Legal Regulation in Digital Medicine
Abstract
The civilized world has achieved enormous progress in digital medicine, which is becoming the basis for further healthcare development. In the near future this can significantly improve people`s life , increase budget efficiency in the sphere of health, improve health indicators and life expectancy of the next generation. In this situation, digital medicine does not fully guarantee exclusion of any data leakage risks. This means that the use of better technologies in health care will require stricter compliance with a complex network of existing laws and regulations, which vary depending on the country, jurisdiction and region (for example, the European Union).However, this global process implementation requires strong political will to protect citizens from confidential data misuse, to increase responsibility of manufacturers and consumers of digital equipment and technologies to their citizens and the state.
References
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[1] 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. Cited August 21, 2019. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2018:233:FIN.
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[28] https://www.ibm.com/watson/health/value-based-care/enable-effective-care.
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[31] Johnson, K.J., Gehlert, S. 2014. Return of results from genomic sequencing: a policy discussion of secondary findings for cancer predisposition. J Cancer Policy, 2(3):75–80. DOI:10.1016/j.jcpo.2014.05.001.
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[33] Kim, H., Kim, S.Y., Joly, Y. 2018. South Korea: in the midst of a privacy reform centered on data sharing. Hum Genet, 137(8):627-635. DOI:10.1007/s00439-018-1920-1.
[34] Maxwell, J., Heesters, N., Stine, K., Barret, M. 2016. Precision medicine initiative (PMI) data security principles implementation guide. US Department of Health and Human Services (HHS) - The Office of the National Coordinator for Health Information Technology (ONC). http://www.healthit.gov/sites/default/files/pmi_security_ig_v16-clean.pdf. Accessed 20 March 2017
[35] Meskó, B., et al. 2017. Digital health is the cultural transformation of traditional healthcare. Mobile Healthcare. 3: 38. DOI: http://dx.doi.org/10.21037/mhealth.2017.08.07.
[36] Mitchell, C., Ploem, C. 2018. Legal challenges for the implementation of advanced clinical digital decision support systems in Europe. J Clin Transl Res. 18;3 (Suppl 3): 424-430. eCollection 2018 Dec 17.
[37] O’Donoghue, J., et al. 2019. Protocol for a systematic review and qualitative synthesis of information quality frameworks in eHealth. BMJ Open. 9 (3): e024722. DOI:10.1136/bmjopen-2018-024722.
[38] Olimid, D.A., Olimid, A.P., Ifrim, Chen, F. 2018. Ethical governance of the medical research: clinical investigation and informed consent under the new EU Medical Devices Regulation (2017∕745). Rom J Morphol Embryol.; 59(4):1305-1310.
[39] Parra-Calderón, C.L., et al. 2018. Desiderata for digital consent in genomic research. J Community Genet 9, 191–194. https://doi.org/10.1007/s12687-017-0355-z.
[40] Perkins, B.A., et al. 2018. Precision medicine screening using whole-genome sequencing and advanced imaging to identify disease risk in adults. Proc Natl Acad Sci USA. 115(14):3686–3691. DOI:10.1073/pnas.1706096114.
[41] Personal Information Protection Act of 2011. 2017. Act No. 14839. http://elaw.klri.re.kr/kor_service/lawView.do?hseq=46731andlang=ENG. Accessed 20 May 2018.
[42] Regulation (EU) 2016/679 of the European Parliament of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data on the free movement of such data, repealing Directive 95/46/EC (General Data Protection Regulation).
[43] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices. OJ L 117/1 (5 May 2017)
[44] Regulation of the European Parliament and of the Council (EU) 679/2016 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). 2016. OJ L 119/1.
[45] Rule 11, Annex VIII Medical Devices Regulation.
[46] Shneiderman, B. 2016. Opinion: The dangers of faulty, biased, or malicious algorithms requires independent oversight. Proc Natl Acad Sci.; 113:13538–40.
[47] Stoddart, J., Chan, B., Joly, Y. 2016. The European Union's Adequacy Approach to Privacy and International Data Sharing in Health Research. J Law Med Ethics, 44(1):143-55. doi: 10.1177/1073110516644205.
