When does federal HIPAA privacy law override Maryland's medical records confidentiality law?
Apply this to your situation
This page answers the general question as of 2003. Ezel answers yours: what it means for your facts, under current Maryland law, with citations.
Plain-English summary
Shortly after the federal HIPAA Privacy Rule took effect in 2003, the chair of Maryland's State Advisory Council on Medical Privacy and Confidentiality asked the Attorney General for guidance on when the new federal regulations preempt Maryland's existing Confidentiality of Medical Records Law. The opinion laid out a structured framework: first ask whether a real conflict exists at all (is it impossible to follow both laws, or does the state law obstruct HIPAA's purposes), and if so, whether the state law nonetheless survives because it falls under a HIPAA carve-out for public health or regulatory reporting, because it is "more stringent" than the comparable federal standard, or because HHS has separately determined it is necessary or addresses controlled substances.
Applying that framework to specific recurring questions, the opinion concluded that most of Maryland's medical records law survives HIPAA because the two schemes are similarly structured and Maryland's protections are generally equal to or stronger than HIPAA's floor: restrictions on redisclosure, physician disciplinary reporting and subpoenas, patient authorization form requirements, parental access to a minor's records, and research disclosures were all found not preempted. The opinion identified one clear area of conflict: Maryland's law allowing providers to charge patients an inflation-adjusted retrieval and handling fee (at least $15 at the time) for copies of their own medical records is preempted by HIPAA's rule limiting patient-access fees to the cost of copying, postage, and any requested summary, since HHS had deliberately excluded retrieval and handling costs from what may be charged to a patient requesting the patient's own records.
Currency note
This opinion was issued in 2003. Subsequent statutory amendments, court decisions, or later AG opinions may have changed the analysis. Treat this page as historical context, not current legal advice. Verify current law before relying on any specific rule, fee amount, or preemption conclusion mentioned here, particularly since HIPAA's implementing regulations and Maryland's medical records fee amounts have both been revised multiple times since 2003.
Common questions
Does HIPAA completely replace Maryland's medical privacy law?
No, according to this opinion. It found the two laws are similarly structured and mostly compatible, since HIPAA sets a national floor of privacy protection and defers to state law wherever the state law is at least as protective, falls under a specific statutory carve-out, or does not actually conflict with HIPAA's requirements.
Could a Maryland provider charge a patient a flat retrieval fee for a copy of the patient's own medical record under HIPAA?
This opinion concluded no, at least not the specific Maryland retrieval and handling fee then in place. It found that fee preempted by HIPAA because federal regulators had deliberately excluded retrieval and handling costs from the charges a covered entity may pass on to a patient requesting the patient's own records, while Maryland's separate copying-fee and postage charges were not affected.
Does Maryland law let a parent see a minor child's medical or mental health records?
This opinion found no preemption issue here, since HIPAA expressly defers to state law on parental access to a minor's records, and Maryland's medical records law ties a parent's access rights to the minor's own legal capacity to consent to the underlying treatment.
Background and statutory framework
Maryland's Confidentiality of Medical Records Law appears at Health-General Article §4-301 et seq. and predates HIPAA's federal Privacy Rule, which HHS adopted under the Health Insurance Portability and Accountability Act of 1996 and which took effect April 14, 2003. HIPAA contains a selective preemption provision: it generally supersedes contrary state law, but expressly carves out state public health reporting laws and certain state regulatory, licensure, and investigatory reporting activities, and separately defers to any state law that is "more stringent" than the comparable federal standard.
The opinion applied established Supremacy Clause preemption doctrine, including the presumption against finding a conflict between state and federal law described in Rice v. Santa Fe Elevator Corp. and California v. ARC Am. Corp., alongside HIPAA's own regulatory definitions of "contrary" (the impossibility test and the obstacle test) and "more stringent" state law. It compared the two statutory schemes provision by provision, including patient authorization requirements, redisclosure restrictions, disclosure to state licensing boards under the Health Occupations Article, and patient-access fees, drawing on Warner v. Lerner and Dr. K v. Board of Physician Quality Assurance for the Maryland law's underlying purpose and constitutional privacy backdrop.
