Medical Device Legal News with Sam Bernstein: Episode 10
Drafting Consumer Breach Notices — From a Litigation Perspective - Unauthorized Access Podcast
IP|Trend: Dust up After the Breach
Hot Topics Roundtable for Fund Managers - Cybersecurity, Valuation, and 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
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
This year has started with the Federal Trade Commission's (FTC) renewed attention to its Health Breach Notification Rule (Breach Rule) and the publication of the Health Privacy resource page to help companies with their...more
The Federal Trade Commission (FTC) adopted a policy statement on Sept. 15, 2021, emphasizing that developers of digital health apps, connected devices and other health products have obligations under the Health Breach...more
The worldwide COVID-19 pandemic visited on America in the past several months has quickly reinvigorated the foundational and important debate concerning where, in a free society, individual autonomy ends (or should end) and...more
On May 22, 2020, the Federal Trade Commission (the “FTC”) published its decennial request for public comment (the “RFC”) on the FTC’s Health Breach Notification Rule (the “HBN Rule”)....more
The Department of Health and Human Services (HHS) announced a Request for Information (RFI) regarding how the HIPAA Privacy, Security, and Breach Notification Rules could be modified to reduce regulatory burdens and to...more
Earlier this month, New York Attorney General Eric Schneiderman announced his state had entered into a settlement with CoPilot Provider Support Services, Inc. (CoPilot)—a settlement resulting from CoPilot’s violation of the...more
What covered entities and business associates can do to prepare for the next round of audits. On July 11, the HIPAA Phase 2 audits commenced when 167 covered entities received notice of a desk audit from the Department...more
The HHS Office for Civil Rights (OCR) must improve its oversight and enforcement of patient information privacy and security rules by “covered entities” and their business associates under the Health Information Portability...more
Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called "Phase 2 Audits" are set to commence...more
The HIPAA Breach Notification Rule requires covered entities to notify the Secretary of the Department of Health and Human Services (HHS) if a breach of unsecured protected health information (PHI) is discovered. As most...more
A Massachusetts-based dermatology practice recently agreed to pay $150,000 to settle claims that it failed to have sufficient policies and procedures in place to address a breach notification requirement under the HITECH Act....more
Adult and Pediatric Dermatology (A&P Dermatology) of Concord, Massachusetts has entered into a resolution agreement with the Department of Health and Human Services (HHS) to settle potential violations of the Health Insurance...more
On December 26, 2013, Adult & Pediatric Dermatology, a dermatology practice located in Massachusetts, agreed to pay a $150,000 fine after it lost an unencrypted thumb drive containing over 2,000 patients’ health records, and...more
On December 26, 2013, the U.S. Department of Health and Human Services Office for Civil Rights (HHS) announced that it had reached an agreement with a Northeastern dermatology practice to settle potential HIPAA violations...more
Throughout 2013, HHS OCR has stated that covered entities of all sizes need to give priority to securing ePHI. In addition, HHS OCR has recommended that covered entities identify and mitigate risks before an incident occurs....more
Hospitals and health care providers must often look to third party vendors offering cloud computing solutions, but are these companies well-prepared to meet the HIPPA/HITECH Act privacy and security requirements as well as...more
Don’t look now, but another HIPAA deadline is just around the corner. As we noted last month, the deadline is looming for employer-sponsored health benefit plans to come into compliance with U.S. Department of Health...more
As the countdown to the compliance deadline for the Health Information Technology for Economic and Clinical Health (HITECH) Act Omnibus Rule begins, we offer the following as a reminder of tasks that covered entities,...more