On January 28, 2020, the Food and Drug Administration (FDA) announced that the Office of Prescription Drug Promotion (OPDP) will conduct two studies to examine how payment disclosure statements and the types of endorsers in drug advertisements affect consumers’ understanding of the information provided in the advertisements. Below is a summary of the studies. FDA invites comments on (1) whether studies like these are necessary for FDA to perform its duties, (2) the accuracy of…

Proposed amendment AB 713, if passed, would hopefully provide clarity to businesses working with clinical research data. The amendment proposes matching CCPA de-identification standards to those set forth in the Health Insurance Portability and Accountability Act (HIPAA), in addition to equally important clarifications for life sciences companies, health care providers and medical researchers. In particular, AB 713 covers five major principles: HIPAA De-identification Privacy Disclosure Business Associates Medical Research Product and Medical Device Tracking…

On Thursday, January 23, 2020 at 12:00 PM ET, Reed Smith will be hosting “Digital Health 101”, a CLE webinar covering: Federal and state health care regulatory and reimbursement issues, including fraud and abuse implications and insurance coverage for digital health devices and services Applicability of federal and state privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA), Telephone Consumer Protection Act (TCPA), California Consumer Privacy Act (CCPA), biometric privacy laws, and Federal…

On December 23, 2019, the U.S. Food and Drug Administration (FDA) published in the Federal Register a set of proposed rules covering the requirements and procedures for importing under Section 804 of the federal Food, Drug, and Cosmetic Act (FDCA) prescription drugs from Canada. It is these proposed rules under which prescription drugs intended for the Canadian market could be imported and distributed in the United States. Separately, FDA also published a draft guidance on…

On Wednesday, November 20, a three-judge panel of the U.S. Court of Appeals for the Eleventh Circuit heard oral argument in the closely watched False Claims Act (FCA) case of United States ex rel. Ruckh v. Salus Rehabilitation, Inc.  The case involves questions regarding how to interpret and apply the FCA’s materiality standard set forth in the Supreme Court’s decision in Universal Health Services, Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989…

As 2019 comes to an end, the United States Food & Drug Administration’s (“FDA” or the “Agency”) Center for Veterinary Medicine has published a new draft Guidance for Industry #256, “Compounding Animal Drugs from Bulk Drug Substances” (the “Draft Guidance”).  The Draft Guidance addresses FDA’s regulatory approach to compounding animal drugs from bulk drug substances.  Many in the industry may recall that FDA previously published draft Guidance for Industry #230, similarly titled, “Compounding Animal Drugs…

The U.S. Department of Health and Human Services Office for Civil Rights’ (OCR) recent imposition of a civil monetary penalty (CMP) against a Health Insurance Portability and Accountability Act of 1996 (HIPAA) covered entity demonstrates the need to ensure that HIPAA compliance programs are in place, are audited regularly, and emphasize the importance of promptly responding to and remediating alleged non-compliance (especially in response to direct requests from OCR). On November 7, 2019, OCR announced…