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There has been increased policy discourse urging a "rebalancing" of health systems from institutionally-based to community-based approaches. This paper offers an analysis of the subsectoral dynamics that condition opportunities to strengthen community-based care relative to acute care. We report on the results of a policy study in Ontario, Canada that explored factors impacting on the capacity to expand community-based care. In so doing, we highlight the challenges associated with the community subsector's ability to develop 'critical' status and challenge the dominance of the acute subsector. We conclude that attempts to rebalance health systems toward community-based care should begin by understanding that health care is not a monolithic policy sector, but rather a collection of proximate policy sub-sectors, inclusive of community care, acute care, and institutional care, each with their own internal characteristics and dynamics that impact sectoral directions., (Copyright © 2018 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objectives: We explored public preferences for involvement in health policy decisions, across the contexts of medical research and healthcare., Approach: We e-surveyed a sample of Canadians, categorizing respondents by preferences for decision control: (1) more authority; (2) more input; (3) status quo. Two generalized ordered logistic regressions assessed influences on preferences., Results: The participation rate was 94%; 1,102 completed responses met quality criteria. The dominant preference was for more input (average = 52.0%), followed by status quo (average = 24.9%) and more authority (average = 21.1%), though preferences for more control were higher in healthcare (57.2%) than medical research (46.8%). Preferences for greater control were associated with constructs related to reduced trust in healthcare systems., Conclusion: The public expects health policy to account for public views, but not base decisions primarily on these views. More involvement was expected in healthcare than medical research policy. As opportunities for public involvement in health research grow, we anticipate increased desired involvement., (Copyright © 2017 Longwoods Publishing.)

The cost of whole genome sequencing is dropping rapidly. There has been a great deal of enthusiasm about the potential for this technological advance to transform clinical care. Given the interest and significant investment in genomics, this seems an ideal time to consider what the evidence tells us about potential benefits and harms, particularly in the context of health care policy. The scale and pace of adoption of this powerful new technology should be driven by clinical need, clinical evidence, and a commitment to put patients at the centre of health care policy., Competing Interests: The authors have declared that no competing interests exist.

Newborn screening has been practised as a form of preventive medicine since the 1960s, and has attracted increased attention in recent years as technological capacities expand. Like other emerging economies, India faces pressure to expand infant screening, though developments have been halting. The promise of newborn screening is the reduction of infant mortality and morbidity from a host of rare, typically genetic, disorders. Deciding what priority should be placed on the realisation of this promise, together with the practical challenge of coordinating the screening enterprise, requires the use of decision making frameworks that address both clinical criteria and values conflicts. Frameworks for public health ethics can aid sound policy development in India, and help to inform the larger international debate about the expansion and benefits of NBS.

Background: While processes of adoption and the impacts of various health technologies have been extensively studied by health services and policy researchers, the influence of policy makers' governing styles on these processes have been largely neglected. Through a comparative analysis of non-invasive prenatal testing (NIPT) in the Canadian provinces of Ontario and Quebec, this article examines how decisions about this technology were shaped by contrasting political ideologies, resulting in vastly different innovation and adoption strategies and outcomes. Methods: A comparative qualitative investigation comprising of a document analysis followed by semi-structured interviews with key informants. Interview participants were researchers, clinicians, and private sector medical laboratory employees based in Ontario and Quebec, Canada. Interviews were conducted both in person and virtually– owing partly to the COVID-19 pandemic – to garner perspectives regarding the adoption and innovation processes surrounding non-invasive prenatal testing in both provinces. All interviews were recorded and transcribed verbatim and data were analyzed using thematic analysis. Results: Through an analysis of 21 in-depth interview transcripts and key documents, the research team identified three central themes: 1) health officials in each province demonstrated a unique approach to using the existing scholarly literature on NIPT; 2) each provincial government demonstrated its own preference for service delivery, with Ontario preferring private and Quebec preferring public; and finally, 3) both Ontario and Quebec's strategies to NIPT adoption and innovation was contextualized within each province's unique financial positioning and concerns. These findings illustrate how both Quebec's nationalist focus and use of industrial policy and Ontario's 'New Public Management' style had implications for how this emerging healthcare technology was made available within each province's publicly-financed health system. Conclusions: Our study reveals how these governments' differing approaches to using data and research, public versus private service delivery, and financial goals and concerns resulted in distinct testing technologies, access, and timelines for NIPT adoption. Our analysis demonstrates the need for health policy researchers, policy makers, and others to move beyond analyses solely considering clinical and health economic evidence to understand the impact of political ideologies and governing styles. [ABSTRACT FROM AUTHOR]

