MedTrainer

JUNE 5, 2023

After years in limbo, USP <800> compliance will be required, effective November 1, 2023. It’s the first USP standard that’s enforceable by State Boards of Pharmacy, OSHA, and the FDA. What’s Needed for USP <800> Compliance?

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Hall Render

SEPTEMBER 14, 2023

On May 2, 2023, in a move intended to accelerate the adoption of digital health technologies, the U.S. Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices.

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Hall Render

SEPTEMBER 15, 2023

In June 2023, the Food and Drug Administration (“FDA”) released Draft Guidance outlining its current view of the psychedelic research landscape. While the FDA does not define psychedelics, it indicated that the shorthand term “psychedelic” includes “classic psychedelics,” which are typically understood to be 5-HT2 agonists (e.g.,

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HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. Beginning later this year and continuing into the first half of 2023, however, these products will likely start to appear. 4 And compliance decrease over time. . – What new opportunities will arise? Introducing OTC hearing aids. Potential pitfalls.

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HIT Consultant

APRIL 4, 2023

What You Should Know: 2023 started off with the hallmarks of a rebound year. Q1 Funding Soars, But 2023 May Struggle to Catch Up to 2019 Q1 2023 U.S. If funding for the next three quarters matches the average funding across the prior three quarters, 2023 is on pace for the lowest level of annual funding since 2019.

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FDA Medicaid Medicaid COVID-19 52

AIHC

JUNE 6, 2023

OpenAI’s ChatGPT 2023 & the National Institutes of Health AI is developing at lightning speed. OpenAI’s ChatGPT 2023 & the National Institutes of Health AI is developing at lightning speed. This is certainly an area where advanced technology is needed to reduce overhead, improve compliance and reduce billing errors.

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Compliance Medical Billing HIPAA Due Diligence 59

Hall Render

OCTOBER 5, 2023

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. study sponsor, regulatory agencies, etc.)

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AIHC

JUNE 6, 2023

OpenAI’s ChatGPT 2023 & the National Institutes of Health AI is developing at lightning speed. OpenAI’s ChatGPT 2023 & the National Institutes of Health AI is developing at lightning speed. This is certainly an area where advanced technology is needed to reduce overhead, improve compliance and reduce billing errors.

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52

Hall Render

JUNE 5, 2024

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. Stage 3: Effective May 6, 2027 Three years after the Final Rule’s publication, the FDA will enforce all remaining quality system requirements (under 21 C.F.R.

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Hall Render

FEBRUARY 7, 2023

On January 3, 2023, the U.S. February 9, 2023 UPDATE : A number of lawsuits have been filed challenging FDA’s approval of mifepristone and the REMS. Overview Since 2000, mifepristone (brand name Mifeprix) has been FDA approved for the medical termination of pregnancy through ten weeks’ gestation.

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HIT Consultant

APRIL 12, 2024

What You Should Know: – Philips Respironics , a subsidiary of Royal Philips, has finalized a consent decree with the US Department of Justice (DOJ) and Food and Drug Administration (FDA) to address issues raised during a 2021 inspection of a Philips facility in Pennsylvania. These costs are estimated at 100 basis points in 2024.

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HIT Consultant

MARCH 14, 2024

Nasdaq Delisting Better Therapeutics previously disclosed the potential delisting of its stock from the Nasdaq Stock Market due to non-compliance with listing standards. The Company developed a proprietary platform for the development of FDA-regulated, software-based solutions for T2D, heart disease and other conditions.

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FDA Compliance 97

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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Healthcare IT Today

SEPTEMBER 3, 2023

In a report , the Digital Medicine Society identified three priorities for successful digital health product innovation: Alignment between the FDA and payer decision-makers, alternate pathways to market for novel products, and better coordination among FDA business units. Sales Banner Health chose nference for biomedical data analysis.

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SQA

FEBRUARY 15, 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 of the Quality and Safety of Medical Devices , which will come into force on 01 March 2023. The ongoing training of personnel was inadequate.

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Healthcare Law Today

JANUARY 11, 2023

On January 4, 2023, the Department of Justice issued a press release stating that Jet Medical Inc. Food and Drug Administration (FDA) prior to distribution. The lawsuit alleged that the device was not approved or authorized by the FDA and that the procedure was not covered by Medicare. and Martech Medical Products Inc.,

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FDA Governance Medicare Medicare 59

Natalia Mazina

JUNE 26, 2023

counterfeit, unapproved, or potentially dangerous)) Notification (trading partners must notify FDA if they suspect that the product is illegitimate). The Act sets six compliance deadlines. The last one is coming up on November 27, 2023 and pertains to enhanced product tracing.

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Compliance FDA 52

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. Much has happened since then.

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FDA HIPAA Compliance Regulatory Compliance 45

Verisys

SEPTEMBER 21, 2023

A big thanks to our compliance team, who monitors state, federal, and international updates. PA Nurse Licensure Compact Washington: As of July 24, 2023, nurses who hold an active, unencumbered license via the Nurse Licensure Compact (NLC) are able to practice in the state of Washington. Here is our monthly regulatory update.

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Licensing Nurses FDA Compliance 52

Healthcare IT Today

NOVEMBER 12, 2023

RapidAI received FDA clearance for Rapid SDH , which helps to detect bleeding in the brain. Health Payment Systems selected Madaket Health to manage its provider directory and roster requirements for No Surprises Act compliance. Healthcare consumer data vendor Freshpaint launched its Healthcare Privacy Platform.

