Compliance Now

JULY 15, 2022

The letter that the Departments recently released reminds insurance carriers and employers with non-grandfathered group health plans of their obligations under the ACA’s preventive service requirements to cover, at no cost to the participant, at least one form of contraception within each of the 18 contraceptive categories that the U.S.

ACA 100

ACA FDA Compliance 100

Exeed Regulatory Compliance

MARCH 22, 2020

A new FDA guidance provides much-needed relief during a pandemic. FDA has just revised its relatively less known 2012 guidance entitled “Post-market Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” to clarify that the guidance is applicable to any pandemic, not just an influenza pandemic.

FDA 52

FDA Nursing Homes Compliance COVID-19 52

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

FDA 60

FDA HIPAA Compliance 60

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

FDA 60

FDA HIPAA Compliance 60

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

FDA 60

FDA HIPAA Compliance 60

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

FDA 60

FDA HIPAA Compliance 60

Health Law Advisor

JULY 11, 2023

Word Embeddings If you’re one of my three regular readers, you might remember that I’ve already introduced word embeddings I trained on FDA records. In February 2023, I wrote a post on using NLP to assess FDA’s compliance with notice and comment in guidance development. [1] Instead, I’m going to look for bias in other topics.

FDA 40

FDA Hospitals Compliance 40

Natalia Mazina

DECEMBER 13, 2023

This post answers some of these questions by summarizing major changes and discussing some of the pitfalls on the way to compliance. Summary of the 2023 USP Changes: The latest update went into effect on November 1, 2023 and still causes many questions, such as when compliance is due. Full compliance was due back on November 1, 2023.

Compliance 52

Compliance Hospitals FDA Governance 52

Dot Compliance

MARCH 30, 2022

Companies that manufacture pharmaceutical, medical, and biotechnology products are required to achieve compliance with an array of safety regulations and quality standards. The bar chart of your defect categories is arranged in descending order, and the line graph is added to track the cumulative percentage total. Source: [link].

FDA 52

FDA Compliance 52

HIT Consultant

JANUARY 21, 2022

– The Series B funding will allow Casana to accelerate FDA submission of the Heart Seat with the goal to obtain FDA approval and bring this important new device to patients in 2022. The biggest challenge for most home health monitoring devices is poor patient compliance. Novel Effortless Home Health Monitoring.

FDA 96

FDA COVID-19 Doctors Compliance 96

Compliance Now

AUGUST 1, 2022

Covered plans are required to automatically cover a least one form of contraception in each of the categories below without applying medical management. Other types of contraceptive services or products approved by the FDA must also be covered, even if they do not fall into one of the categories listed above. Medical Management.

FDA 100

FDA Medicare Medicare Governance 100

Health Law Advisor

MAY 3, 2022

We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Further, from a warning letter standpoint, without inspection data, FDA focused in other compliance realms than it typically might. Just a short while ago FDA recommenced inspections.

FDA 52

FDA Compliance 52

HIT Consultant

SEPTEMBER 26, 2023

What You Should Know: Exo (pronounced “echo”), a medical imaging software and device company, today unveiled a category-redefining handheld ultrasound device, Exo Iris™, to put high-performance medical imaging into the hands—and pockets—of every caregiver. They can also store exams on Exo’s secure cloud environment.

FDA 119

FDA Nurses Hospitals Compliance 119

Dot Compliance

APRIL 14, 2023

Falling under the category of machine learning (ML), generative AI is a category of algorithms that generate content (e.g., 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.

FDA 52

FDA Compliance 52

HIT Consultant

JUNE 11, 2023

The reason is that embedded IoT devices – which both categories are part of – carry significant volumes of legacy software and run on limited-power computing hardware. Like the UN regulations, manufacturers who could not prove their compliance with the cybersecurity best practices would be blocked from selling their medical devices.

FDA 95

FDA Compliance 95

Health Law Advisor

FEBRUARY 1, 2022

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

FDA 52

FDA Compliance 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. The post Part 2: Who Regulates Healthcare AI?

FDA 45

FDA HIPAA Compliance Regulatory Compliance 45

Dot Compliance

FEBRUARY 8, 2022

To determine whether a particular software falls under the category of SaMD or whether it is considered a member of one of the three other subclasses, two questions must be answered: Does the software provide a direct medical benefit when used (correctly), and can it place the patient at risk if it is used incorrectly or malfunctions?

