LS&HC Horizons 2023 - Flipbook - Page 25
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Privacy and Cybersecurity
25
The upcoming impact of the Data Act on medical devices
and health wearables
Following other EU digital initiatives focused
on boosting the potential of data, the Data Act
regulation (still a proposal) seeks to establish
rules on fair access to and use of data. Providers
of medical devices and/or health wearables that
obtain, generate, or collect data of users will
have to consider the Data Act, where the service
is placed in the EU, as it establishes a number
of new obligations on them.
Among others, the Data Act envisages the right
of users to have access to, and share, the data
originated from their use with third parties.
Such data may include information recorded
intentionally by the user, data generated as
a by-product of the user’s action (such as
performance data), and even those without any
action by the user (such as when the product is
in ‘standby mode’). Companies shall implement
appropriate mechanisms to enable the exercise
of such rights.
Santiago De Ampuero
Castellanos
Senior Associate, Madrid
The Data Act sets forth the obligation to
provide users with certain information before
the purchase, rent, or lease of the medical
device and/or health wearable, such as the
nature and volume of the data to be generated.
Additionally, as a result of its provisions on
interoperability, the Data Act will contribute
to more data being available, including for and
within the sectoral data spaces.
The Data Act is still in development and
companies will have time to get up to speed
(but should not relax too much...).
Juan Ramón Robles
Associate, Madrid
Joanna Rozanska
Associate, Madrid
