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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
In October 2023, the International Organization for Standardization (ISO) published ISO 7101, Healthcare organization management: Management systems for quality in healthcare organizations. ISO 7101 is the latest in a series...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
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
On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to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
In order to comply with the provisions of the EU Medical Device Regulation (EU MDR) and the (coming) Spanish MDR, the Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for Medicinal Products and Medical...more
Increasing mental health care needs for minors present a range of legal issues for children, parents, health care providers and health care payors. While state laws typically govern who has the power to consent to or refuse...more
In response to media reports regarding alleged deficient practices in some of Georgia’s long-term care facilities, House Bill 987 (“HB 987”) was signed into law on June 30, 2020, amending Title 31 of the O.C.G.A....more
On February 1, 2022, the Texas Board of Pharmacy voted to send proposed amendments to its Central Fill Rule under 22 Tex. Admin. Code § 291.125 back to staff for a redraft....more
The Centers for Medicare & Medicaid Services (CMS) issued a Final Rule on November 15, 2021, (November 2021 Final Rule) repealing its regulatory definition of "reasonable and necessary," which had previously been finalized in...more
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
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
As we wrote on July 28, 2021, Senator Chuck Grassley has sponsored a bill (S. 2428) that would amend the False Claims Act (FCA) in several significant ways that are unfavorable to defendants. On October 28, 2021, the Senate...more
New Rule Finalizes Penalties for Violating the 2021 Price Transparency Rule - On November 2, 2021, CMS published the 2022 Hospital Outpatient Prospective Payment System Final Rule that addressed its previously-proposed...more
The Washington Department of Health (DOH) has amended WAC 246-50, the rules applicable to coordinated quality improvement programs (CQIPs) for non-hospital organizations. The amendments go into effect on May 21, 2021. ...more
On 19 January 2021, the U.S. Department of Health and Human Services (the Department or HHS) published in the Federal Register Final Rule entitled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET).” The...more
On Tuesday, September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule addressing the Medicare coverage standard and expedited coverage for certain medical devices. If finalized, the...more
Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more
The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...more
The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the implementation of the rules governing...more
To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years, the Food and Drug Administration’s (FDA)...more
Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more
Speaking Tuesday, May 21, at the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, FDA Chief of Staff Lauren Silvis emphasized that over-the-counter (OTC) monograph reform remains a “top...more
March 4, 2019 was the mid-point of the 120 day regular session of Colorado’s General Assembly. Before adjournment on May 3, 2019, significant legislative actions and resulting changes in the regulatory framework seem likely...more