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Basic HIPAA Student Updated

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    The bullet

    ripped through the city councilwomans

    body, shredding muscles she had proudly

    toned in the gym. As the ambulance spedher toward the hospital, word of the gunshot

    reached reporters, who gathered in the

    emergency room to hunt down informationon the councilwoman.

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    Was it

    attempted murder or attempted suicide?

    Could it be terrorism?

    Nearby, family tearfully awaited news of the

    fate of the councilwoman, who was now

    unconscious.

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    In addition

    to caring for the councilwoman and her

    injuries, GW medical staff must also take care to

    follow HIPAA regulations to protect the

    councilwomans privacy. The following slides willintroduce HIPAA, including the reasons for the

    legislation and how it impacts medical care.

    At the end of the presentation you will be asked tocomplete several questions to assess yourunderstanding of HIPAA and its impact on day-to-day medical care. You must answer the questionsin order to complete the HIPAA training.

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    By the time

    youve completed this slideshow, you

    will be able to answer the following

    questions:What is HIPAA and to whom does it apply?

    What is PHI and how is it protected?

    When are additional authorizations required?Am I personally liable if I violate HIPAA?

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    The Health Insurance Portability and

    Accountability Act (HIPAA)

    HIPAA is a law passed by Congress in 1996.Among its goals are:

    To reduce health care costs nationwide by

    requiring use of electronic data interchange(EDI) for routine health care transactions, forexample, making and paying service claims, and

    health insurance transactions

    To protect the security and privacy of themedical records used in these EDI transactions

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    HIPAA In Context

    HIPAA contains Security and Privacy rules

    responding to healthcare concerns: Fears that once patients records are stored

    electronically on networks, a couple of clicks can

    transmit those records all over the world Loss of personal control over personal

    information

    Anger at a constant barrage of marketing

    messages

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    HIPAA security and privacy

    rules Establish federally mandated requirements

    for the creation, transmission, receipt,collection, storage, use, and disclosure ofindividually identifiable health information.

    Affect anyone who encounters patientinformation (physicians, nurses, healthcarestudents, patient records managers,information systems staff, dieticians, etc.)

    HIPAA uses the term protected healthinformation (PHI).

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    Protected Health Information (PHI)

    Information relating to an identifiedindividuals

    past, present, or future:

    Physical or mental health or condition

    Provision of health care services

    Payment for provision of health care

    45 CFR 164.501

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    PHI PHI includes oral or recorded information, maintained or

    transmitted in any form or medium (e.g., consultations, paperor electronic history & physical information, patient records,lab data, x-rays, etc.).

    PHI information is created, received, collected by any

    provider (e.g. office practice, hospital, lab, etc.) thattransmits health information in electronic form,

    health plan, or

    health care clearinghouse

    The law refers to these as HIPAA covered entities and thework that they perform that makes them covered entities isdefined as covered functions.

    HIPAA extends to covered entities using and/or disclosing PHI.

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    HIPAA Philosophy: Patient-Consumer:

    Is entitled to notice about how their PHI will be used Major exception is an emergency

    Must expect that, within a medical care facility, PHI will beshared to facilitate care, payment, business operations

    Is entitled to expect that caregivers will be careful about howPHI is used and disclosed

    Has a right of access to PHI

    Has a right to protest mistakes in PHI (in the designatedrecord set) and have PHI corrected or otherwise amended

    Is entitled to control the use of PHI in certain circumstances:Research, Fund-raising, Marketing

    Should know that the government can get PHI for lawenforcement and health care oversight

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    HIPAA Business Associate (BA)

    HIPAA extends beyond the walls of the covered

    entity. For example, under Business Associatecontracts (BACs) , a contract laboratory or a

    separate radiology practice that contracts with a

    physicians office or hospital will be subject to thesame HIPAA regulations as the physician or

    hospital. This means that if, for example, a

    hospital cannot disclose a patients HIV status to

    an insurance company, the hospitals contractlaboratory -- the hospitals business associate --

    also cannot disclose HIV status to the insurance

    company.

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    HIPAA Requires That Covered

    Entities Give Patients a Notice of

    Privacy Practices (NPP) NPP advises the individual about the covered entitys

    privacy practices.

    Distribution of NPP by doctors and hospitals isusually done at time of first face-to-face meeting. Major exceptions:

    Emergencies

    Incapacitated patient Doctor or hospital must try to get individuals written

    acknowledgement of receipt of NPP, or make awritten record of why the acknowledgement was not

    obtained.

