LEGAL FOUNDATION OF DETERMINING CRITERIA OF IMPROPER RENDERING OF MEDICAL AID IN RUSSIAN FEDERATION
Palavras-chave:
medical aid, medical service, public health, criteria of improper rendering of medical aid.Resumo
This scientific paper is aimed at reviewing the applicable laws governing the medical aid rendering to the Russian Federation citizens, in particular, the RF Civil Code, the Federal Law dated 21.11.2011 No. 323-FZ “On fundamental healthcare principles in the Russian Federation”, the RF Law dated 07.07.1992 No. 2300-1 “On Protection of Consumers’ Rights”, and a number of subordinate regulatory legal acts. The article’s authors tried to analyze and to reveal criteria of improper rendering of medical aid in the Russian Federation. The authors substantiated that the medical aid, as a complex of measures, which are aimed at maintaining and (or) recovering the health and which include the rendering of medical services, must correspond to the criteria of a proper quality, a proper volume, it must be rendered by highly-qualified specialists properly, at the appropriate time and with complying with the established rights of the patients, and a notion of improper medical aid is defined. A general scientific dialectical method and a complex of scientific approaches of obtaining knowledge (formally-legal, system-structural, formally-logical) is the research’s methodological framework. The results, which the authors obtained, consist in the fact that as criteria of improper rendering of the medical aid, it is necessary to consider the conditions, volume, safety, quality, non-conformity of the medical aid with the goals, for which this medical aid is usually rendered, violation of the patients’ rights, non-optimal choice of a technology of the medical aid rendering, violation of the rights of execution of the medical documentation. In the conclusion the authors formulated the basic conclusions of the research, substantiated the necessity to develop and to enshrine an enumeration of criteria of the improper rendering of the medical aid in the applicable laws.
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RF Civil Code (the first part) dated 30.11.1994 No. 51-FZ (revised on 03.08.2018) // RF official gazette. 1994. No. 32. Article 3301. [Grazhdansky kodeks RF (chast pervaya) ot 30.11.1994 No, 51-FZ (red. ot 03.08.2018) // Sobranie zakonodatelstva RF. 1994. No. 32. St. 3301.] Гражданский кодекс РФ (часть первая) от 30.11.1994 г. № 51-ФЗ (ред. от 03.08.2018) // Собрание законодательства РФ. 1994. № 32. Ст. 3301.
Federal Law dated 21.11.2011 No. 323-FZ “On fundamental healthcare principles in the Russian Federation” // RF official gazette. 2011. No. 48. Article 6724. [Federalny zakon ot 21.11.2011 No. 323-FZ “Ob osnovakh okhrany zdorovia grazhdan v Rissiiskoi Federatsii” // Sobranie zakonodatelstva RF. 2011. No. 48. St. 6724.] Федеральный закон от 21.11.2011 г. № 323-ФЗ «Об основах охраны здоровья граждан в Российской Федерации» // Собрание законодательства РФ. 2011. № 48. Ст. 6724.
RF law dated 07.07.1992 No. 2300-1 “On Protection of the Consumers’ Rights” (revised on 29.07.2018) // Vedomosty of SND and RF Supreme Soviet. 1992. No. 15. Article 766. [Zakon RF ot 07.07.1992 No. 2300-1 “O zaschite prav potrebitelei” (red. ot 29.07.2018) // Vedomosti SND i VS RF. 1992. No. 15. St. 766.] Закон РФ от 07.07.1992 г. № 2300-1 «О защите прав потребителей» (ред. от 29.07.2018) // Ведомости СНД и ВС РФ. 1992. № 15. Ст. 766.
Federal Law dated 04.05.2011 No. 99-ФЗ “On Licensing Certain Activities” (revised on 27.12.2018) // RF official gazette. 2011. No. 19. Article 2716. [Federalny zakon ot 04.05.2011 No. 99-FZ “O litsenzirovanii itdelnykh vidov deyatelnosti” (red. ot 27.12.2018) // Sobranie zakonodatelstva RF. 2011. No. 19. St. 2716.] Федеральный закон от 04.05.2011 № 99-ФЗ «О лицензировании отдельных видов деятельности» (ред. от 27.12.2018) // Собрание законодательства РФ. 2011. № 19. Ст. 2716.
