December 2, 2010.M Under the Health Information Technology for Economic and Clinical Health Act (HITECH Act), enacted as part of the American Recovery and Reinvestment Act of 2009, covered entities are required to report to the Secretary of the Department of Health and Human Services (HHS) any breach affecting 500 or more individuals within 60 days of discovery of the breach by the covered entity or its business associate. The HHS Office for Civil Rights (OCR), which is responsible for HIPAA privacy and security enforcement, is required to post these HIPAA privacy or security breaches on its Web site (please note that this URL is a change from the initial…
Tag: HITECH Act
HHS Pulls Breach Notification Final Rule
The HIPAA Administrative Simplification; Notification in the Case of Breach Final Rule (Regulation Identifier Number (RIN) 0991-AB56) has been at the Office of Management and Budget (OMB) since May 14, 2010, for Executive Order (EO) 12866 review and approval prior to publication in the Federal Register. On July 28, 2010, HHS “withdrew” this Final Rule, with the following explanation: “The Interim Final Rule for Breach Notification for Unsecured Protected Health Information, issued pursuant to the Health Information Technology for Economic and Clinical Health (HITECH) Act, was published in the Federal Register on August 24, 2009, and became effective on September 23, 2009. During the 60-day public comment period on the…
OCR Reports 107 Breaches Affecting Over 4 Million Individuals (II)
The Office for Civil Rights (OCR) regularly updates its Web site listing of breaches affecting 500 or more individuals. As of July 2, 2010, there were 107 breaches listed that were reported to have occurred between September 22, 2009 and June 11, 2010. Individuals affected by these publicly listed breaches totaled 4,086,980. Six of the 107 breaches, or 5.6% of the total, affected 3,353,627 individuals, or 82% of the total. This is the second of three postings that analyzes the data from these 107 breaches. This posting (II) covers paper breaches. The first posting (I) covered electronic breaches, and the final posting (III) looks at the prevalence of business associate…
Final Rules for EHR Incentives and Certification Criteria at OMB for Review
The Office of Management and Budget (OMB) received in early July for Executive Order (EO) 12866 Regulatory Planning and Review two Final Rules relating to electronic health record (EHR) incentives and certification criteria required under the Health Information Technology for Economic and Clinical Health Act (HITECH Act) that was enacted on February 17, 2009 as part of the American Recovery and Reinvestment Act of 2009. On Friday, July 2, 2010, OMB received from the Office of the Secretary at the Department of Health and Human Services (HHS) for review Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule. The Interim Final…
OMB Completes Review of HIPAA/HITECH Act Privacy, Security, Enforcement Rule Modifications NPRM
On July 1, 2010, the Office of Management and Budget (OMB) completed review of the Notice of Proposed Rulemaking (NPRM) entitled: Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act [HITECH Act](RIN: 0991-AB57). The NPRM was received at OMB for review on April 12, 2010. It likely will be published in the Federal Register imminently. Legal authority for the NPRM is in Sections 13400 to 13410 of Subtitle D (Privacy) of the HITECH Act, which was enacted as part of the American Recovery and Reinvestment Act of 2009 (Public Law 111-5), enacted on February 17, 2009. Those sections cover:…
OCR Reports 107 Breaches Affecting Over 4 Million Individuals (I)
As of the July 4th holiday weekend, the Office for Civil Rights (OCR) has updated again its Web site listing of breaches affecting 500 or more individuals. As of July 2, 2010, there were 107 breaches listed that were reported to have occurred between September 22, 2009 and June 11, 2010. Individuals affected by these publicly listed breaches totaled 4,086,980. Six of the 107 breaches, or 5.6% of the total, affected 3,353,627 individuals, or 82% of the total. This is the first of three postings that analyzes the data from these 107 breaches. This posting (I) covers electronic breaches, the next posting (II) covers hard copy (paper) breaches, and the…
ONC Releases Final Rule for Temporary HIT Certification Program
On Friday afternoon, June 18, the Office of the National Coordinator for Health Information Technology (ONC) of the Department of Health and Human Services (HHS) released the final rule: Establishment of the Temporary Certification Program for Health Information Technology. The final rule can be viewed in portable document format (pdf) online at: http://www.federalreigster.gov/…. The final rule will be published in the Federal Register, most likely next week, and will be effective upon date of publication. The summary of the final rule is reproduced here: “This final rule establishes a temporary certification program for the purposes of testing and certifying health information technology. This final rule is established under the…
Final Rule on EHR Certification Programs Imminent
The Office of Management and Budget (OMB) completed its review of the Proposed Establishment of Certification Programs for Health Information Technology final rule on June 14, 2010, so publication in the Federal Register is imminent. This final rule explains the proposed establishment of certification programs for voluntary certification of health information technology, as specified in section 3001(c)(5) of the HITECH Act, which is available on the hipaa.com site. This final rule is a follow-on to the proposed rule of the same title that was published in the Federal Register on March 10, 2010 (75 Federal Register 11327-11373), the summary of which appears below. “Under the authority granted to the National…
Reported Breaches of 500 or More Individuals up to 93 and Affecting Over 2.5 Million Individuals; Enforcement and Penalties
As of Friday, June 4, 2010, 93 breaches affecting 500 or more individuals have been reported on the Office for Civil Rights (OCR) Web site. The total number affected has gone beyond 2-1/2 million individuals today, and stands at 2,565,352 individuals. Of the 87 breaches involving breach of hard copy or electronic protected health information, 26% involve hard copy or paper records and 74% records on electronic media or devices. Overall, 71% of the 93 breaches involve theft or loss of records, many of which might have been avoided by appropriate securing of hard copy records and electronic media and devices. Below we remind readers of the Department of Health…
HHS’ ONC Releases Proposed Rule for Temporary and Permanent HIT Certification Programs
On Wednesday, March 10, 2010, the Office of the National Coordinator for Health Information Technology (ONC) of the Department of Health and Human Services (HHS) published in the Federal Register the Proposed Rule (NPRM) for Proposed Establishment of Certification Programs for Health Information Technology. [75 Federal Register 11327-11373] We present the summary of the NPRM. “SUMMARY. Under the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the Health Information Technology for Economic and Clinical Health (HITECH ) Act, this rule proposes the establishment of two certification programs for purposes of testing and certifying…