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1 www. medtecheurope .org The Value of Diagnostic Information (VODI) A broader concept of v alue for diagnostics Innovation in healthcare is a driving force in the quest to balance cost containment and health care quality 1 ,2 . In value - based healthcare systems, choices among innovative medical technologies such as novel in vitro diagnostics would be based on the overall value provided to different stakeholders – including patients - while decisions on coverage and uptake would be based on that value rather than only on the costs 2 . The concept and measurement of value for diagnostic technologi es is different than for therapeutics. Diagnostics can be considered complex interventions 3 as they provide information that can influence a range of possible outcomes (effects) 4 according to the perspective taken: patient clinical benefit as well as socie tal gains of early detection and prevention of advanced disease, value of knowing for individual patients, economic savings and/or improved resource efficiencies for health care institutions and/or health systems, improved management of patient flow from t he perspective of health care providers, among others. That information has value (can be actionable) by enabling the different users to make decisions on the expected best course of action with less uncertainty. Many interacting contextual factors play a key role when determining the consequences of diagnostic information, such as the availability of therapeutic options in the different care pathways. This means that in order to capture the full value of diagnostic information, and appropriately take into account what matters to patients and to society, HTA assessors and decision makers should consider the full range of consequences or usefulness of diagnostic information beyond the clinical domain, including its impact on patient relevant outcomes, use of resources from a health system perspective, considering how that utility vary among different users, in different health care pathways and settings, and over time. Interested in exploring the full potential of diagnostic information to improve societal as well as individual health outcomes in a sustainable way 5 , an international multi - stakeholder partnership 6 platform has gathered to cooperate in this field. As we believe it is necessary to define relevant and pragmatic outcomes to measure, assess and rewar d valuable innovative diagnostics, as a first step to ensure they effectively and equally reach the patients and health systems that can benefit from them 7 , we have agreed to cooperate in the building, advancement and recognition of the value of diagnostic information in all its dimensions. As an initial milestone, the VODI platform has produced a concept paper on the value of diagnostic information, highlighting the need to consider a wider concept of clinical utility of diagnostic tests, comprising multip le dimensions of value and multiple outcome measures, relevant for decision making. 1 Omachonu V. Innovation in Healthcare Delivery Systems: A Conceptual Framework. The Innovation Journal: The Public Sector Inno vation Journal, Volume 15(1), 2010 2 Lee D. Understanding the Medical and Nonmedical Value of Diagnostic Testing. Value in Health Volume 13, Issue 2, pages 310 – 314, M arch/April 2010 3 Petticrew M. Complex interventions and their implications for s ystematic reviews: a pragmatic approach.Journal of Clinical Epidemiology. Vol 6, issue 11. 2013. 4 Medical Research Council UK .Developing and interpreting complex interventions. New guidance.2006. 5 Garber A, Goldman DP, Jena AB. The promise of health care cost containment. Health Aff (Millwood) 2007;26:1545 – 7. 6 Members of the VODI Platform: comple te with the participants who have signed the charter 7 Porter M. What is Value in Health Care? N Engl. J Med. 363:26, 2010