RF Government Decree dated 16.04.2012 No. 291 “On Licensing of Medical Activities (except for the said activities, which is implemented by the medical organizations and other organizations, which belong to the private health care system, in the innovation center “Skolkovo”)” // RF official gazette. 2012. No. 17. Article 1965. [Postanovlenie Pravitelstva RF ot 16.04.2012 No. 291 “O litsenzirovanii meditsinskoi deyatelnosti (za isklucheniem ukazannoi deyatelnosti, osuschestvlyaemoi meditsinskimi organizatsiyami i drugimi organizatsiyami, vkhodyaschimi v chstnuyu sistemu zsravookhranenia, na territorii innivatsionnogo tsentra “Skolkovo”)” // Sobranie zakonodatelstva RF. 2012. No. 17. St. 1965.] Постановление Правительства РФ от 16.04.2012 № 291 «О лицензировании медицинской деятельности (за исключением указанной деятельности, осуществляемой медицинскими организациями и другими организациями, входящими в частную систему здравоохранения, на территории инновационного центра «Сколково»)» // Собрание законодательства РФ. 2012. № 17. Ст. 1965.
RF Government Decree dated 28.11.2014 No. 1273 “On program of the state guarantees of gratuitous rendering of the medical aid to the citizens for 2015 and for the planning period of 2016 and 2017” RF official gazette. 2014. No. 49 (Part VI). Article 6975. [Postanovlenie gravitelstva RF ot 28.11.2014 No. 1273 “О Programmr gosudarstvennykh garantii besplatnogo okazania grazhdanam meditsinskoi pomoschi na 2015 god i na planovy period 2016 i 2017 godov” // Sobranie zakonodatelstva RF. 2014. No. 49 (chast VI). St. 6975.] Постановление Правительства РФ от 28.11.2014 № 1273 «О Программе государственных гарантий бесплатного оказания гражданам медицинской помощи на 2015 год и на плановый период 2016 и 2017 годов» // Собрание законодательства РФ. 2014. № 49 (часть VI). Ст. 6975.
RF Government Decree dated 04.10.2012 No. 1006 “On Approval of the Rules of Rendering by the Medical Organizations of the Paid Medical Services” // RF official gazette. 2012. No. 41. Article 5628. [Postanovlenie Pravitelstva RF ot 04.10.2012 No. 1006 “Ob utverzhdenii Pravil predostavlenia meditsinskimi organizatsiyami platnykh meditsinskikh uslug” // Sobranie zakonodatelstva RF. 2012. No. 41. St. 5628.] Постановление Правительства РФ от 04.10.2012 № 1006 «Об утверждении Правил предоставления медицинскими организациями платных медицинских услуг» // Собрание законодательства РФ. 2012. № 41. Ст. 5628.
Decree of the Chief State Sanitary Doctor of the Russian Federation dated May 18, 2010 No. 58 (revised on 10.06.2016) “On Approval of SanPiN 2.1.3.2630-10 “Public health requirements for the organizations, which carry out the medical activities” // Bulletin of Federal Agency Regulations. No.36. 06.09.2010. [Postanovlenie glavnogo gosudarstennogo sanitarnogo vracha RF ot 18.05.2010 No. 58 (red. ot 10.06.2016) “Ob utverzhdenii SanPin 2.1.3.2630-10 “Sanitarno-epidemiologicheskie trebovania k organizatsiam, osuschestvlyauschim meditsinskuyu deyateknost” // Bulleten normativnykh aktov federalnykh organov ispolnitelnoi vlasti. No. 36. 06.09.2010.] Постановление Главного государственного санитарного врача РФ от 18.05.2010 № 58 (ред. от 10.06.2016) «Об утверждении СанПиН 2.1.3.2630-10 «Санитарно-эпидемиологические требования к организациям, осуществляющим медицинскую деятельность» // Бюллетень нормативных актов федеральных органов исполнительной власти. № 36. 06.09.2010.
