Framing Sign Language as a Health Need in Canadian and International Policy.

Although in Canada, hearing screening and early intervention are presented as a health need, we question whether young deaf and hard of hearing children's access to language is adequately supported by public health and children's services. The Ontario Infant Hearing Program has the stated mandate of supporting the language development of deaf and hard of hearing infants and young children. However, this program presents parents with early intervention service options involving either spoken or signed language, but not both together. This policy effectively restricts access to sign language learning for a majority of Ontario's deaf children. Consequently, some deaf children suffer language deprivation and its deleterious effects on cognition and emotional development. In support of our arguments, we refer to Article 25 of the United Nations Convention on the Rights of Persons with Disabilities (CRPD), which Canada has signed and ratified. The CRPD supports recognition of deaf children's right to sign language as a health need because language deprivation occurs in many children who are not offered sign language, and this is a permanent impairment imposed on top of hearing loss. We conclude that in Canada, health services for deaf children do not align with accessibility and human rights legislation, thus creating a policy gap that leaves deaf children vulnerable to additional impairment.

Generating Global Priority for Addressing Rheumatic Heart Disease: A Qualitative Policy Analysis.

Background Rheumatic heart disease (RHD) poses a high burden in low-income countries, as well as among indigenous and other socioeconomically disadvantaged populations in high-income countries. Despite its severity and preventability, RHD receives insufficient global attention and resources. We conducted a qualitative policy analysis to investigate the reasons for recent growth but ongoing inadequacy in global priority for addressing RHD. Methods and Results Drawing on social science scholarship, we conducted a thematic analysis, triangulating among peer-reviewed literature, organizational documents, and 20 semistructured interviews with individuals involved in RHD research, clinical practice, and advocacy. The analysis indicates that RHD proponents face 3 linked challenges, all shaped by the nature of the issue. With respect to leadership and governance, the fact that RHD affects mostly poor populations in dispersed regions complicates efforts to coordinate activities among RHD proponents and to engage international organizations and donors. With respect to solution definition, the dearth of data on aspects of clinical management in low-income settings, difficulties preventing and addressing the disease, and the fact that RHD intersects with several disease specialties have fueled proponent disagreements about how best to address the disease. With respect to positioning, a perception that RHD is largely a problem for low-income countries and the ambiguity on its status as a noncommunicable disease have complicated efforts to convince policy makers to act. Conclusions To augment RHD global priority, proponents will need to establish more effective governance mechanisms to facilitate collective action, manage differences surrounding solutions, and identify positionings that resonate with policy makers and funders.

Treading a tightrope: Professional perspectives on balancing the rights of patient's and relative's under the Mental Health Act in England.

Involuntary detention is used internationally to detain and treat people who are deemed to have a mental disorder. In England and Wales, approved mental health professionals (AMHPs) co-ordinate Mental Health Act assessments which allow for patients to be detained. AMHPs have legal duties to identify, inform and consult with a patient's nearest relative (NR), who are, in turn, given powers to initiate or challenge detention. Our study takes an original approach through examining how AMHPs interpret their duties towards nearest relatives. We adopted a two-stage design, which involved an online questionnaire with 55 AMHPs and focus group discussions with 33 AMHPs. The research was conducted in England between 2017 and 2018. Our questionnaire found that a high proportion of AMHPs reported that they had spoken to NRs for background information when assessing patients under the Mental Health Act. However, AMHPs were less likely to ask patients about their views of involving the NR prior to assessment. Focus group findings showed that AMHPs saw the NR role as offering an important 'safeguard' on the basis that NRs could provide information about the patient and advocate on their behalf. AMHPs identified practical difficulties in balancing their legal obligation towards NRs and patients; particularly where issues of potential abuse were raised or where patients had identified that they did not want NR involvement. While AMHPs stated that they sought to prioritise patient wishes regarding confidentiality, their accounts identified that patient consent about information sharing was sometimes implied rather than sought explicitly. Our findings reinforce conclusions by the recent Independent Review of the MHA, which states that current NR provisions are 'outdated, variable and insufficient'. We identify that current practice could be improved using advanced choice documents and outline implications for AMHP practice.

Nationwide Actions Against Heart Failure Pandemic in Japan　- What Should We Do From Academia?

