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mHealth innovation converges data exchange between EMR/EHR's, clinical informatics, wireless mobile devices, and the Internet all of which are heavily regulated by multilateral global agencies responsible for enforcing legislation and guidelines. �

A large majority of mHealth innovators have computer science and technical backgrounds, and while familiar with software / hardware engineering, FTC/ FCC regulations and applicable standards, many are unaware how heavily regulated and different the health IT space is. �Until mHealth technology emerged, electronic medical records, and health systems had regulatory oversight �by separate agencies and applicable standards (HHS oversight,HL7 standards) than computerized systems used in clinical trials such as electronic data capture (EDC), electronic trial master files (eTMF) and eRegulatory Systems�(FDA oversight,CDISC standards). �

All regulatory agencies listed above mandate that standard operating procedures (SOP) mapped to industry standards and regulatory requirements has to exist and be documented for every step of the software development lifecycle (SDLC) and all operational business processes, procedures, training, and workflow. Additionally, documentation has to exist to prove that these specified requirements were followed.

There are additional regulations and standards requirements placed on mHealth companies if hosting or data warehousing any data exchange containing personal health information (PHI) or a if medical device is part of the mHealth technology product offering a complete new set of dynamic regulatory requirements and standards apply that differ in each Country.

While overlap of oversight occurs between US government agencies responsible for overseeing and enforcing mHealth technology sectors, once you know who they are, it's fairly easy for mHealth innovators to access and navigate the websites of the various agencies and access, identify and download regulatory requirements and guidelines applicable to mHealth. The same goes for regulatory agencies outside the US (OUS)�Most of the sites have incorporated RSS feeds allowing mHealth innovators to be apprised of any changes or new requirements.

It's imperative that mHealth innovators perform regulatory and standards requirements due diligence while still in the product development commercialization planning stage, and certainly prior to actually developing an mHealth technology or application as the regulatory requirements will have a direct impact on the functional specifications, manufacturing, target market sector and commercialization plans, and business operational processes.�

Why is this important? �Because regulatory agencies audit. �

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