Using the attached form, complete this weeks reflections related to your readings, assignments, and implications for current or future practice.

Reflective Journal

Name:

Date:

1. Summarize and reflect on this week’s, readings and learning activities.

2. How will these concepts impact your own professional practice now or in the future?

Reflective Journal Rubric

20 pts

Exemplary

Developing

Needs Improvement

Discussion Criteria

10 Points

7 Points

4 Points

Faculty Comments

Application of Course Knowledge 

Journal contributes reflections and unique perspectives or insights gleaned from weekly objectives or examples from the healthcare field.

Journal entry has limited application of course knowledge and demonstration of perspectives.

Journal does not reflect application of course knowledge and personal insights or examples from healthcare.

Grammar, Syntax, APA Format

APA format, grammar, spelling, and/or punctuation are accurate, or with zero to three errors.

Four to six errors in APA format, grammar, spelling, and syntax noted.

Journal entry contains greater than six errors in APA format, grammar, spelling, and/or punctuation or repeatedly makes the same errors after faculty feedback.

Chapter 16:

Required Reporting

and Mandatory Disclosure Laws

Fundamentals of Law for Health Informatics and Information Management, Third Edition

© 2017 American Health Information Management Association

© 2017 American Health Information Management Association
Required Reporting

Federal and state laws require reporting certain protected health information to protect the health and safety of a community.

Information collected in this manner is not considered public information and patient privacy and confidentiality are protected.

© 2017 American Health Information Management Association
HIPAA and Required Reporting Considerations
Disclosure without patient authorization or agreement
HIPAA Privacy Rule: 12 public interest and benefits activities exceptions (see figure 16.1)
Individual not given opportunity to agree or object to disclosure, no authorization required
Amount disclosed defined by state law, public health, serious threat to health or safety

© 2017 American Health Information Management Association
HIPAA and Required Reporting Considerations (continued)
Preemption
Provides that federal law must be followed when federal and state laws conflict, unless the state law is more stringent on matter than federal law
State law will prevail if there are provisions of state law, including state procedures for reporting of disease or injury, child abuse, birth, or death, or for the conduct of public health surveillance, investigation, or intervention (45 CFR 160.203)

© 2017 American Health Information Management Association
HIPAA and Required Reporting Considerations
Notice of privacy practice
Under HIPAA, generally “. . . an individual has a right to adequate notice of the uses and disclosures of protected health information that may be made by the covered entity. . .” (45 CFR 164.520).
Notice of Privacy Practices should include information regarding reporting without patient authorization under state and federal law

© 2017 American Health Information Management Association
HIPAA and Required Reporting Considerations
Accounting of disclosures
Privacy Rule requires the tracking of disclosures of PHI made in writing, electronically, by telephone, or orally
Organization must track disclosures in a central tracking system that enables departments to record disclosures

© 2017 American Health Information Management Association
Common State Reporting Requirements
Abuse and neglect of children
Reporting required by state law
Reportable to law enforcement
Types of neglect include
Neglect
Physical abuse
Sexual abuse
Emotional abuse
Child: Any person under of 18 or physically or mentally handicapped up to age of 21

© 2017 American Health Information Management Association
Common State Reporting Requirements (continued)
Abuse and neglect of children
State laws define who must report
Protection from liability for reporting in good faith
Privilege exemptions
Must be orally reported immediately with written reports in a prescribed timeframe
No conflict with HIPAA regarding authorization for disclosure due to public interest and benefit exceptions

© 2017 American Health Information Management Association
Common State Reporting Requirements (continued)
Abuse and neglect of the elderly and disabled
Includes individuals 60 years of age and older
Disability attributable to mental or physical impairment that results in functional limits
Types of abuse
Physical
Emotional
Financial
Sexual
Neglect
Abandonment

