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| Implications of Regulation in Health Care | Week 5 Application | | Tiffany Littlejohn | 2/9/2014 |

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Implications of Regulation in Health Care In today’s highly competitive regulated healthcare environment, it is so important for different companies to bring to their market new medical technology and to keep them in their market. Therefore, managing different regulatory issues is an essential key to a strategic advantage. Currently, there are strong standards and guidelines put into place to ensure that all devices are well safety equipped, well studied before putting it out in the market and have less negative reactions. The strongest way to judge efficacy of any technology is data acquisition through randomized clinical trials (Berkowitz, Robert, 2010). Off course, this is not possible or even feasible in certain cases. Properly designed case series and cohort studies can provide and prove hypothesis. Observational and epidemiological studies can help identify unexpected deviations and outcomes. Meta-analysis can then take in to consideration all the available evidence and summarize the current state of knowledge. Incorporation of Cost-Effectiveness Analysis and Cost-Benefit Analysis help calculate and extrapolate economic aspects of any medical technology. Technology continues to affect the healthcare industry (Berkowitz, Robert, 2010). Currently, the industry is moving towards the electronic medical record (EMR), data reporting from the EMR, and availability from systems that can communicate with each other. As technology changes, so must the healthcare industry. The ability to change, adapt, and use new technologies is critical to the development of healthcare initiatives. As with the healthcare industry, we should understand that the future of technology within the industry is a positive force. With improved technologies, medical information has the potential to flow across departments and potentially other facilities (Moebius, Wanda, 2013). Increased government regulation of the medical device industry produces higher expenses, a longer time to return investment capital, and greater uncertainty (Cranfield University, 2013). As a result there are fewer new ventures and reduced efforts to develop new technology in established companies (Cranfield University, 2013). The current federal regulatory framework has shifted from monitoring the product to monitoring the process. The inability to reach perfect performance in such a regulated environment subject to continuous and fluid interpretation guarantees non-compliance and growing ethical tension (Berkowitz, Robert, 2010). Without new medical technology, we may be unable to maintain quality medical coverage in the face of rising demand. The government’s role should be to provide targeted funding to support development of new technology and developing regulations and policies that incentivize innovation and promote the dissemination and widespread use of technology (Booz, Allen & Hamilton, 2008). The federal government does play other roles as well by promoting different innovations across a very wide spread of activities within healthcare. Different types of federal funding for health care research could possibly help fuel innovation of new medical technology, services and products. The success of these efforts is very critical to innovation to decrease healthcare costs and improve different health outcomes and could be a great benefit to all health care professionals and patients. Reference:
Berkowitz, Robert. (2010). Impact of Government Regulation on Health Care Technology. Retrieved from http://adsabs.harvard.edu/abs/1994SPIE.2307..305B
Booz, Allen & Hamilton. (2008). The Federal Government’s Key Role in Healthcare Innovation. Retrieved from http://www.boozallen.com/media/file/The-Federal-Governments-Key-Role-in-Healthcare-Innovation-wp.pdf
Cranfield University. (2013). Medical Technology Regulatory Affairs. Retrieved from https://www.cranfield.ac.uk/courses/masters/medical-technology-regulatory-affairs.html
Moebius, Wanda. (2013). Medical Technology Industry. Retrieved from http://advamed.org/news/38/medical-technology-industry-calls-for-regulatory-convergence-in-u-s-e-u-trade-deal

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...practice to the full extent of their education and training.” (The Future of Nursing, 2010) “Nurses should achieve higher levels of education and training through an improved education system that promotes seamless academic progression.” (The Future of Nursing, 2010) “Nurses should be full partners, with physicians and other health professionals, in redesigning health care in the United States.” (The Future of Nursing, 2010) In 2008, the Robert Wood Johnson Foundation approached the Institute of Medicine (IOM) to propose a partnership between the two organizations to assess and respond to the need to transform the nursing profession. The report covers the theory that nurses will be able to fill the new and expanded roles of the healthcare system. By reviewing these key points presented the transformation of the nursing profession, nurses must have the education to enable them to provide patient centered care with the safest and most effective delivery. Additionally, they must engage with physicians and other health care professionals to deliver efficient and effective care and assume leadership roles in the restructure of the health care system. Impact of IOM Report on Nursing Education According to Thomas Sullivan’s report “nurses have the ability to act as partners with other health professionals and to lead the improvement and redesign of the healthcare” (Sullivan 2010). America will need to improve the education process, the nursing leadership, and how...

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