Best Practice Guidance for Creation and Management of Innovations in Health care and Information and Communications Technologies.

Governments and publics in Europe and around the world have turned to innovation in response to the manifold economic, environmental, and societal challenges we are facing. However, innovations often end up in what is popularly termed as the "valley of death" between upstream creation and downstream product development and implementation. Consequently, the benefits of innovation do not always reach the citizens. In addition, critically informed governance of innovations matter because it allows steering of innovations in response to the values and end points desired by society. With the COVID-19 pandemic, we have witnessed the rise of digital health and new information and communications technologies (ICTs). The pandemic underscored the need for innovation governance between global North and the global South. We report and discuss, in this study, the development of the innXchange innovation wheel to improve innovation creation and management, using a case study of cooperation between Europe and Africa. The innovation wheel offers best practice guidance and framework to build capacity for innovation dimensions such as partnership mobilization, evaluation, and monitoring, not to mention innovation literacy. The framework emphasizes active engagement of all key stakeholders from the very beginning, also referred to as "systematic early dialog." We propose the incorporation of systematic early dialog as the best practice guidance in global South and global North cooperation for health care and ICT innovation. The framework is a novel instrument to help overcome the current barriers in planetary health innovation management and consequently, bring breakthrough discoveries in ICTs and innovative ideas to the people.

Diagnosis of Chlamydia trachomatis genital infections in the era of genomic medicine.

PURPOSE: Chlamydial genital infections constitute significant sexually transmitted infections worldwide. The often asymptomatic status of C. trachomatis (CT) infections leads to an increased burden on human reproductive health, especially in middle- and low-income settings. Early detection and management of these infections could play a decisive role in controlling this public health burden. The objective of this review is to provide an insight into the evolution of diagnostic methods for CT infections through the development of new molecular technologies, emphasizing on -omics' technologies and their significance as diagnostic tools both for effective patient management and control of disease transmission. METHODS: Narrative review of the diagnostic methodologies of CT infections and the impact of the introduction of -omics' technologies on their diagnosis by review of the literature. RESULTS: Various methodologies are discussed with respect to working principles, required specifications, advantages, and disadvantages. Implementing the most accurate methods in diagnosis is highlighted as the cornerstone in managing CT infections. CONCLUSION: Diagnostics based on -omics' technologies are considered to be the most pertinent modalities in CT testing when compared to other available methods. There is a need to modify these effective and accurate diagnostic tools in order to render them more available and feasible in all settings, especially aiming on turning them to rapid point-of-care tests for effective patient management and disease control.

Global Open Health Data Cooperatives Cloud in an Era of COVID-19 and Planetary Health.

Big data in both the public domain and the health care industry are growing rapidly, for example, with broad availability of next-generation sequencing and large-scale phenomics datasets on patient-reported outcomes. In parallel, we are witnessing new research approaches that demand sharing of data for the benefit of planetary society. Health data cooperatives (HDCs) is one such approach, where health data are owned and governed collectively by citizens who take part in the HDCs. Data stored in HDCs should remain readily available for translation to public health practice but at the same time, governed in a critically informed manner to ensure data integrity, veracity, and privacy, to name a few pressing concerns. As a solution, we suggest that data generated from high-throughput omics research and phenomics can be stored in an open cloud platform so that researchers around the globe can share health data and work collaboratively. We describe here the Global Open Health Data Cooperatives Cloud (GOHDCC) as a proposed cloud platform-based model for the sharing of health data between different HDCCs around the globe. GOHDCC's main objective is to share health data on a global scale for robust and responsible global science, research, and development. GOHDCC is a citizen-oriented model cooperatively governed by citizens. The model essentially represents a global sharing platform that could benefit all stakeholders along the health care value chain.

Blockchain for Digital Health: Prospects and Challenges.

An open distributed ledger system, blockchain records digital transactions and offers the potential to disruptively transform the way we conduct biomedical research, provide health care, and perform economic transactions. This expert review provides the overarching background, key definitions, prospects and socio-technical challenges at the intersection of blockchain and digital health. In addition, we discuss the tenets of next-generation technology policy for blockchain, drawing from the field of responsible innovation.

Digital Transformation and Governance Innovation for Public Biobanks and Free/Libre Open Source Software Using a Blockchain Technology.

Digitalization and digital health are transforming research practices, while economic growth is increasingly driven by the information commons. In the case of biological sciences, information commons, such as public biobanks and free/libre open source software (FLOSS), are of paramount importance for both research and the bioeconomy. In a time of digitalization, however, information commons are vulnerable to violations, such as the free-rider problem, that render the commons unsustainable. Consequently, it has been argued that the enclosure of the informational common resources is the only means to effectively exploit them. Given the social and economic importance of the information commons, the new digital environment in biology and health requires governance innovation that will regulate the social embedding of the commons and their relationship to the free market, that is, a new political economy is needed. In this context, the need for a core common infrastructure, stretching from the physical to the logical and content layer of the information environment, that will guarantee the protection of the commons from both violations and enclosures, has been highlighted. Focusing on the interaction between two biological/bioinformatics commons, namely public biobanks and the FLOSS, we have set up an ecosystem relying on a blockchain technology. The proposed governance mechanism protects the information commons from the free-rider problem and guarantees their sustainability without hampering their operational framework. Our model demonstrates the interdependence and protection of the information commons not as an abstract theoretical exercise, but rather as a physical reality on the digital ontological matrix.

International consortium for personalized medicine: an international survey about the future of personalized medicine.

Aim: The ICPerMed, international initiative promoting personalized medicine, has realized a survey among a group of experts, to define a common vision for the deployment of personalized medicine across healthcare systems until 2030. Materials & methods: ICPerMed defined five perspectives (p.4) and addressed an online questionnaire to 97 international experts to collect their views. Results: Seventy (72%) of the 97 experts effectively answered the survey from which 69 answers were exploitable. Respondents from a variety of international profiles approved the five proposed perspectives and reported required actions and best practices. Conclusion: There is a large consensus among experts directly involved in shaping international strategies and policies, calling for voluntarist public policies, new IT platforms enabling data-driven approaches, large-scale educational programs and new financing models.

Use of Free/Libre Open Source Software in Sepsis "-Omics" Research: A Bibliometric, Comparative Analysis Among the United States, EU-28 Member States, and China.

"-Omics" systems sciences are at the epicenter of personalized medicine and public health, and drivers of knowledge-based biotechnology innovation. Bioinformatics, a core component of omics research, is one of the disciplines that first employed Free/Libre Open Source Software (FLOSS), and thus provided a fertile ground for its further development. Understanding the use and characteristics of FLOSS deployed in the omics field is valuable for future innovation strategies, policy and funding priorities. We conducted a bibliometric, longitudinal study of the use of FLOSS in sepsis omics research from 2011 to 2015 in the United States, EU-28 and China. Because sepsis is an interdisciplinary field at the intersection of multiple omics technologies and medical specialties, it was chosen as a model innovation ecosystem for this empirical analysis, which used publicly available data. Despite development of and competition from proprietary commercial software, scholars in omics continue to employ FLOSS routinely, and independent of the type of omics technology they work with. The number of articles using FLOSS increased significantly over time in the EU-28, as opposed to the United States and China (R = 0.96, p = 0.004). Furthermore, in an era where sharing of knowledge is being strongly advocated and promoted by public agencies and social institutions, we discuss possible correlations between the use of FLOSS and various funding sources in omics research. These observations and analyses provide new insights into the use of FLOSS in sepsis omics research across three (supra)national regions. Further benchmarking studies are warranted for FLOSS trends in other omics fields and geographical settings. These could, in time, lead to the development of new composite innovation and technology use metrics in omics systems sciences and bioinformatics communities.

Multi-Omics Research Trends in Sepsis: A Bibliometric, Comparative Analysis Between the United States, the European Union 28 Member States, and China.

