Innovaare Compliance

FEBRUARY 14, 2022

Healthcare organizations establish Compliance Departments with the primary purpose of providing compliance oversight for the organization. Operational teams—such as the Member Services Department and the Appeals & Grievances Department—have significant compliance regulations, so they must know to maintain compliance.

Compliance 52

Compliance Regulatory Compliance Medicaid Medicaid 52

Healthcare IT Today

DECEMBER 29, 2023

As part of the partnership, R1 has entered into a definitive agreement to acquire the Acclara business for $675 million in cash and warrants to purchase 12.2 Providence is among the top 10 U.S. integrated delivery networks (IDNs), recognized for leadership in developing innovative delivery models and a commitment to technology.

Regulatory Compliance 104

Regulatory Compliance Compliance Hospitals 104

HIPAA Journal

AUGUST 21, 2023

A key role of these early data leak solutions was aligning organizations in compliance with these healthcare regulations. Our aim with Safetica DLP is to bridge this gap, offering a tool that simplifies the compliance process for these smaller entities, making it more intuitive and less resource-intensive.

HIPAA 71

HIPAA Compliance Regulatory Compliance Regulations Compliance 71

YouCompli

JUNE 6, 2023

An effective compliance program requires risk mitigation. Sharon Parsley, JD, MBA, CHC, CHRC contributes a regular post on compliance officer effectiveness for the YouCompli blog. Risk assessment has not traditionally been considered a core element of a compliance program. Why conduct a risk assessment?

Compliance 52

Compliance Compliance Officers Regulatory Compliance Hospitals 52

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. Some healthcare organizations are minimally training their staff for compliance, hoping it will be sufficient.

Hospitals 97

Hospitals Regulatory Compliance HIPAA Compliance 97

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.

FDA 79

FDA Compliance Regulatory Compliance Medicaid 79

HIPAA Journal

JANUARY 9, 2024

Dotty Bollinger, Founder, Integrity Healthcare Advisors The HIPAA Journal has spoken with Dotty Bollinger, who is a healthcare compliance consultant and founder of Integrity Healthcare Advisors. Dotty Bollinger is an Executive Partner on the Compliance & Risk Management at SCALE Healthcare. What is your current position?

HIPAA 52

HIPAA Compliance Compliance Officers Regulatory 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

JANUARY 8, 2024

It is key for pharmaceutical companies to recognize that efficiency does not override compliance, patient safety or regulatory standards. While tools like artificial intelligence (AI) show a lot of promise for the pharmaceutical regulatory industry, many are not quite ready for all the challenges that will follow.

Pharmaceutical Industry 85

Pharmaceutical Industry Due Diligence Compliance Regulatory Compliance 85

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

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

Dot Compliance

SEPTEMBER 11, 2022

It depends on other accepted standards for its definition, application, and actual execution such as ISO 9001. The United States Food and Drug Administration (FDA) has the authority to enforce compliance with the Code of Federal Regulations , which has significant consequences if disregarded. ISO 9001 with Dot Compliance.

Pharmaceutical Industry 52

Pharmaceutical Industry Compliance FDA Regulatory Compliance 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

Dot Compliance

AUGUST 25, 2022

It requires focused organizational effort, careful planning, and a complete comprehension of the tasks necessary for compliance. As the first three are introductions and provide scope, definitions, and other basic information, this article concentrates on the latter five parts. QMS digital transformation with Dot Compliance.

Compliance 52

Compliance 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. There are repercussions if there is no response within 15 days, and this sit well in terms of quality and compliance. How Dot Compliance QMS can help manage FDA 483s and Warning Letters.

FDA 52

FDA Compliance 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

Healthcare Law Today

JANUARY 20, 2022

Finally, billing and coding mistakes can have an adverse effect on earnings, value, and create compliance concerns. Thus, compliance with the AKS is vital to the health of the overall relationship. This is especially important given new legislation and regulatory guidance regarding surprise billing. Section1320a-7b).

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 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

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

DECEMBER 12, 2022

He advises entrepreneurial health care providers and technology companies on business arrangements, compliance, and corporate matters in telemedicine, digital health, remote patient monitoring, and click-and-mortar services. Mark, how would you describe the current regulatory and legal environment for telemedicine companies?

Telemedicine 49

Telemedicine Fraud Governance Compliance 49

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

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

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

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 103

Hospitals Regulatory Compliance Compliance Licensing 103

Healthcare IT Today

DECEMBER 20, 2023

Compliance and Privacy Regulations : The healthcare industry is subject to strict regulations such as HIPAA in the US, and GDPR in Europe. They streamline the often complex requirements definition and test case development processes by providing industry-specific, predefined implementation assets.

Compliance 89

Compliance Regulatory Compliance COVID-19 Hospitals 89

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

The entire shipment, which contained 435 boxes of the 25-pack, was sent to Health Canada for compliance follow-up. 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. and one distributor, Healthful Plus.

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