Tantangan Etika dan Hukum Penggunaan Rekam Medis Elektronik dalam Era Personalized Medicine

Rani Tiyas Budiyanti; Penggalih Mahardika Herlambang; Nurhasmadiar Nandini

doi:10.22146/jkesvo.41994

Tantangan Etika dan Hukum Penggunaan Rekam Medis Elektronik dalam Era Personalized Medicine

https://doi.org/10.22146/jkesvo.41994

Rani Tiyas Budiyanti^(1*), Penggalih Mahardika Herlambang⁽²⁾, Nurhasmadiar Nandini⁽³⁾

(1) Administrasi dan Kebijakan Kesehatan, Fakultas Kesehatan Masyarakat, Universitas Diponegoro, Semarang
(2) Prodi Rekam Medis, Fakultas Kesehatan, Universitas Dian Nuswantoro, Semarang
(3) Administrasi dan Kebijakan Kesehatan, Fakultas Kesehatan Masyarakat, Universitas Diponegoro, Semarang
(*) Corresponding Author

Abstract

Background: Personalized medicine is one of the health treatment approaches that has developed in the last ten years. This treatment is specific because it considers the genomics of patients and requires a complete database or medical record covering clinical and genomic data. Nevertheless, there are ethical and legal challenges in the implementation of electronic medical records in personalized medicine.

Objective: This study aimed to determine the ethical and legal challenges in the use of electronic medical records in personalized medicine based on previous literature.

Methods: The method used in this study was literature review with sources from journals, books, and articles on electronic medical records, personalized medicine, as well as legal and ethical aspects related both domestically and abroad.

Results: Ethical and legal challenges that can occurred in the use of electronic medical records in the personalized medicine era include security and ownership of data, legal responsibility, genomic discrimination, and changes in the relationship between doctors and patients.Conclusion: Indonesia does not yet have specific regulations regarding data security, data ownership, and data sharing in the health sector. Further regulations regarding the use of electronic medical records in the personalized era are needed so that their implementation does not conflict with the ethics and laws that apply in Indonesia

Keywords

personalized medicine; electronic medical record; ethics; law

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References

Alterovitz, G. et al. (2015) ‘SMART on FHIR Genomics: Facilitating standardized clinico-genomic apps’, Journal of the American Medical Informatics Association, 22(6), pp. 1173–1178. doi: 10.1093/jamia/ocv045.

Bennet, C. (2003) ‘The human Genome Project and The Future of Medical Practice’, African Journal of Biotechnology, 2(12), pp. 649–656.

Brothers, K. B. and Rothstein, M. A. (2015) ‘Ethical, legal and social implications of incorporating personalized medicine into healthcare’, Personalized Medicine, pp. 43–51. doi: 10.2217/pme.14.65.

Budiyanti, R. T., Arso, S. P. and Herlambang, P. M. (2018) ‘Rekam Medis Elektronik Berbasis Cloud’, Cermin Dunia Kedokteran Edisi 268, 45(9).

Chouchane, L. et al. (2011) ‘Personalized medicine: A patient - centered paradigm’, Journal of Translational Medicine. doi: 10.1186/1479-5876-9-206.

Davis, R. and Khoury, M. (2005) ‘The journey of personalized medicine’, Personalized Medicine, 2(1), pp. 1–4. doi: doi: 10.1517/17410541.2.1.1.

Global Alliance for Genomics and Health (2017) Overview of Global Alliance for Genomics and Health. Available at: https://www.ga4gh.org/aboutus/ .

Health Level Seven International (2013) HL7 Version 2 Implementation Guide: Clinical Genomics; Fully LOINC-Qualified Genetic Variation Model (US Realm).

Kementerian Kesehatan Republik Indonesia (2008) Peraturan Menteri Kesehatan Nomor 269 tahun 2008 tentang Rekam Medis. Indonesia.

Knoppers, B. M. (2001) ‘Duty to recontact: a legal harbinger?’, American Journal of Medical Genetics, 103(4), p. 277. Available at: http://onlinelibrary.wiley.com/doi/10.1002/ajmg.1543/abstract.

Menteri Komunikasi dan Informatika (2016) Peraturan Menteri Komunikasi dan Informatika Nomor 20 tahun 2016 Tentang Perlindungan Data Pribadi, Republik Indonesia. doi: 10.1111/j.1469-7610.2010.02280.x.

Ontario Personalized Medicine Network Subcomitte Report (OPMN) (2013) Summary of International Strategies for Personalized Medicine. Available at: http://www.ontariogenomics.ca/wp-content/uploads/sites/1/2015/09/OPMN-REPORTS_SummaryofInternationalStrategiesforPersonalizedMedicine.pdf (Accessed: 18 December 2018).

Rogowski, W. et al. (2014) ‘Concepts of “Personalization” in Personalized Medicine: Implications for Economic Evaluation’, PharmacoEconomics, 33(1), pp. 49–59. doi: 10.1007/s40273-014-0211-5.

Rothstein, M. A. and Joly, Y. (2009) ‘Genetic information and insurance underwriting: contemporary issues and approaches in the global economy’, in Atkinson, P. A., Glasner. Peter Egon, and Lock, M. (eds) Handbook of Genetics and Society: Mapping the New Genomic Era. New York: Routledge, pp. 127–144. Available at: https://yannjoly.openum.ca/publications/genetic-information-and-insurance-underwriting-contemporary-issues-and-approaches-in-the-global-economy-insurance/.

Saif, S. M. et al. (2011) ‘A Network engineering Solution for Data sharing across healthcare providers and protects patients health data privacy using EHR System’, Journal of Global Research in Computer Science, 2(8), pp. 67–72. Available at: http://capella.summon.serialssolutions.com/link/eJx9Uttum0AQJZdW6iWfkbyswBh8AUs0cuukTRsnbWiaqi_WsDuYTWCX7i44_rl-W9c4iVqp6gNizpkzZy7gOG_S6_n88sJNT9L0zL6rFWaBVyvJPN1UlRSeRsWh1FqWjeFSaI_Kyg3C4dgdRoMd5-XNt_j8y_B8Fn7e3f1VGFNPer1VG5c_hyULa1sOihb_dPFKnilQa49CjWU.

Shabo, A. (2005) ‘The implications of electronic health record for personalized medicine.’, Biomedical papers of the Medical Faculty of the University Palack??, Olomouc, Czechoslovakia, 149(2). doi: 10.2217/17410541.2.3.251.

Stanek, E. J. et al. (2012) ‘Adoption of pharmacogenomic testing by US physicians: Results of a nationwide survey’, Clinical Pharmacology and Therapeutics, 91(3), pp. 450–458. doi: 10.1038/clpt.2011.306.

Tran, L. D., Zimmerman, F. J. and Fielding, J. E. (2017) ‘Public health and the economy could be served by reallocating medical expenditures to social programs’, SSM - Population Health, 3, pp. 185–191. doi: 10.1016/j.ssmph.2017.01.004.

Vazquez, E. S. (2004) ‘Personalized therapy: an interdisciplinary challenge’, Personalized Medicine, 1(1), pp. 127–130. Available at: http://www.futuremedicine.com/doi/abs/10.1517/17410541.1.1.127.

DOI: https://doi.org/10.22146/jkesvo.41994