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    Notice of Privacy Practices (NPP)

    Requirement for simple English (and otherlanguages when appropriate), but the concepts

    still can confuse most people.

    Rules permit a layered notice, allowing acover page that explains the main points of the

    NPP.

    Note that the specific policies and proceduresfor administration of the NPP will vary from

    one covered entity to another.

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    HIPAA At GW

    Covered Entities GW Hospital (operated by District Hospital

    Partners, L.L.P.)

    Medical Faculty Associates, Inc.

    GW itself is not a covered entity Some units of GW are providers, but

    None of these units electronically bills a standardtransaction

    But GW protects PHI in a variety of settings,including research and medical education,because it gets PHI from covered entities

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    HIPAA Liability

    Institutional and Personal

    Considerations HIPAA imposes new duties on health care institutions (such as

    the GW Hospital) and on health care professionals, including

    doctors, nurses, technicians, medical students, and

    administrators.

    The privacy and security HIPAA statute is shown on the next

    slide. Plaintiffs lawyers will argue that, to achieve what is

    outlined in the red box, hospitals and health care professionals

    must make the effort outlined in the yellow box. As in malpractice litigation, plaintiffs lawyers will assert that

    the statute and HHSs interpretation of it require a high

    standard of care for privacy and security of patient data.

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    HIPAA - Statutory Standard

    Each [covered entity] who maintains or transmits health

    information shall maintain reasonable and appropriateadministrative, technical, and physical safeguards --

    (A) to ensure the integrity and confidentiality of the

    information; and

    (B) to protect againstany reasonably anticipated(i) threats or hazards to thesecurity or integrity of the

    information; and

    (ii) unauthorized uses or disclosures of the information;

    and(C) otherwise to ensure compliance with this part by the

    officers and employees of such person.

    (42 USC 1320d-2(d)(2))

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    HIPAA Liability

    Institutional and Personal

    Considerations We do not yet know how the courts will

    interpret the statute, but there are penalties at

    every level for violations.

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    Institutional and Personal Liability

    HIPAA criminal violations can be prosecuted against

    institutionsand individuals

    Patients can bring lawsuits in state court against

    institutionsand individuals for wrongful disclosure of

    PHI Claims might include: negligent disclosure, disclosure in

    breach of patient-physician confidentiality, invasion of

    privacy, breach of warranty, etc.

    There is the potential forpersonalfinancial liability fordamages (direct and punitiveakin to malpractice)

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    HIPAA Sources of Liability

    Note that patients whose PHI (protected health information) isimproperly used or disclosed may file private law suits against a

    hospital and against each individual (physician, nurse,

    technician, administrator, medical student, or other staff

    member) who appears to be involved in the alleged violation.

    These lawsuits will resemble malpractice actions.

    An individual involved in an improper use or disclosure of PHI

    may face individual financial liability as the result of a judges

    or a jurys judgment. (This is in addition to liability imposedon the hospital or physician practice institutionally.)

    In addition, there is the possibility of criminal charges

    (including imprisonment).

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    HIPAA Sources of Liability

    Private law suits by patients

    Criminal penalties (42 USC 1320d-6) - DOJ/

    U.S. Attorney

    $50,000-250,000, 1-10 years, depending on motive

    Civil penalties (42 USC 1320d-5) - HHS/ OCR

    $100 per violation up to an annual limit of $25,000

    per individual

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    Disclosure of PHI: The Minimum

    Necessary Rule

    As a general matter, the amount of PHI used or

    disclosed is restricted to the minimum (amount

    of information) necessary. Translated, thismeans that healthcare providers and health

    plans must make reasonable efforts not to use,

    disclose, or request more than the minimum

    amount of PHI necessary to accomplish theintended legitimate purpose.

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    Minimum Necessary Rule Exceptions to minimum necessary disclosure:

    Disclosure to a provider for treatment (anything andeverything in the medical record may be important)

    Release authorized by individual or for individuals

    own review

    Disclosure to comply with HIPAA requirements(e.g., to HHS Office of Civil Rights or Inspector

    General)

    Disclosure required by law (e.g., to law enforcement)

    Preamble stresses reasonableness and flexibility.

