Best Practices in Vendor Risk and Compliance Management

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Best practices in vendor risk and compliance management need to be inculcated by vendors who deal with them because of the enormous risk their activities carry. Implementation of best practices in vendor risk and compliance management goes a long way in checking risks and with it, the adverse fallouts of a vendor management program.

First of all, why do organizations have a vendor partnership? It is because this kind of arrangement helps them to take care of their logistics and other aspects of their business in a much more streamlined and economical fashion, and this in turn helps them to concentrate and focus on their core business better. A strategic vendor partnership helps organizations manage their products and services better, and more economically. The root to this is inculcation of best practices in vendor risk and compliance management.

vendor-risk-and-compliance-managementThe importance of best practices in vendor risk and compliance management can be understood from the fact that when companies outsource their operations, or particular parts of them, or some of their activities, this does not include organizational responsibility. So, the onus of ensuring compliance with regulatory guidelines and making sure that the vendor has implemented best practices in vendor risk and compliance management lies squarely with the organization that outsources.

Burden is on the organization that hires vendorsThis places a heavy responsibility on them, since of late regulatory guidelines for best practices in vendor risk and compliance management have become all the more stringent. While outsourcing part of their activity or operations or logistics or even parts of product development to vendors; companies have to be very sure that they are in tune with best practices in vendor risk and compliance management.

vendor-risk-and-compliance-managementThe basis to implementing best practices in vendor risk and compliance management is to get a clear comprehension of vendor responsibilities. Many organizations make the mistake of assuming that best practices in vendor risk and compliance management need to be implemented only at the stage of selecting the vendor. This is disastrous thinking, because selection of the vendor is just the beginning of the outsourcing program. These organizations have to make sure that best practices in vendor risk and compliance management is a continuous program and activity, and hence utmost care has to go into managing them at all times.

Reasons for increased need for implementation of best practices in vendor risk and compliance managementThe need for adaption and implementation of best practices in vendor risk and compliance management has become all the more acute and necessary in view of the following factors:

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The increasing role of the social media in healthcare

 

The increasing role of the social media in healthcare 6With the social media having moved beyond being a platform for sharing personal information; its role in healthcare has nearly exploded of late. This is mainly because the growth of the social media has more or less coincided with that of the electronic records in healthcare.

Whatever the identifiable or unidentifiable reasons for the convergence of social media in healthcare; the fact is that social media in healthcare is a major phenomenon that is here to stay.

Social media in healthcare is being analyzed for potentially huge business opportunity, and it is being taken up for serious discussion in legal circles, with the American Congress and many other legislative bodies around the world thinking of taking serious steps for regulating it.

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The most fundamental aspect of social media in healthcare is that its growth has been helped by the core feature it brings: its ease of adaption in this sector. Healthcare information, as we all know, is very vital, and speed is of great importance. This is why social media in healthcare has come to be one of the most talked about scenarios in the healthcare today, propped in no less measure by the gigantic size of the American healthcare economy.

The advantages social media brings into healthcare

 

The increasing role of the social media in healthcare 1As just seen, the social media in healthcare facilitate great use because they help transmit information at a pace that was difficult to imagine till recently. With the development of the electronic health records (EHR) in the US, technology has made possible the customization of health records. A platform like the social media can help accelerate this pace enormously. It can also help practitioners and other stakeholders of healthcare information, such as Business Associates and Covered Entities and a host of related ones gather information and transmit it and process it at lightning speed.

Concerns

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The enormous benefits that the social media bring into healthcare notwithstanding; there is room for serious concern.

Like all other technology-driven tools, the social media in healthcare comes with an inherent risk: the laxity of records. Loose or nil security or healthcare records are a serious cause for concern. The recent breaches in health data have cost many healthcare organizations in the US millions of dollars.

The social media in healthcare give an opportunity for marketers to pitch their products or services, but they also open up lots of opportunity for the unscrupulous among these to exploit and manipulate this information. This is akin to the potential drawbacks credit cards and other such facilities bring. The social media in healthcare is a tool that is open to a high degree of vulnerability to breach. This is all the more true of new technologies, such as the cloud, which the social media in healthcare have embraced with open arms.

So, while the social media in healthcare is a force to reckon with, it is not something that is totally free of drawbacks. Till regulatory action frees the sector of these, the social media in healthcare will continue to grow, albeit with its concerns.

