EHEALTH AND NEW LEGAL PROBLEMS

Yıl 2018, Cilt: 9 Sayı: 1, 477 - 506, 30.06.2018

Elif Küzeci

https://doi.org/10.21492/inuhfd.410571

Cited By: 4

Öz

Electronic
health, shortly eHealth mainly refers to health informatics and means usage of
Information Communication Technologies (ICTs) for health purposes. The rapid
evolution of eHealth applications causes a transformation not only in
healthcare, but also in the relationship between health professionals and
patients. On the one hand, these developments can enable longer and healthier
life for human beings. On the other hand, they present some side effects.
Indeed, the rapid development of health informatics raises new problems related
to personal data protection. To solve these problems, the role of the intrinsic
structure of the technology should be recognised. From this point of view, this
article begins with describing new developments related to eHealth. In the
light of these instances, the study tries to evaluate the legal problems in the
field and to propose some new solutions. In this sense, there needs to be a
perspective which strengthens the control of data subject on her personal
health related data, supports transparency of the process and takes into
consideration different components of technology. Projecting this perspective
to the interpretation of both the current regulations and the construction of
new ones can be helpful to create a balance between fundamental rights and
technological developments. To protect the rights of individuals without
setting barriers to technology as well as applying ethical principles that
systematise this perspective will foster a healthier future.         

Anahtar Kelimeler

Health law, health informatics technologies, eHealth, information-communication technologies (ICTs), health related data protection

SAĞLIK BİLİŞİM TEKNOLOJİLERİ VE YENİ HUKUKSAL SORU(N)LAR

Öz

Elektronik
Sağlık ya da kısaca e-Sağlık olarak da nitelenebilecek sağlık bilişim
teknolojileri, yeni iletişim teknolojilerinin (Information Communication
Technologies-ICTs) sağlık amacıyla kullanılmasını ifade eder. Sağlık bilişim
teknolojilerindeki hızlı gelişim geleneksel sağlık hizmeti sunumunda ve
hasta-hekim ilişkisinde dönüşüm yaratmaktadır. Bu gelişmenin daha uzun ve daha
sağlıklı bir yaşam için pek çok olanak sunduğu açıktır. Ancak bazı yan etkileri
olduğu da belirtilmelidir. Nitekim sağlık bilişim teknolojilerindeki hızlı
gelişim kişisel verilerin işlenme süreçleri ile ilgili yeni sorular ve sorunlar
gündeme getirmektedir. Bu soruların yetkin bir şekilde yanıtlanması,
yürürlükteki hukuk kurallarını yorumlarken ve gelecekteki hukuk kurallarını
tasarlarken teknolojinin kendine özgü yapısını dikkate almayı gerektirir. Bu
çalışma kapsamında öncelikle e-sağlık uygulamalarının getirdiği yenilikler
karşısında ortaya çıkan hukuksal sorular değerlendirilmiştir. Ardından ise bu
sorunlara çözüm olacağı umulan bazı öneriler geliştirilmiştir. Kanımızca bu
sorunların çözülebilmesi, veri öznesinin kendine ilişkin bilgiler üzerindeki
denetimini güçlendiren, sürecin şeffaflığını destekleyen ve teknolojinin
kendine özgü unsurlarını dikkate alan bir bakış açısı ile olanaklıdır.  Bu bakış açısının mevcut hukuk kurallarının
yorumuna ve yeni kuralların tasarımına yansıtılması, hak ve özgürlükler ile
teknolojik gelişmeler arasında dengenin kurulması açısından yararlı sonuçlar
verebilir. Ayrıca teknolojinin önüne bariyerler koymadan bireyin haklarını
korumak için hukuk kurallarının yanında bu bakış açısını sistemleştiren etik
kurallara da başvurulması daha sağlıklı bir gelecek kurmakta yardımcı
olacaktır. 

