Urgent Need for Developing a Framework for the Governance of AI in Healthcare.

Lately, the application or integration of Artificial Intelligence in various areas of the Healthcare domain has been a prime attraction; this includes diagnostics, medicine/drugs, medical devices, interventions/procedures, imaging, therapies as well as treatment regimes, and these areas are in direct relation with the patient care, which is the core subject of the improvements envisioned through the implementation of AI. Although carrying this practice with a focused objective of improvisation in providing quality care, the overall concept of such implementations misses the governance path which can comply with any available regulatory environment, which unfortunately at this stage does not exist. As these implementations would have a direct impact on patients care, there is an urgent need to institute a robust governance and compliance framework in order to ensure the efficacy, safety, privacy, and ethical considerations. The onus of pioneering this initiative of building a governance framework for the implementation of healthcare artificial intelligence primarily rests with the Food and Drug Authority of the respective country, it is also important for this authority to further organizing the governance framework in agreement or collaboration with other international authorities.

Fundamentals of Implementing a National Clinical Registries Program.

A National registry program is a resource intensive initiative involving multiple stakeholders, multi-institutional/multi-role/multi-users collaborative effort, where various aspects starting from work culture, research culture, registry conceptualization, resource availability, data format, data storage/retrieval techniques, data sharing protocols, data/dataset standards, data quality etc. vary drastically between different institutions. The biggest challenge for a national program will be to map these aspects under a common umbrella to establish standards for operations/execution, policies and procedures, which means aligning the registry operations with the operative process of each institution at first, due to this only a handful initiatives are implemented with limited success, hence it is advisable to study such implementations in great details as a guideline to build a solid foundation for future national initiatives[1][2]. The idea goes around building a solid database for holding all clinical registries under a single repository, along with streamlining and generalizing the policies and procedures for any disease or medical device registry, in order to save infrastructure spending, streamlining, saving on management and operational costs and overheads.

Introducing a Research Management System to Speed Up and Streamline Clinical Research Activities.

Clinical Research is a complicated process within a research institution or a tertiary care hospital, almost all research project proposal needs to get an institutional review board (IRB) approval before any research activity takes place. IRB approval involves various processes, in form of sub-committees through which the proposal is reviewed. It is of utmost importance to understand the complete functioning of an IRB, in order to automate the various processes using a management system. The Research office entity forms the central body managing the IRB functions. It provides all sorts of administrative support as far as guidelines, documentation, communication and co-ordination is concerned; hence the research office forms the administrative wing of the IRB. Further the IRB has several sub-committees such as the Ethics Committee, Basic Research committee and the Animal Care and Use Committee. Each committee has a chairperson and several members from different specialty to cover all the aspects of research. Each committee may have its own process/workflow of approval, but usually the process of each committee is somewhat similar to each other. Apart from these workflows process the things that needs to be digitized would include researcher's profile, pre-award and post-award management, publication management, graduate student management and research analytics for the organization.