Apple’s new guidelines will have a bigger impact than the FDA.
Tag: FDA Guidance
The best of iMedicalApps, the first installment of March
March is here, and that means nicer weather along with March Madness! Because we know you have busy lives (along with a lot of basketball to watch) we have condensed for you our top, favorite posts of March thus far. For this installment, we discuss everything from the new iPad to ways you can take an idea for a healthcare app and turn it into a reality. We also look at ways social media is influencing various aspects of patient care.
What are the legal implications when adverse drug effects surface on social media ?
[We are pleased to present this guest article by Dr. McMenamin, who was a practicing emergency physician before turning his sights to the practice of law. He is currently a partner at McGuireWoods LLP specializing in health-related litigation.] By: Joseph McMenamin, MD, JD Before a pharmaceutical company may lawfully sell a new drug in the […]
Accessorizing isn’t just a fashion issue – mobile apps that work with medical devices present a distinct challenge
This session discussed the fragmentation of the healhcare industry and the challenges that arise from classifying an app as an accessory for FDA regulation.
Should your medical apps be regulated in the same way as a defibrillator?
The second session of the day focuses on the level of oversight and the proposed approach to utilize the current device classifications and oversight controls.
Future scope of regulation debated at FDA mobile medical apps workshop
This post is part of iMedicalApps coverage of the FDA meeting regarding its draft guidance of mobile medical apps. This two day meeting is an important milestone in the mHealth industry so stay tuned for regular updates throughout the conference. You can follow the conference as #FDAmhdef