[48] Study Panel for the Future of Science and Technology, European Parliamentary Research Service – EPRS; Scientific Foresight Unit – STOA. 2019. Understanding algorithmic decision-making: Opportunities and challenges. PE 624.261 – March http://www.europarl.europa.eu/RegData/etudes/STUD/2019/624261/EPRS_STU(2019)624261_EN.pdf.
[49] Tenenbaum, J.D., et al. 2016. An informatics research agenda to support precision medicine: seven key areas. Journal of American Medical Informatics Association [Internet]. 1(919):ocv213. http://jamia.oxfordjournals.org/lookup/doi/10.1093/jamia/ocv213.
[50] The Digital Medicine (DiMe) Society. 2019. www.dimesociety.org.
[51] The Federal Law ‘On Amending Certain Legislative Acts of the Russian Federation on the Application of Information Technologies in the Field of Health Care’ dated July 29, 2017 N 242-FЗ (latest revision). fz242-29-7-18.pd
[52] The Lancet Public Health. 2019. Next generation public health: towards precision and fairness. Lancet Public Health, 4(5):PE209.
[53] U.S. Food and Drug Administration. [Internet]. Silver Spring: U.S. Food and Drug Administration; c1995-2017 (cited 2017 May 3). U.S. Department of Health and Human Services. https://www.fda.gov/medicaldevices/digitalhealth/#mobileapp.
[54] UNESCO. 2003. International Declaration on Human Genetic Data. UNESCO, Paris, http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/human-genetic-data/. Accessed 21 Jun 2019.
[2] Act on the Secondary Use of Health and Social Data. https://stm.fi/documents/1271139/1365571/The+Act+on+the+Secondary+Use+of+Health+and+Social+Data/a2bca08c-d067-3e54-45d1-18096de0ed76/The+Act+on+the+Secondary+Use+of+Health+and+Social+Data.pdf.
[3] Art 51; Rule 11, Annex VIII Medical Devices Regulation.
[4] Article 29 Data Protection Working Party, ‘Guidelines on Automated individual decision-making and Profiling for the purposes of Regulation 2016/679’ (European Commission, 13th Feb 2018).
[5] Article 29 Working Group on Data Protection. 2007. Working Document on the processing of personal data relating to health in electronic health records (EHR), WP 131 [cit. 2019 January 13]. https://ec.europa.eu/justice/article-29/documentation/opinion-recommendation/files/2007/wp131_en.pdf.
[6] Arts 61-62, Medical Devices Regulation.
[7] Based C, Care C, Group W, Group SW. 2016. HL7 CDA ® R2 Implementation Guide: Privacy Consent Directives, Release 1 January 2016 HL7 Normative Ballot 3 Sponsored by, 2016; (January).
[8] Bhavnani, S.P., Narula, J., Sengupta, P.P. 2016. Mobile technology and the digitization of healthcare. European Heart Journal, 37 (18): 1428–38. DOI: 10.1093/eurheartj/ehv770.
[9] Budin-Ljøsne I, et al. 2017b. Dynamic consent: a potential solution to some of the challenges of modern biomedical research [internet]. Vol. 18, BMC Medical Ethics. 4. http://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-016-0162-9.
[10] California AB-375 Privacy: personal information: businesses. AB-375.
[11] Chang, A. 2018. The Facebook and Cambridge Analytica scandal, explained with a simple diagram. Vox https://www.vox.com/policy-and-politics/2018/3/23/17151916/facebook-cambridge-analytica-trumpdiagram.
[12] Char, D.S., Shah, N.H., Magnus, D. 2018. Implementing Machine Learning in Health Care - Addressing Ethical Challenges. N Engl J Med.;378(11):981–3.
[13] Chen, C.E, et al. 2019. Characteristics of Digital Health Studies Registered in ClinicalTrials.gov. JAMA Internal Medicine. 179 (6): 838–840. DOI: 10.1001/jamainternmed.2018.7235.
[14] Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Mid-Term Review on the implementation of the Digital Single Market Strategy A Connected Digital Single Market for All. SWD. 2017. https://eur-lex.europa.eu/content/news/digital_market.html.
[15] 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. Cited August 21, 2019. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2018:233:FIN.
[1] 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. Cited August 21, 2019. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2018:233:FIN.
[16] Datenschutzgesetz (DSG). 2015. Baeriswyl B, Pärli K, editorial board. Berne: Stämpfli Handkommentar.
