HIT Consultant

NOVEMBER 21, 2021

ONC established eight categories of “reasonable and necessary” activities that would not constitute information blocking even where data is withheld. At its core, information blocking is a legal and compliance issue. Leigh Burchell, Vice President of Policy & Government Affairs, Allscripts. Study the exceptions framework.

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Healthcare Law Blog

NOVEMBER 10, 2023

INTRODUCTION Recent developments at the Federal Circuit and the USPTO can inform evolving patent strategy on medical technology. In one case, the Federal Circuit invalidated a patent relating to catheter insertion technology. In the second decision, the PTAB affirmed a final rejection of claims involving heart failure stratification.

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AIHC

JUNE 14, 2023

Artificial Intelligence & Regulatory Compliance Written by Joanne Byron , BS, LPN, CCA, CHA, CHCO, CHBS, CHCM, CIFHA, CMDP, COCAS, CORCM, OHCC, ICDCT-CM/PCS This article follows Part 1 - Basics of Artificial Intelligence (AI) and Healthcare Compliance published by AIHC on June 6, 2023. So, Who Regulates Healthcare AI?

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Compliancy Group

APRIL 7, 2022

In April of 2022, OCR issued a public Request for Information (RFI). Under this new Section 13412, when deciding to conduct an audit or issue a fine, the HHS Secretary must consider whether a covered entity or business associate has adequately demonstrated that it had recognized security practices in place for the previous twelve months. .

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HIPAA Journal

SEPTEMBER 5, 2023

The Act will impact a number of US-based healthcare IT companies and may influence future federal and state legislation in the United States. The Digital Services Act is a new EU law that updates the existing EU Electronic Commerce Directive.

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YouCompli

DECEMBER 14, 2022

This will help you understand the key issues facing them. I find that the more time I spend with colleagues during times of relative calm, the better our work together goes when an issue does arise. Build relationships with key clinical and operational areas. Meet regularly with nursing leadership. Physicians. I bet you have too.

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HIPAA Journal

NOVEMBER 18, 2022

healthcare industry is currently engaged in a cyber war against a widely dispersed set of adversaries, which include hordes of financially-motivated hackers and organized cybercriminal groups, hacktivists, and nation-state-sponsored threat actors. The Australian Federal Police (AFP) claims to know which group is behind the attack.

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Healthcare Law Blog

AUGUST 3, 2023

As we previewed in our blog article in March on the establishment of California’s new Office of Health Care Affordability (OHCA), OHCA has issued proposed regulations available on the OHCA website, that provide anticipated details on OHCA’s advance review authority regarding certain transactions in the healthcare space.

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SQA

FEBRUARY 15, 2023

From 01 December 2022, all provincial-level drug regulatory authorities shall issue the Certificate of a Pharmaceutical Product in accordance with the new template. The electronic certificate and the paper version are equally authentic. Efforts should be made to promote and guide the use of electronic certificates.

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Health Blawg

JANUARY 16, 2019

There’s an RFI out right now, published as part of the federales’ “ Regulatory Sprint to Coordinated Care ,” announced by HHS Secretary Alex Azar in mid-2018. Well, that moment has arrived (maybe). Hey, coordinated care is a good idea. We can all agree on that. The HIPAA RFI came next. The regs were finalized in 2003.)

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Health Blawg

JANUARY 16, 2019

There’s an RFI out right now, published as part of the federales’ “ Regulatory Sprint to Coordinated Care ,” announced by HHS Secretary Alex Azar in mid-2018. Well, that moment has arrived (maybe). Hey, coordinated care is a good idea. We can all agree on that. The HIPAA RFI came next. The regs were finalized in 2003.)

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YouCompli

JUNE 14, 2023

This article considers the government’s increasing interest in patient rights in relationship to covered entities or business associates and what proactive compliance officers can do to fulfill those obligations through effective monitoring. A business associate is defined at 45 C.F.R. The variables are in the details.

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Healthcare Law Blog

MAY 16, 2022

On April 29, 2022 , the Centers for Medicare and Medicaid Services (“CMS”), issued the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Final Rule”). With a few exceptions, the Final Rule is a wholesale codification of the proposed rule.

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Hall Render

JULY 14, 2023

On Friday, June 20, 2023, the Centers for Medicare & Medicaid Services (“CMS”) posted a pre-publication copy of the Calendar Year (“CY”) 2024 Home Health Prospective Payment System Rate Update (“PPS Rule”), which has since been published in the Federal Register and is currently open for comment. in June 2022.

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Bill of Health

JULY 28, 2022

The Journal , which is published by Oxford University Press, is the first fully open-access, peer-reviewed legal journal to focus on these issues. The following excerpts highlight the cutting-edge scholarship published in the Journal ‘s most recent issue, which closed in June 2022.

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SQA

DECEMBER 16, 2022

SQA Regulatory Surveillance Summary for September and October 2022. This guidance will help applicants interpret how to implement Essential Principles of Medical Device Safety and Performance using information that was issued in March 2020. Agência Nacional de Vigilância Sanitária (ANVISA). CMDE Announcement No. CMDE Announcement No.

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SQA

MAY 24, 2023

The objective is to reinforce actions for the prevention and control of diseases such as dengue and chikungunya, arboviruses transmitted by the Aedes aegypti mosquito. For this, it is necessary to maintain regular active surveillance and vector control so that the risk of disease transmission is reduced.

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SQA

APRIL 30, 2021

SQA Regulatory Surveillance Summary #3, 2021. The main export destinations include the United Kingdom, Canada, Mexico, Japan, Saudi Arabia, Hong Kong, Singapore, United States, Chile, and Malaysia. These APAs commit the vaccine producers to deliver to EU Member States a pre-agreed number of vaccines.