"-Omics" research is in transition with the recent rise of multi-omics technology platforms. Integration of "-omics" and multi-omics research is of high priority in sepsis, a heterogeneous syndrome that is widely recognized as a global health burden and a priority biomedical funding field. We report here an original study on bibliometric trends in the use of "-omics" technologies, and multi-omics approaches in particular, in sepsis research in three (supra)national settings, the United States, the European Union 28 Member States (EU-28), and China. Using a 5-year longitudinal bibliometric study design from 2011 to 2015, we analyzed the sepsis-related research articles in English language that included at least one or multi-omics technologies in publicly available form in Medline (free full texts). We found that the United States has had the lead (almost one-third of publications) in the inclusion of an "-omics" or multi-omics technology in sepsis within the study period. However, both China and the EU-28 displayed a significant increase in the number of publications that employed one or more types of "-omics" research (p < 0.005), while the EU-28 displayed a significant increase especially in multi-omics research articles in sepsis (p < 0.05). Notably, more than half of the multi-omics research studies in the sepsis knowledge domain had a university or government/state funding source. Among the multi-omics research publications in sepsis, the combination of genomics and transcriptomics was the most frequent (40.5%), followed by genomics and proteomics (20.4%). We suggest that the lead of the United States in the field of "-omics" and multi-omics research in sepsis is likely at stake, with both the EU-28 and China rapidly increasing their research capacity. Moreover, "triple omics" that combine genomics, proteomics, and metabolomics analyses appear to be uncommon in sepsis, and yet much needed for triangulation of systems science data. These observations have implications for "-omics" technology policy and global research funding strategic foresight.

The Creation and Management of Innovations in Healthcare and ICT: The European and African Experience.

The purpose of the study was to gain new insights into innovation systems by comparing state-of-the-art of existing approaches of innovation creation and innovation management in healthcare and ICT. It is unique, in that it compares countries in Africa with countries in Europe in order to identify similarities and differences regarding the creation and management of innovations. The main similarity is that early dialogue between different stakeholders was underrepresented during the whole innovation process in all countries. Our results also indicated that the various stakeholders often work in silos. The main difference was that the countries face problems at different stages of the innovation process. Whereas European countries face more problems in the innovation creation process, African countries experience difficulty sustaining and managing innovation. To overcome barriers, we suggest the application of systematic early dialogue between all key stakeholders.

Antibiotics-Induced Obesity: A Mitochondrial Perspective.

Antibiotics are the first line of treatment against infections and have contributed immensely to reduce the morbidity and mortality rates. Recently, extensive use of antibiotics has led to alterations of the gut microbiome, predisposition to various diseases and most importantly, increase in the emergence of antibiotic-resistant bacteria, which poses a major threat to global public health. Another major issue faced worldwide due to unregulated use of antibiotics in children as well as in adults is the influence of metabolism and body weight homeostasis, leading to obesity. Apart from the involvement of biosocial causes influencing diet, physical activity, and antibiotic use, pathogenesis of obesity is linked to interconnected functional alterations in cells, tissues and organs due to biochemical, epigenetic and genetic factors. Mitochondrial dysfunction is one such factor, which is becoming the primary focus of various aspects of research on multifactorial complex diseases and is providing new perspectives on etiology, biomarker-based diagnosis, and drug sensitivity. Through this review, we have made an attempt to present the interplay between use of antibiotics, obesity, and associated mitochondrial dysfunction. This may provide insights into the molecular basis, genetic predisposition and environmental triggers, which in turn may have potential clinical applications in the management of antibiotic use.

Big Data for Public Health Policy-Making: Policy Empowerment.

Digitization is considered to radically transform healthcare. As such, with seemingly unlimited opportunities to collect data, it will play an important role in the public health policy-making process. In this context, health data cooperatives (HDC) are a key component and core element for public health policy-making and for exploiting the potential of all the existing and rapidly emerging data sources. Being able to leverage all the data requires overcoming the computational, algorithmic, and technological challenges that characterize today's highly heterogeneous data landscape, as well as a host of diverse regulatory, normative, governance, and policy constraints. The full potential of big data can only be realized if data are being made accessible and shared. Treating research data as a public good, creating HDC to empower citizens through citizen-owned health data, and allowing data access for research and the development of new diagnostics, therapies, and public health policies will yield the transformative impact of digital health. The HDC model for data governance is an arrangement, based on moral codes, that encourages citizens to participate in the improvement of their own health. This then enables public health institutions and policymakers to monitor policy changes and evaluate their impact and risk on a population level.

