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Wardynski & Partners | July 2022

Persons using medical services in Poland are subject to special legal protection. Regardless of their nationality, all patients have the same rights. Our guide explains the key patient rights and legal solutions concerning citizens of Ukraine. A guide prepared by Małgorzata Sokołowska and Natalia Falęcka-Tyszka from the firm’s Healthcare practicehttps://wardynski.com.pl/upload/2022/04/realizacja-swiadczen-opieki-zdrowotnej_en ...

Waller | April 2020

The Coronavirus Aid, Relief, and Economics Security Act (the “CARES Act”) added an additional $100 billion to the Public Health and Social Services Emergency Fund (the “Relief Fund”) to provide funding to healthcare providers responding to the coronavirus pandemic ...

Carey | July 2021

As of today, July 26 the Chilean borders will open so that all those who have a “Mobility Pass” can exit the country, although current restrictions for non-resident foreigners have been maintained. The is subject to modification in view of the development of the Covid-19 outbreak in the national territory ...

Waller | August 2011

Three proposed rules for the establishment of Affordable Insurance Exchanges – intended to create competitive marketplaces for private health insurance and a key component of the healthcare reform legislation enacted in March 2010 – were released today by Departments of Health and Human Services and Treasury ...

Dinsmore & Shohl LLP | November 2018

Recently, the Ohio Department of Medicaid (ODM) proposed the adoption of Ohio Administrative Code 5160-1-32.1 (the Proposed Rule), which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA privacy rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information ...

Waller | February 2017

In one of the first concrete developments related to the Affordable Care Act (ACA) changes following Dr Thomas E Price’s approval as Secretary of the Department of Health and Human Services (HHS), a Notice of Proposed Rule making was recently released by HHS. The recent release by HHS stated a goal of helping to stabilize the individual and small group marketplaces established by the ACA ...

Wardynski & Partners | March 2012

At the end of 2011 the Polish utility sector received a present from the government in the form of a long-awaited package of proposed energy legislation. How could it change the rules of the market? February was the deadline for public comment on a legislative package including the proposed new Energy Law, Gas Law and Renewable Energy Sources Act ...

Dinsmore & Shohl LLP | January 2020

In December of 2019, the State of Ohio Board of Pharmacy (“Board”) proposed rule changes for medical marijuana dispensaries. These proposed rule changes came on the heels of increased regulatory scrutiny of ownership structures and consulting arrangements in recent months.1 The proposed rules ostensibly seek to revise and clarify the Board’s position on changes of ownership and control of medical marijuana dispensaries ...

Waller | January 2021

The regulatory change proposed by the Department of Health and Human Services (HHS) in the recent HIPAA Notice of Proposed Rulemaking (NPRM) is another step toward HHS’s objective to encourage a patient-centric healthcare environment. The HIPAA NPRM proposes to tilt the balance of protecting privacy and facilitating the availability of information toward loosening restrictions on disclosures of patient information ...

More than three years after initial publication, the State Medical Board of Ohio's proposed revisions to its light-based device (laser) rules are now advancing toward possible enactment, as the Medical Board has announced amendments to the proposal and scheduled public rules hearing for May 17, 2021 ...

Hanson Bridgett LLP | February 2019

On February 13, 2019, Assembly Member Ash Kalra, District 27 (San Jose), introduced AB-506. If passed, AB-506 would amend California Health and Safety Code Sections 1423, 1424, and 1424.5 to grant the Department of Public Health the authority to issue more citations and higher penalty amounts ...

Wardynski & Partners | April 2012

The proposed new Renewable Energy Sources Act would significantly change the system of support for electricity produced in Poland from renewable resources. If the bill is enacted, companies in the power industry in Poland will have to make major revisions to their business plans ...

Asters | October 2013

In 2012, the Ukrainian government has conducted three tenders for production-sharing agreements (hereinafter - SRS) in respect of hydrocarbons that will be produced on land for 2 subsurface areas and in one section of the Black Sea shelf ...

