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. Department of Health and Human Services (HHS) has finalized amendments to more closely align the Part 2 substance use disorder (SUD) regulations with HIPAA. These changes have the potential to streamline compliance...more
The U.S. Biden administration announced Thursday that 28 health care providers and payers have signed the White House’s voluntary commitment aimed at ensuring the safe development of artificial intelligence (AI), adding to...more
President Biden’s groundbreaking Executive Order on artificial intelligence carries significant implications for the health and life science industry. The Order tasks federal agencies, including those responsible for health...more
Adding to the growing trend of policymakers interested in regulating health and wellness data, last week U.S. Senator Bill Cassidy requested stakeholder feedback to help identify solutions to modernize HIPAA and ensure all...more
9/12/2023
/ Biometric Information ,
Consumer Privacy Rights ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Patient Privacy Rights ,
Personally Identifiable Information ,
Privacy Laws ,
Regulatory Agenda
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
This week the U.S. Department of Health and Human Services, the agency responsible for HIPAA enforcement, announced the formation of three new divisions within the Office for Civil Rights (“OCR”). The new divisions –...more
Health companies cannot use online tracking technologies like other consumer organizations. This refrain, repeated frequently by regulators, litigants and the media in recent months, may now have found its clearest voice in...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
Recent U.S. Department of Health Human Services (HHS) regulatory actions emphasize the role emerging technologies play in the provision of healthcare, particularly as clinical innovations proliferate in response to the...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
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
10/6/2021
/ American Recovery and Reinvestment Act ,
Application Programming Interface (APIs) ,
Breach Notification Rule ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Mobile Health Apps ,
Policy Statement ,
Popular
The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the Republican-led H.R. 19, the “Lower Costs, More Cures Act of 2021” and a reintroduced...more
4/26/2021
/ Biden Administration ,
Critical Infrastructure Sectors ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part D ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda
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 November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more
11/25/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Healthcare Reform ,
MCOs ,
Medicaid Drug Rebate Program ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Safe Harbors ,
Stark Law
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
On February 12, 2018, the White House Office of Management and Budget released an overview of the president's Fiscal Year (FY) 2019 Budget (the Budget), which makes, among many others, several proposals regarding drug pricing...more
2/16/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Budget ,
MDRP ,
Medicaid Reimbursements ,
Medical Reimbursement ,
Medicare Part B ,
Medicare Part D ,
Section 340B ,
Trump Administration
On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the...more
2/13/2017
/ 21st Century Cures Act ,
Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biotechnology ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
IRB ,
NPRM ,
Scientific Research ,
The Common Rule