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
With 2025 barely three weeks old, the US Department of Health and Human Services Office for Civil Rights (OCR) has already announced six enforcement actions for the new year. Particularly significant is the advancement of...more
The HHS Centers for Medicare & Medicaid Services (CMS) and Wisconsin Physicians Service Insurance Corporation (WPS) are notifying 946,801 people whose protected health information or other personally identifiable information...more
On May 31, 2024, more than four months after the February 2024 Change Healthcare ransomware attack, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) updated its Change Healthcare FAQs. ...more
On April 26, 2024, the Federal Trade Commission (“FTC”) announced it had finalized changes to modernize the Health Breach Notification Rule (the “HBNR”) by clarifying its applicability to health and wellness apps and other...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 February 16, 2024, the HHS Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) published a final version of the cybersecurity resource guide (the “Guide”) with respect to the HIPAA...more
On June 30, 2023, Mount Desert Island Hospital (“MDIH”) filed a notice of data breach with the U.S. Department of Health and Human Services Office for Civil Rights after discovering that an unauthorized party had gained...more
Privacy Briefs: June 2023 - Long-term care pharmacy network PharMerica disclosed a breach involving more than 5.8 million patients, making it the largest breach reported to the HHS Office for Civil Rights (OCR) in the last...more
Health and Human Services Organization Discloses Ransomware Attack and Breach from Early 2022 - On January 5, 2023, Maternal & Family Health Services (MFHS) disclosed that a ransomware attack occurred on April 4, 2022, and...more
Report on Patient Privacy 22, no. 8 (August, 2022) - Oklahoma State University Center for Health Sciences’ (OSUCHS) breach might not have seemed all that serious at the time: No data is believed to have been misused,...more
The U.S. Department of Health & Human Services (HHS) just announced increased penalty amounts for entities who violate the privacy, security, and breach notification rules under the Health Insurance Portability and...more
A new Policy Statement from the US Federal Trade Commission places companies that offer consumer-facing health apps and connected health and wellness devices on notice that they may be covered by a Health Breach Notification...more
The Federal Trade Commission (“FTC”) recently issued an important policy statement to health apps and other connected devices that collect or use consumers’ health information. The FTC’s policy statement effectively...more
Recently, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS), the agency enforcing the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach...more
The Department of Health and Human Services’ (“HHS”) Office for Civil Rights (“OCR”) is responsible for enforcing the Privacy and Security Rules of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)....more
The deadline to submit notice to the Department of Health and Human Services (HHS) of small HIPAA breaches (those that affected fewer than 500 individuals) discovered in calendar year 2017 is March 1, 2018....more
March 1, 2017 is the date by which HIPAA covered entities must notify the U.S. Department of Health and Human Services Office for Civil Rights (OCR) of “small” breaches of unsecured protected health information that were...more
On January 9, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) took action against a health system for non-timely reporting of a breach of protected health information. It was the first...more
Between June and November 2016, the Department of Health and Human Services Office of Civil Rights (HHS OCR) has announced seven high-dollar settlements to resolve alleged violations of the HIPAA privacy, security, and breach...more
As part of the ongoing HHS OCR HIPAA audit initiative, it is conducting “HIPAA desk audits.” These audits don’t involve auditors coming in your facility. Instead, covered entities are being asked to submit documents on...more
On October 6, 2016, the Department of Health and Human Services Office for Civil Rights (“OCR”) issued guidance on complying with HIPAA privacy, security, and breach notification rules when using cloud computing technology...more
Covered entities and business associates can expect increased scrutiny for breaches of unsecured protected health information affecting fewer than 500 individuals. Starting August 2016, the U.S. Department of Health and Human...more
The Department of Health & Human Services (DHHS) Office of Civil Rights (OCR) recently announced it will devote more resources to investigate smaller HIPAA breaches. Before this announcement, OCR typically opened...more
On August 18, 2016, the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced plans to expand its investigations of reported breaches of the Health Insurance Portability and...more
In our April 8, 2016, advisory, we discussed the U.S. Department of Health and Human Services’ (HHS) Office of Civil Rights (OCR) “Phase 2” audit program. Then, we could only make educated guesses about what documents OCR...more