Challenges in delivering primary care via telemedicine during COVID-19 pandemic in India: A review synthesis using systems approach.

Background: Countries, including India, were quick to adopt telemedicine for delivering primary care in response to the widespread disruptions due to the coronavirus disease 2019 (COVID-19) pandemic. This expeditious adoption was critical and the challenges faced during this exigency could guide the design and delivery of future telemedicine applications toward strengthening primary healthcare services. Methods: To identify the challenges in delivering primary care via telemedicine technology in the Indian context, a scoping review was conducted. Drawing from the systems approach in healthcare delivery, the review findings are summarized at four levels, patient, provider, healthcare organizations, and policy. Results: The initial search yielded 247 articles and 13 met our inclusion criteria. This review highlighted that telemedicine facilitated the continuity of care during COVID-19 but not without challenges. Low levels of education and computer literacy along with the language barriers posed the predominant challenges at the patient level. Providers had concerns related to digital literacy, clinical process flows, legal liabilities, and unethical behavior of the patients. The policy-level challenges include data privacy and security, reimbursement models, unethical behavior by the patient, or provider, and regulating prescriptions of psychotropic drugs. A lack of an integrated telehealthcare model covering diagnostics, prescriptions, and medication supply mirrored the existing fragmentation of care delivery. Conclusion: Telemedicine has the potential to improve primary healthcare delivery even beyond COVID-19. Currently, telemedicine applications in India are only facilitating a remote consultation wherein an integrated person-centered care is lacking. There is a need to acknowledge and factor in the inter-connectedness of health system elements for ensuring an effective and efficient healthcare delivery via telemedicine.

Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review.

BACKGROUND: Although well recognized for its scientific value, data sharing from clinical trials remains limited. Steps toward harmonization and standardization are increasing in various pockets of the global scientific community. This issue has gained salience during the COVID-19 pandemic. Even for agencies willing to share data, data exclusivity practices complicate matters; strict regulations by funders affect this even further. Finally, many low- and middle-income countries (LMICs) have weaker institutional mechanisms. This complex of factors hampers research and rapid response during public health emergencies. This drew our attention to the need for a review of the regulatory landscape governing clinical trial data sharing. OBJECTIVE: This review seeks to identify regulatory frameworks and policies that govern clinical trial data sharing and explore key elements of data-sharing mechanisms as outlined in existing regulatory documents. Following from, and based on, this empirical analysis of gaps in existing policy frameworks, we aimed to suggest focal areas for policy interventions on a systematic basis to facilitate clinical trial data sharing. METHODS: We followed the JBI scoping review approach. Our review covered electronic databases and relevant gray literature through a targeted web search. We included records (all publication types, except for conference abstracts) available in English that describe clinical trial data-sharing policies, guidelines, or standard operating procedures. Data extraction was performed independently by 2 authors, and findings were summarized using a narrative synthesis approach. RESULTS: We identified 4 articles and 13 policy documents; none originated from LMICs. Most (11/17, 65%) of the clinical trial agencies mandated a data-sharing agreement; 47% (8/17) of these policies required informed consent by trial participants; and 71% (12/17) outlined requirements for a data-sharing proposal review committee. Data-sharing policies have, a priori, milestone-based timelines when clinical trial data can be shared. We classify clinical trial agencies as following either controlled- or open-access data-sharing models. Incentives to promote data sharing and distinctions between mandated requirements and supportive requirements for informed consent during the data-sharing process remain gray areas, needing explication. To augment participant privacy and confidentiality, a neutral institutional mechanism to oversee dissemination of information from the appropriate data sets and more policy interventions led by LMICs to facilitate data sharing are strongly recommended. CONCLUSIONS: Our review outlines the immediate need for developing a pragmatic data-sharing mechanism that aims to improve research and innovations as well as facilitate cross-border collaborations. Although a one-policy-fits-all approach would not account for regional and subnational legislation, we suggest that a focus on key elements of data-sharing mechanisms can be used to inform the development of flexible yet comprehensive data-sharing policies so that institutional mechanisms rather than disparate efforts guide data generation, which is the foundation of all scientific endeavor.

The global experience of digital health interventions in COVID-19 management.

Digital health interventions are globally playing a significant role to combat coronavirus disease 2019 (COVID-19), which is an infectious disease caused by Severe Acute Respiratory Syndrome coronavirus 2. Here, we present a very brief overview of the multifaceted digital interventions, globally, and in India, for maintaining health and health-care delivery, in the context of the Covid-19 pandemic.