Firm: All
Practice Industry: Healthcare & Pharmaceuticals, Life Sciences
Region: All
Country/ State: All
Tag: All
Carey | February 2023

On February 14 of this year, the Public Health Institute ("ISP") approved -by means of Ex. Res. No. 369/2023- a new guideline regarding the performance of post-authorization safety studies of pharmaceutical products (the "Guideline") ...

Quarles & Brady LLP | February 2023

On December 2, 2022, President Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act (“Marijuana Research Act” or “Act”) into law. The Act aims to help facilitate research on marijuana, directs the Drug Enforcement Administration (DEA) to follow new procedures to register practitioners to conduct marijuana research, and improves the supply of marijuana for research ...

Texas is increasingly a purple political state. The motto of the state's capital city implores its citizens to keep it weird.[1] Recent polling shows that Texans overwhelmingly support medical cannabis.[2] Every one of Texas' neighboring states has a real medical cannabis program ...

Dinsmore & Shohl LLP | February 2023

On February 1, the Federal Trade Commission (“FTC”) announced enforcement action for the first time under its Health Breach Notification Rule[1]. The complaint against telehealth and prescription drug discount provider GoodRx Holdings Inc. (“GoodRx”), alleges its failure to notify consumers and others of its unauthorized disclosures of consumers’ personal health information to Facebook, Google and other companies ...

ALTIUS/Tiberghien | February 2023

Introduction Mdeon, the legally recognised Belgian ethical platform for healthcare professionals and the pharmaceutical industry, announced several new ethics rules applying from 1 January 2023. The present blog post discusses their practical importance for the broader healthcare community, and particularly (i) several new ethic rules in light of the ascendant trend of virtual and hybrid scientific events, and (ii) new maximum hospitality amounts that can be offered to healthcare professionals ...

Dinsmore & Shohl LLP | February 2023

The Department of Justice (“DOJ”) withdrew three longstanding healthcare antitrust enforcement policy statements on the afternoon of Friday, February 3, 2023. The move follows a series of White House antitrust initiatives ...

Dinsmore & Shohl LLP | February 2023

At the end of 2022, the Centers for Medicare and Medicaid (“CMS”) issued a proposed rule that would amend the standard imposed on Medicare providers to report and return overpayments. If finalized, the proposed rule would replace the 60-day overpayment rule’s current “reasonable diligence” standard with the False Claims Act “knowingly” standard ...

Dinsmore & Shohl LLP | February 2023

As reported by various news outlets, the State Medical Board of Ohio (“Board”) has, and will continue, to ramp up investigations and enforcement actions related to alleged violations of ethical and professional guidelines. In particular, professional boundaries and sexual misconduct issues will be a primary focus for the Board, as it has been since the revelations of the Dr. Richard Strauss case became public ...

Shoosmiths LLP | February 2023

This week marks Children's Mental Health Week (6-12 February 2023). The focus on mental health has been increasing in recent years, with one in six children aged between five and 16 likely to have experienced mental health challenges. As a result, there are a growing number of workdays lost by parents, guardians, carers, and those with childcare responsibilities, to support and manage such challenges ...

Dinsmore & Shohl LLP | February 2023

On January 1, 2023, the Ohio Board of Nursing joined the multi-state Nurse Licensure Compact (“NLC”), allowing nurses who hold an Ohio nursing license to apply for a multi-state license.    Ohio has joined at least 37 other states that participate in the multi-state license ...

Dinsmore & Shohl LLP | January 2023

As previously discussed in our January 5, 2023 legal alert, the Pennsylvania Department of Human Services (“Pennsylvania DHS”) issued a Medical Assistance Bulletin (the “Bulletin”) in late December, 2022 that had the potential to put 340B savings at risk in Pennsylvania ...

On April 27, 2022,Republic Act No. 11712, or thePublic Health Emergency Benefits and Allowances for Health Care Workers Act(“RA 11712”), was signed into law in recognition of the critical role of health care workers in providing quality health care and ensuring disease prevention in the general population, especially during the pandemic. It seeks to promote the welfare of health care workers through the grant of mandatory benefits and allowances with utmost efficiency ...

With the decreasing number of positive COVID-19 cases, more employees are now returning to on-site work and new COVID-19 testing protocols are in place. The Inter-Agency Task Force for the Management of Emerging Infectious Diseases (“IATF”) provided guidelines for COVID-19 testing requirements for unvaccinated and partially vaccinated employees through its Resolutions No. 148-B and 149. Also, the National COVID-19 Immunization Program opened to the general public nationwide ...

