Healthcare Law and Regulations


Field of Healthcare Regulations

Healthcare regulatory agencies play an essential role in the healthcare sector. Health care regulatory agencies regulate healthcarepractitioners, facilities, provide update information in theindustry, enhance safety, and ensure legal compliance and qualityservices. The Federal or Local governments’ establishes healthcareregulatory agencies that in turn set rules and regulations forhealthcare industry (Fain, Daubresse and Caleb, 2013). The oversightof these healthcare regulatory agencies is mandatory for public andprivate healthcare practice. However, some agencies are voluntarysuch as the accreditation agency that requires voluntaryparticipation and are important since they provide certification andranking for the quality purpose (Louis, 2008).

Government health regulatory bodies and their impact on healthcare sector

Quality and costs are two main variables that challenge the Americanhealth industry. However, with a strong Federal government agencythat implements performance measures and standards for careproviders, cost and quality aspects can be significantly checked.Government permeates all aspects of everyday healthcare services.Examples of these healthcare regulatory agencies include the (FDA)Food and Drug Administration Agency and (CDC) Center for DiseaseControl and Prevention. The government and non-governmental bodieshave various rules and regulatory processes for the healthcaresector. In particular, health care agencies targets healthcarepersonnel, healthcare facilities, and services. Major regulation andoversight are on healthcare practice license, revenue, ownership,regulation enforcement, patient protection and ethical practice.

The impact of government regulatory agencies in the healthcaresector is great. In particular, regulatory agencies ensure thathealthcare practice is conducted in an efficient and safe way whileoffering quality health products and services. Health facilities mustabide by the set regulations and allow constant surveillance on theirinternal practices. The healthcare practitioners are accountable tothe government agencies and must abide by the required ethical andpractice standards. Besides the oversight impact that weedsineffective healthcare practice, healthcare regulatory agencies playan important role in facilitating innovation and development of newproducts and services. It is through heath sector regulatory agenciesthat innovation on rules for medical data sharing was developed.Health regulatory agencies help in information exchanges that supportproduct development and management to enhance benefit and reducerisks. Federal agencies and regulations also support processes andgive incentives that promote the implementation of proveninterventions. Another impact of health regulatory agencies isstrengthening the private-public innovation partnership in thehealthcare industry.

Major regulatory bodies in the health care Sector

Food and Drug Administration (FDA)

FDA is a federal agency that regulates public health throughsupervision and regulation of food safety, prescription drugs,tobacco, vaccines, blood transfusion, dietary supplements, veterinaryproducts and medical devices among others. The FDA regulates consumerproducts worth over the US $ 1 Trillion each year in the UnitedStates (Fain, Daubresse and Caleb, 2013). The regulatory programsunder FDA vary based on product type, possible risks and oversightpowers bestowed on the regulatory body. For instance, FDA monitorsall pharmaceutical products throughout the various processes ofproduction, testing, medical prescription, advertising andpost-marketing effects (Karki, 2005). However, these regulationsdiffer based on products variation such as cosmetics FDA has only aprimary regulatory role on safety and labeling.

Most of the regulatory standards used by FDA are set and published.Various acts legislated by the Congress guides the Food and dietarysupplements regulation by FDA. The FDA in turn analyzes andimplements the food and drug legislation through legal powersbestowed on the body. To this end, all food and dietary supplementssold throughout the United States and outside are subject to FDAinspection. FDA subdivides various substances in categories such asfood additives for the purpose of regulation. All the promotion andadvertising of counter drugs is monitored by FDA and requires thatall pharmaceutical adverts strike a ‘fair balance’ to productbenefits and risks (side effects).

FDA also evaluates drugs sold to consumers as a post-market safetyregulation (Qato and Alexander, 2011). In this case, complaintsarising from a drug tested through FDA are subject to additionalclinical trials as a risk management plan (Karki, 2005). FDAoversight also extends to medical and radiation-emitting devices usedin medical facilities. To this, the FDA requires that allradiation-emitting products meet the safety performance standardrequired (Fain, Daubresse and Caleb, 2013).

Centers for Disease Control and Prevention body (CDC)

The main goal of CDC is to protect and promote public health andsafety through prevention and control of injuries and disability.This regulatory agency sets rules and standards that have a greatimpact on the health industry. In particular, the CDC focuses ondeveloping and applying disease prevention and control measures. Themajor focus area is on infectious diseases, food-borne pathogens,occupational health, environmental health and promoting health. Assuch, as a Federal Agency the CDC supports the government in healthpromotion, preparedness and prevention of diseases in the UnitedStates with the sole aim of improving overall public health. To thisend, CDC has an oversight regulation on public and private healthsectors especially in the prevention, control and treatment ofinfectious as well as chronic diseases.

CDC provides standards for preventing injuries, work hazards,environmental health threats and disabilities. CDC helps in reducingdeaths associated with diseases, strengthening surveillance fordiseases and contributing to health policies. Notable efforts of CDCare the recent studies on deadly diseases such as Ebola and bird flu.The CDC regulations have a great impact on health through research ondeadly diseases to control and prevent epidemics (Field, 2007). Thefight against smallpox, bird flu, bioterrorism and Ebola are goodexamples of how CDC role is effective in fighting deadly diseases.Furthermore, the CDC requires the adoption of safety measures at aworkplace by enforcing standards of safety in all buildingfacilities, and this has a positive impact on people’s lives.

