Compliance Program Implementation and Ethical Decision-Making
Protecting Patient Privacy: Review of A HIPPA Breach
Background
Our facility, called Vila Health, is a medium-sized healthcare facility consisting of community-based hospitals working in Minnesota and Wisconsin. Recently, an incident involving a patient privacy breach and potential HIPPA violation occurred that has put doubt over the healthcare code compliance in our facility. A Vila Health employee shared sensitive protected health information (PHI) related to a patient with their insurance company without prior written consent. This mobilized the working response system of the company, citing the incident as a privacy violation and prohibition of this or any incidence like this in the future. This incident has brought to light the underlying vulnerabilities and potential areas of improvement in healthcare compliance policy. As a member of risk management and quality improvement tasks, I have been directed to address the issue. This briefing will focus on the laws that govern healthcare privacy and confidentiality, ethical considerations of such breaches, and evidence-based practices for prevention in the future.
Problem Summary: Privacy Breach—HIPAA Violation
| The Law, Regulation, Standard | How does the Law, Regulation, or Standard, Apply to the Privacy Breach/HIPAA Violation | |
| Applicable Law(s) | The Health Insurance and Accountability Act (HIPPA), is the primary federal law that protects patient privacy and the security of a patient’s protected health information (PHI) by retaining exclusive rights of patients over their medical information. | The Health Insurance and Accountability Act of 1996 (HIPPA) establishes national standardized rules to protect patient privacy and confidentiality by preventing disclosure of sensitive information. Under Title III of the act, it governs the prevention of healthcare fraud and abuse, and administrative simplifications and standardization for electronic health records. It was born out of the statute’s need to create confidentiality systems to keep PHI private in the wake of the digitalization of health records. This act thus protects patient privacy by limiting access to health data and ensuring penalization of any violations (Edemekong et al., 2022) |
| Applicable Specific Regulation(s) | The HIPPA privacy rule permits the important uses of patient information while protecting their privacy. | Established in 2003, the privacy rule addresses the use and disclosure of PHI by the so-called “covered entities”. These entities include healthcare providers, insurance plans, healthcare organizations, and their business associates. It provides clear regulations to ensure access to medical information is strictly on a need-to-know basis. It prohibits the use and disclosure of this information except with explicit written consent of the patient. The law, however, permits the use and disclosure of PHI, by these entities, without consent in special circumstances to ensure optimal quality of healthcare delivery (Centers for Disease Control and Prevention, 2022) |
| Disclosure | The HIPPA Standards for Privacy of individually identifiable PHI prevents unauthorized access and disclosure of PHI. | The privacy breach in our facility that instigated this briefing, is an example of a direct violation of the HIPPA privacy rule. The privacy rule protects all individually identifiable PHI held or transmitted by any covered entity or its business associate in any form of media, whether electronic, paper, or oral. The penalties for non-compliance can be anywhere between civil monetary or criminal (United States Department of Health and Human Services, 2022). According to Dougherty (2022), the HIPPA breach notification rule states after determining the probability of a privacy breach on the compromise threshold, the covered entity should notify all concerned parties (patient, media, and/or HHS) without reasonable delay from the date of discovery (within 60 days). |
| ` | ||
| Applicable Human Resource Law(s) | ERISA law est. 1974 is a federal law designed to identify standards for healthcare plans in the private sector and the protection of the individuals utilizing them. | This law establishes a strict fiduciary code of conduct for the protection of sensitive electronic medical information. It protects patient privacy against HIPPA violations by recognizing private right of action which is underdeveloped in HIPPA privacy remedy (Geier, 2023). |
| Applicable Industry Accrediting Body Standards | International Accreditors for Continuing Education and Training (IACET), is a non-profit organization dedicated to education and training to ensure HIPPA compliance. | The IACET provides training courses for HIPPA compliance because none of the federal agencies (HHS and OCR) determining compliance endorse certification of compliance. It helps to ensure verified and safe information, legitimacy, and a minimum standard of quality and compliance (Kelvis, 2022). This is important for organizations like us to be able to assess our HIPPA security and compliance policies and update up to code when necessary to avoid a privacy breach incident like we suffered. |
Seven Essential Elements of an Effective Compliance Program
| Number | Element of an Effective Compliance Program
| How Does This Element Apply to the Privacy Breach/HIPAA Violation? |
| 1. | Written policies, procedures, and standards of conduct | A strict HIPPA privacy rule-based code of conduct in our organization could have prevented this breach. Drawing up a written policy module and familiarizing our employees with an attitude of strict compliance will help us to ensure a breach-free care facility (Deo, 2023) |
| 2. | Appointing a compliance officer and compliance committee | A designated compliance officer or regulatory body like a compliance committee would have bridged the gaps in compliance and prevented the breach by taking necessary steps to enforce privacy and compliance policies. In the future, a compliance committee headed by a chief compliance officer will enforce policies, monitor compliance, and use this feedback to correct or improve existing plans to prevent such incidents (Magnusson, 2023) |
| 3. | Effective training and education | A worker trained in HIPPA privacy rules and procedures could have prevented the breach by acting according to regulations. We will establish a training program that will be incorporated into work as a mandatory weekly training workshop managed by members of the compliance committee and supervised by the chief compliance officer. All necessary resources and literature will be provided. This will empower our employees to act consciously whenever dealing with PHI and protect patient privacy as a priority (Magnusson, 2023) |
| 4. | Effective communication | The communication of PHI between the parties of interest should only be done with authorization and in the case of electronic transactions should be protected by a Business Associate Agreement (BAA) in the wake of PHI. This was the main culprit in the privacy breach incident and measures will be set in place to ensure no PHI can be communicated without first presenting written patient consent (Compliancy Group, 2023). An effective system for two-way communication in the hierarchy and an anonymous channel for reporting will also be established to ensure timely reporting of HIPPA violations (Roney, 2023) |
| 5. | Internal monitoring and auditing | According to Tambani (2023), auditing trail systems in organizations ensures accountability, access control, and protection of PHI, and aids in incident reporting. This can help us in tracking and preventing breaches like this in the future and allow us to analyze potential areas of vulnerabilities that can lead to a privacy breach. |
| 6. | Enforcing standards through well-publicized disciplinary guidelines | Disciplinary guidelines with clearly communicated regulatory practices as well as penalties for non-compliance will be enforced. This will promote a culture of accountability and establish the seriousness of a privacy breach both for the patient and the employee responsible for handling PHI (HIPPA Journals, 2023) |
| 7. | Prompt response to offenses and taking corrective action | This breach has highlighted the importance of a security risk analysis and a risk management plan to mitigate potential odds of recurrence of such events. A corrective action plan (CAP) can help us address the underlying compliance issues that lead to HIPPA violations (Badahman, 2019) |
Privacy Breach Consequences
| Covered Entity | Legal Penalty(ies)* | Additional Consequences |
| Individual Leader Within Health Care Organization | Civil and criminal fines and sentences | A fine anywhere from 100$ to 250,000$ and sentences ranging from 1-10 years along with termination of service and loss of license (Edemekong et al., 2022) |
| Other Internal Health Care Organization Stakeholders | Fines and legal action | Up to $50,000 in fines and 1o years of sentences depending upon the tiers of violations (Indiana University Information Technology Services, 2023) |
| Health Care Organization | Fines, lawsuits, and defamation | Money penalties ranging from $63,973 per violation to $1.9 million per annum, costly lawsuits, and loss of revenue from credibility damage (Kelvas,2024) |
Evidence-Based Recommendations
| Number | Evidence-Based Recommendation | Additional Insights/Salient Points | Source(s)* |
| 1. | HIPPA risk analysis and management | `Annual risk point analysis should be done and refreshed as necessary. The risk factors for an imminent HIPPA violation should be identified and analyzed. Risk management steps should be undertaken daily to promote patient privacy by addressing potential areas of breach such as the unauthorized spread of PHI. | (Hales, 2021) |
| 2. | Workforce training | Cybersecurity training for all staff handling PHI should be mandatory to reduce data breaches by Phishing. The employees should also be well versed in HIPPA privacy rules and patient right of access rules to ensure compliance. | (Hales, 2021) |
| 3. | Employee codebooks and reference guides | Written mandates and enforced disciplinary guidelines that impose penalties in case of non-compliance reduce the incidence of privacy breaches. | (Deo, 2023) |
| 4. | Compliance inspectors | A regulatory body ensuring and monitoring compliance, analyzing auditory trails, and providing education and training to employees will improve the chances of compliance and promote a safe environment for patient care. | (Magnusson, 2023) |
| 5. | Swift corrective action | Establishing an automated, quick, and efficient response system that is deployed in case of a privacy breach to correct all potential drivers of non-compliance and contain the damage is crucial in the aftermath of a breach. | (Badahman, 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. | Identify the Ethical Misconduct | Acknowledge that misuse and careless handling of PHI, resulting in disclosure of sensitive individual-specific information raises serious ethical concerns about the privacy and confidentiality of patients causing them subjective distress jeopardizing their care and safety, and compromising rules of autonomy and patient rights to access (Xafis et al., 2019) |
| 2. | Gather Relevant Information | When a data breach occurs, all necessary information should be gathered. A narrative report of the incident, drivers of the breach, potential risk factors and points of weakness, a timeline of reporting, the tier of the breach, and identity, attribute, or inferential disclosure should be determined. Unauthorized access to data and lack of written, informed consent should be noted (HIPPA Journals, 2023) |
| 3. | Identify stakeholders | All stakeholders involving the individuals that are likely to be affected by data breach, the organization, Office of Health and Human Services (HHS), and mass media should be notified (HIPPA Journals, 2023) |
| 4. | Determine options | Consider options to mitigate risks such as risk analysis to trace accountability, legal counsel and collaboration with third-party security firms, implementing counteractive security measures, and how to handle post-breach investigation and procedure of HHS/OCR (Dougherty, 2022) |
| 5. | Evaluate options | Evaluate options against the ethical principles and frameworks judging the ethical intensity of privacy compromise and apply four ethical principles of Principlism to prioritize patient safety and autonomy (Kisselburgh & Beever, 2022) |
| 6. | Decision making | Considering all the stakeholders and the potential implications of a data breach on them, formulate a clear plan of action in the wake of ethical and legal liabilities to improve policies and standards of privacy protection according to the regulatory principles of HHS (Kisselburgh & Beever, 2022) |
Conclusion
Patient privacy and confidentiality are crucial in ensuring optimal healthcare delivery. The HIPPA is the main law that protects patient privacy and enforces damage control in case of a breach. The breach occurring at our facility has highlighted the importance of efforts needed to be employed to ensure the HIPPA privacy rule compliance and ethical standards we need to hold over ourselves to make good on the promise of patient safety. Evidence-based practices involving training and education in security laws and protocols, compliance monitoring authorities and adherence to strict disciplinary guidelines comprise our best plan of action to prevent—such incidents in the future.