© 2017 American Health Information Management Association
Common State Reporting Requirements (continued)
Abuse and neglect of the elderly and disabled
Laws covering abuse in home setting (domestic abuse) versus abuse in institutional setting such as a nursing home
State laws also vary regarding required reporting of abuse of the elderly and disabled
No conflict with HIPAA regarding authorization for disclosure due to public interest and benefit exceptions

© 2017 American Health Information Management Association
Common State Reporting Requirements (continued)
Vital records
Required by state and federal law
National Center for Health Statistics (NCHS) responsible for working with state vital statistic laws
Birth certificates: Completed on every live birth
Two parts to certificate: Identifying information and information on mother’s pregnancy and any birth defects
Laws define how a father is acknowledged and what surname in entered for child

© 2017 American Health Information Management Association
Common State Reporting Requirements
Vital statistics
Death certificates: Usually completed by funeral director
Includes identifying information about the deceased as well as information about the cause of death
Physician must provide the cause of death and sign the death certificate

© 2017 American Health Information Management Association
Common State Reporting Requirements
Communicable diseases
Transmitted from infected person, animal, or inanimate reservoir to a susceptible person or host by either direct or indirect contact
State laws define what diseases are reportable, by whom, and how they should be reported, also have provisions to keep information confidential
Notifiable diseases classified according to their potential for endemic or epidemic spread and danger to public health, reportable within 24 hours usually

© 2017 American Health Information Management Association
Common State Reporting Requirements
Induced termination of pregnancy (abortion)
State law requires healthcare organization where induced termination or pregnancy to report termination
Information typically reported: Date of birth, race, marital status, and county and state of residence; the type of procedure performed; and resulting complications
Birth defects
Information may be obtained from birth certificates filed with the state used to determine trends in birth defects and to look for ways to prevent them

© 2017 American Health Information Management Association
Reportable Deaths
State law determines requirements for reporting certain deaths and what information can be disclosed in various cases (varies by circumstances and law enforcement involvement)
Accidental death
Homicide
Suicide
Sudden death
Suspicious death
Death from abortion
Induced termination of pregnancy

© 2017 American Health Information Management Association
Reportable Deaths
Deaths reportable to medical examiner vs. coroner
ME is typically a physician with pathology training
Coroner appointed or elected official, who may or may not be a physician
Both responsibility for investigating suspicious deaths
MEs and coroners have right to receive medical information needed to investigate the case without authorization and may have subpoena powers to collect such information

© 2017 American Health Information Management Association
Reportable Deaths
Name and address of the deceased
Age of the deceased, if known
Marital status of the deceased
Ethnicity of the deceased
Time of accident or onset of cause of death
Place, mode, and manner of injury
Place of death
Time of death
Location of body
Other pertinent data
Name of person reporting the case, including date and time
Name of physician who pronounced person dead
Information commonly reportable to ME or coroner

© 2017 American Health Information Management Association
Reporting of Wounds: Knife, Gunshot, Burns
Wounds, such as knife wounds, gunshot wounds, and burns indicative of crimes, must also be reported to legal authorities.
States also require reporting of unusual events and other instances that might assist with public health prevention and control programs.

© 2017 American Health Information Management Association
Reporting Fetal Deaths
Refers to death of fetus of particular weight, frequently 500 grams or more, or 22 or more completed weeks of gestation
Depending on state law, responsibility for completing the fetal death certificate may lie with
Designated person in the institution where the fetal death occurred
Funeral director
Other person responsible for internment or cremation of remains
Physician in attendance if fetal death occurred outside an institution
If no one in attendance, must notify ME who completes death certificate

© 2017 American Health Information Management Association
Unusual Events and Other State Reporting Requirements
Some states require reporting of unusual or adverse events
Medication errors
Transfusion reactions
Falls resulting in fractures
Wrong patient/wrong site surgical procedures
Operative complications

