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1.  The federal role in the health information infrastructure: a debate of the pros and cons of government intervention. 
Some observers feel that the federal government should play a more active leadership role in educating the medical community and in coordinating and encouraging a more rapid and effective implementation of clinically relevant applications of wide-area networking. Other people argue that the private sector is recognizing the importance of these issues and will, when the market demands it, adopt and enhance the telecommunications systems that are needed to produce effective uses of the National Information Infrastructure (NII) by the healthcare community. This debate identifies five areas for possible government involvement: convening groups for the development of standards; providing funding for research and development; ensuring the equitable distribution of resources, particularly to places and people considered by private enterprise to provide low opportunities for profit; protecting rights of privacy, intellectual property, and security; and overcoming the jurisdictional barriers to cooperation, particularly when states offer conflicting regulations. Arguments against government involvement include the likely emergence of an adequate infrastructure under free market forces, the often stifling effect of regulation, and the need to avoid a common-and-control mentality in an infrastructure that is best promoted collaboratively.
PMCID: PMC116307  PMID: 8816347
2.  Using Virtual Reality to Provide Health Care Information to People With Intellectual Disabilities: Acceptability, Usability, and Potential Utility 
Background
People with intellectual disabilities have poor access to health care, which may be further compromised by a lack of accessible health information. To be effective, health information must be easily understood and remembered. People with intellectual disabilities learn better from multimodal information sources, and virtual reality offers a 3-dimensional (3D) computer-generated environment that can be used for providing information and learning. To date, research into virtual reality experiences for people with intellectual disabilities has been limited to skill-based training and leisure opportunities within the young to mid age ranges.
Objective
This study assessed the acceptability, usability, and potential utility of a virtual reality experience as a means of providing health care-related information to people with intellectual disabilities. We designed a prototype multimodal experience based on a hospital scenario and situated on an island in the Second Life 3D virtual world. We wanted to know how people of different ages and with varying levels of cognitive function would participate in the customized virtual environment, what they understood from being there, and what they remembered a week later.
Methods
The study drew on qualitative data. We used a participatory research approach that involved working alongside people with intellectual disabilities and their supporters in a community setting. Cognitive function was assessed, using the Matrix Analogies Test and the British Picture Vocabulary Scale, to describe the sample. Participants, supported by facilitators, were video recorded accessing and engaging with the virtual environment. We assessed recall 1 week later, using a specialized interview technique. Data were downloaded into NVivo 8 and analyzed using the framework analysis technique.
Results
Study participants were 20 people aged between 20 and 80 years with mild to severe intellectual disabilities. All participants were able to access the environment and voluntarily stayed there for between 23 and 57 minutes. With facilitator support, all participants moved the avatar themselves. Participants engaged with the scenario as if they were actually there, indicating cognitive presence. Some referred back to previous medical experiences, indicating the potential for experiential knowledge to become the foundation of new learning and retention of knowledge. When interviewed, all participants remembered some aspects of the environment.
Conclusions
A sample of adults with intellectual disabilities of all ages, and with varying levels of cognitive function, accessed and enjoyed a virtual-world environment that drew on a health care-related scenario, and remembered aspects of it a week later. The small sample size limits generalizability of findings, but the potential shown for experiential learning to aid retention of knowledge on which consent is based appears promising. Successfully delivering health care-related information in a non-National Health Service setting indicates potential for delivery in institutional, community, or home settings, thereby widening access to the information.
doi:10.2196/jmir.1917
PMCID: PMC3222201  PMID: 22082765
Learning disabilities; intellectual disabilities; virtual reality; health information; participatory research; capacity to consent; presence
3.  Mychildren’s: Integration of a Personally Controlled Health Record with a Tethered Patient Portal for a Pediatric and Adolescent Population 
Personally controlled health records (PCHRs) and patient portals are increasingly being offered by healthcare institutions, employers, insurance companies and commercial entities to allow patients access to their health information. Both applications offer unique services to provide patients with tools to manage their health. While PCHRs allow users ubiquitous, portable, patient controlled access to their health information, traditional patient portals provide provider-tethered applications allowing patients access, but not control of, certain healthcare information, as well as communication and administrative functions, such as secure messaging, appointment management and prescription refill requests, facilitating care at a specific healthcare facility.