Objectives: Health technology assessment (HTA) traditionally informs decision making for single health technologies, which could lead to ill-informed decisions, suboptimal care, and system inefficiencies. We explored opportunities for conceptualizing the decision space in HTA as a disease management question versus an intervention management question. Methods: Semistructured interviews were conducted between April 2022 and October 2022 with purposefully selected individuals from national and provincial HTA agencies and related organizations in Canada. We conducted manual line by line coding of data informed by our interview guide and sensitizing concepts from the literature. One author coded the data, and findings were independently verified by a second author who coded a subset of transcripts Results: Twenty-four invitations were distributed, and eighteen individuals agreed to participate. A disease management approach to HTA was differentiated from traditional approaches as being disease-based, multi-interventional, and dynamic. There was general support for an explicit care pathway approach to HTA by informing discussions around patient choice and suboptimal care, creating a space where decision makers can collaborate on shared objectives, and in setting up a platform for open dialogue about managing high-cost and high-severity diseases. There are opportunities for a care pathway approach to be implemented that build on the strengths of the existing HTA system in Canada. Conclusions: A disease management approach may enhance the impact of HTA by supporting dynamic decision making that could better inform a proactive, resilient, and sustainable healthcare system in Canada. [ABSTRACT FROM AUTHOR]

The potential for bias in industry‐developed information about noninvasive prenatal testing (NIPT), in addition to the lack of regulatory oversight for this type of product, raises questions about clinical communication and adoption. We identify NIPTs marketed globally and analyze their English‐language consumer‐oriented brochures to determine whether they meet existing policy and ethical guidance from the Nuffield Council on Bioethics on NIPT marketing, how they establish the legitimacy of the test given the lack of regulatory oversight for NIPT, and whether content differs between the brochures from for‐profit and nonprofit entities. In many of these brochures, NIPTs are misrepresented as diagnostic tests, claims lack supporting evidence, regulatory bodies that do not evaluate the test itself are referenced, and clinicians are invoked as authorities on specific NIPTs. Our findings substantiate concerns about the extent to which commercial imperatives operating in the absence of market‐access regulation could exacerbate problems of misrepresentation and inaccuracy in marketing materials. [ABSTRACT FROM AUTHOR]

Joined-up governance (JUG) approaches have gained attention as mechanisms for tackling wicked policy problems, particularly in intersectoral areas such as child health, where multiple ministries that deliver health and social services must collaborate if they are to be effective. Growing attention to the need to invest in early childhood to improve health and developmental trajectories, including through developmental screening, illustrate the challenges of JUG for child health. Using a comparative case study design comprised of the qualitative analysis of documents and key informant interviews, this work sought to explain how and why visible differences in policy choices have been made across two Canadian jurisdictions (Ontario and Manitoba). Specifically, we sought to understand two dimensions of governance (structure and process) alongside an illustrative example—the case of developmental screening, including how insiders viewed the impacts of governance arrangements in this instance. The two jurisdictions shared a commitment to evidence-based policy making and a similar vision of JUG for child health. Despite this, we found divergence in both governance arrangements and outcomes for developmental screening. In Manitoba, collaboration was prioritized, interests were aligned in a structured decision-making process, evidence and evaluation capacity were inherent to agenda setting, and implementation was considered up front. In Ontario, interests were not aligned and instead decision making operated in an opaque and siloed manner, with little consideration of implementation issues. In these contexts, Ontario pursued developmental screening, whereas Manitoba did not. While both jurisdictions aimed at JUG, only Manitoba developed a coordinated JUG system, whereas Ontario operated as a non-system. As a result, Manitoba’s governance system had the capacity to stop ‘rogue’ action, prioritizing investments in accordance with authorized evidence. In contrast, in the absence of a formal system in Ontario, policy ‘entrepreneurs’ were able to seize a window of opportunity to invest in child health. [ABSTRACT FROM AUTHOR]

Objectives: Procurement's important role in healthcare decision making has encouraged criticism and calls for greater collaboration with health technology assessment (HTA), and necessitates detailed analysis of how procurement approaches the decision task.Methods: We reviewed tender documents that solicit medical technologies for patient care in Canada, focusing on request for proposal (RFP) tenders that assess quality and cost, supplemented by a census of all tender types. We extracted data to assess (i) use of group purchasing organizations (GPOs) as buyers, (ii) evaluation criteria and rubrics, and (iii) contract terms, as indicators of supplier type and market conditions.Results: GPOs were dominant buyers for RFPs (54/97) and all tender types (120/226), and RFPs were the most common tender (92/226), with few price-only tenders (11/226). Evaluation criteria for quality were technical, including clinical or material specifications, as well as vendor experience and qualifications; "total cost" was frequently referenced (83/97), but inconsistently used. The most common (47/97) evaluative rubric was summed scores, or summed scores after excluding those below a mandatory minimum (22/97), with majority weight (64.1 percent, 62.9 percent) assigned to quality criteria. Where specified, expected contract lengths with successful suppliers were high (mean, 3.93 years; average renewal, 2.14 years), and most buyers (37/42) expected to award to a single supplier.Conclusions: Procurement's evaluative approach is distinctive. While aiming to go beyond price in the acquisition of most medical technologies, it adopts a narrow approach to assessing quality and costs, but also attends to factors little considered by HTA, suggesting opportunities for mutual lesson learning. [ABSTRACT FROM AUTHOR]

