News & Analysis as of

Patient Safety Regulatory Requirements

Cranfill Sumner LLP

Anesthesia in North Carolina Dentistry: Safety, Regulation, and Future Trends

Cranfill Sumner LLP on

The administration of anesthesia in dental offices across North Carolina is under heightened scrutiny. A series of tragic patient deaths, public advocacy, and legislative interest have prompted the North Carolina State Board...more

Knobbe Martens

Global Market Size and Technological Advancements for Implantable Medical Devices Continue to Grow

Knobbe Martens on

A recent report by Precedence Research estimates the global market size for implantable medical devices will grow from USD 97.62 Billion in 2024 to USD 178.15 Billion by 2034: The rapid increase in the global market size of...more

Gardner Law

Product Liability Prevention: A Proactive Approach for FDA-Regulated Industries

Gardner Law on

Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant...more

Foley & Lardner LLP

FDA & OHRP Draft Guidance: Including Tissue Biopsies in Clinical Trials

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more

Goodell, DeVries, Leech & Dann, LLP

Understanding CMS “Immediate Jeopardy” Investigations in Healthcare Facilities

When it comes to ensuring patient safety, healthcare facilities operate under a complex regulatory framework, including oversight from the Centers for Medicare & Medicaid Services (CMS). One of the more intense processes CMS...more

Epstein Becker & Green

Interested in Opening a Medical Spa? (Part II): Here’s (More) That You Need to Know

Epstein Becker & Green on

In April, we shared with you our thoughts on what to consider before opening in or investing in a medical spa, thinking about corporate structure, scope of practice, licenses and registrations, referral restrictions, HIPAA...more

Seyfarth Shaw LLP

Texas Lawmakers Enact New Laws Reforming Texas Medical Board Disciplinary Authority and Increasing Hospital Reporting Obligations

Seyfarth Shaw LLP on

On June 13, 2023, Texas Governor Greg Abbott signed a major new patient safety bill into law that is intended both to reform the disciplinary authority of the Texas Medical Board (TMB) and to better protect patients from...more

Akerman LLP - Health Law Rx

Florida Continues Pursuit of Improved Patient Safety

Florida is continuing its efforts to improve patient safety in hospitals and ambulatory surgical centers (ASCs).  The Florida Legislature previously approved a requirement that hospitals and ambulatory surgical centers (ASCs)...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Regional Healthcare Compliance Conference - Seattle - July 23rd, 8:25 am - 4:30 pm PDT

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

Bricker Graydon LLP

CMS announces reduced psychiatric hospital burden with new survey process

Bricker Graydon LLP on

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

McDermott Will & Schulte

The New Appendix Q – CMS State Operations Manual Changes Overhaul Immediate Jeopardy for Providers and Suppliers

The Centers for Medicare and Medicaid Services issued a Quality, Safety and Oversight Memo on March 5, 2019, which will change how state agency and CMS surveyors will analyze and identify situations of Immediate Jeopardy. ...more

Baker Donelson

Requirements for Participation Guidance for LTC Surveyors Published

Baker Donelson on

The State Operations Manual Guidance for Long Term Care Surveyors (Appendix PP), effective November 28, 2017, has undergone substantial revision. As a result of regulatory changes, the F-tags for surveys have been renumbered....more

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