Dot Compliance

NOVEMBER 2, 2022

The FDA sends an FDA Form 483 Observation, also known as a “inspectional observation” or “Form 483” to draw attention to any potential legal infractions discovered during a routine inspection. These are issued after a 483 FDA inspection. Without FDA notification, companies may get this paper in the mail.

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Compliancy Group

AUGUST 14, 2023

Regulatory compliance in the healthcare industry plays a crucial role in patient safety, maintaining quality standards, and preventing fraud and abuse. Rated #1 on G2 “Compliancy Group makes a highly complex process easy to understand.” Learn More × Rated #1 on G2 for Healthcare Compliance Find Out More! Please Wait.

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HIPAA Journal

DECEMBER 8, 2022

The online tool asks a series of questions about the nature of the app, the service it provides, the information it collects, and how that information is collected, shared, and used. The post FTC and HHS Update Online Compliance Tool for Mobile Health App Developers appeared first on HIPAA Journal.

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Compliance HIPAA FDA Health Insurance 84

MedTrainer

JULY 13, 2023

As the VP of Compliance at MedTrainer, I’m not only intrigued by the potential of this technology, but also by the new questions and concerns related to AI and healthcare compliance. These are some of the most common concerns around AI and healthcare compliance.

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MedTrainer

JUNE 29, 2023

Compliance isn’t a concept with a lot of grey area — you’re either compliant with regulations or you’re not! Unfortunately, this yes or no perspective often leads to the misconception that compliance tracking is easy. And, in fact, there are times when tracking compliance can be as difficult as meeting the compliance standard itself!

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Health Law Advisor

MAY 20, 2022

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.

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Florida Health Care Law Firm

MAY 5, 2022

The FDA does not regulate essential oils, just like it doesn’t regulate herbs or supplements. That means that there is no FDA approval for any essential oil. As long as they don’t market essential oils as if they are medicine or a cure for any issue, they can otherwise say what they like about the products.

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Health Law Advisor

JANUARY 4, 2022

It is common for FDA and others to show a map of the United States with the states color-coded by intensity to showcase the total number of inspections done in that state. Indeed, FDA includes such a map in its newly released dashboard for FDA inspections. Some years FDA may conduct many inspections; other years not so many.

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HIPAA Journal

DECEMBER 26, 2022

Generally, HIPAA compliance for nurses is considered to mean adhering to policies and procedures developed by an organization’s HIPAA Privacy Officer and applying the best practices of security awareness training provided by an organization’s HIPAA Security Officer. Why HIPAA Compliance for Nurses can be a Problem.

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HIPAA Nurses Compliance FDA 55

HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. Health plans offering the OTC benefit can also leverage the opportunity to educate members about the significant role hearing aids can play in improving their overall health. 4 And compliance decrease over time. . About Thomas Tedeschi.

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Hall Render

OCTOBER 5, 2023

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. On August 15, 2023, the U.S. study sponsor, regulatory agencies, etc.)

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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.

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C&M Health Law

OCTOBER 10, 2022

On September 28, 2022, the Food and Drug Administration (FDA) issued Clinical Decision Support Software final guidance. The FDA interprets each of the four non-device criteria in detail and shares multiple examples for clarification. Defining Non-Device Clinical Decision Support Software. Criterion 1.

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Hall Render

NOVEMBER 30, 2023

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”). Part 820 ), unless they fall under an exemption.

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Health Law Advisor

JULY 11, 2023

Often when we talk about bias in word embeddings, we are talking about such things as bias against race or sex. But I’m going to talk about bias a little bit more generally to explore attitudes we have that are manifest in the words we use about any number of topics. Instead, I’m going to look for bias in other topics.

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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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Dot Compliance

MAY 23, 2022

Dot Compliance continues to offer 14-days of free access to its quality and compliance solutions to ensure fast and cost effective QMS adoption. In the life science industry, many companies are recognizing that compliance is not hindered when leveraging pre-configured software technology to accelerate digitization.

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Compliance FDA 52

Dot Compliance

MAY 20, 2022

Dot Compliance continues to offer 14-days of free access to its quality and compliance solutions to ensure fast and cost effective QMS adoption. In the life science industry, many companies are recognizing that compliance is not hindered when leveraging pre-configured software technology to accelerate digitization.

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Compliance FDA 52

Dot Compliance

FEBRUARY 22, 2022

FDA regulations govern what you can claim about your product and whether you can even sell it at all. For companies that manufacture drugs, biotechnology, and related products, demonstrating the safety and effectiveness of your goods to the FDA’s satisfaction has to be a top priority.

