European Council of Medical Orders

Adoption of the CEOM Statement on the use of mobile health (mHealth) in the European Union

The European Council of Medical Orders adopted during its plenary meeting in Luxembourg the CEOM Statement on the use of mobile health (mHealth) in the European Union. It underscores the deontological aspects which have to be considered during the reflection on mobile health.

  1. A European legal framework should be provided for all mHealth applications and connected objects (including applications and connected objects related to the way of life and the well-being of people) which do not fall within the scope of the European medical device regulations in order to provide possible restrictions on their marketing based on the risks they would mean for human health and safety.
  2. A high level of health and safety protection must be guaranteed to the patient whose medical support (diagnosis, patient's treatment and monitoring) is conducted by mHealth tools that are not medical devices as defined in the European legislation.
  3. Public and regulatory authorities (both national and European) implementing policies that promote the use of mHealth devices commit to ensure public health through technical and technological security measures, and informational measures.
  4. While providing medical support, the physician uses certified mHealth technologies, when their use is medically justified and motivated by the patient's interests.
  5. The patient's rights as a user of mHealth applications to his personal data protection, particularly those related to his health, must be respected by developers, suppliers and sellers so that appropriate safeguards are implemented.