Legal Issues in Emergency MedicineAtty. Gerard L. Chan, LL.M.

Professorial Lecturer, University of the Philippines, College of LawProfessorial Lecturer, Ateneo de Manila Univesity John Gokongwei School of ManagementDirector for Legal Affairs, Department of Transportation and Communications (DOTC)

Legal Issues in Emergency MedicineInformed Consent

Privacy, Confidentiality and Reporting (HIPAA)

Emergency Medical Transfer in Active Labor Act (EMTALA)

INFORMED CONSENTA legal condition whereby a person can be said to have given consent to submit to treatment.Based upon a clear appreciation and understanding of the facts, implications and future consequences of an actionAfter having been properly educated by the physician about the risks and benefits of the proposed treatment, and about the viable treatment options, including the option of not undergoing.

INFORMED CONSENTIt is the duty of the physician to inform the patient or his relatives of the nature of the illness, progress of his condition, common accepted treatment, alternatives, risks and probable costs and obtain a voluntary informed consent for any procedure he intends to perform. (Article II, par. 3, Code of Ethics of the Medical Profession, Philippine Medical Association)

Dual Purpose of ConsentTo protect the bodily integrity of the patient (autonomous person) by attaching civil and/or criminal liability to unwanted contact (i.e. contact in the absence of consent)

To provide a defense to a physician who has physically examined an autonomous patient who had consented to the contact.

Essential Elements of ConsentLegal capacity of the parties

Manifestation of conformity of the parties

Conformity must be intelligent, spontaneous and free from vices of consent

Conformity must be real and not simulated

Patient CapacityDecisional Capacity (under Illinois Law)

The ability to understand and appreciate the nature and consequences of a decision regarding medical treatment or foregoing life-sustaining treatment and the ability to communicate an informed decision in the matter as determined by the attending physician

Patients capacity determined by physician

Taking a history from an alert patient with no barriers to communication

Disagreement with the physicians plan does not indicate lack of capacity if the decision was made in a rational way based on values and beliefs

If a patient has capacity to make a given decision, his/her wishes should be respected

Capacity not a static all-or-none ability

Patients decision-making capacity may change over time in the ED and should be reassessed

Factors to Consider in Determining CapacityPresence of conditions impairing mental function

Presence of basic mental functioning (awareness, orientation, memory attention)

Patients understanding of specific treatment-related information

Appreciation of the significance of the information to the patients situation

Patients ability to reason about treatment alternatives in light of values and goals

Complexity of the decision-making task

Risks of the patients decision

Common Errors in Assessment of CapacityAssuming that lack of capacity for one type of decision means lack of capacity for all decisions

Assuming that legal competence is the same as medical decision-making capacity

Presuming that capacity is constant over time

Presuming that psychiatric disorders preclude adequate capacity

Failing to ensure that patient has relevant and consistent information before making a decision

Assuming that capacity should only be considered for refusal of treatment

Failing to recognize that decision-making capacity varies with the risks/benefits inherent in the decision

Persons Who May Give Informed ConsentPatientSpouseEldest ChildParents of the patientGrandparents of the patientBrother or sister of the patientNearest kin availableThe State (highest official in the hospital)

Quantum of Information for Valid Informed ConsentThe quantum of information needed will be on a case to case basis. A physician is not negligent if he acted in accordance with a practice accepted as proper by a reasonable body of medical people skilled in that particular art

Chatterton v. Gerson (1981)

.once the patient is informed in broad terms of the nature of the procedure which is intended, and gives her consent, that consent is real..Of course, if information is withheld in bad faith, the consent will be vitiated by fraud.

Quantum of Information for Valid Informed ConsentPhysicians generally not held responsible

To disclose risks that are so rare as to be immaterial; orTo disclose risks that are considered common knowledgeCaveat: In the Emergency Department:

Better to give more, not less, information to the patientBest option to disclose all material risks, including those that are common knowledge

Exceptions to the Right to Informed ConsentEmergencies

Render needed emergency treatment in situations where consent cannot be obtained or cannot be ascertained in a timely fashion due to the nature of the illnessBasis: Implied Consent

A reasonable person would, if able, give consent to such emergency or life-saving treatment

Public Health Imperatives

When public good overrides individual patient autonomy

High-risk communicable diseases

Patients with mental illness who pose a danger to themselves and the public

Documentation of ConsentIn obtaining informed consent, process is the most important

Generally: Oral consent is as good a written consent

But: Documentation signed by the patient can aid the provider should the consent process be challenged later on

Therefore: Document. Document. Document.

