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Consent,
Privacy and
Medical
Records
Topics Covered on This Page
Consent for Treatment
Minor Consent
Privacy And Medical Information
Access To
Records
Amendment Of Record
About
the Author
By
Anne Cramer
Primmer,
Piper, Eggleston & Cramer, P.C.
Consent for Treatment
What are the legal
principles leading up to the establishment of a patient’s right to
informed consent?
Our common law in the United States has long recognized that
every human being of adult years and sound mind has the right to
determine what shall be done with his or her body. Initially, this right
was defined in terms of an individual’s right to be free of unwanted
bodily invasion – essentially that a person cannot be “touched” without
his or her explicit permission. As a result, a person who has not given
consent to a “touching,” such as medical treatment, was considered to
have a cause of action against the health care provider for a battery.
What is a battery?
A battery is an intentional “tort” or act that results in harmful
contact with another. A defense to a claim of battery is that the
individual claiming harm consented to the contact. In a medical context,
a health care provider commits a battery if the provider performs a
procedure for which the patient has not given consent.
What is the current law in Vermont regarding
the principle of informed consent?
The duty of a health care provider to obtain consent from a patient for
treatment has been defined by statute in most states, including in
Vermont in 12 V.S.A. §1909, which limits the scope of a medical
malpractice action based on lack of informed consent, and in the
Hospital Patient Bill of Rights, 18 V.S.A. §1852(3) and (4).
The medical malpractice
provision enacted in Vermont (originally in 1975), defines “informed
consent” in the negative, meaning that the lack of informed consent
means the following:
(1) the
failure of the person providing professional treatment or diagnosis to
disclose to the patient such alternatives thereto and the reasonably
foreseeable risks and benefits involved as a reasonable medical
practitioner under similar circumstances would have disclosed in a
manner permitting the patient to make a knowledgeable evaluation; or
(2) the failure to provide to a patient a
reasonable answer to any specific question about foreseeable risks and
benefits. [12 V.S.A. §1909(a)]
The Hospital Patient Bill of
Rights provides the patient the affirmative “right to obtain from a
physician coordinating his or her care, complete and current information
concerning the diagnosis, treatment and any known prognosis in terms the
patient can reasonably be expected to understand.” The patient has the
right, except in emergencies, to receive from the physician information
necessary to give informed consent prior to the start of any procedure
or treatment. Such information should include the medically significant
risks involved with this procedure or treatment, the probable duration
of incapacity and any medically significant alternatives.
Note: the rights are also
set forth in the Medicare Hospital Conditions for Participation, 42 CFR
§482.13.
What is the difference
between a case where the patient has provided no consent to the
treatment or procedure and a case that fails to meet an informed consent
standard?
Where a medical professional performs a treatment or procedure for which
there is no consent, the patient has a cause of action for battery – an
intentional contact or invasion which causes harm. Where the patient has
provided consent for the treatment or procedure employed, but receives
inadequate disclosure of the alternatives and foreseeable risks and
benefits of the alternatives, the cause of action and liability is based
on lack of informed consent and a claim of medical malpractice in
failing to provide the necessary disclosures. [Christman v. Davis,
decision filed October 21, 2005]
Must a medical professional
obtain informed consent in an emergency?
No, where treatment has been provided to address an emergency,
Vermont law specifies that there can be no cause of action for medical
malpractice based on a lack of informed consent. [12 V.S.A. §1909(b);
see 18 V.S.A. §1852(4)]
Under what other
conditions is it permissible for a physician to have treated a patient
without first having obtained informed consent?
The following circumstances have been recognized as defenses to any
claim for medical malpractice based on lack of informed consent: (1)
that the risk that was not disclosed was so commonly known that it would
not need to be affirmatively stated; and that the risk is not
substantial, or (2) the patient had previously assured the medical
professional he would undergo the treatment procedure or procedures
regardless of the risk involved, or (3) the patient indicated to the
medical professional that he did not want to know of the matters to
which he would be entitled to be informed, or (4) consent either by the
patient or on behalf of the patient was not reasonably possible, perhaps
as a result of the patient’s incapacity and the unavailability of any
patient representative, or (5) a reasonably prudent person in the
patient’s position would have undergone the treatment or procedure if he
had not been fully informed. [12 V.S.A. §1909(c)]
Must a patient be
advised of the foreseeable risks and benefits of a treatment or
procedure in the event that the medical professional believes that this
information would adversely affect the patient’s condition?
No, the Vermont statute does recognize a limited “therapeutic privilege”
in the event that a health care professional determines in his or her
best judgment that the release of such information to the individual
could reasonably be expected to adversely and substantially affect the
patient’s condition. However, in this circumstance, the professional
should provide the information relating to foreseeable risks and
benefits or alternatives to a member of the individual’s immediate
family, reciprocal beneficiary, guardian or advance directive agent [12
V.S.A. §1909(d) and 18 V.S.A. §1852(3)], if reasonably available. If
there is a request for a copy of the medical record, the individual is
entitled to access unless one of the limited exceptions under the HIPAA
Privacy Rule, 42 CFR 164.524, applies.
What type of evidence
must be produced by a patient at trial to support a charge of medical
malpractice as a result of lack of informed consent?