Dinsmore & Shohl LLP | January 2023

On January 5, 2023, the Federal Trade Commission (“FTC”) issued a Proposed Rule that would prohibit employers from enforcing non-compete agreements against former employees, contractors, and other workers. Dinsmore & Shohl’s Labor and Employment Group’s legal alert on January 5, provides general information about the changes envisaged in the Proposed Rule ...

Shoosmiths LLP | January 2023

July 2022 saw the formal commencement of the UK Covid-19 Inquiry. Opened by Inquiry Chair Baroness Heather Hallett, we later witnessed preliminary hearings for Modules 1 and 2, held in October and November. As a reminder, Modules 1 and 2 cover the overarching topics of the UK’s pandemic preparedness and resilience, and core political and administrative decision-making throughout the UK (incorporating sub-modules for Scotland, Wales and Northern Ireland), respectively ...

Carey | January 2023

On January 17, 2023, the Institute of Public Health ("ISP") –by means of Res. Ex. No. 106– approved the Good Manufacturing Practice Guideline for Medical Devices and In Vitro Diagnosis Medical Devices (the "Guideline") ...

Shoosmiths LLP | January 2023

To help further the objectives of the Women’s Health Strategy for England (published by the Department of Health and Social Care in July 2022) £1.97m has been awarded to help women in the workplace who are experiencing reproductive health issues. The grant will be shared between 16 charities which include, amongst others, Fertility Network UK, Sands, Tommy’s and Mind ...

Shoosmiths LLP | January 2023

We have recently seen reports about the unbelievable amount of pressure on the NHS, including inaccessibility to GPs; a high degree of emergency admissions; and bed-blocking within hospitals where vulnerable patients cannot be discharged safely. These factors have exacerbated the pressure on our healthcare system to almost unprecedented levels. Medical technologies or MedTech could be the way forward to ease some of the pressure ...

Dinsmore & Shohl LLP | January 2023

The U.S. Department of Justice’s Office of Legal Counsel recently released an advisory opinion[i] regarding Section 1461 of title 18 of the U.S. Code. In it, they write the “Comstock Act”[ii] does not prohibit the mailing of certain medications used to perform abortions where the sender does not believe the medications will be used unlawfully. This opinion comes in the wake of the U.S ...

Shoosmiths LLP | January 2023

As the Covid-19 Inquiry reaches Module 2 of its timeline and it turns its attention to the political and administrative decisions made at the height of the pandemic, Shoosmiths looks at the history of public inquiries to reflect on their purpose and effectiveness in preventing future mistakes of the same kind. Reviewing previous public inquiries may inform us about the likely trajectory of the Covid-19 Inquiry ...

ALTIUS/Tiberghien | January 2023

Hemp seeds have been eaten in the EU for a long time. The seeds may contain trace amounts of tetrahydrocannabinol (THC) because this cannabinoid is a natural constituent of the cannabis plant from which the seeds originate. The EU regulator has decided to harmonize the maximum levels for THC in hemp seeds throughout the Union within the food contaminants framework. Commission Regulation 2022/1393 of 11 August 2022 amends the annex to Regulation No1881/2006 on food contaminants to this effect ...

Dinsmore & Shohl LLP | December 2022

On December 14, 2022, the National Labor Relations Board reinstated a previous test used to determine which employees must be included in an appropriate bargaining unit. In American Steel Construction, Inc., 372 NLRB No. 23 (2022), the Board overruled the test established in PCC Structurals, 365 NLRB No. 160 (2017), and The Boeing Co., 368 NLRB No. 67 (2019), opting to return to the test set forth in Specialty Healthcare & Rehabilitation Center of Mobile, 357 NLRB 934 (2011) ...

Shoosmiths LLP | December 2022

As applications for Module 3 Core Participant (CP) status drew to a close on 5 December 2022, the Inquiry team have announced two key dates, as we continue to monitor progress of the UK Covid-19 Inquiry. No timescales have been given as to when applicants will be informed of the outcome of their CP applications, with the only information provided being that the Inquiry Chair (Baroness Heather Hallett) will be reviewing and determining in 'due course' ...

Buchalter | December 2022

December 2, 2022 By: Anna G. Thomas To increase transparency regarding payments to physicians by drug and medical device companies, Governor Newsom signed AB 1278, which imposes certain additional disclosure obligations on physicians.  Beginning on January 1, 2023, physicians will be required to comply with new patient notice and posting requirements. Notice to Patients Under this law, physicians must provide to patients an Open Payments database notice ...

dots