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© 2017 American Health Information Management Association© 2017 American Health Information Management Association
Chapter 1: Introduction to the
Fundamentals of Law
Fundamentals of Law for Health
Informatics and Information
Management, Third Edition
© 2017 American Health Information Management Association
Defining Law
• Law
– Represents a set of governing rules designed
to protect citizens living in a civilized society
– Establishes order, provides parameters for
conduct, and defines rights and obligations of
government and its citizens
– Controls behavior that threatens public safety
and sets penalties for disobedience
© 2017 American Health Information Management Association
Two Types of Law
• Public law
– Involves federal, state, and local governments
– Defines, regulates, and enforces rights and
duties among individuals and businesses as
related to government.
• Private law
– Involves rules and principles that defines
rights and duties among individuals and
private businesses
© 2017 American Health Information Management Association
Law and Healthcare
• US healthcare is a trillion-dollar business
regulated by federal and state laws,
accrediting bodies, practice standards,
and codes of ethics
• Serves to protect consumers and
providers by requiring accountability for
services and privacy, confidentiality, and
security of health information
© 2017 American Health Information Management Association
Law and Health Information
• Health information
– Data generated and collected as a result of delivering
care to a patient
• Uses of health information
– Primary use—clinical care
– Secondary uses—public health reporting, population
health management, third-party reimbursement,
quality improvement, and patient safety
– Used as evidence in legal cases in which conflict
arises and resolutions is sought through the court
system
© 2017 American Health Information Management Association
Health Information
• Protected under federal law—HIPAA,
defines health information as:
– “It is any information, whether oral or recorded in any
form or medium, that: (1) is created or received by a
health care provider, health plan, public health
authority, employer, life insurer, school or university,
or health care clearinghouse; and (2) relates to the
past, present, or future physical or mental health or
condition of an individual; the provision of health care
to an individual; or the past, present, or future
payment for the provision of health care to an
individual” (45 CFR 160.103).
© 2017 American Health Information Management Association
Health Information Technology
• Push to decrease healthcare costs and
improve quality and safety of healthcare
through use of health information technology
(HIT)
• Movement from paper to electronic health
records (EHRs) and health information
exchanges (HIE) that enable the sharing of
information with multiple parties and across
multiple boundaries
© 2017 American Health Information Management Association
Law and HIT
• Public and private collaborations are
working together to eliminate legal barriers
for sharing electronically stored health
information
– Example: National Governors Association—
roadmap to help states improve health
information flow
© 2017 American Health Information Management Association
Health Records
• Health information comprises a health
record which is defined as:
– “Individually identifiable data, in any medium,
that are collected, processed, stored,
displayed, and used by healthcare
professionals” (AHIMA 2010)
© 2017 American Health Information Management Association
Types of Health Records
• Hybrid health record
• Electronic health record
• Electronic medical record
• Personal health record
© 2017 American Health Information Management Association
Hybrid Health Record
• Record that consists of both paper and
electronic records and media (for example,
film, video, or imaging system) and uses both
manual and electronic processes
• Data in the record may be handwritten, direct
voice entry captured in a word-processing
system, or from provider wireless devices
such as handheld personal computers
© 2017 American Health Information Management Association
Electronic Health Record
• “An electronic record of health-related
information on an individual that conforms
to nationally recognized interoperability
standards and that can be created,
managed, and consulted by authorized
clinicians and staff across more than one
healthcare organization.” The National
Alliance for Health Information Technology
(NAHIT) definition
© 2017 American Health Information Management Association
Electronic Medical Record
• “An electronic record of health-related
information on an individual that can be
created, gathered, managed, and
consulted by authorized clinicians and
staff within one healthcare organization”
The National Alliance for Health
Information Technology definition
© 2017 American Health Information Management Association
Personal Health Record
• “An electronic record of health-related
information on an individual that conforms
to nationally recognized interoperability
standards and that can be drawn from
multiple sources while being managed,
shared, and controlled by the individual”
The National Alliance for Health
Information Technology definition
© 2017 American Health Information Management Association
Protection of Health Information
and Health Records
• Health Insurance Portability and
Accountability Act of 1996 (HIPAA)
– Privacy Rule in effect 2002
– Security Rule in effect 2003
• Health Information Technology for
Economic and Clinical Health Act
(HITECH) of the American Reinvestment
and Recovery Act of 2009 (ARRA)
© 2017 American Health Information Management Association
Privacy and Confidentiality of
Health Information
• Historically key components of the patient-
provider relationship.
• Inherent trust that patient information will be
kept private and protected from unauthorized
access.
