Description: This Act defines agency records subject to disclosure, outlines mandatory disclosure procedures and grants nine exemptions to the statute

What is FOIA?

The Freedom of Information Act (FOIA) represents the implementation of freedom of information legislation in the United States.It was signed into law by President Lyndon B. Johnson on July 4, 1966 and subsequently has been amended in 1996, 2002, 2007. This act allows for the full or partial disclosure of previously unreleased information and documents controlled by the United States Government. This Act defines agency records subject to disclosure, outlines mandatory disclosure procedures and grants nine exemptions to the statute

Background

With the stress on constitutional rights for information, it was considered important to make government information available to the public.  However since some of the information was sensitive and need not necessarily be known by the general public, this law was enacted. The belief was that the people have the ‘right to know’ about government information and could place a request for such information.

Applicability

The act explicitly applies only to executive branch government agencies. These agencies are supposed to declare the process for requesting the information or documents pertaining to the information.  This act also specifies the legal recourse in case the executive agency does not comply with the requirements of the act.

Exemptions

There are nine exemptions to the act and there are several areas of discrepancy in these exemptions. These exemptions were brought about to address the issues of sensitivity and personal rights.

Here are the exemptions

1. Executive orders kept secret in the interest of national defense or foreign policy

2.Records that are solely related to the internal personnel rules and practices of agovernment agency

3. Information that is specifically exempted from disclosure by the legislative statutes

4. Privileged or confidential commercial or financial information and trade secrets

5. Anyinter-agency or intra-agency communication in the form of memoranda or lettersthat is otherwise not available by law to any party other than the ones that are a party to litigation.

6.Files containing personnel information or medical information the disclosure of which can constitute invasion of privacy.

7. Information records compiled for the purpose of law enforcement the disclosure of which

a.    could interfere with enforcement proceedings,

b.    could constitute invasion of privacy,

c.    could disclose identity of a person, state, nation or other entities that disclose information on a confidential basis,

d.    is related to criminal law enforcement,

e.    intelligence information,

f.     information about the techniques of law enforcement the disclosure of which could support or assist in circumvention of the law and

g.    information that can endanger the life or physical safety of an individual.

8. Information related to the regulation or supervision of a financial institution.

9.Certain confidential geological and geophysical information and data including maps.

GlobalCompliancePanel

API is the biologically activesubstance in a drug

Description: A pharmaceutical drug consists of the API and the excipient, the inert substance

Introduction: Active Pharmaceutical Ingredient

An active pharmaceutical ingredient (API) is the substance in a pharmaceutical drug that is biologically active. Some medications may contain more than one active ingredient. The traditional word for the API is pharmacon or pharmakon which originally denoted a magical substance or drug.

Drug Ingredients

A drug in the dosage form consists of two ingredients: One is the API, which is the drug itself, this is the ingredient that treats or relieves the symptoms of the specific medical conditions; the second ingredient is a substance that acts as filler in order to give volume and substance to the tablet or drug. It is called as an excipient, which is the liquid the API is suspended in or is the substance of the tablet. The excipient is a pharmaceutically inert substance.

Every drug is defined based on its active pharmaceutical ingredient. It is important to understand the compatibility of API of one drug with that of the other, because when patients are on multiple medications, these API can interfere with each other. This could have effects ranging from minor side effects to serious repercussions such as life threatening complications.

Pharmaceutical Drugs vs. Herbal Medicines

The APIs are what differentiate a pharmaceutical drug from herbal medicines. In case of herbal medicines, the API are not identified, or there are more than one APIs and in most cases, these APIs although identified cannot be recreated through chemical or laboratory methods. This prevents standardization of herbal medicines; in many cases clinical trials do not provide substantial evidence of positive, or for that matter, any negative effect of a suspected API in herbal medicines.Thus further leads to complications in labeling. Due to non-existence of a standard dosage or identified API, the drug effects are interpreted haphazardly and lose objectivity.

Importance of API

APIs are the essence of pharmaceutical market and, for that matter, global healthcare. While there are several challenges faced by API manufacturing companies in terms of standardization and compliance requirements, there is equally good number of opportunities such as improved credibility and ability to penetrate global markets.

API Awareness

Due to the increased awareness of APIs, and their importance, potential effects and side effects, several online services have come up with information identifying the APIs in pharmaceutical medication. An example is the following website.  The authenticity of information on this website is not guaranteed.

http://www.nps.org.au/consumers/tools__and__tips/medicine_name_finder Medicine Name Finder.

GlobalCompliancePanel

Nutraceuticals are foods that provide medical or health benefits

Description: Since nutraceuticals are preventives, FDA is less stringent in enforcing regulations on nutraceuticals than on drugs

What are Nutraceuticals?

 Definition

Nutraceuticals are defined as food or parts of food that provide medical or health benefits, including the prevention and treatment of disease.  The term ‘nutraceuticals’ combines nutrition and pharmaceutical.

isolated nutrients, herbal products, and processed foods such as cereals, dietary supplements and specific diets,  genetically engineered foods, soups, probiotics, antioxidants, phytochemicals,fortified food products and beverages all fall in the category of nutraceuticals. The term nutraceuticals was originally defined by Dr. Stephen L. DeFelice, founder and chairman of the Foundation of Innovation Medicine (FIM), Crawford, New Jersey

The medicinal components of food are simple or complex chemical components which are derived from plant, food, and microbial sources. These are known to provide medicinal benefits as part of the food and are valuable to long-term health.

Categories of Nutraceuticals

Some of the important categories of nutraceuticals are

1.    Dietary supplements including botanicals such as vitamins,carotene, minerals, and co-enzyme Q, Ginseng, Gingko Balboa and Saint John's Wort.

2.    Functional foods such as oats, bran, Probiotics like oligo-fructose used for control of intestinal problems, Omega-3 used in prevention of heart disease, Canola oil for cholesterol reductionand Stanolshelp in the reduction of cholesterol absorption.

3.    Medicinal foods:lacto-ferine for immunityenhancement,transgenic plants for oral vaccination against infectious diseases.

4.     Some of the other food that is being used for its medicinal value since ancient history areantioxidants such as grapes, flavonoids in citrus fruits, wine, dark chocolate and tea as well asanthocyanin found in berries.

Regulations and the FDA

Unlike pharmaceutical drugs, there are no standard regulations that guide the nutraceuticals industry and nutraceutical products. These are considered under the bracket of dietary supplements for all regulatory purposes.

Nutraceuticals foods are not subject to the stringent testing and regulations as pharmaceutical drugs. The American Nutraceuticals Association works with the Food & Drug Administration in developing industry and scientific standards for products and manufacturers,consumer education, and other related consumer protection roles. The FDA alerts the public as well as the providers about the dietary supplement companies receiving warning letters about their products.

Nutraceuticals - Future

In 2005, the National Academies Institute of Medicine and National Research Council created a blue-ribbon committee to create an improved framework for the Federal Food & Drug Administration to evaluate dietary supplements. Even the improved framework fails to distinguish between “nutraceuticals" and "dietary supplements". Regulations in this direction are yet to be formulated. 

GlobalCompliancePanel 

Glucose Testing Devices are used to measure the blood sugar level

Description: Good glucose control using home monitors lead to fewer complications

Introduction

Glucose Testing Devices are the devices used to measure the blood sugar (glucose) level.  Blood sugar is glucose that is a source of energy to the body. Generally the body regulates the amount of glucose in the blood with the help of insulin, however if the body is unable to regulate the glucose level, the person’s condition can be hypoglycemic, hyperglycemic or diabetic.

Glucose Testing Devices

Most store-bought glucose testing devices are home-use test kits. These devices use a quantitative method to find out the amount of glucose present in a blood sample. The results help in determining the periodic adjustments in treatment. With these tests one can know if the level of glucose is dangerously high or low and monitor the effect of dietary control on the blood glucose level.

In recent years more and more diabetics use the glucose testing devices and The Diabetes Control and Complications Trial of 1993 (http://diabetes.niddk.nih.gov/dm/pubs/control/) also has shown that good glucose control using home monitors led to fewer complications.

