...Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property LaMeka Wright Strayer University LEG 500 June 11, 2014 Samuel Christian, Jr. Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property Being a worldwide successful company takes a lot of hardworking individuals to make this happen. When running a successful company, you will want to make sure you are functioning in an ethical manner and are abiding by the law. “PharmaCare is one of the world’s most successful pharmaceutical companies with a reputation as a caring, ethical, and well-run company that produced high-quality products that saved millions of lives and enhanced the quality of life for millions of others” according to the scenario. However, there has been some unethical behavior going on that involves issues relating to marketing and advertising, intellectual property, and regulation of product safety. This paper will discuss some ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety; argue for or against Direct-to-Consumer marketing by drug companies; determine who regulates compounding pharmacies under the current regulatory scheme, what the Food and Drug Administration (FDA) could/should have done in this scenario, and whether the FDA should be granted more power over compounding pharmacies; decide whether PharmaCare’s use of Colberian intellectual property would be ethical in accordance...
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...specific types of legal authority, regulations or statutes on the operation of any type of health care facility or related industry. The Public Health Service (PHS) has a goal of promoting “the protection of the nation’s physical and mental health” (Pozgar, 2012, p. 27). Included in its mission, it aims to uphold health-related agreements, policies, and programs, as well as enforce laws aimed to ensure safety and protection. PHS is comprised of individual agencies, each with their own goals. The Agency for Healthcare Research and Quality is in charge of “producing and disseminating scientific and policy-relevant information about quality, medical effectiveness, and cost of health care” (Pozgar, 2012, p. 27). The Centers for Disease Control and prevention collaborates to ensure that people and communities can protect their health “through health promotion, prevention of disease, injury and disability, and preparedness for new health threats” (“Centers for Disease,” 2010, para. 1). The Food and Drug Administration protects the public health by ensuring its safety, efficacy, and security. Additionally, it also is “responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health” (“U.S. Department,” 2012, para. 1). Lastly, the National Institute of Health aims to “seek...
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...| Health Law Essay | Health Law A Regulated Enterprise | Introduction to Health Law and PolicyProfessor Voss | By Kimberly Causey | 1/11/2015 | Health Law A Regulated Enterprise The great Statesman Sir Winston Churchhill clearly stated, “If you have ten thousand regulations you destroy all respect for the Law”. When Law Regulators at all tiers interpret various components of the law, the interpretation can convey an unruly mixture of complexities. Likewise, Health Law can be encountered in various aspects on both the State and Federal levels. Thus creating a mixture of regulations by all levels of government. For example, the obvious is the overlapping of police power between the state laws and the preemptive decisions made by which the federal law prevails. Overall, applicable laws have continuously exemplified complexity, specifically in Health Law. Yet, Regulators continue to redefine the laws that are created both on State and Federal levels. For this purpose, I will identify present a mixture of fundamental differences that are encountered at any tier level. Regulations can frequently change in producing guidance about compliance of expected outcomes. What is reasonable and practical at times can produce countless interactions and inconsistency among regulators. For instance, Hall and Showalter both mention their concerns for quality, autonomy, access and cost which will be discussed. Hall presents a great article on “What is Health Law?” He further...
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...Comparison and Contrasts of the United States and Canadian Health Care Systems Devry University HSM 310 Comparison and Contrasts of the United States and Canadian Health Care Systems Canada In the 1960’s, Canada reformed its system providing a universal single payer health care system which covers all services provided by physicians and hospitals it is mostly free at point of use and has most services provided by private entities. Single payer health care is the financing of costs of delivering universal health care for an entire population through a single insurance pool. The government took over full funding of both physician and hospital services, setting minor physician fees and hospital budgets. Everyone is covered at all times. United States of America For the past 8 decades, the U.S. has run its country on a private health care system where the individual pays for their choice of health care. Depending on the coverage of the health care amounts to the cost. In the U.S, government funding for health care is limited to Medicare, Medicaid, Veterans Administration and the State Children’s Health Insurance Program, which covers senior citizens, the very poor, disabled people, veterans and their families and children. The United States is the only country in the developing world that does not have a fundamentally public tax-supported health care system. The National healthcare debate is one that has been a continuing arguing point for the last decade. The goal is...