Analyzing the impact of CDC and FDA regulations for the healthcaresector

The impacts of several regulations that govern the heath careindustry are overwhelming. One body or multiple bodies regulatesevery aspect of the health sector. Pervasiveness of numerous healthregulations are important despite the overwhelming impact they havefor the healthcare sector. However, although the regulatory laws areeffective in promoting good health and protecting life, there aresignificant inconsistencies in the application on various aspects ofthe healthcare industry. The basis of this inconsistency lies is thelack of effective coordination between the Federal, State and localauthorities (Louis, 2008).

Basically, division created in oversight control for healthcare isthe source of inconsistencies. For instance, it is the prerogativerole of the local and state regulators to inspect for sanitation,epidemics and eating joints inspection. However, the CDC under theFederal government covers this area leading to inconsistencyineffective oversight role. The practice of healthcare has severalhurdles. A case in example is the various steps that a registered andaccredited doctor has to undergo before one becomes a certifiedpracticing physician. There are several regulatory bodies bothprivate and public that one has to pass through (Field, 2007).

Another example of the overwhelming impact that the healthcareregulatory laws have on the health industry is the process requiredbefore a new drug is made and sold to the public. For instance, adrug starts with patent protection regulation by Federal Patent andTrademark Office (PTO). The FDA then supervises clinical testingbefore a committee approves the drug through the (NDA) (Karki, 2005).Also, the marketing and advertising protocols must be observed. Themarketing, prescription, and use are subject to supervision by FDA,and this does not stop until the post market analysis is done. Theseare some of the overwhelming effects that the health regulatorybodies have for the health industry (Louis, 2008).

While these regulatory agencies, processes and laws are essential inpromoting good health and preventing loss of lives, there is a needfor consistency and reduction in the bureaucratic process (Louis,2008). A closer assessment indicates that the inconsistencies arejust mere turf wars brought about by the various division bodiesinvolved in the regulation of healthcare products and services. Inpart, the presence of private oversight bodies increases incompetencyas private sectors are less concerned with the sole aim of healthregulations but as a source of economic and political interests.However, the private sector offers more efficient and reliableoversight given that most state and local oversight agencies havepolitical influences. Lack of clear-cut outline tasks for eachoversight body is also another aspect leading to inconsistency andbureaucratic process (Field, 2007).

Nonetheless, it is imperative to state that the American healthcareregulation structure is important in promoting good healthcaredespite the flaws, bureaucratic and sectional complexity. A case inthe picture is the increased public confidence for public healthfacilities and health sector practitioners both in the private andpublic sector. Also, the public is more confident on food, drugs,dietary supplements and cosmetics bought in the local market. Tied tothis is the expanded economy as a result of the increased marketlocally and abroad for the certified food, drugs, and cosmeticproducts.


The American health industry has great healthcare regulatory agenciesthat set standards, rules and supervises all aspects of animal andhuman health. Most healthcare regulatory agencies are Federalgovernment establishments with State and Local governmentscollaborating in their implementation. Major healthcare agencies thathave overwhelming oversight on the American healthcare industry arethe CDC and FDA. These agencies ensure effective healthcare practice,healthy products, and services. In part, the health sector agenciesregulate the conducts and practices of healthcare practitioners,healthcare facilities, and suitability of drugs, foods, and diseasesmanagement.

Although, there are vast regulating agencies in the American healthsystem, inconsistencies in regulations is a common occurrence sincethe existing agencies both public and private are not wellcoordinated. Healthcare practitioners have to wade throughoverwhelming oversight regulations before they are accredited.Similarly, the drug production industry is also heavily impacted bythe healthcare regulations. However, despite these shortcomings theexistence of intricate oversight bodies in the American healthindustry helps to promote a trusted and vibrant healthcare for allpeople.


Field RI. (2007). Health Care Regulation in America: Complexity,Confrontation and Compromise. New York: Oxford University Press.

Karki L (2005). &quotReview of FDA Law Related to Pharmaceuticals:The Hatch-Waxman Act, Regulatory Amendments and Implications for DrugPatent Enforcement.&quot Journal of the Patent &amp TrademarkOffice Society 87: 602–620. Retrieved

Kevin Fain, Matthew Daubresse, G. Caleb Alexander (2013). &quotTheFood and Drug Administration Amendments Act and Post-marketingCommitments.&quot &quotJAMA&quot 310(2): 202-204. Retrieved from

Louis Robichaux. (2008). “Government Wears Many Hats in theHealthcare Arena.” Turnaround Management Association. TheJournal of Corporate Renewal. Accessed from

Qato DM, Alexander GC (2011). &quotPost-MarketingDrug Safety and the Food and Drug Administration`s Risk Evaluationand Mitigation Strategies.&quot JAMA306 (14): 1595–1596. Retrieved from