Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

Product Liability Law & StrategyKickerFeaturesSectionsNewsLJN Newsletters

Mobile Medical Apps and Product Liability

By Beth S. Rose
February 29, 2016

What types of applications do you have on your smartphone? Besides the usual ' Facebook, Twitter, Google and Instagram, chances are that you have a health-related app as well. Think Fitbit (counting steps per day), MyFitnessPal (tracking calories and exercise) or Hello Heart (monitoring blood pressure). Perhaps you know someone with diabetes who uses an app to remotely monitor glucose data. We routinely obtain these apps “free” or at minimal cost from the App Store.

News flash: The Food and Drug Administration (FDA) considers some of these apps to be medical devices subject to agency regulation and oversight. Indeed, earlier this year, the FDA published its final guidance document that explains when it considers mobile apps to be mobile medical applications (MMA) and thus, medical devices subject to regulation. This article examines the FDA's current approach to MMAs and explores the potential implications for product liability litigation if they malfunction.

This premium content is locked for LJN Newsletters subscribers only

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
The DOJ's Corporate Enforcement Policy: One Year Later Image

The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.

The DOJ's New Parameters for Evaluating Corporate Compliance Programs Image

The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.

Use of Deferred Prosecution Agreements In White Collar Investigations Image

This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.

Bankruptcy Sales: Finding a Diamond In the Rough Image

There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.

Compliance Officers: Recent Regulatory Guidance and Enforcement Actions and Mitigating the Risk of Personal Liability Image

This article explores legal developments over the past year that may impact compliance officer personal liability.