Tag: EU Regulation
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EU Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies
Why Early Feasibility Studies Matter for Digital Health Technologies in Europe Digital health technologies (DHTs)—including mobile apps, telemedicine platforms, wearables, and software-based clinical decision aids—are increasingly regulated as medical devices when their intended use involves diagnosis, prevention, or treatment. With rising expectations for robust clinical evidence and iterative software updates, early feasibility studies (EFSs) emerge…
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Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: A Qualitative Interview Study
Introduction Digital health technologies (DHTs) span mobile apps, telemedicine, wearables, and software for clinical decision support. As regulation and validation evolve, early feasibility studies (EFSs) have emerged as a potential way to gather real-world, human-centered data early in development. This article summarizes stakeholder insights from a qualitative study conducted across EU digital health companies and…
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IBAN Verification and October EU Changes: What Changes This Month
VoP Verification of Payee: What Changes for Euro Transfers As October arrives, a wave of EU-wide updates takes effect, with the Verification of Payee (VoP) sitting at the center of banking changes. From 9 October, banks and savings banks across the euro area must compare the recipient’s name with the IBAN before executing a euro…
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VoP IBAN Verification and October EU Regulatory Updates
October brings a mix of EU-wide banking rules, digital health measures, and seasonal adjustments that touch households and businesses alike. Foremost among them is the introduction of Verification of Payee (VoP) for euro transfers, a move intended to reduce errors and curb fraud. Alongside this, banks must ensure real-time euro transfers can be sent free…
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Apple Seeks EU Repeal of Digital Markets Act
Overview of Apple’s Position on the DMA Recently, Apple has made headlines by urging the European Union (EU) to repeal the Digital Markets Act (DMA), a landmark regulation aimed at curbing the dominance of major tech companies. Effective from March 2024, this regulation is designed to ensure fair competition in the digital marketplace, but Apple…
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Apple Calls for Revocation of EU Digital Markets Act
Introduction In a significant move, Apple has urged the European Union (EU) to reconsider and ultimately revoke the Digital Markets Act (DMA), which is set to be implemented in 2024. This regulation aims to curb the monopolistic practices of tech giants and ensure fair competition in the digital marketplace. However, Apple argues that this legislation…
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New EU Regulation Excludes Tech Giants from Financial Data Access
Introduction to the New EU Financial Data Regulation After years of negotiations, the European Union is nearing the finalization of the Financial Data Access (FiDA) regulation. This legislation aims to facilitate easier access to financial data for third-party entities, particularly benefiting local banks and financial institutions. Recent reports indicate that major U.S. tech companies, such…
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EU’s Financial Data Access Regulation: A Major Shift in Tech’s Influence
Introduction to the Financial Data Access Regulation After years of negotiations, the European Union is on the brink of finalizing the Financial Data Access (FiDA) regulation. This new legislation aims to reshape the financial landscape by making it easier for third-party entities to access financial data held by banks and insurance companies. However, it appears…
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EU’s Financial Data Access Law: A Shift in Power Dynamics
Introduction to the Financial Data Access Regulation The newly proposed EU regulation, known as Financial Data Access (FiDA), marks a significant shift in how financial data can be accessed and shared among various stakeholders in Europe. After years of negotiations, this regulation aims to streamline access to financial data held by banks and insurance companies,…