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On June 17, 2001, Texas Governor Rick Perry signed the Texas Medical Privacy Act (aka SB 11) into law, which added chapter 181 to the Texas Health and Safety Code. As reported in the February issue of Pharma Privacy News, on January 30, 2003 state senator Jane Nelson, who championed the original SB 11 bill, introduced SB 330 in order to repeal sections 181.101 and 181.102 of the Code. This bill was signed into law by Governor Perry on April 10, 2003.
Section 181.101 would have required any Texas covered entity as defined by SB 11 - including pharmaceutical companies - to comply with HIPAA's standards relating to uses and disclosures of protected health information (PHI), including distribution of a notice of privacy practices, uses and disclosures of PHI, and individual rights of access and amendment. Because SB 11 defined covered entity and PHI much more broadly than HIPAA does, section 181.101 would have applied to pharmaceutical companies doing research and marketing in Texas.
SB 330 left intact the marketing provisions enacted under SB 11, which places more restrictions on marketing than does HIPAA. Specifically, SB 11 defines marketing as virtually any communication that is paid for by a third party and prohibited any release of PHI for marketing purposes without consent or authorization from the individual. HIPAA allows "case management" or "care management" communications as exceptions, even if the covered entity receives remuneration.
Senate Bill 1136, also introduced by Sen. Nelson, would create a marketing standard in Texas that more closely tracks the HIPAA marketing standard, with stricter standards related to certain product-specific communications that encourage a change in prescription drugs or prescription medical devices. (See Table in Reprint for more details).
SB 1136 passed in the Texas House of Representatives without amendments or other changes on May 23, 2003 and is expected to be signed into law.
Important changes, however, do not take effect until January 1. 2004.
See below for a list of topics covered.
Published 5/27/2003. Free updates for 6 months.
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The table compares the Texas and HIPAA laws with regard to the following:
An appendix to the final security rule published in the Federal Register on 20 February 2003 contains a matrix, which sets out standards and corresponding implementation specifications. The matrix displays, in tabular form, the administrative, physical, and technical safeguard standards and relating implementation specifications described in the final rule in § 164.308, § 164.310, and § 164.312 (18 standards in total).
Our interactive, color-coded version of this matrix makes it easy to tell at a glance which implementation specifications are required and which are "addressable." It also makes it easy to jump from a listing in the table to the relevant section of the rule describing the standard and its corresponding implementation specifications. "Required" implementation specifications are color-coded red, while "Addressable" implementation specifications are in black text. Included is the explanation of "Required" vs. "Addressable" implementation specifications.
Also included are highlights of the major changes in the final rule compared to the proposed rule and how the security rule aligns (or, in some cases, does not align) with the privacy rule.
For a FREE sample, see HIPAA Final Security Rule Interactive Matrix - Physical Safeguards.
Published 2/20/2003.
Reprint available for $75.00
The matrix includes the following standards:
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Pharma Privacy Watch is a quarterly report featuring intelligent analysis of federal, state, and EU privacy regulations, laws and actions of interest to pharmaceutical and other healthcare professionals. Intelligence includes:
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By and large, the final rule adopts the changes proposed in the March 2002 NPRM with few major differences. This summary focuses on modifications, additions and clarifications of the NPRM as they appear in the final rule. Of particular interest to pharmaceutical companies are the provisions and comments related to marketing, uses and disclosures regarding FDA regulated products and activities, and the "limited data set." Consequently, the summary includes further comments related to these issues.
See a sample section (pdf). Or see below for a list of topics covered.
Published 8/14/2002.
Reprint available for $45.00
Topics include:
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Four quarterly Pharma Privacy Watch Reports. Click here for more information and to order online by credit card.
Reprint VS003A:
HIPAA vs. Texas Medical Privacy Act (SB 11) vs. SB 330/SB 1136. Click here for more information and to order online by credit card.
Reprint VS006:
Final HIPAA Security Rule: Interactive Matrix. Click here for more information and to order online by credit card.
Summary of HIPAA Final Privacy Rule. Click here for more information and to order online by credit card.
HIPAA vs. Texas Medical Privacy Act (SB 11) vs. SB 330/SB 1136
(Side-by-Side-by-Side Comparison Table)
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Final HIPAA Security Rule: Interactive Matrix
(Interactive, color-coded Table)
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Pharma Privacy Watch is designed for the busy pharmaceutical executive as well as support staff requiring varying levels of detail. It includes Executive Summaries (see PHARMA-PRIVACY) delivered by e-mail, comprehensive Intelligence (see reprints) and Data Sources delivered via a secure Web site.
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Summary of HIPAA Final Privacy Rule
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