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    Minimum Necessary Rule Applies

    Differently to Treatment, Payment, and

    Health Care Operations (TPO) Patients must provide consent for use of PHI in treatment, payment and

    operations.

    Treatment: Provision, coordination, or management of health care andrelated services.

    Payment: Activities of a health plan to obtain premiums or fulfill coverage

    & benefits responsibilities, or obtain reimbursement (provider/health plan).

    Health Care Operations: Activities of a covered entity relating to covered

    functions including quality assessment, professional qualification review,medical review.

    Practitioners must also distinguish activities which fall outside TPO (e.g.

    research, fundraising, and marketing) and understand that special

    processes that govern these activities.

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    The minimum necessary ruledoes not

    restrict the information used or disclosedin treatment.

    But minimum necessarydoes apply to

    payment and health care operations.

    45 CFR 165.502(b)

    TPO and Minimum Necessary

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    Minimum Necessary Rule and

    Teaching Rounds

    During Rounds or Grand Rounds, the

    minimum necessary rule does notapply. Under HIPAA, Rounds are

    considered part of treatment.

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    K i PHI S

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    Keeping PHI SecureAchieving appropriate security is a multifaceted task

    Initial and on-going risk analysis iterative threat

    assessments Enterprise security management process

    Computer security (includes monitoring)

    Communications security (includes monitoring)

    Physical security: access to premises, equipment, people,data

    Personnel security

    Procedural (business process) security

    Includes security awareness training for entire workforce Security rules limit access to information based on ones job

    A pervasive security cultureawareness & surveillance

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    Keeping PHI Secure

    Several items in the Security Rule are notable:

    Computer faxes, but not paper faxes, are considered

    electronic transmissions

    A call on a standard telephone (non-cell and non-

    mobile) is not an electronic transmission

    There is no distinction between data moving

    externally and internally within an organization.

    Computer workstations must be protected from

    unauthorized access and improper use.

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    HIPAA Security Ruling

    Security defined: controls used to

    protect confidential information from

    unauthorized persons

    Security ruling issued April 2003;

    effective April 21, 2005

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    Keeping PHI Secure

    HIPAA Security Rules are grouped into four

    related categories:

    Administrative procedures

    Physical safeguards

    Protection for data storage

    Protection for data in transit

    Note: Security policies will differ from oneinstitution to another

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    Administrative Procedures

    Covered entities must:

    Establish roles and responsibilities for security

    Design and implement training and awarenessprograms

    Have a security plan

    Conduct a risk assessment Create policies and procedures including a

    password policy

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    Common Password Procedures

    May include:

    Password testing program which will not let

    you use easy to guess passwordsRequiring an alphanumeric combination

    password

    Changing passwords at periodic intervalsPenalties for sharing passwords with anyone

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    Physical Safeguards

    Covered entities will establish policies to ensureaccess control, e.g.

    Locked doors and escorting visitors

    Wearing IDs

    Secure unattended computer workstations

    Password protected screensavers

    Govern usage of PDAs Password protected

    Stored in secure space

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    Protection for Data Storage

    Covered entities will set policies and

    procedures on handling media:

    Diskettes

    Paper

    Magnetic tapes

    Confidential trash

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    Protection for Data in Transit

    Covered entities will institute

    technical measures including:

    Access controls or Encryption

    Entity authentication

    Audit trail Adverse event reporting

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    Faxes

    Misdirected faxes are a serious problem.

    Double-check phone numbers.

    HIPAA security regulations currently

    govern electronic faxes but not paper-based

    faxes.

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    Lets look at this in practice...

    The elevator door slams shut behind youas you walk into your preceptors office

    for your weekly visit.

    The waiting room is crowded and theoffice staff are busy dealing with theoverflow of patients.

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    Youve been following patients

    in Dr. Jones office for several weeks

    now. Dr. Jones has a well-established and

    respected rheumatology practice and getsmore referrals every day. His patients

    range from local individuals to

    Washington and international VIPs.

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    Your job

    is to escort patients from the waiting room tothe exam room, and then conduct the initialhistory and possibly a physical exam.

    As you are escorting your first patient back toexam room two, he mentions that he thought herecognized a patient sitting in the waitingroom. Hes convinced that the guy sitting

    opposite him is a basketball player for theWizards and wants to know why he has anappointment with Dr. Jones.

    How do you respond?

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    About 30 minutes later

    Dr. Jones calls you into exam room one.