Citations and references
Statutes:
- 42 U.S.C. §1320d-7(a)(1), (b), (c), (a)(2)(A)(i), and (a)(2)(A)(ii), HIPAA's express preemption provision and its statutory and administrative exceptions
- 45 CFR §160.202, defining "contrary" state law for preemption purposes
- 45 CFR §160.203(a)(1)(iv), the "necessity" administrative exception to preemption
- 45 CFR §164.502(a), the general HIPAA nondisclosure rule for protected health information
- 45 CFR §164.508(c), required elements of a valid patient authorization under HIPAA
- 45 CFR §164.524, patient right to access and obtain copies of records, including permissible fees
- 45 CFR §164.512(d), permitting disclosure for health oversight activities such as licensing and discipline
- Health-General Article §4-301 et seq., Maryland's Confidentiality of Medical Records Law
- HG §4-301(g), defining "medical record" under Maryland law
- HG §4-301(k), defining "person in interest" entitled to access records
- HG §4-302(d), restricting redisclosure of medical records
- HG §4-303(b), required elements and one-year validity limit for a Maryland authorization
- HG §4-304(c), patient record-copying and retrieval fee provisions
- HG §4-306 and §4-307, disclosures permitted or required without patient authorization, including special mental health record rules
- Health Occupations Article §14-413, requiring hospitals to report physician discipline to the Board of Physicians
- United States Constitution, Article VI, the Supremacy Clause
Cases:
- California v. ARC Am. Corp., 490 U.S. 93, 100-101 (1989), on when state law is preempted by actual conflict with federal law
- Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947), on the presumption against finding a preemptive conflict
- Dr. K v. Board of Physician Quality Assurance, 98 Md. App. 103, 632 A.2d 453 (1993), on the constitutional right of privacy in medical information
- Warner v. Lerner, 348 Md. 733, 738-40, 705 A.2d 1169 (1998), on the scope of Maryland's medical records disclosure rules
Source
- Landing page: https://oag.maryland.gov/resources-info/Pages/attorney-general%E2%80%99s-opinions.aspx
- Original PDF: https://oag.maryland.gov/resources-info/Documents/pdfs/Opinions/2003/88oag205.pdf
Original opinion text
Gen. 205] 205
MEDICAL RECORDS
C ONFIDENTIALITY OF M EDICAL R ECORDS U NDER M ARYLAND
L AW AND THE F EDERAL H EALTH I NSURANCE P ORTABILITY
AND A CCOUNTABILITY A CT OF 1996 (HIPAA)
December 18, 2003
Mr. Robert Baum
Chair, State Advisory Council on
Medical Privacy and Confidentiality
Department of Health & Mental Hygiene
You have asked for our opinion concerning application of the
federal medical privacy regulations that went into effect earlier this
year under the Health Insurance Portability and Accountability Act
of 1996 ("HIPAA"). HIPAA contains a selective preemption
provision that places custodians of medical information in the
position of determining whether federal or State law governs
disclosure of that information in various circumstances. You ask for
guidance on when the new federal regulations preempt existing
State law concerning confidentiality of medical records.
In our opinion, the relationship of HIPAA to existing State
laws turns on the answers to certain questions:
(1) First, one must determine whether a conflict actually
exists, i.e., is the State provision "contrary" to HIPAA in the sense
that:
(a) it is impossible to comply with both the
requirements of HIPAA and the State
law; or
(b) compliance with the State law would be
inconsistent with the objectives of
HIPAA?
In most situations there will be no conflict between State and federal
law and therefore no need to apply the HIPAA preemption
provision, although the HIPAA regulations may create requirements
additional to those under State law.
206 [88 Op. Att'y
(2) Second, if there appears to be a genuine conflict between
the HIPAA regulations and State law, a custodian of medical records
should then consider the following questions:
(a) Does the State statute fall under the
exclusions in HIPAA for public health or
regulatory reporting?
(b) Is the State statute "more stringent" than
its HIPAA counterpart?
(c) Has the Secretary of Health and Human
Services ("HHS") determined that the
State statute is either "necessary" to
achieve one of the permissible State
objectives listed in HIPAA, or that it
addresses controlled substances?
If the answer to any of these questions is yes, the State provision is
not preempted by HIPAA. If the answer to all of these questions is
no, then HIPAA preempts that aspect of State law.[1]
I
HIPAA
Enacted in 1996, the HIPAA statute affected several aspects of
the health care system. See Pub. L. 104-191, 110 Stat. 1936. For
example, it provided for portability (i.e., transferability) of health
insurance coverage for people changing employment. A major
portion of HIPAA, titled "Administrative Simplification," amended
the Social Security Act with the purpose of increasing health care
system accountability and preventing fraud and abuse. Id., Title II,
Subtitle F. That portion of HIPAA required HHS to develop a
program to simplify the filing and payment of health insurance
claims by promoting the use of electronic claims. In concert with
this expansion of electronic claims, HIPAA also compelled the
development of systems to protect the security and privacy of health
care information. To carry out this charge, HHS adopted regulations
governing the confidentiality of medical records, which became
effective April 14, 2003. See 45 CFR Parts 160 and 164.