Heart failure pandemic is rapidly approaching in Japan, requiring nationwide actions. In particular, the Japanese Circulation Society and related societies launched the Stroke and Cardiovascular Disease Control Act, which was passed by the National Diet, as the first ever legislative policy measure against stroke and cardiovascular disease. In association with this, actions against heart failure pandemic from the scientific field are also important. Because heart failure pandemic is a critical problem not only in Japan but also in many developed countries, we believe the nationwide approach, as summarized here, will greatly contribute to the development of cardiovascular medicine, particularly the management and treatment of heart failure worldwide.

The use of 'tie down' in New Zealand prisons​-what is the role of the health sector?

We draw upon two recent reports from the Chief Ombudsman that describe the prison management of people assessed at risk of self-harm or suicide, as cruel, inhuman or degrading treatment or punishment. People were mechanically restrained on 'tie-down' beds by their legs, arms and chest or placed in waist restraints with their hands cuffed behind their backs over prolonged periods. These practices occurred at the direction of, or were approved by, health professionals. We highlight ethical issues for health professionals party to 'tie down' and examine the current guidance and regulatory framework for health professionals working in coercive environments. This article is timely in the context of current Government Inquiries into the criminal justice system and mental health and addictions, the review of the health and disability system, the Correction's Amendment Bill before parliament, and Government plans to expand Waikeria prison to include a 100-bed mental health facility. We call for the use of 'tie down' to be abolished in New Zealand prisons, and for all health professionals to refuse to participate in this practice. Government must make provision for sufficient forensic mental health capacity and capability in the health sector, and ensure timely, equitable access to high-quality, trauma-informed and culturally safe services.

Defining priority medical devices for cancer management: a WHO initiative.

Medical devices are indispensable for cancer management across the entire cancer care continuum, yet many existing medical interventions are not equally accessible to the global population, contributing to disparate mortality rates between countries with different income levels. Improved access to priority medical technologies is required to implement universal health coverage and deliver high-quality cancer care. However, the selection of appropriate medical devices at all income and hospital levels has been difficult because of the extremely large number of devices needed for the full spectrum of cancer care; the wide variety of options within the medical device sector, ranging from small inexpensive disposable devices to sophisticated diagnostic imaging and treatment units; and insufficient in-country expertise, in many countries, to prioritise cancer interventions and to determine associated technologies. In this Policy Review, we describe the methods, process, and outcome of a WHO initiative to define a list of priority medical devices for cancer management. The methods, approved by the WHO Guidelines Review Committee, can be used as a model approach for future endeavours to define and select medical devices for disease management. The resulting list provides ready-to-use guidance for the selection of devices to establish, maintain, and operate necessary clinical units within the continuum of care for six cancer types, with the goal of promoting efficient resource allocation and increasing access to priority medical devices, particularly in low-income and middle-income countries.

State-Level Community Benefit Regulation and Nonprofit Hospitals' Provision of Community Benefits.

Do nonprofit hospitals provide enough community benefits to justify their tax exemptions? States have sought to enhance nonprofit hospitals' accountability and oversight through regulation, including requirements to report community benefits, conduct community health needs assessments, provide minimum levels of community benefits, and adhere to minimum income eligibility standards for charity care. However, little research has assessed these regulations' impact on community benefits. Using 2009-11 Internal Revenue Service data on community benefit spending for more than eighteen hundred hospitals and the Hilltop Institute's data on community benefit regulation, we investigated the relationship between these four types of regulation and the level and types of hospital-provided community benefits. Our multivariate regression analyses showed that only community health needs assessments were consistently associated with greater community benefit spending. The results for reporting and minimum spending requirements were mixed, while minimum income eligibility standards for charity care were unrelated to community benefit spending. State adoption of multiple types of regulation was consistently associated with higher levels of hospital-provided community benefits, possibly because regulatory intensity conveys a strong signal to the hospital community that more spending is expected. This study can inform efforts to design regulations that will encourage hospitals to provide community benefits consistent with policy makers' goals.

Voluntarily Stopping Eating and Drinking Among Patients With Serious Advanced Illness-Clinical, Ethical, and Legal Aspects.

