Exploration of Regulations and Implications for Practice Essay
Modern medicine has made use of revolutionary technology advancements to transform medical intervention from simply managing diseases towards scientific wellness. At the heart of this change is health care informatics, a field that makes use of big data, predictive analytics, and artificial intelligence to drive health breakthroughs for personalized individual and population health. To be more precise, the contrast between the periods pre-informatics and post-informatics is striking as health care has become more proactive and focused on the individual patient even as the complexities of human beings are explored (Hoffman, 2017). Through the use of health informatics, medicine has acquired the potential to create a world free from diseases with the capacity of informatics to process information being leveraged in computer-aided diagnostics to identify and track the risks far earlier, and design new treatments for specific debilitating diseases. From battling epidemics to breakthroughs in combating diseases, health informatics is the common denominator among countless initiatives with the promise the improving wellbeing and health. Like other health care initiatives, informatics projects similarly involve personal health information thereby making them subject to the same regulations and principles that govern the use of health information (McGonigle & Mastrian, 2018). The present paper explores the concept of safety in informatics projects with a focus on relevant regulations and their implications for the project.
General overview of the project
The identified informatics project is targeted at identifying and developing improvement strategies and tools to be used by medical facilities in promoting the safe use of health information technology (IT), as well as diagnosing, monitoring and mitigating health IT-related safety risks. Health informatics was specifically involved in evaluating the survey and participatory results collected from the hospitals and ambulatory practices. The project acknowledges that health care has increasingly been digitized with the adoption of health information technology. However, the digitization introduces health IT-related safety risks and harms. Health IT is intended to make health care safer, but health IT is not necessarily safe as technology is inherently fallible with possibility of software and hardware malfunctions. The article notes that medical facilities must be aware of health IT-related safety risks and engage in process improvements with a focus on identifying and mitigating the risks. The article concludes that organizations must develop and adopt guides to help them optimize the safe use of health IT (Schneider et al., 2014).
Safety issue involved
The safety issue involved is the concerns about health IT safety. Health IT is increasingly being adopted to improve health care safety. However, there is a real concern health IT are not absolutely safe. These technologies are fallible from software and hardware malfunctions. Exploration of Regulations and Implications for Practice Essay In addition, there is a possibility of data being corrupted or lost during transmission. Besides that, they can be intentionally or unintentionally hacked and the information acquired by an unauthorized third party (Schneider et al., 2014).
Stakeholders involved in this practice
The informatics project has identified hospital and ambulatory practices, medical personnel, policy makers, and technology developers as stakeholders. Hospital and ambulatory practices are identified as stakeholders since they adopt health IT with the intention of improving efficiency of service delivery and care safety by ensuring that information management presents the right data as and when required. Medical personnel are considered stakeholders because they make use of the technologies when providing professional care services. Policy makers are considered stakeholders since they determine the policies, principles and regulations governing the use of these stakeholders with a focus on ensuring population safety. Technology developers are considered stakeholders since they determine the architecture of the technology and strive to incorporate the concerns of other stakeholders in the technology design and functionality. In addition, patients are considered as stakeholders because the safety concerns of the technologies have a direct effect on their care outcomes, health and wellness (Lau & Kuziemsky, 2016; Schneider et al., 2014).
Intended goals of the initiative
The informatics project intended to address six goals. The first goal was to explore the challenges that medical organizations face as they seek to identify and mitigate health IT safety risks in their facilities. The second goal was to test technology diagnostic approaches applied in identifying health IT safety risks. The third goal was to develop and conduct activities targeted at identifying and reducing health IT safety risks. The fourth goal was to evaluate the project results. The fifth goal was to evaluate the management and governance approaches that organizations apply to manage health care practices. The final goal was to identify the barriers and facilitators to health IT risk identification and mitigation in health care practices (Schneider et al., 2014).
Actual outcomes of the initiative
Six outcomes were presented in the project. Firstly, there is limited awareness about the safety risks associated with health IT. Secondly, the traditional ‘silo’ approach applied in information management has a negative impact on health IT risk, quality and safety management as the approach impedes the ability to recognize and respond to safety issues. Thirdly, the technical nature of health IT creates a need for external consultation with experts to address health IT concerns. Fourthly, there is a need for health IT risk, quality and safety management expertise in medical organizations and facilities. Fifthly, there is a need for tools and metrics to enable medical organizations to detect, mitigate and monitor health IT safety risks. Finally, there is a need for stronger incentives to technology developers and providers to reduce health IT safety risks (Schneider et al., 2014).
Analyze the initiative
Safe Practice
The project determined that there are five opportunities for ensuring safer practice when using health IT. Firstly, there is a need for greater awareness about health IT safety. This would be achieved by integrating and aligning the health IT safety agenda into the broader safety agenda and engaging stakeholders to identify and mitigate the risks associated with health IT. Secondly, fostering collaboration among disciplines and departments so that each one contributes distinct knowledge to efforts targeted at detecting, analyzing and mitigating health IT safety risks. This would include disseminating best practices, training on core health IT safety terminology and methods, and availing expert consultants. Thirdly, strengthening external facilitation and consultation if the medical facilitate lacks sufficient in-house expertise to effectively detect and mitigate health IT safety through applying a mix of retrospective and proactive methods to analyze safety events and prevent their occurrence. Fourthly, developing and refining effective and usable metrics and tools that help to continuously improve health IT safety. Finally, perceiving health IT safety as a shared responsibility with every stakeholder having the responsibility of optimizing the safety and safe use of health IT (Schneider et al., 2014).
