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Autonomy
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Freedom from external control or influence, eg informed consent
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Beneficence / nonmaleficence
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Action that is done for the beneift of others / an obligation not to inflict harm, eg Hippocratic Oath
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Hippocratic Oath (privacy)
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Whatever I see or hear in the lives of my patients, whether in connection with my professional practice or not, which ought not to be spoken of outside, I will keep secret, as considering all such things to be private.
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Best Interest standard
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Determining the best interest of an individual who cannot make decisions for himself
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Confidentiality
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Rules or promises that limit access to or place restrictions on information discerned or communicated during a patient consultation
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Disclosure
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Information relevant to the patient's understanding of their condition, treatment options, and potential outcomes must be provided in order for the patient to make well-informed decisions
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Fidelity
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Faithfulness to a person, cause, or belief, demonstrated by continuing loyalty and support
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Informed Consent
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Medical intervention should not be done if the patient has not given implicit or explicit consent
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Justice
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Just behavior and treatment to all people
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Rights
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Entitlement or claim others are obliged to respect
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Veracity
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Habitual truthfulness
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Normative ethical theories
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investigate how one should morally act
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Virtue ethics
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the study of character; being 'good' is shown through character rather than deeds or actions (Aristotle)
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Deontology
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the study of the nature of duty and obligation; holds true to obligations to others and society when evaluating an ethical dilemma (Kant)
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Consequentialism
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morality of an action depends on result: branches into Utilitarianism (theory that actions are right if they benefit the majority), Egoism (study of the self and its needs), Intellectualism (action that promotes the most knowledge is best), Care ethics (study of relationships, empathy, vulnerability), Pragmatic ethics (moral progress in society is similar to its progression in science - it evolves), Role ethics (morality based upon relationship with their community)
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Meta-ethics
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seeks to understand ethical properties eg 'what is good'. Semantic theories seeks to answer "what is the meaning of moral terms?", Substantial theories seek to answer "what is the nature of moral judgements?", Justification theories seek to answer "why be moral?"
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Descriptive ethics
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the study of people's attitudes and beliefs on morality
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Applied ethics
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moral examination of private and public life issues that are matters of moral judgment
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Universal Declaration of Human Rights (article 12)
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30 basic human rights (UN). No one shall be subjected to arbitrary interference with his privacy, family, home, or correspondance, nor to attacks upon his honor and reputation. Everyone has the right to the protection of the law against such interference or attacks. Motherhood and childhood are entitled to special care and assistance.
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European Convention on Human Rights (article 8)
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Everyone has the right to respect for his private and family life, his home and his correspondence. There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others.
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Code of Fair Information Practice
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1973: fairness in handling information. 1 No personal data record-keeping systems whose existence is secret. 2. Must be able to find out what info is in a record and how its being used. 3. must be a way to prevent information that was obtained for one purpose from being used for other purposes without the patient's consent. 4. Must be a way for a person to correct or amend a record of identifiable information. 5. Any organization must assure reliability of the data for their intended use and take precautions against misuse.
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Belmont Report (1979)
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1979: several principles : RESPECT for persons; BENEFICENCE: maximize possible benefits and minimize possible harms. JUSTICE ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly the fair distribution of costs and benefits to potential research participants and equally --> implemented in many regulatory agencies
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The Common Rule (1991)
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Since many regulatory agencies subscribe to it and IRB. Code of Federal Regulations
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Conflict of Interest
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COI
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apparent conflict of interest if a leader or someone has a suggestion of divided loyalty then there is possilbity of conflict between loyalties
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US Law : Bill of Rights
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4th ammendment : protection from unreasonable search and seizure.
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Protected Health Information
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PHI
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Individually identifiable information about health status, provision of health care, payment for health care that is created or collected by a CE (or BA of CE) that can be linked to a specific individual
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Health Information Exchange
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HIE
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the mobilization of health care information electronically across organizations within a region, community or hospital system; may also refer to the organization that facilitates the exchange.
