Advice You - Business

FACTA stands for Fair and Accurate Credit Transaction Act. The law went into effect Jan. 1, 2005. FACTA is the law which allows all Americans access to their credit report once per year. So what does that have to do with you?

On June 1, 2005, a new provisio

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

n of FACTA went into effect. It says that any employer (even if you only employ one person) whose action or inaction results in the loss of employee information, can be fined by federal and state government, and sued in civil court. Bet you didn't know tha

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

t. But you need to know, and need to know what you can do to protect yourself.

Small Businesses will be affected the most.

‘"A small businessman who makes a mistake could bear the brunt of a regulation like this," says James Plummer, policy analyst at Cons

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

umer Alert, a non-profit group that focuses on a free-market approach to consumer regulations.’

If you don't shred and information gets out, there are penalties. But what if you do shred all potential employee information, and take all necessary precautions

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

to protect your past, current, and future employees’ identities, and the information still gets out somehow? Under FACTA, you could still be held responsible.

You may not think information theft could happen to you, but neither did a lot of companies, univ

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ersities, government institutions, and businesses that have had employee or customer information stolen from them that have been in the news lately:

Lexis Nexis
University of Northern Colorado
California State University (Chico)
Univer

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

sity of California – Berkeley
University of Maryland
Las Vegas Department of Motor Vehicles
Bank of America
Choice Point
Weld County (CO) Employees (information stolen by an inmate while in jail)

How can you, as an employer, mi

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

nimize your liability?

There are hundreds of things you can do to minimize liability, which are probably things you already do. Document shredding, careful screening of employees who will be coming into contact with personal information of customers and emp

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

loyees, physically locking file drawers with sensitive information, and setting up firewalls on computer equipment connected to the Internet, among hundreds of other solutions, are all good ideas.

As Ben Franklin said, “An ounce of prevention is worth a pou

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

nd of cure”, is definitely the case when it comes to securing personal information. However, no matter what prevention steps you take, there is no 100% effective way to be sure that employee’s information won’t be compromised. Even if the information doesn’t

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

get out from your company, an employee can claim that it did.

That's a scary thought! What if an employee claims that their information was stolen through the actions of your company, but there’s no real proof to back it up? You will end up hiring (or usin

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

g) an attorney to represent and defend you and your company in court. At $200 - $400/hour for most attorneys across the United States, how long can you afford to defend your company?

So what can you do?

One solution that would at least provide an affirmati

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ve defense against the fines, fees, and lawsuits you could incur as an employer, is to offer some sort of Identity Theft protection as a benefit to your employees.

As an employer, you can choose whether or not to pay for this added benefit. However, the mos

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

t important thing you can do is to make the protection available, and have an employee meeting, to help employees understand Identity Theft and the protection that you are making available to them. When you make the protection available, and when your employ

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ees have been educated on the dangers of Identity Theft, they can either elect to have identity theft coverage as a benefit, or they can decline the coverage as a benefit.

If the employee has Identity Theft coverage and becomes a victim, it is beneficial to

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

your business, because an employee with Identity Theft coverage will be notified immediately of the theft, spend less time, less money, and will experience less frustration while trying to have their information restored. This will get them back on the job

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

and focused on work more quickly.

If the employee declines the coverage, and later claims that the information was stolen as a result of you or your company’s actions, you have a piece of paper, with their signature, saying that they attended the presentati

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

on and declined the coverage.

Choosing to not make Identity Theft coverage available leaves you exposed to an unlimited dollar amount that you can be sued for under civil liability, federal fines of up to $2,500.00 per employee per incident, and state fines

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

of up to $1,000.00 per employee per incident.

Recommended course of action? Have a benefits consultant who offers an Identity Theft protection plan present to your employees. Help them set up a 20 minute presentation with your employees, and make it mandat

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ory that all employees attend. You want your employees to be protected from this awful crime. If they choose not to be, but you’ve given the option of being protected, then the liability becomes theirs, not yours, when they become a victim of identity theft.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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While referrals are one of the most important sources of new clients for therapists and coaches, how to get them seems to be something of a mystery. Here is a five-step referral strategy that can switch on your referral faucet, or turn a trickle into a steady flow.

The article provides an overview of the HAZWOPER standard. HAZWOPER is a regulatory standard that specifies training requirements for employees who work with hazardous materials. Its primarily purpose is to protect workers from the dangers inherent in working with hazardous materials.

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