Jessica Luna, J.D. Candidate
On June 17, 2001, Texas Governor Rick Perry signed the Texas Medical Privacy Act into law. S.B.11 (2001). The Act is designed to bring Texas into compliance with Federal standards on patient privacy as enumerated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 65 Fed. Reg. 82,461 (2000). See http://aspe.os.dhhs.gov/admnsimp/Index.htm. The Texas Medical Privacy Act will also expand the protections mandated by HIPAA in three areas. First, the Act applies to a broader range of entities. Second, the Act does not allow a patient’s health information to be marketed, or to be used in marketing, without that patient’s consent or authorization. Third, the Act prohibits the re-identification of information that has been de-identified.
HIPAA was enacted on August 21, 1996. Title I of the Act deals with health insurance access, portability, and renewability. Title II authorized the Secretary of the Department of Health and Human Services (DHHS) to promulgate final regulations for maintaining the privacy and security of health information if Congress did not enact such legislation within 36 months of HIPAA’s enactment. Congress missed the deadline; therefore, the Secretary issued a final regulation dealing with the security and privacy of protected health information (PHI) on December 20, 2000. The HIPAA Privacy Regulation was formally enacted on April 14, 2001. 45 C.F.R. §§160-164 (2000). See http://aspe.hhs.gov/admnsimp/final/PvcTxt01.htm. On July 6, 2001, the Secretary of the DHHS issued guidelines on the Privacy Regulations. The guidelines clarify the requirements and answer questions about the Regulations. See http://www.hhs.gov/ocr/hipaa/index.html#Initial%20Guidance.
HIPAA is the first federal legislation to initiate uniform privacy standards for patient information. Prior to the enactment of the HIPAA Privacy Regulation, it was up to the states to provide legislation to protect the privacy of patient information. The state laws, however, varied greatly and were often too narrow in their application. See "The State of Health Privacy: An Uneven Terrain," http://www.healthprivacy.org. HIPAA sets a floor of ground rules for health care providers, health plans, and health care clearinghouses to follow, in order to protect patients and encourage them to seek needed care. It creates a framework of protection that can be strengthened by both the federal government and by states as health information systems continue to evolve. 65 Fed. Reg. at 82,464. HIPAA’s provisions allow existing state laws that are more protective of privacy to stand, and permit states to make more protective laws in the future. 45 C.F.R. §160.203(b)
The Texas Medical Privacy
Act is an example of a state law that provides more protection for patient
privacy than is provided under HIPAA. The Act adopts the basic tenets of
the HIPAA Privacy Standards and provides additional protections for Texans
in some areas where HIPAA has left gaps. The following chart is a basic
comparison between HIPAA regulations and those of the Texas Medical Privacy
Act. The portions in bold describe sections of the Texas Medical Privacy
Act that fill a gap left by HIPAA.
Topic | HIPAA | Texas Medical Privacy Act |
Covered Entities | Health
Plans, Health Care Clearinghouses, and Health Care Providers who use computers
to transmit health information.
§160.102 |
Any
person who engages in the practice of assembling, collecting, analyzing,
using, evaluating, storing, or transmitting PHI, etc.
§181.001(b)(1)(A)-(D). This covers many more entities and individuals than HIPAA. |
PHI Definition | PHI
is "individually identifiable health information," whether transmitted
orally, electronically, or on paper. Individually identifiable health information,
including demographic information, is information that:
|
PHI
is individually identifiable health information, including demographic
information, that:
|
Patient’s Rights | Individuals
have rights with respect to their medical information, including the right
to:
|
The
Act adopts HIPAA’s standards relating to an individual’s access to his/her
PHI and ability to amend his/her PHI.
§181.101(a)(1)&(2). |
Notice | Requires
that health plans and health care providers provide written notice of their
privacy practices, including:
|
The
Act adopts HIPAA’s standards relating to notice.
§181.101(a)(4). |
Uses and Disclosures of PHI | The
covered entity must obtain written:
|
The
Act adopts HIPAA’s standards relating to uses and disclosures, including
requirements relating to consent.
§181.101(a)(3). |
Uses and Disclosures Allowed Without Consent or Authorization | No
consent or authorization need be obtained prior to the use and disclosure
of PHI for:
|
No
consent or authorization need be obtained prior to the use and disclosure
of PHI for:
|
Minimum Necessary | When
using or disclosing PHI or when requesting PHI from another covered entity,
a covered entity must make reasonable efforts to limit PHI to the minimum
necessary to accomplish the intended purpose of the use, disclosure, or
request. This does not apply to disclosures for treatment and other specified
purposes.
§§164.502(b)(1)&(2) & 164.514(d). |
|
Psychotherapy Notes | A
covered entity must obtain an authorization for any use or disclosure of
psychotherapy notes.
§164.508(a)(2). Exception: Only consent is required for treatment, payment, or health care operations in the following circumstances:
|
A
licensed psychologist or a psychiatrist who is providing psychological
or psychiatric services to an individual is not required to permit the
individual to inspect or copy a personal diary containing PHI relating
to the individual if the information contained in the diary has not been
disclosed to a person other than another psychologist or psychiatrist for
the specific purpose of clinical supervision conducted in the regular course
of treatment.
§181.051(b). |
Research | PHI
may be disclosed to researchers, regardless of the source of funding of
the research, only if the researcher has obtained:
|
The
Texas law includes the same requirements as HIPAA except that consent or
authorization is required for research without an IRB waiver.
§181.102(a)(1)-(4). |
Marketing | An
individual’s PHI may be used for targeted (by health history or status
of recipient) marketing by or for the covered entity without authorization
from the individual. The covered entity must first make the determination
that the health related product may be of value for the condition and must
explain why the individual is being targeted. §164.514(3)(ii).
Anything can be marketed without authorization form an individual in a face-to-face encounter with the individual, and products and services of nominal value can be marketed without restriction. Any other health related product may be marketed to individuals as long as the covered entity is identified as the party making the communication, any remuneration the covered entity may receive is prominently stated, and the patient is given the opportunity to opt-out (except in the case of broad newsletters). §§164.514(e)(2)(i)(A)(B)(C) and 164.514(e)(3). |
PHI
may not be used, disclosed, or sold for marketing purposes without first
obtaining consent or authorization from the individual. Written communications
must explain the recipient’s right to removal from the mailing list, and
removal must be accomplished within five days after the receipt of the
request.
§181.152(a),(b),&(c). The Texas Medical Privacy Act is much more restrictive of marketing than HIPAA is. HIPAA allows covered entities to market virtually all types of health products, with a few restrictions, without obtaining authorization from the individual. The Texas Medical Privacy Act prohibits any release of PHI for marketing purposes without consent or authorization from the individual. |
Enforcement | Civil
penalties:
|
Civil
penalties:
The Secretary may initiate an injunctive claim or a civil claim for:
|
De-identification and Re-identification | De-identified
health information is information that cannot be used to identify the individual
because individual identifiers have been removed. This information is not
considered PHI, and can be used or disclosed without an individual’s consent
or authorization
164.514(a)&(b). A covered entity may assign a code or other means of record identification to allow previously de-identified information to be re-identified, provided that the means of record identification cannot be used to identify the individual, and the covered entity does not disclose the mechanism for reidentification. §164.514(c). |
A
person may not re-identify or attempt to re-identify an individual
who is the subject of any protected health information without obtaining
the individual’s consent or authorization.
§181.151. HIPAA allows de-identified information to be re-identified under specific guidelines, however, the Texas Medical Privacy Act does not allow re-identification at all. |
Compliance Date | April 14, 2003 | September 1, 2003 |
08/30/01