Bioethics in the big data era: health care and beyond / La bioética en el época del "big data": la salud y más allá / La bioètica en l’època del 'big data': la salut i més enllà

"Big data" and data-intensive research approaches are rapidly gaining momentum in health and biomedical research, with potential to transform health at all levels from personal to public. The use of "big data" for health research, however, raises a number of ethical challenges. In this paper I discuss ethical aspects of the advent of big data in health. I argue that although public discourse has focused on immediate concerns relating to use of individuals' information, "big health data" requires us to explore alternative conceptual approaches to research ethics, including the "social contract" model. Further, we need to think beyond health research uses of data to the social consequences of big data epistemology and practice, and the moral implications of "datafying" the human

La ciencia de "big data" (o datos masivos) lleva mucho potencial para la investigación biomédica, y promete una transformación en la salud y la asistencia médica. Al mismo tiempo, el uso de datos de salud en investigación presenta varios retos éticos. En este artículo, exploraré aspectos éticos de la llegada del "big data" al ámbito de la salud. Aunque el discurso público y regulatorio se ha focalizado mucho en el uso de datos del individuo, lidiar con los nuevos desafíos de datos masivos requiere considerar enfoques alternativos a la ética de la investigación, tal como el modelo del "contrato social". Hay que pensar más allá del uso de datos para investigaciones en salud y contemplar las consecuencias sociales de la epistemología y la práctica de "big data" y las implicancias morales de la "datificación" del humano

La ciència del "big data" (o dades massives) comporta un enorme potencial per a la recerca biomèdica, i promet ocasionar una gran transformació en l'àmbit de la salut i l'assistència mèdica. Al mateix temps, l'ús de dades de salut en recerca presenta diversos reptes ètics. En aquest article, analitzaré els aspectes ètics de l'arribada del "big data" a l'àmbit de la salut. Encara que el discurs públic i regulador s'ha focalitzat principalment en l'ús de les dades personals, bregar amb els nous desafiaments que comporten la irrupció de les dades massives requereix enfocaments alternatius a l'ètica de la recerca, com ara el model del «contracte social». A més, cal pensar més enllà de l'ús de dades per a recerques en salut i tenir en compte les conseqüències socials de l'epistemologia i la pràctica del "big data" i les implicacions morals de la "datificació" d'allò que és humà

Healthcare Data Analysis and Return of Investment for Patient Care: Challenges for a University Hospital / Análisis de datos sanitarios y retorno de la inversión para el cuidado de los pacientes: los retos para un hospital universitario / Anàlisi de dades sanitàries i retorn de la inversió per la cura dels pacients: els reptes per un hospital universitari

Ethical and scientific reasons sustain concerns when applying Big Data analytics in Healthcare. Patient’s data must be anonymized and must have enough quality. But the extreme variety of data and their multiple sources combined with many different stakeholders registering data in the Electronic Patient Record without a semantic standardization makes the process harder than in other business. Majority of patient’s data are in natural text or are only communicated verbally without a formal registration. To take a real benefit of the Healthcare data we must ensure their quality, high integrity, explicit meaning, context recording and complete anonymization. Three technologies must be of great help: Standardization for Semantic interoperability, Knowledge representation using Ontologies and advanced Natural Language Processing. Ethical conscience regarding confidentiality and ecological impact of ICTs must be empowered and practiced by individuals and organizations

La aplicación de la analítica de datos masivos en salud levanta preocupaciones éticas y científicas. Los datos de los pacientes deben ser anónimos y de calidad. Pero la gran variedad de datos, sus múltiples fuentes y los diferentes actores que registran datos en la historia clínica del paciente sin un estándar semántico, dificulta más el proceso que en otras áreas. La mayoría de los datos de los pacientes se dan en texto natural o se comunican sólo verbalmente, sin registro formal. Para beneficiarnos efectivamente de los datos de salud tenemos que asegurar su calidad, integridad, contenido explícito, contexto de registro y su completo anonimato. Existen tres tecnologías que pueden ser de gran ayuda: estandarización para la interoperabilidad semántica, representación del conocimiento usando ontologías y el procesamiento avanzado de lenguaje natural. La conciencia ética sobre la confidencialidad y el impacto ecológico de las tecnologías de información y comunicación (TIC) deben ser practicadas y potenciadas por los individuos y las organizaciones