We describe our approach for the design, content creation, policy development, and implementation of MyChildren’s, a unique web-based application leveraging the advantages of both a provider-tethered patient portal and a PCHR to allow patients and their guardians access to the functionality and convenience of a traditional patient portal, as well as the portability and flexibility of a PCHR.
PMCID: PMC2815447  PMID: 20351824
4.  Digital Government and Public Health 
Preventing Chronic Disease  2004;1(4):A02.
Digital government is typically defined as the production and delivery of information and services inside government and between government and the public using a range of information and communication technologies. Two types of government relationships with other entities are government-to-citizen and government-to-government relationships. Both offer opportunities and challenges. Assessment of a public health agency's readiness for digital government includes examination of technical, managerial, and political capabilities. Public health agencies are especially challenged by a lack of funding for technical infrastructure and expertise, by privacy and security issues, and by lack of Internet access for low-income and marginalized populations. Public health agencies understand the difficulties of working across agencies and levels of government, but the development of new, integrated e-programs will require more than technical change — it will require a profound change in paradigm.
PMCID: PMC1277943
5.  The Internet and medicine: past, present, and future. 
The enormous growth of the Internet and the World Wide Web has made these two technologies an important potential adjunct to cost-effective health care research and delivery. This article surveys some recent developments in telecommunications, networking and artificial intelligence that are likely to have a significant impact on improving the efficiency and quality of future health care. Issues discussed include: clinical record keeping on the Internet, Internet-assisted medical diagnosis, privacy and security matters, financial transactions, digital money, bandwidth concerns, multimedia (music, audio and video) information delivery via the Internet, intellectual property, and the concept of Information Philanthropy.
PMCID: PMC2589000  PMID: 9381738
6.  Modeling HIV/AIDS Drug Price Determinants in Brazil: Is Generic Competition a Myth? 
PLoS ONE  2011;6(8):e23478.
Background
Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care.
Methods and Findings
Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition.
Significance
In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries' bargaining power in price negotiations undertaken with originator companies.
doi:10.1371/journal.pone.0023478
PMCID: PMC3156239  PMID: 21858138
7.  Pharmaceutical policies in Canada: another example of federal-provincial discord 
Pharmaceutical policy in Canada is set at both the federal and provincial levels of government. The federal government is responsible for intellectual property rights of manufacturers (patents) and the initial approval and labelling of prescription drugs and for ensuring overall market competitiveness. The provincial government has responsibility and jurisdiction over the funding of all health care services, including pharmaceuticals. Various interactions between the pharmaceutical industry, the federal and provincial governments and consumers have shaped the current landscape for prescription drugs in Canada. One key failing of the system is that the federal government is almost completely insulated from the impact of its policies because, although it regulates drug prices, it does not buy any drugs. In contrast, provincial governments have no jurisdiction over market competitiveness or pricing, yet end up paying for most of the drug expenditures incurred.
PMCID: PMC1231173  PMID: 10701389
8.  Assessing the impact of the Australia-United States Free Trade Agreement on Australian and global medicines policy 
On 1 January 2005, a controversial trade agreement entered into force between Australia and the United States. Though heralded by the parties as facilitating the removal of barriers to free trade (in ways not achievable in multilateral fora), it also contained many trade-restricting intellectual property provisions and others uniquely related to altering pharmaceutical regulation and public health policy in Australia. The latter appear to have particularly focused on the world-respected process of federal government reimbursement after expert cost-effectiveness evaluation, popularly known as the Pharmaceutical Benefits Scheme ('PBS'). It remains uncertain what sort of impacts – if any – the Australia-United States Free Trade Agreement ('AUSFTA') will have on PBS processes such as reference pricing and their important role in facilitating equitable and affordable access to essential medicines.
This is now the field of inquiry for a major three year Australian Research Council ('ARC')-funded study bringing together a team of senior researchers in regulatory theory from the Australian National University and pharmacoeconomics from the University of Newcastle. The project proposes to monitor, assess and analyse the real and potential impacts of the AUSFTA in this area, providing Australian policy-makers with continuing expertise and options.
