Exeed Regulatory Compliance

OCTOBER 12, 2020

The final scope and definition of the intended use is developed based on the target medical purpose, patient and user profiles, location in the body, use environment and the operating principle. Once this scope and definition is clearly established, the next step is to consider all reasonably foreseeable misuses.

Regulatory Compliance 52

Regulatory Compliance Compliance 52

Medisys Compliance

NOVEMBER 10, 2023

Modifier codes and their definitions may change over time. Plastic surgeons and medical billing companies can form a valuable partnership to enhance coding accuracy, improve documentation review, streamline claim processing, ensure regulatory compliance, and maximize reimbursement opportunities.

Medical Billing Outsourcing 59

Medical Billing Outsourcing Medical Billing Regulatory Compliance Compliance 59

Healthcare IT Today

JUNE 7, 2023

We also recommend narrowing the definition of “predictive decision support intervention,” as some interventions are not conducive to source attributes or feedback gathering. Thus, we intend to recommend narrowing the definition of those DSIs impacted by the proposed rule to focus on interruptive alerts that are created by the developer.

FDA 77

FDA Compliance Regulatory Compliance Medicaid 77

HIT Consultant

MAY 4, 2023

But with so many competing training programs — everything from HIPAA and regulatory compliance to handwashing and job-specific training — it’s difficult to break through the noise and gain traction.

Hospitals 97

Hospitals Regulatory Compliance HIPAA Compliance 97

HIPAA Journal

AUGUST 21, 2023

Recognizing the unique challenges faced by small medical practices and health tech companies, especially concerning patient data security and regulatory compliance like HIPAA, we’re refining and enhancing Safetica DLP to ensure it is intuitive, scalable, and effective. Maybe I will try to put my future glasses on.

HIPAA 70

HIPAA Compliance Regulatory Compliance Regulations Compliance 70

YouCompli

MAY 25, 2022

Anstine, JD is a compliance professional and consultant in Colorado. He is writing a series of articles on compliance culture for the YouCompli blog. This post establishes a working definition of compliance culture and puts it in the context of overall healthcare priorities. They’d likely still be in business today.

Compliance 52

Compliance Compliance Officers Fraud Regulatory Compliance 52

HIT Consultant

JULY 12, 2023

ICSRs don’t always provide enough detailed information for PV signal teams to draw a definitive conclusion about patient reactions to specific treatments. PV signal teams must balance growing workloads with maintaining regulatory compliance. ICSRs are inherently delayed.

Regulatory Compliance 52

Regulatory Compliance Compliance Medical Billing FDA 52

MedTrainer

MARCH 28, 2024

Just as perplexing is who is responsible for compliance in healthcare organizations. The answer has as many layers as the definition of compliance itself. Advises on compliance matters, reviews contracts, and handles regulatory and legal issues.

Compliance 52

Compliance Compliance Officers Licensing Regulatory Compliance 52

Healthcare IT Today

JANUARY 8, 2024

Streamlining Regulatory Compliance with AI Automated Compliance Monitoring: In 2024, AI is predicted to automate the monitoring of regulatory compliance in drug development, efficiently tracking changes in global regulatory requirements and ensuring adherence to these evolving standards.

Pharmaceutical Industry 84

Pharmaceutical Industry Due Diligence Compliance Regulatory Compliance 84

Health Care Law Brief

NOVEMBER 17, 2021

More specifically, CMS’s corrections to that rule ultimately reduce the number of arrangements that satisfy the definition of “indirect compensation arrangement” and, thus, decrease the number of arrangements that fall within the prohibitions’ purview. The Current Stark Law Prohibitions. PFS Final Rule at 1046. at 77665; 42 C.F.R.

Medicare 40

Medicare Medicare Payment Systems Medicaid 40

YouCompli

JUNE 6, 2023

Related: New DOJ Guidance on Compliance Programs Released March 2023: Incentives, Compensation Structures, and Consequence Management for Healthcare Compliance In today’s article, I will discuss risk assessment from a “why, what who, and when” perspective. First, a definition: a “risk assessment” can take a lot of forms.

