Compliance Program Implementation and Ethical Decision-Making Template

Compliance Program Implementation and Ethical Decision-Making Template

Compliance Program Implementation and Ethical Decision-Making Template

Background

            Integrating technology in healthcare has led to the development of various policies aimed at protecting health data. Patient data has an increased significance in healthcare delivery, prompting the US government to enact laws that could protect this data. This healthcare scenario will address HIPPA violations. A patient who was set to undergo a surgical procedure at Villa Health Clinic did not sign a written consent at the time of the surgery. Following this delay, the insurance provider did not receive a copy of the consent, as the law states. However, the clinic employee provided the insurer with the necessary information regarding the patient. Despite explaining the issue to the insurance provider, the provider called the supervisor to report the issue as a HIPPA violation.  

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Problem Summary:  Privacy Breach—HIPAA Violation

	Briefly Explain the Law, Regulation, Standard, et cetera*	Briefly Explain How the Law, Regulation, Standard, et cetera Applies to the Privacy Breach/HIPAA Violation
Applicable Law(s)	Health Information Technology for Economic and Clinical Health Act (HITECH) act deals with the online sharing of patient data (Chen & Benusa, 2017).	The hospital violated this law to the point where the clinic shared the electronic medical information with the insurance provider without written patient consent. HIPPA rules and the HITECH act align with the data confidentiality of patients in health care organizations. These rules have widely been applied in the healthcare sector to improve care efficiency and enhance patient outcomes through better decision support systems.
Applicable Specific Regulation(s)	Two major regulations violated in this scenario were 45FR164.504 and 164.506. These regulations state that healthcare organizations do not have the authority to share medical information with the plan sponsor without written consent from the patient (Moore & Frye, 2020).	The act of sharing the medical information of the mentioned patient without written consent violated these regulations. As noted earlier, HIPPA rules are critical for ensuring that patients’ medical records are safe, accurate, and transparent. Various key information is also needed for the database to attain the utmost security. Accessing client medical data require authorized personnel as it will increase information security on the health data. However, in this case, surgical data was shared without the patient’s written consent.
Disclosure	HIPPA regulations hold that it is illegal to disclose private patient information without their consent in written form (Moore & Frye, 2020).	Critical patient information includes imaging reports, laboratory results, social security numbers, immunization history, vital signs, past and current medications, past medical and surgical history, current medical issues, and patient demographics. In this case, the clinic employee shared the information without gaining written consent from the patient. This is violating HIPPA privacy rules.
Applicable Human Resource Law(s)	The employees at Villa Heath are part of health data security system and are responsible for observing the HIPPA regulations. The law prohibits healthcare employees from unauthorized sharing of patient information (Chen & Benusa, 2017).	This law was violated to the point that the employee shared information without gaining the patient’s consent. This appeared like a violation of the privacy rights of the patient. The cultural difference among employees might affect HIPPA policies as some employees would not adhere to the new policy ratified in the organization. The reception of the message on the limitation of the data sharing protocol might send the employees feeling that the management feels the client data is not safe for them. However, educating employees on the policy must be educated before forming part of the organizational culture.
Applicable Industry Accrediting Body Standards	HIPPA violation rules apply in this scenario (Chen & Benusa, 2017).	The employee breached HIPPA regulations by sharing the patient information without gaining their consent. This action violated the privacy rights of the patient.

 

Seven Essential Elements of an Effective Compliance Program

Number	Element of an Effective Compliance Program (Federal Register)*	How Does This Element Apply to the Privacy Breach/HIPAA Violation?
1.	Training and educating employees on HIPPA privacy laws (Gajwani et al., 2022).	This measure would apply to Villa health because the employee who shared the information did not have information on the regulations about sharing medical information. If the employee could have been subjected to effective training on these issues, they could not have violated the policy. The design and implementation of a system such as HIPPA policies require the collaboration and participation of every team member. Identifying relevant team members that can effectively perform designed tasks and responsibilities is vital. Since a HIPPA policy implementation needs to incorporate medical data from various departments, it is imperative to draw team members from multiple departments. In addition, it is vital to integrate various systems to offer the needed information in real-time effectively
2.	Adopting an effective communication platform between supervisors and employees in the clinic (Gajwani et al., 2022).	At Villa Health, the process of sharing medical information with the insurance provided is unclear, and employees seem to lack an understanding of the entire process. If the clinic had a better line of communication regarding such issues, the employees would not have shared the medical information without the employee’s consent.
3.	Tasking compliance officers and compliance committee on such issues (Gajwani et al., 2022).	The compliance officer and the committee will prevent Villa Health from facing such issues as they will be investigating all the situations and ensuring that they align with the required health policies in healthcare.
4.	Writing policies, standards of conducts, and procedures for access by employees at any time (Gajwani et al., 2022).	This procedure would allow employees to remind themselves of the healthcare policies, including the recent changes in HIPPA regulations. Villa Health employees would remain updated on the policies which would limit such violations within the clinic.
5.	Developing a quick response to any form of offense at the clinic and undertaking a fast and corrective actions (Gajwani et al., 2022).	This applies to the presented case at Villa Health because the committee with increased its speed in correcting problems before they affect the normal operation of the clinic.
6.	Effective internal auditing and monitoring (Gajwani et al., 2022).	The internal auditing and monitoring process would allow Villa health to examine the breach’s impact and develop measures that would limit the clinic from facing such violations.
7.	Implementing standards by developing disciplinary guidelines that each employee would have the chance to read (Gajwani et al., 2022).	This would apply to the Villa Health breach because the human resource department and the legal team will be working in unity to identify the breach’s impact and promote learning among employees of such cases.

Privacy Breach Consequences

Covered Entity	Legal penalty (ies)*	Additional Consequences
Individual Leader Within Health Care Organization	The employee responsible for the violation will face the punishment of the Tier A penalties. This would include a fine of $100 on each violation (Heath et al., 2021).	Villa Health’s supervisory team would subject the employee to additional training and place the employee on probation for one month or give a warning letter regarding her conduct.
Other Internal Health Care Organization Stakeholders	The compliance officer would as well face the legal penalty for not offering the required training and cross-examining the conduct of the employees at the clinic. This would be treated as an act of negligence that might attract Tier A or Tier B penalties (Heath et al., 2021).	The compliance may receive a warning letter or be sent to probation for failing to perform their duties effectively within the clinic. They would be required to provide additional training to employees to limit such breaches from happening in the future.
Health Care Organization	The organization will receive a Tier C penalty as they were in a position to prevent the breach but did not act in a positive manner to stop the breach from taking place. This penalty would include $10,000 fine on all incidents cited at the company (Heath et al., 2021).	The organization will have to compensate the patient for the breach of their medical information. The organization may as well support the idea of additional training for all employees to limit new and existing employees from violating these rules.

Evidence-Based Recommendations

Number	Evidence-Based Recommendation	Additional Insights/Salient Points	Source(s)*
1.	Conducting the gap analysis in HIPPA laws	Undeniably, HIPPA rules have been changing more often, thus calling for the organization and employees to remain updated on the new HIPPA laws. This analysis would be essential in comparing the current practices with the OCR audit procedures. The analysis would as well highlight the strengths and weaknesses of the organization. The analysis of the strengths would trigger the development of effective measures to reduce the weaknesses.	(Stuart, 2019)
2.	Offering fresher courses to employees concerning patient information protection and privacy.	This process would assume that all the employees do not have information on patient information protection and privacy. Thus, we would be offering a fresher course to all employees and ensuring such issues do not happen in the future. Besides, it would limit employees from becoming the sources of data breaches at the institution.	(Stuart, 2019)
3.	The compliance committee should investigate the breach widely.	Effective analysis of this issue would allow the committee to identify the genesis of the problem and solve the problem from its primary cause. For instance, if inadequate training was the main cause, then the committee would treat training as a main solution method that would limit the clinic from facing such issues in the future.	(Stuart, 2019)
4.	The clinic should work with the office of civil rights (OCR)	Working closely with OCR will allow the healthcare professionals and patients to understand their rights and privacies concerning personal health information.	(Stuart, 2019)
5.	Developing a culture of constant information sharing.	An effective information sharing process would be important at the clinic as it would not allow employees to act on their own decisions but consult with other professionals to ensure an effective solution to any ethical issue at the clinic.	(Stuart, 2019)

Ethical Decision-Making Framework for Health Care Leaders

Number	Ethical Decision-Making Step*	Apply the Ethical Decision-Making Step to the Privacy Breach/HIPAA Violation
1.	Conducting a background check on the breach (Nelson, 2017).	Commencing an effective analysis of the situation will heighten the understanding of professionals from diverse perspectives. The analysis would determine whether the employee was aware of the HIPPA violation they committed or not.
2.	Identification of the ethical issue or question (Nelson, 2017).	The ethical issue under question is that the medical information of the patient was shared with the insurance provider without written consent, thus violating their privacy rights.
3.	Think about the related ethical principles (Nelson, 2017).	The ethical principle is on the violation of HIPPA privacy standards. In this case, the information about the surgical procedure on the patient remains private information that could not be shared without the patient’s written consent.
4.	Determine effective means of responding to the situation (Nelson, 2017).	The case presented limited options for both the organization and the patient. While the law would act on the employee’s actions, the clinic would as well face a portion of the fines. The discussion, in this case, would align with the fine each party would receive concerning the case.
5.	Recommending the response on the issue (Nelson, 2017).	While the clinic could plead with the patient to stop the legal actions, the best practice would be to offer additional training to employees to reduce such cases in the future. Besides, giving warnings and suspensions would be other options to be considered in this case.
6.	Focus on future ethical conflicts (Nelson, 2017).	Effective training on health professionals would be significant in reducing such occurrences in the future. The training would equip the employees with the recent skills on HIPPA rules and regulations.