To the extent that the AUSFTA medicines provisions may represent an important precedent in a global strategy by industry on cost-effectiveness evaluation of pharmaceuticals, the study will also be of great interest to policy makers in other jurisdictions.
doi:10.1186/1744-8603-1-15
PMCID: PMC1276805  PMID: 16209703
9.  Are Drug Companies Living Up to Their Human Rights Responsibilities? The Perspective of the Former United Nations Special Rapporteur (2002-2008) 
PLoS Medicine  2010;7(9):e1000330.
As one viewpoint of three in the PLoS Medicine Debate on whether drug companies are living up to their human rights responsibilities, Paul Hunt (the UN Special Rapporteur on the Right to Health) and Rajat Khosla argue that pharmaceutical companies have been noncompliant and that better accountability mechanisms are needed.
Background to the debate
The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The “Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines” include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt′s work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines.
doi:10.1371/journal.pmed.1000330
PMCID: PMC2946950  PMID: 20927413
10.  Are Drug Companies Living Up to Their Human Rights Responsibilities? Moving Toward Assessment 
PLoS Medicine  2010;7(9):e1000310.
As one viewpoint of three in the PLoS Medicine Debate on whether drug companies are living up to their human rights responsibilities, Sofia Gruskin and Zyde Raad argue that companies' actions to promote access to medicines, including their interactions with state and non-state actors, must be better monitored.
Background to the debate
The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The “Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines” include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines.
doi:10.1371/journal.pmed.1000310
PMCID: PMC2946953  PMID: 20927356
11.  Driving a decade of change: HIV/AIDS, patents and access to medicines for all 
Since 2000, access to antiretroviral drugs to treat HIV infection has dramatically increased to reach more than five million people in developing countries. Essential to this achievement was the dramatic reduction in antiretroviral prices, a result of global political mobilization that cleared the way for competitive production of generic versions of widely patented medicines.
Global trade rules agreed upon in 1994 required many developing countries to begin offering patents on medicines for the first time. Government and civil society reaction to expected increases in drug prices precipitated a series of events challenging these rules, culminating in the 2001 World Trade Organization's Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health. The Declaration affirmed that patent rules should be interpreted and implemented to protect public health and to promote access to medicines for all. Since Doha, more than 60 low- and middle-income countries have procured generic versions of patented medicines on a large scale.
Despite these changes, however, a "treatment timebomb" awaits. First, increasing numbers of people need access to newer antiretrovirals, but treatment costs are rising since new ARVs are likely to be more widely patented in developing countries. Second, policy space to produce or import generic versions of patented medicines is shrinking in some developing countries. Third, funding for medicines is falling far short of needs. Expanded use of the existing flexibilities in patent law and new models to address the second wave of the access to medicines crisis are required.
One promising new mechanism is the UNITAID-supported Medicines Patent Pool, which seeks to facilitate access to patents to enable competitive generic medicines production and the development of improved products. Such innovative approaches are possible today due to the previous decade of AIDS activism. However, the Pool is just one of a broad set of policies needed to ensure access to medicines for all; other key measures include sufficient and reliable financing, research and development of new products targeted for use in resource-poor settings, and use of patent law flexibilities. Governments must live up to their obligations to protect access to medicines as a fundamental component of the human right to health.
doi:10.1186/1758-2652-14-15
PMCID: PMC3078828  PMID: 21439089
12.  Are Drug Companies Living Up to Their Human Rights Responsibilities? The Merck Perspective 
PLoS Medicine  2010;7(9):e1000343.
As one viewpoint of three in the PLoS Medicine Debate on whether drug companies are living up to their human rights responsibilities, Geralyn Ritter, Vice President of Global Health Policy and Corporate Social Responsibility at Merck & Co., argues that that multiple stakeholders could do more to help States deliver the right to health.
Background to the debate
The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The “Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines” include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines.
doi:10.1371/journal.pmed.1000343
PMCID: PMC2946952  PMID: 20927355
13.  Panel: Trends in Health Care Information Systems 
The panel presents significant trends in demographic and economic forces that are driving healthcare delivery systems, how health care providers are responding to these driving forces, and how information systems are being developed using new technology to help health care providers and consumers. An aging population and rapidly increasing government and business health care expenditures are forcing hospitals and other health care providers to consolidate, compete, become more efficient, and diversify and market their services. Emerging computer technology will facilitate the development of information systems that utilize integrated data bases, communication networks, appropriate input/output devices, and cost effective computing power to provide the financial, management, and medical information required by these evolving provider systems.