    Hes examining the mystery waiting

    room patient (who indeed plays for theWizards), and wants you to see the rare

    condition he exhibits.

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    Once the patient has left

    Dr. Jones reviews the basketball

    players case in detail. Its an unusual

    case and he wants to make sure youvepicked up on all the signs and symptoms.

    The two of you review the lab results, X-

    rays, and patient record in detail.

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    Later that day

    you cross paths with one of your

    friends who is also following patients in

    Dr. Jones office. Excited about thebasketball players unusual case, you

    start telling her a few details about it.

    How much are you allowed to saywithout violating the patients right to

    privacy?

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    Although you were discreet

    and did not mention his name, your

    friends curiosity is piqued. Since she has

    access to the records in Dr. Jones office,it would be fairly easy for her to confirm

    the patients identity and pull his record.

    Would she be violating the patientsprivacy?

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    Legitimate Need

    When you are assigned to a case, you

    have access to patient information.

    However, like all other employees whohave the minimum necessary access to

    perform their job, you cant just access

    patient information to satisfy yourcuriosity.

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    What general information can be

    disclosed to the public? Facility directory may list the individuals:

    name; location in the facility;

    health condition expressed in general terms; and

    religious affiliation.

    The facility may disclose this directory information to members

    of the clergy, unless the individual restricts these disclosures. Example: Methodist patients directory information disclosed to

    Methodist clergy.

    Directory information, except for religious affiliation, may bedisclosed only to other persons who ask for the individual by

    name. Individual may restrict or prohibit some or all uses of directory

    information. If all uses are prohibited, facility can neither confirmnor deny patients presence. Facility must have policies andprocedures for this purpose, and explain them in its Notice ofPrivacy Practices (NPP).

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    Incidental Disclosures Examples of incidental disclosures:

    A patient subject to observation in a waiting area; ICU monitors observed by visitors;

    Conversations between a doctor and a patient in a semi-private room overheard by the rooms other occupant.

    General rule: incidental disclosures are not HIPAAviolations if the covered entity has safeguards in placeand the staff observes them. Example: sign-in sheet in a waiting room is permissible, but

    not if it asks patient to list medical problems so that otherpeople who sign in can see the problems of earlier arrivals.

    Caveat: Be careful! What may appear to be a permissibleincidental violation may still be a HIPAA violation(example: mis-addressed email containing PHI).

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    Disclosures Unrelated to 46/103

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    Disclosures UnrelatedtoTreatment, Payment, and

    Operations (TPO)

    Marketing, fund raising, research

    HIPAA privacy rules identify these activities assignificant threats to privacy.

    Each requires a separate authorization,and

    you are required to follow institutional-specificpolicies and procedures.

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    What is a HIPAA Authorization?

    Written permission from the patient (or the patientslegal representative) to use or disclose PHI for specificpurposes (other than TPOi.e. marketing,fundraising, research)

    Can be revoked in writing at any time By regulation, must include specified elements

    Specific purpose of use or disclosure

    Specific description of persons to which disclosure is to be

    made Expiration date or event (none or end of study ok for

    certain research)

    Signature and date

    Explanation of how to revoke the authorization

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    Typical Uses of HIPAA 48/103

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    Typical Uses of HIPAA

    Authorization

    Research that includes treatment

    Release of psychotherapy notes (HIPAA requiresspecial protection for psych notes)

    Employment-related exam (allows releasing resultsto employer or prospective employer)

    Marketing

    Fundraising

    Patients request to release PHI (patient can releaseto whomever and for whatever purpose)

    As a condition for enrolling in a health plan (butstill does not allow release of psych notes)

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    Special Rules for HIPAA 49/103

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    Special Rules for HIPAA

    Authorizations

    Authorization for release of psychotherapy notes cannot becombined with anything else except another authorization foruse or disclosure of psychotherapy notes

    Authorization for research can be combined with other types

    of written permission for the same research (e.g., informedconsent)

    Covered entity generally cant withhold treatment until thepatient signs an authorization, except for:

    Research involving treatment Enrolling in a health plan (and no psych notes involved)

    A medical exam for an employer or other third party whowill see the results

    HIPAA Authorization on

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    HIPAA Authorization onPsychotherapy Notes

    Definition: psych notes are recorded:

    By a mental health professional who is Documenting or analyzing the contents of a private, joint,

    family, or group counseling, AND IF

    The notes are kept separate from the rest of the patients

    medical record.