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...Assignment 5: Dealing with Fraud Qui Tam is defined by the phrase “he who sues for the king as well as for himself.” This is a type of legal case in which the whistle-blower or relator files on behalf of the government. The government can then decide to take over the prosecution or not. If the government chooses not to proceed with the case, the relator may continue alone (Showalter, 2012). In order to file a suit, both the plaintiff and the allegations must meet certain guidelines. The same allegations should not have been brought to light previously, unless the qui tam plaintiff is the original source of information that was previously disclosed. The federal law provides a solution for whistle-blowers who are discharged, demoted, harassed, or discriminated against. This type of law suit has become popular and effective in fighting fraud and abuse because of this protection (Showalter, 2012). In healthcare, sometimes the qui tam plaintiffs argue that a claim involving a kickback or an illegal doctor self-referral is a violation of the False Claims Act (FCA). The case may be legitimate otherwise. One case is the United States ex rel. Marcus v. Hess. In this WWII case the contractor’s claims were fraudulent because the contract was secured through collusion. Another case, United States ex. rel. Woodard v. Country View Care Center, Inc. involved defendants who submitted cost reports to Medicare payments to “consultants” that was really kickbacks for referrals. The FCA applied...
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...Health Care Professionals Shana N. Settle HSA-500 May 29, 2011 Dr. Kevin Williams Health Care Professionals 1. Identify and describe three reasons there may be a physician shortage rather than a surplus in the United States. There is no denying the fact that there has been a dramatic surplus of employment in a diversity of categories, in the health sector in the United States over the last 30 years, which is a astonishing reflection of the essential place health and health care possesses in the lives of Americans, yet traditional health care occupations- physicians, dentists, and pharmacists- have declined, some dramatically. In regards to physicians, the picture is not so evident. The number of physicians in the United States did increase rapidly over the last 40 years, but by the early 2000s there seemed to be a shortage (?) as some would argue. However, there have been many “cross-cutting forces that have affected the U.S. health care system in the last several decades” (Williams & Torrens, 2009, p. 269). One reason to assume this conclusion is the “more restrictive elements” of managed care. Patients and doctors, alike, have been dissatisfied with their limited choices, from tightly controlled reimbursement to ‘non-physicians’ control of their workloads, respectively. As a result, there has been a movement away from insurance arrangements back to coverage that more resembles fee-for-service plans, especially PPOs (Williams...
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...healthcare that is provided to prisoners in an institution within the United States, along with the foundation of such an agency and who regulates the licenses, accreditation, certifications, and authorization for employment for those who work within one of these facilities. The Federal Bureau of Prisons The Federal Bureau of Prisons (BOP) is an agency that was created on May 14, 1930 and approved of by then president Herbert Hoover. Its main headquarters is in Washington, D.C. The BOP is a subdivision of the United States Justice Department and is responsible for the administration of the federal prison system. Its sole purpose is to provide more open-minded and compassionate care to those who are federal inmates within the United States prison system. This agency is also responsible for providing medically needed health care to inmates in agreement with federal and state laws. One of the most negative aspects that the BOP is responsible for is carrying out all judicially mandated federal executions, including the lethal injection of inmates who have been sentenced to death for a crime they have committed (Federal, 2012). This agency also maintains the lethal injection chamber of a prison before, during, and after an execution, making sure that the lethal injection is set up appropriately and that all goes as humane as possible during such an event. The structure of the BOP is made up just about the same as any other agency. This agency has several divisions with boards...