Usage

In general, most devices require the patient to prick the fingertip with a lancet to get a drop of blood. This blood is then placed on a disposable "test strip" which is coated with chemicals that react with glucose in the blood. Then the test strip is placed into the device meter and the meters report results in milligrams of glucose per deciliter of blood or mg/dl.

The treating physicians specify how often one should test ones glucose level. The standard levels for fasting blood glucose level (fasting for 8-10 hours) should be lower than 126 mg/dL and the blood glucose level immediately after eating food should be lower than 200 mg/dL.

Accuracy

The accuracy of these devices varies based on the quality of the device, the test strips, and also on ones RBC count.

Interfering substances

Some substances, such as Vitamin C and uric acid, or certain medication for co-morbidities, certain ingredients of the food, may interfere with the glucose testing and thus alter the results. Altitude, temperature, and humidity are some of the environmental factors that affect the glucose test results are

Glucose testing devices available in the market differ basically in the ease of use, accuracy, testing speed, overall size, ability to store test results in memory, cost of the device and variety of test strips.

Home Test Results vs. Laboratory Test Results

Most home blood glucose meters measure glucose in whole blood whereas most lab tests measure glucose in plasma.  The lab test results may be 10-15% higher than the home test results. Some home test devices these days give values that are plasma equivalent.

GlobalCompliancePanel

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

Compliance means conforming to set standards

Description: Compliance is monitored by the bodies that enact different compliance standards and laws.

Understanding the Idea of Compliance

What is compliance?

Compliance means conforming to set standards, or rules and regulations or abiding by the laws of the land. While some compliance standards like the ISO focus on adhering to standard procedures, some others require adheringto quality or safety standards, and a host of others like HIPAA and banking standards may require all the above.

Compliance can be a 'state of being’ or the 'the process of' adhering to compliance standards’.For example: A ‘Standards body’ like the Institute of Electrical and Electronics Engineers (IEEE) may specify software development standards, this is the 'process’ of adhering to rules. Now, if the software is distributed in compliance with the vendors licensing agreement, this is 'being' in accordance with rules.

Need for compliance

Formulation of compliance standards is rooted in several factors and events in the past and has evolved over time. Some standards are set keeping future possibilities in view. The factors and purposes that have influenced the need for compliance standards are:

1.    Ethical, safety, accountability, transparency and traceability reasons

2.    To ensure quality of products and services

3.    For documentation and review purposes

4.    To prevent possible legal hassles

5.    For performance analysis or other statistical analysis

6.    To incorporate Best Practices and for the common good

Types of compliance

There are several types of compliance standards for specific fields like corporate, healthcare, banking, patient, clinical, Human Resources, food safety, trade and logistics, regulatory and quality compliance and more.

Monitoring compliance

Compliance is monitored by the bodies that enact different compliance standards and laws. While some are government bodies like the HIPAA regulatory body and FDA for drug administration and compliance, there are several independent bodies that monitor other compliance standards, such as the ISO, IEEE and others.

Advantages of compliance

1.    Compliance standards help in inculcating ethical, fair and best practices

2.    By adhering to compliance standards in manufacturing and servicing, one can bring about consistency in products and performance

3.    Avoids redundancy, misunderstanding, misinterpretation and litigation

4.    Protects the rights of all stakeholders

5.    Checks wastage, misuse or misappropriation of funds or material or power

6.    Prevents scams, scandals, and data theft, and ensures safety, security and privacy of data  and builds reputation

7.    Helps in easy supervision due to a standardized system being in place.

Non-compliance

Non- compliance is failure or refusal to comply with the set standards. This may lead to

1.    Fines or penalties by the governing bodies

2.    Compliance certificate getting cancelled

3.    Litigation and bad reputation

4.    Financial loss or loss of business

5.    Inspections and checks from other governing bodies

6.    Getting Business license cancelled or privileges scrapped off

 GlobalCompliancePanel

In vitro diagnostics are performed outside the living organism in a controlled environment

Description: These are medical devices and other accessories that are used to perform tests on samples that are extracted from the living organisms

Understanding In-Vitro Diagnostics

In vitro diagnostics: Introduction

The word ‘invitro’ means ‘in glass’ in Latin. In vitro diagnostics are performed outside the living organism in a controlled environment, generally in a test tube.  The diagnostic tests can include simple blood cell count to sophisticated DNA technology applications. These tests are generally conducted in pathology laboratories of hospitals, drug development facilities and other research facilities.

