HIT Consultant

JUNE 11, 2023

David Barzilai, VP of Sales and Marketing at Karamba Security There is a fine line that connects the cars we drive and the medical devices we occasionally use. 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.

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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.

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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft).

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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft).

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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft).

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft).

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FDA HIPAA Compliance 60

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.

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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.

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FDA COVID-19 Doctors Compliance 96

Dot Compliance

OCTOBER 10, 2022

The process of ensuring medical equipment will operate safely and correctly is known as medical device validation. Each manufacturer employee that works on creating medical equipment must complete the necessary training. Personnel must have clear understanding of both medical device process and medical device procedure.

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FDA Compliance 52

Dot Compliance

OCTOBER 10, 2022

The process of ensuring medical equipment will operate safely and correctly is known as medical device validation. Each manufacturer employee that works on creating medical equipment must complete the necessary training. Personnel must have clear understanding of both medical device process and medical device procedure.

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FDA Compliance 52

Dot Compliance

FEBRUARY 8, 2022

The digital revolution and IoMT (Internet of Medical Things) has transformed the healthcare landscape. Software and connected devices are now being used to power disruptive medical technologies and solutions. What is Software as a Medical Device (SaMD)?

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FDA Compliance 52

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.

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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.

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FDA Compliance COVID-19 Public Health 52

Health Law Advisor

MAY 3, 2022

In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Just a short while ago FDA recommenced inspections.

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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.

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FDA HIPAA Compliance Regulatory Compliance 45

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.

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FDA Compliance 52

SQA

DECEMBER 16, 2022

ANVISA’s Questions & Answers (Q&A) on Medical Cannabis for Clinical Investigations, 14 September 2022. Brazil’s ANVISA Announces Major Medical Device Registration Updates, 16 September 2022. China: National Medical Products Administration (NMPA). 07 Medical Diagnostic and Monitoring Equipment.

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FDA Compliance COVID-19 Licensing 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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FDA Licensing Governance Compliance 40

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.,

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Regulatory Compliance Compliance FDA 52

SQA

OCTOBER 18, 2022

The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada. device identifier “COV-19C25.” that the devices were counterfeit. appears to no longer be manufacturing medical devices.

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

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.

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

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Medicare Medicare COVID-19 Telemedicine 52

Exeed Regulatory Compliance

FEBRUARY 24, 2020

These are very basic terms used for analyzing safety risks associated with a medical device. At the most basic level, use of a medical device itself is a hazard. One problem we have seen in practice is when people look at failure modes associated with a medical device as part of their risk analysis.

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Drug & Device Law

JANUARY 15, 2024

As we discussed at length in this post, since the 1940s, the Pennsylvania Supreme Court and other courts applying Pennsylvania law have refused to subject prescription medical products to strict liability. Neither Lewis nor Tincher involved prescription medical products, but rather what we describe as “things that go clank.”

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Drug & Device Law

JANUARY 30, 2023

The availability of this type of cutting-edge presentations is yet another reason why drug and medical device manufactures would be well served by joining PLAC. For those of you accessing the Blog on mobile devices, this post may be hard to read. So, here are links to both the slide images and the accompanying text.

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Drug & Device Law

SEPTEMBER 18, 2023

Bexis has been updating the preemption chapter of his treatise on drug/device product liability litigation. 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.” McLaughlin v.

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FDA Fraud Governance Compliance 59