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Just Other Articles - Payment Card Industry Data Security Standard - A Twelve Step Program
As of September 30th 2007 all businesses handling cardholder (irrespective of size) data must be fully compliant with strict security measures imposed by the leading credit card companies. Credit card theft is the most common form of identity t
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
heft (26%) as of 2006. With over 1.3 billion credit cards in circulation as of 2004, and over 33 billion dollars in balances on those cards, companies are finding their networks, and credit card systems under attack by thieves.
In order to pro
In order to pro
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ect cardholder data from theft or fraud, American Express, Visa, MasterCard, and Discover have developed what is known as PCI DSS ( Payment Card Industry Data Security Standards) These standards involve 12 steps needed become compliant, or face
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
fines of up to $500,000, plus legal expenses, and even losing the ability to accept credit cards.
These twelve steps are:
1. Install and maintain a firewall to protect cardholder data
2. Do not use vendor supplied defaults for passwo
These twelve steps are:
1. Install and maintain a firewall to protect cardholder data
2. Do not use vendor supplied defaults for passwo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
rds or other security parameters
3. Protect stored cardholder data
4. Encrypt cardholder data across public networks (I.E. The Internet)
5. Use and regularly update antivirus software
6. Develop and maintain secure systems a
3. Protect stored cardholder data
4. Encrypt cardholder data across public networks (I.E. The Internet)
5. Use and regularly update antivirus software
6. Develop and maintain secure systems a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
d applications
7. Assign a unique ID for each computer user
8. Restrict data access on cardholder data to a need to know basis
9. Restrict physical access to cardholder data
10. Track and monitor all access to network data
7. Assign a unique ID for each computer user
8. Restrict data access on cardholder data to a need to know basis
9. Restrict physical access to cardholder data
10. Track and monitor all access to network data
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
>
11. Regularly test security systems and processes
12. Maintain a policy for information security for employees and contractors
Compliance with PCI DSS, can be divided in to 3 main stages,
Collecting and storing: Secure collection and
12. Maintain a policy for information security for employees and contractors
Compliance with PCI DSS, can be divided in to 3 main stages,
Collecting and storing: Secure collection and
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
tamper-proof storage of all log data so that it is available for analysis.
Reporting: Being able to prove compliance on the spot if audited and present evidence that controls are in place for protecting data.
Monitoring and alerting: Have sys
Reporting: Being able to prove compliance on the spot if audited and present evidence that controls are in place for protecting data.
Monitoring and alerting: Have sys
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ems in place such as auto-alerting, to help administrators constantly monitor access and usage of data. Administrators are warned of problems immediately and can rapidly address them. These systems should also extend to the log data itself – th
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
re must be proof that log data is being collected and stored.
Businesses that accept, or process or disposes of credit card information are divided into two groups for PCI DSS purposes. The first group is defined as merchant, the other service
Businesses that accept, or process or disposes of credit card information are divided into two groups for PCI DSS purposes. The first group is defined as merchant, the other service
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
provider. Merchants are generally retail, higher education, healthcare, travel, energy and finance businesses. The PCI DSS assigns such business into one of four different levels each with its own compliance process.
Level 1: A merchant has ha
Level 1: A merchant has ha
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
d data compromised or more than 6 million transactions per year. Level 1 merchants must have annual onsite security audits, and scan networks quarterly.
Level 2: Merchants between 1 -6 million transactions annually. Level 2 merchants must comp
Level 2: Merchants between 1 -6 million transactions annually. Level 2 merchants must comp
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ete annual self assessments and quarterly network scans.
Level 3: Merchants with between 20,000 to 1 million transactions annually. Level 3 merchants must complete annual self assessments and quarterly network scans.
Level 4: All other mercha
Level 3: Merchants with between 20,000 to 1 million transactions annually. Level 3 merchants must complete annual self assessments and quarterly network scans.
Level 4: All other mercha
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ts. Level 4 merchants must complete annual self assessments and quarterly network scans.
Service providers are those businesses that generally are in the payment gateway, host e-commerce sites, credit reporting agencies, paper shredding busine
Service providers are those businesses that generally are in the payment gateway, host e-commerce sites, credit reporting agencies, paper shredding busine
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
sses. They fall into one of three different levels.
Level 1: All processors and payment gateways must have annual PCI DSS Security Assessments and quarterly network scans.
Level 2: Any service provider that is not level 1 and processes more t
Level 1: All processors and payment gateways must have annual PCI DSS Security Assessments and quarterly network scans.
Level 2: Any service provider that is not level 1 and processes more t
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
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
an 1 million transactions, must have annual PCI DSS Security Assessments and quarterly network scans.
Level 3: Any service provider that is not level 1 and processes fewer than 1 million transactions, must complete annual self assessment and q
Level 3: Any service provider that is not level 1 and processes fewer than 1 million transactions, must complete annual self assessment and q
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
arterly network scans.
What are the consequences of not complying?
Card companies may impose fines on their member banking institutions when merchants are found to be non-compliant with PCI DSS. Acquiring banks may in turn contractually oblig
What are the consequences of not complying?
Card companies may impose fines on their member banking institutions when merchants are found to be non-compliant with PCI DSS. Acquiring banks may in turn contractually oblig
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e merchants to indemnify and reimburse them for such fines. Fines could go up to $500,000 per incident if data is compromised and merchants are found to be non-compliant. In the worst case scenario, merchants could also risk losing the ability
.
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
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
o process customers' credit card transactions.
Businesses from which cardholder data has been compromised are obliged to notify legal authorities and are expected to offer free credit-protection services to those potentially affected.
There m
Businesses from which cardholder data has been compromised are obliged to notify legal authorities and are expected to offer free credit-protection services to those potentially affected.
There m
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
y be other consequences besides the fines. Cardholder data loss, whether accidental or through theft, may also lead to legal action being taken by cardholders. Such a step will result in bad publicity, which may in turn lead to loss of business
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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