 Conclusion

            Dealing with private patient information requires strict adherence to HIPPA standards. Observing these guidelines would reduce the chances of the employees and the organization facing legal actions. The fines regarding HIPPA violations are heavy and might affect the financial position of healthcare organizations. These HIPPA regulations are in place to protect patient privacy, and it’s the role of healthcare institutions to adhere to these standards. This incident at Villa Health should undergo practical analysis and investigation to determine its occurrence and the factors that lead to its occurrence. Practical training should then be offered to all employees to ensure that such cases do not feature in the institution again. Besides, undertaking the need analysis at the institution would be necessary in identifying the urgent needs of employees. The analysis would be important in solving issues affecting the company from the source of the problems.

References

Chen, J. Q., & Benusa, A. (2017). HIPAA security compliance challenges: The case for small healthcare providers. International Journal of Healthcare Management, 10(2), 135-146. https://doi.org/10.1080/20479700.2016.1270875

Gajwani, A., Shah, A., Patil, R., Gucer, D., & Osier, N. (2022). Training undergraduate students in HIPAA compliance. Accountability in Research, 1-12. https://doi.org/10.1080/08989621.2022.2037428

Heath, M., Porter, T. H., & Silvera, G. (2021). Hospital characteristics associated with HIPAA breaches. International Journal of Healthcare Management, 1-10. https://doi.org/10.1080/20479700.2020.1870349

Moore, W., & Frye, S. (2020). Review of HIPAA, part 2: limitations, rights, violations, and role for the imaging technologist. Journal of Nuclear Medicine Technology, 48(1), 17-23. DOI: https://doi.org/10.2967/jnmt.119.227827

Nelson, W. (2017). Making Ethical Decisions. Healthcare Management Ethics. ISSN/ISBN: 0883-5381

Stuart, L. (2019). Guidance for Psychologists on HIPAA Breach Notification Rule. PsycEXTRA Dataset.

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Compliance Program Implementation and Ethical Decision-Making Template
Background
Include a short paragraph of no more than five or six sentences describing the known details about the privacy breach/HIPAA violation.
Problem Summary: Privacy Breach—HIPAA Violation
Briefly Explain the Law, Regulation, Standard, et cetera* Briefly Explain How the Law, Regulation, Standard, et cetera Applies to the Privacy Breach/HIPAA Violation
Applicable Law(s)
Applicable Specific Regulation(s)
Disclosure
Applicable Human Resource Law(s)
Applicable Industry Accrediting Body Standards
*Include citations from authoritative government, accrediting body, and peer-reviewed industry sources.
Add additional salient points if needed:

Seven Essential Elements of an Effective Compliance Program
Number Element of an Effective Compliance Program
(Federal Register)* How Does This Element Apply to the Privacy Breach/HIPAA Violation?
1.
2.
3.
4.
5.
6.
7.
*Include source citation(s).
Privacy Breach Consequences
Covered Entity Legal Penalty(ies)* Additional Consequences
Individual Leader Within Health Care Organization
Other Internal Health Care Organization Stakeholders
Health Care Organization
*Include citation(s) from authoritative government and related sources.

Evidence-Based Recommendations
Number Evidence-Based Recommendation Additional Insights/Salient Points Source(s)*
1.
2.
3.
4.
5.
*Include citation(s) for human resource laws, professional codes of ethical conduct/standards, previous case precedents, and current alleged health care legal violations. Example: DOJ/OIG, CMS/HHS, et cetera websites.
https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/examples/all-cases/index.html?language=es
Ethical Decision-Making Framework for Health Care Leaders
Number Ethical Decision-Making Step* Apply the Ethical Decision-Making Step to the Privacy Breach/HIPAA Violation
1.
2.
3.
4.
5.
6.
*Include citation. Example: https://ache.org/abt_ache/EthicsToolkit/JA15_ethic_reprint.pdf

Conclusion
Include a short paragraph that summarizes: key concepts, importance of compliance, best practices to monitor for future quality improvements, and a short list of resources. Be sure to include all appropriate citations.