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Healthcare › Mobile Medical Applications

Troutman Pepper

Software as a Medical Device: FDA Releases Draft Guidance

Troutman Pepper on

Companies that develop software that functions as a medical device should be aware that the Food and Drug Administration (FDA) has issued draft guidance that, once finalized, will classify the endless variety of Software as a...more

Knobbe Martens

FDA Issues Guidances for Medical Device-Related Apps and Systems

Knobbe Martens on

The U.S. Food and Drug Administration (“FDA”) recently issued guidance on an array of medical device-related software and systems. A first guidance for ”Data Systems and Imaging Devices” issued on February 9, 2015, and...more

Kelley Drye & Warren LLP

FDA Extends Risk-Based Medical App Approach to Medical Device Data Systems in New Guidance

Kelley Drye & Warren LLP on

The recent release of two guidance documents addressing current FDA enforcement policies for medical devices that are Medical Device Data Systems (MDDS) and mobile applications (mobile apps), provide further evidence that...more

Sheppard Mullin Richter & Hampton LLP

Mobile Health Apps are in a Boom Phase – Why is it so Hard for Pharmaceutical Companies to Find Users?

Sheppard Mullin Richter & Hampton LLP on

Mobile medical and health applications have been in a boom phase for the past few years, but despite this trend, one group of entities has had trouble breaking into the mobile medical app sphere, pharmaceutical (i.e., pharma)...more

Cooley LLP

Lawmakers Call to Clarify HHS’ Mobile Medical App Regulation

Cooley LLP on

The mobile medical application marketplace has developed into a $68 billion industry; however, the U.S. Department of Health and Human Services (HHS) has not yet updated guidance regarding the Health Insurance Portability and...more

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