The Federal Trade Commission ("FTC") intends to "strengthen and modernize" the Health Breach Notification Rule with revamped and increased scrutiny on entities holding health information, including health apps, websites, and...more
Pursuant to California's Health Care Quality and Affordability Act (the "HCQA"), the newly created Office of Health Care Affordability ("OHCA") recently proposed statewide health care cost targets and standards and goals for...more
New, first-of-their-kind consumer health data privacy laws in Washington and Nevada are designed to provide state-level protections for personal health data not covered by the Health Insurance Portability and Accountability...more
The Department of Health and Human Services ("HHS") has released voluntary cybersecurity performance goals for the health care and public health sectors, which outline an increasingly standardized regulatory approach and...more
2/19/2024
/ Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Popular ,
Proposed Regulation ,
Public Health
The Department of Health and Human Services ("HHS") has released a concept paper outlining its new cybersecurity strategies for the health care sector, identifying cybersecurity priorities, potential future regulations and...more
1/12/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
OCR ,
Popular ,
Proposed Rules ,
Public Health ,
Regulatory Requirements ,
Risk Mitigation
The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more
12/20/2023
/ Bayh-Dole Act ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health and Safety ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Intellectual Property Protection ,
Inventions ,
Life Sciences ,
March-in-Rights ,
NIST ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs
The U.S. Department of Health and Human Services ("HHS") Office of Civil Rights ("OCR") has entered into its first settlement of potential Health Insurance Portability and Accountability Act ("HIPAA") violations arising out...more
12/6/2023
/ Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Violations ,
Hospitals ,
Life Sciences ,
OCR ,
Ransomware
In Short -
The Situation: On November 6, 2023, the Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") released its "General Compliance Program Guidance" ("GCPG"). The GCPG...more
12/1/2023
/ Anti-Kickback Statute ,
Compliance Management Systems ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Federal Register ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
OIG ,
Physicians ,
Stark Law
The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more
10/31/2023
/ Comment Period ,
FDA Approval ,
Food and Drug Act ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform
With the swipe of a pen, California Governor Gavin Newsom starts the California Food Safety Act countdown to a 2027 statewide ban on four popular food additives.
Starting January 1, 2027, companies manufacturing, selling,...more
10/20/2023
/ Additive Manufacturing ,
California ,
Dietary Supplements ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Products . ,
Food Safety ,
New Legislation ,
Public Health ,
Regulatory Reform ,
State Bans
Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more
Heralding the significant changes coming to the U.S. cosmetics industry starting in 2023, the U.S. Food and Drug Administration ("FDA") has issued draft guidance to companies regarding cosmetic facility registrations and...more
8/23/2023
/ Comment Period ,
Cosmetics ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Listing Rules ,
Manufacturers ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
Product Identifiers ,
Product Labels ,
Product Packaging ,
Registration Requirement
The U.S. Department of Health and Human Services, Office of Inspector General ("OIG") has provided insight into the applicability of the discount and group purchasing organization safe harbors to payments retained by pharmacy...more
The Federal Trade Commission seeks to clarify how the Health Breach Notification Rule applies to health records collected by health apps and similar consumer health technologies. ...more
Note From the Editors -
This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more
5/15/2023
/ Clinical Trials ,
Data Collection ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
OIG ,
Popular ,
Substance Abuse ,
Telehealth
The sweeping law imposes new requirements on the processing and sale of consumer health data in the state.
On April 27, 2023, Washington State Governor Inslee signed the "My Health My Data Act" ("Act"). This Act marks the...more
Following several years of lead-up, including public engagement, the review of more than 13,000 comments, and conducting focus group studies, on February 22, 2023, the U.S. Food and Drug Administration ("FDA") issued a draft...more
On January 31, 2023, the Food and Drug Administration ("FDA") announced plans to redesign its Human Foods Program (the "Program") to better coordinate the agency's regulation of food products....more
The Senate Judiciary Committee is showing renewed Congressional interest in oversight of the pharmaceutical industry, with five bipartisan drug bills on the agenda for review and discussion on February 9, 2023....more
The Federal Trade Commission ("FTC") has brought its first enforcement action for violations of the Health Breach Notification Rule ("HBNR"), signaling heightened federal agency scrutiny of digital health platforms,...more
The United States Department of Agriculture ("USDA") published the Strengthening Organic Enforcement ("SOE") Final Rule to improve farm-to-market traceability, deter and detect instances of organic fraud, increase oversight,...more
In Short -
The Situation: With the calendar officially turned to a new year several significant changes and regulatory initiatives are on the horizon at the Food and Drug Administration ("FDA")....more
On November 7, 2022, the U.S. Food and Drug Administration ("FDA") sent the Food Safety Modernization Act ("FSMA") Final Rule on Requirements for Additional Traceability Records for Certain Foods to the Office of the Federal...more
The Centers for Medicare & Medicaid Services and other agencies together issued final regulations concerning the independent dispute resolution process for settling provider-payor disputes over reimbursement for...more
On March 15, 2022, President Biden signed into law the Consolidated Appropriations Act, 2022 (the "Act"), extending certain Medicare telehealth reimbursement flexibilities for 151 days following the end of the declared...more