Drawing on institutional theory, this article articulates qualitative insights from a program of research on Canadian health technology-based ventures to examine the rules that characterize economic policy, capital investment, and regulatory approval as well as the way these institutions enable and constrain the development of ventures at an early stage. Our findings clarify how economic policy integrates these ventures into the entrepreneurial domain, how capital investment configures them for economic value extraction, and how regulatory approval fully releases their market value. These findings help to revisit current policy modernization initiatives by calling attention to the convergence among the three institutions. Rather than operating solely as a source of constraints, these institutions provide a highly integrated market-oriented space for health technology-based entrepreneurial activities to unfold. [ABSTRACT FROM AUTHOR]

Background: New technologies constitute an important cost-driver in healthcare, but the dynamics that lead to their emergence remains poorly understood from a health policy standpoint. The goal of this paper is to clarify how entrepreneurs, investors, and regulatory agencies influence the value of emerging health technologies. Methods: Our 5-year qualitative research program examined the processes through which new health technologies were envisioned, financed, developed and commercialized by entrepreneurial clinical teams operating in Quebec's (Canada) publicly funded healthcare system. Results: Entrepreneurs have a direct influence over a new technology's value proposition, but investors actively transform this value. Investors support a technology that can find a market, no matter its intrinsic value for clinical practice or healthcare systems. Regulatory agencies reinforce the "double" value of a new technology --as a health intervention and as an economic commodity-- and provide economic worth to the venture that is bringing the technology to market. Conclusion: Policy-oriented initiatives such as early health technology assessment (HTA) and coverage with evidence may provide technology developers with useful input regarding the decisions they make at an early stage. But to foster technologies that bring more value to healthcare systems, policy-makers must actively support the consideration of health policy issues in innovation policy. [ABSTRACT FROM AUTHOR]

Community-based primary health care describes a model of service provision that is oriented to the population health needs and wants of service users and communities, and has particular relevance to supporting the growing proportion of the population with multiple chronic conditions. Internationally, aspirations for community-based primary health care have stimulated local initiatives and influenced the design of policy solutions. However, the ways in which these ideas and influences find their way into policy and practice is strongly mediated by policy settings and institutional legacies of particular jurisdictions. This paper seeks to compare the key institutional and policy features of Ontario, Québec and New Zealand that shape the 'space available' for models of community-based primary health care to take root and develop. Our analysis suggests that two key conditions are the integration of relevant health and social sector organisations, and the range of policy levers that are available and used by governments. New Zealand has the most favourable conditions, and Ontario the least favourable. All jurisdictions, however, share a crucial barrier, namely the 'barbed-wire fence' that separates funding of medical and 'non-medical' primary care services, and the clear interests primary care doctors have in maintaining this fence. Moves in the direction of system-wide community-based primary health care require a gradual dismantling of this fence. [ABSTRACT FROM AUTHOR]

Recent expansion of the molecular diagnostics industry has revealed weaknesses in Canada's regulatory system for laboratory-developed tests, which are not subject to statutory regulations on medical devices. Absent regulation as medical devices, the only controls on test performance are laboratory regulation and accreditation, which are heterogeneous and sometimes flawed and do not necessarily include assessment of test validity, safety and efficacy. Diagnostics developed as "test kits" and sold to laboratories, hospitals and clinics are considered to be in vitro diagnostics devices under Medical Devices Regulation in accordance with the federal I Food and Drugs Act i . [Extracted from the article]

Objectives Newborn bloodspot screening ( NBS) panels have expanded to include conditions for which treatment effects are less certain, creating debate about population-based screening criteria. We investigated Canadian public expectations and values regarding the types of conditions that should be included in NBS and whether parents should provide consent. Methods Eight focus groups ( FG; n = 60) included education, deliberative discussion and pre-/post-questionnaires. Data were analysed quantitatively and qualitatively. Results Quantitatively, the majority supported NBS for serious disorders for which treatment is not available (95-98, 82%). A majority endorsed screening without explicit consent (77-88%) for treatable disorders, but 62% supported unpressured choice for screening for untreatable disorders. Qualitatively, participants valued treatment-related benefits for infants and informational benefits for families. Concern for anxiety, stigma and unwanted knowledge depended upon disease context and strength of countervailing benefits. Conclusions Anticipated benefits of expanded infant screening were prioritized over harms, with information provision perceived as a mechanism for mitigating harms and enabling choice. However, we urge caution around the potential for public enthusiasm to foster unlimited uptake of infant screening technologies. [ABSTRACT FROM AUTHOR]

The challenge of novel and high cost health technologies has encouraged the growth of regulatory agencies such as Health Technology Assessment (HTA) organizations and Group Procurement Organizations (GPO). Yet the existence of several agencies in the same polycentric regulatory regime raises questions about whether and how their work can be coordinated. Drawing on a case study of GPOs and HTA agencies across four provinces in Canada, involving document review and key informant interviews (n = 44) conducted between 2013 and 2016, we explore the separate evolution of these agencies, emerging connections between them for non-drug technologies, and the organizational processes and evaluative judgments that underpin coordination efforts. HTA agencies and GPOs developed separately; connections emerged recently in three provinces and suggest four modes of coordination. One mode aligns most closely with that recommended by health economists and HTA practitioners, whereby HTA precedes procurement, with coverage decisions informing technology acquisition. The second mode is a version of the first, where procurement refers cases to HTA for coverage or technology management support; unlike the first, it recognizes procurement's evaluative strengths. Yet both the first and second modes focus on exceptional cases and will be infrequent. The third mode is more systemic, reflecting a generalized complementary of purpose as public agencies. HTA could support GPOs in contested technology acquisition efforts through timely and responsive input, while procurement could expand HTA's impact and inform HTA's growing interest in responsible innovation and environmental sustainability. The final mode is non-coordination, reflecting the potential for agencies to occupy quite distinct regulatory niches within the same regime. We conclude that consistency and convergence around a single model of resource allocation is not inevitable; nor is it necessary for coordinated effort. Thus, where differences in regulatory practice and epistemology persist, mutual accommodation and shared learning may prove most productive. • Regulatory agencies to manage technology adoption have grown internationally. • HTA agencies and Group Procurement Organizations now exist in the same regime. • We identify four "modes of coordination" in the regime, including no coordination. • Only one mode aligns with the assumption of shared problem solving, guided by HTA. • Mutual learning is needed given differences in regulatory practice & epistemology. [ABSTRACT FROM AUTHOR]

The scholarship on responsible research and innovation (RRI) aims to align the processes and outcomes of innovation with societal values by involving a broad range of stakeholders from a very early stage. Though this scholarship offers a new lens to consider the challenges new health technologies raise for health systems around the world, there is a need to define the dimensions that specifically characterise responsible innovation in health (RIH). The present article aims to introduce an integrative RIH framework drawing on the RRI literature, the international literature on health systems as well as specific bodies of knowledge that shed light on key dimensions of health innovations. Combining inductive and deductive theory-building strategies and concomitant with the development of a formal tool to assess the responsibility of innovations, we developed a framework that is comprised of nine dimensions organised within five value domains, namely population health, health system, economic, organisational and environmental. RIH provides health and innovation policy-makers with a common framework that supports the development of innovations that can tackle significant system-level challenges, including sustainability and equity. [ABSTRACT FROM AUTHOR]

Background: Growing interest in public involvement in health research has led to organisational and policy change. Additionally, an emerging body of policy-oriented scholarship has begun to identify the organisational and network arrangements that shape public involvement activity. Such developments suggest the need to clearly conceptualise and characterise public involvement in health research in terms of governance.Methods: We drew on an established health research system framework to analyse governance functions related to public involvement, adapting scoping review methods to identify evidence from a corpus of journal papers and policy reports. We drew on the logics of aggregation and top down configuration, using a qualitative interpretive approach to combine and link findings from different studies into framework categories.Results: We identified a total of 32 scholarly papers and 13 policy reports (n = 45 included papers) with relevance to governance for public involvement. Included papers were broadly consonant in identifying the need for activity to specify and support public involvement across all four governance functions of stewardship, financing, creating and sustaining resources, and research production and use. However, different visions for public involvement, and the activity required to implement it and achieve impact, were particularly evident with respect to the stewardship function, which seeks to set overall directions for research while addressing the potentially competing demands of a system's many constituents.Conclusions: A governance perspective has considerable value for public involvement in health research systems, supporting efforts to coordinate and institutionalise the burgeoning public involvement enterprise. Furthermore, it highlights challenges for what is, ultimately, a highly political intervention, suggesting that diverse publics must be both involved within health research systems and enrolled as governors of them. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "Health Systems and Policy Research in Europe: Horizon 2020," by Kieran Walshe et al. in the August 24, 2013 issue.