News & Analysis as of

Health Insurance Portability and Accountability Act (HIPAA) Prescription Drugs

McCarter & English, LLP

Medicare Technology Standards for Prescribing Part D Drugs

The Centers for Medicare & Medicaid Services (CMS), the Office of the National Coordinator for Health Information Technology (ONC), and thr Department of Health and Human Services (HHS) published 89 FR 51238 (the Final Rule),...more

Gardner Law

Navigating HIPAA and State Privacy Laws for Drug and Device Manufacturers

Gardner Law on

The Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...more

Holland & Knight LLP

Holland & Knight Health Dose: May 21, 2024

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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

Holland & Knight LLP

Holland & Knight Health Dose: April 30, 2024

Holland & Knight LLP on

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

McDermott+

McDermottPlus Check-Up: April 26, 2024

McDermott+ on

A Quiet Healthcare Week on Capitol Hill. Congress was largely in recess this week, although the Senate returned briefly to complete consideration of a long-awaited foreign aid bill. Both chambers will return to session the...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

Gardner Law on

Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Goodwin

SAMHSA Final Rule Codifies Opioid Treatment Program Telehealth and Take-Home Medication Flexibilities

Goodwin on

On February 2, 2024, the Department of Health and Human Services (HHS) issued a Final Rule that expands access to medications for the treatment of opioid use disorder (OUD) via telehealth modalities and “take-home” doses....more

Venable LLP

February 29 Deadlines for Group Health Plans

Venable LLP on

February 29 brings two annual deadlines for employers that sponsor a group health plan for their employees. Medicare Part D—Creditable Coverage Disclosure to CMS - An employer with a group health plan that provides...more

Robinson+Cole Health Law Diagnosis

HHS Finalizes Updates to “Part 2” Regulations to Align Disclosure Rules with HIPAA and Promote More Coordinated Substance Use...

On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder...more

Manatt, Phelps & Phillips, LLP

Executive Summary: Tracking Telehealth Changes State-by-State in Response to COVID-19 - August 2023

Illinois passed S.B. 1913, which requires Medicaid FFS and Medicaid managed care plans to provide coverage of mental health services, substance use disorder treatment, and ‘behavioral telehealth services’. Requires Medicaid...more

Manatt, Phelps & Phillips, LLP

Executive Summary: Tracking Telehealth Changes State-by-State in Response to COVID-19 - June 2023 #2

H.R. 4189 / S. 2016: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act ....more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q3 2023 and Beyond

Goodwin on

As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more

Kerr Russell

Accessing/Disclosing Prescription Information On Software Platforms

Kerr Russell on

Question: Our eScribe software allows us to access a patient’s prescription history. We are able to see what medications have been prescribed by other health care providers. MAPS also allows us to do this. When requesting...more

Paul Hastings LLP

Finance in Five Minutes: Healthcare Finance Checkup

Paul Hastings LLP on

While mergers and acquisitions, and attendant financings may not be at a blistering pace globally, the prognosis for deal activity in the healthcare sector remains healthy, in particular as the consolidation of providers, the...more

Gardner Law

New WA Privacy Law ‘Turns The Beat Around’ on Drug and Device Makers

Gardner Law on

The Washington My Health My Data Act ("MHMDA") may not have been written by Earth, Wind, & Fire, but it is certainly poised to make medical device and pharmaceutical manufacturers move to a new beat like a classic disco hit....more

Bodman

The Expiration of the COVID-19 Public Health Emergency: Part II – Impact on the Provision of Medical Services via Telehealth

Bodman on

As announced by the White House on January 30, 2023, the public health emergency (PHE) is set to end on May 11, 2023. The end of the PHE also brings an end to several flexibilities that were implemented that impact telehealth...more

Kerr Russell

Understanding Michigan’s E-Prescribing Requirement Exceptions And Waiver Process

Kerr Russell on

Effective January 1, 2023, the Michigan Department of Licensing and Regulatory Affairs, Bureau of Professional Licensing (the “Department”), will begin enforcing the Michigan Public Health Code’s requirement that all...more

McDermott Will & Emery

[Webinar] 340B ESP AND HIPAA COMPLIANCE - December 6th, 12:00 pm - 1:00 pm EST

McDermott Will & Emery on

Many pharmaceutical manufacturers currently require 340B covered entities to provide de-identified pharmacy claims data for dispensed 340B drugs to a third party, 340B ESP, as a condition of receiving discounts under the 340B...more

Alston & Bird

Alston & Bird Health Care Week in Review - April 2022 #2

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Managed Care Compliance Conference - February 8th - 9th, 8:25 am - 3:45 pm CST

Can’t attend the conference in-person? The virtual Managed Care Compliance Conference, February 8–9, allows you to hear from industry professionals just like you—all from the comfort of your home or office. Geared towards...more

Manatt, Phelps & Phillips, LLP

Telehealth: Regulation, Compliance, Audit and Investigation

I. Introduction - Use and acceptance of telehealth technologies have grown very substantially since the start of the COVID-19 pandemic. This growth has been substantially facilitated by waivers and relaxations of existing...more

Health Care Compliance Association (HCCA)

[Event] 2022 Managed Care Compliance Conference - January 30th - February 1st, Phoenix, AZ

Attend our annual event for those who manage compliance at health plan providers. Explore topics and issues that are pertinent to industry professionals like you. Learn the latest practices, share strategies, and connect with...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - July 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - December 2020

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Ward and Smith, P.A.

Time for a Checkup: Recent North Carolina Efforts Regarding Telehealth - Part II

Ward and Smith, P.A. on

The pandemic has also overhauled how physicians and health care providers practice in North Carolina, with many offices switching to virtual exams to help stop the spread of the coronavirus. North Carolina Medical Board's...more

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