In Vitro Diagnostic Device

In Vitro Diagnostic Devices are medical devices and other accessories that are used to perform tests on samples that are extracted from the living organisms. These samples could be blood, tissue, urine, or other pus cells that are taken from the living organism, generally human beings. A detailed observation of these samples for the content and the quantity or count of different contents helps in identifying a medical condition, or in identifying the severity of the medical condition. These diagnostics devices can also be used to check the effects of medication or other treatments on a medical condition.  IVD devices include reagents, calibrators, specimen receptacles, meters, control materials, software, kits and many other related instruments.

IVD Disciplines

There are several IVD disciplines such as clinical chemistry, haemostasis, haematology, molecular diagnostics, immunochemistry, and microbiology. The focus area of each of these disciplines is different although all of them aim at infection detection, diagnosis or prevention of medical conditions as well as drug therapy monitoring. IVD diagnostic techniques are extensively used in research and drug formulation.

Specimen Receptacle

Specimen receptacles are the devices that contain and preserve the specimens or samples derived from the human body. These are specifically designed and manufactured with the intention of being put to use for in vitro diagnostic examination. 

Common InVitro Tests

Common tests include liver enzymes, blood tests for glucose, levels of electrolytes such as calcium, sodium, and potassium, thyroid tests, blood composition tests, lipid profile, and tests for drugs.

In Vitro Diagnostic Directive (IVDD)

The Directive 98/79/EC by the European Parliament and the Council has brought about In Vitro Diagnostics Directive which specifies regulatory requirements  for compliance following which the product can be allowed for CE marking. This is important for manufacturers to gain access to the markets in the European Economic Area (EEA). This is done in order to safeguard patient’s health and safety and to ensure that the product meets the required quality standards and performs as intended.

Indispensible IVD

IVD diagnostics has become an essential and indispensible part of global health care. Rapid technological advancement , increased awareness about healthcare as well as improved drug development techniques have all contributed to make in vitro diagnostics an important part of healthcare industry.

GlobalCompliancePanel

High Performance Computing can help understand the secrets of the DNA

Description: Understanding the secrets of DNA is the key to the next generation of medical care involving extremely personalized treatment

The Use of High-Performance Computing in Understanding the Secrets of DNA

Introduction

High-performance computing (HPC) is the use of advanced teraflop computer systems, such as supercomputers or cluster of computers, to solve complicated and time consuming scientific research problems. Integrated circuits (ICs) such as field programmable gate arrays (FPGA) and high-speed microprocessors are the foundation of such hybrid computing platforms. Hybrid systems are not only faster than supercomputers or clustered computers but also flexible and cheaper.

2 (DNA) is a nucleic acid that contains genetic instructions for functioning, growth and reproduction of living organisms.DNA is composed of Adenine, Guanine, Cytosine and Thymine. These four nucleotide bases are commonly abbreviated as A, G, C and T. Understanding the secrets of DNA is very important as it is the key to the next generation of medical care involving extremely personalized treatment.

Technology and Applications

The use of HPC in the field of genetic engineering, forensics, bio-informatics and DNA nanotechnology is advancing drug discovery and personalized healthcare. Some of the technologies used are as follows:

·         Bio-IT equipment: Determine entire genome or genetic makeup of an individual by sequencing millions of DNA bases

·         Dye-terminator sequencing:Use of fluorescent dyes, each of which emits light at a different wavelength, to label the nucleotide bases and the sequence is read by using a laser beam.

·         FPGAs:Speed up parallel processing of algorithms exponentially for gene sequence search, detection and comparison and help pinpoint the origins of Alzheimer’s disease and cancer

Evolutionary, functional and structural relationships are explored by looking for similarities or mismatches in regions between two DNA sequences. Genomic analysis and sequencing in large clinical trials are more efficient than traditional drug discovery approaches. These studies help in drug discovery and subjects who will respond to the discovered drugs.

Consumer Genomics

HPC has strengthened consumer genomics in predictive medicine and made non-invasive and easy administration of genetic testing possible. Just send in a saliva sample and get back comprehensive web-based report on the subject’s predisposition to diseases like diabetes, cancer, heart diseases and more.

Pharmagenomics

Pharmagenomics deals with treatment of the patient based on his or her specific genetic makeup. It helps physicians to select optimal medicine for their patients especially for diseases such as asthma, cancer, diabetes, HIV and tuberculosis. HPC has reduced the cost of personal genomic sequencing and the costs are only going to drop further as more people starting sequencing.

GlobalCompliancePanel

The USP is a standards-setting authority

Description: The aim is to improve people’s health around the world

The US Pharmacopoeia

Introduction

The United States Pharmacopeia (USP) is a non–governmental, not for profit, public standards–setting authority founded in 1820 for prescription and over–the–counter medicines and other healthcare products that are manufactured or sold in the United States.

USP also sets standards for food ingredients and dietary supplements which are widely recognized all over the world.  The standards are set to ensure quality, purity, strength, and consistency of the products which is critical to the public health.

USP Mission

To improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.

USP Programs and Services

USP carries out the following programs and services

1.    Product Quality–Documentary Standards

These are written standards for medicines, dietary supplements and food ingredients. These are used by regulatory agencies and manufacturers to ensure that their products meet the appropriate requirements of quality, purity, consistency and strength.

2.    Setting  product Quality–Reference Standards

The written standards work as reference standards for manufacturers and regulatory agencies. By federal law, certain prescription and over-the-counter medicines available in the United States must meet USP public standards.

3.    Provides standards for healthcare quality and safety

The FCC is a compendium of standards used for determining, verifying and standardizing quality and purity of food ingredients like preservatives, flavorings, colorings and nutrients all over the world. These standards for food ingredients were formulated by USP.

4.    Promotes the Quality of Medicines Program

This program focuses on improving the quality of medicines intended to treat HIV, malaria and tuberculosis and growth of drug-resistant strains of these diseases.

5.    Provides Product Quality–Verification Services

Performs testing and audit programs for dietary supplement products and ingredients. Products that meet the requirements of the program can display the USP Verified Dietary Supplement Mark on their labels. The products that meet the USP standards can display USP mark which means that they meet the USP standards; these are not necessarily verified by USP.

6.    Provides Education on quality, purity, strength and consistency of products that can be achieved by adhering to the standards.

7.    Promoting Drug Quality in Developing Countries

Information relating to various aspects of drug use is provided to practitioners, pharmacists, and others healthcare decision making authorities.

8.    International co-operation and standardization

Promotes international co-operation and standardization in order to enhance purity, quality, strength and consistency of over-the-counter medication, dietary supplements, and food ingredients.

                   GlobalCompliancePanel

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

Hand-held ECG devices could impact the home-care cardiac patients

Description:  This device could make emergency care for cardiac patients much easier and accessible

The Promise of Hand-Held ECG Device

Introduction

Electrocardiograph is a medical device that generates electrocardiography (ECG), a recording of the electrical activity of the heart over time. ECG is usually a wavy line showing the overall rhythm of the heart. It is a non-invasive recording  obtained by detecting and amplifying electrical changes between two skin electrodes placed on either side of the heart.

ECG Devices

The first generation of ECG devices was not only big but also printed on a graph paper. The next generation of devices came up with display panel for monitoring information and stored collected data for later analysis. However these were still complicated for general use outside healthcare facilities. The new generations of devices are portable, simple to operate and technologically advanced. Hand-held ECG deviceseither operate independently or work as an accessory to a computer system or a mobile phone.

Detecting and managing irregularities in the heart at an early stage is crucial to preventing worsening of heart diseases. Such devices can revolutionize healthcare in general and cardiac care in particular,putting patients in control on their health.Patients who have erratic heart rhythms, or those who suffer from atrial fibrillations, or the ones who have sustained transient ischemic attack, as well as all those patients who are diagnosed of any heart related condition can make use of this device.

