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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.

If regulatory agencies site major findings of deviations from requirements they will recall your mHealth app and/or product.

The regional and local expertise of standards organizations on a global scale are critical to the accelerated development of Global mHealth Open Standards. Although, for standards organizations who don't typically offer published openly available standards without membership, participation in an Open Standards development initiative might be considered challenging however, standards pertaining to mHealth constitute segmented and specific sets of applicable standards which could be submitted

Additionally, As regulatory and standards experts it is our responsibility to ACT. Just as our Commander in Chief so eloquently stated "What is required of us is a new era of responsibility. We must recognize that we have duties to ourselves, our nation, and the world." It's a fact that commercialized mHealth applications are being sold and actively used that are exchanging personal health data (PHI) hosted and warehoused on company servers without the required quality and regulatory programs, procedures, and documentation needed to be in compliance.

Just as regulatory agencies will hold both small and large mHealth technology corporations accountable for regulatory and standards deviations. As regulatory and standards experts, we are just as accountable in protecting the privacy of personal health information exchange, ensuring consumer and patient safety, and we must unite in an expedited global collaborative effort to provide mHealth innovators with standards, tools and guidance they need to integrate corporate and regulatory responsibility into their foundation to remain viable, drive shareholder value, and sustain innovation.

IMHSC recognizes that Global mHealth Open Standards mapped to regulatory requirements are required to protect the privacy of personal health information and to support and sustain mHealth technology innovation, adoption & implementation.

Since most global standards organizations have their information and publicly available standards published on Wikipedia IMHSC considers Wikipedia as the logical platform and as the central Polylinguistic repository for the analytical review, gap analysis and collaboration for the development and publishing of International mHealth Open Standards.

Phase One - Call to Action

IMHSC calls for worldwide convergence and open participation including individuals, public, and private industry, standards organizations, government, and non government regulatory agencies to select a member representative to continuously update standards, policies, legislation, cyberlaws, requirements, and best practice recommendations on Wikipedia.

Australia

SA - Standards Australia Through a Memorandum of Understanding with the Australian government SA is recognized as the peak non-government standards development in Australia. SA Wiki

Europe

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