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What is Information Governance?
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.
How IG differs from Information Management?
IG: a strategic function with a top-down approach considering what needs to happen (with the organizations information)
Information Management: is a bottom-up function concerned with getting the work done
- Responsible for the day-to-day information-related operations
What is Tort law?
A civil wrong (other than breach of contract)• Committed against a person or property for which a court provides aremedy in the form of an action for damages• An act or omission that is intentional, unintentional (negligence) orstrict liability• Examples:• Intentional - performing surgery without a valid consent• Unintentional (Negligence) - failure to diagnose a ruptured ectopic pregnancy• Strict liability - implanting a defective hip prosthetic
What is Intentional Tort?
Action taken by one person with the intent to harm another person.
What is Battery?
The intentional touching of another's person in a socially impermissible manner, without that person's consent.
Example: Performing surgery without consent may qualify as battery.
What is Assault?
• The deliberate threat and the apparent present ability to do physical harm. • No actual contact is necessary; involves infringement on the mental security or tranquility of another
What is False Imprisonment?
The unlawful restraint of an individual's personal liberty or the unlawful restraint or confinement of an individual • Healthcare exception - patient of danger to themselves or others
What is Defamation (libel/slander)?
Libel - written (signs, letters, photos)
Slander - spoken
Defense options in defamation cases
Truth - the statement made is true
• Statement made in good faith (public interest) and provider had the responsibility to do so (privilege)
• Example: Notifying the department of health that a patient has an STD
What is Invasion of Privacy?
• Violation of right of person to be free from unwarranted publicity and exposure to public view • Also, right to live one's life without having one's name, picture or private affair made public against one's will
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
• Divulging patient information to improper sources
• Patient must demonstrate that the following elements to prove violation:
• Provider-patient relationship existed
• Information was acquired during the relationship
• Information was necessary for the physician's treatment of the patient in a professional capacity
What is Medical Abandonment?
• Wrongful cessation of the provision of care to a patient
• After 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
• Provider cannot withdraw care unless adequate notice is given
• Preferably notice is in writing and with suggestions for alternate care, offer to share records
• In Pennsylvania, it is considered unprofessional conduct for a physician to abandon a patient
What is EMTALA?
Emergency Medical Treatment and Active Labor Act
Federal law that prohibits the refusal to examine and stabilize patients with emergent medical conditions
• Any patient presenting to an Emergency Department requesting evaluation or treatment must be examined
• If patient has emergent medical condition, patient must be stabilized regardless of patient's insurance type or ability to bay
• Intent is to prevent "patient dumping"
What is Compliance?
Being 'in compliance' is ensuring that legal, ethical, professional standards and internal policies are being followed
• One major objective is to ensure that organization is preventing fraud (e.g., improper billing)
• 'Compliance' is used for other laws/regulations such as HIPAA
What is Fraud?
• Deception made for personal gain
• Can include may illegal activities
• Imposter/forgery (Frank Abagnale - Catch Me If You Can)
• Academia - falsifying research findings
• False advertising
• False billing --- major healthcare concern
• Quackery --- medical treatments that don't work
• Investment fraud
Patient Self-Discrimination Act
informing all adult patients of their right to accept or refuse medical treatment, and the right to execute an advance directive
What is an advance directive?
Written instruction recognized under state law and relating to the provision of medical care when the individual is incapacitated
Living Will (advanced directive)
A written document that allows a competent adult to indicate his or her wishes regarding life prolonging treatment
Durable Power of Attorney (POA) for Healthcare (advanced directive)
Document through which a competent adult (principal) names inwriting another adult (AKA: surrogate, agent, attorney-in-fact)
• To make any medical decisions on their behalf in the event they becomes incapacitated (loses decision-making capacity)
Difference between Living Will and Durable POA
Durable power of attorney is more flexible than a living will because it addresses a broader scope of medical circumstances in which patient is incapacitated (not just terminal or permanently unconscious)
• Examples: Applies to: incompetence (dementia), under anesthesia
Difference between a POA and durable POA
• A (regular) power of attorney ceases to be effective when principal is incompetent/incapacitated
• A "durable" power of attorney continues to be effective despite the principal becoming disabled/incapacitated/in competent
What is a court ordered treatment?
Patient ordered by the government (court) to undergo test or treatment that they do not consent to.
Examples: Involuntary commitment of individuals with mental illness who are danger of causing harm to themselves or others
• Court-ordered substance abuse treatment for someone convicted of substance-related crime
• Obtaining a blood sample (DUI scenario) - order a specimen to be obtained, even though the patient/accused does not wish to provide it.
What is 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 (e.g., next of kin) can be identified
DNR Order
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.
What is POLST?
The Practitioner Orders for Life Sustaining Treatment
Enables patients to indicate their preferences regarding life-sustaining treatment
What is Negligence?