Anahtar Kelimeler

Sağlık hukuku, sağlık bilişim teknolojileri, e-Sağlık, enformasyon ve iletişim teknolojileri, kişisel sağlık verilerinin korunması.

Kaynakça

• A revolution in health care is coming, Welcome to Doctor You, The Economist, 1 Şubat 2018.
• ANDREESSEN, Marc, “Why Software Is Eating the World?”, The Wall Street Journal, 20 Ağustos 2011.
• Article 29 Data Protection Working Party: Working Document on the processing of personal data relating to health in electronic health records (EHR), WP 131, 15 Şubat 2007.
• Article 29 Working Party: “Health Data in Apps and Devices” (Annex), Avrupa Komisyonu’nun m-Sağlık uygulamalarının ne zaman kişisel veri düzenlemelerinin kapsamına gireceğine ilişkin 29. Madde Veri Koruma Grubuna ilettiği mektuba cevaben, ekli belge, 5 Şubat 2015, s. 5 (https://autoriteitpersoonsgegevens.nl/sites/default/files/atoms/files/20150205_letter_art29wp_ec_health_ data_after_plenary_annex_en.pdf) (Erişim Tarihi: 20 Mart 2018).
• Article 29 Working Party: Opinion 02/2013 on apps on smart devices, 00461/13/EN WP 202, 27 Şubat 2013, s. 5 vd.
• BAUER, Christoph: “Grundprinzipien des Datenschutzes bei E-Health”, in Bauer,Christoph/ Eickmeier, Frank/ Eckard, Michael (ed.), E-Health, Datenschutz, Datensicherheit, Herausforderungen und Lösungen im IoT-Zeitalter,Springer, Almanya 2018,s. 33.
• BURKELL, Jacquelyn Ann: “Remembering me: big data, individual identity, and the psychological necessity of forgetting”, Ethics and Information Technology, 18(1), 2016, s. 17-23.
• CALLENS, Stefaan “The EU Legal Framework on e-Health”, in Mossialos, Elias/ Permanand, Govin/ Baeten, Rita/ Hervey, Tamara K. (ed.), Health Systems Governance in Europe, The Role of European Union Law and Policy, Cambridge University Press, Birleşik Krallık 2010.
• CAPLAN, Jeremy: “Cause of death. Sloppy doctors”, Time, 15 Ocak 2007.
• CHAWLA, Nitesh/ DAVIS, V. Darcy A.: “Bringin Big Data to Personalized Healthcare: A Paient-Centered Framework”, Journal of General Internal Medicine, 28, 2013, s. 660-665.
• CHUNG, Jason: “What Should We Do About Artificial Intelligence in Health Care?”, NYSBA Health Law Journal, 22(3), 2017, s. 37-40.
• COHEN, Ronnie: “Blood pressure apps may be dangerously wrong”, Reuters, 23 Aralık 2014.
• COHEN,Julie E.: “What Privacy Is For”, Harvard Law Review, 126, 2013, s. 1904-1933.
• Consultative Committee of the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (T-PD): Guidelines on the protection of individuals with regard to the processing of personal data in a world of Big Data, T-PD(2017)01, 23 Ocak 2017.
• CRAWFORD, Kate/ SCHULTZ, Jason: “Big Data And Due Process: Toward A Framework To Redress Predictive Privacy Harms”, Boston College Law Review, 5, 2014, s. 93-128.
• Data doctors: How AI is changing healthcare, The Guardian (International Edition), 26 Ocak 2018.
• DICK, Richard S./STEEN, Elaine B./ DETMER, Don E.: The Computer Based Patient Report, National Academy Press, ABD 1997.
• DRABIAK, Katherine/ EMPTOR, Caveat, “How the Intersection of Big Data and Consumer Genomics Exponentially Increases Informational Privacy Risks”, Health Matrix, 27, 2017, s. 149-159.
• DUHIGG, Charles: “How companies learn your secrets”, The New York Times, 16 Şubat 2012.
