Mobile Health

If an mHealth system is intended to improve lifestyle behaviors and is marketed in sporting goods stores, it does not require FDA regulatory approval.

“If it is intended to improve lifestyle behaviors, and marketed in sporting good stores, it does not require FDA regulatory approval.”

Additional privacy and confidentiality concerns arise when health-related data are sent to individuals' mobile devices for notification and intervention purposes.

“For notification and intervention purposes, additional privacy and confidentiality concerns arise when sending health-related data to an individuals’ mobile devices.16”

• cites [16] Kang HG, Mahoney DF, Hoenig H, In situ monitoring of health in older adults: technologies and issues. J Am Geriatr Soc 2010; 58(8): 1579– 86. 20646105Not checked yet

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In the United States, mobile handset ownership is higher among Latinos and African Americans than among whites, at 87% versus 80%.

“According to the Pew Internet and American Life Project11 mobile handset ownership in the U.S. is higher among Latinos and African Americans than among whites (87% vs 80%)”

• cites [11] Pew Research Center. Mobile Access 2010. www.pewinternet.org/Reports/2010/Mobile-Access-2010.aspx.Not checked yet

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The newness and variety of devices and platforms make it difficult to evaluate mHealth technologies.

“The newness and variety of devices and platforms contribute to the difficulty in evaluating mHealth technologies.”

If a similar system is intended to be part of what a healthcare provider prescribes for adults with type 2 diabetes, it becomes subject to FDA approval.

“However, if a similar system is intended to be part of what a healthcare provider prescribes for adults with type 2 diabetes, it then becomes subject to FDA approval.”

Health information technology companies are developing personalized health records that let individuals text information into their care plans and receive text messages from those records.

“Health information technology (HIT) companies are developing personalized health records (PHRs) where individuals can text information directly into their care plans and also receive text messages from their PHRs (e.g., Keas Inc.; www.keas.com).”

• cites www.keas.comNot checked yet

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Consumer demand, productivity and customer-service cost pressures, provider acceptance, and participation by major technology companies all contribute to a large increase in the availability of mobile devices that support mHealth.

“Consumer demand, the push to improve productivity and reduce costs for customer service, the increasing acceptance on the part of providers, and the participation of major technology companies such as Microsoft, Google, Intel, Qualcomm, Nokia, and Apple all contribute to a sea change of availability of mobile devices supporting mHealth.”

The rapid growth of smartphone medical and health/fitness apps shows that developers see a current market for mobile health.

“The rapid growth of smart phone medical and health/fitness apps demonstrates that developers see a current market for mobile health.”

The intended use of an mHealth system determines whether regulatory approval is required.

“The intended use of this system determines whether regulatory approval is required.”

At the joint workshop, the FDA and FCC formally agreed to work together to promote initiatives related to the review and use of FDA-regulated medical devices.

“FDA and FCC formally agreed “to work together to promote initiatives related to the review and use of FDA-regulated medical devices,”15”

• cites [15] Federal Communications Commission, and the U.S. Food and Drug Administration. Memorandum of understanding between the Federal Communications Commission and the Food and Drug Administration Center for Devices and Radiological Health. www.fcc.gov/Daily_Releases/Daily_Business/2010/db0726/DOC-300200A2.pdf.Not checked yet

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The FCC and FDA recently held a jointly sponsored workshop to begin providing appropriate clarification on regulatory requirements between the two agencies.

“FCC and FDA recently held a jointly sponsored workshop to begin the process of providing “appropriate clarification” on regulatory requirements between the two federal agencies.14”

• cites [14] Federal Communications Commission, and the U.S. Food and Drug Administration. Enabling the Convergence of Communications and Medical Systems Workshop. www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM219932.pdf.Not checked yet

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Disparities in access to mobile health are diminishing.

“The promising news about mobile health is that disparities in access are diminishing.”

• cites [11] Pew Research Center. Mobile Access 2010. www.pewinternet.org/Reports/2010/Mobile-Access-2010.aspx.Not checked yet

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Currently there is limited evidence on how well and under what circumstances mobile phones and other mobile or wireless devices compare with or improve current means of improving health and health care.

“there is currently limited evidence about how well and under what circumstances mobile phones (and other mobile/wireless devices) compare with or enhance current means to improve health and health care.8”

• cites [8] Patrick K, Griswold W, Raab F, Intille SS. Health and the mobile phone. Am J Prev Med 2008; 35(2): 177– 81. 18550322 PMC2527290 sourceNot checked yet

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