    NOTE: Its the therapists choice whether to keep therecords separate, although the practice or institution mayhave policies to guide that choice.

    Psych notes exclude:

    Medication prescription and monitoring,

    Session start and stop times,

    Modalities and frequencies of treatment,

    Results of clinical tests, and

    Any summary of diagnosis, functional status, treatment

    plan, symptoms, prognosis, and progress to date.

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    Special Rules Regarding HIPAA

    Authorization Generally, a HIPAA authorization is required for use

    of psych notes. Exceptions:

    Use of the notes by the originator for treatment,

    Use by the covered entity for its own training programs

    under appropriate supervision,

    Use in defense of a legal action,

    Disclosure to HHS for HIPAA enforcement, and

    Certain coroners/ medical examiners or other

    governmental health oversight activities.

    The institution will have policies and procedures to

    control the use and disclosure of psych notes.

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    Marketing

    Definition: Communication about a product or service toencourage its purchase or use

    Covered entity does not need authorization to use PHI formarketing when it observes these procedures

    Face-to-face encounter:

    Products or services of nominal value; or

    Concerns health-related products and services of thecovered entity or a third party, and

    Allows patient to opt out of future communications; and

    Entity determines that the communication may bebeneficial to health of type or class targeted

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    Fundraising

    General rule: A HIPAA authorization isrequired to use or disclose any PHI for anyfundraising purpose.

    Limited exception: A covered entity, for

    fundraisingon its own behalf only, may usedemographic information and dates of healthcare service (and no other PHI), or disclosethose limited categories of PHI to: a business associate performing fund raising for the

    covered entity, or

    an institutionally related foundation.

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    Fundraising

    Covered entitys notice of privacy practices (NPP)

    should include a statement that it may contact the

    individual for its fundraising.

    Patients can decide they dont want to be subject to

    fundraising (OPT-OUT), and the covered entity andits workforce must respect those wishes.

    Covered entitys fundraising materials must explain

    to the individual how to OPT-OUT of fundraising.

    Covered entity must reasonably ensure that a patient

    or other individual who OPTS-OUT receives no more

    fundraising communications.

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    Research Under HIPAA

    Each institution will modify its InstitutionalReview Board rules to include new HIPAA

    requirements.

    At GW, these modifications are in process. The GW research community, including the

    MFA and the GW Hospital, will cooperate in

    implementing these new research rules and

    accompanying policies and procedures.

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    HIPAA and Research

    HIPAA applies to all human subject research involving the creation, use, ordisclosure of PHI (e.g. clinical trials, medical record/chart reviews,epidemiological studies, and social/behavioral studies)

    Principal Investigators (PIs) proposing to create, use and

    /or disclose PHI for research purposes must now receiveHIPAA research approval and then human subjectprotections approval from the GW Institutional ReviewBoard (IRB).

    Under GWs implementation of HIPAA, all PIs proposing

    to create, use, or disclose PHI for research purposes mustnow complete this general HIPAA training program and

    a more specific HIPAA research-related training program.

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    HIPAA and ResearchResearchers may create, use, and/or disclose PHI for research

    purposes: With an individual study specific research authorization

    (similar to study specific informed consent form (ICF)) or

    Without a research authorization, as follows: With an Approved Waiver of Research Authorization issued by the

    GW Privacy Board (PB); With complete de-identification of PHI;

    Note: Just removing a patients name does not sufficiently disguise theindividuals identity. There are up to 18 identifiers involved in the de-identification process.

    Limited Data Set Information (with a Data Use Agreement);

    Preparatory to Research; or

    Research on Decedents

    Caveat: Decedent research is not covered under human subjectprotection regulations, but is covered under HIPAA researchregulations.

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    Privacy Rule and Research Databases

    When you come upon a research database keep in

    mind that it may be subject to HIPAA. Considerthe following:

    Does a database contain PHI?

    Where did the PHI come from?

    Where is it going?

    Who has access? At GW? Elsewhere?

    What security safeguards follow the PHI?

    What liability if the data are misused? For GW?

    For other institutions?

    For me (and co-workers) personally?

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    Dr. Jones recently

    joined efforts with GW to participate in anew arthritis study sponsored by a largepharmaceutical company. Dr. Smith is the

    principal investigator on the trial. The clinicaltrial will compare the effectiveness and GIimpact of NSAIDs vs. a new medication inindividuals with arthritis symptoms.