The HIPAA regulations, also referred to as the "Privacy Rule,"
establish national standards for the protection of health information.
According to HHS, "[a] major goal of the Privacy Rule is to assure
that individuals' health information is properly protected while
allowing the flow of health information needed to provide and
promote high quality health care and to protect the public's health
and well being." Office of Civil Rights, Department of Health and
Human Services, Summary of the HIPAA Privacy Rule (May 2003
rev.) at p.1.[2]
The HIPAA regulations attempt to achieve that goal in
language that is based on elaborate definitions of key terms. The
regulations govern the confidentiality of "protected health
information" in the custody of "covered entities." The term
"covered entity" encompasses health plans, health care
clearinghouses,[3] and providers who transmit health information
electronically. 45 CFR §160.103. "Protected health information" is
individually identifiable health information maintained or
transmitted in any form or medium. 45 CFR §164.501.[4] The
regulations do not restrict the use or disclosure of "de-identified"
information, i.e., health information that neither identifies nor
provides a reasonable basis to identify an individual. See 45 CFR
§§164.502(d), 164.514(a), (b).
In essence, the regulations provide that "[a] covered entity may
not use or disclose protected health information, except as permitted
or required by [the HIPAA regulations]. 45 CFR §164.502(a).
HIPAA requires a covered entity to extend these restrictions by
contract to its "business associates" who receive protected health
information to assist in its treatment, payment, and health care
operations. 45 CFR §164.502(e)(1), §164.504(e).[5] The remainder
of the regulations details when and how protected health information
may be disclosed. In general, a covered entity must notify a patient
of its privacy practices and must obtain the patient's authorization
for disclosure of the patient's health information, unless the
disclosure is for treatment, payment, or health care operations or
otherwise meets specified exceptions. See 45 CFR §§164.506,
164.508, 164.512.
The HIPAA regulations also confer certain affirmative rights
on patients. A patient generally has a right to inspect and obtain a
copy of his or her medical records. 45 CFR §164.524. In addition,
the regulations provide standards and procedures for an individual
to seek an amendment of a medical record. 45 CFR §164.526.
Subject to a number of exceptions, an individual is also entitled to
an accounting of disclosures of his or her medical records. 45 CFR
§164.528.
II
HIPAA Preemption
A. Federal Preemption
Under the Supremacy Clause of the federal Constitution,[6] when
Congress passes a law to regulate a particular field, the resulting
federal law may completely preempt state law in several ways. First,
Congress may expressly preempt state law. Second, in the absence
of express preemption, preemption is implied when Congress intends
that federal law "occupy a given field." Third, state law will be
preempted when it actually conflicts with federal law. California v.
ARC Am. Corp., 490 U.S. 93, 100-101 (1989). Conflict between
state and federal law is not presumed, and whenever possible, state
and federal provisions should be construed in a manner to make
them compatible. See Rice v. Santa Fe Elevator Corp., 331 U.S.
218, 230 (1947); 84 Opinions of the Attorney General 91, 97 (1999);
but see The Supreme Court, 1999 Term, 114 Harv. L. Rev. 339
(2000) (arguing that the presumption is not a strong one and is often
violated). Moreover, even when it expressly preempts state law,
Congress does not always do so entirely. Instead, Congress
sometimes selectively preempts state law, preserving part of state
law by a savings clause. See 2 Rotunda & Nowak, Treatise on
Constitutional Law (3d ed. 1999), §12.1 at p. 200.
HIPAA contains a selective preemption provision with respect
to medical record confidentiality. It establishes a general rule of
federal preemption of state law. However, HIPAA saves state law
in several ways: it carves out two major areas in which its rules are
inapplicable; it provides for administrative determination of two
other types of exceptions; and it defers to state law when a state
provision is "more stringent" than the corresponding federal
provision.[7] In practice, the HIPAA regulations do not effect a
wholesale federal preemption of the field of medical record privacy,
but rather establish a national floor of medical privacy protection.
See 65 Fed Reg. 82461, 82580 (December 28, 2000) (Discussion of
Comments, Final Privacy Rule).
B. General Rule under HIPAA: Express Statutory Preemption
Subject to certain exceptions, Congress expressly adopted the
general rule that the HIPAA statute, and any "standard or
implementation specification" adopted under HIPAA "shall
supersede any contrary provision of State law, including a provision
of State law that requires medical or health plan records ... to be
maintained in written rather than electronic form." 42 U.S.C.
§1320d-7(a)(1).
C. Statutory Exceptions to HIPAA Preemption
Congress designated two areas of state law, known as
"statutory carve-outs," where HIPAA does not trump or override
state law. Another statutory provision preserves any state law that
is "more stringent" than the federal standard.
1. Public Health
In one exception, HIPAA lists a number of activities carried
out under state public health laws. In particular, Congress provided
that "[n]othing in this part shall be construed to invalidate or limit"
the authority, power, or procedures established under any law for the
following areas:
1. the reporting of disease or injury;
2. the reporting of child abuse;
3. the reporting of birth or death;
4. public health surveillance;
5. public health investigation; or
6. public health intervention.
42 U.S.C. §1320d-7(b); 45 CFR §160.203(c). Under this exception,
state and local health departments and other agencies may continue
to conduct traditional state public health activities without
conforming their activities to HIPAA.
2. State Regulatory Reporting by Health Plans
Another statutory exception expressly saves certain other state
regulatory reporting, licensure, and investigatory activities from
federal preemption. These include requirements that a health plan
report or provide access to information for:
1. management audits;
2. financial audits;
3. program monitoring and evaluation;
4. facility licensure or certification; or
5. individual licensure or certification.
42 U.S.C. §1320d-7(c); 45 CFR §160.203(d). This allows state
health departments and licensing boards to continue traditional state
licensure and programmatic review and evaluative activities
concerning health plans [8] without having to conform to HIPAA.
3. "More Stringent" State Law
HIPAA also provides an exception for a state law that is
"contrary" to the federal regulations if the provision of state law
"imposes requirements, standards, or implementation specifications
that are more stringent than" the comparable federal standard. Pub.
L. 104-191, §264(c)(2) incorporated by reference in 42 U.S.C.
§1320d-7(a)(2)(B) (emphasis added);[9] see also 45 CFR §160.203(b).
HHS has fleshed out this savings clause through definitions in
the HIPAA regulations. First, the regulations set the bar high for
finding a conflict between HIPAA and state law. They define
"contrary" to mean either: 1) that an entity would find it impossible
to comply with both the state and federal provisions ("impossibility
test"); or 2) that the provision of the state law stands as an obstacle
to the full purposes and objectives of HIPAA ("obstacle test"). 45
CFR §160.202.
Similarly, HHS has defined the term "more stringent" to mean
that the state law would: restrict a disclosure permitted under
HIPAA, grant an individual greater access to the individual's own
health information, more severely restrict the scope or duration of
authorized access by another person, require greater record-keeping,
or generally provide greater privacy protection to the individual who
is the subject of the record. 45 C.F.R. §160.202.
D. Administrative Exceptions
State law is also not preempted if the Secretary of HHS makes
certain determinations. These administrative exceptions to federal
preemption fall into two categories.
1. Necessity
A state law survives federal preemption if the Secretary of
HHS determines that the state law is "necessary" for one of the
following reasons:
1. to prevent fraud and abuse;
2. to ensure appropriate state regulation of
insurance and health plans;
3. for state reporting on health care delivery
or costs, or
4. for other purposes.
42 U.S.C. §1320d-7(a)(2)(A)(i); 45 CFR §160.203(a)(1). Under the
HIPAA regulations, a state law provision is "necessary" for "other
purposes" when it serves a "compelling need related to public health,
safety, or welfare" and the Secretary determines that the intrusion
into privacy permitted by the state law is outweighed by the
compelling need that the law serves. 45 CFR §160.203(a)(1)(iv).
Application of this "necessity" exception is difficult to gauge
because, while the regulations set forth procedures for a state to seek
the requisite determination from the Secretary, they do not state a
timetable for HHS to make that determination. 45 CFR §160.204.
It is not clear how permissive HHS will be in allowing current state
regulatory activities that may be contrary to HIPAA to continue
under the "necessity" exception. Therefore, for the purpose of an
initial preemption analysis, we will not assume that a "necessity"
exception will apply.
2. State Law Addressing Controlled Substances
State law is also not preempted if the HHS Secretary
determines that the state provision at issue "addresses controlled
substances." 42 U.S.C. §1320d-7(a)(2)(A)(ii). The HHS regulations
interpret this exception to cover situations in which the state law
"has as its principal purpose the regulation of the manufacture,
registration, distribution, dispensing, or other control of any
controlled substances [as defined under federal or state law]." 45
CFR §160.203(a)(2). This carves out state laws used in the civil or
criminal regulation of controlled substances. While it appears
unlikely that the HHS Secretary will be restrictive in making these
exception determinations, a state must apply to HHS for a
determination. See 45 CFR §160.204.