Note: General Consent Forms

Only provide general consent for treatment

Covers only standard examinations and basic procedures

Does not include consent for detailed, risky or invasive procedures

Consent

Informed RefusalPatients

Refuse part of a treatment planRefuse to be evaluated entirelyWish to leave before the completion of the planned evaluation

Steps to be undertaken

Ensure that there are no miscommunications or misunderstandings at the root of the refusal

Correct issues that may prevent an open, non-contentious discussion such as

A meal, blanket, call to a personal physician, additional pain medication

Develop an alternative to the original plan

ED Departure Against Medical Advice and ED ElopementReasonable treatment should be provided as appropriate and concordant with the patients wishes even though patient leaves against medical advice

Document situations when patient leaves against advice which must contain:

Documentation of capacity (with examples and examination clearly noted)

Discussion of the risks reviewed with the patientOffers of alternative treatments if availableEfforts to involve family or clergy in the decisionExplanation of any potentially problematic entries in the chartPatients signature, and in case of refusal to sign, documentation of that factDocumentation of treatment and follow-up providedStatement that an offer of care at any time was provided to the patient

PRIVACY, CONFIDENTIALITY AND REPORTING (HIPAA)Health Insurance Portability and Accountability Act of 1996 (HIPAA)

US law for protection of health care privacy and confidentiality of individualsEstablishes standards for the security, exchange and integrity of electronic health informationSet rules for fair information practices for health care

Protected Health Information (PHI) is

any information, including genetic information, whether oral or recorded in any form or medium, which

Is created or received by a health care provider, health plan, public health authority, employer , life insurer, school or university, or health care clearinghouse; and

Relates to the past, present or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present or future payment for the provision of health care to an individual

Disclosure of Protected Health InformationOnly the minimum amount of information required to accomplish the purpose will be releasedPHI may be used without authorization in the following cases:

Treatment

Management and coordination of health care and related services including consultations and referrals

Payment

Use PHI to obtain payment or be reimbursed for care provided to an individual

Operations

Quality improvement, employee evaluation and credentialing, auditing programs

12 National Priorities

12 National Priorities for which PHI may be Disclosed without AuthorizationWhen required by lawPublic health reporting (e.g. vital statistics, disease, adverse event reporting)Reporting abuse, neglect or domestic violenceHealth oversight activities (e.g. inspections, audits)Judicial and administrative proceedings

Law enforcement purposes (e.g. criminal investigations)Disclosures about deceased persons to medical examiners, coroners and funeral directorsOrgan, eye and tissue donation purposesSome types of research (e.g., where an institutional review board has waived authorization requirement)Avert a serious threat to the health or safety of the publicSpecialized government functions (e.g. military missions or correctional activities)Workers Compensation claims

HIPAA Dos and DontsHIPAA Dos

Talk freely with patients primary physicianDiscuss PHI with consultants and other members of the patients health care teamUse PHI for reimbursement and operational issues

Release records to the patient or an authorized representativeDiscuss PHI with family or friends if the patient is in an emergency situation, unable to consent and the information is beneficial to the patient

HIPAA DontsDiscuss patients or PHI in public or unsecured areasLeave computers with access to PHI logged on and unattendedDiscuss PHI in front of others without permissionSpeak loudly when discussing PHI, particularly in public areasLook at records for which you have no legitimate purpose as a provider

Physician - Patient Privileged Communication Under Philippine LawsStatutory Privileged Communication

A person authorized to practice medicine, surgery or obstetrics cannot in a civil case, without the consent of the patient be examined as to any advice or treatment given by him or any information which he may have acquired in attending such patient in a professional capacity,

which information was necessary to enable him to act in that capacity, and which would blacken the reputation of the patient (Section 24, par. c. Rule 130, Rules of Court)

Ethical or Professional Confidential Information

The physician is obliged to respect the confidentiality of all information he acquires on the basis of his professional capacity, and not to divulge this information to third parties, unless there is a law, a court order, or a waiver from the patient or when the common good so requires.

