 Shabani, M. ve Yilmaz, S. (2022) Lawfulness in secondary use of health data: Interplay between three regulatory frameworks of GDPR, DGA & EHDS, Technology and Regulation, 2022: 128–134. https://doi.org/10.26116/techreg.2022.013 Slokenberga, S. (2021) Setting the foundations: Individual rights, public interest, scientific research and biobanking, in Slokenberga, S., Tzortzatou, O. ve Reichel, J. (Eds.), GDPR and Biobanking: Individual Rights, Public Interest and Research Regulation Across Europe. New York: Springer International Publishing, 11–30. Stevens, M., Kraaijeveld, S.R. ve Sharon, T. (2024) Sphere transgressions: Reflecting on the risks of Big Tech expansionism, Information, Communication & Society, 27(15): 2587–2599. https://doi.org/10.1080/1369118X.2024.2353782. Sweeney, L. (2013) Discrimination in online ad delivery, arXiv:1301.6822 [cs]. https://arxiv.org/abs/1301.6822 Şevik, İ. ve Çiçeklioğlu, M. (2024) Sağlığın ticari belirleyicileri çerçevesiyle Türkiye’de konutun finansallaşması ve sağlık ilişkisi, Toplum ve Hekim, 39(3): 228–240. Taichman, D.B., ve ark. (2016) Sharing clinical trial data: A proposal from the international committee of medical journal editors, JAMA, 315: 467–468. Tangcharoensathien, V., Boonperm, J. ve Jongudomsuk, P. (2010) Sharing health data: Developing country perspectives, Bulletin of the World Health Organization, 88(6): 468–469. https://doi.org/10.2471/BLT.10.079129 Terzis, P. ve Santamaria Echeverria, E.O. (2023) Interoperability and governance in the European Health Data Space regulation, Medical Law International, 23(4): 368–376. https://doi.org/10.1177/09685332231165692 Türk Tabipleri Birliği Web Sitesi. (2024) Yapay Zeka, Emek ve Toplumsal Sağlık Atölyesi” İstanbul’da Yapıldı. Erişim Tarihi: 29 Temmuz 2025 https://www.ttb.org.tr/haber_goster.php?Guid=5dd39b20-a257-11ef-87e0-6a7f3cb0bc9e Vayena, E., ve ark. (2018) Policy implications of big data in the health sector, Bulletin of the World Health Organization, 96(1): 66–68. https://doi.org/10.2471/BLT.17.197426 Veale, M. (2020) Privacy is not the problem with the Apple-Google contact-tracing toolkit, The Guardian, 1 Temmuz. https://www.theguardian.com/commentisfree/2020/jul/01/apple-google-contact-tracing-app-tech-giant-digital-rights Verily (2023) How digital biomarkers could transform evidence generation, Verily Perspectives, https://verily.com/perspectives/innovating-healthcare-digital-biomarkers Vezzoso, S. (2021) The dawn of pro-competition data regulation for gatekeepers in the EU, European Competition Journal, 17: 391–399. Vezyridis, P. ve Timmons, S. (2017) Understanding the care.data conundrum: New information flows for economic growth, Big Data & Society, 4(1). https://doi.org/10.1177/2053951716688490 Vincent, J. (2018) DeepMind’s AI can detect over 50 eye diseases as accurately as a doctor, The Verge, 13 Ağustos. https://www.theverge.com/2018/8/13/17670156/deepmind-ai-eye-disease-doctor-moorfields Von Grafenstein, M. (2018) The Principle of Purpose Limitation in Data Protection Laws: The Risk-Based Approach, Principles, and Private Standards as Elements for Regulating Innovation. Nomos, 109–124. Wired (2016) Care.data NHS England project closed. Wired. [Erişim Tarihi 11 Temmuz 2025] https://www.wired.com/story/care-data-nhs-england-closed/ World Bank Group (2023) Implementation Know-How Brief: Data Governance in Health. Digital-in-Health Flagship Program. Yeung, K. ve Bygrave, L.A. (2022) Demystifying the modernized European data protection regime: Cross-disciplinary insights from legal and regulatory governance scholarship, Regulation & Governance, 16: 137–140.

Geliş Tarihi / Received Date

  • 14.07.2025

Kabul Tarihi / Accepted Date

  • 31.07.2025