Devices

FTC Takes on Digital Health Information Sharing

Three SheppardMullins attorneys say a recent Federal Trade Commission (FTC) settlement highlights the importance of accurately describing how information is collected, used, and shared in digital health apps. In an online FDA Law Update Blog post, the attorneys say FTC settled with Flo Health, Inc., a fertility-tracking app, based on promises the company made on how health data would be shared.

As part of the settlement, the attorneys write, Flo must notify affected users about the disclosure of their personal information and instruct any third party that received users’ health information to destroy the data. Also, separate from any privacy policy or terms of use, before sharing any health information with a third party in the future, Flo must disclose the categories of health information that will be shared, the identities of the third parties, the purpose of such disclosure and how any information will be used, and obtain users’ affirmative express consent.

The attorneys conclude that the settlement is a reminder that companies in the health and wellness space have privacy and security obligations even if HIPAA regulations do not apply to them.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome