LEGAL 3

Restraint of Trade

•Distributors/sellers of contracts cannot work outside of a prescribed region; eg. Can't locate a franchise within a 5-mile radius of other franchise

Confidentiality Agreements

•Do not share information about services, clients, etc.

Durable Power of Attorney (POA) for Healthcare

•Document through which a competent adult (principal) names in writing another adult (AKA: surrogate, agent, attorney-in-fact) to make any medical decisions on his or her behalf in the event he or she becomes incapacitated (loses decision-making capacity) •Durable power of attorney is more flexible than a living will because it addresses a broader scope of medical decisions (beyond terminal decisions)

who may enter into contracts?

•Entered into by parties with the legal authority to do so •Legally competent adult (if a minor signed a contract - voidable as though it never existed; prisoner's rights restricted as to ability to enter into contracts) oGovernment oCorporations/companies -corporations have articles of incorporation (charter) which limit (personal) liability; an agent of the corporation (e.g., president/CEO) signed contract in that capacity

Accountability

An accountable member of senior leadership, or a person of comparable authority, shall oversee the information governance program and delegate program responsibility for information management to appropriate individuals. The organization should adopt policies and procedures to guide its workforce and agents and ensure that its program can be audited.

Protection

An information governance program must ensure that the appropriate levels of protection from breach, corruption, and loss are provided for information that is private, confidential, secret, classified, essential to business continuity, or otherwise requires protection.

Integrity

An information governance program shall be constructed so the information generated by, managed for, or provided to the organization has a reasonable and suitable guarantee of authenticity and reliability.

Compliance

An information governance program shall be constructed to comply with applicable laws, regulations, standards, and organizational policies.

What legal recourse does patient have if informed consent not obtained

Failure to Obtain Informed Consent Patients have two modes of legal recourse if believe that informed consent wasn't obtained 1) Medical malpractice (negligence claim) - provider failed to provide sufficient information about procedure, alternatives, risks, etc. (need to prove, duty, breach, injury and causation) •Primary duty to obtain informed consent rests with the provider who will perform procedure (physician) •Healthcare organizations generally do not have an independent duty to obtain informed consent. However they are sometimes charged with malpractice for failure to have effective mechanisms to protect their patients (e.g., mechanisms to ensure that the patient's informed consent was obtained prior to surgery) 2) Claim of battery - (nonconsensual touching)

intentional tort

Intentional torts differ from negligence in two ways: with intentional torts, intent must be present and the wrongdoer must realize to a substantial certainty that harm would result and intentional tort involves a willful act.

Centralized

Is when one ROI unit (typically HIM) handles all the ROI requests for the entire institution.

Be able to discuss/explain the (potential) impacts of HIE on ROI process

Patient Portals and Health Information Exchange - Impact on ROI Health Information Exchange allows health care professionals and patients to access and securely share a patient's medical information electronically. Patient portals are any system with the ability to provide access to individual patient health information in a secure manner through the Internet. •The "US Patient Portal Market for Hospitals and Physicians: Overview and Outlook, 2012-2017 report" predicts 221 percent growth in patient portals by 2017. The report also found that half of US hospitals and 40 percent of office-based physicians have a portal through their electronic health record (EHR) or practice management system. •There is no standardization among patient portal products for what information will or will not be made available. Therefore, the data a patient can access via the portal is dependent on a facility's internal policies. For example, results that require a physician's explanation or an appointment to discuss—such as lab tests or pathology results—may or may not be available through a patient portal. •Physicians also have trouble accepting the concept of full health information access, with 65 percent of doctors in Accenture's 2013 survey titled "Patient Access to Electronic Health Records: What Does the Doctor Order?" which suggests that patients should only have limited access, not complete transparency. •Patient portal to records containing sensitive diagnoses which have additional related laws and statutes, such as mental health, alcohol and drug abuse, AIDS and HIV, or development disabilities need additional security.

Availability

An organization shall maintain information in a manner that ensures timely, accurate, and efficient retrieval.

