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Posted on Nov 4, 2013 in Editorial | 0 comments

An Update on mHealth Regulation in the United States

Barbara A. Binzak Blumenfeld, PhD, JD1, William A. Garvin, JD1

1Counsels for Buchanan Ingersoll & Rooney PC

Journal MTM 2:3:1–3, 2013


In a previous issue of the Journal of Mobile Technology and Medicine, we provided an overview of the regulation in the United States of mobile health (“mHealth”) and mobile medical applications (“mobile medical apps”).1 On September 25, 2013, the United States Food and Drug Administration (“FDA”) released a Final Guidance for Industry and FDA Staff on Mobile Medical Applications (“Final Mobile Medical Apps Guidance” or “Final Guidance”).2 While the basic framework for regulating mobile medical apps in the United States has remained unchanged from our previous article, the new guidance provides further clarity that should be carefully considered by those developing mobile medical apps.

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Posted on Oct 27, 2013 in News | 0 comments

Devices and Apps Which Already Have FDA Approval

The FDA guidelines which were recently published have required FDA approval for certain types of apps and mobile attachments which are essentially designed to function as medical devices which would have otherwise required FDA clerance.  Here are some FDA approved programs which are a great model for future devices/apps.

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Posted on Sep 11, 2013 in News | 0 comments

Will Apple’s Touch ID Fingerprint Recognition Revolutionise mHealth Security?

With the announcement of Apple’s iPhone 5S, the new “Touch ID” fingerprint scanner represents an evolution in mHealth security.  As previously discussed in our Editorial over a year ago, one of the growing concerns around the use of mHealth are security issues.

Given the lack of clear guidelines, and poor support from hospitals, many clinicians have patient related information on their personal smartphones.  These can vary from clinical photos taken for documentation and communication with other clinical staff, to emails containing sensitive information.

With hardware encryption, enabled by default on many new smartphones, this means that lost phones cannot have data extracted from them without the correct passcode.  Together with a strong passcode and solid encryption, data on a lost phone is generally quite secure.  However the issue is that over 50% of smartphone users do not have a passcode enabled, and as such a lost phone with clinical data is a catastrophe.   Speaking to clinicians who were yet to enable passcodes on their mobile devices, the main reason was the simple hassle of typing in a passcode so often.

With the introduction of Apple’s Touch ID fingerprint recognition, there is no longer an excuse not to have a “passcode” (this time in the form of a fingerprint) on your smartphone.  The new Apple iPhone 5S has a fingerprint recognition module built into the “home” button on the iPhone.  After registering your finger print, simply touching the home screen button will unlock the device for you seamlessly.  Should the phone be lost, without your fingerprint, the contents of the device will be secure.

Healthcare workers now have a convenient, and highly secure way to protect clinical data on their smartphones.  Apple’s new Touch ID technology is a great step forward in the field of mHealth security, and will undoubtedly protect sensitive clinical information.

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Posted on Dec 3, 2012 in Conference | 0 comments

Satisfying Clinical Research Guidance and Regulations for mHealth Technologies

Brian Moyer1, Christopher Whalen1, Lisa Hoopengardner2, Yentram Huyen3, Katie Watkins2, Michael Holdsworth1, Jiwen Sun4, Kevin Newell2, Susan Vogel5, Ruma Das6, Alex Rosenthal3, Michael Tartakovsky3
1Research Data and Communication Technologies, Inc,
USA;  2Clinical Research Directorate/Clinical Monitoring Research
Program, SAIC-Frederick, Inc., Frederick National Laboratory for
Cancer Research, Maryland, USA; 3Office of Cyber
Infrastructure and Computational Biology, National Institute of
Allergy and Infectious Diseases, National Institutes of Health, USA; 4Dell Services, Federal Government, USA; 5Regulatory Compliance and Human
Subjects Protection Branch, Division of Clinical Research, National
Allergy and Infectious Disease, National Institute of Health, USA; 6Dell-PSGS – Efficiency
System Technology Inc. USA

Journal MTM 1:4S:33, 2012


The Office of Cyber Infrastructure and Computational Biology (OCICB) of the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH has been developing a solution that complies with current guidance frameworks and regulatory requirements while leveraging the potentials offered by mHealth technologies for data collection. OCICB has designed an mHealth solution that maps to the paper processes developed over the past century for clinical research. We designed the system for use in regions of low to middle-income countries where the patients often have no other clinical record. For our pilot, we selected a natural history study that does not have the same regulatory requirements as an Investigational New Drug (IND) study. We retained our existing paper-based clinical data capture management system in order to compare quality control reports between paper-based and mobile electronic capture methods. The solution complies with regulatory frameworks and requirements such as Good Clinical Practices and 21 CFR Part 11, which requires full audit trails of the data collection process at the source and the validation stages. It also provides the capacity for workflows that support the data validation process within the field research framework. We expect to show that the accuracy of data collection improves using mobile source data collection. This will reduce the time and cost of validating the collected data before final analysis for clinical research while maintaining the regulatory framework that protects patient interests. The solution will further provide clinical monitors with the ability to remotely access the source data and thus reduce the cost of travel for monitoring as well as reducing the impact on patients due to mistakes made while entering the data.

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Posted on Nov 30, 2012 in Conference | 0 comments

WelTel Retain: A randomized controlled trial protocol of a text-messaging intervention to improve patient retention in pre-antiretroviral therapy HIV care

Mia Van Der Kop1, DavidOjakaa2,Lennie Bazira2, LehanaThabane3,LilianMbau2,HelenGakuruh2 Koki Kinagwi2, Edward Mills4, Carlo Marra5, Richard Lester5,

1University of British Columbia Centre for Disease Control, Vancouver, Canada,  2 African Medical and Research Foundation, Nairobi, Kenya 3McMaster University, Hamilton,Canada4University of Ottawa, Ottawa, Canada5University of British Columbia, Vancouver,  Canada

Journal MTM 1:4S:1, 2012



High levels of patient retention after first clinical contact contribute to the timely initiation of antiretroviral therapy (ART) and better health outcomes. In Kenya (WelTel Kenya1), a weekly short message service (SMS) text message led to improved ART adherence and viral load suppression.

The objectives of this study are to: 1) determine if the WelTel intervention improves retention in Stage 1 HIV care (patient receives CD4 count results); 2) determine whether the WelTel intervention improves 12-month retention; and 3) evaluate the cost-effectiveness of the WelTel intervention.

A randomized controlled trial will be conducted at the Kibera Community Health Centre in Nairobi, Kenya. Over one year, HIV positive individuals newly enrolling at the clinic will be recruited and randomly allocated to an intervention or control arm (standard care) at a 1:1 ratio. Intervention arm participants will receive a weekly SMS ‘check-in’ to which they will be required to respond within 48 hours. An HIV clinician will follow-up and triage any problems that are identified. Patients will be followed for one year, with a primary endpoint of retention in care at 12 months.

This study is in a pre-enrolment phase; a recruitment target of 686 participants provides 80% power to detect a proportionate difference of 15% in the primary outcome (alpha=0.05). Data will be analyzed according to intention to treat principles. Chi-squared tests will be used for categorical outcomes; and t-tests or Mann-Whitney U tests for continuous outcomes.

The WelTel Retain trial will contribute important information on the effectiveness of an established mHealth intervention to engage patients in care during the first year of HIV care, before initiating ART. Trial results and cost-effectiveness evaluation will inform how WelTel might contribute to the long-term success of PEPFAR-funded programs and towards a sustainable global HIV/AIDS response

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