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Health Insurance Portability and Accountability Act (1996)
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HIPAA
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aka Kennedy-Kassenaum Act, protects health insurance coverage for personnel when lose/change jobs; governs electronic transactions in health care; standards a focus: standards for financial transaction and code sets; unique identifiers for patients (never came to be), healthcare providers, and employers; development of privacy and security standards for transmission of data. eg requires HCPCS for transactions involving health care information
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Office of Civil Rights
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OCR
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Enforces HIPAA security and privacy rules
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HIPAA Privacy rule
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How, when, and to whom PHI may be disclosed
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HIPAA Security rule
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Secures PHI using administrative, technical, and physical safeguards
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Covered Entity
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CE
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Health care providers, Health plans, Health care clearinghouses (nonstandard <-> standard format)
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Business Associate
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BA
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separate person/organization a CE contracts with to help it with its health care activities
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HIPAA Preemption Analysis
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determine the difference between HIPAA laws and the state's laws
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American Recovery and Reinvestment Act (2009)
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ARRA
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831B, aka stimulus or recovery act
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Health Information Technology for Economic and Clinical Health Act (2009)
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HITECH
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Refers to Title XIII in part A and title IV in part B of ARRA; Established MU requirements for EHRs; Established the ONC for HIT; Established HIT policy and standards committee. Expands HIPAA.
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HITECH changes to HIPAA
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Privacy and security rules apply to BAs; increased enforcement including civil and criminal penalties; limited data sets; security risk assessment; breach notification requirements; new rules for accounting and reporting disclosures of PHI, charitable fundraising and sales of PHI. BA agreements may need to be updated and demonstrate documented policies/procedures; BA must notify CE and HHS of breaches
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Deidentified Data
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Not considered PHI (ie not covered by the privacy rule): health information that does not identify an individual and with respect to which there is no reasonable basis to believe that the information can be used to identify an individual is not individually identifiable health information. Can be disclosed without restriction
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Expert determination
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One method to deidentify data: a person with appropriate knowledge and experience with statistical principles and methods for rendering information not indiviudally identifiable determines that the risk is very small that the information could be used alone or with other information to identify an individual and documents the method and results of the analysis
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Limited Data Set / Safe Harbor
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A form of PHI that a CE is permitted to disclose for research, public health, or health care operations without obtaining consent; data use agreement contract required for research. Must remove names, street addresses, email, SSN, phone numbers, MRN, health plan beneficiary numbers, account numbers, device and vehicle identifiers, photos. DOB (year only, if age < 89) is kosher.
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Office of the National Coordinator for Healthcare IT
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ONC
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Established in 2004 by legislative order, mandated in HITECH; oversees national activities to promote HIT and HIE; established certification crtieria for EHR; established HIE standards
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Standards, Implementation Specifications & Certification Criteria
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S&CC
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Specifies capabilities and functions that complete EHRs and EHR modules must perform in order to be certified under the ONC HIT certification program
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Certified EHR Technology
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CEHRT
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Certified by ONC, provides users security that the systems have the basic features need to attest to MU.
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Certified Health IT Product List
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CHPL
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Published by the ONC: authoritative comprehensive listing of CEHRT and EHR modules
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Accredited Testing Laboratory
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ATL
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tests and certified EHR
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Computerized Provider Order Entry
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CPOE
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process which allows the ordering practitoner to use a computer to directly enter medical orders; patient safety advantage (Bates, 1998, 55% reduction in nonintercepted serious medication errors)
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View, download, transmit
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VDT
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Meaningful Use
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MU
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EHR incentive program for EPs; must use CEHRT, e-prescribing, HIE, report CQMs; MU criteria map to one or more of five goals: improving quality safety efficiency, engaging patients, increasing coordination, improving health status of population, ensuring privacy and security
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Eligible Professional
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EP
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Med/dental/pod/optom/chiro Doc + <90% hospital based (Medicare route). Med/dental/NP/CNM/PA, >30% medicaid vol or >20% pedi (Medicaid route)
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Eligible Hospital
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EH
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Hospitals paid under IPPS, Medicare Advantage Hospitals through Medicare. Acute care hospitals and children's hospitals through Medicaid
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Critical Access Hospital
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CAH
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a designation given to certain rural hospitals by CMS
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MU stages
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1 (2010): capturing/sharing data (implementing system). 2 (2014): advanced care processes with decision support. 3(2017?): improved clinical outcomes through quality, safety, and efficiency measures.