 

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Export, Import and Trade Compliance Principle – an understanding

Export, import and trade compliance principle is a very important guiding standard for governing trade policies and ensuring compliance with the set national, regional and global trade norms. It helps to define an organization’s adherence to the export, import and trade compliance principle laid out by the government and also offers an understanding of the government’s outlook and stance in these matters.

There are two aspects of the export, import and trade compliance principle:

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General export, import and trade compliance principles

 

As can be understood from the description of the concept of export, import and trade compliance principle; export, import and trade compliance principles laid out by the government and requiring compliance with their guidelines are fixed. Organizations cannot manipulate or tamper them. Doing so, naturally, invites penalties.

However, the export, import and trade compliance principles set out by individual companies are conditioned by their own ethics and culture. These are a reflection of how organizations carry out their export, import and trade compliance principle, something that they themselves have laid out.

export-import-and-trade-compliance-principleAdapting the right export, import and trade compliance principle and implementing it is a reflection of how well the organization understands the business and the market and how well it is able to maintain its integrity among its circles. Needless to say, an organization that says one thing and does another is seen in a negative light by its peers.

 

Organizations specialize in helping to implement export, import and trade compliance principle

 

Just as there are many organizations which are in the business of ensuring many complex fields such as governance, risk and compliance (GRC) and technology compliance; several organizations specialize in helping organizations implement both the export, import and trade compliance principle as laid out by the government, and their own export, import and trade compliance principles.

export-import-and-trade-compliance-principleWhether an organization gets its export, import and trade compliance principle implemented through an outside, third party or does it on its own; there is no escaping the fact that export, import and trade compliance principle is something that is mandatory to state and implement accordingly.

Overlaps and alignments of organizational, governmental and trade bloc requirements

export-import-and-trade-compliance-principleEven when organizations draw up their own export, import and trade compliance principle; they are bound to include the latest and relevant regulations, policies and procedures as laid out by the government. Many internal export, import and trade compliance principles and external (those prescribed and required by the government) overlap on many occasions with those of trade blocs such as the North American Free Trade Agreement (NAFTA), European Union Preferential Trade Agreement, Association of Southeast Asian Nations (ASEAN), Mercosur, etc. Export, import and trade compliance principles from these different sources should align with each other.

Reasons for export, import and trade compliance principle implementation

 

The export, import and trade compliance principles laid out by respective governments are in place because of many important reasons.

 

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Data Mining and Signal Detection in Pharmacovigilance

Data Mining and Signal Detection in Pharmacovigilance

A signal is described by the World Health Organization as any information that is reported on a possible or potential causal relationship between a drug and the adverse event it spawns. This relationship can be of virtually any nature, so long as it concerns the drug and the subject, and it could be either new or one with a precedent.

Data mining can be described as the method of obtaining data from target groups to help the clinical study come to important assessments and conclusions. Many a time, it is not clear whether a drug’s expected benefits outweighs the potential risks it brings about or vice versa, till the drug goes for marketing authorization. In order to assess this to the extent possible, clinical pharmacologists weigh the benefit and risk evaluation of medicines using tools such as data mining. Data mining is done both at the individual level of a subject and at the macro level of the population at large. These two methods are usually inseparable from each other, in that almost no study is done exclusively for one group.

Given its ability to help pharmacologists discern the various patterns that emerge from a clinical study; data mining is acquiring a position of importance of late and is being used in almost all stages of drug development. This could range from the earliest stage, namely drug discovery and could go up to post-marketing surveillance.

The WHO’s Uppsala Monitoring Centre

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In order to make the results of very clinical study done in every part of the world accessible to everyone – a formidable task without doubt – the WHO has formulated the Uppsala Monitoring Center. This is a universal database of all the results obtained from clinical research the world over. Although voluntary and missing data from a many studies; the UMC is a comprehensive attempt at establishing a data mining and signal detection system that is accessible to everyone concerned. The UMC can thus be considered the universal data mining and signal detection database.

With over 2.5 million case reports of various clinical studies done all around the world, the UMC has evolved over time as a data mining and signal detection database. It initially started by requiring principals of clinical studies to generate new drug and Adverse Drug Reactions (ADR) combinations every three months. With the growth in the number of studies and the variety of issues they threw up; this was no longer considered feasible.

The UMC then started out to create its own method, by which the principles of making an objective initial assessment of all new drug and ADR combinations started getting implemented as they emerged. To this were added the requirements of bringing about a transparent selection of drug – ADR combinations for review, as well as suggest a quantitative aid to data mining and signal detection.

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Today, the UMC uses several methodologies to carry out its task of being at the forefront of data mining and signal detection. It uses the Bayesian Confidence Propagation Neural Network, which uses Bayesian statistics within the architecture of a neural network for data mining and signal detection.

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What is logistics and supply chain management?

What is logistics and supply chain management

Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed.

Logistics and supply chain management is emerging as a major area of business because of the evolution and growth of globalization. Many products and goods are produced in one country and consumed in another situated thousands of miles away. The right logistics and supply chain management helps to deliver the goods and products to the right person, at the right time, at the right place and in the right condition. Lack of proper logistics and supply chain management is a recipe for disaster.

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What is logistics and supply chain management?Among the lay people, there is a tendency to use the two words synonymously and interchangeably. In trade, however, there are major differences between the two. Logistics is just a part of the supply chain. In simple, general and broad terms, one can understand the difference between logistics and supply chain in the following ways:

Logistics is a part of supply chain, meaning that it is a set of activities that are carried out within an organization. Supply chain, on the other hand, is the full set of activities that are carried out from start to finish, i.e., from the time it departs the organization that it is leaving till the time it reaches its logical destination. In this process, supply chain management involves the coordination and collaboration of many entities. In this sense, supply chain is a whole set of activities, of which logistics is only a part.

Another way of understanding logistics and supply chain management 

logistic-and-supply-chain-managementAnother way of understanding logistics and supply chain management is this:

Logistics can be understood as being a discipline in which the following activities are involved:

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On the other hand, supply chain management can be said to include more extended activities, which include:

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Logistics and its extended activitiesLogistics often is described in terms of inbound and outbound logistics. Simply put, inbound logistics is the movement of raw materials and goods that are bought by and transported into a company. When these are processed and finished and shipped to customers; they become part of outbound logistics.

Logistics and supply chain management in a broader contextWhen one tries to get an understanding of logistics and supply chain management at a higher or broader level in the way logistics has been described above; supply chain management can be understood as consisting of these elements:

logistic-and-supply-chain-managementA sound supply chain system seeks to create value for the organization by building and utilizing logistics infrastructure. Logistics and supply chain management become meaningful when the organization synergizes demand with supply, stock and supply and inventory management

 

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Risk Management and Compliance in the Healthcare Industry

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Risk management and compliance in the healthcare industry requires a high degree of foresight, observation and knowledge of the regulatory rules and principles. Apart from being aware of the regulations, risk management and compliance in the healthcare industry is a lot about being smart, inventive and observative about the day-to-day aspects of the workings of the industry, as this highly operationalized activity is changing at a rapid pace.

Risk managers in charge of risk management and compliance in the healthcare industry need to equip the Board of Directors of the healthcare settings in which they work with much more than just the regulations that need to be put in place. They also need to impart insights into how this is to be done while keeping the costs low and at the same time, improving business.

These are the most important factors that make risk management and compliance in the healthcare industry extremely important:

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Regulatory pressure is too much to bear

 

In the current scenario of highly reinvigorated regulatory oversight in the healthcare industry, there is heavy pressure on risk managers to implement risk management and compliance in the healthcare industry in an optimal manner. The fervor of regulatory requirements and level of supervision from the regulatory bodies have gone up so drastically of late that in a recent survey, PriceWaterhouseCooper found out that half the people on the corporate board governance in hospitals said that they regard risk management as their greatest priority for the next few years.

This trend is triggered by a host of factors, all of which could contribute to making risk management and compliance in the healthcare industry all the more critical in the years ahead. Some of the factors that have accelerated this sense of urgency and criticality are:

Burgeoning cost of healthcare: 

risk-management-and-compliance-in-the-healthcare-industryAs the US healthcare industry grows into a multi-trillion dollar industry; there is a need for ensuring risk management and compliance in the healthcare industry.

Rapid increase in many diseases: Many diseases in the US are mostly a result of undisciplined and profligate lifestyles. This has placed a heavy burden on the healthcare sector to both implement preventive measures and improve standards in healthcare administration.

Technological improvements: History has shown that every improvement in technology has brought about more and more illnesses and disease, as technology makes people more sedentary. This has increased the pressure of risk management and compliance in the healthcare industry, as they are under higher pressure to implement strategies aimed at containing these.

Need to reinvent to stay ahead of the curve

 

All these factors are pushing corporate boards in healthcare to take a relook at the way risk management and compliance in the healthcare industry has been functioning. They have realized the need to implement these with a fresher and more urgent, yet intuitive approach. They need not just the judiciousness needed for grasping the present state of affairs in the industry; they need to also have sufficient foresight in anticipating the kind of change the industry is likely to undergo in the next few years.

risk-management-and-compliance-in-the-healthcare-industryThe proper understanding and implementation of risk management and compliance in the healthcare industry sits at the core of this need for hospitals to stay abreast and ahead of the competition. Relying on traditional models of risk management and compliance in the healthcare industry is likely to take them only that far. The risk managers need to have the ability to develop enterprise-wide risk management strategies that withstand the onslaught of rapid changes and absorb them into the system.

 

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What are the potential areas of risk management?

 

What are the potential areas of risk management.jpgThe most critical aspect of risk management is the identification of potential areas of risk management. This helps the organization to stay focused on the areas in which it could possibly face risks, rather than taking an aimless view and shooting about in the dark.

In a very broad sense, the potential areas of risk management include all areas of a business, because simply no area of the business is exempt from a risk. Talk about finance, and it comes with a risk. What about manufacturing? And what about operations or marketing? How about human resources? In this very expansive sense, every area or activity of the business is among the potential areas of risk management.

Potential areas of risk management could lie simply anywhere

potential-areas-of-risk-managementOn top of these potential areas of risk management that each part of the business is prone to; there are also the other industry-related risks that inhere into any business. The risks of running, say, a firecracker business, are much higher than running a grocery store. So, potential areas of risk management should ideally include a very broad discussion on every aspect of risk management.

However, when one takes an overview of the potential areas of risk management instead of trying to break down the elements of each function in which there are potential areas of risk management; one can classify these among them:

Generic risks: As we have been discussing, any business, absolutely any business, comes with some degree of risk. And, each business comes with its own generic risk, such as falling short of funding at crunch times, core people leaving the organization at important times, logistics failures at critical times, and so on.

potential-areas-of-risk-managementProduct specific risks: As the title suggests, this kind of risk is specific to the product that the business deals with. Some products come with their unique risks, and hence, this kind of risk counts among the potential areas of risk management.

People-specific risks: These can happen in a business in which much depends on a few important people. The inefficiency or departure of such people could be among the potential areas of risk management for businesses or projects that are dependent on people.

potential-areas-of-risk-managementFinancial risks: Obviously among the top potential areas of risk management; financial risks come into play when the organization is not able to meet its bottom lines due to a variety of factors. Not getting funds on time, not getting payments from customers on time, not being able to service debts are some of the factors of financial risks.

Technology risks: Technology is a high area of risk, because it keeps changing at a breakneck speed. If organizations don’t keep up with the pace, technology risks could count among potential areas of risk management.

potential-areas-of-risk-managementMarket risks: Market risks are yet another of the potential areas of risk management because most businesses are run on the assumption or speculation that a market is going to grow at a certain rate or pace. If the estimate of this market goes wrong, it affects the business negatively.

Customer risks: The ultimate decider of the business is the customer. If a customer gets irate at a bad product or service and issues bad press, it could become one of the biggest of the potential areas of risk management.

potential-areas-of-risk-managementReal estate risks: For some businesses, especially retail, the location of the business is a major factor. In many instances, the choice of location could often decide the fate of the business. Imagine setting up a high end retail store in the vicinity of a slum. Does that make sense? Yet, even if a business chooses the right location, it could sometimes be forced to relocate due to factors such as legal issues of the property, making this among the potential areas of risk management.

Finally, what needs to be said is that the list above is by no means a comprehensive one. The potential areas of risk management, as we have discussed at the beginning, are simply too many and too fluid and subjective. They could vary from market to market, product to product and business to business. A business that is perceptive about the market has to make the right assessment of the potential areas of risk management before it starts one. It should also be ready to face the potential areas of risk management if it is up against any factor that lies beyond its reach or forecast.

 

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