Hand-held ECG devices in the market

There are several makes of hand-held ECG devices available in the market today at affordable prices.

Most of these devices are single lead electrocardiographic monitor. They record the users’ cardiac functions by tracing the heart’s electrical activity and display in a waveform. These are most suitable for daily or regular health checkup, especially suitable for those who have been diagnosed with heart related conditions.These devices are intended for self-testing and make it convenient to use whenever the patient want to have routine checks. Most of these devices are almost wireless and do not require conducting gel either. These devices are small in size and weigh a few hundred grams.

The reading from these devices can be stored on a computer or even on a smartphone. These are sure to control fatalities due to heart related medical conditions.

GlobalCompliancePanel

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

The E-cigarette could be the next best thing to happen to smokers

Description: The E-cigarette has the potential to alter smoking habits and wean heavy smokers away

Introduction

Electronic cigarette (e-cigarette), also known as vaporize cigarette, is an electronic device powered by a battery that simulates a real cigarette by providing doses of nicotine or other substances with physical sensation and flavor close to that of inhaled tobacco smoke without generating any smoke.

E-cigarettes are effective as they do not cause any withdrawal symptoms or cravings and are reusable with cartridges, containing different substances and dosages. Therefore switching from a real cigarette to an e-cigarette is easier than using nicotine gums, lozenges, patchesor other nicotine replacement products. Different dosages and non-nicotine substances help to gradually kick the smoking habit.

Construction & Operation

E-cigarette resembles a real cigarette with an elongated tube made up of a cartridge, atomizer, battery and electronic circuits. The cartridge, or mouthpiece, is a reservoir for nicotine or other substances which is vaporized by the atomizer, or the heating element, using the rechargeable battery and airflow sensors which activate the atomizer. Some units even have an LED at the tip which glows during operation mimicking a real cigarette.

An atomizer lasts for a quarter to half a year on average use while a cartridge is equivalent to a pack of cigarettes. Some units use a combination of a cartridge and an atomizer known as cartomizer. Nicotine cartridges usually have nicotine dissolved in propylene glycol or vegetable glycerin and are available in different concentrations. Nicotine cartridges also come with a wide variety of flavoring from fruit flavors to flavors of branded cigarettes.

Benefits

E-cigarettes help quit smoking without losing the smoking satisfaction. The real benefit of e-cigarettes is that it helps prevent or eliminate the nasty stuff of real cigarettes including:

·         Tar, carbon monoxide and other dangerous chemicals

·         Foul tobacco odor from the smoker, smoker’s clothes and the smoking environment

·         Yellow stains on smoker’s teeth

·         Smoke  and ashes that pollute the environment

·         Dirty looks from passersby

E-cigarettes can be smoked in most no-smoking zones as they do not emit any harmful secondhand smoke, for other people in the zone, and also as they cannot start a fire, as the heating element is concealed. E-cigarettes can be used in restaurants, theaters and airplanes without disturbing others.

Risks & Concerns

E-cigarettes although safer than real cigarettes may not help quit smoking as they are addictive due to nicotine and can lead tonicotine poisoning. Studies have revealed differences in the levels of nicotine specified on the cartridges with the levels they actually contained. There were traces of nicotine in nicotine-free cartridges and inconsistent delivery of vapors in many units. As e-cigarettes are not yet classified as medical device due to the absence of clinical trials, they are easily available in the market as tobacco/nicotine product and keeping them out of the hands of minors is not easy.

GlobalCompliancePanel



webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com


Phone: 800-447-9407
Fax: 302-288-6884

Stent surgery could be a lasting solution for ED

Description: This new medical procedure looks like a promising, permanent alternative to medications and other treatments

The Promise of Stent Surgery for Erectile Dysfunction

What is Erectile Dysfunction?

Erectile Dysfunction (ED) is the inability to develop or maintain erection of the penis. ED is a sexual dysfunction commonly known as male impotence. Some of the important causes of ED include cardiovascular diseases, diabetes, neurological problems and even side effects from drugs.