Compliance 52

Compliance Compliance Officers Regulatory Compliance Hospitals 52

HIPAA Journal

JANUARY 9, 2024

As a registered nurse, I loved regulatory compliance and risk management. Amending the definition of health care operations to clarify the scope of permitted uses and disclosures for individual-level care coordination and case management that constitute health care operations. As a kid I had always dreamed I’d go to law school.

HIPAA 52

HIPAA Compliance Compliance Officers Regulatory Compliance 52

Dot Compliance

APRIL 12, 2022

Then we will provide general guidelines for producing labels that will benefit your customers and meet regulatory obligations. The FDA definition of a medical device is something that diagnoses, cures, treats, or prevents a disease or health condition, or otherwise alters the structure or function of the body.

FDA 52

FDA Compliance Regulatory Compliance 52

Exeed Regulatory Compliance

FEBRUARY 24, 2020

So, in this blog, we will review the definition of these terms, highlight a few areas of confusion and give examples for a better understanding of how they are related to each other. We will consider that when we get to the definition of harm later in this blog. It is a very broad definition.

FDA 52

FDA 52

Exeed Regulatory Compliance

APRIL 2, 2020

FDA expects a clear definition of the purpose of these interfaces, including the type of data being exchanged and methods of transmission. These interfaces provide powerful functionalities, but they also introduce new risks. Design requirements will directly relate to the purpose and associated risks.

FDA 52

FDA Medical Device Industry Doctors Regulatory Compliance 52

Healthcare Law Today

JANUARY 20, 2022

It is noteworthy that requirements of the IOAS, including compliance with the definition of “group practice” are well beyond the scope of this discussion, but should be reviewed, in depth, with counsel knowledgeable with them. As noted above, non-compliance with the Stark Law’s requirements can be costly.

Compliance 52

Compliance Medicare Medicare COVID-19 52

AIHC

NOVEMBER 3, 2023

This definition focuses on the outcomes of the diagnostic process, recognizing that diagnosis is an iterative process that solidifies as more information becomes available. Read more about current regulatory oversight on the AIHC blog: Who Regulates Healthcare AI?

Department of Veterans Affairs 59

Department of Veterans Affairs Hospitals Compliance Nurses 59

Health Law Advisor

OCTOBER 5, 2022

For example, if a corporation operates in a highly regulated industry, then its history of regulatory compliance should be compared to that of similarly situated companies in that industry. There is no definition given for “reasonable design.” in that case, of the FCPA and other anti-corruption laws).

Compliance Officers 52

Compliance Officers Compliance Due Diligence Governance 52

Innovaare Compliance

NOVEMBER 29, 2023

Beginning January 1, 2024, the negotiated price must include all pharmacy price concessions according to the new definitions of “negotiated price” and “price concession” at § 423.100 and § 423.2305 to reflect the lowest possible reimbursement a network pharmacy will receive for a drug. [1]

Medicare 52

Medicare Medicare Compliance Medicaid 52

Exeed Regulatory Compliance

JULY 10, 2020

So, there are two parts to the definition of these devices – what they are and how they are used. A clear description of both these parts is required to understand the applicable regulatory requirements outlined by the FDA.

COVID-19 52

COVID-19 FDA Medical Device Industry Public Health 52

Healthcare Law Blog

NOVEMBER 10, 2023

One basis for early action has been legal consequences arising from preparations for marketing and sale of a medical device invention, including regulatory compliance. The Federal Circuit reversed, applying traditional contract law principles and thus finding that the letter was a commercial offer for sale.

Regulatory Compliance 52

Regulatory Compliance Compliance 52

Dot Compliance

SEPTEMBER 11, 2022

It depends on other accepted standards for its definition, application, and actual execution such as ISO 9001. The Quality Management System (QMS) doesn’t have any independent standards.

Pharmaceutical Industry 52

Pharmaceutical Industry Compliance FDA Regulatory Compliance 52

Dot Compliance

NOVEMBER 2, 2022

Regulation infractions may not be definitively determined by an FDA Form 483, but they are nonetheless reason for worry and require prompt attention. An FDA Form 483 Observation may concern the company’s building, tools, controls, procedures, goods, personnel conduct, or records.

