EU Data Act Must Consider ‘Sectoral Peculiarities’ Says Medtech Industry
The European Commission’s proposed Data Act is among a growing pile of horizontal regulations set to impact the medtech industry. But changes should be made to protect trade secrets and other sector-specific nuances, MedTech Europe warns.
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While the European Health Data Space and its objectives should be a positive regulatory development for the EU health sector, DIGITALEUROPE stresses that the risk of counterproductive conflicts with other proposed laws around AI and data must be addressed.
The second half of 2022 has seen much debate and concern from EU medtech stakeholders around numerous proposed horizontal rules that will affect digital products. Changes in policies around AI, cybersecurity and data-sharing are likely to be an even bigger theme in 2023.
Several elements of the EU Data Act proposal will apply to the medical device industry. An expert researcher outlines where clarity is needed to prevent issues with interpretation, particularly in the fields of cybersecurity and data sharing.