The EU Data Act's HealthTech Impact
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The EU Data Act is a foundational piece of European Union legislation that significantly re-engineers HealthTech data governance, business models, and regulatory risk by mandating greater data access and sharing rights for users of connected products, including medical devices and health wearables.
The primary impact is a shift from the manufacturer's near-exclusive control over device-generated data to a user-centric model, promoting competition and innovation in the aftermarket for digital health services.
⚙️ Structural Re-engineering of HealthTech
The Data Act aims to unlock the economic value of Internet of Things (IoT) data by making it more accessible.HealthTech, which relies heavily on connected medical devices and wearables, is directly within its scope.
Data Governance and Access
The Act introduces an obligation for data holders (typically device manufacturers or service providers) to make data accessible to the user (the person or entity using the connected product) and, upon the user's request, to a third party.
User Rights: Users of connected medical devices (e.g., continuous glucose monitors, smart insulin pens, fitness trackers) have the right to access and share the data generated by their use of the product, including real-time and raw data, free of charge.
Data Holder Obligations: Manufacturers must design their products and related services to ensure data is accessible by default, and they must establish secure, machine-readable mechanisms for data access and sharing upon request.
Personal Data and GDPR: The Data Act complements, but does not override, the General Data Protection Regulation (GDPR). Since HealthTech data often includes sensitive personal health data, data sharing requests must still comply with GDPR, typically requiring the data subject's explicit consent for the lawful processing and sharing of their personal data.
Business Model Transformation
The shift in data access rights challenges the traditional business models of HealthTech manufacturers that have historically relied on exclusive control over device data for competitive advantage, aftermarket services, and monetisation.
The EU Data Act: A Structural Re-engineering of HealthTech Data Governance, Business Models and Regulatory Risk
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