News & Analysis as of

Health Insurance Portability and Accountability Act (HIPAA) Digital Health Healthcare

Clark Hill PLC

Beyond HIPAA: How state laws are reshaping health data compliance

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We are in an era where smartphones track sleep patterns, fitness apps monitor heart rates, and online searches reveal sensitive medical inquiries. As a result, the notion of “health data” has expanded dramatically. This...more

Latham & Watkins LLP

CMS Seeks Healthcare Industry Input on Future of Digital Health

Latham & Watkins LLP on

Comments on the RFI, due by June 16, present a rare opportunity to shape future technology standards, reporting requirements, and business opportunities....more

Baker Donelson

DOJ Bulk Data Rule: Key Takeaways for Healthcare and Life Sciences

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The Data Security Program (DSP), implemented by the Department of Justice's National Security Division (DOJ/NSD) under Executive Order 14117 (Preventing Access to Americans' Bulk Sensitive Personal Data and United States...more

Sheppard Mullin Richter & Hampton LLP

New York’s Health Information Privacy Act: A Turning Point for Digital Health or a Roadblock to Innovation?

The proposed New York Health Information Privacy Act (NYHIPA), currently awaiting Governor Kathy Hochul’s signature, represents a major step in the state’s approach to protecting personal health data in the digital age. At...more

Foley & Lardner LLP

New York’s Proposed Health Information Privacy Act Takes Aim at Digital Health Companies

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The New York Health Information Privacy Act (NYHIPA), if enacted, could create a chilling effect on patient access and engagement to readily available digital health care services relied upon by New Yorkers. Digital health...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

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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

Quarles & Brady LLP

FTC Publishes Final Rule amending Health Breach Notification Rule

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The Federal Trade Commission (“FTC”) recently published its Final Rule amending the Health Breach Notification Rule (“HBNR”). The updated HBNR, which regulates entities that handle certain personal health information, other...more

Whiteford

Client Alert: What You Need to Know About the FTC’s Changes to the Health Breach Notification Rule and How to Comply

Whiteford on

The Federal Trade Commission (FTC) issued a final rule to amend its Health Breach Notification Rule (HBN Rule). The HBN Rule requires certain entities that handle unsecured personally identifiable health data to notify...more

Seyfarth Shaw LLP

Keeping with the Times - FTC Expands Scope of Health Breach Notification Rule, Even as HHS Announces Its Own HIPAA Update

Seyfarth Shaw LLP on

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

Foley Hoag LLP - Security, Privacy and the...

FTC's Updated Health Data Breach Rule Covers Apps, Other New Tech

The FTC has updated its HBNR to clarify that the rule also restricts marketing practices involving personal health information. This update to the HBNR was announced on April 26, 2024, and follows several recent enforcement...more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2024

Jones Day on

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

J.S. Held

Inside the Healthcare Industry: Understanding Emerging Data Privacy & Security Risks and Regulations

J.S. Held on

According to the Theft Resource Center and its 2022 data breach reports, data privacy and security threats are impacting all aspects of the healthcare industry – from providers to payers to medical device companies to...more

Jones Day

Vital Signs: Digital Health Law Update | Fall 2023

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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

Perkins Coie

The New Health Privacy Landscape—Out of the Frying Pan and Into the Fire

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Just a few years ago, the legal landscape governing health-related personal information was relatively simple: Protected Health Information (PHI) was regulated under Health Insurance Portability and Accountability Act...more

Proskauer - Health Care Law Brief

OIG Issues Final Information Blocking Enforcement Rule and Highlights the Potential for Referrals to the FTC and FCA Liability

On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more

Sheppard Mullin Richter & Hampton LLP

Regulators Send Warning Letter to Hospitals and Telehealth Providers About Tracking Technology Use

The FTC and OCR at HHS are continuing to scrutinize the use of tracking technologies that may reveal information about a person’s health or health status. Both agencies recently sent a letter to a reported 130 hospitals and...more

Nelson Mullins Riley & Scarborough LLP

FTC Proposes to Vastly Expand the Health Breach Notification Rule

The Federal Trade Commission (FTC) recently proposed changes to the Health Breach Notification Rule (Rule), enacted in 2009, to clarify that the Rule applies directly to an estimated 170,000 health and wellness mobile...more

Sheppard Mullin Richter & Hampton LLP

FTC Looks to Update Health Breach Notification Rule, Targeting Digital Health Industry

The FTC recently proposed amendments to the Health Breach Notification Rule (HBNR). This is on trend with its aggressive interest over the last couple of years in health data not covered by HIPAA....more

McDermott Will & Schulte

Key Takeaways | Putting Employee Wellness Programs to Work

During this session, panelists discussed the unique opportunities and challenges of digital-health wellness programs that partner with employers and health plans in considering, adopting and operationalizing wellness programs...more

McDermott Will & Schulte

In Case You Missed It: Highlights | When Digital and Life Sciences Intersect

In this session, panelists discussed common pitfalls that life sciences companies face as they explore ways to incorporate digital-health strategies into product and service offerings, as well as approaches for successful...more

Fenwick & West Life Sciences Group

A Complex Regulatory Landscape Emerges for Telemedicine

Every year, Rock Health surveys the digital health landscape, noting the changing trends related to adoption by providers, patients and payers of these innovative new technologies....more

Perkins Coie

FTC Claims Sharing User Health Data With Advertising Platforms Is a “Security Breach”

Perkins Coie on

For the first time, the Federal Trade Commission has brought an enforcement action under its 2009 Health Breach Notification Rule (HBNR). The case was brought against a digital health company, GoodRx Holdings, Inc., for...more

Proskauer - Health Care Law Brief

Key Legal Issues Facing Telehealth Platforms, as Compliance Concerns Bubble for Platforms Launched During the Public Health...

The onset of the COVID-19 public health emergency (“PHE”) led to a surge in the use of telehealth by health care providers. In addition, the PHE fueled a boom in the number of direct-to-consumer (“DTC”) telehealth platforms,...more

Sheppard Mullin Richter & Hampton LLP

FTC Warns Digital Health Industry to Comply with its Breach Notification Rule

The use of apps, wearables, and other devices used to track health and wellness data have continued to rise. The FTC again signaled its focus on this growing industry in a statement on the scope of the Health Breach...more

McDermott Will & Schulte

Collaborative Transformation - Focus on Innovation Centers - Avoiding Pitfalls in Data-Focused Collaborations, Ventures and...

There are myriad opportunities for hospitals and health systems (HHSs) to engage in data-focused collaborations with other stakeholders in the healthcare industry. These collaborations include, to an increasing extent,...more

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