Retention

An organization shall maintain its information for an appropriate time, taking into account its legal, regulatory, fiscal, operational, and historical requirements.

Disposition

An organization shall provide secure and appropriate disposition for information no longer required to be maintained by applicable laws and the organization's policies.

Transparency

An organization's processes and activities relating to information governance should be documented in an open and verifiable manner. Documentation shall be available to the organization's workforce and other appropriate interested parties within any legal or regulatory limitations and consistent with the organization's business needs.

Is hospital outsourcing of ROI function common?

Approximately 80 percent of U.S. hospitals outsource some portion of the ROI process

IG Principles

" A TIP CARD" . . . Accountability Transparency Integrity Protection Compliance Availability Retention Disposition

Information Governance

-A strategic function with a top-down approach considering what needs to happen (with the organization's information) -Sets organizational goals, direction and limitations

Decentralized

-When HIM as well as other units (radiology, clinics) process ROI requests where the related health record is maintained. -Policies and procedures need to be standardized for the decentralized processing

Elements of Negligence

-duty to care -breach of duty -injury -causation

Typical Rights/Principles

1. Respect and Nondiscrimination. Patient has a right to considerate, respectful and nondiscriminatory care from doctors, health plan representatives, and other health care providers. 2. Participation in Treatment Decisions. Right to know treatment options and to participate in decisions about care. Parents, guardians, family members, or other individuals that patient designate can represent you if you cannot make your own decisions. 3. Access to Emergency Services. Right to receive screening and stabilization emergency services whenever and wherever needed, without prior authorization or financial penalty -Even if patient does not fall within a class of patients that would be admitted to a hospital. Hospitals/employees must provide reasonable care to individuals who present in need of immediate attention. 4. Confidentiality of Health Information and Right to Privacy. Patient has right to talk in confidence with health care providers and to have health care information protected. 5. Right to Know Names/Roles of Caregivers 6. Be informed of method that can help a patient resolve problems or issues he/she may have (Policy for appeal, how to contact patient representative, etc.)

Typical Patient Responsibilities

1. To fully disclose information about condition 2. Report unexpected changes in condition to treating physician 3. Make it known whether he/she understands plan of care and what is expected of patient 4. Follow treatment plan 5. Follow rules and regulations of the institution (hospital) 6. Not to administer medications not prescribed by the physician 7. Keep appointments and when unable to do so, notify practitioner/institution 8. Accept the consequences of not refusing treatment or not following instructions 9. Be considerate of the rights of others, including healthcare personnel 10. Be respectful of the property of others and of the facility 11. Recognize the effect of life-style as it affects one's personal health 12. Provide correct information about sources of payment

Elements of contracts

1.Offer - offer by one party to do (or not do) something if the other party agrees to do (or not do) something •Preliminary negotiations are NOT offers 2.Consideration - Each party must give up something of value in exchange for something of value 3.Acceptance - mutual assent; both parties agree and understand

Patient Rights and Responsibilities

On admission, patient is informed, in writing, of his/her rights and responsibilities

Living Will

A written document that allows a competent adult to indicate his or her wishes regarding life prolonging treatment

Federal False Claims Act - What is it? Whistleblower

Federal False Claims Act (and similar State-level laws) •Protect against charging the government for services that were not provided oNo requirement to prove that the defendant actually intended to commit fraud; plaintiff or prosecutors need only prove that the defendant had actual knowledge that the information was false, acted in deliberate ignorance of the truth, or acted with reckless disregard of the truth oKNOWN OR SHOULD HAVE KNOWN (the billing rules) oWhistleblowers can sue companies or individuals that commit fraud against the federal government oEmployers are prohibited from retaliating against whistleblowers (also referred to as qui tam actions); oWhistleblower gets between 15% and 30% of any award or settlement amount

EMTALA - what issue does it address?

Federal Law (Emergency Medical Treatment and Active Labor Act, EMTALA) •Prohibits the refusal to examine and stabilize patients with emergent medical condition oMajor intent is to prevent patient "dumping"

Explain/justify the costs that a hospital charged a requestor for copies of records. (The requestor is irate and doesn't understand why it isn't around $0.05 per page which is what it costs at Staples to make copies.)