• It is important to understand differences
between privacy, confidentiality, and security
and how the concepts relate to law
© 2017 American Health Information Management Association
Privacy
• Privacy is an important social value; it means “a
right to be left alone.”
• Definitions
– “Privacy is a right of individuals to be let [sic] alone
and to be protected against physical or psychological
invasion or the misuse of their property. It includes
freedom from intrusion or observation into one's
private affairs, the right to maintain control over
certain personal information, and the freedom to act
without outside interference” (ASTM 2010)
– “Right to limit the disclosure of personal information”
(Joint Commission 2016)
© 2017 American Health Information Management Association
Confidentiality
• Results from sharing private thoughts with
someone else in confidence
• Definitions
– “Status accorded to data or information indicating that
it is sensitive for some reason, and therefore it needs
to be protected against theft, disclosure, or improper
use, or both, and must be disseminated only to
authorized individuals or organizations with a need to
know” (ASTM 2010)
– “Protection of data or information from being made
available or disclosed to an unauthorized person(s) or
process(es)” (The Joint Commission 2016)
© 2017 American Health Information Management Association
Confidentiality (continued)
• Privileged communication
– Confidentiality, as recognized by law, stems from
a relationship where information is shared
between two parties such as attorney and client,
clergy and parishioner, husband and wife, or
physician and patient. The information or
communication shared in these relationships is
considered “privileged.”
• Confidentiality obligates healthcare providers
(individuals and organizations) to protect
patient information
© 2017 American Health Information Management Association
Security
• Relates to privacy and confidentiality
– Pertains to the physical and electronic protection
of information that preserves these concepts
• Definition
– “Prevent unauthorized access, use, disclosure,
modification, or destruction of information or
interference with system operations in an
information system” (Joint Commission 2016)
© 2017 American Health Information Management Association
Security (continued)
• ASTM E 31 offers two perspectives
– Data security
– Systems security
© 2017 American Health Information Management Association
ASTM E 31—Data Security
• Data security is defined as
– “The result of effective data protection measures; the sum
of measures that safeguard data and computer programs
from undesired occurrences and exposure to accidental or
intentional access or disclosure to unauthorized persons,
or a combination thereof; accidental or malicious
alteration; unauthorized copying; or loss by theft or
destruction by hardware failures, software deficiencies,
operating mistakes; physical damage by fire, water,
smoke, excessive temperature, electrical failure or
sabotage; or a combination thereof. Data security exists
when data are protected from accidental or intentional
disclosure to unauthorized persons and from unauthorized
or accidental alteration” (ASTM 2010).
© 2017 American Health Information Management Association
ASTM E 31—System Security
• System security is defined as
– The totality of safeguards including hardware,
software, personnel policies, information practice
policies, disaster preparedness, and oversight of
these components. Security protects both the system
and the information contained within from
unauthorized access from without and from misuse
from within. Security enables the entity or system to
protect the confidential information it stores from
unauthorized access, disclosure, or misuse, thereby
protecting the privacy of the individuals who are the
subjects of the stored information” (ASTM 2010).
© 2017 American Health Information Management Association
US Code on Information
Security
• Protecting information and information systems from
unauthorized access, use, disclosure, disruption,
modification, or destruction in order to provide
– Integrity, which means guarding against improper
information modifications or destruction, and includes
ensuring information non-repudiation and authenticity
– Confidentiality, which means preserving authorized
restrictions on access and disclosure, including means for
protecting personal privacy and propriety information
– Availability, which means ensuring timely and reliable
access to and use of information
© 2017 American Health Information Management Association
Ownership of Health Record
• Ownership of the health record
– Traditionally granted to healthcare provider who
generates the record. However, state and federal
laws have long upheld the right of the patient to
control the information within the record
– The HIPAA Privacy Rule (45 CFR 164.524–526)
grants a patient the right to access, view, copy, or
amend the record.
– Ownership does not permit providers to share or
sell patient-identifiable medical information as
they wish.
© 2017 American Health Information Management Association
Custodian of Health Records
• “Individual who has been designated as
having responsibility for the care, custody,
control, and proper safekeeping and
disclosure of health records for such
persons or institutions that prepare and
maintain records of healthcare” (AHIMA
2010)
• Role of custodian = gatekeeper
© 2017 American Health Information Management Association
Stewardship
• Similar to role of custodianship
• Goes beyond physical record to include
– “Responsibilities for ensuring integrity
(accuracy, completeness, timeliness) and
security (protection of privacy as well as from
tampering, loss or destruction) within the
context of electronic information and records
management” (Davidson 2010)
© 2017 American Health Information Management Association
Information Governance
• Stewardship as a component of
information governance which is the
“strategic management of enterprise
electronic information including the
standards, policies, and procedures for
access, use, and control of that
information” (Johns 2015)
© 2017 American Health Information Management Association
Stewardship and Governance
• Role of steward requires leadership,
responsibility and governance to ensure
consistent application of, and compliance
with policies across organization-wide
distributed information systems.