FDA 52

FDA Compliance 52

SQA

FEBRUARY 26, 2024

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. The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot.

FDA 52

FDA Compliance COVID-19 Public Health 52

Dot Compliance

OCTOBER 10, 2022

When the product itself cannot be examined, process validation guarantees that the procedures used to make the device comply with FDA rules. From 2011 to 2015, the top FDA warning letter citation for design controls was design validation. Dot Compliance and Medical Device Validation. Contact Dot Compliance.

FDA 52

FDA Compliance 52

Dot Compliance

OCTOBER 10, 2022

When the product itself cannot be examined, process validation guarantees that the procedures used to make the device comply with FDA rules. From 2011 to 2015, the top FDA warning letter citation for design controls was design validation. Dot Compliance and Medical Device Validation. Contact Dot Compliance.

FDA 52

FDA Compliance 52

SQA

OCTOBER 18, 2022

The entire shipment, which contained 435 boxes of the 25-pack, was sent to Health Canada for compliance follow-up. After this date, the CAP’s compliance team will remove non-compliant ads using targeted software, and those who continue to promote it may be referred to the MHRA for further enforcement action. Health Advance Inc.

US Department of Health and Human Services 40

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

SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

Healthcare IT Today

AUGUST 9, 2022

Data analytics can be broken down into four distinct categories — diagnostic, descriptive, prescriptive and predictive — all of which analyze both current and historical data to predict certain outcomes as they relate to an individual. Another use of AI in the healthcare industry surrounds data analytics. Overall Recommendations .

Informed Consent 123

Informed Consent FDA Hospitals Compliance 123

Dot Compliance

JANUARY 20, 2023

With 95% of life sciences executives surveyed saying the development of innovative products is their focus for 2023, quality management will be a top priority to reduce risks and costs, increase regulatory compliance, and accelerate the product development lifecycle. Because most RWD comes in the form of unstructured data (e.g.,

Regulatory Compliance 52

Regulatory Compliance Compliance FDA 52

SQA

MAY 24, 2023

The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers.

FDA 40

FDA Licensing Governance Compliance 40

Healthcare Law Today

NOVEMBER 9, 2022

In 2020, CMS established a new Part B benefit category for opioid use disorder (OUD) treatment provided by OTPs. The covered benefit includes MAT for patients with OUD, a leading treatment modality that combines prescribing FDA-approved medication (e.g.,

Medicare 52

Medicare Medicare COVID-19 Telemedicine 52

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

US Department of Health and Human Services 40

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

Healthcare Law Blog

NOVEMBER 13, 2023

This proposal would shift the burden from CMS to the MA organization to demonstrate compliance with this standard. As a result, the substitution of biosimilar biological products, the broader category of substitute products which still includes interchangeable biological products, for the reference product would be a “maintenance change.”

Medicare 59

Medicare Medicare Medicaid Medicaid 59

Exeed Regulatory Compliance

FEBRUARY 24, 2020

It is helpful to make a master hazards list under different categories so you can evaluate them holistically within the scope of a given medical device. It is not unusual to see “Other” as one of the most frequently used complaint codes because a reported condition may not always fall under any of the exiting categories.

FDA 52

FDA 52

Hall Render

FEBRUARY 16, 2024

CALIFORNIA 8 ASCs opening in Florida, California and New York A bankrupt California hospital left a health care desert. medical office sale in Bridgewater Low pay in primary care is leading to a care crisis in New Jersey N.J. hospitals are offering higher pay, flexible hours, and even child care to retain workers, survey finds St.

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Drug & Device Law

MARCH 6, 2024

We’d like to ask candidates to state the amount of the national debt, list the countries bordering Ukraine, describe what product categories are the U.S’s biggest exports, explain price elasticity, etc. (In If the expert is trashing regulatory compliance, let’s see if that expert knows which people at the company and FDA were involved.

Regulatory Compliance 98

Regulatory Compliance FDA Compliance 98

Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

Compliance 52

Compliance FDA Governance State Policy 52

Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” without adversely affecting FDA’s ability to monitor and react to such events.

FDA 59

FDA Fraud Governance Compliance 59