Health and Health-Related Connected Objects: Regulatory Intersections, Grey Zones and Blind Spots

Area of Science:

• Health Law
• Data Privacy Law
• Regulatory Compliance

Background:

• Connected objects generate vast amounts of health data.
• The EU legal framework for health data is fragmented.
• Recent legislation like the European Health Data Space (EHDS) Act adds complexity.

Purpose of the Study:

• Analyze the EU legal framework for connected health objects and data.
• Identify legal uncertainties and gaps in current regulations.
• Evaluate the adequacy of existing safeguards from a patient-centric perspective.

Main Methods:

• Legal analysis of EU regulations (EHDS Act, GDPR, MDR, Data Act, AI Act).
• Examination of intersections between various legal instruments.
• Focus on data quality, device acceptability, data access, and privacy.

Main Results:

• The EU legal framework is characterized by complex intersections and grey zones.
• Existing regulations and certification mechanisms offer insufficient protection.
• The current framework is overly complex, cumbersome, and opaque for health sector users.

Conclusions:

• Current regulatory safeguards for connected health objects and data are inadequate.
• The legal framework fails to adequately address user needs in the health sector.
• A simplified, more transparent, and user-focused regulatory approach is needed.