FDA 52

FDA Compliance Regulatory Compliance 52

Dot Compliance

AUGUST 25, 2022

As the first three are introductions and provide scope, definitions, and other basic information, this article concentrates on the latter five parts. Instead, it was found that medical equipment did not require the most current updates to ISO 9001:2015. ISO 13485:2016 requirements. In all, ISO 13485 has eight parts.

Compliance 52

Compliance Regulatory Compliance 52

Health Care Law Brief

JUNE 26, 2022

UnitedHealthcare drew the Supreme Court’s attention to the fact that “the Medicare statute explicitly links these provisions”— i.e. , the definition of an “overpayment” incorporates by reference “subchapter XVIII,” which “includes the actuarial-equivalence requirement.”

Overpayments 52

Overpayments Overpayment Medicare Medicare 52

Exeed Regulatory Compliance

JULY 31, 2020

An emergency of this magnitude requires an all-hands-on-deck approach and you should definitely consider the FDA to be on your side if you have a potential solution to help solve this crisis. The amount of data needed for a pre-EUA discussion with the FDA will depend on a variety of factors.

FDA 52

FDA COVID-19 US Department of Health and Human Services Public Health 52

Healthcare IT Today

JANUARY 9, 2024

Jon Maack, President at Definitive Healthcare Healthcare data is growing at an unwieldy pace – it currently accounts for about one-third of the world’s data volume, and is expected to reach 175 zettabytes globally by 2025. We will continue to see a shift where interoperability is the foundation for limitless innovation.

Hospitals 101

Hospitals Regulatory Compliance Compliance Licensing 101

Healthcare Law Today

DECEMBER 12, 2022

Yes, I definitely echo what Mark says, and to not, kind of repeat everything, I would describe it, really, as evolving and heightened, right? change comes an evolving regulatory and legal landscape. Yeah, Mark definitely said the magic words there of narrow and define the scope. Maureen Stewart. Nate Lacktman. Maureen Stewart.

Telemedicine 49

Telemedicine Fraud Governance Compliance 49

Healthcare IT Today

DECEMBER 20, 2023

Health systems, hospitals, and related providers must comply with 629 discrete regulatory requirements across nine domains and spend nearly $39 billion a year on regulatory administrative activities, while an average-sized hospital dedicates 59 full-time equivalent employees to regulatory compliance, over one-quarter of whom are doctors and nurses.

Compliance 88

Compliance Regulatory Compliance COVID-19 Hospitals 88

Exeed Regulatory Compliance

OCTOBER 5, 2020

The Risk Analysis Process The risk analysis process involves the following 4 steps: Intended use and reasonably foreseeable misuse : Risk analysis begins with a clear definition and scope of the intended use(s) of a medical device. In addition, we need to consider all reasonably foreseeable misuses in the context of the intended use.

Regulatory Compliance 52

Regulatory Compliance Compliance 52

Health Care Law Brief

AUGUST 22, 2023

7] Substance of Notice to State Regulators; Confidentiality of Disclosures The contents of each state’s required pre‑transaction notice are set forth in statute, regulation, and/or sub‑regulatory guidance. 8] Confidentiality is a key consideration for parties submitting information pursuant to these new laws.

Regulatory Compliance 52

Regulatory Compliance Compliance 52

Exeed Regulatory Compliance

APRIL 6, 2020

Decontamination does not mean sterilization, which has a very clear definition as shown in the graphic below. Here, it is important to note that decontamination is only one of the ways to reprocess medical devices in the industry. Similarly, there is difference between disinfection and decontamination.

COVID-19 52

COVID-19 FDA Public Health 52

SQA

OCTOBER 18, 2022

Sections include Terms and Definitions, ML System, ML Approaches, ML Pipeline, and Annex A: Example Data Flow and Date use Statements for Supervised Learning Process. Medicines and Healthcare Products Regulatory Agency (MHRA) . United States Food and Drug Administration (FDA) – Recalls.

US Department of Health and Human Services 40

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

Drug & Device Law

MARCH 6, 2024

But he is definitely not stupid. If the expert is trashing regulatory compliance, let’s see if that expert knows which people at the company and FDA were involved. You’ve almost certainly seen Senator Kennedy on the news or the weekend talking head shows. He is not close to being camera shy. Far from it. Who was in charge?

Regulatory Compliance 98

Regulatory Compliance FDA Compliance 98