• DUMORTIER, Jos/VERHENNEMAN: “Legal Regulation of Electronic Health ecords: A Comparative Analysis of Europe and the US”, in George, Carlisle/ Whitehouse, Diane/ Duquenoy, Penny (ed.),eHealth: Legal, Ethical and Governance Challenges, Springer, Almanya 2013, s. 25-56.
• European Commission: Attitudes towards the impact of digitisation and automation on daily life, Special Eurobarometer 460 (Summary), Avrupa Birliği 2017, s. 17 (http://ec.europa.eu/commfrontoffice/publicopinion/index.cfm), (Erişim Tarihi: 20 Mart 2018).
• European Commission: eHealth Action Plan 2012-2020 - Innovative healthcare for the 21st century, Communication from the Commission to the European Parliament, The Council, The European Economic and Social Committee and The Committee of the Regions, , COM(2012) 736 final, Brüksel, 6 Aralık 2012, s. 4.
• European Commission: Green Paper on mobile health (“mHealth”), COM(2014) 219 final, Belçika 10 Nisan 2014.
• European Commission:Accelerating the Development of the eHealth Market in Europe, eHealth Taskforce report 2007, Luxemburg 2007, s. 10.
• EXTER,André den: “eHealth Law: The Final Frontier”, in Hervey Tamara K./ Young, Calum Alasdair/ Bishop, Louise E., Research Handbook on Health Law and Policy, Edward Elgar Publishing, Birleşik Krallık 2017.
• FEDER, Barnaby J.:“Remote Control for Health Care”, The New York Times, 9 Eylül 2006, http://www.nytimes.com/2006/09/09/business/09node.html (Erişim Tarihi: 19 Mart 2018).
• FLANAGAN, Mary/ HOWE, Daniel C./NISSENBAUM, Helen: “Embodying Values in Technology”, in OVEN, Jeroen van den/ WECKERT, John (ed.), Information Technology and Moral Philosophy, Cambridge University Press, Birleşik Krallık 2008, s. 322-353.
• FOLLEN, Morris C.: Computer Medical Databases, The First Six Decades (1950-2010), Springer, Birleşik Krallık 2012, s. 33-55.
• FOUCAULT, Michael Hapishanenin Doğuşu, çev. Mehmet Ali Kılıçbay, 3. Baskı, İmge, Ankara 2006.
• FRIEDMAN, Lauren F.: “One of society’s greatest achievements-in a simple chart of the past 175 years”, Business Insider, 19 Haziran 2015.
• GOODMAN, Marc:“An Internet of Hackable Things”, The Wired World of 2016, Ocak 2016, s. 94-95.
• GREENLEAF,Graham: “Sheherezade and the 101 Data Privacy Laws: Origins, Significance and Global Trajectories”, Journal of Law, Information and Science, 1( 23), 2014, s.4-49. GYMREK Melissa/ McGUIRE, Amy L./ GOLAN, David/ HALPERIN, Eran/ ERLICH, Yaniv: “Identifying Personal Genomes by Surname Inference”, Science, 339( 6117), 2013, s. 321-324.
• HAMET, Pavel/ TREMBLAY,Johanne: “Artificial Intelligence in Medicine”, Metabolism Clinical and Experimental, 9, 2017, s. 536-540.
• HEENEY, J./ HAWKINS, N./ VRIES, J. De/ BODDINGTON, P./ KAYE, J.: “Assessing the Privacy Risks of Data Sharing in Genomics”, Public Health Genomics, 14, 2011, s. 17-25.
• Hippocrates, Loeb Classical Library, çev. W. H. S. Jones, Harvard University Press.
• HOGG, Tad: “Distributed Control of Microscopic Robots in Biomedical Applications”, in Mikhail PROKOPENKO (ed.), Advances in Applied Self-Organizing Systems, Advanced Information and Knowledge Processing, Springer, Birleşik Krallık 2013, s.179-208.
