What professional, ethical, and regulatory standards must be incorporated into the design and implementation of the system?

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Informatics systems have implications for professional, regulatory and ethical standards. That is because they make use of protected health information as inputs. To be more precise, there is an inherent expectation for patient information to be protected. However, informatics systems rely on this information thereby presenting concerns that can be potentially preempted through implementing the standards that act as guides to ensure that information security and confidentiality expectations are not violated. These standards have an overlap with the health care practice standards that are already in use in managing all health care information. In fact, regardless of context, there is an expectation of information integrity, non-maleficence, beneficence, justice, equality, confidentiality, and autonomy. In addition, these standards include an expectation of accountability, legitimate infringement, least intrusive alternative, openness, access, security and privacy for all informatics activities (Davis & LaCour, 2014). In addition, the regulatory standards must be observed, particularly the legislation intention to protect patient information. That is because they have legal implications with possibility of judicial intervention and penalties for violations. Examples of the relevant regulatory regulations include the 21st Century Cures Act of 2016, Medicare Access & CHIP (Children’s Health Insurance Program) Reauthorization Act of 2015, Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, Affordable Care Act of 2010, Health Insurance Portability and Accountability Act (HIPAA) of 1996, Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, and Privacy Act of 1974. Benchmark – Electronic Health Record Implementation Paper. In addition, there is a need to observe the regulations presented by the institutional review boards (IRB), Medicare laws, and patient records confidentiality rules (Hoffman 2017).

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