Such obligation extends even after the death of the patient. (Article II, par. 4, Code of Ethics of the Medical Profession, Philippine Medical Association)

Note: Duty of Confidentiality Extends to the Hospitals

Cases Where Privilege Does Not ApplyWhen disclosure is necessary to serve the best interest of justicePD 169 requires physicians to report to the nearest police station any victim of serious and less serious physical injuries that comes to his knowledgePD 603 requires physicians to report in writing within 48 hours to the provincial or city fiscal or to the local council for protection of children any case of maltreatment or abused child

When disclosure will serve public health and safety

Physician obliged to report the existence of contagious or communicable disease so that necessary public health measures can be adapted

When the patient waives the confidential nature of such information

EMERGENCY MEDICAL TREATMENT AND ACTIVE LABOR ACT 1986 (EMTALA)Patient Dumping

Refusal to treat because of patients inability to pay or insufficient insurance, OR

Transferring or discharging emergency patients due to high diagnosis and treatment costs

EMTALA applies when

An individual comes to the emergency department andA request is made for examination or treatment of a medical condition

Three Obligations Imposed by EMTALA on Hospitals Operating EDsProvide medical screening examination to determine whether an emergency medical condition (EMC) exists

Stabilize the patient within the hospitals capability

Accept transfers from hospitals who lack capacity to treat unstable emergency medical conditions

Provide Screening Examination to Determine whether EMC Exists Participating hospital may not delay examination and treatment to inquire about methods of payment, insurance coverage, citizenship or legal status

But: Hospitals may follow reasonable registration procedures, including inquiring about insurance, provided this does not delay screening examination or discourage patients from remaining for evaluation

Therefore: Request for co-payments or down-payments deferred until after screening examinations to avoid appearance that the request for payment could have deterred a patient from continuing emergency care

Emergency DepartmentA specially equipped and staffed area of the hospital used a significant portion of the time for initial evaluation and treatment of outpatients for emergency medical conditions

Hospital-based outpatient clinics not equipped to handle medical emergencies are not obligated under EMTALA and can simply refer patients to a nearby ED for care

Patient on hospital property who makes a request for treatment for an EMC, triggers the hospitals EMTALA duty

Presentation by AmbulanceOnce an ambulance arrives on hospital grounds and a request is made for screening examination, EMTALA appliesBut: if ambulance arrives at a hospital solely for the purpose of transferring the patient to another institution, EMTALA not triggered since no request for evaluation or treatment is made

However: if ambulance or patient requests evaluation or treatment from the facility, then EMTALA is triggered

Emergency Medical Condition (EMC)A condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in placing the individuals health [or health of an unborn child] in serious jeopardy, serious impairment to bodily functions, or serious dysfunction of bodily organs

Includes psychiatric and substance abuse or withdrawal conditionsA pregnant woman with an EMC must be treated until delivery is complete, unless a transfer is appropriate

EMC is a medical decision

Law gives little guidance as to what constitutes an EMCIf no EMC exists, EMTALA does not apply to the patientPhysician must be aware that an EMC exists before he/she is liable under EMTALA

Medical Screening ExaminationProcess required to reach, with reasonable clinical confidence, the point at which it can be determined whether an EMC exists

May involve a simple process (i.e. history or physical examination); or Complex process (i.e. ancillary studies, consultants and procedures)

Screening must be the same for every patient presenting with similar symptoms or complaints to be EMTALA compliant

Nurse triage does not meet the hospital obligation to provide a medical screening examination

Stabilize Patient within Hospitals CapabilityStabilize

To provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of an individual from a facility, or, with respect to [a pregnant woman having contractions], to deliver (including the placenta)

Does not require that the underlying medical condition be resolved

Patient with difficulty breathing and a history of asthma may be stable once provided with medication and oxygen despite the fact that the underlying condition of asthma is still presentHospitals may not discharge a patient prior to stabilization on the basis of patients cancelled insurance or discontinued payment during the course of his stay.

Decision regarding whether the patient is stable rests with the physician actually treating the patientBurden of proof for stability rests with the transferring hospitalAfter stabilization, EMTALA no longer applies, patients may be discharged or admitted for further careOnce admitted, the hospitals EMTALA duty is considered complete

Accept Transfers from HospitalsPatient considered stable for transfer if treating physician determines that no material deterioration will occur during the transfer between facilities

EMTALA does not apply to transfer of stable patients

Hospital may not transfer unstable patient unless

A physician certifies that the medical benefits expected from the transfer outweigh the risks; orA patient makes a transfer request in writing after being informed of the hospitals obligations under EMTALA and the risks of transferHospital must report any time it has reason to believe it may have received an individual who has been transferred in an unstable medical condition from another hospital in violation of EMTALA

Reverse Dumping

Failure of centers with specialized capabilities to appropriately accept patients transferred to them