    At last weeks staff meeting Dr. Jonesdescribed the study criteria and asked everyoneto keep an eye out for possible participants.

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    Youre feeling very well-connected,

    not only are you working in Dr. Jones

    office, but you also recently spoke with Dr.

    Smith. He was a guest lecturer in one ofyour classes.

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    Patient Follow-Up Visit

    Another patient youve been following returnsfor a follow-up visit. The arthritis in his wristhas increased and doesnt seem to respond toibuprofen anymore. He is an ardentracquetball player and the pain is interferingwith his game. Since his early retirement, hesbeen able to play a lot more and the pain hasbecome problematic.

    This patient seems like a perfect candidate forthe study. How do you proceed? Since youvealready met Dr. Smith, can you contact himdirectly?

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    HIPAA and Clinical Trials

    No, you cannot contact Dr. Smith directly. You

    must follow the research policies and

    procedures of the specific institution.

    Administrative Requirements for 63/103

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    Administrative Requirements for

    HIPAA Compliance

    Each hospital or physician practice will have its ownset of policies for documenting HIPAA compliance

    and imposing sanctions.

    At each different facility or practice, expect to be briefed on

    HIPAA policies before you start work. If you arent briefed, ask to be briefed. Otherwise, you

    have no way to control your personal HIPAA litigation

    risk.

    Document all complaints received Sanction members of workforce who fail to comply

    (how stringent determined by institutional policy)

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    HIPAAs Relationship to State Law

    Generally

    preempts

    less stringent

    state law

    Seeks to enforce

    more stringentstate law

    Gray areaswhen

    is state law more

    stringent? (Not

    always obvious.)

    Disclosures to Local State and65/103

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    Disclosures to Local, State, and

    Federal Government

    HIPAA permits disclosures to all levels of government

    for health oversight such as mandatory reporting of

    infectious disease.

    Disclosures of PHI are also permitted for lawenforcement and national security purposes.

    Rules are complicated.

    Covered entities need policies and procedures to guide staff,

    plus careful training.

    When a government official or agent seeks PHI, follow the

    covered entitys policies and procedures.

    If in doubt, check with privacy officer or counsel.

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    Disclosures to the Press There is no obligation to disclose PHI to the press.

    There is no obligation to answer the press questionsabout patients.

    A patient has the right not to be listed in the hospitalsdirectory. In that case the hospital and staff can

    neither confirm nor deny the patients presence! Answering press questions about a patient or

    disclosing PHI to the press can be a HIPAA violationwith criminal and civil liability consequences,

    personally and institutionally.

    Follow the institutions press relations policies to theletterlet the public relations office answer thepresss questions.

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    Back to the councilwoman in the ER...

    Councilwoman presents as:

    56 yo F with single gunshot wound to the

    torso and loss of consciousness The ER staff work to stabilize her vital

    signs.

    How does HIPAA apply in this situation?

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    HIPAA and the ER

    Who are the covered entities in this case?

    the ambulance service

    the hospital the ER physicians

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    HIPAA and the ER

    Provide the patient with the hospitals NPP

    statement and obtain her signature upon receipt.

    Obtain the patients consent to use her PHI for

    treatment, payment, and health care operations. Since she is unconscious, the emergency situation

    exception applies, and these signatures can be obtained

    later when the patient is conscious.

    In this case, another law (EMTALA, the EmergencyTreatment and Active Labor Medical Act) takes

    precedence and requires treatment without authorization.

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    Her family arrives.

    and disclose their fear that the

    councilwoman shot herself due to her

    long-running private battle withdepression. The hospital treatment team

    wants to see her psychiatric treatment

    records and psychotherapy notes. How

    does HIPAA impact these requests?

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    HIPAA and Medical Records

    Psychotherapy notes are off-limits without patientauthorization.

    Patient record information (i.e. her use of anti-

    depressant medication) may be available withoutpatient authorization if the mental health providerbelieves in good faith that the information isnecessary in order to prevent or lessen a serious

    threat to her health. If not, the councilwoman must provide authorization

    to have these medical records released to the hospitaland ER physicians.

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    The ER nurse

    wants to access the hospital

    information system to view medical

    records from the councilwomans priorvisits. How does HIPAA impact the

    hospitals electronic patient record

    system?

