Stephen Gilbert

Real-time high-quality data on the performance of digital health applications is needed for feedback-led optimization and to ensure safety and performance, particularly if they will have on-market updates. Developers must verify that applications accurately and consistently fulfill their intended purpose in real-world use. In particular, new thinking from regulators recognizes the importance of monitoring real-world performance. It is acknowledged that real-world data can deliver information… Mehr anzeigen

Real-time high-quality data on the performance of digital health applications is needed for feedback-led optimization and to ensure safety and performance, particularly if they will have on-market updates. Developers must verify that applications accurately and consistently fulfill their intended purpose in real-world use. In particular, new thinking from regulators recognizes the importance of monitoring real-world performance. It is acknowledged that real-world data can deliver information from wider patient populations than are generally included in controlled studies, and in certain circumstances, this can enable extensions of the application’s intended purpose. Proactive postmarket surveillance surveys are an important source of real-world data that are distinct from clinical investigations but may vary in quality and, if inappropriately designed, can be subject to uncontrolled bias. We aimed to describe the practice of real-world data gathering through patient-reported and clinician-reported outcomes and high-quality surveys and identify challenges, uncertainties, and health policy gaps. Weniger anzeigen

Chatbots powered by artificial intelligence used in patient care are regulated as medical devices, but their unreliability precludes approval as such.

Artificial intelligence (AI) and machine learning medical tools have the potential to be transformative in care delivery; however, this change will only be realized if accompanied by effective governance that ensures patient safety and public trust. Recent digital health initiatives have called for tighter governance of digital health. A correct balance must be found between ensuring product safety and performance while also enabling the innovation needed to deliver better approaches for… Mehr anzeigen

Artificial intelligence (AI) and machine learning medical tools have the potential to be transformative in care delivery; however, this change will only be realized if accompanied by effective governance that ensures patient safety and public trust. Recent digital health initiatives have called for tighter governance of digital health. A correct balance must be found between ensuring product safety and performance while also enabling the innovation needed to deliver better approaches for patients and affordable efficient health care for society. This requires innovative, fit-for-purpose approaches to regulation. Digital health technologies, particularly AI-based tools, pose specific challenges to the development and implementation of functional regulation. The approaches of regulatory science and “better regulation” have a critical role in developing and evaluating solutions to these problems and ensuring effective implementation. We describe the divergent approaches of the European Union and the United States in the implementation of new regulatory approaches in digital health, and we consider the United Kingdom as a third example, which is in a unique position of developing a new post-Brexit regulatory framework. Weniger anzeigen

Mobile apps are the primary means by which consumers access digital health and wellness software, with delivery dominated by the ‘Apple App Store’ and the ‘Google Play Store’. Through these virtual storefronts Apple and Google act as the distributor (and sometimes, importer) of many thousands of health and wellness apps into the EU, some of which have a medical purpose. As a result of changes to EU law which came into effect in May 2021, they must now ensure that apps are compliant with medical… Mehr anzeigen

Mobile apps are the primary means by which consumers access digital health and wellness software, with delivery dominated by the ‘Apple App Store’ and the ‘Google Play Store’. Through these virtual storefronts Apple and Google act as the distributor (and sometimes, importer) of many thousands of health and wellness apps into the EU, some of which have a medical purpose. As a result of changes to EU law which came into effect in May 2021, they must now ensure that apps are compliant with medical devices regulation and to inform authorities of serious incidents arising from their use. The extent to which these new rules are being complied with in practice is uneven, and in some areas unclear. In light of EU legislation related to competition, which came into effect in November 2022, it is also unclear how conflicts of interest can be managed between Apple and Google’s roles as gateway duopoly importers and distributors whilst also developers of their own competitive health products. Finally, with the proposed European health data space regulation, wellness apps will be voluntarily registered and labelled in a fashion more like medical devices than consumer software. We explore the implications of these new regulations and propose future models that could resolve the apparent conflicts. All stakeholders would benefit from improved app store models to sustainably evolve safer, better, and fairer provision of digital health applications in the EU. As EU legislation comes into force it could serve as a template for other regions globally. Weniger anzeigen