At the May 9-10, 2023, Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee, U.S. Food and Drug Administration (FDA) advisers voted that the agency should grant a bid to support making
Health Care Law Today
Health Care Law Today, published by Foley & Lardner LLP, focuses on legal developments and regulatory issues affecting the healthcare industry. The blog covers topics such as digital health investment trends, telehealth privacy and security best practices, Medicare policy changes including behavioral health service expansions, remote patient monitoring regulations, and compliance with state vaccination requirements for healthcare facilities. It addresses the intersection of healthcare delivery, technology, and law, providing updates on federal and state regulations, reimbursement policies, and risk management strategies relevant to healthcare providers, payers, and investors.
Latest from Health Care Law Today - Page 6
Sequencing the Impact: How AI is Boosting Genomic Medicine
By Oyvind Dahle
The rapid development of artificial intelligence (AI) systems will significantly impact businesses that rely on genomic data analysis for research and development of therapeutics and diagnostic decision-making. This article provides an overview of current trends in using AI systems to…
Employee Benefit Plans: Applying the ERISA Controlled Group and Affiliated Service Group Rules in the Health Care Industry
Entities interested in entering into health care related endeavors must consider compliance with the corporate practice of medicine doctrine. In a number of states, the corporate practice of medicine doctrine prohibits corporations from practicing medicine or employing a physician to…
Florida’s New Prohibition on Offshoring Patient Information
Florida health care providers and digital health technology platforms should be on alert that a newly passed law requires providers using certified electronic health record technology (CEHRT) to ensure that all patient information, regardless of whether the data is stored…
Gender Affirming Care Restricted Under Missouri Bill
On May 10, 2023, the Missouri legislature passed a bill restricting access to gender affirming care for individuals under the age of 18. The bill is now headed to Governor Parson’s desk for signature. Given the Governor’s previous comments encouraging…
FDA and SAMHSA Issue Joint Statement in Support of Reducing Barriers to Evidence Based Treatments
On May 9, 2023, the U.S. Food and Drug Administration (FDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a joint statement regarding both agencies’ commitment to providing evidence-based treatments for opioid use disorder (OUD).
In the…
Public Nuisance Claims: Altria’s Vaping Trial Highlights Potential Expansion
The recent trial in a case now settled highlights the potential expansion of public nuisance claims under California law, and in large-scale public nuisance actions more broadly.
On April 24, 2023, opening arguments began in San Francisco United School District…
Software as a Medical Device: Challenges Facing the Industry
Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations that utilize software and medical…
FDA’s New Guidance Proposes Flexible Use of AI in Medical Devices
On April 3, 2023, U.S. Food and Drug Administration (FDA) issued its much anticipated draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions” (Draft Guidance).
While FDA has already…
DEA Extends Telemedicine Flexibilities for Prescribing of Controlled Medications
On May 10, 2023, the Drug Enforcement Agency (DEA) released a new regulation – “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” – temporarily extending the “full set” of DEA’s COVID-19 waivers for prescribing controlled substances via…