PMCID: PMC2578534
14.  Challenges for Australia's Bio/Nanopharma Policies: trade deals, public goods and reference pricing in sustainable industrial renewal 
Industrial renewal in the bio/nanopharma sector is important for the long term strength of the Australian economy and for the health of its citizens. A variety of factors, however, may have caused inadequate attention to focus on systematically promoting domestic generic and small biotechnology manufacturers in Australian health policy.
Despite recent clarifications of 'springboarding' capacity in intellectual property legislation, federal government requirements for specific generic price reductions on market entry and the potential erosion of reference pricing through new F1 and F2 categories for the purposes of Pharmaceutical Benefits Scheme (PBS) assessments, do not appear to be coherently designed to sustainably position this industry sector in 'biologics,' nanotherapeutics and pharmacogenetics.
There also appears to have been little attention paid in this context to policies fostering industry sustainability and public affordability (as encouraged by the National Medicines Policy). One notable example includes that failure to consider facilitating mutual exchanges on regulatory assessment of health technology safety and cost-effectiveness (including reference pricing) in the context of ongoing free trade negotiations between Australia and China (the latter soon to possess the world's largest generic pharmaceutical manufacturing capacity). The importance of a thriving Australian domestic generic pharmaceutical and bio/nano tech industry in terms of biosecurity, similarly appears to have been given insufficient policy attention.
Reasons for such policy oversights may relate to increasing interrelationships between generic and 'brand-name' manufacturers and the scale of investment required for the Australian generics and bio/nano technology sector to be a significant driver of local production. It might also result from singularly effective lobbying pressure exerted by Medicines Australia, the 'brand-name' pharmaceutical industry association, utilising controversial interpretations of reward of pharmaceutical 'innovation' provisions in the Australia-US Free Trade Agreement (AUSFTA) through the policy-development mechanisms of the AUSFTA Medicines Working Group and most recently an Innovative Medicines Working Group with the Department of Health and Ageing. This paper critically analyses such arguments in the context of emerging challenges for sustainable industrial renewal in Australia's bio/nanopharma sector.
doi:10.1186/1743-8462-4-9
PMCID: PMC1894805  PMID: 17543114
15.  Scaling up antiretroviral therapy in Uganda: using supply chain management to appraise health systems strengthening 
Background
Strengthened national health systems are necessary for effective and sustained expansion of antiretroviral therapy (ART). ART and its supply chain management in Uganda are largely based on parallel and externally supported efforts. The question arises whether systems are being strengthened to sustain access to ART. This study applies systems thinking to assess supply chain management, the role of external support and whether investments create the needed synergies to strengthen health systems.
Methods
This study uses the WHO health systems framework and examines the issues of governance, financing, information, human resources and service delivery in relation to supply chain management of medicines and the technologies. It looks at links and causal chains between supply chain management for ART and the national supply system for essential drugs. It combines data from the literature and key informant interviews with observations at health service delivery level in a study district.
Results
Current drug supply chain management in Uganda is characterized by parallel processes and information systems that result in poor quality and inefficiencies. Less than expected health system performance, stock outs and other shortages affect ART and primary care in general. Poor performance of supply chain management is amplified by weak conditions at all levels of the health system, including the areas of financing, governance, human resources and information. Governance issues include the lack to follow up initial policy intentions and a focus on narrow, short-term approaches.
Conclusion
The opportunity and need to use ART investments for an essential supply chain management and strengthened health system has not been exploited. By applying a systems perspective this work indicates the seriousness of missing system prerequisites. The findings suggest that root causes and capacities across the system have to be addressed synergistically to enable systems that can match and accommodate investments in disease-specific interventions. The multiplicity and complexity of existing challenges require a long-term and systems perspective essentially in contrast to the current short term and program-specific nature of external assistance.
doi:10.1186/1744-8603-7-25
PMCID: PMC3161852  PMID: 21806826
16.  The SAIL Databank: building a national architecture for e-health research and evaluation 
Background
Vast quantities of electronic data are collected about patients and service users as they pass through health service and other public sector organisations, and these data present enormous potential for research and policy evaluation. The Health Information Research Unit (HIRU) aims to realise the potential of electronically-held, person-based, routinely-collected data to conduct and support health-related studies. However, there are considerable challenges that must be addressed before such data can be used for these purposes, to ensure compliance with the legislation and guidelines generally known as Information Governance.
