Data breaches impact on healthcare organization and business associates 

Methodology
The methodology section has to be thought out carefully and written in full detail. It is the most important part of the protocol. It should include information on the research design, the research subjects, interventions introduced, observations to be made and sample size.

Research design (1-2 paragraphs)
The choice of the design should be explained in relation to the study objectives.

Research subjects (1 page)
Depending on the type of the study, the following questions should be answered:
● What are the criteria for inclusion or selection?
● What are the criteria for exclusion?
● In intervention studies, how will subjects be allocated to index and comparison groups?
● What are the criteria for discontinuation?

Interventions and/or Observations (1-3 pages)
Intervention: if an intervention is introduced (e.g., mobile device, training program, decision support tools), a description must be given, and whether they are already commercially available, or in phases of experimentation. For technology that is commercially available, the protocol must state their proprietary names and manufacturer. For interventions that are still in the experimental stage (or that are commercially available but are being used for a different indication), additional information should be provided on available pre-clinical investigations.

Observations: Information should be provided on the observations to be made, how they will be made, and how frequently will they be made. If the observation is made by a questionnaire, this should be appended to the protocol.

Sample size (1 page)
The protocol should provide information and justification about sample size. A larger sample size than needed to test the research hypothesis increases the cost and duration of the study and will be unethical if it exposes human subjects to any potential unnecessary risk without additional benefit. A smaller sample size than needed can also be unethical if it exposes human subjects to risk with no benefit to scientific knowledge. The basis on which sample size is calculated should be explained in the methodology section of the protocol. Calculation of sample size has been made easy by computer software programs, but the principles underlying the estimation should be well understood.

Data management and analysis (1-2 pages)
The protocol should provide information on how the data will be managed, including data coding for computer analysis, monitoring and verification. Information should also be provided on the available computer facility. The statistical methods used for the analysis of data should be clearly outlined.

Ethical considerations (1 page)
All research protocols in the biomedical field (including health information and health informatics research) particularly if it involves human subjects, must include a section addressing ethical considerations. This includes two components: The first is a written approval of the appropriate ethics review committee, together with a written form for informed consent, where appropriate. The second is a special section, preferably in the format of a checklist (see bulleted points below), to address all possible ethical concerns. Simply getting the ethical approval is not enough.

Is the research design adequate to provide answers to the research question? It is 
unethical to expose subjects to research that will have no value.

Is the method of selection of research subjects justified? The use of vulnerable subjects as research participants needs special justification. Vulnerable subjects include those in prison, minors and persons with mental disability. Particularly in international research, it is important to ensure that the population in which the study is conducted will benefit from any potential outcome of the research. They should not be doing it to the benefit of another population. Justification is needed for any inducement, financial or otherwise, for participants to be enrolled in the study.

Are interventions justified, in terms of risks/benefits ratio? Risks are not limited to physical harm. Psychological and social risks must also be considered.

For observations made, have measures been taken to ensure confidentiality?

References
The protocol should end with relevant references on the subject in APA style.

My research Question: Data breaches are impacted by the type of organization (hospital versus business associate).

Null: Data breaches are not impacted by the type of organization (hospital versus business associate).

Alternative: Data breaches are impacted by the type of organization.

Independent Variable: Level of use of the different types of breaches methods.

Dependent Variable: Instances of data breach coming to the organization itself or business associate

The research methods below need to change:

I wrote up something in the paper under the methodology section but it is not clear and same with what is below.. so I need to focus more on everything regarding methodology and the subcategories under it like listed in the directions above

Research Method: I would survey the amount of use of each form of data breach method like the use of laptops, smartphones, a paper format of PHI being used. This would make a baseline prevalence of the PHI being used for a healthcare organization and business associates. This information would guide my research question and then narrow down the top breach methods of PHI between both the organization and business associates.

By the way the word document I sent. I can give you clarification if you like. Pages 1-9 is teacher advice. 10- 19 is what I have finished so far and all the yellow highlighted part are instructions.

I am humbling requesting that the proposal is complete by Sunday 22 nd Midnight PST. It is absolutely imperative as my deadline is Sunday. Anything I can do to assist I will be available. Also please relay to me your questions or concerns so everything is clear in the paper. This assignment is primarily focused on the methodology section of the paper. In this part of the proposal is where the survey method I will be using has to be used in a pilot study which is due the follow Sunday on the 29th. I really appreciate all your effort and understanding.