III
State Medical Records Law
The Maryland Confidentiality of Medical Records Law ("State
medical records law") appears in Annotated Code of Maryland,
Health-General Article ("HG") §4-301 et seq. That law sets forth
restrictions on the disclosure of medical records that, like the HIPAA
regulations, are designed to preserve the confidentiality of medical
information pertaining to individuals. For purposes of the statute,
"medical record" is defined broadly and includes information
transmitted in any form, if the information is identified with a
particular patient and relates to the health care of that patient. HG
§4-301(g).
Under the medical records law, a patient has certain rights to
inspect and obtain copies of medical records, and to have corrections
made to those records. HG §4-304. The law requires health care
providers and others to preserve the confidentiality of medical
records, although it permits disclosure with the written authorization
or stipulation of the patient or another authorized person.[10] HG §§4-
302, 4-303, 4-306(b)(6)(ii). It also delineates those limited
circumstances in which medical records may or must be disclosed
without the permission of the patient. HG §§4-305, 4-306. See
generally Warner v. Lerner, 348 Md. 733, 738-40, 705 A.2d 1169
(1998). Even when disclosure is authorized, the Maryland law
restricts the use and redisclosure of the records by the person
receiving them. HG §4-302(d).[11] Special restrictions apply to
mental health records. HG §4-307. Finally, the State medical
records law creates liability rules and penalties for a failure to
comply with the law. HG §§4-308, 4-309.
IV
Preemption Analysis
A. In General
Many provisions of the federal HIPAA regulations and the
State medical records law are easily harmonized, especially given
the presumption against finding a conflict between federal and state
law that would result in preemption of State law. Both laws are
similarly structured. Each regulates disclosure of health care
information by health care providers. Compare 45 CFR §§160.102,
160.103 with HG §§4-301(h), 4-302(a). Each establishes a general
rule protecting the confidentiality of patient records. Compare 45
CFR §164.502(a) with HG §4-302(a). Patients are to have ready
access to their own records and an ability to amend those records.
Compare 45 CFR §§164.524, 164.526 with HG §4-304. Access is
granted to others who provide ancillary treatment, payment, or other
health care operations for patients. Compare 45 CFR §164.506 with
HG §4-305(b). Other disclosures generally require patient
authorization. Compare 45 CFR §164.508 with HG §4-303. Certain
limited disclosures without patient authorization, for recognized
public purposes, are required or permitted. Compare 45 CFR
§164.512 with HG §4-306. Both laws punish violations with civil
and criminal penalties. Compare 42 U.S.C. §§1320d-5, 1320d-6 with
HG §4-309.
There are also significant differences between the two laws.
HIPAA and its regulations regulate only certain "covered entities",
basically, providers who engage in electronic transactions, health
plans, and claims clearinghouses. See 45 CFR §160.102(a). By
contrast, the State law, by placing restrictions on redisclosure of
records, extends to anyone who receives medical records. See HG
§4-302(g). The State medical records law is much less detailed than
the HIPAA regulations; it focuses sparingly on whether disclosures
are authorized for specific purposes. By contrast, HIPAA is
extraordinarily prescriptive, specifying the management of health
care information and personnel in significant detail. Thus, while
Maryland law and HIPAA, for the most part, have similar disclosure
and nondisclosure provisions, HIPAA is much more detailed. Yet
those additional HIPAA requirements do not necessarily create a
conflict with the State law.
B. Specific Applications
By necessity, an opinion cannot answer all of the myriad
questions that may arise about the relationship of the State medical
records law and the HIPAA regulations. However, a review of
selected examples will illustrate the analysis that must be applied to
answer those questions.
1. Redisclosure of Information
HIPAA controls only "covered entities," which are health
plans, claims clearinghouses, and providers that transmit information
in electronic form. 45 CFR §§160.102, 160.103 Indeed, HIPAA
requires authorization forms to state that, once information is
disclosed to a third party pursuant to an authorization, its
confidentiality is not protected by HIPAA. 45 CFR
§164.508(c)(1)(vi). The State medical records law primarily
regulates health care facilities and providers, and their agents and
employees, but also precludes any person from redisclosing medical
record information, except as authorized by the patient or as
otherwise permitted by law. HG §4-302(d).
The two laws thus appear to be inconsistent. However,
Maryland's redisclosure provision survives preemption for two
reasons. First, the restrictions on redisclosure are not contrary to
HIPAA, as it is not impossible to comply with both HIPAA and
those restrictions. Nor do the redisclosure restrictions pose an
obstacle to HIPAA, but rather supplement it. Thus, under the
HIPAA regulations, the Maryland redisclosure restrictions are not a
State law "contrary" to HIPAA.
Second, even if the Maryland provision could be characterized
as contrary to HIPAA, it survives preemption because it is "more
stringent" than HIPAA, that is, it provides greater protection for
patient information. Thus, the Maryland restrictions on redisclosure
of medical records are not preempted by HIPAA.[12]
2. Hospital Physician Disciplinary Reports and
Subpoenas
Maryland law requires a hospital to file a report with the Board
of Physicians, the State physician licensing board, when it has
disciplined a physician. Annotated Code of Maryland, Health
Occupations Article ("HO"), §14-413. The report must include the
reason for the discipline. Often this report induces the physician
licensing board to issue a subpoena to the hospital and physician for
medical records. Under the State medical records law, the hospital
and physician must comply with the subpoena and disclose those
records to the board, whether or not the patient has authorized or
consented to the disclosure. HG §§4-306(b)(2), 4-307(k)(1)(vi)1.
The obligation to comply with this reporting requirement and
any subpoenas are not affected by HIPAA. For health plans, the
State reporting and individual licensure or certification activities are
statutorily carved out of the ambit of HIPAA, so Maryland law is
unaffected and no further preemption analysis is required. For
providers, HIPAA allows disclosure of health care information for
health oversight activities authorized by law, including licensing and
disciplinary activities. 45 CFR §164.512(d).
Thus, these disclosures fit within the class of disclosures
compelled under State law and permitted under HIPAA.[13] If State
law compels disclosure of health information and HIPAA is either
inapplicable or permissive regarding the disclosure, then disclosure
mandated by State law may continue unabated.
3. Patient Authorization Forms
Both HIPAA and the State medical records law allow for
disclosures made with the authorization of a patient or other "person
in interest." They each specify necessary elements for an
authorization to be valid.
Under HIPAA, an authorization must contain: 1) a description
of the information to be disclosed; 2) identification of the persons to
whom the information is to be disclosed; 3) identification of the
person authorized to disclose the information; 4) a description of the
purpose of the disclosure; 5) an expiration date for the authorization;
6) a note that the authorization may be revoked; 7) a warning that
any released information may be beyond the reach of HIPAA; 8) a
statement regarding whether the Privacy Rule allows benefits to be
conditioned on granting the authorization; 9) a signature and date,
and 10) if the authorization is made by a personal representative of
the patient, that person's capacity. 45 CFR §164.508(c). If health
information is to be used for marketing and the entity disclosing the
information will receive remuneration in connection with that
marketing, the authorization form must disclose that fact. 45 CFR
§164.508(a)(3)(ii).
The State medical records law specifies five elements for an
authorization: 1) the document must be in writing; 2) it must be
signed and dated by the "person in interest"; 3) it must include the
name of the disclosing provider; 4) it must identify the party to
whom records are disclosed; and 5) it must state the period of time
the authorization is valid. HG §4-303(b). The Maryland law, with
a couple of exceptions, sets a maximum length of one year for an
authorization to be valid. HG §4-303(b)(4).
In this case, the provisions are slightly different, but easily
accommodated, and thus not "contrary" for purposes of preemption.
An authorization that contains the necessary HIPAA elements will
also comply with the Maryland law if it contains an expiration date
of no longer than one year. The HIPAA regulations specifically
allow for additional elements in an authorization form, so long as
they are not inconsistent with the elements required by HIPAA. 45
CFR §164.508(b)(1)(ii). The federal warning that any redisclosure
of information may not be protected under federal law should be
tempered with a statement that wrongful redisclosure is prohibited
under Maryland law.
The specific expiration limit in Maryland law and the limits on
redisclosure do not conflict with HIPAA and are both more stringent
than the HIPAA regulations. Thus, HIPAA does not preempt those
provisions. Of course, an authorization form must contain all of the
HIPAA elements as well.
4. Fees for Copies of Records
The Maryland medical records law governs fees for records
provided to a person in interest "or any other authorized person"
who requests a copy of a medical record. HG §4-304(c). In
particular, it allows providers to charge a preparation and retrieval
fee of up to $15, a copying fee of up to 50 cents per page, and actual
postage and handling fees, all subject to annual adjustment for
inflation as measured by the Consumer Price Index. HG §4-
304(c)(3)-(4).[14]
HIPAA sets some limits on the fees that an individual may be
charged for access to the individual's own health records. It allows
covered entities to impose a reasonable, cost-based fee, provided that
the fee includes only the cost of copying, postage, and preparation
of any summary (if a summary is requested by the patient). 45 CFR
§164.524(c)(4). HHS has indicated that the cost of retrieving or
handling information in response to a patient request for records was
deliberately excluded from the list of permissible charges. See 65
Fed. Reg. 82461, 82557 (December 28, 2000).
