March 26, 2013. Today is the first big milestone since the January 25, 2013, publication in the Federal Register of the Final Rule: Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act [HITECH Act] and the Genetic Information Nondiscrimination Act; Other Modifications of the HIPAA Rules. Today is the effective date of the Final Rule, and covered entities and business associates must comply by September 23, 2013.
“Significant rules (defined by Executive Order 12866) and major rules (defined by the Small Business Regulatory Enforcement Fairness Act) are required to have a 60 day delayed effective date,” which was the case with the Final Rule discussed herein.
Here are comments from the preamble of the Final Rule pertaining to the effective and compliance dates:
“The final rule is effective on March 26, 2013. Covered entities and business associates of all sizes will have 180 days beyond the effective date of the final rule to come into compliance with most of the final rule’s provisions, including the modifications to the Breach Notification Rule and the changes to the HIPAA Privacy Rule under GINA. We understand that some covered entities, business associates, and subcontractors remain concerned that a 180-day period does not provide sufficient time to come into compliance with the modifications. However, we believe not only that providing a 180-day compliance period best comports with section 1175(b)(2) of the Social Security Act, 42 U.S.C. 1320d–4, and our implementing provision at 45 CFR 160.104(c)(1), which require the Secretary to provide at least a 180-day period for covered entities to comply with modifications to standards and implementation specifications in the HIPAA Rules, but also that providing a 180-day compliance period best protects the privacy and security of patient information, in accordance with the goals of the HITECH Act.
“In addition, to make clear to the industry our expectation that going forward we will provide a 180-day compliance date for future modifications to the HIPAA Rules, we adopt the provision we proposed at 45 CFR 160.105, which provides that with respect to new or modified standards or implementation specifications in the HIPAA Rules, except as otherwise provided, covered entities and business associates must comply with the applicable new or modified standards or implementation specifications no later than 180 days from the effective date of any such change. In cases where a future modification necessitates a longer compliance period, the Department will expressly provide for one, as it has done in this rulemaking with respect to the time permitted for business associate agreements to be modified.
“For the reasons proposed, the final rule also retains the compliance date provisions at 45 CFR 164.534 and 164.318, which provide the compliance dates of April 14, 2003, and April 20, 2005, for initial implementation of the HIPAA Privacy and Security Rules, respectively. We note that 160.105 regarding the compliance date of new or modified standards or implementation specifications does not apply to modifications to the provisions of the HIPAA Enforcement Rule, because such provisions are not standards or implementation specifications (as the terms are defined at 160.103). Such provisions are in effect and apply at the time the final rule becomes effective or as otherwise specifically provided. In addition, as explained above, our general rule for a 180-day compliance period for new or modified standards would not apply where we expressly provide a different compliance period in the regulation for one or more provisions. For purposes of this rule, the 180-day compliance period would not govern the time period required to modify those business associate agreements that qualify for the longer transition period in 164.532….
“Finally, the provisions of section 13402(j) of the HITECH Act apply to breaches of unsecured protected health information discovered on or after September 23, 2009, the date of the publication of the interim final rule. Thus, during the 180 day period before compliance with this final rule is required, covered entities and business associates are still required to comply with the breach notification requirements under the HITECH Act and must continue to comply with the requirements of the interim final rule. We believe that this transition period provides covered entities and business associates with adequate time to come into compliance with the revisions in this final rule and at the same time to continue to fulfill their breach notification obligations under the HITECH Act.”
78 Federal Register 5569-5570
For provisions of the modifications of the Final Rule, you may access them through electronic Code of Federal Regulation links available at www.ecfr.gov. On the opening screen, scroll down to “Title 45: Public Welfare” and click “Go.” Then, click on “1-199: Subtitle A–Department of Health and Human Services.” Scroll down to “Subchapter C: Administrative Date Standards and Related Requirements” for the “Parts” and “Subparts” of interest, click, and you can then access desired sections. For example, Part 164 is “Security and Privacy,” and Subpart C is “Security Standards for the Protection of Electronic Protected Health Information,” Subpart D is “Notification in the Case of Breach of Unsecured Protected Health Information,” and Subpart E is” Privacy of Individually Identifiable Health Information.”
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