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Natalia Mazina

DECEMBER 13, 2023

Since the new United States Pharmacopeia (USP) guidelines went into effect on November 1, 2023, I have been receiving many inquiries regarding their impact on compounders. This post answers some of these questions by summarizing major changes and discussing some of the pitfalls on the way to compliance.

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Compliance Hospitals FDA Governance 52

HIT Consultant

MAY 30, 2024

The deadline stipulated by the DSCSA has passed in November 2023. Presently, we are in a “stabilization period” where the FDA is temporarily exercising enforcement discretion for specific requirements of the DSCSA. The role of simulation technology in the pursuit of DSCSA compliance As companies in the U.S.

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Healthcare IT Today

AUGUST 28, 2023

Regarding medication, several new psychiatric treatments have been approved by the FDA, including Auvelity for major depressive disorder, the SAINT transcranial magnetic stimulation protocol for treatment-resistant depression, and Zurzuvae for postpartum depression. The No Surprises Act was signed into law in 2020 and took effect last year.

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US Department of Health and Human Services Telemedicine Hospitals Compliance 117

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. As a result, the COVID-19 public health emergency (PHE) declared under Section 319 of the Public Health Service act, is expected to end officially on May 11, 2023.

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Public Health COVID-19 COVID-19 Vaccine Medicare 52

Healthcare IT Today

JUNE 7, 2023

Many of our concerns center on the proposed implementation timeframes associated with various concepts included in HTI-1, as well as ONC’s failure to sufficiently consider the burden compliance will place on provider organizations and health IT developers. 31, 2024, compliance timeline is unrealistic.

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FDA Compliance Regulatory Compliance Medicaid 97

HIT Consultant

JANUARY 3, 2023

While Valencell was established as a technology provider in consumer sports and fitness wearables, its foundational technology has the potential to realize the dream of seamless chronic disease management through easy-to-use, high-compliance digital health solutions. Meeting Demands Under Pressure.

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FDA Compliance 98

HIT Consultant

JUNE 11, 2023

Last December, the US Consolidated Appropriations Act, 2023 gave the Food and Drug Administration 90 days to come up with compulsory instructions imposed on medical device manufacturers to implement cybersecurity best practices as part of their software development lifecycle and lifelong support policies.

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Dot Compliance

APRIL 14, 2023

McKinsey, Jan 2023) Among MedTech executives surveyed, 91% believe emerging technologies, including cloud and AI, will have a positive impact on their organizations. But a manager faced with 100 data points, all requiring investigation, creates a tremendous problem for the company in the modern quality and compliance space.

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FDA Compliance 52

Innovaare Compliance

JANUARY 15, 2024

6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D. With a team of compliance specialists, Inovaare provides in-depth technical expertise and compliance preparedness evaluation, guidance, and support.

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Medicare Medicare Compliance FDA 52

Healthcare IT Today

JANUARY 8, 2024

The excitement around new tools took hold of all industries in 2023, and the potential is expansive. It is key for pharmaceutical companies to recognize that efficiency does not override compliance, patient safety or regulatory standards. There are considerable risks to adoption that may have deep compliance implications.

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SQA

AUGUST 8, 2023

The new standard, RDC 786/2023 , was published in the Official Gazette on 10 May 2023 and will enter into force on 01 August 2023, but establishments will have up to 180 days to comply with the updated rules. The rules of RDC 786/2023 correspond to a normative update, which replaces RDC 302/2005.

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FDA Compliance COVID-19 World Health 40

SQA

OCTOBER 18, 2023

The measure, adopted through Resolution – RE 2910/2023 , was made after the Agency was informed by the Sanitary Surveillance of Goiás about the occurrence of serious adverse events associated with the incorrect use of the products.

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FDA Compliance Licensing World Health 40

SQA

MAY 24, 2023

ANVISA Resumes Inspections in the Area of Technovigilance, 29 March 2023 In partnership with local Health Surveillance, ANVISA technical teams carried out in March 2023 two (2) medical device manufacturer inspections with an aim to strengthen the monitoring of these products in Brazil, ensuring their safety, performance, and quality.

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Healthcare IT Today

AUGUST 21, 2023

billion in 2022, RFID in the global healthcare market is projected to grow at a CAGR of 17.85% from 2023 to 2030. FDA’s Drug Supply Chain Security Act (DSCSA). Its ability to provide real-time information and automate processes has increased its adoption in the healthcare industry. Valued at USD 3.95

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HIPAA Regulatory Compliance Hospitals FDA 98

SQA

JUNE 10, 2021

ANVISA has also released a set of 106 proposals for Regulatory Projects that will compose the 2021-2023 Regulatory Agenda. As such, manufacturers and importers that have already submitted their applications to CDSCO may continue marketing their devices in India as they prepare for compliance.

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FDA COVID-19 COVID-19 Vaccine Compliance 52

HIPAA Journal

OCTOBER 21, 2022

Compound prescription medications are not FDA approved but can be legally prescribed by a physician who determines that standard medications are not appropriate for a particular patient. He is due to be sentenced on Feb. Alario faces up to one year in jail and a $50,000 fine for his role in the scheme.

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Fraud HIPAA FDA Health Insurance 62

Healthcare Law Today

NOVEMBER 9, 2022

Starting January 1, 2023, Medicare will cover telehealth-based treatment services delivered by federally-accredited opioid treatment programs (OTPs), commonly referred to as “methadone clinics.” Details of the new coverage rules are contained in the 2023 Physician Fee Schedule (PFS) Final Rule (Final Rule), and summarized below.

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