OCR of HHS FINALLY Issues HIPAA/HITECH Act Privacy, Security, Enforcement, and Breach Notification Modifications Final Rule

January 18, 2013. On January 16, 2013, the Office of Management and Budget (OMB) completed its EO 12866 regulatory review of RIN:  0945-AA03, and the long-awaited release of the Department of Health and Human Services’ Office for Civil Rights (OCR) so-called “Omnibus” Final Rule was published at 4:15 PM on January 17, 2013, in pre-publication final draft form on the Federal Register’s Electronic Public Inspection Desk.  Publication in the Federal Register is scheduled for Friday, January 25, 2013.  The title of the Final Rule is:  45 CFR Parts 160 and 164:  Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and…

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Five HIPAA Compliance Activities Your Organization Must Undertake

HIPAA Administrative Simplification was enacted on August 21, 1996 as Subtitle F of Title II of Public Law 104-191. The so-called HITECH Act “Omnibus” regulation that modifies HIPAA privacy and security provisions will be published in the Federal Register by the end of this summer, according to the head of HHS’ National Coordinator for Health Information Technology, Farzad Mostashari, M.D. Based on the timeline in the Notice of Proposed Rule Making, compliance by all covered entities and their business associates would be required 240 days after publication, most likely sometime in May 2013, assuming the end-of-summer deadline is met.  All covered entities and their business associates will be required to comply with provisions of…

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OCR Publishes HIPAA/HITECH Act Privacy and Security Compliance Audit Protocol

July 9, 2012.  Late in June, the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) published its HIPAA/HITECH Act Privacy and Security Compliance Audit Protocol.  Here is OCR’s description of the program, which outlines 77 audit procedures for the HIPAA Security Rule and 88 audit procedures for the HIPAA Privacy and HITECH Act Breach Notification Rules: “The OCR HIPAA Audit program analyzes processes, controls, and policies of selected covered entities pursuant to the HITECH Act audit mandate.  OCR established a comprehensive audit protocol that contains the requirements to be assessed through these performance audits.  The entire audit protocol is organized around modules, representing separate…

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OCR’s Publicly Disclosed Large Breaches Now Top 20 Million Impacted Individuals

May 16, 2012.  The Department of Health and Human Services’ (HHS) HIPAA/HITECH Act privacy and security enforcement arm, Office for Civil Rights (OCR), is responsible under the HITECH Act to publicly disclose privacy and security breaches that affect 500 or more individuals on its Breach Notification Web site.  With the now reported Utah Department of Health hacking/IT incident breach occurring in the period March 10-April 2, 2012 and affecting a reported 780,000 individuals, the total number in 435 breaches reported since September 22, 2009, now totals 20,079,189 impacted individuals.  Of the total number of breaches where location of breached information is known (e.g., electronic or hard copy source), 72% of…

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ONC Issues Meaningful Use Guide for Privacy & Security Attestation Compliance

May 9, 2012.  The Office of the National Coordinator for Health Information Technology (ONC) has issued a Guide to Privacy and Security of Health Information (Version 1.1 022312).  This Guide is targeted to medical practitioners who participate in the Medicare and Medicaid Program for Adoption and Meaningful Use of Certified Electronic Health Record Technology. Chapters are: 1. What Is Privacy & Security and Why Does It Matter? 2. Privacy & Security and Meaningful Use. 3.  Privacy & Security Step Plan for Meaningful Use. 4.  Integrating Privacy and Security into Your Practice. 5.  Privacy and Security Resources. The Guide highlights two of the Stage 1 Meaningful Use Objectives and Corresponding Measures…

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Finally, HIPAA/HITECH Act Privacy, Security, Breach Notification, Enforcement Final Rules at OMB

March 24, 2012.   Today, the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB) in the Executive Office of the President showed that it had received the much-delayed Department of Health and Human Services (HHS) Office for Civil Rights (OCR) Final Rules entitled:  Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (RIN:  0945-AA03). Following review by OMB, the rules will be published in the Federal Register, most likely in April if OMB’s review is timely. The Abstract of the Rules reads:  “The Department of Health and Human Services Office for Civil Rights will issue final rules to modify the HIPAA Privacy, Security,…

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BCBST Pays $1.5 Million to HHS to Settle Potential HIPAA Privacy and Security Violations

On March 13, 2012, Blue Cross Blue Shield of Tennessee (BCBST) agreed to a payment of $1.5 million to the Department of Health and Human Services (HHS) and to a corrective action plan as part of a Resolution Agreement with HHS for potential violation of Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rule violations.  According to a HHS Press Release of the same date, “the enforcement action [by HHS’ Office for Civil Rights (OCR)] is the first resulting from a breach report required by the Health Information Technology for Economic and Clinical Health (HITECH) Act Breach Notification Rule.” According to the HHS Press Release: “The investigation followed…

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CMS Publishes Stage 2 Meaningful Use Incentive Program NPRM

On March 7, 2012, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register its 132-page notice of proposed rule making (NPRM):  Medicare and Medicaid Programs; Electronic Health Record Incentive Program–Stage 2.  Comments to the Department of Health and Human Services (HHS) may be made until 5 PM on May 7, 2012. The summary of the NPRM is included here: “This proposed rule would specify the Stage 2 criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and/or Medicaid electronic health record (EHR) incentive payments.  In addition, it would specify payment adjustments under Medicare for covered…

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CMS Initiates 90-Day Enforcement Discretion for 5010 Compliance

January 1, 2012, is the date for covered entities to achieve compliance with ASC X12 Version 5010, NCPDP Telecom D.0, and NCPDP Medicaid Subrogation 3.0 transaction standards. Covered entities include healthcare providers, health plans, and healthcare clearinghouses. Small health plans have until January 1, 2013, to comply with the NCPDP Medicaid Subrogation 3.0 standard. The Center for Medicare & Medicaid Services (CMS) Office of E-Health Standards and Services (OESS) is responsible for enforcement of compliance with electronic transaction standards.  CMS announced on November 17, 2011, that “[w]hile enforcement action will not be taken [from January 1-March 31, 2012], OESS will continue to accept complaints associated with compliance with Version 5010,…

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OCR Announces November 2011 Start of Privacy and Security Compliance Audits

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is responsible for privacy and security enforcement under Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health (HITECH) Act provisions. OCR has announced that it is initiating compliance audits beginning this month, as authorized by the HITECH Act.  This action precedes the imminent release of the Final HIPAA/HITECH Act Privacy, Security, Breach Notification, and Enforcement Rules, expected before the end of 2011, and will strengthen enforcement and accountability for compliance with existing and forthcoming Rule modifications.   To avoid the consequences of potential penalties for non-compliance, covered entities and business…

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