Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 206: Supporting Patient Care with Darra Coleman of Prisma Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 179: Obesity Effects on the Workforce & Economy with Tim Dall, Healthcare Economist
Opting Out of Medicare: When and How to Do It
Patient Steering and Charting
From NC State to Changing the State of Health Information Networks, with Medicom Technologies’ Malcolm Benitz
Hospice Law Insights - Innovators Series: A Conversation with Michael McHale, President and CEO of TRU Community Care
Patient Records Requests: What You Need to Know
PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
What patients misunderstand about their right of informed consent
Similarities in Diversity between a Law Firm’s Culture and a Clinical Trial
Polypharmacy is Medspeak for taking more than one prescription medication at a time. About one in five Americans over age 49 is a polypharmicist, of sorts....more
On August 5, 2024, FDA’s Center for Devices and Radiological Health (CDRH) published a discussion paper entitled, “Discussion Paper: Health Equity For Medical Devices” (Discussion Paper), to aid in its efforts to advance...more
Abiomed, Inc., a subsidiary of Johnson & Johnson, is facing lawsuits across the country related to the company’s Impella heart pumps. Since June of last year, the company has issued multiple recalls for these implantable...more
Recently, the Department of Health and Human Services Office of Inspector General (“OIG”) released Advisory Opinion (“Opinion”) 24-02 regarding patient assistance funds provided by a non-profit charitable organization...more
On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more
I. WHY THIS CASE MADE THE LIST - A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more
Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are...more
On January 19, 2023, the U.S. Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA) held a “listening session” focusing on USPTO-FDA collaboration initiatives proposed pursuant to President Biden's...more
Hello readers! Today’s post focuses on a topic we’ve touched on a few times in the past – Medicaid drug formularies. Back in December 2021, the state of Oregon released a draft Medicaid waiver proposal that caught the...more
The ABA Washington Health Law Summit is the premier legal conference focusing on health law policy and, as a result, offers insight into current and future major policy issues. But, as always at this conference, there are...more
The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the...more
This past March 2021, the U.S. Food and Drug Administration (FDA) issued a safety communication that provides information and recommendations for patients who have or are considering a STAR (Scandinavian Total Ankle...more
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
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
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
A pharmaceutical manufacturer has received a green light from the Office of Inspector General (OIG) to provide financial assistance for travel, lodging and other expenses to certain patients prescribed the manufacturer's...more
To date, two COVID-19 vaccines have been authorized for emergency use by the FDA. Produced by Pfizer and Moderna, the vaccines are in full distribution throughout the world; however they differ slightly in certain respects....more
On August 31, 2020, the California legislature passed California AB 713, which amends the California Consumer Privacy Act (CCPA) to except from its requirements certain health information, including information that has been...more
In an attempt to reduce the risk of death from opioid overdose, the U.S. Food and Drug Administration (“FDA”) issued a Drug Safety Communication recommending that providers discuss the availability of Naloxone, the opioid...more
In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical...more
On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more
• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions. • The revised draft guidance on CDS further elaborates on how to make CDS...more
The digital health market is projected to reach $536.6 billion by 2025 and transform every aspect of healthcare. Which advances hold true potential and which are just hype? Find out at a new Manatt webinar. Digital...more
The U.S. Food and Drug Administration (FDA) continues advancing regulatory policies tailored to the digital health community. On September 26, 2019, the agency issued a series of guidance documents that interpret several of...more
On July 9, 2019, the U.S. Food & Drug Administration (FDA) released the final guidance document “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry,” which provides information...more