Vermont statutory law, as well as court precedent, requires that expert
medical testimony must be presented to support an allegation that a
patient was not provided sufficient information to give informed consent
to treatment or a procedure.
If a patient consents to
a treatment or procedure after being fully informed of the risks,
benefits and alternatives, and the medical professional performs a
treatment or procedure with similar risks, benefits and alternatives,
but not the same treatment or procedure, does the patient have a cause
of action for malpractice based on lack of informed consent?
The answer to this question depends upon whether a different treatment
or procedure was performed or whether the treatment or procedure
performed was “within” the conduct for which consent was obtained. For
instance, in the case of Christman v. Davis, the patient gave
consent to a tissue graft to address root exposure. The periodontist
decided to do a less invasive flap procedure instead after an anesthetic
was administered. Afterwards, the patient was surprised by this change.
When the desired results were not achieved, the patient sued for dental
malpractice based on lack of informed consent and for battery. The
Vermont Supreme Court found that the treatment/procedure provided was
within the bounds of the consent obtained and thus there could be no
cause of action for battery as consent was obtained and the dentist
simply exercised professional judgment. The Court noted that there may
have been an actionable claim for malpractice due to lack of informed
consent, but this claim had previously been dismissed.
Must a patient’s consent be provided in
writing to qualify as informed consent?
There is no specific requirement that informed consent be given in
writing or acknowledged in writing. However, given the time delays
attendant to any challenge to a medical procedure for lack of informed
consent, obtaining written acknowledgement is prudent and is considered
the accepted practice. Additionally, for professionals treating patients
in a hospital or ambulatory care setting, evidence of informed consent
must be obtained to meet the Medicare Conditions of Participation, 42
CFR §482.13 and JCAHO Accreditation Standards.
Who is responsible for securing informed
consent?
The professional who will be providing treatment has the duty to secure
the patient’s informed consent. Although the treating professional need
not perform this task personally, he or she is the one who faces
liability if it is not performed or is performed inadequately or
improperly. Additionally, the Hospital Bill of Rights provides that the
patient has the right to obtain this information from the physician who
is coordinating the patient’s care.
What information must
the health care professional disclose to the patient before informed
consent can be fairly given?
The professional must give the patient information regarding the
reasonably foreseeable risks and benefits of the proposed treatment or
procedure and also of the alternatives to the proposed treatment or
procedure.
What risks, benefits and alternatives must
be disclosed?
The treating professional must disclose any “reasonably foreseeable
risks” that a “reasonable . . . medical practitioner under similar
circumstances would have disclosed.” Essentially, the evaluation must be
that the information provided permits the patient to make a
knowledgeable evaluation of the treatment or procedure.
How must the information be disclosed?
Vermont’s statutory provisions anticipate that the patient has an
opportunity to question the professional regarding foreseeable risks and
benefits. As a result, a face-to-face explanation is advisable although,
not necessarily required. Providing the patient with written or video
information about the risks, benefits and alternatives may also satisfy
the standard in many instances. However, it must be a meaningful
communication such that the patient needs to be able to read or
understand the language and vocabulary utilized. Additionally, although
informed consent is a process rather than a form, documenting the
process on a form is important in order to demonstrate the information
provided by the professional to the patient, the questions asked by the
patient, and to have evidence of the patient’s signature at the time
such information is given.
For what treatments or procedures is
informed consent required?
Vermont law does not designate the types of treatment, procedure or
surgeries which require the professional to obtain a patient’s informed
consent before acting. However, a defense to a claim of medical
malpractice for lack of informed consent may be based on allegations
that the risk that was not disclosed is so commonly known and
insubstantial that informed consent was not necessary.
What are the exceptions to the principle of
informed consent?
The following exceptions have been set forth in the statute:
- If the patient is in an
emergency medical condition, no informed consent is necessary;
- The risk not disclosed is
too commonly known to require disclosure and is not substantial;
- The patient had assured the
medical practitioner that he/she would undergo the treatment procedure
or diagnosis regardless of risk involved;
- The patient indicated to
the medical practitioner that he/she did not want to be informed of
the matters to which he/she would be entitled to be informed;
- Consent by or on behalf of
the patient was not reasonably possible;
- A reasonably prudent person
in the patient’s position would have undergone the treatment or
diagnosis if he/she had been fully informed, or
- Therapeutic privilege – in
the event that a medical practitioner has concluded that disclosure of
the risks and benefits could reasonably be expected to adversely and
substantially affect the patient’s condition, disclosure does not need
to be made to the patient, but it should be made to a member of the
individual’s immediately family, if possible.
Any discussion about informed
consent, or exceptions to informed consent should be documented in the
medical record including the reasons for any exception. An executed
patient consent form should be maintained in the record or a reason
noted as to why a form was not signed.
What is the legal age of informed consent in
Vermont?
Eighteen (18). In Vermont any individual under the age of 18 is
considered a minor. In most circumstances, minors are not capable of
giving informed consent to their own medical care.
Who can give informed consent to health care for
a minor?
In Vermont, the following individuals may give informed consent to
health care for a minor:
- A guardian or
representative who has been appointed by a judge to make healthcare
decisions for the child;
- A parent. (adopted or
biological)
Who can give informed consent to health care
when the minor’s parents are divorced?
In general, both parents can make health care decisions for the child.
If the parents are divorced, the informed consent of either parent may
be assumed to be sufficient. Of course, every divorce decree is
different and there are situations where a judge has entered an order in
which one or both of the parents is no longer authorized to make health
care decisions for their child. In those situations, health care
professionals are obligated to follow the judge’s order. If one parent
claims that he or she has exclusive control of medical decision-making,
he or she should be asked to present relevant family court documents.
Can a parent or guardian delegate authority for
giving informed consent to medical treatment for a minor?
Vermont law is silent on this question. It is reasonable to assume that
where the parent(s) or guardian(s) will not be reasonably available to
give informed consent to medical treatment (e.g., vacations, illness,
etc.), they may delegate this authority to a selected adult. Because
there are no clear guidelines for determining the legality of an
apparent delegation of this parental authority, providers should make
reasonable efforts to obtain parental informed consent and should use
their professional judgment and exercise greater caution in providing
services involving any increased risk. If the office has a written
consent on file that has been signed by the parent authorizing the
physician and his/her staff to provide medical care to the child, there
is little or no risk in providing the child with routine medical care.
In situations where the treatment is non-routine or poses some degree of
risk to the child, it is always advisable to consult with the parent
before proceeding. Asking parents ahead of time to document
authorization for medical treatment in their absence is recommended.
When faced with a situation where the minor has
been brought to the office by a grandparent or adult sibling, should a
provider refuse treatment until informed consent from the
parent/guardian has been obtained?
No. As long as the health care professional has exercised due care and
made a good faith determination that the grandparent or adult sibling
has been authorized by the child’s parent or guardian to act as the
agent in obtaining medical care for the minor, liability is unlikely if
the parent later claims that the grandparent or sibling lacked
authorization. Of course, if the medical care will involve anything more
than routine, low-risk procedures, the health care professional should
make every effort to obtain the parent’s specific informed consent
before providing this type of care. Health care professionals are
expected to use good judgment in determining which procedures require
specific parental informed consent.
Can a minor ever give informed consent for his
or her own health care?
Yes. Minors who are married or have ever been married, and minors
on active U.S. military duty, may give informed consent to their own
health care. Minors emancipated by court order may also give
informed consent to their own health care.
What is the definition of an “emancipated
minor?”
To become emancipated, a probate court must determine that a minor: 1)
is sixteen (16) years of age; 2) has lived separate and apart from his
or her parents or legal guardians for at least three (3) months; and 3)
is self-sufficient, managing his or her own financial affairs. [12 V.S.A.
§ 7151(a)(1)]
Are there any special situations where an
unemancipated minor may give informed consent to their own health care?
Yes. Minors 12 years or older may give informed consent to treatment for
sexually transmitted diseases (including HIV and AIDS), drug dependence,
and alcoholism. But if a minor requires immediate hospitalization for
treatment of any of these conditions, the parents must be notified of
the hospitalization. [18 V.S.A. § 4226]
Minors 14 years or older may also voluntarily admit
themselves to a hospital for mental health related treatment if they
give informed consent in writing. Minors under 14 may admit themselves
to a hospital for mental health related treatment by providing their own
written informed consent and a written application from a parent or
guardian. [18 V.S.A. § 7503]
Minors of any age may give informed consent to
medical treatment associated with rape, incest, or sexual abuse. Health
care providers are required to report such incidents to SRS within 24
hours. [33 V.S.A. § 4911 et seq.]
Is parental informed consent required before a
minor can terminate a pregnancy or receive contraceptive
devices/medications?
Current U.S. Supreme Court rulings and Vermont state law permit
unemancipated minors to give informed consent to abortions and medical
treatment necessary to obtain contraceptive devices and medications. In
determining whether the minor’s informed consent is sufficient, health
care providers should carefully assess whether the minor understands the
nature and risks of the proposed treatment and is capable of making an
informed, rational choice. The following factors should be considered:
age, ability, experience, education, maturity level, conduct and
demeanor. There should be little legal risk if the provider determines
that notifying the parent or guardian is in the best interests of the
child. It is always important to document decisions and the basis for
the decision.
Is parental informed consent required before
minors are provided pregnancy, prenatal and delivery care?
Vermont law is silent as to whether pregnant, unemancipated minors
can give informed consent to reproductive services. Because cases
involving other reproductive services, such as abortion and
contraception, have allowed minors considerable freedom, health care
providers should evaluate whether the minor’s informed consent is
sufficient using the criteria outlined above.
Are there any situations where providers need
not obtain informed consent from anyone before providing the minor with
health care?
Yes. When dealing with an emergency – a situation in which immediate
treatment is needed to save the patient’s life or health – where, for
some reason, informed consent cannot be obtained, treatment may be
provided without obtaining informed consent. Of course, it is good
practice to try and obtain informed consent as soon as possible even in
an emergency situation. [12 V.S.A. § 1909(b)]
If adolescents drive themselves to their
appointments, should providers obtain parental informed consent before
treating the minor?
In those situations, again, the health care professional is expected to
exercise sound judgment as to whether the parent must be contacted. If
the office has a written consent on file that has been signed by the
parent authorizing the physician and his/her staff to provide medical
care to the child, there is little or no risk in providing the child
with routine medical care. In situations where the treatment is
non-routine or poses some degree of risk to the child, it is always
advisable to consult with the parent before proceeding.
In situations where it is not required to obtain
the parent or guardian’s informed consent (e.g., treatment for venereal
disease or substance abuse), is the parent or guardian responsible for
the costs of this medical care?
Yes. Generally, parents or guardians are responsible for support of
their unemancipated minors if the treatment is medically necessary.
In situations where it is not required to obtain
the parent or guardian’s informed consent, may the physician inform the
minor’s parents of the medical treatment?
In the case of substance abuse, federal regulations prohibit the
physician from disclosing this treatment to the parent or guardian
unless the minor lacks the capacity to make rational decisions, the
situation poses a substantial threat to the child’s life or well-being,
and the physician determines that this threat may be reduced by
communicating the treatment to the parents. Generally, ethical/medical
rather than legal concerns control the decision to inform parents in
situations where it is not required to obtain the parent’s or guardian’s
informed consent. There should be little legal risk of informing parents
or guardians if the disclosure is in the best interests of the child.
Note that parents may become aware of the visit, if their insurance is
used to pay for care.
In addition to obtaining informed consent from
the parent or guardian, must providers also obtain informed consent from
the minor?
No. If the parent or guardian is authorized to informed consent, health
care professionals are not also required to obtain the informed consent
of the minor. Of course, depending on the age and maturity level of the
child, it is good practice to explain the procedure to the child and
attempt to obtain his or her informed consent and cooperation.
In situations where an unemancipated minor has a
child of her own, who is authorized to give informed consent for care of
the minor’s child?
The child’s parent, regardless of age, is authorized to make
decisions for her own minor child. This may lead to the anomalous
situation where the parent is not legally capable of giving informed
consent to her own health care, but can make decisions on behalf of her
infant.
When minors are in the state’s custody, who is
authorized to provide informed consent for their health care?
The commissioner of SRS has authority under Vermont statute to step
into the shoes of the parent and thus is authorized to provide informed
consent for a minor’s health care just as a parent would as outline
above. The commissioner has additional authority to delegate this
responsibility to other members of the department.
Are minors in SRS custody able to receive
contraceptive services?
According to SRS policy, caseworkers will ensure that appropriate
supportive counseling and contraceptive services are available to teens
in custody.
May minors in SRS custody receive
pregnancy-related services without informing their parents?
SRS staff may or may not inform parents of teens in custody about
their pregnancy-related care, depending upon the department’s
determination of what is in the best interests of the minor.
Who is authorized to consent to treatment when a
child is in custody of the Department of Corrections?
The Department of Corrections has exclusive authority to consent to
medical treatment for children in the custody of the department. The
commissioner of Corrections designates health staff to represent the
state. As a matter of policy, the department tries to involve the
child's parents whenever possible to obtain their input and background
information.
When a minor in corrections custody receives
medical care from a provider outside the prison, can the corrections
officer accompanying the minor receive medical records of the visit?
Yes, the health care professional may give the records to the
corrections officer transporting the patient in a sealed envelope
marked: "To the attention of the responsible Department of Corrections
health authority." Records may also be mailed to the "designated health
authority" at the facility where the child is residing.
When minors are in custody of the commissioner
of Corrections who has access to their medical records or health care
information?
-
The following individuals have access to health
care information about a minor in custody of the Department of
Corrections:
-
The commissioner, deputy commissioner, director
of correctional services, clinical director, medical director and
their designees - on an as needed basis;
-
Health care providers designated by the
Department of Corrections;
-
Non-health staff employed by the Department of
Corrections have access as determined by health services staff.
Persons in custody are entitled to reasonable
opportunities to discuss their medical care and treatment with health
care providers. Guardians, including parents, have the same type of
access to discuss care that the person in custody has.
Resources Related to Minor Consent:
-
Consent to treatment for STD, drug, alcohol 18
V.S.A. § 4226
-
Voluntary admission for mental health treatment
18 V.S.A. § 7503
-
Medical treatment associated with rape, incest,
or sexual abuse 33 V.S.A. § 4911
-
Emancipation: 12 V.S.A § 7151
-
Corrections: 28 V.S.A. § 1104; Department of
Corrections Directive 254.02 Access to Health Care Records
-
Social Services: 33 V.S.A. § 5502 (a)(10); also
Social Services Policy Manual: Working with Families No. 74, 10/27/99
-
Emergency: 12 V.S.A. § 1909(b)
What federal and state rules govern the
confidentiality of medical records in Vermont?
Health care providers must consider the requirements of the Health
Insurance Portability and Accountability Act of 1996 (HIPAA) and its
implementing regulations governing the electronic transfer and security
of data and the privacy of medical information found at 45 CFR Parts 160
and 164. These regulations allow a provider to use and disclose health
information for (1) providing treatment to the individual patient, (2)
seeking payment for services or (3) for the provider’s “health care
operations.”
The HIPAA regulations provide
a “floor’ for protecting the privacy of identifiable health information,
but they do not preempt state laws which are more protective of privacy
or provide greater patient rights to access information.
