Real-world data (RWD) collected in routine health care processes and transformed to real-world evidence have become increasingly interesting within the research and medical communities to enhance medical research and support regulatory decision-making. Despite numerous European initiatives, there is still no cross-border consensus or guideline determining which qualities RWD must meet in order to be acceptable for decision-making within regulatory or routine clinical decision support. In the absence of guidelines defining the quality standards for RWD, an overview and first recommendations for quality criteria for RWD in pharmaceutical research and health care decision-making is needed in Austria. An Austrian multistakeholder expert group led by Gesellschaft für Pharmazeutische Medizin (Austrian Society for Pharmaceutical Medicine) met regularly; reviewed and discussed guidelines, frameworks, use cases, or viewpoints; and agreed unanimously on a set of quality criteria for RWD. This consensus statement was derived from the quality criteria for RWD to be used more effectively for medical research purposes beyond the registry-based studies discussed in the European Medicines Agency guideline for registry-based studies. This paper summarizes the recommendations for the quality criteria of RWD, which represents a minimum set of requirements. In order to future-proof registry-based studies, RWD should follow high-quality standards and be subjected to the quality assurance measures needed to underpin data quality. Furthermore, specific RWD quality aspects for individual use cases (eg, medical or pharmacoeconomic research), market authorization processes, or postmarket authorization phases have yet to be elaborated.

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It has become a trope to speak of the increasing value of health data in our societies. Such rhetoric is highly performative: it creates expectations, channels and justifies investments in data technologies and infrastructures, and portrays deliberations on political and legal issues as obstacles to the flow of data. Yet, important epistemic and political questions remain unexamined, such as how the value of data is created, what data journeys are envisioned by policies and regulation, and for whom data types are (intended to be) valuable. Drawing on two empirical cases, (a) interviews with physicians on the topic of digital selfcare, and (b) expectations of stakeholders on the use of Real-World Data in clinical trials, as well as existing literature, we propose a typology of what health data help us to do. This typology is intended to foster reflection about the different roles and values that data use unfolds. We conclude by discussing how regulation can better accommodate practices of valuation in the health data domain, with a particular focus on identifying regulatory challenges and opportunities for EU-level policy makers, and how Covid-19 has shed light on new aspects of each case.

Purpose-The purpose of this paper is to discuss the prospects of a Southeast Asian knowledge economy in light of regional integration processes and the participation of Southeast Asia in global innovation networks. Design/methodology/approach-The evidence base is a combination of quantitative data on R&D investments, patent applications and publications, with qualitative data from 40 semi-structured expert interviews conducted with innovation experts, research managers and policymakers in six ASEAN Member States. Findings-Despite economic growth and increases in R&D inputs and outputs in individual ASEAN Member States, innovation policy at regional ASEAN level remains weak. In addition, the economic integration of the ASEAN Economic Community is progressing slowly. In this environment, evidence is presented for a certain level of regional integration when it comes to the exploitation of knowledge produced within and outside of ASEAN. While a regional market for knowledge exploitation is conceivable, this is not accompanied by the regional integration of knowledge production. Practical implications-The main practical implication of this argument is the need for ASEAN policymakers to appreciate the disconnection between regional knowledge production and exploitation. This paper offers conceptual tools to engage in ASEAN-level policy discussions on this issue that can help facilitate the best possible regional outcome. Originality/value-Despite several studies on the ASEAN Economic Community process, there has been no contribution so far that combines a discussion of the economic integration process with a look at the regional knowledge economy and innovation systems. This perspective does not only contribute to innovation systems literature, but also entails important policy lessons.