Life Sciences Horizons Brochure 2025 - Flipbook - Page 25
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2025 Horizons Life Sciences and Health Care
EU Data Act: Connected devices and data sharing obligations
The EU Data Act (“Regulation (EU) 2023/2854”)
introduces new changes for manufacturers of
connected medical devices and wearable health
products that collect or produce data from the user
or their environment. The Act aims to put users of
connected products in control of their data and allows
them to access and share data generated by these
products. This includes data entered by users and
data created or collected by the device, whether in
active use or in standby mode. However, the EU Data
Act will not require companies to share data that
has been processed or analyzed to create new
information, such as health conclusions generated
by software.
Manufacturers will be required to design connected products and
services in a way that ensures data generated by their use is easily
accessible to users. Upon the user's request, manufacturers will
have to provide this data to the user or to a third party chosen by
the user. Third parties will only be able to use the data for
purposes and under conditions agreed upon with the user. Users
and third parties may not use the data to develop products that
compete with the original product or to derive insights about
the economic situation, assets, and production methods of
the manufacturer.
To navigate these changes effectively, manufacturers must take
a proactive and strategic approach. As a first step, we advise to:
Perform an impact assessment and gap analysis to assess
the impact on the manufacturer’s business, products, policies
and procedures.
Develop or expand existing data governance framework
to ensure compliance and optimized data use.
Update existing design and development strategies to
ensure that connected products are designed in such a way that
product data and related data are by design directly accessible
to users.
Develop or expand existing trade secret protection
strategies and data use and sharing strategies to ensure
appropriate technical and contractual safeguards are in place
to protect trade secrets and confidential business information
and to safely share data with users and third parties.
The EU Data Act entered into force on 11 January 2024, with
most provisions becoming applicable from 12 September 2025.
Manufacturers placing connected medical devices and health
wearables on the EU market are advised to assess their obligations
under the EU Data Act and take steps to work towards compliance.
Fabien Roy
Partner
Brussels
Chantal Van Dam
Counsel
Amsterdam
Hélène Boland
Senior Associate
Brussels
