Legal & Regulatory
Consent
Informed consent requires capacity, disclosure of risks, benefits, and alternatives, voluntariness, and documentation. The emergency exception applies when immediate treatment is needed and no surrogate is available. Minor consent rules vary by state for emancipated minors and specific services (reproductive health, mental health, substance use).
Federal statutes
- EMTALA: applies to Medicare-participating hospitals with an emergency department; requires a medical screening exam and stabilizing treatment regardless of insurance status; transfers require certification and acceptance. It is not a malpractice statute.
- HIPAA: Privacy Rule (use and disclosure), Security Rule (ePHI safeguards), and Breach Notification. HIPAA is a floor-stricter state law is not preempted.
- Anti-Kickback Statute: intent-based, criminal. Stark: strict liability, civil, physician self-referral for designated health services.
- False Claims Act: qui tam actions and treble damages; compliance programs and corporate integrity agreements are common responses.
Liability theories
Respondeat superior (employer liability for employees), ostensible agency (holding a physician out as one’s own), and corporate negligence (the organization breached its own duties). Damages caps and tort reform vary by state.
Traps
EMTALA applies regardless of ability to pay, not only to Medicare patients. Stark requires no intent; the Anti-Kickback Statute does. HIPAA does not preempt more stringent state privacy law.
Rule of thumb
Stabilize first, transfer second, and document the transfer certification.