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 U.S. Department of Health and Human Services (HHS) any privacy or security 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 privacy and security enforcement under the Health Insurance Portability and Accountability Act (HIPAA) and HITECH Act provisions that strengthened privacy and security enforcement, is required to post those breaches…
Category: Enforcement
200 Breaches Impacting Almost 5.9 Million Individuals, with Theft and Loss of Laptops and PEDs Major Cause
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…
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…
HIPAA Privacy, Security, Enforcement Rule Modifications NPRM at Federal Register
This morning, July 8, 2010, HHS’ Modifications to the HIPAA Privacy, Security, and Enforcement Rules under the Health Information Technology for Economic and Clinical Health Act Notice of Proposed Rulemaking (NPRM) was posted at the Federal Register for public access prior to publication. It will be published on Wednesday, July 14, 2010. The 234 page NPRM can be accessed in portable document format (pdf) online at: http://www.ofr.gov/OFRUpload/OFRData/2010-16718_PI.pdf. There will be a 60-day comment period relating to the content of the NPRM. HIPAA.com will provide a synopsis of the NPRM in a series of postings following publication in the Federal Register.
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…
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…
FTC Delays Enforcement of FTC Red Flags Rule Fifth Time
The original FTC Red Flags Rule compliance date deadline was extended three times from the original date of November 1, 2008, with an expected compliance date of November 1, 2009. Just prior to that date, the FTC extended for the fourth time the deadline for compliance to June 1, 2010. On May 28, 2010, the June 1, 2010, compliance date was extended a fifth time to December 31, 2010[1]: “At the request of several Members of Congress, the Federal Trade Commission is further delaying enforcement of the ‘Red Flags’ Rule through December 31, 2010, while Congress considers legislation that would affect the scope of entities covered by the Rule. Today’s…
OCR Stepping Up HIPAA Security Enforcement
Health Data Management (HDM) reported today, May 12, that the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) is going to strengthen HIPAA Security Rule enforcement, based on statements made on Tuesday, May 11 by the OCR Deputy Director for Privacy, Susan McAndrew, at the Safeguarding Health Information conference in Washington, DC, co-sponsored by OCR and the National Institute of Standards and Technology (NIST). “To boost enforcement of the security rule, OCR has added investigators in 10 regional offices, McAndrew notes,” as reported by Joe Goedert in the HDM article, “OCR Boosting Security Enforcement,” which is available online. This report comes several days after…