Many facilities charge for retrieval fees, per page copying costs and postage for ROI requests. Attorneys, patients and other requestors often express that charges for copies of records seem excessive - especially when compared to fees charges at local copy stores like Staples. The ROI process is complex and the total cost to provide a copy involves much more than just making copies. Costs for ROI also include: •Salary and benefits for ROI staff •Time/effort to log, and review request for legitimacy and completeness •Time/effort to find, retrieve and refile the record •Applications such as ROI tracking systems •Peripherals such as copiers, printers, and fax machines •Forms such as ROI release forms and fax cover sheets •Routine supplies including staples, pens, paper, envelopes, toner, etc. •Postage •Fees for off-site storage and retrieval •If the electronic documents can be written to an alternative media such as DVD without first printing the documents and scanning them, then the posted cost of the DVD should be added. (For security concerns, including the spread of computer viruses, media supplied by requestors should not be used.) •Overhead such as utilities, space, furnishings, maintenance, housekeeping, human resources, payroll, etc.

Assault

The deliberate threat, coupled with the apparent present ability, to do physical harm. No actual contact is necessary; involves infringement on the mental security or tranquility of another

Slander

Verbal form of defamation

Disclosure

The release, transfer, provision of, access to, or divulging in any other manner of release of information outside the entity holding the information

Information governance (IG)

The set of multi-disciplinary structures, policies, procedures, processes and controls implemented to manage information at an enterprise level, supporting an organization's immediate and future regulatory, legal, risk, environmental and operational requirements

use PHI

The sharing, employment, application, utilization, examination, or analysis of such information within an entity that maintains such information

Libel

Written form of defamation (signs, letters, photos)

Anti-Trust Laws

general understanding; what do these laws prevent/foster (Brondnik Chapter 15 gives good overview) •Federal law prohibits knowingly and willfully soliciting or receiving any remuneration (that is, anything of value) or knowingly and willfully offering remuneration, whether direct or indirect, overt or covert, in cash or in kind, in return for referring a patient for the furnishing of any item or service or purchasing, leasing, ordering, or arranging for the purchase, lease, or ordering of any item of service paid for in whole or in part by a federal program. oExample, paying a physician for referrals would be prohibited.

Malpractice

negligence of a professional person

Defenses to a defamation action

oTruth and privilege (responsibility to do so) oExample: Healthcare providers are legally protected when reporting of STD to health department oPatient may use defamation as a theory of liability for improper disclosure of information; Hard to do because medical record entries are usually true. Also, the presence of a valid patient authorization would serve as a defense.

Battery; also, is customary and reasonable touching considered to be battery?

• The intentional touching of another's person in a socially impermissible manner, without that person's consent; involves a violation of another's physical integrity oTypical routine touching (e.g., on a crowded subway - person voluntarily enters the situation. Thus a reasonably prudent person would expect being bumped into or touched by others. This is NOT battery. Similarly, in healthcare, patients can expect that routine processes of care (dressing changes) would require touching.

Information Management

•A bottom-up function concerned with getting the work done •Responsible for the day-to-day information-related operations

Standard of care in healthcare

•A diagnostic and treatment process that a clinician should follow for a certain type of patient, illness, or clinical circumstances. •Radiation therapy as one standard of care (not the only standard) for lung CA oCourt often relies or testimony of expert witness as to what is the standard of care

Court ordered treatment - give examples of when this might be done

•A patient may be ordered by the government (court) to undergo test or treatment: oInvoluntary commitment of individuals with mental illness who are danger of causing harm to themselves or others oCourt-ordered substance abuse treatment for someone convicted of a DUI

Causation

•A reasonable, close and causal connection or relationship between the defendant's negligent conduct and resulting damages must be proven •Need also to demonstrate that harm was reasonably foreseeable •Reasonable anticipation that harm or injury was likely to result from an act or an omission of an act oExample: Patient prescribed medication. Patient has allergic reaction. Is it a common reaction? Did patient reveal history of allergies to similar drugs?