It thus appears that there is a conflict between the Maryland
law and HIPAA with respect to the charges that may be assessed
against a patient who requests a copy of the patient's own records.
The Maryland law allows a provider to charge an adjusted retrieval
and handling charge of $15 or more; HIPAA, as clarified by the
HHS commentary, does not. The Maryland provision is preempted
by the HIPAA regulations, insofar as it applies to patient requests.[15]
The authorization under Maryland law to charge a 50-cents-per-page
inflation-adjustable copying fee and actual postage costs appears to
remain valid as not contradicted by, and perhaps filling a void left
open under, HIPAA.
5. Parental Access to Records of Unemancipated Minors
HIPAA looks to state law regarding parental access to the
records of unemancipated minors. The HIPAA regulations give a
parent in such situations the right to view the minor's records to the
extent that state law allows it. 45 CFR §164.502(g)(3). Thus,
HIPAA defers to state law and reflects any ambiguity found in state
law.
The State medical records law ties the ability of a parent to
exercise rights regarding disclosure of a minor child's records to the
minor's capacity under Maryland law to consent to treatment. HG
§4-301(k)(4), (5). Specifically, a minor has the same capacity as an
adult to consent to treatment for drug abuse, alcoholism, venereal
disease, pregnancy, contraception, injuries from rape or sexual
offense, and initial medical screening of the minor into a detention
center. HG §20-102(c). A minor at least 16 years old has the right
to consent to treatment for mental or emotional disorders. HG §20-
104. There is a special rule related to the provision of abortion. HG
§20-103. For mental health and abortion services, physician
professional judgment plays a role in the decision whether to
disclose information to the parent about the treatment of a minor.
HG §§20-103(c) and 20-104(b).
Since HIPAA expressly defers to state law on this subject,
there is no preemption issue.
6. Research
A complex area in HIPAA involves disclosures for research
purposes. The State medical records law does not regulate
disclosure of medical information if the information is not
individually identifiable, or, alternatively, allows researcher access
without the patient's prior authorization if the researcher
acknowledges a duty not to redisclose any individually identifiable
information and complies with institutional review board
requirements. HG §§4-301(g) and 4-305(b)(2)(i).
HIPAA establishes detailed standards, linked with other federal
regulations, for institutional or privacy review board waiver of the
need for patient authorization for the disclosure of health
information. 45 CFR §§164.501 and 164.512(i). HIPAA also
allows certain disclosures without patient authorization or formal
waiver from an institutional review or privacy board for preparation
of research protocols and for research on decedents. 45 CFR
§164.512(i). In addition, it permits the disclosure of protected health
information without certain identifying information pursuant to a
"limited data set agreement." 45 CFR §164.514. In this regard,
unlike State law, HIPAA specifies certain elements that must be
eliminated from the health information to make the disclosed
information not identifiable. On this topic, insofar as HIPAA is
more detailed, federal law supplements, but does not supplant, the
requirements of State law.
V
Conclusion
In these early stages of HIPAA implementation, significant
questions regarding federal preemption are likely to arise. The
relationship of HIPAA to existing State laws will turn on the
following analysis:
(1) First, one must determine whether a conflict between
HIPAA and State law actually exists, i.e. is the State provision
"contrary" to HIPAA in the sense that:
(a) it is impossible to comply with both the
requirements of HIPAA and the State
law; or
(b) compliance with the State law would be
inconsistent with the objectives of
HIPAA?
In most situations there will be no conflict between State and federal
law and therefore no need to apply the HIPAA preemption
provision, although HIPAA may effectively supplement the
requirements of State law.
(2) If there appears to be a genuine conflict between the
HIPAA regulations and State law, a custodian of medical records
should then consider the following questions:
(a) Does the State statute fall under the
exclusions in HIPAA for public health or
regulatory reporting?
(b) Is the State statute "more stringent" than
its HIPAA counterpart?
(c) Has the HHS Secretary determined that
the State statute is either "necessary" to
achieve one of the permissible State
objectives listed in HIPAA, or that it
addresses controlled substances?
If the answer to any of these questions is yes, the State provision is
not preempted by HIPAA. If the answer to all of these questions is
no, then HIPAA preempts that aspect of State law.
J. Joseph Curran, Jr.
Attorney General
C. Frederick Ryland
Assistant Attorney General
Robert N. McDonald
Chief Counsel
Opinions and Advice
[1] This opinion discusses the interplay of HIPAA and the State
medical records law. Other federal laws, such as drug and alcohol
confidentiality regulations, may also restrict health information
disclosures in specific circumstances. See 42 U.S.C. §290dd-2.