Methods
A set of objectives was identified to address the challenges and establish the Secure Anonymised Information Linkage (SAIL) system in accordance with Information Governance. These were to: 1) ensure data transportation is secure; 2) operate a reliable record matching technique to enable accurate record linkage across datasets; 3) anonymise and encrypt the data to prevent re-identification of individuals; 4) apply measures to address disclosure risk in data views created for researchers; 5) ensure data access is controlled and authorised; 6) establish methods for scrutinising proposals for data utilisation and approving output; and 7) gain external verification of compliance with Information Governance.
Results
The SAIL databank has been established and it operates on a DB2 platform (Data Warehouse Edition on AIX) running on an IBM 'P' series Supercomputer: Blue-C. The findings of an independent internal audit were favourable and concluded that the systems in place provide adequate assurance of compliance with Information Governance. This expanding databank already holds over 500 million anonymised and encrypted individual-level records from a range of sources relevant to health and well-being. This includes national datasets covering the whole of Wales (approximately 3 million population) and local provider-level datasets, with further growth in progress. The utility of the databank is demonstrated by increasing engagement in high quality research studies.
Conclusion
Through the pragmatic approach that has been adopted, we have been able to address the key challenges in establishing a national databank of anonymised person-based records, so that the data are available for research and evaluation whilst meeting the requirements of Information Governance.
doi:10.1186/1472-6963-9-157
PMCID: PMC2744675  PMID: 19732426
17.  Aid alignment for global health research: the role of HIROs 
The lack of a mechanism that aligns financial flows for global health research towards public health priorities limits the impact of health research on health and health equity. Collaborative groups of health research funders appear to be particularly well situated to ameliorate this situation and to initiate discussion on aid alignment for global health research. One such group is the Heads of International Research Organizations (HIROs), which brings together a large number of major government and philanthropic funders of biomedical research. Surprisingly, there is hardly any information publicly available on HIROs' objectives, or on how it aims to achieve more harmonization in the field of research for health. Greater transparency on HIROs' objectives and on its current efforts towards addressing the gap between global health research needs and investments would be desirable, given the enormous potential benefits of more coordination by this group.
doi:10.1186/1478-4505-9-12
PMCID: PMC3065442  PMID: 21414202
18.  Holding services to account 
Background
Recently, the frequency of audit inspections of health services for people with intellectual disability (ID) in the UK has increased, from occasional inquiries to a systematic audit of all services. From 2008, a process of continuous audit ‘surveillance’ of specialist health services is to be introduced. Similar regimes of inspection are in place for social care services.
Aim
To explore the conceptual positions which inform audit, through detailed examination of the investigation into the learning disability service at Sutton and Merton.
Findings
Audit is distinct from evaluation because it neither provides opportunities for service staff to give an account of their work nor represents a search for knowledge. Audit investigates adherence to government policy. In ID, audits measure aspirations derived from normalisation, despite research showing that some of these aspirations have not been achieved by any service. As audit consumes significant public resource, it is questionable whether the dominant finding of the Healthcare Commission's investigation into Sutton and Merton, that the ID service was chronically under-funded, represents value for money.
Discussion and conclusions
While basic checks on minimum standards will always be necessary, service excellence requires not audit but research-driven evaluation. Audits inhibit rather than open-up debate about improving support to people with ID. They impose an ideology, squander resource, and demoralise carers and staff. Evaluations challenge the implicit management-versus-professional binary enacted by audit, and can inform new care systems which make effective use of all those engaged with people with ID.
doi:10.1111/j.1365-2788.2008.01068.x
PMCID: PMC3083524  PMID: 18498335
audit; evaluation; Healthcare Commission; value for money
19.  Children with Orofacial Clefts: Health-Care Use and Costs Among a Privately Insured Population 
Public Health Reports  2009;124(3):447-453.