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...Allowable Margin of Illegal Immigration Keith Rulli HUM 111 12-23-2012 Stephanie Washington Shrinking The Allowable Margin of Illegal Immigration With the U.S. citizens and government both aware of the immigration crisis in this country, it is not the time for the government to blink or lollygag in bringing about resolutions. A proper strategy will cause the appropriate change to the situation, and with it a peace will come to this country. The irony of the situation is that it may only come after amnesty is granted toward the current ballpark figure of 12,000,000 illegal immigrants in this country. Otherwise, immigration would remain a vehement issue. The scope of issues regarding immigration is immense because of its impact on American productivity and the American way of life for so many people. Individuals and groups from many different walks of life and different professional fields hold diverse views. Some of the main standpoints from which the situation can be viewed include racial, economical (costs and benefits), environmental, legal, health care, education, political, and family (especially children). Altogether, the plan for Immigration Reform proposed by the Obama administration has great potential to curb problems arising from illegal immigration, close some of the loopholes in the American system, and reinforce the legitimacy of America's laws, policies, values, and the interests of this nation. One of the points of debate in immigration policy is whether...
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...professional, it is vital that you understand the scope of an organization’s legal and ethical responsibilities. To minimize liabilities and reduce risks from electronic, physical threats and reduce the losses from legal action, the information security practitioner must understand the current legal environment, stay current as new laws and regulations emerge, and watch for issues that need attention. Law and Ethics in Information Security As individuals we elect to trade some aspects of personal freedom for social order. Laws are rules adopted for determining expected behavior in modern society and are drawn from ethics, which define socially acceptable behaviors. Ethics in turn are based on cultural mores: fixed moral attitudes or customs of a particular group. Some ethics are recognized as universal among cultures. Slides 9 Types of Law Civil law represents a wide variety of laws that are recorded in volumes of legal “code” available for review by the average citizen. Criminal law addresses violations harmful to society and is actively enforced through prosecution by the state. Tort law allows individuals to seek recourse against others in the event of personal, physical, or financial injury. Private law regulates the relationship between the individual and the organization, and encompasses family law, commercial law, and labor law. Public law regulates the structure and administration of government agencies and their relationships with citizens, employees,...
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...general power to protect the health of its population within its geographic borders as long as the laws do not obstruct the rights of individuals guaranteed by the constitution. The federal government regulates health matters through the powers granted to the federal government in the federal constitution. This allows the federal government to create benefit programs and to indirectly regulate local activities that it would not have the authority to regulate directly. For example, the federal government created the Medicare program to pay for health care for the elderly and disabled, and Medicaid to pay for health care for the poor. Health care institutions that receive federal money in payment for services to Medicare and Medicaid recipients have to abide by federal regulations in order to keep receiving federal funds. According to Pozgar (2012), “a tort law is a civil wrong, other than a breach of contract, committed against a person or property for which a court provides a remedy in the form of an action for damages”. Within the general field of health care there is a good deal of discussion of tort law and health care because tort actions comprise what are more commonly known as medical malpractice or medical negligence actions. A medical malpractice or medical negligence suit can be raised against a physician or health care provider accused of having violated some standard of care that is recognized in the medical industry. A standard of care is simply a minimum threshold...
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...Control of Health Care in Puerto Rico Josie Valentín Walden University Overview of the health care system The Puerto Rico Department of Health (PRDH), the State Health Agency (SHA), is a free-standing, independent agency. Under its jurisdiction are all the health-related affairs of Puerto Rico. The PRDH performs the following functions: Planning, evaluating, and regulating as well as auditing the programmatic, administrative, and fiscal aspects of health facilities and services. The PRDH performs these duties in the public and private health sectors of the commonwealth. The system is driven by health needs or problems to produce health results or outcomes. The government’s role in health, once limited primarily to protecting the public from epidemics of infectious diseases. This information are Retrieved from http://www.cdc.gov /phppo/inpho/profile/pr Who controls health care in Puerto Rico today? Why? Several affiliated organizations function under the SHA. Included in this group are the General Health Council, Administration of Health Facilities and Services, Administration of Medical Services of Puerto Rico, and Central Areawide Comprehensive Health Services Corporation (CACHSC). The CACHSC is a private non-profit organization which serves as fiscal agent to the SHA for Federal grants earmarked to provide high-quality primary and migrant health care to medically underserved and low income residents of the mountainous municipalities. The General Council of...
