Health Technology Assessment for Cardiovascular Digital Health Technologies and Artificial Intelligence: Why Is It Different?

Innovations in health care are growing exponentially, resulting in improved quality of and access to care, as well as rising societal costs of care and variable reimbursement. In recent years, digital health technologies and artificial intelligence have become of increasing interest in cardiovascular medicine owing to their unique ability to empower patients and to use increasing quantities of data for moving toward personalised and precision medicine. Health technology assessment agencies evaluate the money spent on a health care intervention or technology to attain a given clinical impact and make recommendations for reimbursement considerations. However, there is a scarcity of economic evaluations of cardiovascular digital health technologies and artificial intelligence. The current health technology assessment framework is not equipped to address the unique, dynamic, and unpredictable value considerations of these technologies and highlight the need to better approach the digital health technologies and artificial intelligence health technology assessment process. In this review, we compare digital health technologies and artificial intelligence with traditional health care technologies, review existing health technology assessment frameworks, and discuss challenges and opportunities related to cardiovascular digital health technologies and artificial intelligence health technology assessment. Specifically, we argue that health technology assessments for digital health technologies and artificial intelligence applications must allow for a much shorter device life cycle, given the rapid and even potentially continuously iterative nature of this technology, and thus an evidence base that maybe less mature, compared with traditional health technologies and interventions.

Decline in Public Spending on Biopharmaceutics in Brazil

Abstract Biopharmaceuticals, mainly monoclonal antibodies, and fusion proteins are drugs that have gained notoriety in the treatment of various chronic and inflammatory diseases and have high prices. The study aimed to verify which monoclonal antibodies and fusion proteins were most incorporated into the Unified Health System (SUS), which therapeutic indication most benefited from them and to analyze public spending on these biopharmaceuticals from January 2012 to September 2019. This study performed a qualitative and quantitative analysis of biopharmaceuticals incorporated by SUS. The data were collected on the websites of CONITEC and the Health Price Bank. The results demonstrated that subcutaneous adalimumab was most frequently incorporated, and the most requested therapeutic indication was rheumatoid arthritis. Public spending on biopharmaceuticals exceeded R$ 28 billion (more than US$ 140 billion). However, a downward trend was confirmed (-266.7%) in the period evaluated. Despite the increase in demand and public spending on biologics in general, in Brazil and worldwide, the results of this research show that there was a drop in public spending on the biopharmaceuticals studied in the last seven years.

Adopting medical technology: the case for a fast-tracked approach.

The NHS has always struggled to effectively adopt innovative medical technologies. A report by The Medical Technology Group argues that a new system for the widespread adoption of technology is needed. The report argues that, considering the growing backlog of procedures caused by the COVID-19 pandemic, medical technology can increase efficiency and deliver better outcomes for patients, while helping the NHS to recover.

Making the COVID-19 Pandemic a Driver for Digital Health: Brazilian Strategies.

The COVID-19 outbreak exposed several problems faced by health systems worldwide, especially concerning the safe and rapid generation and sharing of health data. However, this pandemic scenario has also facilitated the rapid implementation and monitoring of technologies in the health field. In view of the occurrence of the public emergency caused by SARS-CoV-2 in Brazil, the Department of Informatics of the Brazilian Unified Health System created a contingency plan. In this paper, we aim to report the digital health strategies applied in Brazil and the first results obtained during the fight against COVID-19. Conecte SUS, a platform created to store all the health data of an individual throughout their life, is the center point of the Brazilian digital strategy. Access to the platform can be obtained through an app by the patient and the health professionals involved in the case. Health data sharing became possible due to the creation of the National Health Data Network (Rede Nacional de Dados em Saúde, RNDS). A mobile app was developed to guide citizens regarding the need to go to a health facility and to assist in disseminating official news about the virus. The mobile app can also alert the user if they have had contact with an infected person. The official numbers of cases and available hospital beds are updated and published daily on a website containing interactive graphs. These data are obtained due to creating a web-based notification system that uses the RNDS to share information about the cases. Preclinical care through telemedicine has become essential to prevent overload in health facilities. The exchange of experiences between medical teams from large centers and small hospitals was made possible using telehealth. Brazil took a giant step toward digital health adoption, creating and implementing important initiatives; however, these initiatives do not yet cover the entire health system. It is expected that the sharing of health data that are maintained and authorized by the patient will become a reality in the near future. The intention is to obtain better clinical outcomes, cost reduction, and faster and better services in the public health network.

A strategy for empowering clinicians and increasing innovation: the Magic Wand Initiative.

Clinicians play a critical role in recognizing, initiating, and adopting innovative solutions to clinical problems. Increasing clinician involvement in problem-based innovation will help identify and solve unmet medical needs. The overall objective of our program was to increase clinician involvement in problem-based innovation. We pioneered and piloted the "Magic Wand" Initiative (MWI) at Massachusetts General Hospital Department of Dermatology, by inviting clinical faculty to voluntarily participate in problem-driven innovation. The primary outcome was the number of unmet clinical needs identified and pursued by clinicians, who were 'activated' to initiate problem-based innovation. Other objectives were to enhance clinician-to-clinician dialogue and to develop specific strategic framework for clinician-led, problem-driven research. This pilot MWI was started in 2013 with an announcement at dermatology faculty meeting inviting all clinical faculty to participate on volunteer basis. Academic dermatologists were the main participants in this program. They also contacted, collaborated and worked with research faculty, industry experts and lawyers. Out of 30 unmet needs identified by clinicians participating in MWI, eight are actively being pursued by clinicians. Three of those cases presented here have achieved publications, grant funding, prototype devices and product for patient use. In conclusion, MWI is an innovative approach that educates and equips clinician to identify and solve problems and engages them as leaders in their healthcare ecosystem. MWI has achieved concrete measurable success, affirming that if clinicians are empowered and supported to identify and solve existing unmet medical problems, new and innovative solutions can be invented to improve patient care.

Harnessing Digital Health Technologies During and After the COVID-19 Pandemic: Context Matters.

A common development observed during the COVID-19 pandemic is the renewed reliance on digital health technologies. Prior to the pandemic, the uptake of digital health technologies to directly strengthen public health systems had been unsatisfactory; however, a relentless acceleration took place within health care systems during the COVID-19 pandemic. Therefore, digital health technologies could not be prescinded from the organizational and institutional merits of the systems in which they were introduced. The Italian National Health Service is strongly decentralized, with the national government exercising general stewardship and regions responsible for the delivery of health care services. Together with the substantial lack of digital efforts previously, these institutional characteristics resulted in delays in the uptake of appropriate solutions, territorial differences, and issues in engaging the appropriate health care professionals during the pandemic. An in-depth analysis of the organizational context is instrumental in fully interpreting the contribution of digital health during the pandemic and providing the foundation for the digital reconstruction of what is to come after.

A new Korean Research Investment for Global Health Technology (RIGHT) Fund to advance innovative neglected-disease technologies.

In 2018, the government of the Republic of Korea (ROK), South Korean life science companies, and a group of international funders led by the Bill & Melinda Gates Foundation launched a new and innovative funding agency to support neglected-disease research and development (R&D). The new venture is known as the Research Investment for Global Health Technology (RIGHT) Fund.

Adoption of Regulations for Cell Therapy Development: Linkage Between Taiwan and Japan.

Although cell-based therapy has become a promising treatment, its practice and evaluation process remain unstandardized. Therefore, Japan initiated a dual-track regulatory framework for cell-based therapy aiming to promote and regulate the therapies to ensure that patients can access safe and effective treatments. Influenced by such pathway, Taiwan adopted the framework and initiated its own cell-based therapy regulation in 2018. This paper discusses how Japan has influenced Taiwan in developing regulations for cell-based therapy.

Mapping the coevolution, leadership and financing of research on viral vectors, RNAi, CRISPR/Cas9 and other genomic editing technologies.

Genomic editing technologies are developing rapidly, promising significant developments for biomedicine, agriculture and other fields. In the present investigation, we analyzed and compared the process of innovation for six genomic technologies: viral vectors, RNAi, TALENs, meganucleases, ZFNs and CRISPR/Cas including the profile of the main research institutions and their funders, to understand how innovation evolved and what institutions influenced research trajectories. A Web of Science search of papers on viral vectors RNAi, CRISPR/Cas, TALENs, ZFNs and meganucleases was used to build a citation network of 16,746 papers. An analysis of network clustering combined with text mining was performed. For viral vectors, a long-term process of incremental innovation was identified, which was largely publicly funded in the United States and the European Union. The trajectory of RNAi research included clusters related to the study of RNAi as a biological phenomenon and its use in functional genomics, biomedicine and pest control. A British philanthropic organization and a US pharmaceutical company played a key role in the development of basic RNAi research and clinical application respectively, in addition to government and academic institutions. In the case of CRISPR/Cas research, basic science discoveries led to the technical improvements, and these two in turn provided the information required for the development of biomedical, agricultural, livestock and industrial applications. The trajectory of CRISPR/Cas research exhibits a geopolitical division of the investigation efforts between the US, as the main producer and funder of basic research and technical improvements, and Chinese research institutions increasingly leading applied research. Our results reflect a change in the model for financing science, with reduced public financing for basic science and applied research on publicly funded technological developments in the US, and the emergence of China as a scientific superpower, with implications for the development of applications of genomic technologies.

[Positioning the medico-social sector as a stakeholder in digital transformation]. / Positionner le secteur médico-social comme acteur de la transformation numérique.

In the Île-de-France region, the medico-social sector is implementing a project to develop digital tools in institutions. With the support of the regional health agency, this project will lead to the selection of publishers by the end of 2019 who will offer the institutions business tools tailored to their needs, secure and interoperable to be part of the e-track programme.

Stanford's Biodesign Innovation program: Teaching opportunities for value-driven innovation in surgery.

The Stanford Biodesign Innovation process, which identifies meaningful clinical needs, develops solutions to meet those needs, and plans for subsequent implementation in clinical practice, is an effective training approach for new generations of healthcare innovators. Continued success of this process hinges on its evolution in response to changes in healthcare delivery and an ever-increasing demand for economically viable solutions. In this article, we provide perspective on opportunities for value-driven innovation in surgery and relate these to value-related teaching elements currently integrated in the Stanford Biodesign process.

Psychosis, vulnerability, and the moral significance of biomedical innovation in psychiatry. Why ethicists should join efforts.

The study of the neuroscience and genomics of mental illness are increasingly intertwined. This is mostly due to the translation of medical technologies into psychiatry and to technological convergence. This article focuses on psychosis. I argue that the convergence of neuroscience and genomics in the context of psychosis is morally problematic, and that ethics scholarship should go beyond the identification of a number of ethical, legal, and social issues. My argument is composed of two strands. First, I argue that we should respond to technological convergence by developing an integrated, patient-centred approach focused on the assessment of individual vulnerabilities. Responding to technological convergence requires that we (i) integrate insights from several areas of ethics, (ii) translate bioethical principles into the mental health context, and (iii) proactively try to anticipate future ethical concerns. Second, I argue that a nuanced understanding of the concept of vulnerability might help us to accomplish this task. I borrow Florencia Luna's notion of 'layers of vulnerability' to show how potential harms or wrongs to individuals who experience psychosis can be conceptualised as stemming from different sources, or layers, of vulnerability. I argue that a layered notion of vulnerability might serve as a common ground to achieve the ethical integration needed to ensure that biomedical innovation can truly benefit, and not harm, individuals who suffer from psychosis.

Decision-Making on New Non-Drug Health Technologies by Hospitals and Health Authorities in Canada.

INTRODUCTION: Unlike those for publicly funded drugs in Canada, coverage decision-making processes for non-drug health technologies (NDTs) are not well understood. OBJECTIVES: This paper aims to describe existing NDT decision-making processes in different healthcare organizations across Canada. METHODS: A self-administered survey was used to determine demographic and financial characteristics of organizations, followed by in-depth interviews with senior leadership of consenting organizations to understand the processes for making funding decisions on NDTs. RESULTS: Seventy-three and 48 organizations completed self-administered surveys and telephone interviews, respectively (with 45 participating in both ways). Fifty-five different processes were identified, the majority of which addressed capital equipment. Most involved multidisciplinary committees (with medical and non-medical representation), but the types of information used to inform deliberations varied. Across all processes, decision-making criteria included local considerations such as alignment with organizational priorities. CONCLUSIONS: NDT decision-making processes vary in complexity, depending on characteristics of the healthcare organization and context.

The Introduction of New Non-Drug Health Technologies into Canadian Healthcare Institutions: Opportunities and Challenges.

INTRODUCTION: A recent pan-Canadian survey of 48 health organizations concluded that structures, processes, factors and information used to support funding decisions on new non-drug health technologies (NDTs) vary within and across jurisdictions in Canada. METHODS: A self-administered survey was used to determine demographic and financial characteristics of organizations, followed by in-depth interviews with senior leadership of consenting organizations to understand the processes for making funding decisions on NDTs. RESULTS: Seventy-three and 48 organizations completed self-administered surveys and telephone interviews, respectively (with 45 participating in both ways). Fifty-five different processes were identified, the majority of which addressed capital equipment. Most involved multidisciplinary committees (with medical and non-medical representation), but the types of information used to inform deliberations varied. Across all processes, decision-making criteria included local considerations such as alignment with organizational priorities. CONCLUSIONS: NDT decision-making processes vary in complexity, depending on characteristics of the healthcare organization and context.