Medical Ethics, Legal and Regulatory Issues 7 Flashcards

A 71-year-old patient with advanced glaucoma has a remaining visual field of 8 degrees in his better eye and categorically refuses to stop driving, citing that it is his only means of independence. He is cognitively intact and fully understands the risk. After thorough counseling, he remains resolute. As the COT documenting this encounter, what is the MOST appropriate next step?

Answer: Escalate to the supervising physician, who must determine whether applicable state mandatory reporting laws require disclosure to licensing authorities

While patient autonomy is a cornerstone of medical ethics, it does not override a physician's legal duty-to-warn obligations where third parties face serious foreseeable harm. Many states have mandatory reporting laws for physicians regarding patients who are unsafe to drive. The COT's role is to escalate to the supervising physician — not to independently contact the DMV or withhold care. The physician then determines the legal obligation under state-specific statutes.

A patient enrolled in an IRB-approved ophthalmic research study signs informed consent at enrollment. Six months into the study, the patient develops moderate dementia and can no longer meaningfully understand the study procedures or risks. The patient's adult daughter presents herself as the decision-maker and requests that her parent remain enrolled. What is the most ethically appropriate course of action?

Answer: Pause participation, consult the IRB, and follow the study protocol's provisions for surrogate consent before making any decision

Research ethics require ongoing decisional capacity — consent obtained at enrollment does not carry forward indefinitely when a participant loses capacity. Federal regulations (45 CFR 46) and Good Clinical Practice guidelines require that the IRB-approved protocol specify how loss of capacity is handled. The IRB must be consulted, and surrogate consent (if permitted by the protocol and applicable law) must follow a formal process. Simply continuing based on prior consent or informal surrogate agreement is ethically and legally insufficient.

Your ophthalmology practice receives a subpoena duces tecum from an attorney representing the plaintiff in a personal injury lawsuit, demanding the complete medical records of a current patient. The patient has not provided a signed HIPAA authorization. The office manager instructs staff to immediately copy and send all records. What is the correct response?

Answer: Contact the practice's legal counsel before releasing any records, as an attorney-issued subpoena does not automatically constitute a court order under HIPAA

This is a critical HIPAA distinction: a subpoena issued by an attorney is NOT the same as a court order signed by a judge. Under 45 CFR 164.512(e), a covered entity may disclose records in response to a subpoena only after receiving satisfactory assurance that the patient was notified and given an opportunity to object, or that a qualified protective order is in place. Automatically complying without legal review risks a HIPAA violation. Legal counsel must evaluate whether the subpoena meets HIPAA's conditions before any release.

A pharmaceutical company invites your practice's ophthalmologists to an all-expenses-paid dinner where a company representative presents data on a new prostaglandin analog. Following the dinners, your supervising physician begins prescribing this medication at a rate four times higher than before, including for patients on Medicare. Which federal statute is MOST directly implicated by this arrangement?

Answer: The Anti-Kickback Statute, which prohibits offering or receiving anything of value to induce referrals or recommendations of items covered by federal healthcare programs

The Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b) prohibits offering, paying, soliciting, or receiving anything of value — including meals and entertainment — to induce or reward referrals or recommendations of items or services reimbursable by federal healthcare programs. Sponsored meals intended to influence prescribing behavior fall squarely within this statute's reach. While the False Claims Act could also be implicated downstream, the Anti-Kickback Statute is the most directly applicable law governing the inducement itself.

During a slit-lamp exam, a COT notices that a colleague — who is treating a different patient in an adjacent lane — approaches and quietly asks for the address of the current patient, who has a documented HIV diagnosis visible in the open chart, stating it is 'for a referral.' What is the MOST appropriate response?

Answer: Decline, close or cover the chart, and report the request to a supervisor or the practice's privacy officer

HIPAA's minimum necessary standard requires that access to protected health information (PHI) be limited to what is needed for a specific, legitimate purpose. A verbal request from a colleague in a clinical area — especially for a patient with a sensitive diagnosis like HIV — does not constitute a valid treatment relationship or proper access pathway. The COT must decline, protect the PHI, and report the incident to a supervisor or privacy officer. Providing the information, even with a future reminder, still constitutes a potential HIPAA breach.

A 15-year-old patient presents alone for a routine contact lens evaluation. Midway through the exam, the patient's parent calls the office and demands to immediately receive the patient's full prescription and all clinical findings, citing parental rights. The patient, who is not emancipated and is receiving standard ophthalmic care, has not signed a release. What is the MOST legally accurate statement governing this situation?

Answer: The parent has automatic legal access to the minor's medical records for routine care, unless a specific state law exception applies

Under HIPAA, a parent or legal guardian is generally considered the personal representative of a minor child and has the right to access the child's PHI for routine medical care. However, this is not unconditional — state laws may create exceptions (e.g., if the minor has the right to consent to the care independently, or if a court has limited parental access). For standard ophthalmic care where no such exception applies, the parent's access rights are generally valid. The COT should follow office policy and, if uncertain, escalate to a supervisor rather than assuming the minor controls access.