The ability of OCR to enforce expansive portions of its controversial web tracking guidance has been severely limited. A federal district court ruled that the guidance exceeded the agency’s authority, and in particular...more
The HIPAA Privacy Rule has been modified by the US Department of Health and Human Services (HHS) to increase privacy protections for reproductive health care information. These changes, which will take effect in early 2026,...more
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) updated its guidance concerning compliance obligations for HIPAA covered entities and business associates using online tracking...more
The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,” which permits an exception from the...more
The FTC continues to scrutinize the privacy practices of consumer health companies. After taking action against patient couponing and mental health companies, the FTC has now turned its attention to genetic testing....more
The U.S. Department of Health and Human Services (“HHS”) is proposing changes to HIPAA that would increase protections for reproductive health care information. If finalized, these changes would prohibit HIPAA-regulated...more
HIPAA covered entities will be required to change their HIPAA Notices of Privacy Practices (NPPs) if a recent proposed rule by the US Department of Health and Human Services is finalized. The Proposed Rule is designed to...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
12/6/2022
/ CARES Act ,
Comment Period ,
Confidential Information ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Information Sharing ,
Medical Records ,
NPRM ,
Patient Privacy Rights ,
SAMHSA ,
Substance Abuse
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
States continue to enact laws targeting the protection of genetic data with two important developments in California and Florida. California’s Genetic Information Privacy Act (“GIPA”), which came into effect on January 1,...more
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
HIPAA Privacy Rule changes that have the potential to significantly impact patients, covered entities, and business associates were proposed by the Department of Health and Human Services (HHS) in a Notice of Proposed...more
On April 8, the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) issued guidance discussing how HHS human subjects protection regulations....more