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    HIPAA and Electronic Patient Records

    Access to prior records is appropriate if she has

    been admitted or is being treated in the ER.

    Access to relevant past records is only availableto those team members directly involved in her

    care (i.e. Need to know rule).

    Access is limited to appropriate individuals via an

    access control system. Nurses must be authenticated by the system and

    only able to view records on a need-to-know basis.

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    Workstations must be in secure locations

    or otherwise protected from

    unauthorized access. Hospital must have a data back-up and

    disaster recovery plan.

    HIPAA and Electronic Patient Records

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    The police

    have already started investigating the

    councilwomans possible attack. They have a

    suspect in custody, but need additional

    information to add to the police investigation.

    A detective calls the hospital to get details on

    the type of gunshot wound suffered by the

    councilwoman. How does HIPAA affectdisclosure of a patients PHI to police?

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    HIPAA and PHI Disclosure to Police

    The hospital may disclose a patients PHI to the

    police without consent only if:

    The police suspect she is a crime victim

    The doctor cant obtain authorization at the

    moment (in this case because she is unconscious)

    The police state that, if the law was broken, it was

    not broken by the councilwoman; the information is

    needed immediately and will not be held against the

    councilwoman

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    HIPAA and PHI Disclosure to Police

    In the physicians best judgment, disclosure topolice is in the councilwomans best interest.

    Note: The physician can still opt to refuse disclosure if s/he

    feels it is not in the patients best interest.

    Exception:

    HIPAA also permits PHI disclosure without authorization

    if it is required, due to legal mandatory reportingrequirements (e.g., gunshots must be reported in somestates) or public health monitoring activities (e.g., anthrax).

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    The councilwomans condition

    has improved. She is stable and has

    regained consciousness. Her conscious

    state allows the hospital to collect neededHIPAA information. What is collected?

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    First

    Present the hospital NPP (Notice of PrivacyPractices).If the physicians and hospital have declared

    themselves an organized health carearrangement (OHCA) under HIPAA, then theycan use a joint NPP; otherwise the treatingattending physicians must also present their own

    NPPs separately. Obtain her written acknowledgement that

    shes received and read the NPP.

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    Then

    Inform her that her name and basic facts

    about her condition and hospital location

    will be added to the hospitals directory,unless she objects.

    Advise her of her options not to be listed

    in the directory at all, and not to have areligious preference listed in the

    directory.

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    Several hours have passed

    and her family and the media are

    pressing for information on her condition

    and prognosis. What level of disclosure ispermitted to these groups under HIPAA?

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    HIPAA and PHI Disclosure

    Family-- the physician is required to ask the

    councilwoman if she objects to sharing PHI

    with family. If she were still unconscious, the

    physician must use his/her best judgment.

    At all times the physician must be discreet and

    avoid talking loudly about patient conditions inpublic areas (hallways, waiting rooms, elevators).

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    HIPAA and PHI Disclosure Pressif the councilwoman has agreed to

    be added to the hospitals directory, the

    general disclosure rule applies.

    Therefore, the following information canbe released to the press

    Name

    Location in the facilityHealth condition expressed in general terms

    Religious affiliation

    butonly if the patient is asked about by name.

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    The ERs screening software

    has flagged the councilwoman as a

    candidate for an ongoing research study

    on female gunshot victims. The researchcoordinator appears at the

    councilwomans bedside, obtains

    informed consent, and then begins the

    research protocol. Is this consistent with

    HIPAA regulations?

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    HIPAA and Research Studies

    Yes, but only if the researcher has

    followed GWs procedures for reviews

    preparatory to research.

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    In between cases,

    the ER physician who treated the

    councilwoman dictates his notes, which

    are then sent to a transcriptionist. Thehospital has a contract with an outside

    company to provide transcription

    services. Does HIPAA affect this business

    relationship?

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    HIPAA and Business Associates

    Yes, all outside vendors who come in

    contact with PHI must be covered by

    business associate contracts asrequired by HIPAA.

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    The councilwoman recovers

    enough from her injury to be

    discharged from the hospital.

    Some time later the she visits her doctorfor a follow-up visit. She is prescribed a

    new medication and given some samples

    to take with her. How does HIPAA affectthis follow-up visit?

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    HIPAA and Follow-up Visits

    Although providing free samples is considered amarketing activity, since it is face-to-face, it isapproved by HIPAA.

