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Advice You - Legal Process Outsourcing (LPO): Addressing Security Concerns
A major concern for law firms that are considering whether or not to take the legal process outsourcing (LPO) plunge is that of data protection. Client confidentiality is so rooted in the legal culture, and is such a fundamental aspect of professional legal ethics, that the mere notion of a pair of eyes glimpsing data from acros
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
s the Atlantic and Pacific oceans sends shivers up the spines of many lawyers. Yet the ironic part is that there is a group of entities whose obsession with security issues may make that of attorneys seem a trivial thing – the outsourcing companies themselves. The building and maintaining of relationships with current and futur
; 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
clients is the lifeblood for service providers.
As outsourcing becomes more widespread and competition in the marketplace grows, the ability to illustrate the existence (and continued use) of powerful safeguards will increasingly become one of the significant factors for companies that are deciding which provider to link up wit
As outsourcing becomes more widespread and competition in the marketplace grows, the ability to illustrate the existence (and continued use) of powerful safeguards will increasingly become one of the significant factors for companies that are deciding which provider to link up wit
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
. Consequently, the leading outsourcing companies take security concerns extremely seriously, which may explain why many domestic studies have shown that the outsourcing process is no less secure, and may in fact be even more secure, than having the same services performed in-house.
Process fidelity is definitely necessary in t
Process fidelity is definitely necessary in t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
e legal arena, but this needs to be placed in perspective. While legal documentation does sometimes consist of sensitive information, the sensitivity often stems from the defining characteristics of litigation and practice procedures. Law firms are no different from other companies in that they do not like to have their business
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ractices broadcasted to the general public. However, concerning the type of damage that can be caused by leaking of information, legal data is in general substantially less sensitive than other types of data that have been outsourced for years on a massive scale. When the fact that large banks, financial institutions, and even
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
he IRS are outsourcing on an extended basis, the entire issue of data protection insofar as LPO is concerned is put into clearer perspective. Suddenly, summons and complaints and discovery materials take on a whole new light when attorneys digest the fact that extensive credit histories, records of financial transactions and tax
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
orms are being processed by the millions overseas.
However, this is not to say that legal information should not be afforded the highest degree of protection, especially regarding issues of conflict of interest. The legal community is one that is tightly bound together and thrives on the flow of information between affiliates a
However, this is not to say that legal information should not be afforded the highest degree of protection, especially regarding issues of conflict of interest. The legal community is one that is tightly bound together and thrives on the flow of information between affiliates a
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
d adversaries. On a regular basis, members of the defense bars network with members of the plaintiff bars. Moreover, many of the same lawyers frequent the same courtrooms in the same venues, and attend the same continued legal education courses and alumni events. Thus in order to be supremely effective, outsourcing models must
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
place great emphasis on separation of competing interests.
The question therefore becomes: How can a law firm be assured that they are not outsourcing work to a company that is also working on the same matter for opposing counsel? While the chances of this happening may be somewhat slim, it is still a viable concern. The fact
The question therefore becomes: How can a law firm be assured that they are not outsourcing work to a company that is also working on the same matter for opposing counsel? While the chances of this happening may be somewhat slim, it is still a viable concern. The fact
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
that most providers are obligated to keep the identity of their clients confidential makes it difficult for a firm to ascertain whether a current adversary is outsourcing work to the same provider.
Protections for the outsourcing firms can certainly be put into place. First and foremost, the contract between provider and client
Protections for the outsourcing firms can certainly be put into place. First and foremost, the contract between provider and client
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
should make it absolutely clear that the provider must inform the client as soon as it learns of any possible conflict issues.
Second, the firm should make sure that the provider it chooses is able to clearly articulate – and, if possible, demonstrate – the security safeguards it has implemented to ensure the validity of the pro
Second, the firm should make sure that the provider it chooses is able to clearly articulate – and, if possible, demonstrate – the security safeguards it has implemented to ensure the validity of the pro
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
ess. These safeguards should be included in the statement of work agreement, in list format, along with the additional provision that the security devices must be maintained for the breadth of the contract. Thus determination of liability of the contracting parties for any security breach that results in measurable damages will
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
be easier to ascertain.
Third, due to the fact that technology and business procedures must often become intertwined in order for the outsourcing process to run efficiently, the security program used by the vendor should exist on both the physical and virtual levels for it to be as comprehensive as possible. It would be somewha
Third, due to the fact that technology and business procedures must often become intertwined in order for the outsourcing process to run efficiently, the security program used by the vendor should exist on both the physical and virtual levels for it to be as comprehensive as possible. It would be somewha
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
contradictory for an outsourcing company to rely on the fact that the production staff for two adverse law firms exists in separate offices, on separate floors or even in different cities. The very premise behind the outsourcing process is that physical separation is not a complete bar to the sharing of information – as such, a
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
company cannot on one hand praise the concept that geographical differences are no longer barriers to the exchange of information and data, while relying strictly on geographical barriers as the only security measures put in place by the company. There is no doubt that physical separation of the production staff for adverse busi
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
esses is a good step; however, virtual separation is needed as well in order to create a robust security model.
Important questions that law firms may need answered before an outsourcing program is initiated include: How does the provider structure their production units? Are these units separated, and if they are, along what
Important questions that law firms may need answered before an outsourcing program is initiated include: How does the provider structure their production units? Are these units separated, and if they are, along what
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ines does the separation occur? What is the architecture of the physical premises where the work takes place? What kind of office equipment exists in that location? What types of things are prohibited from being brought to the work site? What tracking and auditing features are used in the technology that allows the process to
.
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
ake place? Who is responsible for the tracking and auditing? The general rule of thumb is that if the question is important enough for the attorney to ask, then it should be included in the written contract.
Once the above questions and issues are addressed to the inquiring firm’s satisfaction, the ties can be loosened and the
Once the above questions and issues are addressed to the inquiring firm’s satisfaction, the ties can be loosened and the
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
dress shoes put on the desk, because one major aspect of the outsourcing phenomenon has been resolved. True, other issues do abound, but this one is a biggie. If the security concerns can be alleviated, then one huge step has been taken towards reaching the ultimate goal of commencing a mutually beneficial business relationship
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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