European healthcare systems readiness to shift from 'one-size fits all' to personalized medicine.

Personalized medicine (PM) is no longer an abstract healthcare approach. It has become a reality over the last years and is already successfully applied in the various medical fields. Although there are success stories of implementing PM, there are still many more opportunities to further implement and make full use of the potential of PM. We assessed the system readiness of healthcare systems in Europe to shift from the predominant 'one size fits all' healthcare approach to PM. We conclude that European healthcare systems are only partially ready for PM. Key challenges such as integration of big data, health literacy, reimbursement and regulatory issues need to be overcome in order to strengthen the implementation and uptake of PM.

Metabolomics in Sepsis and Its Impact on Public Health.

Sepsis, with its often devastating consequences for patients and their families, remains a major public health concern that poses an increasing financial burden. Early resuscitation together with the elucidation of the biological pathways and pathophysiological mechanisms with the use of "-omics" technologies have started changing the clinical and research landscape in sepsis. Metabolomics (i.e., the study of the metabolome), an "-omics" technology further down in the "-omics" cascade between the genome and the phenome, could be particularly fruitful in sepsis research with the potential to alter the clinical practice. Apart from its benefit for the individual patient, metabolomics has an impact on public health that extends beyond its applications in medicine. In this review, we present recent developments in metabolomics research in sepsis, with a focus on pneumonia, and we discuss the impact of metabolomics on public health, with a focus on free/libre open source software.

Clinical Trial Data as Public Goods: Fair Trade and the Virtual Knowledge Bank as a Solution to the Free Rider Problem - A Framework for the Promotion of Innovation by Facilitation of Clinical Trial Data Sharing among Biopharmaceutical Companies in the Era of Omics and Big Data.

BACKGROUND: Knowledge in the era of Omics and Big Data has been increasingly conceptualized as a public good. Sharing of de-identified patient data has been advocated as a means to increase confidence and public trust in the results of clinical trials. On the other hand, research has shown that the current research and development model of the biopharmaceutical industry has reached its innovation capacity. In response to that, the biopharmaceutical industry has adopted open innovation practices, with sharing of clinical trial data being among the most interesting ones. However, due to the free rider problem, clinical trial data sharing among biopharmaceutical companies could undermine their innovativeness. METHOD: Based on the theory of public goods, we have developed a commons arrangement and devised a model, which enables secure and fair clinical trial data sharing over a Virtual Knowledge Bank based on a web platform. Our model uses data as a virtual currency and treats knowledge as a club good. RESULTS: Fair sharing of clinical trial data over the Virtual Knowledge Bank has positive effects on the innovation capacity of the biopharmaceutical industry without compromising the intellectual rights, proprietary interests and competitiveness of the latter. CONCLUSION: The Virtual Knowledge Bank is a sustainable and self-expanding model for secure and fair clinical trial data sharing that allows for sharing of clinical trial data, while at the same time it increases the innovation capacity of the biopharmaceutical industry.

Are Allopathic and Holistic Medicine Incommensurable?

The shift from the Aristotelian to the Newtonian scientific paradigm gave birth to progresses in the natural, hard sciences and contributed to the emergence of modernity. Allopathic medicine gradually implemented those progresses, transforming itself into contemporary biomedicine. In the early 20th century, replacement of Newtonian physics by quantum mechanics and Einstein's theory of relativity resulted in a new paradigm shift in the natural, hard sciences. This shift gave birth to post-modern perceptions, which attempt to put those changes in context. Within this new context, holistic therapeutic approaches are considered more compatible with the new paradigm. Different paradigms in the natural, hard sciences are considered to be incommensurable (in the Kuhnian sense). This incommensurability is also transferred to the different societal contexts, the different «Weltanschauungen¼ that rely on different scientific paradigms. However, drawing on arguments that range from historical and philosophical to practical and sociological ones, we argue that, although based on different scientific paradigms, allopathic and holistic medicine are not incommensurable, but rather complementary. This may be related to the inherent attributes of medicine, a fact that reinforces the debate on its epistemological status.