Health Tech Podcast - Episode 3: HIPAA, HITECH and TCPA
The Biggest Changes in HIPAA/HITECH Omnibus Rule & Recommended Action Steps—Ted Kobus
The U.S. Department of Health and Human Services (HHS) continued its commitment to timely and full access to health records on June 24, 2024, through the finalization of its information blocking disincentives rule for...more
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has, as part of its mandate, the responsibility to enforce the Health Insurance Portability and Accountability Act (HIPAA) Security Rule....more
Newly effective regulations governing confidentiality of Substance Use Disorder (SUD) records now more closely mirror regulations implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and other...more
The U.S. Department of Health and Human Services (HHS) this week released final amendments to the HIPAA Privacy Rule to further protect the privacy of protected health information (PHI) related to reproductive health care....more
The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) recently published an executive summary (Report) outlining key enforcement activities of the Health Insurance Portability and...more
On Feb. 16, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published its 2022 Annual Report to Congress. ...more
Healthcare organizations continue to be prime targets of cyberattacks. It is well-established that cyberattacks can lead to financial loss, reputational damage, and, in some cases, risks to patient care and safety. The recent...more
On February 14, 2024, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued two reports to Congress as required by the Health Information Technology for Economic and Clinical Health...more
On February 8, 2024, the U.S. Department of Health & Human Services (HHS) released a final rule modifying 42 CFR Part 2 (Part 2) provisions regarding the confidentiality of Substance Use Disorder (SUD) Patient Records. The...more
After more than a year since the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued the proposed changes to the...more
A new HHS Final Rule overhauls the federal Part 2 regulations on the confidentiality of substance use disorder (SUD) records. Our Heath Care Health Care and Privacy, Cyber & Data Strategy Groups unpack how the changes will...more
The U.S. Department of Health & Human Services (HHS) through the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office for Civil Rights recently issued a Final Rule amending the Confidentiality of...more
Last week, the Department of Health and Human Services (HHS) released a final rule intended to implement a 2020 modification to the federal substance use disorder (SUD) privacy statute. The final rule more closely aligns the...more
On the second to last business day of last year, the U.S. Court of Appeals for the Eighth Circuit addressed when a private organization can invoke the federal officer removal statute, 28 U.S.C. § 1442. If a private...more
The U.S. Department of Health and Human Services ("HHS") issued a concept paper describing its overarching strategy to address healthcare cybersecurity. The concept paper builds on the Biden-Harris Administration's National...more
On April 17, 2023, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) issued a notice of proposed rulemaking to modify the Standards for Privacy for Individually Identifiable...more
The Notifications of Enforcement Discretion issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act during the...more
The U.S. Department of Health and Human Service’s Office of Civil Rights (“OCR”) has announced that several notifications of enforcement discretion issued during the COVID-19 public health emergency (“PHE”) will expire...more
On February 27, 2023, the U.S. Department of Health and Human Services (HHS) announced that its law enforcement agency – the Office for Civil Rights (OCR) – will reorganize, adding new divisions to better address the rapid...more
On November 28, 2022, the U.S. Department of Health and Human Services (“HHS”) proposed sweeping changes to the rules that govern use and disclosure of protected health information (“PHI”) about patients receiving substance...more
The U.S. Department of Health and Human Services (HHS) has proposed to significantly revise rules governing patient records in substance use disorder (SUD) programs, commonly known as the Part 2 rules, with important...more
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced June 10, 2022 that it is producing a video presentation on “recognized security practices” as set forth in the recent amendment of...more
Sponsors of clinical trials in the United States have a regulatory responsibility under 21 CFR Part 312.50 to monitor the progress of clinical studies. Historically, Sponsors performed in-person monitoring visits of every...more
Enforcement Actions - In its first announcement of enforcement actions in 2022, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) simultaneously announced the resolution of three...more
The US Department of Health Human Services (HHS) is seeking public comments about the appropriate role of “recognized security practices” in enforcement of the HIPAA Security Rule. Congress, through an amendment to the HITECH...more