Shoosmiths LLP | October 2023

Module 5 will assess the robustness and effectiveness of procurement processes, the adequacy of items obtained (including their specification, quality, and volume) and the effectiveness of their distribution. It will also consider the UK-wide procurement of lateral flow and PCR tests. The provisional scope for this module lists three key areas of investigation ...

Lavery Lawyers | September 2014

In an unanimous decision dated September 4, 20141 , the Court of Appeal confirmed that the 45-day time limit under the Act Respecting Health Services and Social Services2 (ARHSSS) to allow the medical examiner and the local service quality and complaints commissioner to process a user complaint is not mandatory but rather serves to indicate that the Legislator intends the complaint to be diligently processed ...

Shoosmiths LLP | July 2011

On 1 October 2011 all private sewers and lateral drains in existence on 1 July 2011 that drain to the public network will transfer to the ownership of the water and sewerage companies. This transfer will apply to residential and commercial properties in England and Wales. It will bring about the biggest change in responsibility for sewerage services since 1937 ...

Hanson Bridgett LLP | September 2020

Key Points HHS Provider Relief Fund payments are being extended to private pay assisted living facilities under Phase II. Relief will be equal to 2 percent of annual gross revenue from resident care. Interested providers must act swiftly: the deadline to submit basic information to HHS is Sept. 13 Provider relief funds need not be repaid if recipients comply with the program criteria. HHS Announcement: On Sept.1, the U.S ...

Waller | October 2021

On October 14, 2021, the Massachusetts Attorney General’s Office announced a $25 million healthcare fraud settlement against a private equity firm and former executives of the firm’s portfolio company. The settlement is significant because it is the largest healthcare fraud settlement in the country to date against a private equity firm based on the firm’s oversight of its healthcare portfolio company ...

Dinsmore & Shohl LLP | January 2020

The Centers for Medicare & Medicaid Services (CMS) recently released a final rule, which will require hospitals to publicly disclose pricing information, effective January 1, 2021 ...

PLMJ | July 2022

Impact on the activity of the pharmaceutical industry At the end of 2021, two laws were published to regulate the general framework for the prevention of corruption in the activity of companies: (i) Decree-Law 109-E/2021 of 9 December, which establishes the general rules for the prevention of corruption (“RGPC”) and (ii) Law 93/2021 of 20 December, which creates rules to protect whistleblowers (“RJPDI”) ...

Haynes and Boone, LLP | August 2015

The FDA recently issued final guidance regarding the size, shape, and other physical characteristics of generic-manufactured tablet and capsule dosage forms. The guidance noted that differences in physical characteristics of a dosage form could affect patient compliance and acceptability of medication regimens, or could lead to medication errors. The main reason for the FDA’s guidance appears to be that many patients can experience difficulty swallowing tablets and capsules ...

Dinsmore & Shohl LLP | September 2021

President Joe Biden announced Thursday, Sept. 9, that in the coming weeks, companies with 100 or more employees will be required to ensure their employees are vaccinated against COVID-19 or test negative for COVID-19 at least once a week.[1] Additionally, employers must provide employees time off to get vaccinated and to recover from any side effects. Press Secretary Jen Psaki previewed the forthcoming requirements in her briefing to the press on Thursday ...

Hunton Andrews Kurth LLP | December 2012

The U.S. District Court for the Eastern District of Virginia recently overturned the United States Patent & Trademark Office ("USPTO") interpretation of the patent term adjustment ("PTA") statute in Exelixis, Inc. v. Kappos. Similar to Wyeth v. Kappos, where a previous USPTO interpretation of the PTA statute was overturned, the Exelixis decision promises to add months and even years to the patent term of many patents ...

Dinsmore & Shohl LLP | March 2024

At any hour, your company is vulnerable to cybercriminals aiming to cripple your operations. The repercussions are vast, from productivity loss to compromising sensitive information, which erodes trust with customers and employees alike. The financial toll and reputational harm can be severe and lasting. Whether facing a widespread assault or a precise strike, these attacks are escalating in frequency, sophistication and financial impact ...

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