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.
Tag: Federal Register
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:…
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…
OCR Identifies 36 Entities with Breaches Affecting 500 or More Individuals
On Monday, February 22, 2010, the federal government, through the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS), began enforcing the Breach Notification Rule for breaches occurring on or after that date. The Breach Notification for Unsecured Protected Health Information; Interim Final Rule, was published in the Federal Register on Monday, August 24, 2009 [74 FR 42739-42770] and was effective September 23, 2009. Since September 22, 2009, 36 breaches of privacy or security of protected health information (PHI) affecting 500 or more individuals have been reported to OCR. The total number of individuals affected was 1,073,657, with two of the breaches involving 359,000 (FL)…
Exploring HIPAA and HITECH Act Definitions: Part 16
From now through early December, HIPAA.com is providing a run through of HIPAA transaction & code set, privacy, and security definitions, along with relevant HITECH Act definitions pertaining to breach notification, securing of protected health information, and electronic health record (EHR) standards development and adoption. These definitions are key to understanding the referenced HIPAA and HITECH Act enabling regulations that are effective now and that will require compliance by covered entities and business associates now or in the months ahead, as indicated in HIPAA.com’s timeline. Each posting will contain three definitions, with a date reference to the Federal Register, Code of Federal Regulations (CFR), or statute, as appropriate. Exploring HIPAA…
Exploring HIPAA and HITECH Act Definitions: Part 15
From now through December, HIPAA.com is providing a run through of HIPAA transaction & code set, privacy, and security definitions, along with relevant HITECH Act definitions pertaining to breach notification, securing of protected health information, and electronic health record (EHR) standards development and adoption. These definitions are key to understanding the referenced HIPAA and HITECH Act enabling regulations that are effective now and that will require compliance by covered entities and business associates now or in the months ahead, as indicated in HIPAA.com’s timeline. Each posting will contain three definitions, with a date reference to the Federal Register, Code of Federal Regulations (CFR), or statute, as appropriate. Exploring HIPAA and…