As many mobile apps pertain to health, the FDA is focused on the subset of mobile medical apps that are subject to oversight by the FDA to promote innovation and to protect patient safety. The FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”). Given the rapid expansion and broad applicability of mobile apps, the FDA has issued its guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority. This virtual briefing will give you insight into the importance of this guidance and what you need to know to apply it for your organization’s journey to mHealth.
• Explore what the new implications from this guidance mean to the healthcare industry
• Discuss how the guidance will this impact manufacturers and distributors of apps
• Explain how this guidance will simultaneously have a positive effect on innovation and patient safety
• Study the risk based approach to mobile medical app and medical device oversight
|11AM-11:30AM CT||The FDA’s Mobile Medical Application Guidance: 101 Overview and Industry Implications|
|Abstract: This guidance explains the FDA’s intentions to focus its oversight on a subset of mobile apps. Mobile medical apps as defined include only those mobile apps that meet the statutory definition of a device and either are intended to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device. This session will explore the evolution of the draft guidance and the significant updates provided in the final guidance.
|11:45AM-12:15PM CT||Examining the Impact of Mobile Medical Applications Risk Awareness for Health IT Professionals|
|Abstract: For mobile medical apps, manufacturers must meet the requirements associated with the applicable device classification. If the mobile medical app, on its own, falls within a medical device classification, its manufacturer is subject to the requirements associated with that classification. A mobile medical app, like other devices, may be classified as class I (general controls), class II (special controls in addition to general controls), or class III (premarket approval). This session will discuss the three types of apps that the final FDA intends to regulate, what apps are not subject to regulation, and what apps are up to FDA’s enforcement discretion.
|12:30PM-1PM CT||Medical Mobile Applications Usage: Patient Safety Implications|
|Abstract: Care coordination is critical to achieving patient safety, and real time access to healthcare information is greatly enhanced through mHealth. This discussion will review how the FDA guidance and FDASIA framework recommendations will impact the use of medical mobile applications.
|1:15PM-1:45PM CT||Redefining Mobility in Tomorrow’s Hospital…Today|
|Abstract: Health IT often ranges in complexity from devices that can take years to master to everyday solutions found in many current households. When it comes to putting mobile devices to use in ways that help to improve patient outcomes and overall satisfaction, ease of use and overall convenience are key. Follow one community hospital that has taken a proactive approach to this challenge by utilizing smart phone technology to enable secure secondary patient result notifications, voice and text communications, and other alerting functions all in a form factor that many can already use without any formal training.
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Brought to you by:
HIMSS mHealth Community, powered by mHIMSS, www.himss.org/mobilehealthit
mHIMSS is the globally-focused mobile initiative of HIMSS entirely focused on the use of mobile technologies to improve quality, accessibility, safety, and cost-effectiveness of care. mHIMSS builds on existing strengths of HIMSS: Convening stakeholders, Sharing knowledge, Providing world-class education, Public policy, and Research.