L’aplicació de l’analítica de dades massives en salut aixeca preocupacions ètiques i científiques. Les dades dels pacients han de ser anònimes i de qualitat. Però la gran varietat de dades, les seves múltiples fonts i els diferents actors que enregistren dades en la història clínica del pacient sense un estàndard semàntic en dificulta el procés. La major part de les dades dels pacients es donen en text natural o es comuniquen només verbalment, sense cap registre formal. Per beneficiar-nos efectivament de les dades de salut hem d'assegurar la seva qualitat, integritat, contingut explícit, context de registre i anonimat. Existeixen tres tecnologies que poden ser de gran ajuda: estandardització per a la interoperabilitat semàntica, representació del coneixement usant ontologies i el processament avançat de llenguatge natural. La consciència ètica sobre la confidencialitat i l’impacte ecològic de les tecnologies d'informació i comunicació (TIC) han de ser practicats i potenciats tant pels individus com per les organitzacions

TMI! ethical challenges in managing and using large patient data sets.

The advent and expansion of electronic medical record systems and open-access databases are creating a "data tsunami." As this wave descends, we must anticipate and address several ethical and social risks: threats to patient privacy, threats to the reputations of various social groups, and threats to public trust in biomedical research.

The process of installing REDCap, a web based database supporting biomedical research: the first year.

BACKGROUND: Clinical and research data are essential for patient care, research and healthcare system planning. REDCapTM is a web-based tool for research data curatorship developed at Vanderbilt University in Nashville, USA. The Faculty of Health Sciences at the University of the Witwatersrand, Johannesburg South Africa identified the need for a cost effective data management instrument. REDCap was installed as per the user agreement with Vanderbilt University in August 2012. OBJECTIVES: In order to assist other institutions that may lack the in-house Information Technology capacity, this paper describes the installation and support of REDCap and incorporates an analysis of user uptake over the first year of use. METHODS: We reviewed the staffing requirements, costs of installation, process of installation and necessary infrastructure and end-user requests following the introduction of REDCap at Wits. The University Legal Office and Human Research Ethics Committee were consulted regarding the REDCap end-user agreement. Bi-monthly user meetings resulted in a training workshop in August 2013. We compared our REDCap software user numbers and records before and after the first training workshop. RESULTS: Human resources were recruited from existing staff. Installation costs were limited to servers and security certificates. The total costs to provide a functional REDCap platform was less than $9000. Eighty-one (81) users were registered in the first year. After the first training workshop the user numbers increased by 59 in one month and the total number of active users to 140 by the end of August 2013. Custom software applications for REDCap were created by collaboration between clinicians and software developers. CONCLUSION: REDCap was installed and maintained at limited cost. A small number of people with defined skills can support multiple REDCap users in two to four hours a week. End user training increased in the number of users, number of projects created and the number of projects moved to production.

Ethical, legal and social issues for personal health records and applications.

Robert Wood Johnson Foundation's Project HealthDesign included funding of an ethical, legal and social issues (ELSI) team, to serve in an advisory capacity to the nine design projects. In that capacity, the authors had the opportunity to analyze the personal health record (PHR) and personal health application (PHA) implementations for recurring themes. PHRs and PHAs invert the long-standing paradigm of health care institutions as the authoritative data-holders and data-processors in the system. With PHRs and PHAs, the individual is the center of his or her own health data universe, a position that brings new benefits but also entails new responsibilities for patients and other parties in the health information infrastructure. Implications for law, policy and practice follow from this shift. This article summarizes the issues raised by the first phase of Project HealthDesign projects, categorizing them into four topics: privacy and confidentiality, data security, decision support, and HIPAA and related legal-regulatory requirements. Discussion and resolution of these issues will be critical to successful PHR/PHA implementations in the years to come.

Current products and practice. How to create and manage a regional orthognathic database.

This is a report on the use of a regional database of patients undergoing orthognathic treatment in the South West of England. The benefits and difficulties of using a regional database are discussed.

Ethical issues in public health informatics: implications for system design when sharing geographic information.

Public health programs today constitute a multi-professional inter-organizational environment, where both health service and other organizations are involved. Developing information systems, including the IT security measures needed to suit this complex context, is a challenge. To ensure that all involved organizations work together towards a common goal, i.e., promotion of health, an intuitive strategy would be to share information freely in these programs. However, in practice it is seldom possible to realize this ideal scenario. One reason may be that ethical issues are often ignored in the system development process. This investigation uses case study methods to explore ethical obstacles originating in the shared use of geographic health information in public health programs and how this affects the design of information systems. Concerns involving confidentiality caused by geographically referenced health information and influences of professional and organizational codes are discussed. The experience presented shows that disregard of ethical issues can result in a prolonged development process for public health information systems. Finally, a theoretical model of design issues based on the case study results is presented.