Latest Publications

Share:

U.S. District Court Invalidates HHS Guidance Overreading HIPAA's Application to Online Technologies

On June 20, 2024, a U.S. federal district court held, in a suit brought by Jones Day, that the Department of Health and Human Services ("HHS") had misapplied the Health Insurance Portability and Accountability Act ("HIPAA")...more

Vital Signs: Digital Health Law Update | Spring 2024

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

FTC's Final Health Breach Notification Rule: Expanded Scope, New Obligations, and Modified Reporting Requirements

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

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more

New State Health Privacy Laws—Moving Beyond HIPAA and Recasting Consumer Health Data Rights?

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

Vital Signs: Digital Health Law Update | Winter 2024

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more

Federal Agencies Launch Joint Inquiry Into Private Investment in Health Care

DOJ, FTC, and HHS jointly announced the launching of a cross-government public inquiry into increasing private equity and corporate involvement in health care, the latest announcement in a string of public statements from the...more

HHS Releases Cybersecurity Performance Goals to Enhance Cybersecurity for Health Care and Public Health Sectors

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

HHS Announces Upcoming Federal Strategies to Enhance Cybersecurity for Health Care and Public Health Sectors

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

HHS Enters Into First-Ever Ransomware Resolution Agreement and Corrective Action Plan

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

New York Governor Proposes Stringent Cybersecurity Regulations for Hospitals

New York is the first state to propose cybersecurity requirements for all hospitals operating in the state to address patient safety and other cybersecurity related issues....more

HHS-OIG Issues Long-Anticipated General Compliance Program Guidance for All Health Care Stakeholders

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

Vital Signs: Digital Health Law Update | Fall 2023

We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, our lawyers describe the increasingly common regulation of...more

Vital Signs Digital Health Law Update | Summer 2023

We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we take an in-depth look at generative artificial intelligence...more

Medical Payment Products and Health Care Pricing Practices Draw CFPB Attention

The Consumer Financial Protection Bureau (“CFPB”), Department of Health and Human Services (“HHS”), and United States Treasury have issued an interagency Request for Information (“RFI”) focused on the offering and provision...more

Congress Authorizes Competitive Multivendor Contracts in U.S. Organ Transplant System

This new legislation supports the Health Resources and Services Administration ("HRSA") modernization initiative announced in March, including several actions to strengthen accountability and transparency in the Organ...more

FTC Proposes Updates to the Health Breach Notification Rule for Health Apps and Consumer Health Technologies

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

Vital Signs Digital Health Law Update | Spring 2023

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

My Health, My Data: Washington Enacts First State Comprehensive Health Privacy Law

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

Consumer Health Information and Increased Scrutiny: FTC Brings First Action Under Health Breach Notification Rule

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

U.S. National Institute of Standards and Technology Releases AI Risk Management Framework

The National Institute of Standards and Technology ("NIST") has released its AI Risk Management Framework ("AI RMF") as a resource to reportedly assist individuals, organizations, and society identify risks associated with...more

White House Announces Artificial Intelligence Bill of Rights

The Artificial Intelligence Bill of Rights sets forth voluntary guidelines that companies utilizing or developing technology with artificial intelligence can follow to protect users....more

California Attorney General Initiates Novel Investigation Into Potential Health Care Algorithm Bias

On August 31, 2022, the California Attorney General delivered letters to 30 hospitals and health systems across California requesting information regarding commercial decision-making technology tools and their potential...more

Vital Signs: Digital Health Law Update | July 2022

Lawyer Spotlight: Artificial intelligence innovations continue to fuel advances across diverse life science applications, including drug discovery and digital health. This month, we highlight two lawyers who help clients...more

U.S. Federal Actions Support Continued Telehealth Services for Medicare Beneficiaries

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

55 Results
 / 
View per page
Page: of 3

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide