Against the backdrop of the growing use of digital technologies and artificial intelligence (AI)-based solutions in healthcare, COMBAT DR-TB project partners from Moldova and Tajikistan are examining the regulatory opportunities and barriers to the use of portable AI-enabled X-ray equipment for community-based TB screening and early detection.
As limited access to screening services in vulnerable communities and hard-to-reach areas contributes to late diagnosis and further transmission of the disease, community-based use of portable AI-enabled X-ray technologies is expected to contribute to:
- active screening in communities;
- early detection of presumptive TB cases;
- expanding services for vulnerable populations;
- reducing the burden on healthcare infrastructure.
However, the use of such technologies by civil society organisations (CSOs) may be constrained by a number of barriers, including:
- the regulatory framework governing medical devices and radiation safety;
- current licensing and permitting requirements;
- personal data protection legislation;
- the lack of clear regulation governing the use of AI in healthcare;
- institutional and operational constraints.
To examine the situation in greater detail, SMIT (Moldova) and KNCV Tajikistan have initiated a comprehensive analysis of the regulatory, legal and institutional frameworks governing the use of portable AI-enabled X-ray equipment by CSOs.
The main objective of the analysis is to identify existing regulatory barriers and develop practical recommendations for possible reforms or for creating an enabling environment for CSOs to introduce innovative technologies for TB screening and early detection.
The analysis will include:
- a desk review of the legal, regulatory and institutional frameworks governing the use of portable AI-enabled X-ray equipment, including the use of AI solutions in healthcare; CSO activities in the health sector; personal data protection; radiation safety; and licensing and permitting procedures;
- an assessment of existing practices in the use of portable AI-enabled X-ray equipment by CSOs, including the identification of legal, regulatory and administrative barriers and gaps;
- qualitative and quantitative components of the analysis;
- engagement with national and local stakeholders (e.g. NTPs, community organisations, patient groups, etc.) to validate the findings and ensure that the analysis reflects the current situation in the country, as well as country-specific limitations and contextual factors;
- consolidation of the findings into a comprehensive analytical report, followed by the presentation of the findings to a broad range of partners.
The analysis is being conducted with the support of TBEC as part of the regional COMBAT DR-TB project, funded by Unitaid.