[17] Exchange of Electronic Health Records across the EU. Cited August 21, 2019. Available from: https://ec.europa.eu/digital-single-market/en/exchange-electronic-health-records-across-eu.
[18] FDA US Food and Drug Administration. Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) - Discussion Paper and Request for Feedback. Cited: September 23, 2019. https://www.fda.gov/media/122535/download.
[19] Final Report and Action Plan from the European Commission Expert Group on FAIR Data – Turning FAIR into reality. 2018. https://ec.europa.eu/info/sites/info/files/turning_fair_into_reality_0.pd.
[20] Global Alliance for Genomics and Health. 2014. Framework for responsible sharing of genomic and health-related data. https://www.ga4gh.org/ga4ghtoolkit/regulatoryandethics/framework-for-responsible-sharing-genomic-and-health-related-data/. Accessed 21 June 2018
[21] Goodman, KW. 2016. Ethical and Legal Issues in Decision Support. In: Clinical Decision Support Systems [Internet] Springer, Cham:131–46. https://link.springer.com/ chapter/10.1007/978-3-319-31913-18 (cited 2017 Aug 21). (Health Informatics).
[22] Grady, C. 2015. Enduring and emerging challenges of informed consent. N Engl J Med [Internet] 372(9):855–62. http://www.nejm.org/doi/full/10.1056/NEJMra1411250?query=TOC%5Cn. http://www.nejm.org/doi/pdf/10.1056/NEJMra1411250.
[23] Grossman, R.L. et al. 2016. Toward a shared vision for cancer genome data. N Engl J Med., 375:1109–1112. DOI:10.1056/NEJMp1607591.
[24] Hempel, D. 2015. Oncoguide System- a Computerized Interactive Assistance System for the Diagnosis and Treatment of CML / MPN and MDS. Blood,126:5145 - 5145.
[25] Horgan, D., Bernini, C., Thomas, P.P.M., Morre, S.A. 2019. Cooperating on data: the missing element in bringing real innovation to Europe’s healthcare system. Public Health Genomics. DOI:10.1159/000503296.
[26] Horgan, D., Romao, M., Morré, S.A., Kalra, D. 2019. Artificial Intelligence: Power for Civilisation - and for Better Healthcare. Public Health Genomics, 22(5-6):145-161. DOI:10.1159/000504785. Epub 2019 Dec 13.
[27] https://deepmind.com/applied/deepmind-health.
[28] https://www.ibm.com/watson/health/value-based-care/enable-effective-care.
[29] Innovative Solutions for Research in Healthcare. Developing a novel approach to deliver better precision medicine in Europe. The EMA standpoint. Cited: August 21, 2019. http://www.europarl.europa.eu/cmsdata/159164/Guido%20Rasi.pdf.
[30] Jeong, G. 2017. Assessment of direct-to-consumer genetic testing policy in Korea based on consumer preference. Public Health Genom., 20:166–173. DOI: 10.1159/000479290.
[31] Johnson, K.J., Gehlert, S. 2014. Return of results from genomic sequencing: a policy discussion of secondary findings for cancer predisposition. J Cancer Policy, 2(3):75–80. DOI:10.1016/j.jcpo.2014.05.001.
[32] Kawamoto, D. Tech Companies Embrace Some GDPR Privacy Practices Outside of Europe. (n.d.). http://www.govtech.com/policy/Tech-Companies-Embrace-Some-GDPR-Privacy-Practices-Outside-of-Europe.html.
[33] Kim, H., Kim, S.Y., Joly, Y. 2018. South Korea: in the midst of a privacy reform centered on data sharing. Hum Genet, 137(8):627-635. DOI:10.1007/s00439-018-1920-1.
[34] Maxwell, J., Heesters, N., Stine, K., Barret, M. 2016. Precision medicine initiative (PMI) data security principles implementation guide. US Department of Health and Human Services (HHS) - The Office of the National Coordinator for Health Information Technology (ONC). http://www.healthit.gov/sites/default/files/pmi_security_ig_v16-clean.pdf. Accessed 20 March 2017
[35] Meskó, B., et al. 2017. Digital health is the cultural transformation of traditional healthcare. Mobile Healthcare. 3: 38. DOI: http://dx.doi.org/10.21037/mhealth.2017.08.07.
