RESUMO
Smartphone applications ("apps") with artificial intelligence (AI) algorithms are increasingly used in healthcare. Widespread adoption of these apps must be supported by a robust evidence-base and app manufacturers' claims appropriately regulated. Current CE marking assessment processes inadequately protect the public against the risks created by using smartphone diagnostic apps.
Assuntos
Inteligência Artificial , Aprovação de Teste para Diagnóstico , Aplicativos Móveis , Neoplasias Cutâneas/diagnóstico , Adulto , Algoritmos , Inteligência Artificial/legislação & jurisprudência , Inteligência Artificial/normas , Aprovação de Teste para Diagnóstico/legislação & jurisprudência , Aprovação de Teste para Diagnóstico/normas , Detecção Precoce de Câncer/instrumentação , Detecção Precoce de Câncer/métodos , Detecção Precoce de Câncer/normas , Europa (Continente) , União Europeia , Medicina Baseada em Evidências , Humanos , Aplicativos Móveis/legislação & jurisprudência , Aplicativos Móveis/normas , Lesões Pré-Cancerosas/diagnóstico , Medição de Risco , Sensibilidade e Especificidade , Neoplasias Cutâneas/etiologia , Neoplasias Cutâneas/patologia , Smartphone/legislação & jurisprudência , Smartphone/normas , Estados Unidos , United States Food and Drug AdministrationRESUMO
In recent years, new technologies used in the field of ophthalmology have been emerging and developing rapidly. Two major aspects of these advancements are teleophthalmology and smartphones, which have enabled practitioners to achieve optimal outcomes in record time with minimal costs. Several rules and regulations have been applied to these technologies in order to frame them under the appropriate medico-legal ethics, and specialized committees have been dedicated to maintaining their efficacy and avoiding shortcomings. In addition multiple studies and case reports conducted worldwide have assessed them according to specific diseases or global concerns. This review article constitutes an up-to date account of almost all of the applications and medico-legal perspectives of technologies used in ophthalmology in order to summarize and better visualize their advantages and disadvantages.
Assuntos
Ética Médica , Oftalmologia/legislação & jurisprudência , Smartphone/legislação & jurisprudência , Telemedicina/legislação & jurisprudência , Atenção à Saúde/legislação & jurisprudência , Humanos , Responsabilidade LegalRESUMO
BACKGROUND: The pilot use of a smartphone platform for electronic informed consent (e-Consent) in large vessel occlusion acute stroke (LVOS) trials has recently been reported. The degree of satisfaction from Legal Authorized Representatives (LARs) with regard to this process remains to be established. METHODS: A single-center study evaluating the experience of LARs with the use of e-Consent in a LVOS randomized trial of an investigational drug administered within 12 hours of last known normal was carried out. A structured survey was used to evaluate the experience of the LARs with the e-consenting process. RESULTS: From February to November 2018, 60 consecutive patients were e-Consented. Of these, 53 LARs completed the survey. The median (IQR) age of the patients was 63 (53-70) years, baseline/discharge National Institutes of Health Stroke Scale score was 17 (12-20)/3(1-12), and 45% were independent at discharge. The survey was applied in person in 43% of cases and via telephone in 57%. Median LAR age was 48 (39-59) years, 64% were female, and a multi-ethnic composition was observed. Forty percent of LARs had less than tertiary level of education (high-school or less). Regarding the e-Consent, 98% of LARs reported to be 'clear' and 83% felt 'very comfortable' in signing. The overall experience was 'excellent/good' in 91%. Despite the positive general impression regarding the use of e-Consent, 12 LARs (22%) would have preferred paper consent. Multivariable regression indicated that lower educational status (tertiary education or less: OR 5.09, 95% CI 1.02 to 25.48; p=0.04) and lower baseline ASPECTS score (OR 0.63, 95% CI 0.41 to 0.96; p=0.03) were independently associated with preference for paper consent. CONCLUSIONS: e-Consent was overall very well perceived by LARs in a randomized clinical trial of LVOS. A minority of proxies, who were more commonly less formally educated, would have preferred paper consenting.