Under Vermont law, the patient
privilege statute, 12 V.S.A. §1612, provides greater protection than the
HIPAA privacy rule and requires that doctors, chiropractors, dentists,
nurses and mental health professionals must not disclose any information
acquired in attending a patient unless the patient waives the
confidentiality or it is waived by an express provision of law. Hospital
patients and nursing home residents are further protected by the
confidentiality provisions contained in the Patient Bill of Rights, 18
V.S.A. §1852(7) and the Nursing Home Bill of Rights, 33 V.S.A. §7301(8)
which emphasizes that the patient/resident must authorize the release or
use of their records outside of the treatment team or the facility.
Where pharmacy, mental health treatment, or substance abuse treatment
records are at issue, there are additional federal and state laws to
consider as will be discussed below.
Are prescription records
given the same confidentiality protection as other medical records?
Under the federal HIPAA privacy
regulations, prescription records are treated the same as other health
records and are subject to the same confidentiality provisions. Vermont
law separately provides for the confidentiality of prescriptions,
pharmacy orders and records relating to regulated drugs, but
specifically mandates that these records shall be open to inspection to
law enforcement agents enforcing federal and state drug laws and to
agents of professional licensing boards. [18 V.S.A. §4211 and 4218]
The law also specifies that no
privilege of confidentiality shall apply to information communicated to
a physician to unlawfully obtain a regulated drug by fraud, deceit,
false representations, etc. [18 V.S.A. §4223(a) and (b)] Examples of
such unlawful behavior may include, failing to disclose that the patient
is receiving regulated drugs from another prescriber, pretending to be
an established patient of another physician to a covering physician,
altering a prescription for 10 pills to be a prescription for 100 by
adding a zero, or a patient saying they are taking a drug when a screen
shows they are not.
What additional
protection is given to mental health treatment records in Vermont?
Information and records pertaining to the treatment of mental illness
and developmental disability or to involuntary hospitalization must be
kept confidential, including information which directly or indirectly
identifies the patient, unless one of the very limited exceptions apply
or the patient or legal guardian consents. [18 V.S.A. §7103(a)] Under
the HIPAA privacy regulations, psychotherapy notes, which refer to notes
recorded by a mental health professional and documenting or analyzing a
conversation during a counseling session, are kept separate from the
rest of an individual health record and require specific authorization
from an individual to be released. [45 CFR §164.501 and §164.508(a)(2)]
What rules apply to the confidentiality of substance abuse treatment
records?
Federal law affords separate provisions and protection to the
confidentiality of alcohol and substance abuse treatment program records
as set forth in 42 CFR Part 2. These provisions prohibit disclosure of
the identity of anyone receiving treatment and require a specific
consent or authorization form (distinct from the form required by the
HIPAA privacy regulations) be executed by the patient before the
disclosure of any treatment related information. When these records are
disclosed, they must include language that they may not be further
disclosed or released without the individual’s specific written consent.
[42 CFR §2.32]
Under what circumstances may a Vermont provider
disclose health information or medical records without a patient’s
consent or authorization?
Under Vermont law, such disclosures may be made only where there are
“express provisions of law” or a court order. Disclosures required by
“express provisions of law” include the following incidents:
Child Abuse. Health
care providers are obligated to contact the Department of Children and
Families when they have reasonable cause to believe that any child has
been abused or neglected. [33 V.S.A. §§4911-4920]
Crime Victim Under Age of
Sixteen. Health care providers are required to disclose information
that a patient under the age of sixteen has been a victim of a crime.
[12 V.S.A. §1612]
Abuse, neglect or
exploitation of vulnerable adults. Similarly, providers must report
to the Department of Aging and Independent Living when they have
reasonable cause to believe that a disabled adult or an adult suffering
from infirmities of age or an adult receiving personal care services at
home or at a licensed facility has been abused, neglected or exploited.
[33 V.S.A. §§6901-6914] Note, however, that under the HIPAA Privacy
Rule, the victim or his or her personal representative is to be notified
of such a report or disclosure unless it is believed that such
notification might place the individual at risk of serious harm. See
45 CFR 164.512(c)(2).
Firearm-related injuries.
Health care providers treating bullet wounds, gunshot wounds, powder
burns or other injuries caused by the discharge of a firearm must report
such cases to local law enforcement officials or to the state police.
[13 V.S.A. §4012]
Suspicious Deaths. A
suicide or an unusual, unnatural or suspicious death must be reported by
a physician to a medical examiner.
Communicable diseases.