What is stent surgery?

Stents are mesh-like tubes that are made of plastic or metal. If made of metals, these are not detected by metal detectors making them safe to use in any arteries. These stents are like collapsed scaffolding. When inserted into the artery, they expand and stay expanded, thus promoting smooth flow of blood and overall good health.

Stent surgery involves insertion of an artificial tube permanently into an artery to keep it open. The stent improves flow of blood in an artery where drugs may not be effective. Stent surgery or stenting has been successful for treating blocked and collapsed arteries and is now being used for penile arteries to eliminate ED.

How is stent surgery for ED performed?

First, a series of x-rays are taken to see if an injected colored dye shows up in the thinner section of artery in question. Then a stent is inserted in the said artery through the groin. This procedure is slightly different from those used for keeping the arteries around the heart open.

Who benefits from stent surgery for ED?

Stent surgery for ED is beneficial for those men who had ED due to traumatic injury and for those who found drugs ineffective or not as effective as desired. It is estimated that nearly 30% of men suffering from ED could be helped with this procedure. The major benefit is that erection will feel spontaneous rather than medically induced.

What are the risks involved in stent surgery for ED?

Stent surgery for ED is a new medical procedure that has been successfully completed by a few well known hospitals in Europe. The risks are similar to stenting other arteries except that penile arteries are even narrower and increases the risks several times over. Further,not much is known about the long term or side effects of an implanted pelvic stent. Although the stent surgery has the potential for offering promising results, further research is necessary to rule out any complications or any previously undetected problems.

GlobalCompliancePanel

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

HIPAA Security Rule is applicable to all covered entities

Description: The HIPAA Security Rule directs the way a covered entity will comply with the act.

Simple Understanding of the HIPAA Security Rule

 HIPAA Security Rule is one of five important rules formulated in Title II of Health Insurance Portability and Accountability Act, orHIPAA for administrativesimplification.

Essence of Security Rule

This rule is applicable to all covered entities that hold Protected Health Information (PHI) in electronic form.

There are three main categories of safeguards that are required for compliance with this rule.They are administrative safeguards, physical safeguards and technical safeguards.

For each of these categories, security standards are identified and each standard has a 'required' component and an 'addressable' component of implementation specification.

While the 'required' component of the standard is needed for compliance, the 'addressable' component of the standard is to be determined by the covered entities and is flexible.

AdministrativeSafeguards

These are the clearly defined policies and procedures that direct the way a covered entity will comply with the act. The important aspects addressed here are:

1.    Ongoing training on PHI and HIPAA to the staff.

2.    Recruitment of designated Privacy Officer

3.    Documented administrative procedure to access, share, authorize, modify, document, discuss or terminate information related to PHI.

4.    Outsourced business process must follow the same standards as the outsourcing entity.

5.    Internal and external audit for HIPAA compliances

6.    Contingency plans in case of emergencies or security breach.

PhysicalSafeguards

These are the policies and procedures aimed at controlling access to records of PHI to avoid inappropriate access and misuse. The focus here is on physical form of records and storage components such as computer systems and hard drives.

The important points addressed here are:

1.    Electronic hardware containing PHI must be protected.

2.    Access to such hardware or computer system must be controlled

3.    Facility security plan, escorts and visitor sign-in systems must be put in place.

GlobalCompliancePanel

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

HIPAA seeks to prevent fraud or abuse of the healthcare system

Description: HIPAA defines 'Protected Health Information'as any information pertaining to the health status of individual

Simple understanding of the HIPAA Privacy Rule

HIPAA Privacy Rule is one of the five rules formulated for administrative simplification. Administrative simplification is addressed in Title II of Health Insurance Portability and Accountability Act, or HIPAA. Along with administrative simplification, the Title II of HIPAA through the major five rules aims at defining offenses related to healthcare, has programs in place to prevent fraud or abuse of the healthcare system and sets penalties for such offenses. This is very evident in the Privacy Rule regulations.

Applicability

The Privacy Rule applies to the entities called as 'covered entities' by HIPAA. Theseconsist of all the entities involved in the healthcare system like the health insurance companies, community health information system, medical providers, healthcare billing services, healthcare clearing houses, healthcare claims administrators, and any big or small healthcare facilities.