SYNOPSIS
Objectives
Orofacial clefts are common birth defects that often require multiple surgeries and medical treatments during childhood. We used health-care insurance claims data to estimate health-care expenditures for infants and children ≤10 years of age with an orofacial cleft.
Methods
The data were derived from the 2000–2004 MarketScan® Commercial Claims and Encounters databases, which include person-specific information on health-care use, expenditures, and enrollment for approximately 50 large employers, health plans, and government and public organizations. Health insurance claims data from 821,619 children ≤10 years of age enrolled in employer-sponsored plans during 2004 were analyzed. Expenditures for inpatient admissions, outpatient services, and prescription drug claims were calculated for children with and those without an orofacial cleft.
Results
The difference in annual mean costs (i.e., incremental costs) between children aged 0 through 10 years with an orofacial cleft and those without an orofacial cleft was $13,405. The mean and median costs for children ≤10 years of age with an orofacial cleft were eight times higher than for children of the same age without an orofacial cleft. Mean costs for infants with a cleft and another major, unrelated defect were 25 times higher than those for an infant without a cleft, and five times higher than for infants with an isolated cleft.
Conclusion
These findings document substantially elevated medical care costs for privately insured children with an orofacial cleft. Additional study of the economic burden associated with this condition should include a broader range of economic costs.
PMCID: PMC2663882  PMID: 19445422
20.  Assessment of the vaccine industry in Iran in context of accession to WTO: a survey study 
Background
The vaccine industry is one of the most important health-related industries. It can be affected by accession to the World Trade Organization (WTO) because of probable dramatic changes in the business environment. Iran has already initiated accession negotiations.
Purpose of the study
In this paper, we investigate the position of, challenges to, and opportunities for vaccine manufacturing in Iran with regard to accession to the WTO.
Methods
This is a qualitative and cross sectional study. To collect information, we designed a questionnaire and interviewed some of the vaccine industry’s key opinion leaders in Iran. Before the interviews were conducted, the questionnaires were sent to these individuals by email.
Results
According to the interviewees, the country’s main challenges with regard to accession to the WTO are the lack of firm internal intellectual property (IP) rules, not being recognized as pre-qualified by the World Health Organization (WHO), the use of old equipment, and a lack of cooperation with global vaccine companies.
Major conclusions
Iran’s local vaccine industry, with a long history and international reputation that could be used as an advantage, is faced with several challenges, such as problems with keeping up with Current Good Manufacturing Practice (cGMP), a lack of adequate and meaningful investment in research and development (R&D), and limitations on private sector participation in the production of vaccines.
Gradual privatization of the industry, improved international relations, utilization of the R&D power of small hi-tech companies, consistent education of human resources, and modernization of infrastructures and equipment are among the suggested solutions.
doi:10.1186/2008-2231-20-19
PMCID: PMC3555710  PMID: 23351841
Vaccine; WTO; Iran; WHO
21.  Recovery in Scotland: Beyond service development 
Over the last ten years there has been significant activity related to the promotion and support of recovery in Scotland, much of it linked to the work of the Scottish Recovery Network. A range of government policies have consistently identified recovery as a guiding principle of both service design and mental health improvement efforts. New learning has been developed and shared, workforce competencies reviewed and training developed, and a range of national initiatives put in place. In Scotland, as elsewhere, these efforts have tended to focus primarily on ensuring that mental health services offer environments and practices that support personal recovery. While service improvement is crucial, a wider challenge is ensuring that opportunities and support for self-directed recovery are enhanced outside statutory services. Providing examples, this paper will look at the development of recovery in Scotland – including the work of the Scottish Recovery Network – and consider the potential for building on progress made by rebalancing efforts to support personal recovery, highlighting the importance of public attitudes and community-based learning approaches. We will also touch on the role of identity in personal recovery and consider cultural issues related to the promotion of recovery in Scotland.