Health care providers are obligated to report incidents of certain
listed communicable diseases, including tuberculosis and venereal
diseases, to the Department of Health. [18 V.S.A. §§1001, 1004, 1007,
1041-1048, 1091-1106]
Fetal deaths. Health
care providers are also obligated by statute to report fetal deaths to
the Department of Health. [18 V.S.A. §§5221-5224]
Cancer. Providers are
required to report each case of cancer to the Department of Health
within 120 days of diagnosis, unless the patient has been previously
diagnosed or admitted for cancer treatment at a hospital facility in
Vermont. [18 V.S.A. §§151-156]
Lead Poisoning. Health
Care providers or their employees must report any diagnosis of lead
poisoning to the Department of Health, and any laboratory in Vermont
analyzing the blood samples of children under the age of six must make
reports as required by the Department. [18 V.S.A. §1755(d)]
Blood Alcohol Level
Reporting. If a blood test is performed in a hospital emergency room
on a patient who was involved in a motor vehicle accident and the blood
tests show that the patient’s blood alcohol level exceeded the level
prohibited by law, the health care provider shall report that fact to a
law enforcement agency having jurisdiction over the area where the
accident occurred. [23 V.S.A. §1203b]
Duty to Warn. The
Vermont Supreme Court has held that in certain instances, mental health
counselors may be obligated to breach patient confidentiality and warn
potential victims, if they know or should know that a patient poses a
serious risk of danger to an identifiable victim. [Peck v. Counseling
Service of Addison County, 146 Vt. 62 (1985)]
What liability or
penalties could be imposed on a provider who wrongfully discloses the
medical information of a Vermont patient?
Under the HIPAA privacy rules a civil penalty may be imposed by the U.S.
Department of Health and Human Services Office of Civil Rights (OCR)
ranging from $100 to a maximum of $25,000. Criminal penalties for
certain egregious wrongful disclosures could escalate up to $250,000. To
date, the OCR has taken a restrained approach to enforcement, and in
most cases will provide education or other assistance before
prosecuting.
Under Vermont law, there is no
general penalty or cause of action for the wrongful release of
confidential medical information. However, there is a statutory
provision which imposes either a $500 fine or up to one year of
imprisonment for the wrongful disclosure of information related to
hospitalization for mental illness. [18 V.S.A. §7103(c)]
Although in other states a
person harmed by a wrongful disclosure of medical information may have a
cause of action for invasion of privacy, defamation or breach of
contract or fiduciary trust, Vermont has no statutory law or reported
case law which establishes a clear right or cause of action to the
individual.
How long must a
provider retain medical records?
Hospitals are required to retain medical records for a minimum of ten
years as part of their state licensure obligations. [18 V.S.A. §1905(8)]
The licensure laws are silent for other providers. Retention of medical
records for longer periods of time is recommended, however.
The Vermont Statute of
Limitations governing medical malpractice or personal injury actions
allows a cause of action to be brought within three years of the
discovery of the injury. [12 V.S.A. §512(4)] Under a variety of
facts, an extensive period of time may pass before a particular medical
problem is discovered. Litigation cases involving the past exposure of
an individual to toxic or hazardous substances, such as asbestos, as
well as the cases questioning the past prescription of various drugs,
such as diethylstilbestrol (DES), demonstrate the benefit to the patient
of retaining medical records for as extensive a time period as a
patient’s full lifespan.
It simply cannot be known when
a variety of latent medical conditions will be “discovered.”
In any event, children’s
records should be retained until at least three years following their
eighteenth birthday because the statute of limitations for a minor to
sue for a cause of action does not begin until the minor reaches the age
of majority. [12 V.S.A. §551(a)]
What period of time is recommended for
retaining the records of a deceased patient?
The wrongful death statute requires court actions to be commenced two
years from the date of death. The survival of actions law; however,
permits court actions to be commenced two years after the date of
issuance of letters testamentary by the probate court, which can be some
time after the death. Physicians should check with the court with
respect to the timing of the issuance of letters testamentary. As a
general rule, it is recommended that a provider retain records of
deceased patients for no less than three years after the patient’s
death.
May a provider in Vermont release medical records
or disclose medical information in response to a subpoena?
No, unless the patient has authorized or consented to the release, or,
in the rare instance, that the subpoena has been issued by a Vermont or
federal court rather than an attorney. The Vermont patient privilege
statute [12 V.S.A. §1612] and the mental health information statute [18
V.S.A. §7103] permit disclosures without patient consent only if
directed by a court of law. A civil subpoena, commonly issued by
attorneys, does not override the patient privilege of confidentiality.
Vermont law is to be distinguished as much stricter than the HIPAA
privacy regulation which permits a health care provider to disclose
health information in response to a subpoena if certain efforts have
been made to notify the individual. [45 CFR §164.512(e)]
What should a provider
do if he is served a subpoena for medical records or to testify about
medical information?
The following steps are recommended:
-
Determine whether there is a proper basis for
releasing the patient’s records. For instance, a patient authorization
may be attached to the subpoena. If so, the provider is authorized to
release patient information in response to the subpoena.
-
If no proper legal basis appears for releasing
the records, contact the party issuing the subpoena to seek a
voluntary resolution. Explain that the subpoenaed documents or
information cannot be released without the patient’s authorization,
and that none appears. Often, a subpoena will be withdrawn on this
basis or authorization will be obtained. If the former occurs,
document the withdrawal of the subpoena in writing by a follow-up
letter.
-
If the subpoena is not voluntarily withdrawn, and
there remains no evident legal basis for releasing the records or
information sought, determine whether the subpoena has been validly
issued. Note that a subpoena issued by another state court is not
valid in Vermont and requires no response. There may be other
technical defects in the subpoena as outlined above. (Check with your
attorney.)
-
If the subpoena is valid, a response must be made
before the return date. Counsel should be contacted to make an
appropriate response, either by written objection, a motion to quash
or by a motion for protective order.
-
Under appropriate circumstances, it may be
desirable to contact a patient in response to a subpoena to determine
whether the patient will consent to the release of the requested
documents or records.
