HCS 468 Week 2 Health Law and Policy Analysis: Ethical Concerns Example

A Tumor Marker at 11 at Night: Health Law and Policy Analysis of a Laboratory's Rule on Releasing Results Directly to Patients, and the Ethical Concerns It Raises

[Student Name]

University of Phoenix

HCS/468: Regulatory and Compliance within the Health Care Industry

Week 2 Assignment

[Instructor Name]

[Date]

The laboratory, its app and its cases are composites written for a model paper; the federal rule and survey findings come from the sources listed.

At 11 at night, a composite 54-year-old woman opened the app of the independent laboratory that had drawn her blood that afternoon. Her primary care physician had added a cancer antigen test because of vague abdominal symptoms. The value was several times the upper limit of normal, flagged in red. There was no explanation, and her physician's office would not open until eight. She searched the test name online and spent the night reading about ovarian cancer. Her physician later explained that the marker can rise for many benign reasons, and imaging was normal. She called the laboratory to complain. Her complaint is the starting point for this analysis.

The Law

Before 2014, many laboratories could release results only to the ordering clinician, and patients who asked the laboratory directly were turned away. The federal rule titled CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports, published in February 2014, changed that. It amended the laboratory regulations to allow laboratories to give completed reports to patients and removed the exception that had excluded laboratories from the HIPAA right of access. As a result, a laboratory that is a covered entity must provide a patient, or a personal representative, with completed test reports on request.

The Law's Purpose

The rule's purpose was to strengthen patients' ability to take part in their own care. Results that arrive only through a clinician can be delayed or lost, and follow-up of abnormal results in outpatient care is a known safety gap. Direct access lets patients notice when an expected result has not been discussed and ask about it.

The Laboratory's Policy

The laboratory went further than the right to request. Its policy, adopted after later federal rules restricted practices that interfere with access to electronic health information, releases every verified result to the patient's app at the same moment it goes to the ordering clinician, with no delay by test type. The laboratory's legal counsel advised that holding results back to let clinicians call first could be treated as interference unless a specific exception applied, and that the most common exception requires a professional judgment about harm for the individual patient, not a blanket delay.

Where the Policy Goes Beyond the Law

The 2014 rule creates a right to request reports; it does not require a laboratory to push every result to an app automatically. The laboratory chose automatic release for three reasons. Patients were already requesting results by phone, which consumed staff time. Several large health systems in its market release results immediately through their portals, so patients expected the same. And counsel judged that a policy of routine delay would be hard to defend under the later federal limits on withholding electronic information. The choice was defensible, but it means the laboratory, not only the law, owns the consequences of how results arrive.

Stakeholders

Patients gain speed and control. Ordering physicians lose the chance to frame bad news and field calls from anxious patients. The laboratory gains compliance and patient satisfaction but takes complaints like this one. Payers and the health system may see extra visits driven by worry.

Ethical Principle: Autonomy

Respect for autonomy supports the policy. The results are about the patient's body, and adults have a right to information about themselves without waiting for someone else's permission (Beauchamp & Childress, 2019). Many patients who see results early are better prepared for the conversation with their clinician.

Ethical Principles: Beneficence and Nonmaleficence

Beneficence asks the laboratory to benefit patients; nonmaleficence asks it to avoid causing harm. Seeing a frightening number alone at night, without context, caused this patient real distress. Some results, such as a new HIV diagnosis, a cancer marker or certain genetic findings, carry meaning that a number and a reference range cannot convey. The ethical problem is not that the patient learned the truth, but that she learned half of it at the worst possible time.

Evidence on the Concern

Steitz et al. (2023) surveyed more than 8,000 patients and care partners at four academic medical centers who had viewed results through a portal after federal rules required immediate release. About 96% preferred to receive results immediately, including about 95% of those whose results were not normal. Only 7.5% of those asked said that seeing results before hearing from a clinician increased their worry, but increased worry was more common among people with abnormal results, 16.5%, than among those with normal results, 5.0%.

Ethical Principle: Justice

Justice asks whether burdens fall fairly. Patients with lower health literacy or limited English are more likely to misread a flagged value and less able to find reliable explanations at night. A policy that releases the same bare report to everyone may serve confident readers well and others poorly.

Law and Ethics Are Not the Same

The laboratory's policy is legal, and a blanket delay would likely create legal risk. Yet a legal policy can still be improved ethically. The question is not whether to release results but how to release them.

Policy Revisions

First, every result in the app will carry a plain-language explanation of what the test measures and a note that abnormal values have many causes, with a link to a reliable patient resource. Second, patients will choose at registration whether to see sensitive results immediately or after a set number of days, a choice the patient controls rather than the laboratory. Third, the laboratory will offer ordering physicians a short script for telling patients, before a test is drawn, that results may appear before the office calls. Fourth, the patient service line will be staffed until 10 at night to explain what a report says, though staff will not interpret results clinically.

Responding to the Complaint

The laboratory's patient relations manager called the woman two days after her complaint. She apologized for the night the patient had spent, explained that the law gives patients the right to their results and that many patients want them quickly, and asked what would have helped. The patient said a single sentence explaining that the marker is not a cancer test on its own would have let her sleep. That answer shaped the first revision below, and the patient agreed to review the draft wording.

Conclusion

The 2014 rule gave patients a right the laboratory must honor, and the evidence shows most patients value it. The ethical concern is narrower: abnormal, high-stakes results delivered without context can harm some patients, most of all those least equipped to interpret them. Explanations, patient choice and advance warning let the laboratory keep faith with both autonomy and the duty to avoid harm.

References

Beauchamp, T. L., & Childress, J. F. (2019). Principles of biomedical ethics (8th ed.). Oxford University Press.

CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports, 79 Fed. Reg. 7290 (2014). https://www.federalregister.gov/d/2014-02280

Steitz, B. D., Turer, R. W., Lin, C.-T., MacDonald, S., Salmi, L., Wright, A., Lehmann, C. U., Langford, K., McDonald, S. A., Reese, T. J., Sternberg, P., Chen, Q., Rosenbloom, S. T., & DesRoches, C. M. (2023). Perspectives of patients about immediate access to test results through an online patient portal. JAMA Network Open, 6(3), Article e233572. https://doi.org/10.1001/jamanetworkopen.2023.3572