Exeed Regulatory Compliance

FEBRUARY 25, 2020

According to a 2018 report from Deloitte , the IoMT market is expected to grow from $41 billion in 2017 to $158 billion by 2022. In this blog, we are focusing on a recently cleared innovation in the challenging space of diabetes management that highlights some of the key ingredients of success for innovative, connected medical devices.

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Healthcare Law Blog

FEBRUARY 1, 2022

In the attached article , we highlight some of the key legal considerations that the digital health industry can expect in the coming year from the perspective of: (1) telehealth related laws and regulations, (2) FDA, (3) privacy and cybersecurity, (4) fraud and abuse, and (5) antitrust issues.

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SQA

JULY 8, 2022

SQA Regulatory Surveillance Summary 2022 – May. Health Canada, Non-Compliant Drug Inspections, 1Q 2022. inspected on 25 January 2022: findings relate to premises, manufacturing control, quality control, sanitation, stability, raw material testing, equipment, and records ( West Penetone Inc. Health Canada. Observations ).

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Hall Render

SEPTEMBER 6, 2023

After no enforcement actions for the first six months of 2023, enforcement from the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) is heating up with two new letters issued in the month of August. Hall Render blog posts and articles are intended for informational purposes only.

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Health Law Advisor

AUGUST 2, 2022

My goal in nearly every device submission is to try to get through the FDA process with as little attention from FDA as possible. But when a seasoned person looks at it who has experience with FDA, their first thought is, do I really want FDA more involved in the process? Free advice! That’s not a criticism.

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Hall Render

OCTOBER 18, 2022

Defendant pharmaceutical manufacturers applied for and received approval from the FDA to manufacture Gamunex at a facility converted for that purpose. Grifols USA, LLC , 2022 WL 7785044, at *1 (2nd Cir. Hall Render blog posts and articles are intended for informational purposes only. United States ex rel. at *1 & fn.

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Hall Render

JULY 14, 2023

On June 7, 2023, the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first Untitled Letter of the year regarding violative promotional materials for a prescription drug indicated for the treatment of endogenous hypercortisolemia (high cortisol) in adults with Cushing’s syndrome.

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Health Law Advisor

FEBRUARY 1, 2023

Introduction Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar.

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Jane Sarashon

DECEMBER 27, 2021

In October 2021, the Consumer Technology Association (CTA) announced that Robert Ford, CEO and President of Abbott, would give a keynote speech at CES 2022, the world’s largest annual convention of the technology industry.

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Healthcare Law Blog

MAY 31, 2022

Medical devices are regulated by the Food and Drug Administration (“FDA”) and many of the applications and technologies used to deliver or access healthcare in the metaverse may be classified as a medical device. [3] 4] CDRH Proposed Guidances for Fiscal Year 2022 (FY2022) | FDA. [5] Medical Device Regulations. 1, 2021). [2]

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SQA

FEBRUARY 15, 2023

Relevant matters are hereby announced as follows: As of 01 December 2022, the Electronic Certificates of Documentation for Export of APIs to the EU and Certificate of a Pharmaceutical Product will be put into use. Efforts should be made to promote and guide the use of electronic certificates.

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Innovaare Compliance

JANUARY 15, 2024

The Prescription Drug Program, commonly known as Medicare Part D, is undergoing significant transformations in 2025 due to the Inflation Reduction Act (IRA) of 2022. This blog delves into the details of these changes and their implications for plan sponsors and beneficiaries. Rebates from the selected drugs may change.

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SQA

MAY 17, 2022

SQA Regulatory Surveillance Summary 2022 – Spring. Brazil’s ANVISA Issues Registration Rules for Software, 01 April 2022. ANVISA has published new regulations focused on software as a medical device (SaMD), set to take effect on 01 July 2022. Agência Nacional de Vigilância Sanitária (ANVISA).

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Hall Render

JANUARY 11, 2023

On December 7, 2022, the Federal Trade Commission (“FTC”) in conjunction with the U.S. The Tool is a result of collaborative efforts between the FTC, HHS Office for Civil Rights (“OCR”), HHS Office of the National Coordinator for Health Information Technology (“ONC”) and the Food and Drug Administration (“FDA”). Regulatory Landscape.

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Bill of Health

MAY 10, 2023

Only 14 states have fertility insurance coverage of IVF, and legislation in the 2021-2022 Congress on that score stalled. In addition, gay male donors are excluded from providing their sperm by the FDA. A vial of sperm can easily cost more than $1,000. And this is to say nothing of the costs of associated procedures.

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SQA

DECEMBER 16, 2022

SQA Regulatory Surveillance Summary for September and October 2022. ANVISA’s Questions & Answers (Q&A) on Medical Cannabis for Clinical Investigations, 14 September 2022. ANVISA published answers to questions received during an online seminar on clinical research of medicinal cannabis held in May 2022. 30 of 2022.

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Health Law Advisor

AUGUST 1, 2023

Both Colleen and Brad have decades of experience in FDA regulation, but we have different impressions on that topic, so we decided to inform the debate with a systematic look at the data. To tie the MDR data with the recall data, we are using K numbers, the numbers that FDA assigns during the course of a 510(k) review.

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Bill of Health

MARCH 28, 2022

Food & Drug Administration (FDA) encouraged several states to adopt policies that prioritized race or ethnicity in the allocation of monoclonal antibody treatments and oral antivirals for the treatment of SARS-CoV-2. In addition, a January 21, 2022 MMWR report concluded that Black patients with COVID-19 were 22.4% By James Lytle.