Order of the Ministry of Health of Russia dated 20.12.2012 No. 1177н (revised on 10.08.2015) “On Approval of the order of giving the informed voluntary consent to the medical intervention and refusal from the medical intervention in relation to certain types of medical interventions, forms of informed military consent to the medical intervention and forms of refusal of the medical intervention” // Russian newspaper. No. 145. 05.07.2013. [Prikaz Minzdrava Rossii ot 20.12.2012 No. 1177н (red. ot 10.08.2015) “Ob utverzhdeniaporyadka dachi informirivannogo dobrovolnogo soglasia na meditsinskoe vmeshatelstvo iptkaza ot meditsinskogo vmeshatelstva v otnoshenii opredelyunnykh vidov meditsinskikh vmeshatelstv, form informirovannogo dobeovolnogo soglasia na meditsinskoe vmeshatelstvo iform otkaza ot meditsynskogo vmeshatelstva” // Rossiiskata gazeta. No. 145. 05.07.2013.] Приказ Минздрава России от 20.12.2012 № 1177н (ред. от 10.08.2015) «Об утверждении порядка дачи информированного добровольного согласия на медицинское вмешательство и отказа от медицинского вмешательства в отношении определенных видов медицинских вмешательств, форм информированного добровольного согласия на медицинское вмешательство и форм отказа от медицинского вмешательства» // Российская газета. № 145. 05.07.2013.
Order of the Ministry of health of Russia dated 08.10.2015 No. 707н (revised on 15.06.2017) “On Approval of Qualification requirements for medical and pharmaceutical workers with higher education on the training program “Health care and medical sciences” // Official online-portal of the legal information http://www.pravo.gov.ru, 27.10.2015. [Prikaz Minzdrava Rossii ot 08.10.2015 No. 707н (red. ot 15.06.2017) “Ob utverzhdenii Kvaliifikatsionnykh trebovanii k meditsinskim i farmatsevticheskim rabotnikam s vysshim obrazovaniem po napravleniu podgotovki “Zdravookhranenie i Meditsinskie uskugi” // Ofitsialny internet-portal pravovoi informatsii http://www.pravo.gov.ru, 27.10.2015.] Приказ Минздрава России от 08.10.2015 № 707н (ред. от 15.06.2017) «Об утверждении Квалификационных требований к медицинским и фармацевтическим работникам с высшим образованием по направлению подготовки «Здравоохранение и медицинские науки» // Официальный интернет-портал правовой информации http://www.pravo.gov.ru, 27.10.2015.
Order of the Ministry of Health of Russia dated 29.11.2012 No. 982н (revised on 10.02.2016) “On Approval of conditions and an order of issue of the specialist’s certificate to medical and pharmaceutical workers, a form and technical requirements of the specialist’s certificate” // Russian newspaper. No. 80.12.04.2013. [Prikaz Minzdrava Rossii ot 29.11.2012 No. 982н (red. ot 10.02.2016) “Ob utverzhdenii uslovii i podyadka vydachi sertifikata spetsialista meditsinskim i formatsevticheskim rabotnikam, for,y i tekhnicheskikh trebovanii sertifikata speteialista” // Rossiiskaya gazeta. No. 80.12.04.2013.] Приказ Минздрава России от 29.11.2012 № 982н (ред. от 10.02.2016) «Об утверждении условий и порядка выдачи сертификата специалиста медицинским и фармацевтическим работникам, формы и технических требований сертификата специалиста» // Российская газета. № 80.12.04.2013.
Order of Ministry of Health of Russia dated 03.08.2012 № 66н “On Approval of an order and time of improvement by the medical workers and pharmaceutical workers of their professional knowledge and skills by means of training according to additional professional educational programs in educational and scientific organizations” // Russian newspaper. No. 215. 19.09.2012. [Prikaz Minzdrava Rissii ot 03.08.2012 No. 66н “Ob utverzhdenii Poryadka i srokov sovershenstvovania meditsinskimi rabotnikami i farmatsevticheskimi rabotnikami professionalnykh znanii i navykov putyom obuchenia po dopolnitelnym professionalnym obrazovatelnym programmam vorrazovatelnykh i nauchnykh organizatsiakh” // Rossiiskaya gazeta. № 215. 19.09.2012.] Приказ Минздрава России от 03.08.2012 № 66н «Об утверждении Порядка и сроков совершенствования медицинскими работниками и фармацевтическими работниками профессиональных знаний и навыков путем обучения по дополнительным профессиональным образовательным программам в образовательных и научных организациях» // Российская газета. № 215. 19.09.2012.
