A panel discussion moderated by Sofia Guerra of Bessemer Venture Partners aptly titled “The Great Leveling Out” provided some clear insights into how investors view the current state of play in digital health markets. Laura Veroneau, Managing Director of Optum
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.
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Episode 29: Let’s Talk Compliance: How Compliance Issues Affect Health Care Transactions
In this episode, partner Jana Kolarik of Foley’s Health Care Practice Group interviews partner Roger Strode of Foley’s Health Care and Transactional Practice Groups and Michael Ramey, managing principal of PYA’s Strategic and Transaction Solutions on how compliance issues…
ORI Proposes New Rulemaking for Research Misconduct Regulations
On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct (the Proposed Rule), which
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FDA Laboratory Developed Test Oversight: What Stakeholders Need to Know About Proposed Overhaul
After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory developed tests (LDTs).
If the proposed rule…
DEA Extends Telemedicine Flexibilities for Prescribing of Controlled Medications: Second Time is the Charm
On October 6, 2023, the Drug Enforcement Administration (DEA) released a second temporary rule extending the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. This second extension, issued shortly after DEA’s listening session on a potential new Telemedicine Special Registration…
The No Surprises Act: The Departments Proposed Another Increase to IDR Fee, Will it Stick?
On September 26, 2023, the Departments of Health & Human Services (HHS), Labor, and the Treasury (collectively, the Departments) jointly proposed rules (September Rule) updating the administrative fee and Certified Independent Dispute Resolution (IDR) entity fee ranges for the Federal IDR…
CMS Proposes New All-Payor, Total-Cost-of-Care Model (AHEAD Model), Funding Opportunity for States
On September 5, 2023, the Centers for Medicare & Medicaid Services (CMS) announced a new all-payor, total-cost-of-care model that is designed to tackle growing health care costs, boost population health functions, and reduce disparities in health outcomes. The model is…
FDA: Approval for PTSD MDMA-Assisted Therapy is One Step Closer
The long-anticipated results of a recent clinical study demonstrate the potential therapeutic benefits of psychedelic substances. The results of the confirmatory phase 3 study to test the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) for the treatment of patients with…
Key Contractual Considerations for Health AI and Hospital Collaborations
If artificial intelligence (AI) is the vehicle that will revolutionize health care, data is the fuel that will propel the revolution. Health AI startups have recognized an unprecedented opportunity to create a transformative network effect, akin to many data companies,…
DTC Promotional Labeling and Advertisements: Quantitative Efficacy Wins Over FDA in Final Guidance on Presenting Risk Information
In June 2023, the U.S. Food and Drug Administration (FDA) published final guidance (Guidance) on presenting risk and efficacy information for direct-to-consumer (DTC) promotional labeling and advertisements for prescription drug and biologic products for humans and drug products for animals.…