The Mobile Patient Series
How are clinical trials, home-use devices and research and compliance affected by and informing mobile technologies.
The Mobile Patient: FDA Guidance for Devices Intended for Home Use
November 20, 2014
Danielle Macario, Ph.D.
Affiliated Board Member,
Ashutosh Sabharwal, Ph.D.
Professor of Electrical and Computer Engineering,
The growth of home use devices is opening new opportunities for today's medical community. As diagnosis and treatment pathways improve, more patients live with chronic conditions that less frequently require treatment at professional healthcare facilities. The convenience and relatively low cost of home treatments has lead to increased demand for effective and safe devices.
The FDA's approval is necessary for these devices to reach the market, and those that do not surmount that hurdle have no hope for success. Though the Agency's recent guidance document sets forth some of its key parameters, much uncertainty persists. Device developers, and providers, must address these sometimes vague guidelines as well as the risks created by less than absolute control of patient adherence.
Considering the interaction of these and other factors on healthcare delivery, how can one assess a home treatment product's viability for FDA approval? In this session, we aim to explore that question and share firsthand experiences that will shine some light on the process.
President & CEO
Manufacturing Support Associate II
In the race to develop health and wellness smartphone apps for healthcare, few are truly patient centric; i.e. easy for patients to record health data, connected with external devices and apps, interactive for personal health status, meaningful for clinical decisions, and HIPAA compliant to enable collaborative care team communication. By building upon its secure, cloud-based platform, a new solution promotes patient activation and engagement with health while allowing multiple care givers, including physicians, specialists, and wellness support networks, to collaborate in real time.
This webinar will address both the technology and the design principles that significantly enhance adherence, with particularly emphasis on the application of patient-centric software tools and mobile apps in the clinical trial setting.