Workplace Violence in Health Care: Dissecting the Legal Landscape and Implications for Employers – Diagnosing Health Care
TortsCenter Podcast | Episode 5 | Higher Standards or Higher Stakes
Cannabis Law Now Podcast: Cannabis Companies and the Corporate Transparency Act
Third-Party Risk Management in Bank-Fintech Partnerships: Strategies and Insights — Payments Pros – The Payments Law Podcast
Compliance Unveiled: 10 Must-Know Tips for the Pregnant Workers Fairness Act & Independent Contractor Rules
Examining FinCEN FAQs, Proposed Legislation and Other CTA Developments
Webinar: Corporate Transparency Act
Year in Review: Key Regulatory Updates in 2023
DE Under 3: Potential Elimination of EEO-1 Type 4 & 8 Reports
Consumer Finance Monitor Podcast Episode: Perspectives on Counseling on the Creation of Consumer Finance Products, with Guest Joseph Schuster, Managing Director and Senior Counsel, Goldman Sachs
Webinar Recording - Artificial Intelligence An Overview of the U.S. and EU Regulatory Landscape
On-Demand Webinar | Regulatory Uncertainty and Linear Infrastructure Projects: Where Are We and What’s Ahead?
Welcome to Regulatory Matters
Abdul Rahman Al Jaabari on a Virtual Reality Code of Ethics & Business Conduct
Pamela Para on Effective Investigations in Healthcare
M&A in the Cannabis Sector
On-Demand Webinar | Linear Infrastructure Redux: Adapting Your Projects to Meet the New Regulatory Climate
Wiley Webinar: Biotech Briefings – U.S. Department of Agriculture – Plant Pests and Importation Part 330
Healthcare Tech: What Legal Pitfalls Should Tech Companies Avoid As They Jump Into Healthcare?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - FDA Regulated Natural Products: Leveraging IP and Regulatory Requirements to Maximize Possible Return on Investment
Change Healthcare Inc. has amended its initial breach report to the HHS Office for Civil Rights (OCR) to state that 100 million individuals were impacted by its mammoth ransomware attack and breach. However, as of Oct. 24,...more
Let’s review for a moment. It’s not a HIPAA violation to be a victim of ransomware. It’s not a HIPAA violation to pay a ransom. It’s up to the covered entity (CE) to determine if a security or privacy incident is a...more
Health care providers often find themselves in the position of collecting direct payments for medical services through patient payment plans. While providers must adhere to a myriad of health care laws when doing so, they...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
On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more
United Healthcare Group (UHG) CEO Andrew Witty was in a board meeting on Feb. 21 when officials interrupted with the news that Change Healthcare—a clearinghouse UHG subsidiary Optum had purchased for $1.3 billion in October...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
Reflecting on lessons learned and complaints received during the COVID-19 pandemic, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released detailed frequently asked questions (FAQs)...more
On December 7, 2023, the Senate Budget Committee (the “Committee”) launched a bipartisan investigation into the reality of private equity ownership of hospitals in the United States. This investigation stems from concerns...more
As we have previously reported, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. On November 10, 2023, the PMPRB published its Scoping Paper...more
Due diligence properly performed in connection with the purchase and sale of a health care entity is simply different—vastly so—than due diligence performed in other contexts. Failure to recognize this reality can lead to...more
As many are aware, compliance with price transparency requirements continues to lag. Under the final rule, effective January 1, 2021, hospitals are required to provide clear, accessible pricing information online about the...more
Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more
In case you missed it, the Connecticut Department of Public Health (DPH) issued two Orders last week affecting patients with disabilities and patients who are minors in certain health care facilities. Both Orders went into...more
The widespread use of social media platforms make them ideal for companies trying to reach a large audience. Pharmaceutical and consumer products industries frequently maintain their own social media accounts and partner with...more
On January 13, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a new streamlined survey and certification process for psychiatric hospitals as part of the agency’s “Patients over Paperwork” initiative. ...more
As of January 1, 2020, when a patient (or their representative) submits a written allegation of sexual abuse or sexual misconduct to a health care entity, that entity must report the allegation to the appropriate state...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 Centers for Medicare and Medicaid Services (CMS) is moving forward with its Patients over Paperwork initiative, which was created in accordance with President Trump’s Executive Order directing federal agencies to reduce...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 August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder...more
Effective July 1, 2019, The Patients Right to Know Act of 2018 (SB 1448) will require both Doctors of Medicine (“M.D.s”) and Doctors of Osteopathic Medicine (“D.O.s”) to provide notice to all patients prior to their...more