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…

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EHR Incentive and Certification Criteria Final Rules Published in Federal Register

The EHR Incentive and Certification final rules were published in the Federal Register this morning, July 28, 2010.  HIPAA.com provides the title, summary, effective date, and URL for each below. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “42 CFR Parts 412, 413, 422, and 495;  Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Final Rule, Federal Register, 75(144), Wednesday, July 28, 2010, pp. 44313-44588. Summary:  This final rule implements the provisions of the American Recovery and Reinvestment Act of 2009 (ARRA)(Public Law 111-5) that provide incentive payments to eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs) participating in Medicare and Medicaid programs…

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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…

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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…

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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…

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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…

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OCR Issues Draft Guidance on Security Risk Analysis

The Office for Civil Rights (OCR) of the Department of Health and Human Services  (HHS) issued on May 7, 2010, Security Rule Draft Guidance on Risk Analysis. This is the first in a “series of guidance documents [that] will assist organizations in identifying and implementing the most effective and appropriate administrative, physical, and technical safeguards to protect the confidentiality, integrity, and availability of electronic protected health information.  The materials will be updated annually, as appropriate.” This eight-page document is available online. The Draft Guidance on Risk makes the following key points: “The Security Rule does not prescribe a specific risk analysis methodology, recognizing that methods will vary dependent on the…

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Prison Time for Privacy Breach of PHI; OCR Breach List Continues to Grow; More Training Needed

Health Data Management  reported in its April 29, 2010, online HDM Daily that “[a] former researcher at the UCLA School of Medicine has been sentenced to four months in federal prison for violations of the HIPAA privacy rule.”  You may access and read the article by Joseph Goedert,  “Prison for HIPAA Privacy Violater“. On the same day, April 29, the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) reported on its Web site 67 entities reporting “Breaches Affecting 500 or More Individuals” over the period September 22, 2009 to March 19, 2010.  That is up from the 36 that OCR listed on its initial…

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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…

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HHS Publishes EHR Standards, Implementation Specifications and Certification Criteria IFR

HHS published today in the Federal Register:  “Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology”  75 FR 2013-2047.  This Interim Final Rule (IFR) is effective February 2, 2010.  Comments on the IFR may be submitted to HHS no later than March 15, 2010.  Here is the Summary from the IFR: “The Department of Health and Human Services (HHS) is issuing this interim final rule with a request for comments to adopt an initial set of standards, implementation specifications, and certification criteria, as required by section 3004(b)(1) of the Public Health Service Act.  This interim final rule represents the first step in…

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