Medicamentos digitales. La autonomía del paciente a debate

  1. Morla González, Marina 1
  1. 1 Universidad de León
    info

    Universidad de León

    León, España

    ROR https://ror.org/02tzt0b78

Aldizkaria:
Dilemata
  1. Ostalé García, Julio (ed. lit.)

ISSN: 1989-7022

Argitalpen urtea: 2019

Zenbakien izenburua: Popper y las éticas aplicadas

Zenbakia: 29

Orrialdeak: 121-134

Mota: Artikulua

Beste argitalpen batzuk: Dilemata

Laburpena

The recent approval by the FDA of the very first digital pill has originated multiple reactions among legal and medical circles. We are refering to the first medicine which incorporates a digital sensor, an ingestible event marker that tracks the medicine ingestion in order to measure the adherence to the patient’s treatment. That data is sent to the patient’s smartphone, to the relatives designated by the patient and to her doctor. Risks originated by this ultimate digital medicine innovation and its utility for the medical community and for other agents in the health care sector is what we analyse in this article.

Erreferentzia bibliografikoak

  • Antares Biofarma (2013): Impacto económico de la no adherencia en los costes farmacéuticos. Fecha de consulta: 20/12/2018. https://www.antares-consulting.com/es_ES/main/detallepublicacion/Publicacion/79/apartado/B/idUnidad/1
  • Bates, J. (2015): “Predictive Health Care: How the IoT Can Save Lives”. RTInsights.com. Fecha de consulta: 20/12/2018. https://www.rtinsights.com/predictive_health_care_9162/
  • Belluck, P. (2017). “First Digital Pill Approved to Worries About Biomedical “Big Brother”, New York Times. Fecha de consulta: 20/12/2018. https://www.nytimes.com/2017/11/13/health/digital-pill-fda.html
  • Brandom, R. (2015). “The frightening promise of self-tracking pills”, The Verge. Última consulta: 20/12/2018. https://www.theverge.com/2015/10/7/9466121/proteus-digital-pill-tracking-privacy-quantified-self
  • Caplan, A. (2015): “Would You Take a ‘Digital’ Pill? Bioethicist Warns About Privacy Risk”, NBC News. Última consulta: 20/12/2018. https://www.nbcnews.com/health/healthnews/bioethicist-digital-snitch-pill-may-destroy-our-medical-privacy-n430091
  • Cohen, I., Amarasingham, R., Shah, A., Xie, B., Lo, B. (2014). “The Legal And Ethical Concerns That Arise From Using Complex Predictive Analytics In Health Care”, Health Affairs, Vol. 33, Nº. 7, pp. 1139-1147.
  • Chicago Tribune (2017), “This “smart pill” can help Rush Patients remember their meds”. Última consulta: 12/8/2018. http://www.tronc.com/gdpr/chicagotribune.com/
  • De Lorenzo Abogados. (2013). “El secreto médico derivado”. De Lorenzo Abogados Blog. http://www.delorenzoabogados.es/blog/?p=52 Última consulta: 20/12/2018.
  • De Miguel, I. (2010). “La objeción de conciencia del farmacéutico; una mirada crítica”, Revista de Derecho UNED, Nº. 6, pp. 173-198.
  • Food and Drug Administration, EEUU. (2014). “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/ guidancedocuments/ucm356190.pdf Fecha de consulta: 18/12/2018.
  • Food and Drug Administration, EEUU. (2016). “Postmarket Management of Cybersecurity in Medical Devices”. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guid nc edocuments/ ucm482022.pdf Última consulta: 18/12/2018.
  • Giota, Kyriaki G.; Kleftaras, George (2014): “Mental Health Apps: Innovations, Risks and Ethical Considerations”, E-Health Telecommunication Systems and Networks, Nº 3, pp. 19-23.
  • Grupo Banco Mundial. (2016). Dividendos Digitales. Informe sobre el desarrollo mundial. Última consulta: 12/12/2018. http://documents.worldbank.org/curated/en/658821468186546535/pdf/102724WDRWDR2016Overview-SPANISH-WebResBox-394840B-OUO-9.pdf
  • Grupo de trabajo del artículo 29 sobre protección de datos. (2014). Dictamen 05/2014 sobre técnicas de anonimización. http://ec.europa.eu/justice/dataprotection/article29/documentation/opinionrecommendation/ files/2014/wp216_es.pdf
  • Ho, M.; Rumsfeld, J.; Masoudi, F.; et al. (2006) “Effect of Medication Nonadherence on Hospitalization and Mortality Among Patients With Diabetes Mellitus”, Arch Intern Med. Vol. 166, Nº17, pp. 1836-1841.
  • Iuga, A.; McGuire, M. (2014). “Adherence and health care costs”, Risk Management and Healthcare Policy, Nº 7, pp. 35-44.
  • Klugman, C.; Dunn, L.; Schwartz, J.; Cohen, I. (2017). “The Ethics of Smart Pills and Self-Acting Devices: Autonomy, Truth-Telling, and Trust at the Dawn of Digital Medicine”, American Journal of Bioethics, Vol. 18, Nº 9, pp. 1-30.