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MU stage 1
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Existence and basic use of an EHR; core and menu objectives; payments began 2010(EH), 2011(EPs)
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MU stage 2
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MU2
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Objectives announced 2012; start delayed to 2014; raised bar with emphasis on patient engagement and HIE. 7 broad categories: CQMs, Clinical, Utilization, Public Health, Privacy & Security, Patient Engagement, Care Coordination
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MU modified stage 2
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2015-17; single set of objectives/measures. 10 for EPs (1 Public Health), EHR 2014-certified. Reporting period based on calendar year.
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Modified Stage 2 MU Objectives (EP requirements)
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1. Protect PHI (conduct security analysis) 2. CDS (x5, drug-drug, drug allergy) 3. CPOE (>60% med, >30% labs, >30% rads) 4. E-prescribing (>50%) 5. HIE (summary record (CCD), e-transmit >10%) 6. Patient Specific Education (provided to >10%) 7. Medication Reconciliation (>50% transitions) 8. VDT (>50% pts provided access to VDT (within 4d), at least 1 pt did. 9 Secure messaging to patients 10. Public Health Reporting (immunization or syndromic surveilance reporting, specialized registry
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Modified Stage 2 MU Objectives (EH requirements)
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9 Objectives. No secure message objective. E-prescribing for hospital >10 hospital dc rx, patient specific education >10%
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MU Incentive
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44-63k for EPs, 2-9M for EHs var by medicare vs medicaid, amount of medicare/aid pts seen, discharges per year
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Patient Protection and Affordable Care Act (2010)
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PPACA
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small business tax credits; closing the donut hole; requirement for large employers (>50) to offer coverage; expanding medicaid (<133% of poverty level), health insurance exchanges, prohibiting denial for prexisting illness, tax increases, individual mandate, and much more.
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Physician Payments Sunshine Act
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aka Open Payments program, enacted with ACA, requires manufactures of drugs/devices to report payments and gifts given to physicians and teaching hospitals.
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Medicare Access and CHIP Reauthorization Act of 2015
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MACRA
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Emphasis on high-quality high-value health care; development of new measures and quality reporting. Stabilizes fee updates: annual positive updates of 0.5%/yr to 2019. 2020-2025 freeze; 2026- MDs can receive a 0.75% increase if they participate in APMs (otherwise 0.25% increase); consolidates medicare quality programs (MIPS; subsets PQRS,VM,EHR penalties in 2018, new composite score); bonus pool for top performers (500M/yr); cost is 213B, offset by 70B in savings; access to data; quality metrics public; requires EHR interoperability by 2018
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Merit-Based Incentive Program
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MIPS
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Reporting begins in 2017. Penalites start 2019. MIPS will be the only Medicare quality reporting program: separate MU, PQRS, VM will phase out. Will be administered at the NPI level. =MU+PQRS+VBM+Clinical Practice Improvement (6 categories - pending, participation in PCMH). Performance threshold
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Alternative Payment Model
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APM
|
Altenative to MIPS. Provides 5% bonus (2019-2024). Requires CEHR, quality masures, 'more than nominal financial risk'
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Value-Based Modfiier
|
VBM
|
Created by ACA, mandates CMS apply a value modifier under MPFS; to evaluate cost and quality measures to calculate payment for Medicare services.
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Physician Fee Schedule
|
PFS
|
|
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Performance management
|
|
The process of collecting and tracking data to assess progress towards goals and determining if the wanted results are achieved: 1. Define performance standards that encompass organizational goals 2. Define measurements that can empirically assess these goals 3. Report the progress of measurements to assess performance and determine whether goals are met 4. Continuously improve programs or processes to better meet organizational goals
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Utilization management
|
|
evaluation of whether health care services, procedures, facilities are appropriate and medically needed
|
|
Medicare Sustainable Growth Rate
|
SGR
|
1997-2015; ended with MACRA; a method to ensure the yearly increase in the expense per Medicare beneficiary did not exceed the growth in GDP.