Failure to exercise the standard care that a reasonable person would give under similar circumstances
What is Malpractice?
provider failed to provide sufficient information about procedure, alternatives, risks, etc. (need to prove, duty, breach, injury and causation)
Elements of Negligence
1. Duty, The defendant owed the plaintiff a legal duty of care.
2. Breach, The defendant violated that duty by acting or failing to act in a certain way.
3. Causation, The defendant's actions or inaction caused the plaintiff's injury.
4. Damages, The plaintiff was harmed or injured as a result of the defendant's actions.
Standard of care in Healthcare (definition)
is the minimum level of care that a medical professional is expected to provide to a patient. It's also known as best practice, standard medical care, or standard therapy.
What is Res ipsa loquitor?
A negligent act could only have occurred due to someone else's negligence.
What is Corporate negligence?
occurs when a business fails to meet the standard of care expected of it, resulting in harm or loss. Also known as corporate liability or hospital liability.
Corporate negligence – What is expected from hospitals under this legal concept and thus, how could a hospital be found negligent under it?
Expectation: a hospital is expected to maintain proper standards of care for patients by ensuring adequate staffing, implementing safety policies, properly credentialing physicians, and maintaining safe facilities
Found negligent: if they fail to uphold these duties, leading to patient harm
Significance of Darling case
is significant because it marked a landmark shift in medical malpractice law by establishing that hospitals can be held directly liable for the negligence of their doctors, essentially setting a precedent for hospitals to be accountable for the quality of care provided within their facilities, a concept previously not widely recognized; this significantly increased the responsibility of hospitals to properly supervise and credential their medical staff
What is Healthcare Consent?
Who is responsible to obtain, role of obtaining signature on form
The voluntary agreement by a person who possesses sufficient mental capacity to make an intelligent choice to allow a medical procedure and/or proposed by another to be performed on himself or herself
What is Informed Consent?
legal doctrine that provides that a patient has a right to know the potential risks, benefits and alternatives to a procedure.
Differences between express, implied, and general/blanket consents
• 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
What are 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 asset forth under the contract
Elements of a Contract
Offer - offer made by one party to do (or not do) something if the other party agrees to do (or not do) something
Consideration - Each party must give up something of value in exchange for something of value
Acceptance - mutual assent; both parties agree and understand
Who may enter info on a Contract?
legally competent adult, government, or corporations
Remedies for breach (Contract)
Court orders performance of the contractual obligation
• awarded damages ($$)
AUTO-RENEWAL/EVERGREEN CLAUSE
Clause which means contract continues unless notice is given
• Good to have termination clause that requires written notice if either party plans to terminate the contract
• Consider time needed to find new vendor when including time requirement for written notice
CONFIDENTIALITY/NON-DISCLOSURE CLAUSE
Obligation to keep confidential any private or secret information concerning an organization's products/services, method of doing business, business relationships or financial affairs
• Obligation to secure and safeguard confidential patient health information
HOLD HARMLESS/INDEMNIFICATION CLAUSE
Clause in which the contractor accepts responsibility for his or her actions and agrees to indemnify or compensate the healthcare facility for any claims against it that are the result of the contractor's actions or inaction
• EHR Technology Example: EHR vendor would want to be protected from liability in a patient malpractice suit. Clause would state that hospital would hold EHR vendor harmless (indemnify) from a claim from a patient for damages
STANDARDS OF PERFORMANCE CLAUSE
Contractor's obligations to meet or exceed applicable standards
• Quality expectations
• Timeliness
• Other (e.g., staff qualifications or credentials, codes of practice or regulations to be followed)
• Consequence for not meeting performance expectation (payment penalty)
NONSOLICITATION CLAUSE
When appropriate, a clause that neither party (e.g., vendor and hospital) will solicit an employee of the other party for a specified period without prior written approval of the other party
• May further state, if work for a competitor, party may not solicit any business clients or use any confidential information of the other party
RETURN OF PROPERTY
Clause that stipulates if and when the parties must return any property they received from each other
• Can include physical property, information, documents, equipment, files, and intellectual property.
• May see a separate clause for the return of Confidential Information
DISPUTE RESOLUTION CLAUSE
Clause that sets out the process by which the parties intend to resolve any disputes which may arise out of their contract
• May include rules that require the parties to engage in alternative dispute resolution options, such as mediation and arbitration
ASSIGNABILITY CLAUSE
Clause that typically prohibits turning over (assigning to) the rights and obligations agreed to in the contract to another entity
• For example, would prevent a first vendor with whom you have a contract from contracting out the work to be performed to another vendor
BUSINESS INTERRUPTION CLAUSE
Deals 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
• Also called "force majeure" clause (French for "superior force")
• Buyer of services would work to get a narrowly defined clause related to issues that are" reasonably beyond the control of the parties"
• Sample Language (very generic): 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.
COMMON CLAUSES CONTAINED INEMPLOYMENT AGREEMENTS
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
• Confidentiality Agreements - Do not share information about services, clients, etc.