The principle of patient safety as a soft law mechanism in the light of international and domestic standards

Robert Tabaszewski

Katolicki Uniwersytet Lubelski Jana Pawła II , Poland
https://orcid.org/0000-0002-7737-0056


Abstract

The article deals with the concept of patient safety as a soft law mechanism in the light of international and domestic standards. It was shown that patient safety should be recognized as a necessary foundation of health care systems, and should be based on a preventive attitude and systematic analysis and feedback from different reporting systems: patients’ reports, complaints and claims, as well as systematic reporting of incidents, including complications, by healthcare personnel. According to the Recommendation Rec(2006)7 of the Committee of Ministers on the management of patient safety and prevention of adverse events in healthcare to member states, there is a legal need to assess patient safety on an ongoing basis, implement a learning organization, demonstrate ongoing safety improvement and determine when lapses in patient safety occur. The article deals with the issue of state obligations in this regard.

Keywords:

personal security, patient safety, patient rights, European Court of Human Rights, domestic obligations, soft law



Bailey T.M., Ries N.M., Legal Issues in Patient Safety: The Example of Nosocomial Infection, Healthcare Quarterly 2005, nr 8.

Balcerzak M., Zalecenia KM RE jako forma pozatraktatowej działalności normatywnej i harmonizującej w dziedzinie praw człowieka, w: Rada Europy – 60 lat na rzecz jedności europejskiej, red. I. Głuszyńska, K. Lankosz, Bielsko-Biała 2009.

Balcerzak M., Podstawy międzynarodowej ochrony praw człowieka, Toruń 2017.

Boulanger J., Keohane C., Yeats A., Role of Patient Safety Organizations in Improving Patient Safety, Obstetrics and Gynecology Clinics of North America 2019, nr 46(2).

Bujny J., Prawa pacjenta. Między autonomią a paternalizmem, Warszawa 2007.

Carayon P., Wood K.E., Patient Safety: The Role of Human Factors and Systems Engineering, Studies in Health Technology and Informatics 2010, t. 153.

Cohen J., Ezer T., Human rights in patient care: A theoretical and practical framework, Health Affairs 2013, t. 15, nr 2.

Gajewski P., Bała M., Zdarzenia niepożądane jako element oceny jakości opieki medycznej w programie akredytacji szpitali, Medycyna Praktyczna 2012, nr 11.

Guillod O., Medical Error Disclosure and Patient Safety: Legal Aspects, The Journal of Public Health Research 2013, t. 2.

Karkowska D., Prawa pacjenta, Warszawa 2009.

Klich A., Prawo do informacji jako prawo pacjenta i konsumenta. Wybrane zagadnienia, w: Sposoby pojmowania bezpieczeństwa w wybranych obszarach życia publicznego. Zbiór studiów, red. K. Flaga-Gieruszyńska et al., Gorzów Wielkopolski 2013.

Kulesza E., Ochrona danych o stanie zdrowia w świetle ustawodawstwa europejskiego i polskiej ustawy o ochronie danych osobowych, Prawo i Medycyna 2000, nr 1(5).

Lundgaard M., Raboel L., Jensen E.B., Anhoej J., Pedersen B.L., The Danish patient safety experience: the Act on Patient Safety in the Danish health care system, Italian Journal of Public Health 2005, t. 2, nr 2.

Luxford K., ‘First, do no harm’: shifting the paradigm towards a culture of health, Patient Experience Journal 2016, t. 3, nr 2.

Mann J.M., Dignity and health: the UDHR’s revolutionary first article, Health and Human Rights 1998, nr 3.

Menkes J., Soft law i ius cogens a prawo międzynarodowe, w: Ius cogens, soft law. Dwa bieguny prawa międzynarodowego publicznego, red. B. Kunika, M. Ingelevič-Citak, Kraków 2017.

McHale J.V., Regulating patient safety in the European Union: reazlistic aspiration or unattainable goal?, w: Patient Safety Law Policy and Practice, red. J. Tingle, P. Bark, New York 2011.

Nordenfelt L., The Varieties of dignity, Medicine, Health Care and Philosophy 2003, nr 2.

O’Mathúna D.P., Scott P.A., McAuley A., Walsh-Daneshmandi B.D., Health Care Rights and Responsibilities. A Review of the European Charter of Patients’ Rights, Dublin 2005.

Office of the United Nations High Commissioner for Human Rights, What is the Right to Health?, Fact Sheet 2008, nr 31.

Orzeszyna K., Godność ludzka podstawą praw człowieka, w: Człowiek – jego prawa i odpowiedzialność, red. R. Tabaszewski, Lublin 2013.

Perneger T., The Council of Europe recommendation Rec(2006)7 on management of patient safety and prevention of adverse events in health care, International Journal for Quality in Health Care 2008, t. 5, nr 20.

Poździoch S., Prawo pacjenta do bezpieczeństwa – regulacje europejskie i polskie, Państwo i Społeczeństwo 2013, nr 1.

Riedel E.H., The human right to social security: Some challenges, w: Social Security as a human right, Berlin 2007.

Rosi E., European Soft-Law and Organization of National Judiciarie, w: Judicial Power in a Globalized World, Liber Amicorum Vincent De Gaetano, red. P. Pinto de Albuquerque, K. Wojtyczek, Cham 2019.

Sage W.M., Medical Liability and Patient Safety, Health Law 2003, nr 7/8.

Schwarcz L., Soft Law as Governing Law, Duke Law School Public Law & Legal Theory Series Paper 2019, nr 8.

Sharkey S., Lacroix H., Commentary: Patient Safety in the Home, Healthcare Quarterly 2020, nr 22.

Sokol D.K., “First do no harm” revisited, BMJ 2013, nr 347.

Szawarski Z., Dignity and responsibility, Dialectics and Humanism 1986, nr 2–3.

Tabaszewski R., Prawo do zdrowia w systemach ochrony praw człowieka, Lublin 2016.

Tabaszewski R., Ewolucja zdrowia jako kategorii prawnej w systemie ochrony praw człowieka Rady Europy, Studia Ełckie 2019, z. 4. doi: 10.32090/SE.210429

Tabaszewski R., Prawo pacjenta europejskiego do bezpieczeństwo osobistego, w: Unia Europejska w przededniu Brexitu, red. J. Barcik, M. Półtorak, Warszawa 2018.

Terpan F., Soft Law in the European Union — The Changing Nature of EU Law, European Law Journal 2015, t. 21, z. 1.

Trubek D.M., Cottrell M.P., Nance M., “Soft Law,” “Hard Law,” and European Integration: Toward a Theory of Hybridity, University of Wisconsin Legal Studies Research Paper 2005, nr 1002.

Tingle J., The development of a patient safety policy agenda, w: Patient Safety Law Policy and Practice, red. J. Tingle, P. Bark, New York 2011.

Zikos D., Diomidous M., Mantas J., A framework for Develepment of Patient Safety Education and Training Guidelines, w: Seamless Care, Safe Care: The Challenges of Interoperability and Patient, red. B. Blobel, Rejkjavik 2010.


Published
2020-09-30


Tabaszewski, R. (2020). Koncepcja patient safety jako norma soft law na tle konwencyjnych zobowiązań władz krajowych w systemie Rady Europy. Studia Prawnicze KUL, (3), 313–334. https://doi.org/10.31743/sp.9585

Robert Tabaszewski 
Katolicki Uniwersytet Lubelski Jana Pawła II https://orcid.org/0000-0002-7737-0056



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