Patients with advanced illnesses sometimes request that physicians help hasten their death. Increasingly in North America and Europe, legal options allow physicians to perform this role. Among death-hastening options, the spotlight has been on physician-assisted death. However, voluntarily stopping eating and drinking (VSED) is also a course that patients may choose. Although VSED theoretically does not require physician involvement, clinician participation is critical in terms of initial assessment and ongoing management. In this review, we examine both clinical issues in assessing patients who are considering VSED and the clinical challenges that may emerge during VSED. We also explore some of the underlying ethical and legal considerations for physicians who either care for or decline to care for these patients. Physicians who care for seriously ill patients should be prepared to respond to patients' requests to participate in VSED.

Conducting Community Health Needs Assessments in the Local Public Health Department: A Comparison of Random Digit Dialing and the Community Assessment for Public Health Emergency Response.

CONTEXT: Community health needs assessments (CHNAs) are now required by the Affordable Care Act (ACA) for nonprofit hospitals and the Public Health Accreditation Board (PHAB) for local health departments that seek accreditation. Currently, various primary data collection methods exist that meet the ACA and PHAB requirements. OBJECTIVE: To compare 2 CHNA data collection methods implemented in the same geographical area from a local health department perspective. DESIGN AND SETTING: Two community surveys, one door-to-door and one telephone, in the 76706 zip code area of McLennan County, Texas. PARTICIPANTS: Adult survey respondents (Community Assessment for Public Health Emergency Response [CASPER]: N = 184; random digit dialing [RDD]: N = 133) of the 76706 zip code in McLennan County, Texas. MAIN OUTCOME MEASURES: Survey response rates, sociodemographic characteristics of survey respondents, and self-reported health behaviors from both community survey types. RESULTS: The CASPER survey had a contact rate of 36.0% and a cooperation rate of 60.5%, compared with a 10.1% response rate for the RDD survey. CASPER respondents were younger (26.6% aged 18-24 years), had lower education attainment (17.4% less than high school), and had a higher proportion of Hispanics (24.5%) than RDD respondents (4.6%, 10.5%, and 17.3%, respectively). CASPER respondents were less likely to report being overweight or obese (56.5%), to report days where no fruit or vegetables were consumed (7.1%), and to report days where no walking activity was conducted (9.8%) than RDD respondents (70.2%, 27.8%, and 21.8%, respectively). The CASPER survey cost less to conduct ($13 500) than the RDD survey ($100 000) and was logistically easier for the local health department to conduct using internally available resources. CONCLUSIONS: Local health departments use various data collection methods to conduct CHNAs for their populations and require varying levels of commitment and resources. RDD and CASPER can be used to meet ACA and PHAB requirements, collecting valuable health needs estimates and offer various strengths and weaknesses. PHAB and ACA requirements can be met using the CASPER or RDD survey to conduct CHNAs. However, local health departments may consider the CASPER survey a viable alternative to the RDD survey when time and resources are limited. The CASPER survey offers flexibility and efficiency and requires limited equipment and training.

Regulation and Device Development: Tips for Optimizing Your Experience With the Food and Drug Administration.

Physician-inventors are in a unique position to identify unserved patient needs, and innovate solutions to clinical problems. These solutions may also have associated commercial opportunities. The logistics of developing these medical products, however, can seem a daunting task. One of the primary barriers in the United States is the regulatory process of the Food and Drug Administration (FDA). In this article, we will explore the risk-based approach used by the FDA which forms a framework to consider the regulatory pathway and the process to gain regulatory clearance or approval for medical devices. Inherent device properties and the procedural risk of the devices will determine the rigor with which they are scrutinized by FDA, and the evidentiary requirements to legally market them. Data and evidentiary development will vary depending on risk and regulatory precedent and may or may not require clinical data This regulatory paradigm will determine into which risk-based device class they fit, and whether they are regulated under the 510(k) or premarket approval application pathways. The FDA, although gatekeeper of the US market and tasked with determining which products are safe and effective, can be a powerful ally for product development. They have significant scientific and medical expertise, and mechanisms to both provide guidance, and also to consider novel approaches to product development and evidence development. Early interaction for routine and novel products alike can result in expedited and efficient development. This collaborative approach can be best practice to most expeditiously develop the next generation of products, getting them into the hands of US doctors and into the treatment of US patients.

