| 
 |
|
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
 |
