The Journal of mHealth Vol 1 Issue 1 (Feb 2014) - Page 23

FDA Issues Final Guidance on Mobile Medical Apps • • • • • • • Mobile apps that provide patients a portal into their own health information, such as access to information captured during a previous clinical visit or historical trending and comparison of vital signs (e.g., body temperature, heart rate, blood pressure, or respiratory rate); Mobile apps that aggregate and display trends in personal health incidents (e.g., hospitalisation rates or alert notification rates); Mobile apps that allow a user to collect (electronically or manually entered) blood pressure data and share this data through e-mail, track and trend it, or upload it to a personal or electronic health record; Mobile apps that provide oral health reminders or tracking tools for users with gum disease; Mobile apps that provide prediabetes patients with guidance or tools to help them develop better eating habits or increase physical activity; Mobile apps that display, at opportune times, images or other messages for a substance abuser who wants to stop addictive behavior; Mobile apps* that are intended for individuals to log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness, such as those that: » Provide tools to promote or encourage healthy eating, exercise, weight loss or other activities generally related to a healthy lifestyle or wellness; » Provide dietary logs, calorie counters or make dietary suggestions; » Provide meal planners and recipes; » Track general daily activities or make exercise or posture suggestions; » Track a normal baby’s sleeping and feeding habits; » Actively monitor and trend exercise activity; » Help healthy people track the quantity or quality of their normal sleep patterns; » Provide and track scores from mind-challenging games or generic “brain age” tests; » Provide daily motivational tips (e.g., via text or other types of messaging) to reduce stress and promote a positive mental outlook; » Use social gaming to encourage healthy lifestyle habits; » Calculate calories burned in a workout. *When these items are not marketed, promoted or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or do not otherwise meet the definition of medical device, FDA does not regulate them. When they are marketed, promoted or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or otherwise meet the definition of medical device, FDA intends to exercise enforcement discretion. The publication of this report signifies a step change for developers of applications and services that rely upon mobile delivery for provision of healthcare solutions. The FDA’s clear position allows for developers to more easily interpret the regulatory landscape and to determine the best strategy to ensure compliance. Ref: Mobile Medical Applications – Guidance for Industry and Food and Drug Administration Staff. U.S Department of Health and Human Services Food and Drug Administration. September, 2013. For full report go to: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/ connectedhealth/mobilemedicalapplications  This could be your advertisement Contact Matthew at matthew@simedics.org or on +44 (0)1756 709605 for more details The Journal of mHealth The Global Voice of mHealth 21 The Journal of mHealth