News & Analysis as of

Patients Healthcare Labeling

Health Care Compliance Association (HCCA)

OCR: Rule Halts Disclosures Under ‘Presumption of Lawfulness,’ Shares Model Attestation Form

Attestations are at the heart of permissible disclosures under the HHS Office for Civil Rights’ (OCR) new reproductive health privacy rule—and OCR wants covered entities (CEs) and business associates (BA) to use them now. The...more

Searcy Denney Scarola Barnhart & Shipley

FDA: Blood Volume Expanders Present Severe Risks for Patients

On July 7, 2021, the U.S. Food and Drug Administration (FDA) issued new warnings regarding hydroxyethyl starch (HES) blood volume expanders. Specifically, the FDA is now requiring manufacturers to update the safety labels for...more

Faegre Drinker Biddle & Reath LLP

FDA Solicits Feedback to Create Consistent Process for Labeling Devices

The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20,...more

Searcy Denney Scarola Barnhart & Shipley

FDA Warns of Risk of Failure in Stryker STAR Ankle Replacement Devices

The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers of a “higher than expected risk” of failure in Stryker Scandinavian Total Ankle Replacement (STAR) devices. According to the FDA, the...more

Robins Kaplan LLP

PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA

Robins Kaplan LLP on

The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more

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