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If earlier mostly all information was kept on the papers, the recent informational technologies expanding growth gives medical staff the opportunity to use them in their job. We can not deny the advantages which are coming to every job with using computer and specialized so

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

ftware. But together with this the old, as Hyppoctates outh, there is a problem of information protection.

At first look the health information became more vulnerable with this technologies using, as there are dangers of it’s stealing while the information is stored on the

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

Examples of combination products may in

omputer, as well as when it is transmitted through the Internet. This may lead uninitiated people to say that there is no solution to this issue. Is it really so?

If you are a medical worker, you may face different situations, when the information, you work with, is vulner

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

ble. Sometimes you may wonder where the problem may come from or to feel stressed by the reasons for your electronic information storage and transmitting and the ways you can you do it.

In this article I will try to point the reasons why should we do it and to suggest som

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

practical answers to these sometimes challenging situations. Reasons for protecting medical information

1. Laws

Every country is protecting the patients with different laws. There are different official documents which underline the importance of protecting the confide

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

Combination pro

tiality of people’s health information and as a consequence, their privacy. And this is not an option, this is a obligation of each medical worker. Medical staff should not allow private information misuse

2. Etiquette rules and Hypocrates oath

Etiquette rules require us t

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

o be able to protect the information we get from our neighbors. Hypocrates oath requires a doctor to protect the information, he get from the patients. It says: “Whatever in connection with my professional practice or not in connection with it I may see or hear in the lives

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

of my patients which ought not be spoken abroad I will not divulge, reckoning that all such should be kept secret.” And these requirements, philosophically saying, are designed to protect our safety as well as our patients. Thinking only of our well-being is a limited way to

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

treat this issue.

3. Marketing issues

Looking for medical services, patients may fear, reasonably or not, that their personal health information will be exposed. So, it is of real advantage for you to use strong information protection tools, as one of the key point in deve

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

oping marketing positioning for your services. If you want your services to develop a brand and are really interested to have competitive status, you may not neglect the information protection issue. When you present your services with high information protection opportuniti

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

s, it gives you higher lever of trust and will bring you more patients.

4. Staff and leaders protection from the frauds

Sometimes there are situations, when the information is stolen because of stuff neglection. This also is caused by the lack of serious protection polic

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

Following aspects would a

y for medical services in the company. This may happen because the services managers do not know about safe and easy-to-use computer information protection tools existence and about the places where to look for them. Information technologies availability for the info theft

dd to the challenges in developing combination products:

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

makes this issue more difficult to be understood at first look.

What you need to know about information security?

The most important thing is to remember that there is no unique solution to this complex, but not unsolvable issue. One important thing here is to overcome t

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

e fear of using informational technologies, which offer information protection tools.

1. First, you need to work on physical building and hardware protection.

It is possible to look for the businesses, which provide solutions for the building access security. Nowadays we h

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

ve many products and services in this area. What can be done is just find out which are the security companies in your city and just find out what products and services they have. There are businesses which can offer you hardware protection tools, like locks and wires which

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

re designed specially for the computer type you have . these physical protection tools can help you minimize the risk for your physical computer access.

2. Get a professional advice from the security experts.

Deciding on physical protection is only a part of your task. I

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

Professional from academic institutions, pharmaceutical industries, health care indust

f you are really aware of information protection, you should think of computer access protection and of data protection inside of it. As I am literate in computer access software and utilities, as well as security software, I can give you some suggestions here about using D

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

kart Family Security products.

I suggest you an easy-to-use Dekart Private Disk, which will allow you to encrypt any of your information. You can create a virtual disk with this simple and secure tool, compatible with all medical software, which can be securely installed a

.

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

d encrypted on it. More about it you may read on http://www.dekart.com/products/file_disk_encryption/private_disk/

Another product is Dekart Logon, which may be used for computer

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

Companies that provide selfless information through particip

ccess protection, as well as for passwords management. This product will help you avoid forever a passwords forgetting issue. The computer access passwords can be stored on different devices and keys. More on this on http://www.dekart.com/products/authentication_access/logon

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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