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 The rapid advancement of mHealth electronic and wireless data exchange through technology innovation places the onus on global regulatory and standards
organizations to adopt an execution plan to examine & expand current processes and procedures.

IMHSC's  Polylinguistic platform  facilitates real-time analytical metrics run on existing global regulatory requirements, standards, policies and legislation.


The International mHealth Standardization Consortium IMHSC is a global multidisciplinary non-profit organization created to spearhead the process to collaboratively align and develop Global mHealth Open Standards to support regional & global mHealth technology deployment optimization & interoperability across multiple data architectures & wireless exchanges of personal health information.

Universal mHealth Quality, Compliance & Auditing Program Development and Standardization streamlines processes, procedures, and work-flow requirements mandated by Global Regulatory Agencies & Standards Organizations.

mHealth Quality Programs are required and enforced by multiple global regulatory agencies.  Regulatory agencies enforce existing policies and are actively working to define & develop policies to support new mHealth resolution initiatives that pass through the legislation process. 
US regulatory agencies responsible for the oversight & enforcement of electronic, mobile & wireless technology exchanges of personal health information are:

FDA (Food & Drug Administration) Enforces Human Subjects Protection - Holds Industry responsible for establishing quality, compliance, auditing, documentation & training programs to support technology configuration systems requirements and protection of de-identified personal health information housed in Electronic Computerized Systems used in Clinical Trials. 

FTC (Federal Trade Commission)
The FTC enforces a variety of federal antitrust and consumer-protection laws.  FTC’s authority extends to the Internet.  FTC also enforces the Children’s Online Privacy Protection Act (COPPA ) that gives parents control of what information is collected from their children online – it also applies to operators of sites exchanging PHI through wireless internet web-based mHealth applications collecting or exchanging personal information of children under 13.  FTC Privacy Protection

FCC (Federal Communications Commission)
It is the policy of the FCC to ensure the accuracy and protect the  privacy of every individuals whose protected information is stored in commission systems or records. FCC regulates interstate and international communications by radio, television, wire, satellite, and cable in the U.S. Although the FCC doesn’t regulate the Internet or Internet service providers, it’s responsible for enforcing the Children's Internet Protection Act (CIPA). The FCC and FDA have formed a MOU where new initiatives are under review to support emerging mHealth technologies. FCC Wireless Telecommunication Bureau Rules & Regulations

FCC ID numbers are displayed on telecommunications devices and indicate that the device has received a grant of authorization from the FCC. Manufactures of devices that posses the potential to cause radio frequency interference to other devices are required to meet the FCC technical requirements which may include the granting of an FCC ID number. The rules, located in 47 CFR 2.803 and 47 CFR 2.1204, require that most devices be authorized before they can legally be imported or sold in the USA.

FCC Telecommunications Labeling Requirements

HHS (Health & Human Services) Policies require inter-agency operating divisions to perform PIA (Privacy Impact Assessments) including Centers for Disease CDC, Centers for Medicare & Medicaid (CMS), National Institutes of Health (NIH), Office of the Inspector General (OIG), Indian Health Service (IHS) Regulations

HHS Health Text Message Recommendations

HHS Health Text Messaging Recommendations
CMS (Centers for Medicare & Medicaid Services) Regulations & Guidance

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