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TCLE webinar to offer overview of medical mobile app regulation

Diane Romza-Kutz March 3, 2016

Mobile Medical Apps and FDA’s New Cybersecurity Guidance: It’s a New World

Wednesday, March 16 – Noon to 1 p.m. Central Time

With mobile platforms becoming more user-friendly, and with computers, tablets and smartphones becoming more a part of our everyday lives, we see an increase in the offering of new applications on our mobile platforms. Some of these apps are specifically targeted to assist individuals in the management of their health and wellness, while other apps are targeted to health care providers as tools to assist in the delivery of care.

This webinar, presented by life sciences partner Diane Romza-Kutz  will provide an overview of mobile medical applications, the attendant regulations and potential enforcement efforts on the part of regulators. We will discuss the definition of a mobile medical app, when the app is just an accessory to a mobile platform, and when the app becomes a regulated medical device. Medical Device Data Systems where data is stored and displayed will also be discussed. In addition, we will touch on the new cybersecurity guidance documents issued by the Federal Food and Drug Administration.

Who should attend

  • Manufacturers who create, design, develop, label, re-label, manufacture, or modify to create a medical mobile app software system from multiple components
  • Distributors, and those entities that need to know how the FDA intends to regulate those software applications for intended use on mobile platforms
  • Physicians and their staff who use and implement mobile apps into their practice.

CLE credit is available in California, Illinois and Missouri.