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AdvaMed
AdvaMed, or the Advanced Medical Technology Association, is an American medical device trade association, based in Washington, D.C. It is the largest medical device association in the world with U.S. and international members who are medical technology companies (medical devices, diagnostic products, and health information systems) that collectively represents 80% of U.S. medical technology firms in the United States, that produce close to 90% of annual health care technology purchases in the United States and more than 40% globally. Scott Whitaker is AdvaMed’s president and CEO, and its current board chairman is Peter Arduini, also serves as the CEO of GE HealthCare. Policies AdvaMed’s website states that the organization promotes competitive policies that foster the highest ethical standards, rapid product approvals, appropriate reimbursement, and access to international markets. The Innovation Agenda identifies five core policy pillars: improving the FDA’s regulatory p ...
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Medical Technology
Health technology is defined by the World Health Organization as the "application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives". This includes pharmaceuticals, devices, procedures, and organizational systems used in the healthcare industry, as well as computer-supported information systems. In the United States, these technologies involve standardized physical objects, as well as traditional and designed social means and methods to treat or care for patients. Development Pre-digital era During the pre-digital era, patients suffered from inefficient and faulty clinical systems, processes, and conditions. Many medical errors happened in the past due to undeveloped health technologies. Some examples of these medical errors included adverse drug events and alarm fatigue. When many alarms are repeatedly triggered or activated, especially for unimportant events ...
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Medical Device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act ( ...
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Trade Association
A trade association, also known as an industry trade group, business association, sector association or industry body, is an organization founded and funded by businesses that operate in a specific Industry (economics), industry. Through collaboration between companies within a Business sector, sector, a trade association coordinates public relations activities such as advertising, education, publishing and, especially, lobbying and political action. Associations may offer other services, such as producing conferences, setting industry standards, holding networking or charitable events, or offering classes or educational materials. Many associations are non-profit organizations governed by bylaws and directed by officers who are also members. (FEC: Solicitable Class of Trade Association, Library of Congress). In countries with a social market economy, the role of trade associations is often taken by employers' organizations, which also take a role in social dialogue. Political in ...
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Medical Technology
Health technology is defined by the World Health Organization as the "application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives". This includes pharmaceuticals, devices, procedures, and organizational systems used in the healthcare industry, as well as computer-supported information systems. In the United States, these technologies involve standardized physical objects, as well as traditional and designed social means and methods to treat or care for patients. Development Pre-digital era During the pre-digital era, patients suffered from inefficient and faulty clinical systems, processes, and conditions. Many medical errors happened in the past due to undeveloped health technologies. Some examples of these medical errors included adverse drug events and alarm fatigue. When many alarms are repeatedly triggered or activated, especially for unimportant events ...
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Chief Executive Officer
A chief executive officer (CEO), also known as a chief executive or managing director, is the top-ranking corporate officer charged with the management of an organization, usually a company or a nonprofit organization. CEOs find roles in various organizations, including public and private corporations, Nonprofit organization, nonprofit organizations, and even some government organizations (notably state-owned enterprises). The governor and CEO of a corporation or company typically reports to the board of directors and is charged with maximizing the value of the business, which may include maximizing the profitability, market share, revenue, or another financial metric. In the nonprofit and government sector, CEOs typically aim at achieving outcomes related to the organization's mission, usually provided by legislation. CEOs are also frequently assigned the role of the main manager of the organization and the highest-ranking officer in the C-suite. Origins The term "chief executi ...
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Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ...
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Taxation In The United States
The United States has separate Federal government of the United States, federal, U.S. state, state, and Local government in the United States, local governments with taxes imposed at each of these levels. Taxes are levied on income, payroll, property, sales, Capital gains tax in the United States, capital gains, dividends, imports, estates and gifts, as well as various fees. In 2020, taxes collected by federal, state, and local governments amounted to 25.5% of GDP, below the OECD average of 33.5% of GDP. Income tax in the United States, U.S. tax and transfer policies are Progressive tax, progressive and therefore reduce effective income inequality in the United States, income inequality, as rates of tax generally increase as taxable income increases. As a group, the lowest earning workers, especially those with dependents, pay no income taxes and may actually receive a small subsidy from the federal government (from child credits and the Earned Income Tax Credit). Taxes fall m ...
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Affordable Care Act
The Affordable Care Act (ACA), formally known as the Patient Protection and Affordable Care Act (PPACA) and informally as Obamacare, is a landmark U.S. federal statute enacted by the 111th United States Congress and signed into law by President Barack Obama on March 23, 2010. Together with amendments made to it by the Health Care and Education Reconciliation Act of 2010, it represents the U.S. healthcare system's most significant regulatory overhaul and expansion of coverage since the enactment of Medicare (United States), Medicare and Medicaid in 1965. Most of the act remains in effect. The ACA's major provisions came into force in 2014. By 2016, the uninsured share of the population had roughly halved, with estimates ranging from 20 to 24 million additional people covered. The law also enacted a host of Healthcare industry#Delivery of services, delivery system reforms intended to constrain healthcare costs and improve quality. After it came into effect, increases in overall ...
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Human Factors And Ergonomics
Humans (''Homo sapiens'') or modern humans are the most common and widespread species of primate, and the last surviving species of the genus ''Homo''. They are great apes characterized by their hairlessness, bipedalism, and high intelligence. Humans have large brains, enabling more advanced cognitive skills that facilitate successful adaptation to varied environments, development of sophisticated tools, and formation of complex social structures and civilizations. Humans are highly social, with individual humans tending to belong to a multi-layered network of distinct social groups — from families and peer groups to corporations and political states. As such, social interactions between humans have established a wide variety of values, social norms, languages, and traditions (collectively termed institutions), each of which bolsters human society. Humans are also highly curious: the desire to understand and influence phenomena has motivated humanity's de ...
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United States House Committee On Armed Services
The U.S. House Committee on Armed Services, commonly known as the House Armed Services Committee or HASC, is a standing committee of the United States House of Representatives. It is responsible for funding and oversight of the Department of Defense (DoD) and the United States Armed Forces, as well as substantial portions of the Department of Energy. Its regular legislative product is the National Defense Authorization Act, which has been passed by Congress and signed into law each year since 1962. Jurisdiction The Armed Services Committee has jurisdiction over defense policy generally, ongoing military operations, the organization and reform of the Department of Defense and Department of Energy, counter-drug programs, acquisition and industrial base policy, technology transfer and export controls, joint interoperability, the Cooperative Threat Reduction program, Department of Energy nonproliferation programs, and detainee affairs and policy. History The Armed Services Commit ...
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United States Senate Committee On Armed Services
The Committee on Armed Services, sometimes abbreviated SASC for Senate Armed Services Committee, is a committee of the United States Senate empowered with Congressional oversight, legislative oversight of the Military of the United States, nation's military, including the United States Department of Defense, Department of Defense, military research and development, nuclear power, nuclear energy (as pertaining to national security), benefits for members of the military, the Selective Service System, and other matters related to defense policy. The Armed Services Committee was created as a result of the Legislative Reorganization Act of 1946 following the U.S. victory in World War II. The bill merged the responsibilities of the Committee on Naval Affairs, established in 1816, and the Committee on Military Affairs, also established in 1816. Considered one of the most powerful Senate committees, its broad mandate allowed it to report some of the most extensive and revolutionary ...
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