April 7, 2023 | By Rachel Rose, JD, MBA Overview Whenever I present, which is often, I often receive follow-up questions from participants regarding resources to utilize when creating, reviewing, and/or supplementing a compliance program, including relevant policies and procedures. One resource which should be utilized is the Health Care and Public Health Sector…
December 9, 2022 | By Rachel Rose, JD, MBA Overview Although it is said that “business is global”, there are some nuances to this blanket statement to consider when creating, receiving, maintaining, or transmitting electronic protected health information or electronic health information (herein the blanket term “PHI” is used) internationally.[i] Before delving into items…
June 24, 2022 | By Rachel Rose, JD, MBA By now, providers should appreciate that there are legal ways to structure most arrangements. One area that is fraught with peril are physician owned distributorships, which are also referred to as “PODs”. PODs are defined as: “physician-owned entities that derive revenue from selling, or arranging…
March 18, 2022 | By Rachel Rose, JD, MBA Enacted in 1972, the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) remains a government enforcement favorite, despite being described by some as archaic. As articulated by the U.S. Department of Health and Human Services – Office of the Inspector General (HHS-OIG), “[t]he five most important Federal…
July 23, 2021 | By Rachel Rose, JD, MBA In June 2021, the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) issued Issue Brief, OEI-01-20-00220 (hereinafter “Issue Brief”), which highlighted the results of its review of cybersecurity for networked medical devices in hospitals. The impetus behind the review was…
April 23, 2021 | By By Rachel Rose, JD, MBA Early in 2019, the U.S. Department of Health and Human Services – Office for Civil Rights (HHS-OCR) announced the creation of an initiative to target violations of 45 CFR §164.524(b)(2) for not providing an individual with his/her requested protected health information (PHI) within…
March 23, 2020 | By Rachel Rose, JD, MBA According to the National Institute for Standards and Technology (“NIST”), biometrics is defined as, “[a]utomated recognition of individuals based on their behavioral and biological characteristics [e.g., fingerprints, facial recognition and retinal scans]. In this document, biometrics may be used to unlock authentication tokens and prevent repudiation…
August 7, 2020 | By By Rachel Rose, JD, MBA The Health Information Portability and Accountability Act, Pub. L. 104-191 (Aug. 1996) (“HIPAA”) is often times misapplied. Take the COVID-19 pandemic for example. Despite the U.S. Department of Health and Human Services (“HHS”) and the Office for Civil Rights (“OCR”) reiterating the exceptions present…