Defamation

•Communication to someone about another person that tends to hold that person's reputation up to scorn or ridicule oMust be communicated to a third party

Self Referral (Stark) Laws - just general concepts: a)not allowed to compensate someone for patient referrals(kickbacks) b) providers can't refer to an entity within which he/she or a family member has ownership

•Complex laws that forbade self-referral for a number of services. •In 1989, Congress passed what is known as Stark I, which prohibits a physician from referring Medicare patients to a clinical lab in which the physician or an immediate family member has a financial interest. •In 1995, Congress passed Stark II, which extended the prohibition to other services. Now, physicians and/or immediate family members are prohibited from making referrals to any entity for the furnishing of "designated health services" if that physician or immediate family member has a financial interest in the entity to which the referral is being made. "Designated health service" include clinical labs, occupational therapy, physical therapy, orthotics/prosthetics, hospital services durable medical equipment, parenteral/enteral nutrition services and supplies, radiology, radiation therapy, home health services, and outpatient prescription drugs. oExample, an orthopedic surgeon could not refer patients to his wife's physical therapy practice.

Differences among: express, implied and general/blanket consents (also give examples when each is used)

•Consents may be given in written or spoken word. (Like all legal transactions, written consent is preferred.) Express consent •Using a statement of direct words Implied consent •Presumed by patient's participation or lack of refusal (mother takes holds the baby for the injection) General or blanket consent •Covers a range of services. When signing a hospital admission form, the patient gives permission to receive routine nursing care as ordered by the attending physician. •Most health care institutions have policies that state which health interventions require a signed consent form (eg, surgery, anesthesia, and other invasive procedures)

Remedies for breach

•Court orders performance of the contractual obligation •Awarded damages ($$)

DNR Order

•DNR orders are written in the record to indicate that attempts to resuscitate the patient (e.g., perform CPR) should NOT be performed based on the patient's or patient's representatives wishes that resuscitation efforts not be performed. o Patient's or patient's representative's preferences should be documented as early as possible and should be revisited and revised as appropriate.

Interruption Clause

•Deal with extraordinary and unexpected events (floods, earthquakes, electrical failures, urban riots) that may occur during the life of a contract which may prevent a party from meeting its obligations •Buyer of services would work to get a narrowly defined clause related to issues that are "reasonably beyond the control of the parties" •For example, would you accept a power failure as an acceptable reason for a vendor not providing operation of a key computer system over a substantial period of time? (Expectation would be that vendor is taking necessary precautions to prevent such an interruption) •Sample (very generic) interruption contract clause: "Neither party to this Purchase Order will be held liable where a circumstance beyond its reasonable control occurs and results in that party being unable to carry out its obligations under this Purchase Order."

Fraud - general definition; example of fraud within healthcare

•Deception made for personal gain •Can include many illegal activities: oImposter/forgery (Frank Abagnale - Catch Me If You Can) oAcademia - falsifying research findings oFalse advertising oFalse billing oQuackery oInvestment fraud

Injury

•Defendant can be negligent but if there is no injury sustained there is no liability. •Examples of injury: physical harm, pain, suffering, loss of income or reputation

Healthcare Consent - Who is responsible to obtain, role of obtaining signature on form

•GETTING a form signed is NOT the equivalent of obtaining an informed consent. Documentation of the informed consent discussion is needed. Consent forms do provide some evidence that an informed consent process was conducted. •Interestingly, many courts find a contemporaneous progress note or history and physical (H&P) exam report that includes mention of the informed consent discussion to be much more convincing evidence that a conversation took place than the patient's signature on a standardized form.

