article thumbnail

How to Write a Healthcare Compliance Plan

Compliancy Group

Various laws, regulations, and industry standards govern this sector. This includes federal statutes such as HIPAA (Health Insurance Portability and Accountability Act). These sessions can take various forms, including in-person workshops, online courses, or newsletters highlighting compliance updates. The primary goal?

article thumbnail

Digital Health in the Metaverse: Three Legal Considerations

Healthcare Law Blog

The FTC’s increasing interest in health information that sits outside of HHS/OCR’s reach is likely to only expand in light of health-related metaverse use cases. The Medical Extended Reality Program in the FDA’s Center for Devices and Radiological Health has been formed to address regulatory science gaps and challenges in the area.

FDA 90
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Update from California’s Office of Health Care Affordability (OHCA): Proposed Regulations re Material Change Transactions and Pre-Transaction Review

Healthcare Law Blog

OHCA’s proposed regulations clarify that management services organizations (“ MSOs ”) and pharmacy benefit managers are also considered Health Care Entities within the meaning of the statute. Pursuant to SB 184, a transaction shall not be implemented until 60 days after OHCA issues its final report.

article thumbnail

The Stage is Set: California Finalizes OHCA Regulations Requiring Notice and Review of Material Healthcare Transactions in 2024

Healthcare Law Blog

Health Care Entities Under SB 184, “health care entities”, which include (i) payers , (ii) providers and (iii) fully integrated delivery systems [2] , are potentially subject to OHCA’s CMIR authority. OHCA must notify the submitter within 60 days of the filing if OHCA intends to conduct a CMIR.

article thumbnail

How to Choose the Right eQMS – The Ultimate Guide

Dot Compliance

Consider the following factors to assess the QMS’s compliance capabilities: Regulatory Framework Alignment: Evaluate whether the QMS aligns with the applicable regulatory frameworks governing your industry. The vendor should demonstrate adherence to these regulations and provide documentation as proof.

article thumbnail

How to Choose the Right QMS – The Ultimate Guide

Dot Compliance

Consider the following factors to assess the QMS’s compliance capabilities: Regulatory Framework Alignment: Evaluate whether the QMS aligns with the applicable regulatory frameworks governing your industry. The vendor should demonstrate adherence to these regulations and provide documentation as proof.

article thumbnail

President Biden Signs End-of-Year Legislation Including Telehealth, Medicare & Medicaid, Mental Health, Pandemic Preparedness, and Other Health Care Provisions

C&M Health Law

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

Medicaid 104