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|
Health Information Organization
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HIO
|
oranization that oversees and governs the exchange of health-related information among organizations according to nationally recognized standards.
|
|
HIPAA Privacy rule applied to HIOs
|
|
Correction (can dispute record), Openness and transparancy (about how PHI is used), Individual choice (about how PHI is used), Collection use and disclosure limitation (only to the extent necessary), Safeguards (admin/technical/physical to ensure integrity), Accountability. HIO considered a BA.
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Food and Drug Administration Safety and Innovation Act (2012)
|
FDASIA
|
gives FDA authority to collect user fees from industry, promote innovation through faster patient access to products, increase stakeholder involvement in FDA processes, enhance the safety of the drug supply chain
|
|
The Joint Commission
|
TJC
|
nonprofit accredits and certifies heathcare organizations based on quality and performance standards. Established NPSG.
|
|
National Patient Safety Goals
|
NPSG
|
established by TJC; eg reduction of MDRO, catheter-related blood stream infection, SSI
|
|
Sentinel Event (TJC)
|
|
any unanticipated event in a healthcare setting resulting in death or serious physical or psychological injury to a patient or patients, not related to the natural course of the patient's illness
|
|
JCAHO standard 6.1
|
|
The hospital has a complete and accurate medical record for every individual assessed, cared for, treated or served.
|
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JCAHO standard 6.2
|
|
Records contain patient-specific information, as appropriate, to the care, treatment, and services provided.
|
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JCAHO standard 6.3
|
|
The medical record throughly documents operative or other high risk procedures and the use of moderate or deep sedation or anesthesia.
|
|
JCAHO standard 6.4
|
|
For patients receiving contuing ambulatory care services, the medical record contains a summary list of all significant diagnoses, procedures, drug allergies, and medications. (also in meaningful use)
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|
JCAHO standard 6.5
|
|
Designated qualifed personnel accept and trasncribe verbal orders from authorized individuals.
|
|
JCAHO standard 6.6
|
|
The hospital can provide access to all relevant information from a patient's record when needed for use in patient care, treatment and services.
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|
JCAHO Information Mgmt Standards
|
|
IM planning, privacy, confidentiality, and security.
|
|
ORYX
|
|
Performance measurements and improvement initiative managed by TJC
|
|
Leapfrog
|
|
Voluntary program that described '4 leaps' that would improve safety and quality of US healthcare system. 1. CPOE 2. Evidenced-based hospital referral 3. ICU Physician Staffing 4. Safe Practice Score (a list of NQF-endorsed safe practices)
|
|
Sarbanes-Oxley Act of 2002
|
|
Audit functions for financial data
|
|
21 CFR Part 11 (FDA)
|
|
Part of code of federal regulations that establishes the FDA regulations on electronic records and electronic signatures; defines criteria under which electronic records and signatures are considered trustworthy.
|
|
Family Educational Rights and Privacy Act
|
FERPA
|
protects privacy of student education records.
|
|
Payment Card Industry Data Security Standard
|
PCIDSS
|
|
|
Digital Millenium Copyright Act (1998)
|
DMCA
|
|
|
Patient-Centered Medical Home
|
PCMH
|
Primary care organizational method in which care coordinated by PCP. Should be physician led practice, whole-person orientation, integrated and coordinated care, focus on quality and safety, accessible, compassionate, culturally effective.
|
|
Accountable Care Organization
|
ACO
|
group of doctors, hospitals, other providers who come together voluntarily to give coordinated high quality care to their Medicare patients. Provider reimbursements tied to quality metrics and reduction in the cost of care. Coordinate to reduce medical errors, avoid duplication of services, increase patient involvement, contain costs, share savings (incentive).
|
|
Medicare Shared Savings Program
|
|
basic program for medicare FFS providers
|
|
Advance Payment ACO Model
|
|
supplementary to shared savings program, allows physician-based providers to receive upfront monthly payments to invest in care coordination
|
|
Pioneer ACO Model
|
|
(no longer accepting applications); already provide coordinated care; move to a population based payment similar to Medicare shared savings program
|
|
Independent Payment Advisory Board
|
IPAB
|
changing medicare coverage and reimbursement when cost targets are not met
|
|
Patient-Centered Outcomes Research Institute
|
PCORI
|
Supports comparative effectiveness research
|