© 2017 American Health Information Management Association
Unusual Events and Other State Reporting Requirements (continued)
Some states have implemented prescription drug monitoring programs (PDMPs)
Require pharmacies to report to state data bank on state identified controlled drugs
Nuclear Regulatory Commission (NRC)
Oversight for medical use of ionizing radiation
Medical centers must report to state agency and NRC information on use of radioactive materials and any misadministration of the material

© 2017 American Health Information Management Association
Worker’s Compensation for Occupational Illnesses, Injury, Death
Purpose of legislation
Ensures employees injured on job or become ill as result of job are provided with some means of support while recovering from illness or injury
Process
Employee or employee representative files a worker’s compensation claim
Must sign an authorization to release medical information to the workers’ compensation entity
Information may be disclosed to other state or federal agency without patient authorization

© 2017 American Health Information Management Association
National Reporting Requirements
Serious occurrences or deaths related to restraint or seclusion
Conditions of Participation patients rights rule, accredited hospitals deemed to meet Medicare requirements must report deaths from restraints or seclusion to CMS by phone within one business day
Must document in patient’s health record date and time that the death was reported
Must record in internal log/system with 7 days of death, key patient information

© 2017 American Health Information Management Association
Serious Occurrences or Deaths Related to Restraint or Seclusion
Children’s Health Act of 2000
Restrict the use of restraints and seclusion in all psychiatric facilities that receive federal funds and in non-medical community-based facilities for children and youth
Use of restraints and seclusion restricted to emergency safety situations only
Parent or legal guardian must be notified no later than 24 hours after the occurrence

© 2017 American Health Information Management Association
National Reporting Requirements of Quality Measures
CMS, Joint Commission and other entities require
Quality measures for hospitals, physician’s offices, nursing homes, and other provider entities for purpose of improving the quality and safety of patient care
PHI collected is used for retrospective analysis and real-time reporting to comprehensively evaluate and manage quality improvement efforts
Data submitted to federally supported Quality Improvement Organizations (QIOs), Clinical Data Abstraction Centers (CDACs), CDC, and others

© 2017 American Health Information Management Association
Quality Measures
2010 Affordable Care Act established mandatory quality reporting requirements for long-term care hospitals, inpatient rehabilitation facilities, and hospice programs, went into effect in 2014; may change as new administration works on new healthcare legislation
Mandatory reporting by hospitals already required
Medicare providers that fail to comply with data reporting requirements are subject to 2 percent reduction of reimbursement

© 2017 American Health Information Management Association
National Reporting Requirements
Programs designed to prevent fraud and abuse
Healthcare organizations must provide copies of health records
Recovery Audit Contractors (RACs)
Medicare Administrative Contractors (MACs)
Medicaid Integrity Contractors (MICs)
Purpose of these programs: To measure, prevent, identify, and correct incorrect payments under the Tax Relief and Health Care Act of 2006 and other federal healthcare reform legislations

© 2017 American Health Information Management Association
National Reporting Requirements (continued)
National Practitioner Data Banks (NPDB)
Created by Health Care Quality Improvement Act of 1986, information expanded by Medicare and Medicaid Patient and Program Protection Act of 1987
Purpose: Identify and discipline those who engage in unprofessional behavior and restrict ability of incompetent healthcare practitioners to move from State to State without disclosure or discovery of previous medical malpractice payment and adverse action

© 2017 American Health Information Management Association
National Reporting Requirements
National Practitioner Data Banks (NPDB) (cont.)
NPDB merged with Healthcare Integrity and Protection Data Bank (HIPDB) established under Section 1128E of the Social Security Act; operational in 2000 to establish national healthcare fraud and abuse data collection program for reporting of final adverse actions (not including settlements in which no findings of liability have been made) against healthcare providers, suppliers, or practitioners

© 2017 American Health Information Management Association
NPDB Formal Clearing House
Information reported to the data bank is considered confidential and is not disclosed except as specified by regulation
Requirements include:
Who reports
What information is available
Who can query database