Malyshko А. Yu. Legal status of the Russian Federation citizens when rendering the medical aid: Administrative and legal aspect: Dissertation of Candidate of Juridical Sciences. М., 2004. 164 p. [Malyshko А. Yu. Pravovoi status grazhdan Rossiiskoi Federatsii pri okazanii meditsinskoi pomoschi: Adminstrative-pravovoi aspect: dis. … cand. jurid. nauk. М., 2004. 164 s.] Малышко А. Ю. Правовой статус граждан Российской Федерации при оказании медицинской помощи: Административно-правовой аспект: дис. … канд. юрид. наук. М., 2004. 164 с.
Kanunnikova L.V. Substantiation of a model of rendering the legal aid to the medical workers, institutions and organizations in an entity of the Russian Federation: Author’s abstract … Dissertation of Doctor of Medical Sciences – Novosibirsk, 2006. – 34 p. [Kanunnikova L.V. Obosnovaniamodeli okazakia pravovoi pomoschi meditsinskim rabotnikam, uchrezhdenyam i organizatsiam v subjekte Rossiiskoi Federatsii: avtoref. … dis. d-ra m.n. – Novosibirsk, 2006. – 34 s.] Канунникова Л.В. Обоснование модели оказания правовой помощи медицинским работникам, учреждениям и организациям в субъекте Российской Федерации: автореф. … дис. д-ра м.н. – Новосибирск, 2006. – 34 с.
Antoci, A., Maccioni, A.F., Galeotti, M., Russu, P. Defensive medicine, liability insurance and malpractice litigation in an evolutionary model // Nonlinear Analysis: Real World Applications 47, с. 414-435. DOI: 10.1016/j.nonrwa.2018.08.012
Dubay, L. , Kaestner, R. Email Author,Waidmann, T. Medical malpractice liability and its effect on prenatal care utilization and infant health // Journal of Health EconomicsVolume 20, Issue 4, 2001, Pages 591-611 DOI: : 10.1016/S0167-6296(01)00082-0
Feess, E.Email Author Malpractice liability, technology choice and negative defensive medicine // European Journal of Health EconomicsVolume 13, Issue 2, April 2012, Pages 157-167. DOI: 10.1007/s10198-010-0294-7
Fitzgerald, L. How clinical managers (can) improve the health service // British Journal of Hospital Medicine, 76 (7), pp. 378-379.DOI: 10.12968/hmed.2015.76.7.378
Garcia-Retamero, R. Email Author, Galesic, M., View Correspondence (jump link), Max Planck Institute for Human Develop. On defensive decision making: How doctors make decisions for their patients // Health Expectations. Volume 17, Issue 5, 2014, Pages 664-669. DOI: 10.1111/j.1369-7625.2012.00791.x
Garmann-Johnsen, N.F., Eikebrokk, T.R. Dynamic capabilities in e-health innovation: Implications for policies // Health Policy and Technology, 6 (3), pp. 292-301. DOI: 10.1016/j.hlpt.2017.02.003
Gardiyawasam Pussewalage, H.S., Oleshchuk, V.A. Privacy preserving mechanisms for enforcing security and privacy requirements in E-health solutions // International Journal of Information Management, Part B 36 (6), pp. 1161-1173. DOI: 10.1016/j.ijinfomgt.2016.07.006
Martin, G., Beech, N., Macintosh, R., Bushfield, S. Potential challenges facing distributed leadership in health care: Evidence from the UK National Health Service // Sociology of Health and Illness, 37 (1), pp. 14-29. DOI:10.1111/1467-9566.12171
Studdert, D.M., Mello, M.M., Sage, W.M., DesRoches, C.M., Peugh, J., Zapert, K., Brennan, T.A. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment // Journal of the American Medical AssociationVolume 293, Issue 21, 1 June 2005, Pages 2609-2617. DOI: 10.1001/jama.293.21.2609
Novak, S. Email Author, Djordjevic, N. Information system for evaluation of healthcare expenditure and health monitoring // Physica A: Statistical Mechanics and its Applications. Volume 520, 15 April 2019, Pages 72-80. DOI: 10.1016/j.physa.2019.01.007
Wu, J.-H., Kao, H.-Y., Sambamurthy, V. The integration effort and E-health compatibility effect and the mediating role of E-health synergy on hospital performance // International Journal of Information Management, Part B 36 (6), pp. 1288-1300. DOI: 10.1016/j.ijinfomgt.2016.09.002