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1 Introduction and Overview
Pages 1-6

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From page 1...
... . Specifically, the committee recommended a "renewed national commitment to building an information infrastructure to support health care delivery, consumer health, quality measurement and improvement, public accountability, clinical and health services research, and clinical education" (IOM, 2011, p.
From page 2...
... 3 strives to develop "a practical eHealth framework and information and communications technology (ICT) infrastructure that enables secure access to patient health information among different European healthcare systems." In 2011, the Forum on Drug Discovery, Development, and Translation held a workshop titled "Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020," which called for the increased use of DHRs as a means of harnessing scientific evidence for improved medical decision making (IOM, 2012)
From page 3...
... The session brought together an international group of experts in translational, epidemiological, and health services research along with an ethicist and representative of a big data analytics company. While there are a number of potential uses of DHRs, these speakers, along with other session participants, discussed some of the currently available DHR databases that are being mined to better understand the progression of AD and design more effective clinical trials.
From page 4...
... Specifically, presenta tions and discussions will be designed to help participants • examine current and future applications of digital health records and their impact on clinical trial design; • consider scientific opportunities and challenges associated with applying digital health records to inform AD research design and methodologies; • discuss infrastructure needs and lessons learned from other med ical records-linkage systems; and • explore what kinds of ethical, societal, and legal issues should be considered in applying digital health records on AD research. The committee will develop the agenda for the workshop session, se lect and invite speakers and discussants, and moderate the discussions.
From page 5...
... According to Simon Lovestone, professor of translational neuroscience at Oxford University, reusing data collected from existing population cohort studies and clinical databases, combined with data from a variety of other sources (discussed further in Chapter 2) , can provide a means to understand the progression of disease from its earliest stages among real-world participants, rather than the more rarified group of individuals who volunteer for clinical studies.
From page 6...
... . • Regulations intended to protect the privacy of data may have the unintended consequence of stifling international collaborative medical research (Powell)

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