News & Analysis as of

Regulatory Standards Healthcare Health Care Providers

McDermott Will & Schulte

Trending in Telehealth: February 2025

Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more

McDermott+

Regs Coming Through the End of the Year: Expect the Expected and the Unexpected

McDermott+ on

There could be an all-you-can-eat buffet of regs (and eggs) from now until the end of the year! As you may recall, a July 2024 Regs & Eggs blog post highlighted the spring 2024 “unified agenda” that listed all the regs...more

McDermott Will & Schulte

Trending in Telehealth: September 30 – October 7, 2024

McDermott Will & Schulte on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

J.S. Held

Inside the Healthcare Industry: The Impact of Human Factors & User Experience in Healthcare

J.S. Held on

Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more

McDermott Will & Schulte

Trending in Telehealth: July 16 – 22, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

McDermott Will & Schulte

Trending in Telehealth: May 7 – May 13, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

McCarter & English, LLP

New Jersey Regulatory Update Part II

Part II of our New Jersey Regulatory Update further identifies proposed and adopted regulations that may impact healthcare providers, from additional financial transparency rules impacting facilities to rules attempting to...more

Holland & Hart LLP

24-Hour Mental Holds In Idaho: New Standards, New Problems

Holland & Hart LLP on

Since early 2022, the Idaho legislature has modified the standards for a patient’s capacity to consent to healthcare and 24-hour protective holds. This health law update summarizes the current rules for capacity and consent;...more

Foley Hoag LLP

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

Foley Hoag LLP on

On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more

Nossaman LLP

Medical Group Peer Review: The Next Frontier

Nossaman LLP on

While hospital medical staffs have traditionally handled most of California’s peer review activity, recent trends are forcing more and more medical groups to wrestle with reporting and fair hearing obligations when...more

Hendershot Cowart P.C.

Common Medical Lab Referral & Compensation Arrangements Could Lead to Criminal Charges

Hendershot Cowart P.C. on

EKRA stands for the Eliminating Kickbacks in Recovery Act, and it has become a prominent enforcement tool against fraud in the healthcare and medical testing industries. Although the law was developed in 2018 to help combat...more

Arnall Golden Gregory LLP

A Change Is Gonna Come: AdvaMed Revises Its Code of Ethics on Interactions With Health Care Professionals

In 1964, Sam Cooke sang “A Change is Gonna Come.” In March 2022, the Advanced Medical Technology (AdvaMed) said the same when it announced revisions to its Code of Ethics on Interactions with Health Care Professionals (the...more

Jones Day

Fourth Circuit Limits Who Can Act "Knowingly" Under False Claims Act

Jones Day on

Health care industry participants frequently operate under nuanced legal frameworks that apply to the receipt of government funds. A breach of these regulations can open the door to draconian liability under the FCA even when...more

Proskauer - Health Care Law Brief

CMS Appears to Soften Co-Location Restrictions in Newly-Revised Guidelines

In a November 12, 2021 revision of its prior draft guidelines for hospital co-location compliance with Medicare conditions of participation (COP) for hospitals (QSO-19-13), CMS has apparently softened its approach to...more

Robinson+Cole Health Law Diagnosis

CMS Finalizes Guidance on Hospital Co-Location

On November 12, 2021, the Centers for Medicare & Medicaid Services (CMS) issued finalized guidance (“Guidance”) clarifying that hospitals can share space, services, or personnel with another hospital or health care provider...more

Faegre Drinker Biddle & Reath LLP

FDA Solicits Feedback to Create Consistent Process for Labeling Devices

The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20,...more

McDermott Will & Schulte

[Event] 2019 Healthcare Services Private Equity Leadership Forum - October 25th, New York, NY

Among the most active markets in private equity, the healthcare industry is ripe with opportunity for players in the healthcare services arena that can navigate the fast-paced deal environment and complex regulatory...more

McDermott Will & Schulte

[Event] 2019 European Healthcare Services Private Equity Leadership Forum - September  26th, London, United Kingdom

McDermott’s annual European Healthcare Private Equity Leadership Forum is a must-attend event for executives from top management teams, health and life sciences companies and providers, private equity, family offices,...more

Thomas Fox - Compliance Evangelist

King Lear Week: Part IV – Jackson Provides a Different Interpretation

One of the key differences between healthcare regulators and others, such as anti-trust regulators, is that ensuring access to sufficient quality HCPs, whether they be behavioral HCPs or providers serving other vulnerable and...more

Thomas Fox - Compliance Evangelist

King Lear Week: Part II – Engaging Your Audience

Today, I want to consider how health regulatory agencies are engaging their audiences through independent monitoring, to serve important public policy goals – specifically to help ensure a ready supply of quality health care...more

Mintz - Health Care Viewpoints

Regulators Look to Increase Interoperability and Patient Access to Health Data

Federal regulators are flexing their regulatory muscle to accelerate a long-desired but often elusive goal: the interoperability of health information technology (health IT) systems. Interoperability refers to the ability of...more

Shumaker, Loop & Kendrick, LLP

Client Alert: Florida Health Law Quirks: Guidance for Health Care Businesses Entering Florida

If you are entering into the Florida health care industry for the first time or starting up a health care business in Florida, you should make yourself aware of Florida’s robust health care laws. Most importantly, Florida...more

Robinson+Cole Data Privacy + Security Insider

Proposed New Rules Submitted to OMB on Information Blocking

On September 17, 2018, the federal Office of the National Coordinator for Health Information Technology (ONC) submitted proposed new rules to the Office of Management and Budget (OMB), entitled, “21st Century Cures Act:...more

Robinson+Cole Data Privacy + Security Insider

SAMHSA and ONC Issue Fact Sheets on Confidentiality of Substance Use Disorder Information

In response to the opioid crisis, the Substance Abuse and Mental Health Services Administration (SAMHSA) in collaboration with the Office of the National Coordinator (ONC) recently issued two fact sheets to provide clarity on...more

Holland & Knight LLP

Ten Things to Know About the CMS Long-Term Care Requirements Final Rule

Holland & Knight LLP on

Deadlines are looming to come into compliance with sweeping changes to the Centers for Medicare & Medicaid Services (CMS) requirements for long-term care facilities (LTC) participating in Medicare and Medicaid. The CMS final...more

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