• How your electronic DNA could be the secure login of the future, The Guardian, 18 Temmuz 2014, http://www.theguardian.com/technology/2014/jul/18/how-your-electronic-dna-could-be-the-secure-login-of-the-future (Erişim Tarihi: 5 Mart 2018).
• HUMER, Caroline/ FINKLE, Jim: “Your medical record is worth more to hackers than your credit card”, Reuters, 4 Eylül 2014, https://www.reuters.com/article/us-cybersecurity-hospitals/your-medical-record-is-worth-more-to-hackers-than-your-credit-card-idUSKCN0HJ21I20140924 (Erişim Tarihi: 4 Mart 2018).
• JOURARD, Sidney M.: “Some Psychological Aspects of Privacy”, Law and Contemporary Problems, 2( 31), 1966, s. 307-318.
• KAE, Jane/ WHITLEY, Edgar A./ LUND, David, MORRISON, Michael/ TEARE, Harriet/ MELHAM,Karen: “Dynamic Consent: A Patient Interface for Twenty-First Century Research Networks”, European Journal of Human Genetics, 23, 2015, s. 141-146.
• Largest Healthcare Data Breaches of 2017, HIPAA Journal, 4 Ocak 2018, https://www.hipaajournal.com/largest-healthcare-data-breaches-2017/ (Erişim Tarihi: 5 Mart 2018).
• LIU, Jiajia/ SUN, Wen “Smart Attacks against Intelligent Wearables in People-Centric Internet of Things”, IEEE Communications Magazine, Aralık 2016, s. 44-49 (http://ieeexplore.ieee.org/document/7786109/) (Erişim Tarihi: 21 Mart 2018).
• LIVEI, Dimitri/ SARRI, Anna/Christina SKOULOUDI, Security and Resilince in eHealth, Security Challenges and Risks, ENISA 2015.
• Making Medicines, A Brief History of Pharmacy and Pharmaceuticals, Anderson, Stuart (ed.), Pharmaceutical Press, Büyük Britanya 2005.
• MAKSIMOVIĆ, Mirjana/ VUJOVIĆ, Vladimir: “Internet of Things Based E-health Systems: Ideas, Expectations and Concerns”, in Khan, Samee U./Zomaya, Albert Y./ Abbas, Assad (ed.), Handbook of Large-Scale Distributed Computing in Smart Healthcare, Springer, Almanya 2017.
• MARKS,Mason: “Emergent Medical Data”, 11 Ekim 2017, http://blogs.harvard.edu/billofhealth/2017/10/11/emergent-medical-data/ (Erişim Tarihi: 3 Mart 2018). MOSTERT, Menno/ BREDENOORD, Annelien L./ CIH BIESAART, Monique/ DELDEN, Johannes JM van: “Big Data in Medical Research and EU Data Protection Law: Challenges o the Consent or Anonymise Approach”, European Journal of Human Genetics, 24, 2016, s. 956-960.
• Number of mobile phone users worldwide from 2013 to 2019 (in billions), https://www.statista.com/statistics/274774/forecast-of-mobile-phone-users-worldwide/ (Erişim Tarihi: 13 Mart 2018).
• Overview of the national laws on electronic health records in the EU Member States and their interaction with the provision of cross-border eHealth services, Final report and recommendations, Belçika 2014, s. 23 https://ec.europa.eu/health/sites/health/files/ehealth/docs/laws_report_recommendations_en.pdf (Erişim Tarihi: 20 Mart 2018).
• PEREIRA, Stacey/ GIBBS, Richarda/ McGUIRE, A. Amy L.: “Open Access Data Sharing in Genomic Research”, Genes, 5(3), 2014, s. 739-747.
• RAGHUPATHI, Wullianallur/ RAGHUPATHI, Viju “Big data analytics in healthcare: promise and potential”, Health Information Science and Systems, 2(3), 2014, s. 1-10.
• REGALADO, Antonio: “The Data Made ME Do It”, MIT Technology Review, 3 Mayıs 2013, https://www.technologyreview.com/s/514346/the-data-made-me-do-it/ (Erişim Tarihi: 4 Mart 2018). RISSE, Guenter B.: Mending Bodies, Saving Souls, A History of Hospitals, Oxford University Press, Birleşik Krallık 1999.