A Short Introduction to Intellectual Property Rights.

Intellectual property (IP) is a term that describes a number of distinct types of intangible assets. IP protection allows a rightsholder to exclude others from interfering with or using the property right in specified ways. The main forms of IP are patents, copyrights, trademarks, and trade secrets. Each type of IP protection is different, varying in the subject matter that can be covered, timeframe of protection, and total expense. Although some inventions may be covered by multiple types of IP protection, it is important to consider a number of business and legal factors before selecting the best protection strategy. Some technologies require strong IP protection to commercialize, but unnecessary costs can derail bringing a product to market. IP departments of organizations weigh these various considerations and perform essential IP protection functions. This primer introduces researchers to the main forms of IP and its legal aspects.

Projections of the number of Australians with disability aged 65 and over eligible for the National Disability Insurance Scheme: 2017-2026.

OBJECTIVE: To develop projections of the size of the Australian population aged 65 years and over eligible for disability support through the National Disability Insurance Scheme (NDIS) for the decade following its introduction, to support planning and costing of the scheme. METHODS: We estimate disability and mortality transition probabilities and develop projections of the NDIS-eligible, ageing population from 2017 to 2026. RESULTS: An estimated 8000 men and 10 200 women aged 65 years and over will be eligible for support through the NDIS in 2017 (the scheme's first full year), increasing to 48 800 men and 56 900 women in 2026. CONCLUSIONS: Growth in the NDIS-eligible, ageing population has implications for relative budget allocations between the NDIS and the aged-care system, and projections of the size of this population are useful for calculating the overall cost of the NDIS.

The Progress of US Hospitals in Addressing Community Health Needs.

OBJECTIVES: To identify how US tax-exempt hospitals are progressing in regard to community health needs assessment (CHNA) implementation following the Patient Protection and Affordable Care Act. METHODS: We analyzed data on more than 1500 tax-exempt hospitals in 2013 to assess patterns in CHNA implementation and to determine whether a hospital's institutional and community characteristics are associated with greater progress. RESULTS: Our findings show wide variation among hospitals in CHNA implementation. Hospitals operating as part of a health system as well as hospitals participating in a Medicare accountable care organization showed greater progress in CHNA implementation whereas hospitals serving a greater proportion of uninsured showed less progress. We also found that hospitals reporting the highest level of CHNA implementation progress spent more on community health improvement. CONCLUSIONS: Hospitals widely embraced the regulations to perform a CHNA. Less is known about how hospitals are moving forward to improve population health through the implementation of programs to meet identified community needs.

A Mixed-Methods Approach to Understanding Community Participation in Community Health Needs Assessments.

CONTEXT: Nonprofit hospitals are exempt from paying taxes. To maintain this status, they must provide benefit to the community they serve. In an attempt to improve accountability to these communities and the federal government, the Patient Protection and Affordable Care Act of 2010 includes a provision that requires all nonprofit hospitals to conduct a community health needs assessment (CHNA) and implement strategies to address identified health priorities every 3 years. This Act's provision, operationalized by a regulation developed and enforced by the Internal Revenue Service, mandates the involvement of public health agencies and other community stakeholders in the completion of the CHNA. OBJECTIVE: To better understand community participation in nonprofit hospital-directed community health assessment and health improvement planning activities. DESIGN: Using a 2-phased, mixed-methods study design, we (1) conducted content analysis of 95 CHNA/implementation plan reports and (2) interviewed hospital and health system key informants, consultants, and community stakeholders involved in CHNA and planning processes. Community participation was assessed in terms of types of stakeholders involved and the depth of their involvement. RESULTS: Our findings suggest that many hospitals engaged and involved community stakeholders in certain aspects of the assessment process, but very few engaged a broad array of community stakeholder and community members in meaningful participation throughout the CHNA and health improvement planning process. Vast improvements in community participation and collaborative assessment and planning can be made in future CHNAs. CONCLUSIONS: On the basis of the findings, recommendations are made for further research. Practice implications include expanding community engagement and participation by stakeholder and activity type and using a common community health improvement model that better aligns hospital CHNA processes and implementation strategies with other organizations and agencies.