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Health Law and Regulations Kim Capobianco University of Phoenix Health Law and Ethics HCS/545 Rick Nordahl 19 December 2011
medical devices. medical errors and adverse reactions to treatments. Some agencies such as those for accreditation are voluntary but are important because they provide ranking or certification of quality. efficient and cost-effective care for those who are older adults. . provides information about industry changes. blood products and biologics. The Centers for Medicare and Medicaid Services (CMS) work with health care providers to ensure quality. clinical trials and approval of new products. The Food and Drug Administration (FDA) is responsible for the oversight of drugs. CMS establishes reimbursement levels and standards of care and works to modernize the health care industry such as by implementing electronic record keeping. The FDA monitors safety. alerting the health care industry. Federal. disabled or low income. promote safety and ensure legal compliance and quality service. state and local regulatory agencies often establish rules and regulations for the health care industry and their oversight is mandatory. The Agency for Healthcare Research and Quality (AHRQ) is a federal agency under Health and Human Services working to improve the quality. The FDA also monitors food products to ensure safety of the food supply. Health care regulatory agencies monitor health care practitioners and facilities. funds research projects and provides evidence based practiced guidelines for healthcare practitioners. vaccines. establishing rules for testing.HEALTH LAW Health Law and Regulations 2 This paper will explain the role of governmental regulatory agencies and its impact on the health care agencies. effectiveness and safety of health care. Discuss examples of laws currently faced by the health care industry and the impact of these laws on the hospital. AHRQ gathers information in surveys.
The Occupational Safety and Health Administration (OSHA) establish and monitor safety regulations regarding workers. including but not limited to insufficient staffing and excessive workloads. The link between health care worker fatigue and adverse events is well documented. OSHA provides on-site inspectors to evaluate workplace hazards investigate accidents and provides educational materials to promote safety. 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. 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 well-being. 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 . The National Committee for Quality Assurance and the Accreditation Commission for Healthcare. The Joint Commission has published a Sentinel Event Alert regarding health care worker fatigue and patient safety. The CDC requires health care providers to report some infectious diseases. reimbursement by Medicare/Medicaid often requires accreditation. acknowledge that many factors contribute to fatigue. While it is. national and international agencies/facilities to prevent the spread of disease. maintains statistics of rates of infection and provides resources such as infection control and 3 treatment guidelines. While accreditation is voluntary. 2011). There are also accrediting agencies such as The Joint Commission.HEALTH LAW The Centers for Disease Control and Prevention (CDC) monitors and controls infectious diseases and assists other local.
New Jersey. Studies show that nurses who work 12. Pennsylvania. The impact of prohibiting mandatory overtime has big financial implications to the hospital. Texas and West Virginia have enacted restriction on mandatory overtime except in emergencies. New York. Georgia. 2004). Many administrators feel that is cheaper to pay the overtime than it is to hire another . Minnesota. Iowa.hours in any 24-hour period. Tennessee and Vermont (Michigan Association of Nurses.S. California.5 hours or longer are three times more likely to make an error in patient care (The Joint Commission. Hawaii. 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.HEALTH LAW 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 4 An overwhelming number of studies keep saying the same thing-once a person passes a certain point the risk of mistakes increases significantly. Illinois. almost half the states in the U. Oregon. In response to this admonition concerning mandatory overtime. Connecticut Maine. Missouri. In 2004. Rhode Island. legislation to prohibit mandatory overtime among nurses was introduced in Michigan. Massachusetts. have enacted or introduced legislation regarding mandatory overtime. 2011). Ohio. Florida. Maryland.
(HIPAA) The U. the new regulations provide protection for the privacy of certain individually identifiable health data. Balancing the protection of individual health information with the need to protect public health. identifiable information collected by public health authorities (Thacker. and staff making medical errors this may not be the case.HEALTH LAW 5 nurse and pay for another employee and the benefits that that employee would require. The Privacy rule applies to . Public health practice often requires the acquisition. estimates that an as many as 195. Such information enables public health authorities to implement mandated activities and accomplish public health objectives.000 hospital patient deaths per year result from preventable hospital errors (Michigan Association of Nurses. It was reported that 1 million medical errors occur each year and that 120.S.. injury or disability. 2003). These training start with new employee orientation and often continue with annual update training.000 of these result in death. 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.000 death. 2004). including but not limited to public health surveillance investigation and interventions. However when looking at the long-term costs of employee burnout. Many hours of privacy training and what constitutes PHI. Inc. use and exchange of PHI to perform public health activities. calling in sick. and serve to protect. referred to as protected health information (PHI). Department of Health and Human Services (DHHS) issued this standard. Public 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. In 2004 a study from Health Grades. Another law that is important to health care is Health Insurance Portability Accountability Act of 1996. It is projected the cost of these deaths at $69billion or $575.
tiered penalty structure the amount of penalty depends on the severity of the violation. due to reasonable cause or due to willful neglect (Buck Consultants. 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. . 2011). Under the HHS. which was enacted as part of the American Recovery and Reinvestment Act of 2009. The privacy rule also sets limits and conditions on the uses and disclosures that may be made of such health information without patient authorization. Recently HHS has stepped up its enforcement of HIPAA’s Privacy Rule. The penalty amount varies depending on whether the violation was unknown. The Secretary of Health and Human Services (HHS) is authorized to impose civil money penalties against any entity that violates HIPAA’s Privacy Rule. covered entities must adopt 6 safeguards to protect the privacy of personal health information. In February 2011 HHS issued a Notice of Final Determination finding the Cignet Health of Prince George’s County. expanded the HIPAA’s Privacy requirements. The Health Information Technology and Clinical Health Act (HITECH).3 million on Cignet for its violation. Maryland violated HIPAA’s Privacy rule and HHS imposed a civil monetary penalty of $4. substantially increased the penalties for noncompliance with the Privacy rule and mandated penalties in certain circumstances. health care clearinghouses and those health care providers that conduct certain health care transactions electronically under the Privacy Rule. 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. Less than 2 weeks after announcing the penalties against Cignet.HEALTH LAW health plans.
Healthcare agencies by maintaining accreditations agree to operate maintaining high standards of safety and ethics.HEALTH LAW In conclusion. The agencies protect employees from unscrupulous practices that could endanger the patient. 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. They ensure legal 7 compliance and quality service to the public. facilities and provide information about industry changes. governmental agencies are here to protect and monitor health care practitioners. . Many states have enacted legislation prohibiting mandating overtime to protect nurses from making errors that could result in a sentinel event.
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