Health Law and Regulations
Health Law and Regulations
CSU - Dominguez hills
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Date Created: 11/16/15
Running head: HEALTH LAW 1 Health Law and Regulations Kim Capobianco University of Phoenix Health Law and Ethics HCS/545 Rick Nordahl 19 December 2011 HEALTH LAW 2 Health Law and Regulations This paper will explain the role of governmental regulatory agencies and its impact on the health care agencies. Discuss examples of laws currently faced by the health care industry and the impact of these laws on the hospital. Health care regulatory agencies monitor health care practitioners and facilities, provides information about industry changes, promote safety and ensure legal compliance and quality service. Federal, state and local regulatory agencies often establish rules and regulations for the health care industry and their oversight is mandatory. Some agencies such as those for accreditation are voluntary but are important because they provide ranking or certification of quality. The Food and Drug Administration (FDA) is responsible for the oversight of drugs, medical devices, vaccines, blood products and biologics, establishing rules for testing, clinical trials and approval of new products. The FDA monitors safety, medical errors and adverse reactions to treatments, alerting the health care industry. The FDA also monitors food products to ensure safety of the food supply. The Agency for Healthcare Research and Quality (AHRQ) is a federal agency under Health and Human Services working to improve the quality, effectiveness and safety of health care. AHRQ gathers information in surveys; funds research projects and provides evidence based practiced guidelines for healthcare practitioners. The Centers for Medicare and Medicaid Services (CMS) work with health care providers to ensure quality, efficient and costeffective care for those who are older adults, disabled or low income. CMS establishes reimbursement HEALTH LAW 3 levels and standards of care and works to modernize the health care industry such as by implementing electronic record keeping. The Centers for Disease Control and Prevention (CDC) monitors and controls infectious diseases and assists other local, national and international agencies/facilities to prevent the spread of disease. The CDC requires health care providers to report some infectious diseases, maintains statistics of rates of infection and provides resources such as infection control and treatment guidelines. The Occupational Safety and Health Administration (OSHA) establish and monitor safety regulations regarding workers. OSHA provides onsite inspectors to evaluate workplace hazards investigate accidents and provides educational materials to promote safety. There are also accrediting agencies such as The Joint Commission, The National Committee for Quality Assurance and the Accreditation Commission for Healthcare. While accreditation is voluntary, reimbursement by Medicare/Medicaid often requires accreditation. Accrediting agencies set standards and provide regular thorough inspections of a facility its practices and records to ensure quality of care and com between health care worker compliance with safety standards (Lockwood, 2011). The Joint Commission has published a Sentinel Event Alert regarding health care worker fatigue and patient safety. The link between health care worker fatigue and adverse events is well documented, with a substantial number of studies indicating that the practice of extended work hours contributes to high levels of worker fatigue and reduced productivity. These studies and others show that fatigue increases the risk of adverse events compromises patient safety and increases risk to personal safety and wellbeing. While it is, acknowledge that many factors contribute to fatigue, including but not limited to insufficient staffing and excessive workloads. HEALTH LAW 4 Fatigue resulting from an inadequate amount of sleep or insufficient quality of sleep over an extended period can lead to umber of problems including: Lapses in attention and inability to stay focused Reduced motivation Compromised problem solving Confusion/irritability Memory lapses Impaired communication Slowed or faulty information processing and judgment Diminished reaction time Indifference and loss of empathy An overwhelming number of studies keep saying the same thingonce a person passes a certain point the risk of mistakes increases significantly. Studies show that nurses who work 12.5 hours or longer are three times more likely to make an error in patient care (The Joint Commission, 2011). To reduce error producing fatigue state regulating bodies should prohibit nursing staff from providing patient care in any combination of scheduled shifts mandatory overtime or voluntary overtime exceeding 12 hours in any 24hour period. In response to this admonition concerning mandatory overtime, almost half the states in the U.S. have enacted or introduced legislation regarding mandatory overtime. California, Connecticut Maine, Maryland, Minnesota, New Jersey, Oregon, Texas and West Virginia have enacted restriction on mandatory overtime except in emergencies. In 2004, legislation to prohibit mandatory overtime among nurses was introduced in Michigan, Florida, Georgia, Hawaii, Iowa, Illinois, Massachusetts, HEALTH