January 31, 2013. Today, we briefly identify key changes or reminders regarding breach notification in the preamble of the Final Rule: Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act [HITECH Act] and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules, published in the Federal Register on January 25, 2013. The Final Rule becomes effective March 26, 2013 and requires compliance by covered entities and business associates on September 23, 2013. Earlier this week, we have examined the changed definition of breach, the substitution of the “probability standard” for the current “harm standard” underpinning…
Tag: business associate
HIPAA Final Rule: Breach Risk Assessment Factors for “Probability Standard”
January 29, 2013. Today, we cover the four risk assessment factors pertaining to breach notification in the Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act [HITECH Act] and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules: Final Rule that was published in the Federal Register on Friday, January 25, 2013. As discussed in yesterday’s post, these risk assessment factors are used in assessing the probability of impermissible use or disclosure compromising protected health information, thereby requiring breach notification. This “probability standard” replaces the “harm standard,” becomes effective March 26, 2013, and requires compliance…
Final Rule: Modified Definition of Breach
January 28, 2013. Today, we want to explore the modified definition of breach in the Final HIPAA/HITECH Act Privacy, Security, Breach Notification, and Enforcement Rule published in the Federal Register on Friday, January 25, 2013. Here is the modified definition [45 CFR 164.402, Definitions, effective March 26, 2013; 78 Federal Register 5695]: Breach means the acquisition, access, use, or disclosure of protected health information in a manner not permitted under subpart E [HIPAA Privacy Rule] of this part [Part 164] which compromises the security or privacy of the protected health information. (1) Breach excludes: (i) Any unintentional acquisition, access, or use of protected health information by a workforce member or…
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…
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…
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…
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,…
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,…
HITECH Act Breached Individuals Skyrocket in Latest OCR Web Site Posting
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…
HITECH Act Privacy and Security Final Rules Needed Now
Since September 23, 2009, the enforcement arm of the Department of Health and Human Services (HHS), the Office for Civil Rights (OCR), has been required to publicly disclose breaches involving 500 or more individuals discovered and reported by covered entities and their business associates. As of October 25, 2011, OCR has reported 345 such breaches involving a total of 11,959,488 individuals. Not reflected yet in the OCR disclosed breaches are two involving 6.5 million individuals: a Nemours breach of 1.6 million individuals and a TRICARE breach involving 4.9 million individuals. Together, these two recently reported breaches represent 54.4% of the total number of individuals affected by the publicly disclosed breaches…