June 12, 2020 | By By Bryan Meek, Esq., Brennan, Manna, and Diamond As the COVID-19 pandemic continues to wreak havoc globally, many industries have been forced to adapt to unprecedented challenges while remaining cognizant of everchanging guidance from public health officials and government agencies. Notably, the healthcare industry has been confronted with countless practical…
November 17, 2023 | By Amanda Waesch This past September 2023, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO).1 The Opinion involved a proposed arrangement between an independent pathology laboratory and third-party physician laboratories for the purchase of the technical component of…
April 9, 2021 | By Amanda Waesch In December 2016, Congress passed the 21st Century Cures Act (often simply called the “Cures Act”). Woven within the Cures Act is Section 4004 titled “Information Blocking.”[1] The purpose of this section is to prohibit any action or practice that interferes with or prevents access to electronic…
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…
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…