Mike Honda, the Democratic representative from California, plans to propose a bill establishing a new FDA Office of Mobile Health, according to Kaiser Health News. Honda feels that this is needed to support the mobile health industry.
The role of the office would be to:
- Make recommendations on mobile health application issues
- Create a developer support program to make sure that application developers are following HIPAA privacy regulations.
The FDA has already released a suggested set of guidelines for the regulation of mobile generic ventolin aerosol medical apps. If they don’t function as designed, FDA officials need to ensure the safety of patients.
This follows on the heels of the FDA Safety and Innovation Act that President Obama signed into effect establishing a commission of government agencies to formulate a plan for regulating mobile health apps.
The Commission’s report won’t be released until early 2014 or the end of 2013. We’ll keep you posted!