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Fundamentals of Health Law and Information

  • 1. © 2017 American Health Information Management Association© 2017 American Health Information Management Association Chapter 1: Introduction to the Fundamentals of Law Fundamentals of Law for Health Informatics and Information Management, Third Edition
  • 2. © 2017 American Health Information Management Association Defining Law • Law – Represents a set of governing rules designed to protect citizens living in a civilized society – Establishes order, provides parameters for conduct, and defines rights and obligations of government and its citizens – Controls behavior that threatens public safety and sets penalties for disobedience
  • 3. © 2017 American Health Information Management Association Two Types of Law • Public law – Involves federal, state, and local governments – Defines, regulates, and enforces rights and duties among individuals and businesses as related to government. • Private law – Involves rules and principles that defines rights and duties among individuals and private businesses
  • 4. © 2017 American Health Information Management Association Law and Healthcare • US healthcare is a trillion-dollar business regulated by federal and state laws, accrediting bodies, practice standards, and codes of ethics • Serves to protect consumers and providers by requiring accountability for services and privacy, confidentiality, and security of health information
  • 5. © 2017 American Health Information Management Association Law and Health Information • Health information – Data generated and collected as a result of delivering care to a patient • Uses of health information – Primary use—clinical care – Secondary uses—public health reporting, population health management, third-party reimbursement, quality improvement, and patient safety – Used as evidence in legal cases in which conflict arises and resolutions is sought through the court system
  • 6. © 2017 American Health Information Management Association Health Information • Protected under federal law—HIPAA, defines health information as: – “It is any information, whether oral or recorded in any form or medium, that: (1) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual” (45 CFR 160.103).
  • 7. © 2017 American Health Information Management Association Health Information Technology • Push to decrease healthcare costs and improve quality and safety of healthcare through use of health information technology (HIT) • Movement from paper to electronic health records (EHRs) and health information exchanges (HIE) that enable the sharing of information with multiple parties and across multiple boundaries
  • 8. © 2017 American Health Information Management Association Law and HIT • Public and private collaborations are working together to eliminate legal barriers for sharing electronically stored health information – Example: National Governors Association— roadmap to help states improve health information flow
  • 9. © 2017 American Health Information Management Association Health Records • Health information comprises a health record which is defined as: – “Individually identifiable data, in any medium, that are collected, processed, stored, displayed, and used by healthcare professionals” (AHIMA 2010)
  • 10. © 2017 American Health Information Management Association Types of Health Records • Hybrid health record • Electronic health record • Electronic medical record • Personal health record
  • 11. © 2017 American Health Information Management Association Hybrid Health Record • Record that consists of both paper and electronic records and media (for example, film, video, or imaging system) and uses both manual and electronic processes • Data in the record may be handwritten, direct voice entry captured in a word-processing system, or from provider wireless devices such as handheld personal computers
  • 12. © 2017 American Health Information Management Association Electronic Health Record • “An electronic record of health-related information on an individual that conforms to nationally recognized interoperability standards and that can be created, managed, and consulted by authorized clinicians and staff across more than one healthcare organization.” The National Alliance for Health Information Technology (NAHIT) definition
  • 13. © 2017 American Health Information Management Association Electronic Medical Record • “An electronic record of health-related information on an individual that can be created, gathered, managed, and consulted by authorized clinicians and staff within one healthcare organization” The National Alliance for Health Information Technology definition
  • 14. © 2017 American Health Information Management Association Personal Health Record • “An electronic record of health-related information on an individual that conforms to nationally recognized interoperability standards and that can be drawn from multiple sources while being managed, shared, and controlled by the individual” The National Alliance for Health Information Technology definition
  • 15. © 2017 American Health Information Management Association Protection of Health Information and Health Records • Health Insurance Portability and Accountability Act of 1996 (HIPAA) – Privacy Rule in effect 2002 – Security Rule in effect 2003 • Health Information Technology for Economic and Clinical Health Act (HITECH) of the American Reinvestment and Recovery Act of 2009 (ARRA)
  • 16. © 2017 American Health Information Management Association Privacy and Confidentiality of Health Information • Historically key components of the patient- provider relationship. • Inherent trust that patient information will be kept private and protected from unauthorized access. • It is important to understand differences between privacy, confidentiality, and security and how the concepts relate to law
