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The Stark Law and key considerations for physician employment agreements

One of the major fallouts of the passage of the Affordable Care Act (ACA) or Obamacare is the phenomenal rise in the number of physician practice acquisitions. These are some of the reasons for this rise:

-        Because of physician practice acquisitions, healthcare providers can consolidate and integrate their business better, since acquisition brings about alignment between the business prospects of the referral networks with the hospital’s strategic goals

 

-       …

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Added by Roger Steven on May 17, 2017 at 7:00am — No Comments

Regulations governing how combination products are regulated

The knowledge of combination products and their regulations is essential for regulatory professionals. This is because of the high proportion of combination products in the market, as well as the array of regulations that govern them.

21 CFR 3.2 (e) has a complete definition of a combination product. A combination product is one…

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Added by Adam Fleaming on May 17, 2017 at 6:40am — No Comments

Knowledge of employment laws is absolutely crucial for organizations

As the new presidential administration settles in in the US, employment law…

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Added by John Robinson on May 17, 2017 at 5:56am — No Comments

Tips for transitioning into a new role

A role change is many times inevitable for individuals in many positions. Change, as we all know, is the only constant in a business. When this much is said about businesses, it is but natural that employees in various positions need to be prepared for a change…

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Added by kate smith on May 16, 2017 at 7:02am — No Comments

EPA’s new Revised Section 608 Refrigerant Management Regulations

In late 2016, the US Environmental Protection Agency (EPA) revised Section 608, which deals with refrigerant management regulations. A number of requirements under this section are set to change. They concern the handling requirements that are applicable to ozone depleting refrigerants, and fortify the existing regulations by…

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Added by Adam Fleaming on May 16, 2017 at 6:33am — No Comments

Marketing and promotion of drugs and medical devices

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Added by John Robinson on May 16, 2017 at 6:22am — No Comments

MACRA and HIPAA

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is a federal Act that determines the way in which physicians need to be paid when they treat patients who come to them under Medicare. It substantially alters and replaces the earlier Act in this regard, namely the Balanced Budget Act, which was in force from 1997. Signed into law by then president Barack Obama; MACRA is hailed as his biggest step at reforming the healthcare system in the US since the Affordable Care Act or…

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Added by Roger Steven on May 15, 2017 at 8:08am — No Comments

Thinking and planning strategically is needed to become successful

Strategic planning can be understood as the means by which organizations conceptualize and visualize their long term plans and the way by which they plan to go about achieving them. To implement strategy, organizations need to implement…

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Added by kate smith on May 15, 2017 at 8:00am — No Comments

Use OneNote to manage your meetings

Microsoft OneNote is a program that works as a digital notebook. It saves users the trouble of having to scramble for a piece of paper whenever they feel like scribbling some information or idea down. Moreover, it saves the user the trouble of having to preserve a piece of paper on which the info is jotted down.

Microsoft OneNote helps users to type, write or draw on the digital notebook while continuing to have the same feel as a regular paper and pen. It is…

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Added by Adam Fleaming on May 15, 2017 at 6:08am — No Comments

Key issues in HR auditing

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Added by John Robinson on May 15, 2017 at 5:36am — No Comments

Enhance the effectiveness of being a payroll manager

A payroll manager is essentially responsible for managing the payroll for the employees. The payroll manager has to ensure that the employees are paid on time, in accordance with their pay scale,…

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Added by kate smith on May 12, 2017 at 7:25am — No Comments

Transiting from paper records to electronic for pharmaceutical companies while being compliant

Following the rapid advances being made in the field of information management in the past quarter of a century or so, computers have increasingly come to replace paper as the source in which important documents are created and stored. Till the last decade of the previous century, organizations used paper to record and document information relating to their research, development and business. From around the start of the 1990’s; the shift towards computerization of paper…

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Added by Adam Fleaming on May 12, 2017 at 6:06am — No Comments

HIPAA’s compliance expectations from Business Associate

The Health Information Portability and Accountability Act (HIPAA) regards the Business Associate as a major player. HIPAA defines the Business Associate (BA) as either an organization or a person who works with or provides service to a Covered Entity, who in turn is defined as one who handles or discloses Protected Health Information (PHI).

So, a Business Associate is any person or entity that is involved in creating, receiving, maintaining or transmitting PHI to a Covered Entity for…

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Added by John Robinson on May 11, 2017 at 8:23am — No Comments

Stay interviews help to retain employees

A stay interview is a potent tool for gauging employee moods and attitudes towards her work and the organization. It helps to understand employee thinking about her role and future in the…

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Added by kate smith on May 11, 2017 at 8:19am — No Comments

How does the FDA scrutinize Promotion and Advertising Practices?

The FDA has strict requirements on the way promotion and advertising practices are to be implemented by the industries that it regulates. Section 906 of the Food and Drug Administration Amendments Act (FDAAA), which came into effect in 2008 and amended the section that pertained to this topic previously, namely Section 502(n) of the Federal Food, Drug, and Cosmetic Act (FDCA); now requires that published Direct to Consumer (DTC) advertisements for prescription drugs should…

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Added by Adam Fleaming on May 11, 2017 at 6:23am — No Comments

Thorough understanding of the CERT program is necessary to fix error rates

The Comprehensive Error Rate Testing (CERT) is a program used by the Centers for Medicare & Medicaid Services (CMS) for calculating the rate or extent of improper payments of Medicare Fee-for-Service (FFS). The method used by the CMS under CERT is to pick up a stratified random sample of some 40,000 claims that are statistically valid and calculate and audit it to determine if the payments were made in accordance with the rules relevant to items such as coding, Medicare coverage, and…

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Added by Roger Steven on May 10, 2017 at 8:27am — No Comments

Overcoming the pain of HIPAA enforcement

In many years that it has been in existence, one of the noticeable changes that HIPAA has undergone is in its attitude. The earlier phase of advice and counseling has now given way to hardboiled and unforgiving enforcement. The Office of Civil Rights (OCR) no longer uses the cajoling and persuasive method. It wants to impose super harsh penalties on healthcare organizations which violate its rules.

For starters, healthcare organizations have to reckon with new, ominously higher fines,…

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Added by Roger Steven on May 10, 2017 at 8:24am — No Comments

How to implement technology transfer in pharmaceuticals

Technology transfer is a process that has gained widespread acceptance and prominence in many areas of knowledge all over the world today. Technology transfer can be broadly defined as the way in which technology is transferred from the source of its origin of creation to sources from where it can be developed and/or distributed to a wider area.

Technology transfer is carried out in a number of…

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Added by Adam Fleaming on May 10, 2017 at 6:41am — No Comments

When it comes to employee burnout; prevention is better than cure

Employees have to be fresh in the mind, motivated and energetic if they have to be productive. Employees whose talents are recognized by the organization are more fired up about their job. They are likely to be more innovative, more creative and more loyal.

On the…

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Added by kate smith on May 10, 2017 at 5:36am — No Comments

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Nakul Pratap posted blog posts
yesterday
Roger Steven posted a blog post

HIPAA compliance for offshore vendors

In this age of outsourcing and globalization, and with it, the emerging potential phenomenon of the Internet of Things (IoT); it is quite a tempting proposition for HIPAA Business Associates or Covered Entities to think of outsourcing their processes relating to Protected Health Information (PHI). However, as is to be expected,…See More
Friday
Adam Fleaming posted a blog post

Meeting equipment validation requirements from the FDA and EU

Putting in place a program for calibrating and maintaining test and measurement equipment is a regulatory requirement from both the FDA, under 21 CFR Part 210 and 211, and relevant EU regulations. Both these agencies have regulations that require this program from manufacturers.The purpose of this equipment validation program is to ensure these among others:o  The equipment is…See More
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What's your favorite motivational/safety quote? 98 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by David R Snell Apr 26.

Feedback on a injury prevention product we're building.

Hi everyone!For full transparency ill tell you a little about myself and what I hope to accomplish. My name is Zuber and I'm an engineering student who founded a startup helping to build wearable…Continue

Tags: product, prevention, injury, back, safety

Started by Zuber Ahmed Apr 24.

Best overall personal safety book? 1 Reply

What do you think is  the best all-in-one book out there for optimizing personal safety and the safety of one's family?  Right now I have …Continue

Started by David R Snell. Last reply by David R Snell Apr 21.

Fire codes for residential buildings

Hi,Can anybody kindly give me a hint how to find Fire Codes for residential buildings in different cities in the United States?Continue

Started by Darren Asad Apr 14.

OSHA and Machine Guard Door Safety???

We have what we feel is not a unique situation and were wondering if anyone might of run across this challenge and know more about the requirements.  We are building a small machine system that…Continue

Tags: electric, osha, air, door, interlocked

Started by Scott V Mar 24.

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