Ethical considerations
Although the project does not present a discussion on the ethical considerations, they are intimated. Health IT are relatively new introductions into the health care environment, and they present new ethical challenges. Holding the promise of non-maleficence and beneficence, health IT is intended to improve health care safety. However, aspects of these technologies creates conflicts with the principles of non-maleficence and beneficence. Firstly, the principle of non-maleficence requires of medical personnel and facilities not to intentionally cause harm to the patient, either through acts of omission or commission. This principle would consider it negligent if the use of health IT imposes an unreasonable or careless risk of harm upon the patients. In addition, this principle affirms the need for medical competence by acknowledging that safety concerns may present, but there is a need for fundamental commitment to protect patients from harm. This implies taking affirmative steps to identify and mitigate the health IT-related safety risks (Harman & Cornelius, 2017).
Secondly, the principle of beneficence holds that medical personnel and facilities have a duty to benefit the patient while taking positive steps in preventing and removing harm from the patient. These are self-evident and rational duties that are considered as the primary goal of medicine. This principle is at the heart of healthcare with the expectation by patients that they are entering into a helpful relationship with medical personnel and facilities licensed as competent provide the required medical care in which there is trust that the main objective is to help. This implies that the goal of improving safety by using health IT can be applied only if the technology safety concerns have been addressed by being minimized or eliminated (Harman & Cornelius, 2017). Ensuring that the medical facility provides the proper standard of care that minimizes or avoids safety risks are supported by the moral convictions offered in the principles of non-maleficence and beneficence.
Regulatory considerations
It is evidence that the combination of health IT and informatics as presented in the project hold the promise of non-maleficence and beneficence as it improves patient safety. Aspects of these technologies, however, require regulatory considerations, especially with regards to protecting patients’ personal information. Patients have a right to privacy, and that their medical information accessed by medical personnel would be used with discretion in eth best interest of the patient. As such, the relevant health regulations are targeted at protected health information to ensure that they remain secure when stored and transmitted by health IT (Magnuson & Dixon, 2020). The first regulation is the Privacy Act that regulates the medical information collected and allows patients to know their personal health information that has been collected and assure its veracity as well as obtain its copies. The second regulation is the rule that requires private health information be protected and kept confidential against unauthorized use, destruction or loss. It requires that the patient provide written approval before the information can be forwarded or used, with the expectation that medical facilities would protect the information. The third regulation is the Health Information Technology for Economic and Clinical Health (HITECH) Act that is concerned with promoting health IT to include information security, safety and quality, and securing information exchange. The fourth regulation is Food and Drug Administration Safety and Innovation Act that recommends the regulator framework for health IT to promote patient safety. The final regulation is the 21st Century Cures Act that is targeted at modernizing and personalizing health care, encouraging innovation, supporting research and streamlining health systems (HealthIT.gov, 2020; Magnuson & Dixon, 2020).
Standards of practice
The standards of practice identify health informatics as integration of health science with multiple analytical and information sciences targeted at identifying, defining, managing and communicating data, knowledge, information and wisdom in medical practice. They acknowledge that health informatics is generally about health IT as the standards ensure that health IT are usable, safe and fit for purpose. Also, they support health IT interoperability to facilitate accurate interpretation and use of electronic information in continuity of care, decision-making and other health care purposes. Firstly, data interchange standards are concerned with the format, architecture, templates, user interface and patient data linkage. Secondly, terminologies that presents the technical criteria and representation of clinical domains, concept orientation and permanence, non-ambiguity, and explicit identifiers. Thirdly, knowledge representation with clinical guideline clinical representation models, and representation of medical literature (American Nurses Association, 2015).
References
American Nurses Association (2015). Nursing Informatics: Scope and Standards of Practice. Author.
Harman, L., & Cornelius, F. (2017). Ethical Health Informatics: Challenges and Opportunities (3rd ed.). Jones & Bartlett Learning, LLC.
HealthIT.gov (2020). Health IT Regulation. https://www.healthit.gov/topic/laws-regulation-and-policy/health-it-legislation
Hoffman, S. (2017). Electronic health records and medical big data: law and policy. Cambridge University Press.
Lau, F. & Kuziemsky, C. (2016). Handbook of EHealth Evaluation: An Evidence-Based Approach. University of Victoria.
Magnuson, J., & Dixon, B. (Eds.) (2020). Public Health Informatics and Information Systems (3rd ed.). Springer Nature.
McGonigle, D., & Mastrian, K. (2018). Nursing informatics and the foundation of knowledge (4th ed.). Jones and Bartlett Learning.
Schneider, E., Rigley, S., Meeker, D., Hunter, L., Khodyakov, D., & Rudin, R. (2014). Promoting Patient Safety Through Effective Health Information Technology Risk Management. RAND Health Quarterly, 4(3), 7. https://www.rand.org/pubs/periodicals/health-quarterly/issues/v4/n3/07.html
Exploration of Regulations and Implications for practice
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