[36] Mitchell, C., Ploem, C. 2018. Legal challenges for the implementation of advanced clinical digital decision support systems in Europe. J Clin Transl Res. 18;3 (Suppl 3): 424-430. eCollection 2018 Dec 17.
[37] O’Donoghue, J., et al. 2019. Protocol for a systematic review and qualitative synthesis of information quality frameworks in eHealth. BMJ Open. 9 (3): e024722. DOI:10.1136/bmjopen-2018-024722.
[38] Olimid, D.A., Olimid, A.P., Ifrim, Chen, F. 2018. Ethical governance of the medical research: clinical investigation and informed consent under the new EU Medical Devices Regulation (2017∕745). Rom J Morphol Embryol.; 59(4):1305-1310.
[39] Parra-Calderón, C.L., et al. 2018. Desiderata for digital consent in genomic research. J Community Genet 9, 191–194. https://doi.org/10.1007/s12687-017-0355-z.
[40] Perkins, B.A., et al. 2018. Precision medicine screening using whole-genome sequencing and advanced imaging to identify disease risk in adults. Proc Natl Acad Sci USA. 115(14):3686–3691. DOI:10.1073/pnas.1706096114.
[41] Personal Information Protection Act of 2011. 2017. Act No. 14839. http://elaw.klri.re.kr/kor_service/lawView.do?hseq=46731andlang=ENG. Accessed 20 May 2018.
[42] Regulation (EU) 2016/679 of the European Parliament of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data on the free movement of such data, repealing Directive 95/46/EC (General Data Protection Regulation).
[43] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices. OJ L 117/1 (5 May 2017)
[44] Regulation of the European Parliament and of the Council (EU) 679/2016 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). 2016. OJ L 119/1.
[45] Rule 11, Annex VIII Medical Devices Regulation.
[46] Shneiderman, B. 2016. Opinion: The dangers of faulty, biased, or malicious algorithms requires independent oversight. Proc Natl Acad Sci.; 113:13538–40.
[47] Stoddart, J., Chan, B., Joly, Y. 2016. The European Union's Adequacy Approach to Privacy and International Data Sharing in Health Research. J Law Med Ethics, 44(1):143-55. doi: 10.1177/1073110516644205.
[48] Study Panel for the Future of Science and Technology, European Parliamentary Research Service – EPRS; Scientific Foresight Unit – STOA. 2019. Understanding algorithmic decision-making: Opportunities and challenges. PE 624.261 – March http://www.europarl.europa.eu/RegData/etudes/STUD/2019/624261/EPRS_STU(2019)624261_EN.pdf.
[49] Tenenbaum, J.D., et al. 2016. An informatics research agenda to support precision medicine: seven key areas. Journal of American Medical Informatics Association [Internet]. 1(919):ocv213. http://jamia.oxfordjournals.org/lookup/doi/10.1093/jamia/ocv213.
[50] The Digital Medicine (DiMe) Society. 2019. www.dimesociety.org.
[51] The Federal Law ‘On Amending Certain Legislative Acts of the Russian Federation on the Application of Information Technologies in the Field of Health Care’ dated July 29, 2017 N 242-FЗ (latest revision). fz242-29-7-18.pd
[52] The Lancet Public Health. 2019. Next generation public health: towards precision and fairness. Lancet Public Health, 4(5):PE209.
[53] U.S. Food and Drug Administration. [Internet]. Silver Spring: U.S. Food and Drug Administration; c1995-2017 (cited 2017 May 3). U.S. Department of Health and Human Services. https://www.fda.gov/medicaldevices/digitalhealth/#mobileapp.
[54] UNESCO. 2003. International Declaration on Human Genetic Data. UNESCO, Paris, http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/human-genetic-data/. Accessed 21 Jun 2019.
Published
2020-03-31
How to Cite
OSADCHUK, M.A. et al.
Legal Regulation in Digital Medicine.
Journal of Advanced Research in Law and Economics, [S.l.], v. 11, n. 1, p. 148 – 155, mar. 2020.
ISSN 2068-696X.
Available at: <https://journals.aserspublishing.eu/jarle/article/view/4766>. Date accessed: 05 may 2024.
doi: https://doi.org/10.14505//jarle.v11.1(47).18.
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