A national evaluation analysis and expert interview study of real-world data sources for research and healthcare decision-making

Real-world data (RWD) can provide intel (real-world evidence, RWE) for research and development, as well as policy and regulatory decision-making along the full spectrum of health care. Despite calls from global regulators for international collaborations to integrate RWE into regulatory decision-making and to bridge knowledge gaps, some challenges remain. In this work, we performed an evaluation of Austrian RWD sources using a multilateral query approach, crosschecked against previously published RWD criteria and conducted direct interviews with representative RWD source samples. This article provides an overview of 73 out of 104 RWD sources in a national legislative setting with favourable RWD incentives, which can be used to extrapolate to other EU data regions under the General Data Protection Regulation (GDPR) and upcoming legislation such as the European Health Data Space Act (EHDS). We were able to detect omnipresent challenges associated with data silos, variable standardisation efforts and governance issues. Our findings suggest a strong need for a national health data strategy and governance framework, which should inform researchers, as well as policy- and decision-makers to improve RWD-based research in the healthcare sector to ultimately support actual regulatory decision-making and provide strategic information for governmental health data policies

mHealth und Arzneimittelsicherheit

Hintergrund: Hintergrund des vorliegenden Berichts ist das rasche und unübersichtliche Wachstum der Landschaft an Gesundheits-Apps. Ziel war es, einen Überblick darüber zu schaffen, welche Arten von Gesundheits-Apps es speziell im Arzneimittelbereich gibt, für wen diese relevant sind und welche Zugänge zur Qualitätsbewertung aktuell bestehen. *** Methoden: Neben "desk research"-basierten Literaturstudien betreffend relevante Initiativen und Regularien wurde eine systematische Recherche von Arzneimittel-Apps durchgeführt. *** Ergebnisse: Ergebnis der systematischen Arzneimittel-App-Recherche war eine aus 13 Kategorien bestehende Klassifikation von Arzneimittel-Apps nach Funktion und Nutzergruppe. Die Literaturarbeit ergab eine Überblicksdarstellung von Qualitätsbewertungsansätzen für solche Apps und aktuellen Entwicklungen im regulatorischen Umfeld u. a. in Deutschland. *** Schlussfolgerungen: Der Großteil der arzneimittelbezogenen Apps bedient den Aspekt der Arzneimittelinformation, oft in Verbindung mit Wechselwirkungschecks, Medikationsplänen mit Erinnerungsfunktion und den Angeboten einer Onlineapotheke. Es gibt jedoch eine kleine Anzahl von Apps, die speziellere Funktionen ins Auge fassen wie etwa die Arzneimittelidentifikation, die Dosierung, das Messen von Medikationseffekten oder das direkte Feedback an Hersteller. Es ist zu erwarten, dass die Medizinprodukteverordnung der EU vor allem im Bereich jener Apps, welche diese Funktionen bedienen, bedeutende Auswirkungen haben wird. Aus österreichischer Sicht stellt sich die Frage, ob und wie die Qualitätsbewertung von Gesundheits-Apps zu regeln ist bzw. welche Veränderungen in den Bereichen Marktzulassung und Erstattung nötig sein könnten

A national evaluation analysis and expert interview study of real-world data sources for research and healthcare decision-making

Real-world data (RWD) can provide intel (real-world evidence, RWE) for research and development, as well as policy and regulatory decision-making along the full spectrum of health care. Despite calls from global regulators for international collaborations to integrate RWE into regulatory decision-making and to bridge knowledge gaps, some challenges remain. In this work, we performed an evaluation of Austrian RWD sources using a multilateral query approach, crosschecked against previously published RWD criteria and conducted direct interviews with representative RWD source samples. This article provides an overview of 73 out of 104 RWD sources in a national legislative setting where major attempts are made to enable secondary use of RWD (e.g. law on the organisation of research, "Forschungsorganisationsgesetz"). We were able to detect omnipresent challenges associated with data silos, variable standardisation efforts and governance issues. Our findings suggest a strong need for a national health data strategy and data governance framework, which should inform researchers, as well as policy- and decision-makers, to improve RWD-based research in the healthcare sector to ultimately support actual regulatory decision-making and provide strategic information for governmental health data policies

The European health data space:Too big to succeed?

In May 2022, the European Commission issued the Proposal for a Regulation on the European Health Data Space (EHDS), with the aims of granting citizens increased access to and control of their (electronic) health data across the EU, and facilitating health data re-use for research, innovation, and policymaking. As the first in a series of European domain-specific "data spaces", the EHDS is a high-stakes development that will transform health data governance in the EU region. As an international consortium of experts from health policy, law, ethics and the social sciences, we are concerned that the EHDS Proposal will detract from, rather than lead to the achievement of, its stated aims. We are in no doubt on the benefits of using health data for secondary purposes, and we appreciate attempts to facilitate such uses across borders in a carefully curated manner. Based on the current draft Regulation, however, the EHDS risks undermining rather than enhancing patient control over data; hindering rather than facilitating the work of health professionals and researchers; and eroding rather than increasing the public value generated through health data sharing. Therefore, significant adjustments are needed if the EHDS is to realize its promised benefits. Besides analyzing the implications for key groups and European societies at large who will be affected by the implementation of the EHDS, this contribution advances targeted policy recommendations to address the identified shortcomings of the EHDS Proposal