About this Research Topic

Background

The current state of healthcare continues to be challenged by the massive growth and diversity of healthcare products such as medicines and devices, services, processes, protocols, clinical trials, and massively generated data (including big data) through internal and external systems. Coupled with such massive diverse growth is the diversity of stakeholders of healthcare personnel and experts involved in the regulation of healthcare in general, and medicines, devices, and services. This alludes to massive growth in the exchange of knowledge and information taking place amongst stakeholders involved in the healthcare life cycle that is beyond the boundaries of just one healthcare organization and regulatory bodies. Processes that involve the exchange of regulatory information and knowledge need to be precisely, rigorously, timely, consistently, and completely adhered to. Architecting such processes and linking them to regulatory healthcare requirements demand bridging the gap between such regulatory-linked processes on the one hand and their enactment in the respective IT systems of healthcare care organizations and regulatory bodies nationally, regionally, and internationally, on the other hand.

The present Research Topic aims to highlight state-of-the-the-art research work in process-based and informatics-enabled regulatory healthcare. This collection will hopefully offer not only substantive body of knowledge to policy- and decision- makers in regulatory healthcare. It also provides timely rigorous insights into bridging gaps in the current practices of regulatory healthcare (through modelling, designing, implementing, and evaluating regulatory healthcare processes) driven by informatics methods, tooling and frameworks including Artificial Intelligence (AI) and data analytics. Addressing of legal, social, ethical, and professional issues and their impact on modelling regulatory healthcare processes is a further primary anticipated objective of this journal special topic issue to inform for example: (1) compliance to: good clinical practice, good pharmacovigilance practice, and good medicine manufacturing practice within a highly virtual automated organization; (2) linking regulatory processes with all parties involved in the exchange of information and knowledge in relation for example to (but not limited to) clinical trials, pharmacovigilance, diverse healthcare services and products.

This Research Topic aims to accept research articles within the areas listed below. Submitted abstracts/articles with variations from the scope of these areas may be considered for review, if they fit within the main journal’s special topic theme:

• Frameworks and/or approaches to bridging gaps between regulatory healthcare processes and their enactment in the respective information systems.

• Regulatory frameworks for modelling of the workflows of laboratory functional areas such as serology, chemistry, molecular testing, etc.

• Process architecture and workflow modelling of healthcare processes linked to regulatory requirements.

• Data-driven process improvement of regulatory healthcare processes.

• Process and information modelling of pharmacovigilance processes.

• Modelling of cell therapy, organ transplantation and transfusion processes linked with legal, social, ethical, and professional requirements.

• Approaches to attending to regulatory challenges posed by AI and processes of biological data analytics and medical liability,

• Approaches to capturing and managing regulatory processes and information requirements of clinical trials of complex diseases (such as cancer and others).

• Process and workflow modelling of Institution Review Board (IRB) processes and quality requirements through automation frameworks and systems.

• Methods and/or frameworks for automating the reporting of risk management of healthcare products, devices and services reporting to national, regional, and international regulatory networks.

• Approaches to safety-driven monitoring of healthcare processes, and products during the patient journey. Methods and frameworks for automating the governance of regulatory processes of healthcare including evidence-based clinical practice guidelines.

Keywords: Regulatory Healthcare, Regulatory Medicine, Process-based Regulatory Healthcare, Data Analytics in Healthcare, Workflow Modelling of Healthcare, Regulatory Healthcare Frameworks

Important note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

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