References
Badahman, S. (2019). How to prevent HIPAA violations | Corrective plans by HIPAAtrek. Hipaatrek.com
https://hipaatrek.com/corrective-action-plans/
Centers for Disease Control and Prevention. (2022). Health insurance portability and accountability act of 1996 (HIPAA). Centers for Disease Control and Prevention cdc.gov.
https://www.cdc.gov/phlp/publications/topic/hipaa.html
Compliancy Group. (2023). HIPAA-compliant patient communication. Compliancygroup.com
https://compliancy-group.com/hipaa-compliant-patient-communication/
Deo, S. (2023). Policies and Procedures Required by HIPAA. Google.com; 247BySecurity, Inc.
https://www.google.com/amp/s/blog.24by7security.com/policies-and-procedures-required-by-hipaa%3fhs_amp=true
Dougherty, R. (2022). HIPAA Breach [What it is & how to handle the aftermath]. Kiteworks.com.
https://www.kiteworks.com/hipaa-compliance/hipaa-breach/
EBIA. (2019). Court allows ERISA health plan participant’s invasion of privacy claim to proceed. Tax & Accounting Blog Posts by Thomson Reuters. East Bay Innovation Academy. tax.thomsonreuters.com
https://tax.thomsonreuters.com/blog/court-allows-erisa-health-plan-participants-invasion-of-privacy-claim-to-proceed/
Edemekong, F., Haydel, J., & Annamaraju, P. (2022, February 3). Health insurance portability and accountability act (HIPAA). Nih.gov; StatPearls Publishing.
https://www.ncbi.nlm.nih.gov/books/NBK500019/
Geier, B. (2023). What is the ERISA law? Smartasset.com
https://smartasset.com/financial-advisor/what-is-erisa-law
HALES, M. (2021). Improve HIPAA compliance in three ways. Thehipaaetool®.com
https://thehipaaetool.com/improve-hipaa-compliance-three-ways/
HIPAA Journal. (2023a). Why is HIPAA important? Hipaajournal.com
https://www.hipaajournal.com/why-is-hipaa-important/
HIPAA Journal. (2023b). What are the HIPAA Breach Notification requirements? Hipaajournal.com.
https://www.hipaajournal.com/hipaa-breach-notification-requirements/
Kelvas, D. (2022). What is a HIPAA certification? HIPAAexams.com
https://www.hipaaexams.com/blog/hipaa-certification
Kelvas, D. (2024). What are the penalties for HIPAA violations? HIPAAexams.com
https://www.hipaaexams.com/blog/what-are-the-penalties-for-hipaa-violations
Kisselburgh, L., & Beever, J. (2022). The ethics of privacy in research and design: Principles, practices, and potential. Modern Socio-Technical Perspectives on Privacy, 395–426.
https://doi.org/10.1007/978-3-030-82786-1_17
Tembani., L. (2023). The role of audit trails for HIPAA compliance. Google.com; Paubox.
https://www.google.com/amp/s/www.paubox.com/blog/the-role-of-audit-trails-for-hipaa-compliance%3fhs_amp=true
Magnusson, A. (2023). What is HIPAA Compliance? 2024 Complete Guide | StrongDM. Strongdm.com.
https://www.strongdm.com/hipaa-compliance#:~:text=Designating%20a%20compliance%20officer%20and%20committee&text=This%20puts%20the%20organization%20at
Roney, C. (2023). All You Need to Know about HIPAA Compliance. Endpointprotectorblog.com
https://www.endpointprotector.com/blog/all-you-need-to-know-about-hipaa-compliance/
U.S. Department of Health and Human Services. (2022). Summary of the HIPAA privacy rule. HHS.gov; United States Department of Health and Human Services.
https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html
Indiana University Information Technology Services. (2023). Penalties for violating HIPAA. Kb.iu.edu.
https://kb.iu.edu/d/ayzf
Xafis, V., Schaefer, O., Labude, K., Brassington, I., Ballantyne, A., Lim, Y., Lipworth, W., Lysaght, T., Stewart, C., Sun, S., Laurie, T., & Tai, S. (2019). An ethics framework for big data in health and research. Asian Bioethics Review, 11(3), 227–254.
https://doi.org/10.1007/s41649-019-00099-x