LAW 5 Missouri, New York, Ohio, Pennsylvania, Rhode Island, Tennessee and Vermont (Michigan Association of Nurses, 2004). The impact of prohibiting mandatory overtime has big financial implications to the hospital. Many administrators feel that is cheaper to pay the overtime than it is to hire another nurse and pay for another employee and the benefits that that employee would require. However when looking at the longterm costs of employee burnout, calling in sick, and staff making medical errors this may not be the case. It was reported that 1 million medical errors occur each year and that 120,000 of these result in death. It is projected the cost of these deaths at $69billion or $575,000 death. In 2004 a study from Health Grades, Inc., estimates that an as many as 195,000 hospital patient deaths per year result from preventable hospital errors (Michigan Association of Nurses, 2004). Another law that is important to health care is Health Insurance Portability Accountability Act of 1996. (HIPAA) The U.S. Department of Health and Human Services (DHHS) issued this standard; the new regulations provide protection for the privacy of certain individually identifiable health data, referred to as protected health information (PHI). Balancing the protection of individual health information with the need to protect public health, the Privacy Rule expressly permits disclosures without individual authorization to public health authorities authorized by law to collect or receive the information for the purpose of preventing or controlling disease, injury or disability, including but not limited to public health surveillance investigation and interventions. Public health practice often requires the acquisition, use and exchange of PHI to perform public health activities. Such information enables public health authorities to implement mandated activities and accomplish public health objectives. Public HEALTH LAW 6 health authorities have a long history of respecting the confidentiality of PHI and the majorities of states as well as the federal government have laws that govern the use of, and serve to protect, identifiable information collected by public health authorities (Thacker, 2003). Many hours of privacy training and what constitutes PHI. These training start with new employee orientation and often continue with annual update training. The Privacy rule applies to health plans, health care clearinghouses and those health care providers that conduct certain health care transactions electronically under the Privacy Rule, covered entities must adopt safeguards to protect the privacy of personal health information. The privacy rule also sets limits and conditions on the uses and disclosures that may be made of such health information without patient authorization. The Secretary of Health and Human Services (HHS) is authorized to impose civil money penalties against any entity that violates HIPAA’s Privacy Rule. The Health Information Technology and Clinical Health Act (HITECH), which was enacted as part of the American Recovery and Reinvestment Act of 2009, expanded the HIPAA’s Privacy requirements, substantially increased the penalties for noncompliance with the Privacy rule and mandated penalties in certain circumstances. Under the HHS, tiered penalty structure the amount of penalty depends on the severity of the violation. For violations of the Privacy Rule that occur after the enactment of the HITECH Act the minimum civil money penalties that can be imposed is $100 per violation and the maximum penalty that can be imposed per year is $1.5 million for identical violations. The penalty amount varies depending on whether the violation was unknown, due to reasonable cause or due to willful neglect (Buck Consultants, 2011). Recently HHS has stepped up its enforcement of HIPAA’s Privacy Rule. In February 2011 HHS issued a Notice of Final Determination finding the Cignet Health of Prince George’s HEALTH LAW 7 County, Maryland violated HIPAA’s Privacy rule and HHS imposed a civil monetary penalty of $4.3 million on Cignet for its violation. Less than 2 weeks after announcing the penalties against Cignet, HHS imposed a $1million penalty against Massachusetts General Hospital for alleged violations of HIPAA’s Privacy rule when an employee took documents home secured with only a rubber band on a subway and placed them on the seat next to them leaving them there. In conclusion, governmental agencies are here to protect and monitor health care practitioners, facilities and provide information about industry changes. They ensure legal compliance and quality service to the public. The agencies protect employees from unscrupulous practices that could endanger the patient. Healthcare agencies by maintaining accreditations agree to operate maintaining high standards of safety and ethics. Many states have enacted legislation prohibiting mandating overtime to protect nurses from making errors that could result in a sentinel event. Other regulations that are protecting the consumers is the privacy laws, HHS is now enforcing these laws so that staff will be more conscious of the information they handle and protect the information. HEALTH LAW 8 References zzzzzzz ======Reference placeholder, don't delete====== zzzzzz HEALTH LAW 9
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