Res ipsa loquitur - definition; also that it serves as an exception to having to prove all elements in a negligence case; example

•Generally, negligence is not inferred or presumed from an injury and the plaintiff usually has the burden of proof and must prove all elements or his or her case oThe exception to this rule is the doctrine of Res ipsa loquitur (the thing that speaks for itself), where the facts or circumstances accompanying and injury may raise presumption, or at least permit an inference, of negligence on the party of the defendant charged with negligence •Example: instances where a surgical team leaves surgical instruments in a patient's body after surgery, resulting in injury- such events do not ordinarily occur in the absence of negligence

Guardianship

•In an advanced directive such as a durable POA for healthcare, the patient retains control over who will handle their affairs (can revise the document if he/she wants to do so). •Guardianship is determined by the courts. If a patient is found to be legally incompetent, the court appoints someone to make decisions about the patient's care and property if no authorized or capable agent can be identified. •Guardianship can be limited for specific activities such as healthcare.

Concept of patient must be capable of giving informed concept (examples of when a patient may not)

•In cases of emergency or when patient has been judged legally incompetent, guardian or next of kin can receive the information and sign the consent oFor competent patients, other issues of understanding arise: intoxication, literacy, language barriers, hearing impairments; provider/facility may need to obtain translation services and develop patient educational materials and consent forms in the most common non-English languages spoken by community served

Power of Attorney (POA)

•Is a legal instrument that is used to delegate legal authority to another? The person who signs (executes) a Power of Attorney is called the Principal. The power of Attorney gives legal authority to another person (called an Agent) to make property, financial and other legal decisions for the Principal. oExample of use: POA used if principal is unavailable to sign a legal document oCan see POAs for Healthcare and POAs for finances •A power of attorney (POA) becomes ineffective when the principal becomes incompetent.

Respondeat Superior

•Legal doctrine holding employers liable, in certain cases, for the wrongful actions of their agents (employees) oEmployer/employee relationship must exist (may also apply to some independent contractors) oWrongful act must have occurred within the scope of the employment •Also referred to as vicarious liability (one party held liable for acts of the other)

Duty to care

•Legal obligation of care •Must be a legal relationship between plaintiff and defendant •Care must be provided in an acceptable manner; meet the 'standard or care'

Corporate negligence - What is expected from hospitals under this legal concept and thus, how could a hospital be found negligent under it?

•Organization fails to meet responsibilities it has to general public and its patients oThis doctrine holds a hospital liable if it fails to uphold the proper standard of care owed the patient (ensuring safety and wellbeing) oThis duty is directly between the corporation and the patient; Injured party does NOT have to establish negligence of a third party •Benchmark Case which held a health care facility liable for corporate negligence: Darling vs. Charleston Community Memorial Hospital, 1965 •Prior to Darling hospitals had complete tort immunity because they were charitable organizations

Breach of a confidential relationship

•Provider (physician) violates the provider-patient privilege that statements and conversations made under the circumstances the relationship are assured confidentiality •Patient must demonstrate that the following elements to prove violation: oProvider-patient relationship existed oInformation was acquired during the relationship oInformation was necessary for the physician's treatment of the patient in a professional capacity •Example from Roach: oA pharmacy employee has falsely told others that a patient was being treated for a venereal disease. The South Carolina court held that a pharmacy patient could sue for defamation, but not for breach of confidentiality. However, in Rhode Island and Mississippi there is a patient-pharmacist relationship, the provider owes a duty of confidentiality.

Incidental Disclosure

•Reasonable safeguards must be implemented when designing the ROI process. Recommended practices include: Recommended Practices to minimize incidental disclosure include: oIf a common waiting room is used for patients scheduled to be seen as well as individuals waiting for copies of their records, consideration could be given to using vibrating pagers (like those used in restaurants) instead of calling out patient names. This would avoid an inadvertent disclosure of the patient's name by a given clinic and thereby disclosing the patient's condition or purpose for being at the clinic. oWhen a patient and/or the patient's legal representative has made an appointment to access the patient's records, arrange for the review to occur in a supervised private location (like mini-conference rooms, offices, etc.) to keep others from overhearing the discussions that may take place. oA "clean desk" policy should be followed which means that at the end of a shift, each employee's workspace should be clear of any PHI. This practice is equally important for release of information staff. Documents displaying PHI should be turned over to avoid being seen by a patient or other requestor when they approach the ROI desk. oComputer screens should have privacy shields to limit incidental viewing. oPhone calls should be conducted in a private setting with a quiet voice. oVoice messages should be left to a minimum. For example: "Hello, Mrs. Smith. This is Jane Doe at XYZ oHospital; please contact me in reference to the information you have requested."