Failure to report an EMTALA violation is itself a violation

But an EMTALA violation does not imply medical malpractice

Requirements for an Appropriate Transfer under EMTALATransferring hospital stabilized the patient to the best of its abilityReceiving hospital has the capability and capacity to care for the patientReceiving hospital agrees to accept the individual and provide appropriate medical treatmentTransferring hospital sends all pertinent medical records and written consent to transfer

If transfer was due to failure of an on-call physician to appear, name and address of said physician must be provided to receiving hospital

Transfer performed through qualified personnel and transportation as determined by the transferring physician. Receiving hospital may not condition acceptance on the use of a specific transport service or method

EMTALA Dos and DontsEMTALA Dos

Treat all patients in the same wayProvide a medical screening examination appropriate to the patients complaintsAppropriately transfer patients you cannot stabilizeAccept transfers who require specialized services your hospital offers

Involve on-call specialists when needed to diagnose or stabilize an EMCEducate ED, hospital staff and faculty on EMTALA rulesSee patients quickly and efficiently

EMTALA DontsSubstitute triage for a medical screening examinationDiscourage or coerce patients away from receiving their screening exams and stabilizationAllow to be convinced that a specialist does not need to come to the EDFail to stabilize within your capabilitiesDelay medical screening examination for pre-authorization or registration

Emergency Medical Treatment Under Philippine LawRepublic Act No. 8344, An Act Penalizing Refusal of Hospitals and Medical Clinics to Administer Appropriate Initial Medical Treatment and Support in Emergency or Serious Cases (R.A. No. 8344)

Emergency is a condition or state of a patient wherein based on the objective findings of a prudent medical officer on duty for the day there is immediate danger and where delay in initial support and treatment may cause loss of life or cause permanent disability to the patient (Section 2 (a), R.A. 8344)

Serious Case is a condition of a patient characterized by gravity or danger wherein based on the objective findings of a prudent medical officer on duty for the day when left unattended to, may cause loss of life or cause permanent disability to the patient (Section 2 (b), R.A. 8344)

Stabilize is the provision of necessary care until such time that the patient may be discharged or transferred to another hospital or clinic with a reasonable probability that no physical deterioration would result from or occur during such discharge or transfer (Section 2 (h), R.A. 8344)

Emergency Treatment and Support refers to any medical or surgical measure within the capability of the hospital or medical clinic that is administered by qualified health care professionals to prevent the death or permanent disability of a patient (Section 2 (e), R. A. 8344)

In emergency or serious cases, it shall be unlawful for any proprietor, president, director, manager or any other officer, and/or medical practitioner or employee of a hospital or medical clinic to request, solicit, demand or accept any deposit or any other form of advance payment as a prerequisite for confinement or medical treatment of a patient in such hospital or medical clinic

or to refuse to administer medical treatment and support as dictated by good practice of medicine to prevent death or permanent disability (Section 1, R.A. 8344)

However, by reason of inadequacy of the medical capabilities of the hospital or medical clinic, the attending physician may transfer the patient to a facility where the appropriate care can be given, after the patient or his next of kin consents to said transfer and after the receiving hospital or medical clinic agrees to the transfer (Section 1, R.A. 8344)

When the patient is unconscious, incapable of giving consent and/or unaccompanied, the physician can transfer the patient even without his consent, provided that such transfer shall be done only after necessary emergency treatment and support have been administered to stabilize the patient and after it has been established that such transfer entails less risks than the patient's continued confinement (Section 1, R.A. 8344)

No hospital or clinic, after being informed of the medical indications for such transfer, shall refuse to receive the patient nor demand from the patient or his next of kin any deposit or advance payment (Section 1, R.A. 8344)

After the hospital or medical clinic mentioned above shall have administered medical treatment and support, it may cause the transfer of the patient to an appropriate hospital consistent with the needs of the patient, preferably to a government hospital, specially in the case of poor or indigent patients. (Section 1, R.A. 8344)

Any official, medical practitioner or employee of the hospital or medical clinic who violates the provisions of this Act shall, upon conviction by final judgment, be punished by imprisonment of not less than six (6) months and one (1) day but not more than two (2) years and four (4) months, or a fine of not less than Twenty thousand pesos (P20,000.00), but not more than One hundred thousand pesos (P100,000.00) or both, at the discretion of the court.

If such violation was committed pursuant to an established policy of the hospital or clinic or upon instruction of its management, the director or officer of such hospital or clinic responsible for the formulation and implementation of such policy shall, upon conviction by final judgment, suffer imprisonment of four (4) to six (6) years, or a fine of not less than One hundred thousand pesos

(P100,000.00), but not more than Five hundred thousand pesos (P500,000.00) or both, at the discretion of the court.