doi:10.3109/09540261.2011.650158
PMCID: PMC3581058  PMID: 22385428
22.  HPCC and the National Information Infrastructure: an overview. 
The National Information Infrastructure (NII) or "information superhighway" is a high-priority federal initiative to combine communications networks, computers, databases, and consumer electronics to deliver information services to all U.S. citizens. The NII will be used to improve government and social services while cutting administrative costs. Operated by the private sector, the NII will rely on advanced technologies developed under the direction of the federal High Performance Computing and Communications (HPCC) Program. These include computing systems capable of performing trillions of operations (teraops) per second and networks capable of transmitting billions of bits (gigabits) per second. Among other activities, the HPCC Program supports the national supercomputer research centers, the federal portion of the Internet, and the development of interface software, such as Mosaic, that facilitates access to network information services. Health care has been identified as a critical demonstration area for HPCC technology and an important application area for the NII. As an HPCC participant, the National Library of Medicine (NLM) assists hospitals and medical centers to connect to the Internet through projects directed by the Regional Medical Libraries and through an Internet Connections Program cosponsored by the National Science Foundation. In addition to using the Internet to provide enhanced access to its own information services, NLM sponsors health-related applications of HPCC technology. Examples include the "Visible Human" project and recently awarded contracts for test-bed networks to share patient data and medical images, telemedicine projects to provide consultation and medical care to patients in rural areas, and advanced computer simulations of human anatomy for training in "virtual surgery."
PMCID: PMC225993  PMID: 7703935
23.  Purchaser strategies to influence quality of care: from rhetoric to global applications 
Quality & Safety in Health Care  2006;15(3):171-173.
The potential of purchasers to influence the quality and safety of care has captured the attention of health sector leaders worldwide. Quality based purchasing explicitly seeks to hold providers accountable for the quality and safety of care. Three strategies are available to purchasers: (1) selective contracting based on quality; (2) payment differentials based on quality; and (3) sponsorship of comparative provider report cards. Examples are given to illustrate each of the three strategies. Governments, employers, social insurance funds, community based insurance organizations, health plans, donors, and other buyers of health services are encouraged to explore and debate these purchaser strategies within the context of an overarching national or local quality framework. Public and private funders of operations research are encouraged to support and disseminate evaluations of purchaser efforts to improve quality. This paper is designed to highlight and frame purchasers' strategies explicitly crafted to enhance the quality and safety of care. The ultimate aim is to encourage thoughtful discussion about whether or not one or more purchaser strategy might support a particular country's goals to improve care. Experiences from both developed and developing countries are included to facilitate the exchange of ideas and provide the broadest of perspectives.
doi:10.1136/qshc.2005.014373
PMCID: PMC2464861  PMID: 16751465
purchaser strategies; quality based purchasing; performance based purchasing
24.  Public views on healthcare performance indicators and patient choice 
Patients on certain waiting lists in the UK National Health Service (NHS) are now offered the choice of persevering with their home hospital or switching to another hospital where they will be treated on a guaranteed date. Such decisions require knowledge of performance. We used facilitated focus groups to investigate the views of patients and members of the public on publication of information about the performance of healthcare providers. Six groups with a total of 50 participants met in six different locations in England.
Participants felt that independent monitoring of healthcare performance is necessary, but they were ambivalent about the value of performance indicators and hospital rankings. They tended to distrust government information and preferred the presentational style of 'Dr Foster', a commercial information provider, because it gave more detailed locally relevant information. Many participants felt the NHS did not offer much scope for choice of provider.
If public access to performance information is to succeed in informing referral decisions and raising quality standards, the public and general practitioners will need education on how to interpret and use the data.
PMCID: PMC539537  PMID: 12835446
25.  MED35/450: Evaluation of Internet Health Portals 
Introduction
Currently, more than 22 million U.S. adults use the Internet to access health and medical information. More and more Health Care online portals - entry points for large numbers of online surfers looking for specialized news and information - try to satisfy the exploding demand.
Methods
Using desk-research we have done an in-depth analysis of the emerging health portal market focusing on services offered, revenue strategies, typical online hurdles and threats, commerce and advertising potentials, and case studies of the main players.
Results
We have identified several different groups of health portals and worked out the differences between the U.S. and German market concerning patient and physician services offered. Furthermore, we have evaluated the effectiveness of the Internet as a health and medical information provider compared with other media, such as televisions, newspapers and magazines.
Discussion
Health portals will make patients better informed, more empowered to make health care choices, and, hopefully, healthier individuals.
doi:10.2196/jmir.1.suppl1.e72
PMCID: PMC1761733
Health Portal; Internet; Medical Education; Health Information

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