LS&HC Horizons 2022 - Flipbook - Page 23
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
23
Digital Health and AI
Software as a medical device and its regulatory treatment in Mexico
As part of the digital revolution in health care, software has become a
game-changing element in Mexico. Software is shifting how medical
services are provided, how health information is managed, how new
devices are developed, and how stakeholders of the industry interact.
It was not until December 2021 that the Mexican government
expressly included more clear guidance for software as a medical
device (SaMD).
SaMD is that used for medical purposes, which does not need to be
part of the hardware of the medical device. It is capable of running
on general computing platforms and can be used alone and/or in
combination with other software. Mobile applications meeting this
definition are also considered SaMD.
Ernesto Algaba
Partner, Mexico City
Validation (technical and analytical) requirements, more clear
requirements to be met in all stages of the device's lifecycle, good
documentation practices and principles associated with GMP and
risk management, are now contemplated as part of this regulatory
improvement.
Key risks and challenges include: Cybersecurity and Privacy matters
(to prevent and manage cyber risks); Managing of Health Data (i.e.,
use of sensitive information by non-health professionals); and Clear
and Complete Regulation (advocating for more developed regulations
and better governmental policies and consistent criteria by the
authority, and to converge with global principles).
Cecilia Stahlhut
Counsel, Mexico City