Republic Act No. 9439, An Act Prohibiting the Detention of Patients in Hospitals and Medical Clinics on Grounds of Non-Payment of Hospital Bills or Medical Expenses also known as Hospital Detention Law (R.A. No. 9439)

It shall be unlawful for any hospital or medical clinic in the country to detain or to otherwise cause, directly or indirectly, the detention of patients who have fully or partially recovered or have been adequately attended to or who may have died, for reasons of nonpayment in part or in full of hospital bills or medical expenses (Section 1, R.A. 9439)

Patients who have fully or partially recovered and who already wish to leave the hospital or medical clinic but are financially incapable to settle, in part or in full, their hospitalization expenses, including professional fees and medicines, shall be allowed to leave the hospital or medical clinic, with a right to demand the issuance of the corresponding medical certificate and other pertinent papers required for the release of the patient from the hospital or medical clinic upon the execution of a promissory note covering the unpaid obligation (Section 1, R.A. 9439)

In the case of a deceased patient, the corresponding death certificate and other documents required for interment and other purposes shall be released to any of his surviving relatives requesting for the same (Section 1, R.A. 9439)

Patients who stayed in private rooms are not be covered by this law (Section 1, R.A. 9439)

Any officer or employee of the hospital or medical clinic responsible for releasing patients, who violates the provisions of this Act shall be punished by a fine of not less than Twenty thousand pesos (P20,000.00), but not more than Fifty thousand pesos (P50,000.00), or imprisonment of not less than one month, but not more than six months, or both such fine and imprisonment, at the discretion of the proper court (Section 3, R.A. 9439)

Republic Act No. 6615, An Act Requiring Government and Private Hospitals or Clinics Duly Licensed to Extend Medical Assistance in Emergency Cases (R.A. No. 6615)

All government and private hospitals or clinic duly licensed to operate as such are hereby required to render immediate emergency medical assistance and to provide facilities and medicine within its capabilities to patients in emergency cases who are in danger of dying and/or who may have suffered serious physical injuries (Section 1, R.A. 6615)

Expenses and losses of earnings incurred by a private hospital of clinic for medicines, facilities and services beyond first aid extended to emergency cases as required herein, and not to exceed fifty thousand pesos per year, shall be deductible expenses and losses for income tax purposes which may be carried over for a period of five years, any provision of law or regulation to the contrary notwithstanding (Section 2, R.A. 6615)

Any hospital director, administrator, officer-in-charge or physician in the hospital, medical center or clinic, who shall refuse or fail without good cause to render the appropriate assistance pursuant to the requirements of section one after said case had been brought to his attention, or any nurse, midwife or medical attendant who shall refuse to extend the appropriate assistance, subject to existing rules, or neglect to notify or call a physician shall be punished by imprisonment of one month and one day to one year and one day, and a fine of three hundred pesos to one thousand pesos, without prejudice to the provisions of Republic Act Numbered Twenty-three hundred eighty-two in the case of physicians (Section 3, R.A. 6615)

In the case of government hospitals, the imposition of the penalty upon the person or persons guilty of the violations shall be without prejudice to the administrative action that might be proper (Section 3, R.A. 6615)

In the case of private hospitals, aside from the imposition of penalty upon the person or persons guilty of the violations, the license of the hospital to operate shall, whenever justified, be suspended or revoked (Section 3, 6615)

Summary - Informed ConsentDual Purpose of Informed ConsentElements of Informed ConsentWho may give Informed ConsentQuantum of Information for a Valid Informed ConsentExceptions to Informed ConsentDocumentation of ConsentInformed Refusal and ED Departure against Medical Advice

Summary - Privacy, Confidentiality and ReportingPurpose of HIPAAWhat may not be DisclosedWhat may be Disclosed Physician-Patient Privileged Communication Rule under Philippine Law

Summary - Emergency Medical Transfer in Active LaborEMTALA and Patient DumpingObligations Imposed by EMTALA

Determining Emergency Medical ConditionStabilizeAccept Transfers

EMTALA counterpart under Philippine Law

Medicine is a calling.Medicine is a profession. Medicine is a business.People in business get sued.

Gary N. McAbee, DO, JD

Food For ThoughtAct like the patient is someone you care about. Act like you have the courage and intelligence to tell the difference between necessary and unnecessary care and testing, and that you have done for the patient what you would have done for your own family member.

Henry GL. Common Sense. Ann Emerg Med. 1991; 20:319-320