  • 17. © 2017 American Health Information Management Association Privacy • Privacy is an important social value; it means “a right to be left alone.” • Definitions – “Privacy is a right of individuals to be let [sic] alone and to be protected against physical or psychological invasion or the misuse of their property. It includes freedom from intrusion or observation into one's private affairs, the right to maintain control over certain personal information, and the freedom to act without outside interference” (ASTM 2010) – “Right to limit the disclosure of personal information” (Joint Commission 2016)
  • 18. © 2017 American Health Information Management Association Confidentiality • Results from sharing private thoughts with someone else in confidence • Definitions – “Status accorded to data or information indicating that it is sensitive for some reason, and therefore it needs to be protected against theft, disclosure, or improper use, or both, and must be disseminated only to authorized individuals or organizations with a need to know” (ASTM 2010) – “Protection of data or information from being made available or disclosed to an unauthorized person(s) or process(es)” (The Joint Commission 2016)
  • 19. © 2017 American Health Information Management Association Confidentiality (continued) • Privileged communication – Confidentiality, as recognized by law, stems from a relationship where information is shared between two parties such as attorney and client, clergy and parishioner, husband and wife, or physician and patient. The information or communication shared in these relationships is considered “privileged.” • Confidentiality obligates healthcare providers (individuals and organizations) to protect patient information
  • 20. © 2017 American Health Information Management Association Security • Relates to privacy and confidentiality – Pertains to the physical and electronic protection of information that preserves these concepts • Definition – “Prevent unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system” (Joint Commission 2016)
  • 21. © 2017 American Health Information Management Association Security (continued) • ASTM E 31 offers two perspectives – Data security – Systems security
  • 22. © 2017 American Health Information Management Association ASTM E 31—Data Security • Data security is defined as – “The result of effective data protection measures; the sum of measures that safeguard data and computer programs from undesired occurrences and exposure to accidental or intentional access or disclosure to unauthorized persons, or a combination thereof; accidental or malicious alteration; unauthorized copying; or loss by theft or destruction by hardware failures, software deficiencies, operating mistakes; physical damage by fire, water, smoke, excessive temperature, electrical failure or sabotage; or a combination thereof. Data security exists when data are protected from accidental or intentional disclosure to unauthorized persons and from unauthorized or accidental alteration” (ASTM 2010).
  • 23. © 2017 American Health Information Management Association ASTM E 31—System Security • System security is defined as – The totality of safeguards including hardware, software, personnel policies, information practice policies, disaster preparedness, and oversight of these components. Security protects both the system and the information contained within from unauthorized access from without and from misuse from within. Security enables the entity or system to protect the confidential information it stores from unauthorized access, disclosure, or misuse, thereby protecting the privacy of the individuals who are the subjects of the stored information” (ASTM 2010).
  • 24. © 2017 American Health Information Management Association US Code on Information Security • Protecting information and information systems from unauthorized access, use, disclosure, disruption, modification, or destruction in order to provide – Integrity, which means guarding against improper information modifications or destruction, and includes ensuring information non-repudiation and authenticity – Confidentiality, which means preserving authorized restrictions on access and disclosure, including means for protecting personal privacy and propriety information – Availability, which means ensuring timely and reliable access to and use of information
  • 25. © 2017 American Health Information Management Association Ownership of Health Record • Ownership of the health record – Traditionally granted to healthcare provider who generates the record. However, state and federal laws have long upheld the right of the patient to control the information within the record – The HIPAA Privacy Rule (45 CFR 164.524–526) grants a patient the right to access, view, copy, or amend the record. – Ownership does not permit providers to share or sell patient-identifiable medical information as they wish.
  • 26. © 2017 American Health Information Management Association Custodian of Health Records • “Individual who has been designated as having responsibility for the care, custody, control, and proper safekeeping and disclosure of health records for such persons or institutions that prepare and maintain records of healthcare” (AHIMA 2010) • Role of custodian = gatekeeper
  • 27. © 2017 American Health Information Management Association Stewardship • Similar to role of custodianship • Goes beyond physical record to include – “Responsibilities for ensuring integrity (accuracy, completeness, timeliness) and security (protection of privacy as well as from tampering, loss or destruction) within the context of electronic information and records management” (Davidson 2010)
  • 28. © 2017 American Health Information Management Association Information Governance • Stewardship as a component of information governance which is the “strategic management of enterprise electronic information including the standards, policies, and procedures for access, use, and control of that information” (Johns 2015)
  • 29. © 2017 American Health Information Management Association Stewardship and Governance • Role of steward requires leadership, responsibility and governance to ensure consistent application of, and compliance with policies across organization-wide distributed information systems.