As currently drafted, the California Consumer Privacy Act (“CCPA”) leaves many questions unresolved regarding how the law applies to data collected and used in the health care and life sciences industries, particularly in the research context. Clinical research sponsors and other industry participants have raised concerns about how the CCPA may impede care delivery and … Continue Reading
Despite intensive lobbying from industry groups, multiple amendments before its effective date, and extensive proposed regulations from the California attorney general, the California Consumer Privacy Act (CCPA) went into effect earlier this month with still many questions left unanswered: What compromises will be made regarding employee and business-to-business data? Will there be further insight into … Continue Reading
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a fact sheet clarifying violations of HIPAA (Health Insurance Portability and Accountability Act of 1996) for which a business associate can be held directly liable. The fact sheet outlines 10 specific circumstances for which OCR has authority to take enforcement … Continue Reading
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a new set of Health Insurance Portability and Accountability Act (HIPAA) FAQs building upon prior guidance from OCR. The new FAQs discuss the applicability of HIPAA to covered entities and business associates that interact with health apps and explain when HIPAA regulated … Continue Reading
The U.S. Department of Health and Human Services (“HHS”) filed a Notice of Enforcement Decision (the “Notice of Enforcement”) on April 26, 2019, confirming the agency’s reconsideration of its prior interpretation of the Health Information Technology for Economic and Clinical Health Act’s (the “HITECH Act’s”) penalty structure. Effective immediately, the maximum penalty that the HHS … Continue Reading
In a span of a few weeks in early January 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced two major settlements under the Health Insurance Portability and Accountability Act (“HIPAA”) relating to the breach of protected health information (“PHI”). Neither settlement included an admission of any liability, but … Continue Reading
A November 21, 2013 report published by the Office of the Inspector General (OIG) concluded that The Department of Health & Human Services (HHS) Office for Civil Rights (OCR) is not fully enforcing the HIPAA Security Rule and laid out recommendations for the OCR to implement. The OIG’s report also concluded separately that OCR is … Continue Reading
This post was also written by John E. Wyand. The Department of Health and Human Services’ Office for Civil Rights (OCR) opened an investigation of Adult & Pediatric Dermatology, P.C. (APDerm) after a report was made regarding the theft of an unencrypted flash drive. To settle potential violations of the Health Insurance Portability and Accountability … Continue Reading
Though the National Association of Attorneys General (NAAG) Presidential Initiative “Privacy in a Digital Age” expired in June 2013 when a new NAAG president took over, the state attorneys general have maintained their sharp focus on all things privacy, with no signs that that focus will shift anytime soon. Most recent case in point: a … Continue Reading
This post was also written by Salvatore G. Rotella, Jr., Elizabeth Doyle O’Brien, Jennifer Pike and Zachary A. Portin. After much anticipation, the Office for Civil Rights of the United States Department of Health and Human services published the HITECH Final Rule on January 25, 2013. The final regulation contains substantive and technical modifications and additions … Continue Reading
The long awaited final rule, released yesterday by the Office for Civil Rights (OCR) of the Department of Health and Human Services, modifies the HIPAA Privacy, Security, Breach and Enforcement Rules and is comprised of four final rules which implement the statutory requirements of the Health Information Technology for Economic and Clinical Health Act (HITECH) and the … Continue Reading
As the year is coming to an end, the industry is speculating the release date of the Health Information Technology for Economic and Clinical Health Act (“HITECH”) final rule. The final rule is expected to address modifications to the Privacy, Security, Enforcement, and Breach Notification Rules, and with the release date yet to be determined, … Continue Reading
On March 13, 2012 the Department of Health and Human Services (HHS), Office of Civil Rights (OCR) announced its settlement with Blue Cross Blue Shield of Tennessee (BCBST), marking the first enforcement action resulting from a breach self-report required by HITECH’s Breach Notification Rule. For a more detailed analysis, please click here.… Continue Reading
Firm attorneys Gina M. Cavalier and Brad M. Rostolsky recently wrote about a HIPAA privacy update on the Life Sciences Legal Update blog. Specifically, the Department of Health and Human Services (HHS) today issued a Notice of Proposed Rulemaking implementing provisions of the HITECH Act related to accounting for disclosures of protected health information (PHI). … Continue Reading
This post was also written by Gina Cavalier. Earlier this week, Reed Smith’s blog Life Sciences Legal Update posted that the Department of Health and Human Services’ (HHS), Office for Civil Rights (OCR) announced the imposition of the first ever civil money penalty for violations of the HIPAA Privacy Rule. To learn more about this significant … Continue Reading