• ROSER, Max: "Life Expectancy”, OurWorldInData.org, 2017, https://ourworldindata.org/life-expectancy (Erişim Tarihi: 3 Mart 2018).
• SCHENEIER, Bruce: Data and Goliath, W.W.Norton & Company, ABD 2015.
• SCHMIDT, Eric/ COHEN, Jared: The New Digital Age, Transforming Nations, Businesses, and Our Lives, Vintage, ABD 2014.
• SETHI, Nayta/ LAURIE, Graeme T.: “Delivering proportionate governance in the era of eHealth: Making linkage and privacy work together”, Medical Law International, 13, 2013, s. 168-204.
• SOKOL,Daniel K./ HETTIGE, Samantha: “Poor handwriting remains a significant problem in medicine”, Journal of the Royal Society of Medicine, 12 (99), 2006, s. 645-646.
• SOLUM, Lawrence B.: “Legal Personhood for Artificial Intelligences”, North Carolina Law Review, 7(4) 1992, s. 1231-1287.
• STEINSBEKK, Kristin/ MYSKJA, Solum Bjørn Kåe/ SOLBERG, Berge:“Broad Consent versus Dynamic Consent in Biobank Research: Is Passive Participation a Ethical Problem?”, European Journal of Human Genetics, 21, 2013, s. 897-902.
• SULTAN, Nabil “Reflective thoughts on the potential and challenges of wearable technology for healthcare provision and medical education”, International Journal of Information Management, 35, 2015, s. 523-525.
• TANNER, Adam: Our Bodies, Our Data, How Companies Make Millions Selling Our Medical Records, Beacon Press, ABD 2017.
• The World Bank: “Life expectancy at birth, total (years)”, https://data.worldbank.org/indicator/SP.DYN.LE00.IN (Erişim Tarihi: 24 Şubat 2018).
• THOMPSON, John D./ GOLDIN, Grace: The hospital; a social and architectural history, Yale University Press, ABD 1975.
• US Food and Drug Admnistraion: “FDA approves pill with sensor that digitally tracks if patients have ingested their medication”, 13 Kasım 2017, https://fda.gov/NewsEvents/Newsroom/PressAnnouncement/ucm584933.htm (Erişim Tarihi: 20 Mart 2018).
• WACHTER, Robert: The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine’s Computer Age, Mc Graw-Hill, ABD 2017.
• WANDHWA, Kush/ WRIGHT, David, “eHealth: Frameworks for Assesing Ethical Impacts”, in George, Carlisle/ Whitehouse, Diane/ Duquenoy,,Penny (ed.), eHealth: Legal, Ethical and Governance Challenges, Springer, Almanya 2013, s. 184.
• World Bank: “Mobile cellular subscriptions”, https://data.worldbank.org/indicator/IT.CEL.SETS, (Erişim Tarihi: 23 Mart 2018).
• World Health Organisation: “eHealth at WHO”, http://www.who.int/ehealth/about/en (Erişim Tarihi: 19 Mart 2018).
• World Health Organisation: Global diffusion of eHealth: Making universal health coverage, Report of the third global survey on eHealth, Global Observatory for eHealth, İsviçre 2016.
• World Health Organisation: mHealth, New horizons for health through mobile technologies, Global Observatory for eHealth series-Volume 3, İsviçre 2011, s. 5 http://www.who.int/goe/publications/goe_mhealth_web.pdf, (Erişim Tarihi: 19 Mart 2018).
• World Health Organization, Executive Board: mHealth: use of mobile wireless technologies for public health (Report by the Secretariat), 139th session, Provisional agenda item 6.6, EB 139/8, 27 Mayıs 2016.