Use of nonintrusive sensor-based information and communication technology for real-world evidence for clinical trials in dementia.

Cognitive function is an important end point of treatments in dementia clinical trials. Measuring cognitive function by standardized tests, however, is biased toward highly constrained environments (such as hospitals) in selected samples. Patient-powered real-world evidence using information and communication technology devices, including environmental and wearable sensors, may help to overcome these limitations. This position paper describes current and novel information and communication technology devices and algorithms to monitor behavior and function in people with prodromal and manifest stages of dementia continuously, and discusses clinical, technological, ethical, regulatory, and user-centered requirements for collecting real-world evidence in future randomized controlled trials. Challenges of data safety, quality, and privacy and regulatory requirements need to be addressed by future smart sensor technologies. When these requirements are satisfied, these technologies will provide access to truly user relevant outcomes and broader cohorts of participants than currently sampled in clinical trials.

Towards coherent data policy for biomedical research with ELSI 2.0: orchestrating ethical, legal and social strategies.

As the recent inaugural Ethical, Legal, and Social Issues (ELSI) 2.0 conference made clear, the effects of information communication technology (ICT) are pervasive in biomedical research. Data initiatives are arising in all corners of biomedicine. Data sharing efforts already promised to surpass even the ambitious goals of the National Human Genome Research Institute, only 5 years after publication of its 10-year vision. ELSI research was established, in part, to address challenges of open data access and data sharing. However, by and large, ELSI research projects address particular concerns of a given population, jurisdiction, type of research practice or type of data. This does not necessarily facilitate coherent data policy for sustainable data stewardship. Forward-looking, data friendly strategies need to be considered. Orchestration strategies are needed which overcome barriers to collective action. Here we present challenges policymakers face, and suggest three basics steps towards meeting them. First, policymakers must recognise the systematic change that occurs when ICT enables dataflow itself to become an organising principle of biomedical research. Second, methods for identifying and gathering types of metadata suitable for ELSI research ought to be developed and regulated. Third, policymakers need to organise in ways that mirror the new vision for data-enabled research that data technologies are making possible, as ELSI 2.0 encourages researchers to do. Taking these steps will help ensure research evolves in ways that warrants trust of the public while still supporting widespread ethical access to necessary data, research subjects, samples and findings.

Technology alignment in the presence of regulatory changes: The case of meaningful use of information technology in healthcare.

OBJECTIVES: Using the context of the healthcare sector, this study examines the impact of regulatory change on technology implementation and use. Hospitals are now federally mandated to showcase meaningful use of information technology (IT). We theorize that IT plan scope structured prior to a regulatory change by means of a long-term planning horizon, top management involvement, and steering committee engagement impacts organizations' ability to fulfill meaningful use requirements three to five years later. Furthermore, we contend that this impact is contingent on the specific IT adoption strategy. METHODS: Data from the HIMSS and HITECH Act databases were combined to analyze 688 hospitals. Regression analyses were used to test the hypotheses. RESULTS: The results of this longitudinal study show that frequency of steering committee meetings and length of planning horizon broaden IT plan scope. Broader IT plan scope is positively associated with the ability of organizations to meaningfully use IT. CONCLUSIONS: The link between IT plan scope and meaningful use metric is particularly significant for organizations that adopt a more integrated approach towards IT adoption. Average reimbursement amount differences are provided and discussed between the different IT adoption strategies.

Norway's ICT Accessibility Legislation, Methods and Indicators.

This paper gives an overview of the Norwegian legislation on Universal Design of information and communication technology (ICT) and how the Norwegian Authority for Universal Design of ICT works to enforce and achieve the goals behind the legislation. The Authority uses indicators to check websites for compliance with the regulations. This paper describes the rationale and intended use for the indicators and how they are used for both supervision and benchmarks as well as a way of gathering data to give an overview of the current state of Universal Design of websites in Norway.

Proteção à privacidade e acesso às informações em saúde: tecnologias, direitos e ética / Privacy protection and access to health information technologies, rights and ethics

Seu objetivo é abordar fragilidades, proteção e ampliação do direito à privacidade dos cidadãos. A ênfase recai sobre os dados pessoais em saúde, "dados sensíveis" que, quando utilizados aeticamente, podem acarretar prejuízos para os cidadãos-usuários dos serviços de saúde, tais como situações de discriminação e invasão da intimidade.