The Journal of mHealth Vol 1 Issue 5 (Oct 2014) | Page 38

The Evolving US mHealth Regulatory Landscape
Continued from page 35

law in the United States, but they demonstrate the evolving nature of the regulatory landscape. Similar developments can
be expected in the near-term in Europe.
In the meantime, the general consensus
is that companies in the clinical software
and mobile medical apps industry should
follow the final guidance recently published by the FDA with respect to regulation of their products.
Conclusion
The regulatory framework for the
mHealth market and broader health
IT industry is dynamic and continues
to evolve. So does technology. Many
mHealth and health IT products are
part of complex, interconnected systems which require a refined regulatory
approach. Companies in or close to the
health IT space should closely monitor
the final FDASIA Report and the draft
guidance, as well as the release of additional guidance from the FDA. Having
a thorough understanding of the current
environment is essential to developing

The mHealth Regulatory Coalition was
formed in 2010 with the purpose of
ensuring that the regulatory environment for mHealth technologies allows
for innovation while at the same time
protecting patient safety. The coalition
serves as a thought-leader in the mHealth
ecosystem to provide expertise on which
mHealth technologies should be regulated and how they should be regulated.

lation, including the agency’s reach
into: Apps used for wellness; Low
risk generic IT accessories; Pharmaceutical-related apps; and, Generic
software modules used as parts of
medical software programs.
»» Improving the regulatory environment for those apps subject to FDA
oversight, including: Moderating
the quality system requirements for
app development; identifying a clear
pathway for FDA clearance; creating
a hassle-free way to keep software
up-to-date.
»» Expanding these frameworks to coordinate with other regions around
the world.

The coalition focuses on a number of
issues relevant to the mHealth regulatory
framework, including:

For more information on the mHealth
Regulatory Coalition please visit www.
mhealthregulatorycoalition.org.

»» Participating in the legislative process
to tackle the big