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Healthcare Policy 2010

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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 http://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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