FDA Mobile Medical Apps

FDA and Mobile Apps

HCS/490

Team B

Amy Bodea

Archie De Las Alas

Jason Sabado

Identity and Role of FDA

• Public Health Services
• Department of Health and Human Services
• Office of Commissioner
• Operations, medical products and Tobacco, Foods, Global, Regulatory Operations and Policy.

Can your phone do this?

Wireless Smart Gluco-Monitoring System

• Vitals Monitor- Thermometer-enabled smartphone that monitors temperature and tracks associated symptoms

• Sharing this information with a clinician can help influence need for further guidance

Overview

The iHealth Gluco-Smart App on the App Store. System measures and records glucose levels using a portable testing kit and a Bluetooth-enabled mobile device.

Steinhubl SR, Muse ED and Topol EJ. Can mobile health technologies transform health care? JAMA: 2013; 10.1001/jama.2013.281078.

Taken from: http://venturebeat.com/2013/10/30/ihealth-labs-new-app-enabled-glucose-monitor-brings-apple-like-sleekness-to-diabetics/

Withings Blood Pressure Cuff

Benefits for providers

Any Questions???

• Improved health care knowledge
• Tracking for better diagnosis with data
• Increase availability

Taken from: http://www.withings.com/en/bloodpressuremonitor

• Discuss FDA’s role in regulating mobile medical apps
• FDA's responsibilities
• Mobile Apps
• Advantages for consumer
• Advantages for provider
• How FDA regulating mobile apps may affect consumers choice in health care providers
• Cost for consumers
• Factors that contribute to the consumers choice of providers.
• Conclusion

Mobile Apps

Products and Services FDA Regulates

• Software Program
• Helpful
• Improving Health care
• Provides Guidance

• Safety and Regulation of Food
• Monitoring the different types of medication for safe use.
• Monitoring radiation and how it effects the public
• Governing laws regarding tobacco use

U.S Department of Health & Human Services. (2013)

Choices in Health care

Market place

U.S. Department of Health & Human Services. (2013)

It estimates that 95 million Americans, up 25% from last year, used their smartphones to find health information. Adoption of mobile solutions varied among patient groups (Elawad, n.d.).

What Are Mobile Apps?

Potential for Public Health

Surveillance

Convenient, personalized data and improved patient engagement

More time for provider-patient communication

Conclusion

The FDA defines mobile apps as “software applications that can be executed on a mobile platform…or a web-based software application that is tailored to a mobile platform but is executed on a server.”

References:

U.S. Food and Drug Administration. (2013, Sep 25). Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf

Factors for choice

of provider

• U.S. Food and Drug Administration. (2013, Sep 25). Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf
• Taken from: http://venturebeat.com/2013/10/30/ihealth-labs-new-app-enabled-glucose-monitor-brings-apple-like-sleekness-to-diabetics/
• Taken from: http://www.withings.com/en/bloodpressuremonitor
• Steinhubl SR, Muse ED and Topol EJ. Can mobile health technologies transform health care? JAMA: 2013; 10.1001/jama.2013.281078.
• U.S Department of Health & Human Services. (2013)
• U.S. Food and Drug Administration. (2013, Sep 25). Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf
• U.S. Department of Health & Human Services. (2013) U.S. Food and Drug Administration. Protecting Your Health. Retrieved from http://www.fda.gov/default.htm
• U.S. Department of Health & Human Services. (2013) U.S. Food and Drug Administration. Mobile Devices. Retrieved from http://www.fda.gov/default.htm
• Google image

NBC News Featuring Dr. Eric Topol