    Note: It would be inappropriate (and not proper underHIPAA) for the physician to give a pharmaceuticalcompany the councilwomans name, even if the company

    manufactures her medication(s). The hospital would needa signed authorization from the patient before it couldgive that information to the pharmaceutical company.

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    The following month,

    the councilwoman is contacted by the

    hospital foundation, soliciting a donation.

    Have her privacy rights under HIPAAbeen violated?

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    HIPAA and Fundraising

    No, as long as the NPP stated that her

    PHI might be used for fundraisingand

    the foundation is related to, and supports,the hospital.

    The fundraising request must be specific

    and must give the councilwoman a way toopt out of future solicitations.

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    The medical students

    who participated in the councilwomans

    care at the teaching hospital are writing up

    her case for next months grand roundspresentation. How does HIPAA affect the

    amount or type of information that can be

    included in the presentation?

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    HIPAA and Training

    Because healthcare operations include training ofhealth care students, trainees or practitioners, theminimum necessary rule applies. So does the security

    rule. Prudent application of these rules according tothe institutions policies and procedures will requireomitting her name and other identifying informationthat is unnecessary for teaching purposes.

    She can be referred to by name during rounds orother teaching situations at the discretion of theattending physician/faculty member.

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    The councilwoman

    is organizing her healthcare paperwork

    and returns to the hospital to get a copy

    of her medical record. Does HIPAAprovide the councilwoman with complete

    access to her medical records?

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    HIPAA and Patient Record Access

    No, patients are only entitled to thedesignated record set (PHI used by thecovered entity to make decisions aboutpatients).Care Providers--designated record set is

    medical and billing records

    Health Plans--designated record set isenrollment, payment, claims adjudication,case management records.

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    HIPAA and Patient Record Access

    There is no automatic access to

    psychotherapy notes, or certain other

    information involved in litigation.

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    HIPAA and Patient Record Access

    A patients request for records may be rejected incertain, narrowly defined circumstances, and anexplanation must be provided. For example, disclosing

    the PHI may pose a danger to the patient.Perhaps the councilwomans distraught daughter, inspeculating why her mother was shot, blurted out all kinds offamily secrets to the ER doctor, who included them in therecord. The councilwoman was unconscious and is unaware oftheir inclusion. The hospital decides these notes are not relevantto the councilwomans treatment and withholds them.

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    Once she obtains

    her designated record set and reads

    it, the councilwoman realizes that it states

    she takes Lipitor to lower her cholesterol.She stopped taking the medication

    several years ago and wants to have her

    record corrected. How does HIPAA

    affect patient-initiated changes to medical

    records?

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    HIPAA and Patient Record Changes

    If the hospital agrees to update the record, it must notify

    her (and anyone else she specifies) that her amendment

    was accepted.

    However, the hospital can deny a request to amend the

    record (i.e., if the data are accurate and complete), but

    the councilwoman may appeal.

    If the hospital rejects her appeal, she can add a notice ofdisagreement to her designated record set (DRS). That

    notice of disagreement stays with her DRS.

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    Finally, the councilwoman

    would like to know with whom the

    hospital has shared her PHI, so she

    requests an accounting of her PHIdisclosures. Is this permissible under

    HIPAA?

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    HIPAA and PHI Accounting

    Yes, the hospital must provide an

    accounting of PHI disclosures, but there

    are exceptions to the listing (e.g.,payment, treatment, operations (TPO),

    disclosures pursuant to patient

    authorizations, certain disclosures to law

    enforcement or national security

    officials).

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    Congratulations

    You have successfully completed the GW HIPAAoverview.

    REMEMBER, you must complete and comply withany additional HIPAA instruction or compliance

    programs at each institution (or office) where youhave a clinical rotation.

    Be alert to the fact that HIPAA policies andprocedures will vary from institution to institution,

    and you must comply with the requirements asimplemented at each institution.

    If you have any questions about HIPAA, contact theprivacy officer at the institution(s).

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    Now

    click on the Quiz section of the Prometheuscourse to complete the brief quiz on the HIPAAinformation youve just learned.

    After youve taken the quiz, we suggest youprint out your quiz score by going to the GradeBook section of Prometheus, and then selecting

    the Print option under your browsers Filemenu. You may need to use this printout todocument your completion of the program for


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