Some special comments are in order in responding to investigative or
criminal subpoenas issued by prosecutors and law enforcement agencies.
Subpoenas in this context may be seeking information about a criminal
defendant or suspect, or about a victim (as in a rape case). Resistance
from practitioners to release information may sometimes be interpreted
by law enforcement agencies as lack of cooperation in criminal
enforcement. These problems must be handled delicately and
diplomatically, and may require meetings with local law enforcement
agencies to explain the practitioner’s obligations to protect patient
records and communications. At a minimum, law enforcement officials
could be asked to obtain a district court order in support of a criminal
subpoena. Such an order which the state could obtain ex parte,
would ensure that due consideration is accorded the confidentiality
rights of the patient whose records are being sought.
What should a practitioner do if an officer
has a search warrant for medical records?
The practitioner must comply with the warrant as a search warrant is
only issued after prior judicial approval and a showing of probable
cause. There can be no question in the context of search warrants that a
court order has been issued. The practitioner should call legal counsel
as soon as possible.
Search warrants have a
distinctly different purpose than a subpoena. Search warrants are
limited to criminal proceedings to obtain evidence against a defendant
suspected of a criminal violation. The defendant may be a health care
provider or facility or a patient. Because a search warrant is only
issued after a showing of probable cause, they are executed immediately
and there is no time between issuance and execution for the person
subject to the warrant to challenge its legal validity. Therefore,
challenges to search warrants are always made after the warrant has been
issued and executed and prior to the introduction of the documents or
objects in evidence.
A copy of the search warrant
will be served on the person from whom or from whose premises the
property was taken. In addition, the officer executing the warrant must
provide a receipt for the property taken. (The basic requirements for
state search warrants are set forth in V.R.C.P. 41.)
What rights do the media or press have to
patient information?
The media’s rights to access information are no different than anyone
else’s. They must either have patient authorization or a court order.
Access to
Records
What rules govern a patient’s access to his or her medical
record?
Under Vermont law, practitioners are required to provide patients
prompt access to their records upon written request, and failure to do
so constitutes unprofessional conduct under 3 V.S.A. §129a(a)(8) and 26
V.S.A. §1354(a)(10). These provisions require that copies be provided to
the patient’s representative or succeeding health care practitioner upon
the patient’s written request. The HIPAA Privacy Regulations also
require that records or copies be made available to patients upon
written request, and they provide a thirty day time period for a health
care provider to respond to a patient’s request to inspect or obtain a
copy of their medical record. This response time may be extended for a
second thirty day period. [45 CFR §164.524]
May access to a
patient’s medical record ever be denied to the patient or his or her
representative?
Vermont law requires the prompt and complete disclosure of medical
information. The HIPAA regulations, unlike the Vermont statutes
pertaining to unprofessional conduct, specify limited circumstances
under which a practitioner may deny access to an individual’s health
information. Because Vermont law would be considered to be more
beneficial to a patient, it is likely to govern and preempt any contrary
federal provision. Thus, the process for the review of such a denial by
another practitioner afforded by the HIPAA regulations may be academic.
The HIPAA regulations do allow for a denial in the following
circumstances:
- when a provider, in the
exercise of his or her professional judgment, determines that it is
reasonably likely that access to the requested information would
endanger the life or physical safety of the individual or other person
(sometimes referred to as the “therapeutic privilege”);
- when the requested
information refers to another person and the provider, in the exercise
of professional judgment, determines that access is reasonably likely
to cause substantial harm to that other person; or
- when the request for access
is made by the individual’s personal representative and a provider, in
the exercise of his or her professional judgment, determines that
providing access to that representative is reasonably likely to cause
substantial harm to the individual or another person.
Note that under the HIPAA
privacy regulations, a practitioner may deny access to psychotherapy
notes to the subject patient (45 CFR §164.524) and cannot disclose such
information to others without the patient’s voluntary and specific
authorization. Vermont professional licensing law contains no similar
exception within its unprofessional conduct provisions, as a result this
discussion is largely academic. Vermont law requires the prompt and
complete disclosure to the individual.
If I receive records
from another provider, must I produce them to a patient or where a
patient has authorized the release of all information I maintain?
Yes. The patient has a right to all of their medical information you
maintain regardless of who generated the original documentation.
Must I provide a record labeled “Do Not
Rerelease” to a patient?
Yes. Under Vermont law, a patient has access to all information
pertaining to their medical care. Generally, records labeled “Do Not
Rerelease” are related to alcohol or drug abuse treatment and are
subject to a specific federal regulation which requires the patient to
specifically consent to their further release.
Who may authorize the disclosure of the medical record of a deceased
individual?
The Vermont patient privilege statute requires the disclosure of
information regarding the mental or physical condition of a deceased
patient if the privilege of confidentiality is waived by the decedent’s
personal representative, the surviving spouse or the next of kin of the
decedent. [12 V.S.A. §1612(c)] Vermont law does not specify which
relatives qualify as “next of kin.” Also note that this disclosure
requirement is voided in the event that the practitioner concludes that
the disclosure “would tend to disgrace the memory of the decedent.” No
further guidance has been provided by either legislation or court
precedent to define the scope of this contingent provision.
