Exploiting the potential of large databases of electronic health records for research using rapid search algorithms and an intuitive query interface.

Objective: UK primary care databases, which contain diagnostic, demographic and prescribing information for millions of patients geographically representative of the UK, represent a significant resource for health services and clinical research. They can be used to identify patients with a specified disease or condition (phenotyping) and to investigate patterns of diagnosis and symptoms. Currently, extracting such information manually is time-consuming and requires considerable expertise. In order to exploit more fully the potential of these large and complex databases, our interdisciplinary team developed generic methods allowing access to different types of user. Materials and methods: Using the Clinical Practice Research Datalink database, we have developed an online user-focused system (TrialViz), which enables users interactively to select suitable medical general practices based on two criteria: suitability of the patient base for the intended study (phenotyping) and measures of data quality. Results: An end-to-end system, underpinned by an innovative search algorithm, allows the user to extract information in near real-time via an intuitive query interface and to explore this information using interactive visualization tools. A usability evaluation of this system produced positive results. Discussion: We present the challenges and results in the development of TrialViz and our plans for its extension for wider applications of clinical research. Conclusions: Our fast search algorithms and simple query algorithms represent a significant advance for users of clinical research databases

Developing a distributed electronic health-record store for India

The DIGHT project is addressing the problem of building a scalable and highly available information store for the Electronic Health Records (EHRs) of the over one billion citizens of India

Implementing Pharmacy Informatics in College Curricula: The AACP Technology in Pharmacy Education and Learning Special Interest Group

Many professional organizations have initiatives to increase the awareness and use of informatics in the practice of pharmacy. Within education we must respond to these initiatives and make technology integral to all aspects of the curriculum, inculcating in students the importance of technology in practice. This document proposes 5 central domains for organizing planning related to informatics and technology within pharmacy education. The document is intended to encourage discussion of informatics within pharmacy education and the implications of informatics in future pharmacy practice, and to guide colleges of pharmacy in identifying and analyzing informatics topics to be taught and methods of instruction to be used within the doctor of pharmacy curriculum

Adapting Agile in Regulated (Pharmaceutical) Environment

Pharmaceutical software industries practice traditional approach for years, and when it comes to a change they are struggling to adapt new software methodologies such as agile; which is most commonly used by IT industries. The most significant factor required for successful agile adaptation is to make sure new practices should be aligned with the pharmaceutical regulations and the process should be validated and properly documented as per the guidelines. Apart from this, there are few challenges that Pharmaceutical companies are facing to adopt new changes. Those challenges mentioned in various research articles are highlighted in this research paper. This research paper also mentions the possibility to overcome those challenges while adapting the agile practices for regulated software developments projects. This research contains the proposal of actionable items to make transition easier by making changes to traditional approach. The adaption plan will be developed by using findings from Diagnostic Grifols successful adaptation plan. This research paper highlights the insights of agile approach and the way to customizing the agile activities to meet safety and regulatory needs. Besides, QA activities and its contribution will be explored to ease adaptation processes

"Regulating Healthcare Technologies and Medical Supplies: A Comparative Overview"

A complex relationship exists among EU regulations, current national practices and rules, institutional capacities to implement regulatory adjustments and the legacy of past health and regulatory policy and traditions. However, there is little empirical information on medical devices policy, the medical devices industry, and the assurance of medical device safety and usage. Drawing on a review of the secondary literature and on-going field work, the evidence suggests that the current mix of statecentric and self-regulatory traditions will be as important in determining the implementation and final outcomes of EU-rules as the new rules themselves. EU directives redesign rules, but they do not necessarily lead to institutional change, create institutional capacities, or alter old practices in the short term. Neither EU directives nor national regulatory adjustments determine the "man-machine/skill-experience" interface which is shaped and influenced by local medical traditions and the acceptance of these traditions by local publics

Towards a New Framework for Product Development

In the mid-1980s, Andreasen and Hein first described their model of Integrated Product Development. Many Danish companies quickly embraced the principles of integrated product development and adapted the model to their specific business and product context. However, there is concern amongst many Danish companies that Integrated Product Development no longer provides a sufficient way of describing industry’s product development activity. More specifically, five of these companies have supported a programme of research activities at the Technical University of Denmark, which seeks to develop a new framework for product development. This paper will describe the research approach being taken, present some initial findings, and outline a vision of a new working approach to product development

Consolidated List of Requirements

This document is a consolidated catalogue of requirements for the Electronic Health Care Record (EHCR) and Electronic Health Care Record Architecture (EHCRA), gleaned largely from work done in the EU Framework III and IV programmes and CEN, but also including input from other sources including world-wide standardisation initiatives. The document brings together the relevant work done into a classified inventory of requirements to inform the on-going standardisation process as well as act as a guide to future implementation of EHCRA-based systems. It is meant as a contribution both to understanding of the standard and to the work that is being considered to improve the standard. Major features include the classification into issues affecting the Health Care Record, the EHCR, EHCR processing, EHCR interchange and the sharing of health care information and EHCR systems. The principal information sources are described briefly. It is offered as documentation that is complementary to the four documents of the ENV 13606 Parts I-IV produced by CEN Pts 26,27,28,29. The requirements identified and classified in this deliverable are referenced in other deliverables