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Health Law RX

JULY 18, 2023

On June 27, 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued its long-anticipated final rule amending the OIG’s civil monetary penalty (CMP) regulations as they relate to information blocking (CMP Final Rule or Rule). The CMP Final Rule was published in the Federal Register on July 3, 2023.

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Healthcare Law Blog

JANUARY 12, 2022

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Comments on the draft guidance are due on March 23, 2022.

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Health Law Advisor

JUNE 1, 2023

Would it surprise you if I told you that a popular and well-respected machine learning algorithm developed to predict the onset of sepsis has shown some evidence of racial bias? [1] 1] How can that be, you might ask, for an algorithm that is simply grounded in biology and medical data? Averages. Okay, now you know all the math you need to know.

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Hall Render

AUGUST 12, 2022

On July 15, 2022, the Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) announced its resolution of eleven separate investigations against covered entities for violations of the individual’s right of access under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

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C&M Health Law

FEBRUARY 16, 2021

On November 13, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule , demonstrating long-awaited efforts to streamline the regulatory framework governing the Medicaid and Children’s Health Insurance Program (“CHIP”) managed care programs. State-directed Payments. Risk-sharing Mechanisms.

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HIT Consultant

JULY 28, 2022

Act III of COVID: Navigating the Crosscurrents of Post-Inflation. 2022 ushered in Act III of the market’s latest transitionary period: The Post-Inflation Era. Since 2008, the US economy functioned with remarkably low inflation and interest rates. As the cost of capital went lower and lower during the decade, valuations steadily rose.

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Health Law Advisor

AUGUST 10, 2023

In that regard, last September, FDA issued a final guidance on when and how FDA regulates Clinical Decision Support, or CDS, software tools because FDA considers them to be a medical device under FDA’s jurisdiction. [2] That said, it is equally important that federal regulation not duplicate state regulation of the practice of medicine.

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Kaiser Health News

MARCH 17, 2023

These proposed regulations — and others in at least 11 more states, according to the American Staffing Association industry trade group — come after demand for travel nurses, who work temporary assignments at different facilities, surged to unprecedented levels during the worst of the covid-19 pandemic.

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Healthcare Law Blog

NOVEMBER 13, 2023

The Proposed Rule covers an array of regulatory topics including the Star Ratings program, marketing and communications, agent and broker compensation, health equity, dual eligible special needs plans (“D-SNPs”), utilization management, network adequacy, and access to biosimilars. Below is a summary of some of the Proposed Rule’s key changes.

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SQA

OCTOBER 18, 2022

SQA Regulatory Surveillance Summary for July and August 2022. Based on information to date, the issue appears to be limited to one manufacturer, Health Advance Inc., Health Canada. Counterfeit COVID-19 Antigen Rapid Test Kits Found in Ontario, 05 August 2022. products in color and typeface and uses the BTNX Inc. Health Advance Inc.

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US Department of Health and Human Services FDA COVID-19 Compliance 40

Kaiser Health News

MARCH 17, 2023

These proposed regulations — and others in at least 11 more states, according to the American Staffing Association industry trade group — come after demand for travel nurses, who work temporary assignments at different facilities, surged to unprecedented levels during the worst of the covid-19 pandemic.

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Nurses Hospitals COVID-19 Governance 52

Kaiser Health News

MAY 13, 2022

They were expressing concerns about the privacy of this information — especially for people who live in states with strict limits on abortion — and how it might be used against them. ” said Lucia Savage, chief privacy and regulatory officer for Omada Health, a digital therapeutics company. “Now.” We asked the experts.

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SQA

FEBRUARY 26, 2024

The products found, subject to retention and seizure, were retained by the Federal Revenue Service. The products had been improperly regularized in ANVISA as cosmetics since they are indicated for injectable use, a form that is not authorized for this category of product. and Biometik Indústria e Comércio de Cosméticos.

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Health Law Advisor

JULY 21, 2023

Notably, CMS stated that the agency only anticipates accepting five candidates to participate in the TCET pathway each year. [2] 8] Policymakers across the federal government from both sides of the aisle have actively sought to establish a solution to address the absence of a clear and timely pathway to breakthrough device coverage.

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Kaiser Health News

JANUARY 12, 2023

” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A-Z,” now in its third edition. But the move highlights how abortion is sure to remain a high-visibility issue in the nation’s capital. Cathy McMorris Rodgers (R-Wash.)

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Kaiser Health News

FEBRUARY 9, 2023

” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition. Health care was a recurring theme throughout President Joe Biden’s 2023 State of the Union address on Capitol Hill this week.

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Drug & Device Law

MARCH 6, 2024

Last week we read a couple of online articles, including in the ABA Journal, about the unique questioning style of United States Senator John Kennedy (R- Louisiana) when it comes to federal judicial nominees. Understandably, they decline to predict how they would decide specific issues. It becomes an empty exercise.

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Drug & Device Law

JANUARY 9, 2023

555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. First, it claims to find “helpful guidance,” id. at *7, in Wyeth v. Levine , 555 U.S. 379r(e). 2022 WL 17348351, at *4. Albrecht , 139 S. 2019), and Levine.

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Drug & Device Law

APRIL 28, 2022

State and local government entities from very different parts of the country might want leeway in regulating things like the volume or time of demonstrations. This past weekend, there was an NCAA Division I clash of athletic teams ranked #5 and #7, respectively, that included two children of two different authors of this Blog.

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