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What are the elements of a research proposal, specifically in relation to an HIPAA doctoral dissertation study plan?

HIPAA doctoral dissertation study plan helps researchers conduct studies designed to improve the quality of health care, reduce its cost, improve patient safety, decrease medical errors, and broaden access to essential services. The Health Insurance Portability and Accountability Act (HIPAA) are involved with the regulation and protection of private health information for individuals. In HIPAA doctoral dissertation study plan all forms of health information that are associated with the 18 identifiers specifically defined by HIPAA are considered to be protected health information (PHI) which are subject to HIPAA regulations. This implies that researchers should comply with these regulations.

There are various elements that should be observed as far as HIPAA research plan is concerned. One of the most important elements is to indicate if the research project will have protected health information. The researcher should describe the procedures that will be used to comply with the HIPAA policy. Another important element is that researcher should be able to access and use PHI when necessary to conduct research. In this context, the study plan should be able to help health care decision makers make more informed decisions and develop the quality of health care services.

 

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There is also the vital information and forms that should be included in the research proposal plan. HIPAA Information for Researchers (2010) says that the study plan should outline the procedures to be used in requesting permission for use and exposé of PHI from individuals, process to be utilized in requesting a waiver of authorization from the IRB and then statement that only the identified individual health information is being availed. The research proposal plan for HIPAA is achieved by analyzing large databases of health care information gathered from or maintained by health care providers, institutions, payers, and government agencies.

A HIPAA doctoral dissertation study plan should include elements of covered entities which are health plans, health care clearinghouses, and health care providers that spread health information by electronic means in association with certain defined HIPAA transactions, such as alleges or eligibility examinations. Other elements in this information may comprise of certain data elements, such as dates of service and ZIP Codes which are believed to be specialized private information under the HHS Protection of Human Subjects Regulations.

During the study plan it is important to note that researchers are not represented as covered entities, unless they are also health care providers and are involved in any of the covered electronic operations. Consequently, if researchers of the HIPAA doctoral dissertation study plan are employees or other workforce members of a covered body for example covered hospital or health plan they may have to comply with that entity's Privacy Rule policies and procedures. On the other hand for researchers who are not themselves covered entities, or who are not workforce members of covered entities, may be indirectly affected by the Privacy Rule if covered entities supply their data (HIPAA Information for Researchers, 2010).

Where might a beginning researcher lose logical flow among elements in a study plan?

A beginning researcher may lose logical flow among elements in a study plan because they often work with large, population-level databases containing thousands and even millions of records. Based on this beginning researcher frequently do not interact with the individual subjects of their research and therefore they may end up losing the logical flow. In such situations, getting in touch with data subjects to ask for their consent prior to a health services research study may not be practicable or even possible.

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The researchers and database custodians may not have sought detailed information concerning the rule and how it may impinge on the use and discovery of data for the research. Eventually this will cause a beginning researcher to lose logical flow among elements in a study plan. As one of the study elements, the privacy rule defines research as a methodical exploration, including research improvement, testing, and assessment, premeditated to build up or contribute to general acquaintance. HIPAA doctoral dissertation study plan may have had less contact with the process of research proposal review than biomedical researchers hence causing them to lose logical flow among elements. Due to the type of data used, HIPAA doctoral dissertation study plan often is not regarded as study involving human subjects and may be exempt from the HHS Protection of Human Subjects Regulations.