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Innovaare Compliance

MARCH 1, 2022

in 2022, which is partly offset by a cost-of-living increase of 5.9% The premium increase in 2022 was widely known to be attributable to the potential use of the Alzheimer drug, Aduhelm™ (aducanumab) by Medicare beneficiaries. [2] The monthly premium for Medicare Part B rose 14.5%, from $148.50 in 2021 to $170.00

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SQA

SEPTEMBER 2, 2022

SQA Regulatory Surveillance Summary 2022 – June. Brazil’s ANVISA Repeals Medical Device Regulations Related to The Coronavirus Pandemic, 20 May 2022. ANVISA Extends Brazilian Good Manufacturing Practice Requirements to More Medical Device Manufacturers, 27 May 2022 . By Laurel Hacche & Debra Cortner SQA Associates.

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Hall Render

AUGUST 10, 2023

CMS’s repayment is limited to hospitals that currently have a nursing and allied health training program (or had a training program as of December 29, 2022) and whose cost reports are currently not yet settled for these years or can be reopened. Hall Render blog posts and articles are intended for informational purposes only.

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YouCompli

MARCH 29, 2023

CMS Updates to beneficiary PHE waivers that matter to healthcare compliance Sharon Parsley, JD, MBA, CHC, CHRC, contributes regularly to the YouCompli blog. HHS also advises that daily COVID-19 cases are down 92%, and that COVID-19 related deaths are down more than 80% since the peak of the January 2022 Omicron variant surge.

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MedTrainer

JUNE 5, 2023

It’s the first USP standard that’s enforceable by State Boards of Pharmacy, OSHA, and the FDA. After years in limbo, USP <800> compliance will be required, effective November 1, 2023. It’s vital for organizations to have demonstrable evidence of compliance and documentation to prove alignment with all required standards.

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Healthcare Law Blog

JANUARY 20, 2023

The Food and Drug Administration (the “FDA”) has approved a modification to the Mifepristone Risk Evaluation and Mitigation Strategy (“REMS”) Program, increasing the accessibility of mifepristone for patients with a prescription. [1] Supreme Court held in Dobbs v. Jackson Women’s Health Organization that the U.S.

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Hall Render

MARCH 29, 2023

It is hard to believe that spring is finally here and the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) has yet to take any enforcement action in 2023. Untitled Letters allow a company to correct the violations without any further FDA action. Practical Takeaways Letters.

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Healthcare Law Blog

AUGUST 9, 2023

United States FDA , 2023 U.S. 5, 2022 Leg., 10, 2022). The information included in this article is current as of August 1, 2023, but it does not address all potential legal issues or jurisdictional differences, and the information presented may no longer be current. [1] for Hippocratic Med. LEXIS 61474, at *96 (N.D. 7, 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. Guidance Overview.

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SQA

AUGUST 8, 2023

In August 2022, ANVISA published Resolution RDC 741/2022 , which sets the framework to consider other medical device market regulators’ authorizations. The affected lots of Emerade were distributed in Canada between April 2022 and May 2023. Recalls All Lots of Emerade Epinephrine Auto-Injectors (0.3 mt and 0.5 mg and 0.5

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Health Law Advisor

DECEMBER 6, 2022

I thought this month might be an opportunity to show how two different FDA databases produce quite different results when they should be the same. For context, I should explain that I didn’t set out to find differences in the FDA data sets. I don’t know why, and frankly I hope the FDA changes that. Background.

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SQA

MAY 24, 2023

Following the draft consultation in November 2022, the NMPA announced the issuance of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility for the Quality and Safety of Medical Devices , which will come into force on 01 March 2023.

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Healthcare IT Today

DECEMBER 18, 2022

The Federal Trade Commission released an updated Mobile Health Apps Tool created with input from ONC, OCR, and the FDA. Frost & Sullivan recognized MEDITECH with the 2022 North America Enabling Technology Leadership Award , citing the EHR vendor’s work on clinical decision support.

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SQA

OCTOBER 18, 2023

National Medical Products Administration (NMPA) China GLP Certification Regulation Takes Effect, 01 July 2023 After consulting on the draft in 2022, the NMPA issued the Administrative Measures for Drug Good Laboratory Practice (GLP) Certification earlier this year.

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SQA

APRIL 12, 2023

SQA Regulatory Surveillance Summary for February 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Releases the Results of the 2022 Strategy, 31 January 2023 The ANVISA Strategy Performance and Results Evaluation Report is now available for consultation, for the year 2022.

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Healthcare Law Blog

JANUARY 12, 2022

Yesterday, Oak Street Health talked about its recent addition of behavioral health support and its launch of a comprehensive virtual care network in 2022. A biosimilar is a biologic that is highly similar to, and has no clinically meaningful differences from, an existing biologic medicine that is already approved by the FDA.

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Health Law Advisor

JUNE 1, 2023

For purposes of the rest of this blog post, I’m going to make it easy again. For purposes of this blog post, I’m simply going to illustrate a few obvious examples of how race might ultimately impact the effectiveness of these sepsis algorithms. The FDA has been pursuing a solution. [15] Consider three examples.

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SQA

DECEMBER 10, 2021

Regulators in Europe have updated their implementation plan for sweeping new in-vitro diagnostic (IVD) medical device regulations taking effect in 2022. Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products – General Principles, 15 September 2021. In-house devices. European Medicines Agency (EMA).

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Healthcare Law Blog

AUGUST 17, 2023

FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of Mifepristone in 2000, but reinstating the limitations and restrictions under the pre-2016 protocol. 2528 (2022). Judge Jennifer Walker Elrod wrote the majority opinion. FOOTNOTES [1] Texas v. Biden , 20 F.4th 4th 928, 951 (5th Cir.

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