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FDA Compliance Governance Public Health 98

AIHC

JUNE 6, 2023

ChatGPT has become one of the most talked about advancements in technology. This is certainly an area where advanced technology is needed to reduce overhead, improve compliance and reduce billing errors. GPT-3, the underlying technology powering ChatGPT, can generate content that is almost indistinguishable from text written by humans.

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Compliance Medical Billing HIPAA Due Diligence 59

The Digital Health Corner

AUGUST 7, 2017

The FDA recently announced its Digital Health Innovation Action Plan. Digital health differs significantly from drugs and traditional medical devices around which the FDA has developed its structure and policies over decades. The FDA will have new digital health experts. This plan was both important and necessary.

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AIHC

JUNE 6, 2023

ChatGPT has become one of the most talked about advancements in technology. This is certainly an area where advanced technology is needed to reduce overhead, improve compliance and reduce billing errors. GPT-3, the underlying technology powering ChatGPT, can generate content that is almost indistinguishable from text written by humans.

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52

HIT Consultant

FEBRUARY 1, 2024

However, legitimate concerns about transparency and potential conflicts of interest exist if affiliate relationships or sponsored content are not disclosed. Patients often know more about their lived experience than their doctors, and sharing their first-hand experience can help others discover treatments they’re unaware of.

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Healthcare IT Today

FEBRUARY 12, 2024

As the developer of the world’s first FDA-cleared online visual acuity test, Visibly is committed to growing convenient access to quality vision care nationwide. “We are excited about the possibilities the merger with EyecareLive brings. “Together, we aim to elevate the standard and reach of online vision care.”

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Doctors FDA Telemedicine HIPAA 87

Bill of Health

APRIL 4, 2024

Although the cross-sectoral AI legislation that is now introduced by the European Commission’s Digital Strategy aims to be integrated with existing sectoral legislation such as the MDR, the IVDR and the Machinery Directive, it is uncertain how overlapping regulatory compliance requirements for AI-driven medical devices will be managed in practice.

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FDA Regulatory Compliance Malpractice Health Insurance 282

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.

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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). 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.

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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). 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.

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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). 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.

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FDA HIPAA Compliance 60

Exeed Regulatory Compliance

APRIL 2, 2020

A new FDA guidance offers helpful recommendations for design and premarket submission. One way to understand how FDA is thinking about regulating these devices is to review recently cleared devices. One such example is the Control-IQ technology , a software product recently classified by the FDA as a Class II medical device.

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Exeed Regulatory Compliance

JULY 31, 2020

In a major crisis like this, it is good to know that the FDA has a special authority to quickly allow marketing of medical products that can help diagnose, mitigate or treat this highly infectious disease. You can also watch a brief video about this process below. If the answer is yes, then FDA may not issue an EUA.

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Hall Render

JANUARY 11, 2023

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. Health Information Technology – FAQs on HIPAA and health IT. Practical Takeaways.

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Exeed Regulatory Compliance

JULY 10, 2020

There have been many reports in the media about low-quality face masks and respirators flooding the market in recent months. The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. References FDA (2020, May).

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Exeed Regulatory Compliance

JULY 6, 2020

Let us understand how they help and how FDA plans to regulate them. In particular, we hear a lot about face masks and how they can help prevent the spread of COVID-19. Understanding Non-Medical vs. Medical Purposes This is also a medical purpose , which means a face mask becomes a medical device subject to FDA regulation.

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American Medical Compliance

MAY 16, 2024

Languages: American English Key features: Audio narration, learning activity, and post-assessment Get Certified American Medical Compliance (AMC) is a leader in the industry for compliance, Billing and HR solutions. To become certified, please visit us at American Medical Compliance (AMC).

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Public Health Compliance FDA Hospitals 52

HIT Consultant

OCTOBER 21, 2022

US hospital systems validate the safety, clinical utility, and robustness of newly FDA-approved devices, 510(k) cleared, before adopting them into clinical practice. It is important for company executives and hospital system leadership teams to talk about what is working. Rolland Carlson, CEO of Immunexpress. The answer is two-part.

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Innovaare Compliance

OCTOBER 6, 2022

Annual Election Period (AEP) is about two weeks away when Medicare Advantage Prescription Drug Plans (MAPD) will be signing up new enrollees by the thousands. If you have any questions, or you’d like to discuss these changes with one of our compliance experts, please call us at 1.408.850.2235. or Contact Us.

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