Beyond the Bylaws: The Medical Staff Show - Need to Know: How to Manage Medical Staff Confidentiality and Privilege Protections
The Trend of Threatening Physicians for Personal Gain
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
Podcast - Talking Sickle Cell Trait with NFL Wide Receiver Ty Montgomery and Dr. Anjulika Chawla, MD, FAAP
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
Numerous medical devices sold in the United States are subject to active recalls. If you have a medical device that is subject to an active recall, it will be important to make sure you know what this means for your health...more
Defective medical devices can present serious—and even life-threatening—risks for patients. Yet, sadly, many patients don’t realize that their medical devices are defective until it is too late. Sometimes, manufacturers and...more
Researchers from the National Institutes of Health (NIH) have developed an algorithm that harnesses AI to help accelerate the process of matching potential volunteers for relevant clinical research trials. The algorithm,...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
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
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
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 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
This follows the blog article posted November 28, “Connection and Innovation Take Center Stage at the Patient ENGAGE Conference” and is the second feature regarding the MedCity ENGAGE conference Nov. 6-7 in San Diego. Here,...more
In this issue of Pro Te (Volume 11, No.2), we examine three important topics with practical implications. In many jurisdictions, the medical judgment of physicians is almost sacrosanct – at least insofar as it is...more
It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more
Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...more
On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more
The Food and Drug Administration (FDA) issued guidance yesterday (September 6, 2017) entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices,” which is intended to “assist...more
On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more
The FDA recently announced establishment of the Patient Engagement Advisory Committee (PEAC). According to a notice published by the FDA, the PEAC will advise the Commissioner of the FDA, presently Dr. Stephen Ostroff, M.D.,...more
The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more
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