News & Analysis as of

Public Health Emergency Regulatory Requirements

Holland & Knight LLP

Ministerio del Trabajo de Colombia emitió lineamientos ante emergencia sanitaria

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El Ministerio de Salud y Protección Social de Colombia expidió la Resolución 691 de 2025, mediante la cual declaró la emergencia sanitaria en todo el territorio nacional debido al brote activo del virus de la fiebre amarilla....more

Foley & Lardner LLP

DEA Tightens Buprenorphine Telemedicine Prescribing Rules

Foley & Lardner LLP on

The Drug Enforcement Administration (DEA) and the U.S. Department of Health & Human Services (HHS) just finalized their March 2023 proposed rule regarding telemedicine prescribing of buprenorphine. The final rule, effective...more

Alston & Bird

FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies

Alston & Bird on

Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health...more

Sheppard Mullin Richter & Hampton LLP

Tracking the Waivers: Implications of the Wind Down of the COVID-19 Public Health Emergency

The White House recently announced that the COVID-19 national emergency and public health emergency (PHE) declarations will end on May 11, 2023. These declarations have been in place since the beginning of the COVID-19...more

Burr & Forman

Your Practice and Telemedicine

Burr & Forman on

The COVID-19 pandemic gave way to a rapid increase in virtual care for patients. Now nearly three years on, the American Medical Association found in a recent study that eighty-five percent (85%) of physicians continue to...more

Holland & Hart - Health Law Blog

Prepare for the End of the Public Health Emergency: Compliance Concerns

For nearly three years, federal and state agencies have waived or relaxed regulatory requirements and expanded reimbursement for services due to the COVID-19 public health emergency (PHE), but the signs indicate that the...more

Goodwin

Five Key Regulatory Considerations for Virtual Ketamine Clinics

Goodwin on

The off-label use of ketamine to treat anxiety, depression, and other behavioral health disorders —coupled with the COVID-19 telehealth era—has spurred the opening of virtual ketamine clinics nationwide. Some clinics offer a...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - October 28th, Louisville, KY

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - September 16th, Bloomington, MN

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

Health Care Compliance Association (HCCA)

Telehealth regulatory oversight and enforcement trends

CT magazine (July 2022) - One of the notable impacts of the COVID-19 pandemic on the healthcare industry has been the boom in services provided via telehealth. This boom is in part due to temporary flexibilities applied...more

Proskauer - Health Care Law Brief

Key Legal Issues Facing Telehealth Platforms, as Compliance Concerns Bubble for Platforms Launched During the Public Health...

The onset of the COVID-19 public health emergency (“PHE”) led to a surge in the use of telehealth by health care providers. In addition, the PHE fueled a boom in the number of direct-to-consumer (“DTC”) telehealth platforms,...more

Holland & Knight LLP

Holland & Knight Health Dose: May 10, 2022

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

K&L Gates LLP

COVID-19: State Law Telehealth Considerations: State Licensure Requirements Persist, Permissible TeleHealth Modalities Generally...

K&L Gates LLP on

As the explosion of telemedicine continues during and, as many expect, after the COVID-19 public health emergency (PHE), state laws and regulations that affect the delivery of telemedicine services continue to expand and...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - February 11th, Grapevine, TX

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

Arnall Golden Gregory LLP

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more

Burr & Forman

Labor & Employment E-Note - November 2021

Burr & Forman on

Resources - Safer Federal Workforce Task Force Updates Guidance for Federal Contractors - On November 10, 2021, the Safer Federal Workforce Task Force updated its Guidance for Federal Contractors (“Guidance”). As...more

Littler

Mandatory Employee Vaccines – Coming to A State Near You? (UPDATED)

Littler on

While available vaccines have proven highly effective in controlling COVID-19 and its variants to date, the virus continues to spread — particularly among unvaccinated populations. In the face of flagging interest, officials...more

Littler

Mandatory Employee Vaccines – Coming to A State Near You? (UPDATED)

Littler on

While available vaccines have proven highly effective in controlling COVID-19 and its variants to date, the virus continues to spread — particularly among unvaccinated populations. ...more

Quarles & Brady LLP

Guidance for Federal Contractors Under President Biden’s COVID-19 Executive Order

Quarles & Brady LLP on

President Biden recently issued an Executive Order (Executive Order 14042) requiring covered federal contractors to mandate that their employees are fully vaccinated against COVID‑19. On September 24, 2021, the White House’s...more

Littler

Mandatory Employee Vaccines – Coming to A State Near You? (UPDATED)

Littler on

While available vaccines have proven highly effective in controlling COVID-19 and its variants to date, the virus continues to spread — particularly among unvaccinated populations. In the face of flagging interest, officials...more

FordHarrison

Task Force Guidance Mandates Employees Of Federal Contractors Receive The COVID-19 Vaccine

FordHarrison on

On September 24, 2021, President Biden’s Safer Federal Workforce Task Force issued guidance for federal contractors and subcontractors regarding mandatory COVID-19 workplace safety protocols (“Guidance”). ...more

Burr & Forman

FAR Council Issues Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors Clause

Burr & Forman on

On September 27, 2021 Burr & Forman published COVID-19 Vaccine Guidance for Federal Contractors, noting that the Federal Acquisition Regulations Council was to develop a mandatory Federal Acquisition Regulation (“FAR”) clause...more

Stinson - Government Contracting Matters

FAR Class Deviations Being Issued to Implement Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal...

On September 30, 2021, the Civilian Agency Acquisition Council (CAAC) issued a formal Class Deviation from the Federal Acquisition Regulation (FAR), to implement rollout of the President’s Executive Order 14042, Ensuring...more

Akerman LLP - HR Defense

Federal Contractors Face Dec. 8 Vaccination Deadline

Federal contractors covered by President Biden’s recent Executive Order 14042 must ensure that covered employees are fully vaccinated for COVID-19 no later than December 8, 2021, subject to applicable exceptions, pursuant to...more

Proskauer - Government Contractor Compliance...

FAR Council Issues Contractor Vaccination Contract Clause and Guidance

As previously reported, the Biden Administration issued Executive Order 14042 (“the Order”) last month.  The Order requires, in part, that the Federal Acquisition Regulatory Council (“the FAR Council”) amend the Federal...more

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