What am I allowed
to charge patients, or others such as lawyers and insurance companies,
for providing copies of a patient’s health care record?
Both Vermont law and the HIPAA Privacy Rule address the amount that may
be charged for providing copies of a patient’s health care record. In
sum, you are allowed to charge a reasonable cost-based fee, not to
exceed $.50 per page. If applicable, you may also charge for postage.
Also, practitioners and health care facilities are required to provide
an itemized bill to the recipient of the records copied. However,
Vermont law prohibits any charge for copies of records needed to support
a claim or an appeal for public benefits such as welfare, Social
Security, Medicare or Medicaid. The HIPAA Privacy Rule does not override
this provision.
What is the
difference between the federal regulation and state law on Medical
Record Copy Charges?
The two provisions provide as follows:
-
Vermont Law [18
V.S.A. § 9419] permits a physician office to charge a fee
that is no more than a flat $5.00 fee or
$0.50 per page, whichever is greater. No charges may be imposed when
the records are requested to support a claim or an appeal for public
benefits, such as welfare, Social Security, Medicare or Medicaid.
-
The federal HIPAA Privacy Rule [§164.524(c)(4)] permits offices to
charge a reasonable, cost-based fee for copying a patient’s medical
records, based only on the cost of copying, including the cost of
supplies, equipment lease, and labor for copying the records
requested. The fee may not include charges for searching for the
record or reviewing the record in connection with copying it.
Your
office must follow whichever provision above results in the lower
copying fee. For example, if your office’s reasonable cost-based fee of
copying the records is less than the Vermont allowance of $.50 per page
or $5.00 fee, you must charge the reasonable cost-based fee for the
copies, unless, of course, it is to support a public benefits claim or
appeal in which case no copy charge may be imposed. On the other hand,
if the actual cost of providing copies exceeds the amount permitted by
Vermont law, you are capped by the Vermont statutory allowance and can
charge no more than $.50 per page or a $5.00 fee.
A
provider is permitted to charge for the preparation of an explanation or
summary of a record, in lieu of the full record, if the recipient has
agreed in advance to receive an explanation or summary and if they have
agreed in advance to the fees. A provider may also charge a fee for
mailing, if the patient agrees in advance. A provider should document in
the patient’s record whether they have requested that the record be
mailed to them or have agreed to have the record summarized.
What
am I allowed to charge patients for providing copies of images?
Vermont law allows physician offices to charge a cost-based fee for
providing copies of x-rays, films, models, disks, tapes or health
information maintained in other formats. This provision is consistent
with the HIPAA Privacy Rule.
Amendment of Record
What
procedures should be followed if a physician seeks to amend a medical
record previously created?
If the necessity to correct an entry in a medical record arises, the
correction must be made without erasing, obliterating or deleting the
original medical record entry. Alterations to or deletions of original
records may raise the suspicion of an attempt to conceal the truth.
Whether the correction is made in an electronic record or a paper
record, the original entry should not be changed. The amendment should
include the date and time of the amendment, a notation that the entry is
an amendment, to distinguish it from the original record, and the reason
for the amendment. Health care facilities and professionals should
develop policies on correcting medical records and delegate authority to
make corrections to specific identified individuals.
What rights does a
patient have to amend his or her medical record?
Patients have the right under HIPAA to amend or supplement their own
medical records for as long as the covered entity maintains the
information. The health care professional or facility must act on an
individual’s request for amendment no later than 60 days after it
receives the request. The deadline may be extended up to 30 days.
If a request to
amend is accepted, the covered entity must inform the individual and
make the appropriate amendment. It must then provide the amendment to
entities identified by the individual and to other entities known to
have received the erroneous information.
A request to amend
may be denied if the health care professional or facility determines
that the information or record:
-
Was not created
by the covered entity, unless the originator of the protected health
information is no longer available to make the amendment;
-
Is not part of
the designated record;
-
Would not be
available for inspection under the patient’s right of access; or
-
Is accurate and
complete.
In this situation,
the health care professional or facility must give the patient written
notice of its decision that describes:
-
The basis for
the denial;
-
The patient’s
right to submit a written statement disagreeing with the denial;
-
A statement that
the patient can request the health care professional or facility to
include the patient’s request and the denial with any future
disclosures of the information (if the patient does not file a
statement of disagreement); and
- How the
individual can file a complaint with the covered entity or the
secretary of HHS.
About the
Author
Anne Cramer,
a partner in the law firm of Primmer, Piper, Eggleston & Cramer, P.C.,
serves as counsel to hospitals, nursing homes, community mental health
agencies, physician groups and other private health care interests in
Vermont. Anne and her firm have long served as counsel to the Vermont
Association of Hospitals and Health Systems and also provide counsel to
the Vermont Health Care Association, and the Council for Developmental
and Mental Health Services. She is a member of the American Health
Lawyers Association, and the Health Law Section of the American Bar
Association. In her health law practice, Ms. Cramer emphasizes
compliance with federal and state regulatory requirements, including
fraud and abuse prevention, HIPAA regulations on privacy, antitrust
compliance and employment law. Ms. Cramer lectures frequently on health
law topics generally, and she has been cited in Best Lawyers in
America for her health law related work for over ten years.
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