The World Health Organization is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.
Aims and challenges
Availability of low-cost and robust point-of-care (PoC) diagnostics that are suitable for remote health care centres in low- and middle-income countries (LMICs) would facilitate surveillance and identification of etiological agents (and/or biological responses) as well as guide decisions for timely and appropriate treatment, response, and reporting. Such tools will also contribute to the fight against antimicrobial resistance of many infectious pathogens, due to misuse of antibiotics, antivirals and anti-parasitic drugs in the absence of a clear diagnosis. New affordable diagnostics are also needed for non-communicable diseases. One approach towards such diagnostic tools would be to facilitate, through the adoption of appropriate standards, the development of multipurpose PoC diagnostic devices.
WHO is thus organizing a global consultation on diagnostic standardization (including the development and adoption of device to device and device to Electronic Health Records standards) with the goal of defining what level of standardization would be desirable, what types of standards should be employed for the development of diagnostic devices (particularly PoC and multipurpose), what challenges diagnostics manufacturers would encounter if such standards were adopted, and what would be required to overcome those challenges (including new business models and financial incentives). This consultation could pave the way for the development of standards for PoC diagnostics, should participants agree that this approach should be investigated further.
The objective was to:
- finalize the scope of the meeting
- identify the major skateholders
- explore feed-back and contribution of the major skateholders
- set up the internation committee
- map out similar activities in the area of standards for diagnostics
- propose business models
- develop agenda for the global meeting
- participate to the consultation
- Prepare the next steps of the consultation:
- Creation of a working group to identify each interoperability standards that need to be developed/adopted.
- Creation of a working group to propose and develop new business models for supporting industry in implementing new multipurpose (open) diagnostic platforms for local health care centres in LMICs.
- Creation of an open consortium including diagnostic companies and other relevant stakeholders to develop the new diagnostic platforms based on agreed standards and new business models.