© 2017 American Health Information Management Association
Medical Device Reporting
Safe Medical Devices Act of 1990   
Requires reporting to the FDA and the product manufacturer of medical device occurrences that have or may have contributed to serious illness, serious injury, or death, including occurrences attributed to user error
Medical Device Amendments of 1992 clarified terms and established a single reporting standard for device users, manufacturers, importers, and distributors

© 2017 American Health Information Management Association
Medical Device Reporting (continued)
Medical device: Anything that is used in treatment or diagnosis that is not a drug
X-ray machines, sutures, defibrillators, grafts, syringes, lasers, heating pads, bone screws, pumps, etc.
FDA requires specific information to be reported within 10 days
User facility report number
Name and address of the device manufacturer
Device brand name and common name
Product model, catalog, serial, and lot numbers
Brief description of event reported to manufacturer and the FDA
Where report was submitted (FDA, manufacturer, or distributor)

© 2017 American Health Information Management Association
Medical Device Reporting (continued)
Reporting done through Safety Information and Adverse Event Reporting Program—MedWatch
FDA also encourages voluntary reporting of adverse events related to products or technologies to MedWatch
FDA does not regulate EHRs working with ONC and FCC representatives to improve the safe use of EHR technology, encourages voluntary reporting of problems with EHRs

© 2017 American Health Information Management Association
Medical Device Reporting and HIPAA
HIPAA allows medical device reporting without patient authorization
To collect or report adverse events (or similar activities with respect to food or dietary supplements), product defects or problems (including problems with the use or labeling of a product), or biological product deviations
To track FDA-regulated products
To enable product recalls, repairs, replacements, or look back
To conduct post-marketing surveillance

© 2017 American Health Information Management Association
Medical Device Reporting
Under Freedom of Information and Privacy Act, FDA information may be accessed but FDA is required to delete
Any personal, medical, and similar information that would constitute a clear, unwarranted invasion of personal privacy
Trade secrets and confidential commercial or financial information related to the manufacturer
Identifying information of the reporter of the event

© 2017 American Health Information Management Association
Organ Procurement Organization
Federal law requires that hospitals notify designated organ procurement organization (OPO) in a timely manner regarding specified organ donors who die in the hospital or for whom death is imminent
Hospital and OPO must do annual death record reviews
Hospital is not violating confidentiality by calling the OPO and providing information about an individual who has died
No requirement in statute or regulations that family be informed about hospital’s notification to OPO before OPO can be contacted

© 2017 American Health Information Management Association
Occupational Fatalities, Injuries, and Illnesses
Federal occupational safety and health regulation requires employers to report work-related fatalities, injuries, and illnesses
Healthcare facilities may be required to release medical information relevant to fatality, injury, or illness to appropriate authorities per state law as well

© 2017 American Health Information Management Association
Clinical, Disease, and Outcome-Based Registries
Database containing information about a disease or condition
Used for a broad range of purposes in public health and medicine, from evaluating patient care to monitoring defective devices
May be required by federal or state laws
Common requirement is that data submitted to the registry be maintained in a confidential manner and identity of the patient be protected from disclosure

© 2017 American Health Information Management Association
Federal Registry on Implantable Cardiac Defibrillators (ICDs)
2005: Medicare expanded its coverage ICDs to eligible Medicare beneficiaries
Every hospital that seeks reimbursement for ICDs must participate in ICD registry

© 2017 American Health Information Management Association
Variety of Registries
Type of registry determines what patient information is reported
Cancer registry
Trauma registry
Immunization
Birth defects
Diabetes
Implant
Transplant
Qualified Clinical Data Registries

© 2017 American Health Information Management Association
Disclosures to Public Health Authorities Not Required by Law
Covered entities may disclose PHI to public health entities even if law does not specifically require the disclosure, if the disclosure is for the purpose of
Preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions; or, at the direction of a public health authority, to an official of a foreign government agency that is acting in collaboration with a public health authority (45 CFR 164.512(b))

© 2017 American Health Information Management Association