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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 that 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,
179 Vt. 99 (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?
Yes, Vermont no longer recognizes a “limited” therapeutic privilege and
prior statutory references to such a privilege found in the informed
consent and patient bill of rights provisions have been deleted from
Vermont’s statutes.
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, 12 V.S.A. Section 1908, requires that a patient establish
the standard of care for the treatment or procedure that was not met or
for which insufficient information was provided to give informed
consent. Courts have interpreted this law to mean that normally the
burden of proof imposed by the section will be satisfied only by expert
testimony. See Larson v. Candlish, 144 Vt. 499 (1984). Although
recent cases confirm this standard, a limited exception has been carved
out where the alleged violation of the standard of care is so apparent
that it can be understood by a layperson without the aid of medical
experts. See Provost v. Fletcher Allen Health Care, Inc.,
2005 VT 115, ¶ 12, 179 Vt. 545, 547.
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
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; 3) is
managing his or her own financial affairs; and (4) has demonstrated
ability to be self-sufficient in financial and personal 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 the Department of Children and Families (“DCF”)
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 DCF 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 DCF 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 DCF custody
receive pregnancy-related services without informing their parents?
DCF
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;
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] Additionally, pharmacies are required to submit
a report to the Vermont Prescription Monitoring System (VPMS) for each
outpatient Schedule II, III or IV controlled substance prescription.
[http://healthvermont.gov/adap/VPMS.aspx]
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. [18 V.S.A. § 5205(a)]
Requests
by Chief Medical Examiner.
Information regarding the mental or physical condition of a deceased
patient must be released by a physician, dentist, chiropractor, mental
health provider, or nurse upon request from the chief medical examiner.
[12 V.S.A. § 1612 (c)(2)]
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. 61 (1985)]
What
obligation does a provider have to notify a patient of an unauthorized
use or disclosure of medical information of a Vermont patient?
Although
Vermont law does not require any notification to a patient of a wrongful
disclosure or use of medical information, the federal HITECH Act does.
The Interim Final Rule on Breach Notification, which implements the
HITECH Act breach notification requirements, became effective on
September 23, 2009 and requires providers to notify a patient whose
unsecured medical information has been accessed, acquired or disclosed
as a result of a breach which compromises privacy or security no later
than 60 days after the discovery of the breach. The definition of
breach, as well as the content and methodology of notification are set
forth in the American Medical Association’s guidance, “What You Need to
Know About the New HIPAA Breach Notification Rule.” [See
link.] Providers are required to keep a log of any breaches
discovered and report them to the U.S. Department of Health and Human
Services annually.
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 and the HITECH Act, 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 $1,500,000. The
Vermont Attorney General’s office, along with all states attorney
generals, is authorized to enforce the HIPAA privacy regulations through
injunction or civil penalties ranging from $100 up to a maximum of
$25,000. Criminal penalties for certain egregious wrongful disclosures
may be pursued by the U.S. Department of Justice as well.
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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