Similarly, other State laws govern disclosure of specific health care
information. See, e.g., Annotated Code of Maryland, State Government
Article, §10-617 (disclosure of medical information in the custody of
State and local entities); Annotated Code of Maryland, Health-General
Article ("HG"), §18-337 (disclosure of positive HIV status). Finally, the
constitutional right of privacy also may restrict disclosure in some
circumstances. See Dr. K v. Board of Physician Quality Assurance, 98
Md. App. 103, 632 A.2d 453 (1993), cert. denied, 334 Md. 18, 637 A.2d
1191, cert. denied, 513 U.S. 817 (1994).
[2] See
[3] Health care clearinghouses include billing services and similar
networks. 45 CFR 160.103.
[4] "Health information," in turn, is defined as "any information,
whether oral or recorded in any form or medium, that:
(1) is created by a health care provider, health
plan, public health authority, employer, life
insurer, school or university, or health care
clearinghouse; and
(2) relates to the past, present, or future physical
or mental health or condition of an
individual; the provision of health care to an
individual; or the past, present or future
payment for the provision of health care to
an individual.
45 CFR §160.103.
[5] See Kutzko, et al., HIPAA in Real Time: Practical Implications
of the Federal Privacy Rule, 51 Drake L. Rev. 403, 418 (2003) (arguing
that the HIPAA regulations essentially "pass through" the confidentiality
restrictions from "covered entities" to "business associates").
[6] United States Constitution, Article VI.
[7] This rather complex scheme has generated some confusion as to
when federal or state law prevails. See Bishop, The Final Patient Privacy
Regulations under the Health Insurance Portability and Accountability
Act – Promoting Patient Privacy or Public Confusion?, 37 Ga. L. Rev.
723, 724-28 (2003).
[8] The regulations define "health plan" to include employee welfare
benefit plans, HMOs, health insurers, and a variety of other entities. 42
CFR §160.103.
[9] This savings provision was designed to go into effect only if the
HIPAA privacy standards were promulgated by agency rulemaking by
HHS, rather than by Congressional action. Pub.L. 104-191, §264(c)(1).
Since Congress did not enact a comprehensive medical privacy law by
statute, but instead delegated the task to HHS, the provision is effective.
[10] The statute employs the term "person in interest," which is
defined as:
(1) An adult on whom a health care
provider maintains a medical record;
(2) A person authorized to consent to
health care for an adult consistent with the
authority granted;
(3) A duly appointed personal
representative of a deceased person;
(4) (i) A minor, if the medical record
concerns treatment to which the minor has
the right to consent and has consented
under Title 20, Subtitle 1 of this article; or
(ii) A parent, guardian, custodian,
or a representative of the minor designated
by a court, in the discretion of the
attending physician who provided the
treatment to the minor, as provided in §20-
102 or §20-104 of this article;
(5) If paragraph (4) of this subsection
does not apply to a minor:
(i) A parent of the minor, except
if the parent's authority to consent to
health care for the minor has been
specifically limited by a court order or a
valid separation agreement entered into by
the parents of the minor; or
(ii) A person authorized to
consent to health care for the minor
consistent with the authority granted; or
(6) An attorney appointed in writing
by a person listed in paragraph (1), (2), (3),
(4), or (5) of this subsection.
HG §4-301(k).
[11] The statute states:
A person to whom a medical record is
disclosed may not redisclose the medical record to
any other person unless redisclosure is:
(1) authorized by the person in interest;
(2) otherwise permitted by [the medical
records law]
(3) permitted under [the law concerning
disclosure of child abuse records]; or
(4) directory information.
[12] The State medical records law allows disclosure of a medical
record only as permitted by that law or "as otherwise provided by law."
HG §4-302(a)(2). It might be argued that this provision makes a
permissive disclosure under HIPAA also a permissive disclosure under
the State medical records law. However, this construction would be at
odds with the stated policy that HIPAA sets minimum standards for
confidentiality of medical records and explicitly defers to "more
stringent" State laws.
[13] An eight-page chart listing various mandatory disclosures under
State law was compiled by the Health Law Section of the Maryland State
Bar Association and is available on the MSBA website. See
http://www.msba.org/sec_comm/health/docs/req_chart.pdf.
[14] Fees for record searches and copies of records provided by State
facilities regulated by the Department of Health and Mental Hygiene are
governed by the Public Information Act. See HG §4-304(c)(2)(i).
[15] Because HIPAA contains no restrictions on charges assessed
against non-patients for retrieval and copying of records, there is no
conflict with Maryland law with respect to fees for third party requests.
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