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...The Forces Affecting the System Evangeline Hampton HAS/500 November 5, 2013 Doctor Debra Beazley Abstract The forces, which have affected the development of the health care system in the United States, are economics, technology and legal. The functioning of the health care system in economic development has become an influential issue. Health care is a predominant industry in the United States and is expected to develop further. Health care performance influences the economic growth in several rural communities. The health care system could be an influential organization and supplier of economic development or unimportant segment of the local economic model (Shinberger, 2005). As medical technology evolves, understanding how and when to adopt or invest in it is critically important. Move too early, and the infrastructure needed to support the innovation may not yet be in place; wait too long, and the time to gain competitive advantage may have passed. The economics affects the competition, which exists with the development of technology. The improvement in health care reports economic tasks: capital for the advance change and considering the parties responsible for the cost, and expenses for the product or service it yields. One difficulty is the time-consuming speculation period necessary for different medications or therapies, which needs the food and drug administration approval. Economics, Technology and Legal The health care segment is an essential factor...
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...Technology, and the definitions of health care information, and health care acronyms and remittance terms Jesse Davis Jr. University of Phoenix MBA 533/ Health Information Systems December, 2014 Professor Aimee Kirkendol Health information related acronyms, their translation, and elucidation The field of healthcare is primarily concerned with the care of people requiring preventive and medical care. However healthcare is a business. The business of health care generates trillions of dollars for the national and international health care communities. Health care as a right in the United States precludes the fact that capitalism rules every aspect of citizen life, especially health care. The factors primarily affecting health care include new technologies. The medical technology industry is a 150 to 200 billion industry. Prescription drugs, government regulation, malpractice liability and the aging of the largest generation birthed in the U.S., the Baby Boomers (78 million). Every day in the U.S., 10,000 Baby Boomers reach age 60, putting greater demands on medical services. Chronic diseases, many preventable (diabetes, cancers of the lung and cardio vascular disorders) also contribute to escalating cost of health care. Acronyms reduce the amount of...
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...Information Security, Fourth Edition Chapter 3 Legal, Ethical, and Professional Issues in Information Security Learning Objectives • Upon completion of this material, you should be able to: – Describe the functions of and relationships among laws, regulations, and professional organizations in information security – Differentiate between laws and ethics – Identify major national laws that affect the practice of information security – Explain the role of culture as it applies to ethics in information security Principles of Information Security, 4th Edition 2 Introduction • You must understand scope of an organization’s legal and ethical responsibilities • To minimize liabilities/reduce risks, the information security practitioner must: – Understand current legal environment – Stay current with laws and regulations – Watch for new issues that emerge Principles of Information Security, 4th Edition 3 Law and Ethics in Information Security • Laws: rules that mandate or prohibit certain societal behavior • Ethics: define socially acceptable behavior • Cultural mores: fixed moral attitudes or customs of a particular group; ethics based on these • Laws carry sanctions of a governing authority; ethics do not Principles of Information Security, 4th Edition 4 Organizational Liability and the Need for Counsel • Liability: legal obligation of an entity extending beyond criminal or contract law; includes legal obligation to make restitution • Restitution: to...
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...For the first time in U.S. history, every American will have access to quality, affordable health care under the updated health insurance reform legislation passed by the House. "The Affordable Health Care for America Act or H.R. 3962, blends and updates the three versions of previous bills passed by the House committees. "(Kruger, M. 2010) This bill is expected to ease the out-of-control costs of health insurance, introduce competition into the health care marketplace that will help maintain coverage affordability, protect people’s choices of doctors and health plans, and guarantee all Americans access to quality, consistent , affordable health care. The Association of American Medical Colleges stated in a Mar. 21, 2010 article; "we have taken the first step towards truly transforming health care in this country. This historic vote by the House of Representatives sets into motion long-overdue efforts to cover 32 million uninsured Americans and to assure their access to high-quality care. The nation's medical schools and teaching hospitals have expressed their full support for this bill to President Obama, and now stand ready to work with the administration and Congress to carry out these significant changes to our health care delivery system." (AAMC, 2010) The health care reform bill creates a shared responsibility for health care among individuals, employers and the government to ensure that all Americans have affordable essential health benefits. Two of the key components,...
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