Essence of Privacy Rule

HIPAA defines 'Protected Health Information' (PHI) as any information pertaining to the health status of individual, healthcare provisions and the payments made for such provisions of healthcare that can be linked to an individual. The Privacy Rule in essence regulates the use or disclosure of protected health information by the covered entities.

Rights of the individual to whom the PHI pertains

1.    The PHI must be disclosed to the individual it is pertaining to if the individual requests for the same

2.    The individual has the right to request for correction of inaccurate information

3.    The individual should be notified if the PHI is shared with other covered entities.

4.    The individual can specify the modalities of communication and it should be adhered to in order to protect confidentiality.

Regulations for the covered entities

1.    The PHI must be disclosed to the law when required to do so by law. For example, when reporting child abuse or domestic violence to the child welfare agencies, the PHI may be required to be disclosed.

2.    Reasonable steps must be taken to ensure confidentiality while communicating about the PHI

3.    PHI may be disclosed for the purposes of further provision of treatment or payment, only to the extent necessary.

4.    PHI may be disclosed after an authorization by the individual to covered entities

5.    The covered entities must hire privacy official and a contact person for receiving complaints regarding violation of Privacy Rules

The workforce must be trained on PHI related communications.




GlobalCompliancePanel



webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com


Phone: 800-447-9407
Fax: 302-288-6884

Outsourcing dental devices is good for business, but not for patients

Description: There are doubts about whether dental devices will be as effective when they are procured from developing countries at half or a third of their price

Introduction

Dental devices include dental prosthesis like dentures, used with the support of soft and hard tissues surrounding the oral cavity, custom made for every individual to replace missing teeth.

Outsourcing is the process of contracting a business function, previously performed in-house, to an external provider. From feasibility study to design, research to development, prototype to production and everything in between can be outsourced. One of the major reasons for outsourcing is to focus on core business but in reality the focus has shifted to cost savings.

Concerns

Ignorance

There is a growing concern is that dentists and their patients may be using outsourced products without even being aware of it. Such ignorance can often lead to the use of substandard products that can adversely affect the health of Americans.

Dental offices often send work order to the closest dental work laboratory, known for quality. Some of these laboratories outsource the work to overseas and restrict themselves to administrative duties. The imported product is checked by their skeleton staff for quality and minor adjustments are undertaken in-house.  After relabeling and repackaging, the dental prosthesisfinally ends up at the dental offices.

Cost vs Quality

Dental prosthesisis often outsourced due to low cost of the overseas product. it is cheaper than comparable American dental prostheses by anywhere between 33 and 50%. Dentists often use outsourced dental prosthesison patients who negotiate for a better price and on those who do not have any dental insurance. New dentists are also known to use outsourced dental prosthesis, when they first start their practice, for financial reasons. The quality including material and fixture of the outsourced dental prosthesis is likely to degrade to harmful levels as cost becomes the only criterion for outsourced products.

Lead Poisoning

One of the major concerns is the presence of lead in outsourced dental prosthesis. Lead is a hazardous substance for adults and has serious health risks for growing youngsters. Lead poisoning is often not discovered until irreversible damage has taken place and is usually due to exposure from swallowing or breathing lead particles.

Regulations

The Food and Drug Administration (FDA) requires laboratories, which outsource dental work to overseas, to give information related to outsourcing to the dentists. In reality, dentists obtainsuch information only upon request and the obtained information is usually not passed to the patient as it is not mandatory.

The FDA also oversees imported medical devices or devices that are relabeled, repackaged or manufactured. All medical devices with problems need to be reported but adverse reactions surrounding medical devices are rarely reported.

Therefore, the National Association for Dental Laboratories (NADL) is concerned about the public’s safety and wants all laboratories dealing with dental work to:

·         Register with a state agency

·         Have at least one Certified Dental Technician (CDT)

·         Use FDA approved materials

·         Disclose materials used in dental prosthesis

·         Disclose the point of origin of manufacture

GlobalCompliancePanel

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884