Limitations of Liability

•Relieve health care practitioners •And in some instances lay persons from liability in certain emergency situations •Many states have enacted Good Samaritan laws to relieve healthcare practitioners, and is some instances, laypersons, from liability in certain emergency situations

Patient Self Determination Act -what is it/ what did it do/require?

•State law varies on patient right's related to advanced directive; in some states, right is statutorily provided, in other states, the right has been recognized by the courts •PSDA is federal legislation which requires health care facilities/organizations to: oProvide written information to patient about patient's rights to accept or refuse treatment under prevailing State law oProvide written information to patient about provider's policies related to implementing such rights oDocument in the individual's health record whether or not a patient has executed an advanced directive oNot to condition provision of care or to otherwise discriminate based on whether a patient has or has not executed an advanced directive oEducate staff and community on issues concerning advanced directives

Non-Compete Clauses

•States you cannot work for a competitor for a certain period of time and/or within a certain geographic area •Have been challenged in court; court would determine if duration and geographic area were reasonable

Minimum Necessary and the ROI function

•The entity must not share more information than is minimally necessary to perform the intended task or respond to an authorized request. Examples of implementation of minimum necessary standard: •Limiting access to a ROI specialist to those records for which a request has been received •A patient authorizes a copy of his or her blood typing to be provided to the local Red Cross. The covered entity should not release all of the laboratory data that is available in the patient's record. The disclosure should be limited to only the blood typing report. NOTE: Minimum Necessary Standard does NOT apply to requests related to continuity of care (patient care/treatment) and or requests for patient's personal use.

False imprisonment

•The unlawful restraint of an individual's personal liberty or the unlawful restraint or confinement of an individual •Examples: oAllowed for circumstances of patient presenting danger oObtaining consent to perform procedures is important element to prevent charges of assault and/or battery oImproper use of restraints may be interpreted as false imprisonment (restraints are to be used as a last resort to control behavior)

Invasion of privacy

•Violation of right of person to be free from unwarranted publicity and exposure to public view, as well as the right to live one's life without having one's name, picture or private affair made public against one's will •Healthcare Examples: oDivulging a patient's information to improper sources can be viewed as an invasion of privacy oMonitoring a patient's telephone conversations oAllowing nonmedical personnel to witness a medical procedure without patient's consent oPhotographing a patient without patient's consent MAY be viewed as an invasion of privacy (HIPAA Privacy Rule considers a full face photograph to be PHI)

What is an advance directive?

•Written instruction recognized under state law and relating to the provision of medical care when the individual is incapacitated oShould provide copies to family doctor, other providers, if applicable (hospital, nursing home), family or anyone else involved in your health care decision-making process oGood to review document on a periodic basis

Contracts

•Written or oral agreement that involves legally binding obligations between two or more parties •Purpose: to provide legal recourse should one or more of the parties not perform its obligations as set forth under the contract

Medical Abandonment

•Wrongful cessation of the provision of care to a patient oAfter provider-patient relationship is established, provider is generally is under both an ethical and legal obligation to provide services as long as the patient needs them oProvider cannot withdraw care unless adequate notice (preferably in writing and with suggestions for alternate care, offer to share records) is given oIn Pennsylvania, it is considered unprofessional conduct for a physician to abandon a patient

Tort law (not criminal law) - definition, who (what party) pursues the legal action; objective

•a civil wrong, other than a breach of contract, committed against a person or property for which a court provides a remedy in the form of an action for damages •The court pursues the legal action

Negligence

•a tort; an unintentional commission or omission of an act that a reasonably prudent person would or would not do under the same circumstances Examples: accidentally administering the wrong medication, failing to follow up on an abnormal test result

Breach of duty

•defendant failed to comply with accepted standards of care