  • Mayer-Schönberger, V.; Cukier, K. (2013). Big Data. A Revolution That Will Transform How We Live, Work, and Think. John Murray Pusblishers, Great Britain.
  • Naciones Unidas. (2012). Estudio de las Naciones Unidas sobre el Gobierno Electrónico. Última consulta: 20/8/2018. https://publicadministration.un.org/egovkb/Portals/egovkb/Documents/un/2012-Survey/Complete-Survey-Spanish-2012.pdf
  • National Council on Patient Information and Education. (2007). Enhancing Prescription Medicine Adherence: A National Action Plan. Última consulta: 20/8/2018. http://www.bemedwise.org/docs/enhancingprescriptionmedicineadherence.pdf
  • Otsuka Pharmaceutical Co. Ltd. (2017). “Otsuka And Proteus® Announce The First U.S. FDA Approval Of A Digital Medicine System: ABILIFY MYCITE® (aripiprazole tablets with sensor)”. https://www.otsuka.co.jp/en/ company/newsreleases/2017/20171114_1.html Última consulta: 8/12/2018.
  • Pharmaceutical Technology. (2018). Proteus Digital Health develops pipeline of 31 digital drugs https://www.pharmaceutical-technology.com/news/proteus-digital healthdevelops-pipeline-31-digital-drugs/ Última consulta: 10/12/2018.
  • Reglamento (UE) del Parlamento Europeo y del Consejo, de 27 de abril de 2016 (Reglamento general de Protección de Datos).
  • Salmanowitz, N. (2015). “Digital Pills: High-Tech Medications with High-Stake Implications”, Standford Program in Neuroscience and Society, Standford Law School. https://law.stanford.edu/2015/09/27/digital-pills-high techmedications-with-high-stake-implications/
  • Sanchez-Caro, J. (2010) “La objeción de conciencia sanitaria”, Estudios, Vol. 20, Nª2, pp. 49-54.
  • Sánchez-Caro, J.; Abellán, F. (2003). Derechos y deberes de los pacientes. Ley 41/2002 de noviembre: consentimiento informado, historia clínica, intimidad e instrucciones previas, Comares, Granada.
  • Sentencia de la Audiencia Provincial de Mallorca 20/2015 Audiencia Provincial de Palma de Mallorca, RJ 23/2014.
  • Sentencia del Tribunal Supremo 849/2000, de 26 septiembre, Sala de lo Civil, FJ 1.
  • Shaffer, D.; Kigin, C..; Kaput, J. Gazelle, G. (2002): “What is Digital Medicine?”, en Bushko, Renata G.: Future of Health Technology, IOS Press, Amsterdam, pp. 195-204.
  • Sociedad Española de Geriatría y Gerontología (2015): El 93% de los mayores de 75 años consume algún medicamento Última consulta: 20/12/2018.. https://www.segg.es/publicaciones/2015/06/15/el-93-por-ciento-delos-mayores-de-75-años-consume-algun-medicamento
  • Stein, J. (2014). “The internet of medical things”, Wharton Health Care Management Alumni Association. University of Pennsylvania. https://www.whartonhealthcare.org/the_internet_of_medical_things última consulta: 12/12/2018.
  • Stirratt, M.; Dunbar-Jacob, J., et al. (2015): “Self-report measures of medication adherence behavior: recommendations on optimal use”, TBM, Vol. 5, Nº 4, pp. 470-482.
  • Sweeney, L. (2000): “Simple demographics often identify people uniquely”, Health (San Francisco), Vol. 671, pp. 1-34.
  • Tarodo Soria, Salvador. (2005). Libertad de conciencia y derechos del usuario de los servicios sanitarios. Bilbao, Servicio Editorial de la Universidad del País Vasco.
  • Tarodo Soria, Salvador. (2011). “Consumidores y usuarios”, en Romeo Casabona, C. M.: Enciclopedia de Bioderecho y Bioética, Comares, Granada, Tomo I, pp. 474-476.
  • Triviño Caballero, R. (2014). El peso de la conciencia: la objeción en el ejercicio de las profesiones sanitarias. Madrid, México; CSIC, Plaza y Valdés.
  • Vayena, E.; Haeusermann, T.; Adjekum, A.; Blasimme, A. (2018). “Digital Health: meeting the ethical and policy challenges”, Swiss Med Wkly. 2018:w14571, pág. 1-pág. 9.
  • Virdi, N. (2018). “Digital Medicines to Measure Drug Ingestion Adherence”, en Burnier, Michel: Drug Adherence in Hypertension and Cardiovascular Protection, Switzerland. Springer. pp. 87-98.
  • Vrijens, B.; De Geest, S.; Hughes, D.; et al. (2012). A new taxonomy for describing and defining adherence to medications. British Journal of Clinical Pharmacology, Vol. 73, Nº5, 691–705. https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC3403197/
  • Wamsley, L. (2017). “FDA Approves First Digital Pill That Can Track Whether You’ve Taken It”, The Two Way, NPR. https://www.npr.org/sections/thetwo-way/2017/11/14/564112345/fda-approvesfirstdigital-pill-that-cantrack-if-youve-taken-it
  • World Health Organization. (2003). Adherence to long term therapies. Evidence for action http://apps.who.int/iris/ bitstream/handle/10665/42682/9241545992.pdf;jsessionid=AF5232E2949F89F53A10F99DD3DECA9?sequence=1